bluuebunny/crossref_metadata_2025_split huggingface dataset:
Cerebral regional tissue Oxygen Saturation to Guide Oxygen Delivery in preterm neonates during immediate transition after birth (COSGOD III): multicentre randomised phase 3 clinical trial
Authors: Pichler Gerhard , Goeral Katharina , Hammerl Marlene , Perme Tina , Dempsey Eugene M , Springer Laila , Lista Gianluca , Szczapa Tomasz , Fuchs Hans , Karpinski Lukasz , Bua Jenny , Avian Alexander , Law Brenda , Urlesberger Berndt , Buchmayer Julia , Kiechl-Kohlendorfer Ursula , Kornhauser-Cerar Lilijana , Schwarz Christoph E , Gründler Kerstin , Stucchi Ilaria , Schwaberger Bernhard , Klebermass-Schrehof Katrin , Schmölzer Georg M 
Published: January 2023

Abstract

Objective
To investigate whether monitoring of cerebral tissue oxygen saturation using near infrared spectroscopy in addition to routine monitoring combined with defined treatment guidelines during immediate transition and resuscitation increases survival without cerebral injury of premature infants compared with standard care alone.

Design
Multicentre, multinational, randomised controlled phase 3 trial.

Setting
11 tertiary neonatal intensive care units in six countries in Europe and in Canada.

Participants
1121 pregnant women (<32 weeks’ gestation) were screened prenatally. The primary outcome was analysed in 607 of 655 randomised preterm neonates: 304 neonates in the near infrared spectroscopy group and 303 in the control group.

Intervention
Preterm neonates were randomly assigned to either standard care (control group) or standard care plus monitoring of cerebral oxygen saturation with a dedicated treatment guideline (near infrared spectroscopy group) during immediate transition (first 15 minutes after birth) and resuscitation.

Main outcome measure
The primary outcome, assessed using all cause mortality and serial cerebral ultrasonography, was a composite of survival without cerebral injury. Cerebral injury was defined as any intraventricular haemorrhage or cystic periventricular leukomalacia, or both, at term equivalent age or before discharge.

Results

Cerebral tissue oxygen saturation was similar in both groups. 252 (82.9%) out of 304 neonates (median gestational age 28.9 (interquartile range 26.9-30.6) weeks) in the near infrared spectroscopy group survived without cerebral injury compared with 238 (78.5%) out of 303 neonates (28.6 (26.6-30.6) weeks) in the control group (relative risk 1.06, 95% confidence interval 0.98 to 1.14). 28 neonates died (near infrared spectroscopy group 12 (4.0%)
v
control group 16 (5.3%): relative risk 0.75 (0.33 to 1.70).

Conclusion
Monitoring of cerebral tissue oxygen saturation in combination with dedicated interventions in preterm neonates (<32 weeks’ gestation) during immediate transition and resuscitation after birth did not result in substantially higher survival without cerebral injury compared with standard care alone. Survival without cerebral injury increased by 4.3% but was not statistically significant.

Trial registration

ClinicalTrials.gov
NCT03166722
.
Can prognostic factors for indirect muscle injuries in elite football (soccer) players be identified using data from preseason screening? An exploratory analysis using routinely collected periodic health examination records
Authors: Hughes Tom , Riley Richard , Callaghan Michael J , Sergeant Jamie C 
Published: January 2023

BackgroundIn elite football, periodic health examination (PHE) may be useful for injury risk prediction.ObjectiveTo explore whether PHE-derived variables are prognostic factors for indirect muscle injuries (IMIs) in elite players.DesignRetrospective cohort study.SettingAn English Premier League football club.Participants134 outfield elite male players, over 5 seasons (1 July 2013–19 May 2018).Outcome and analysisThe outcome was any time-loss, lower extremity index IMI (I-IMI). Prognostic associations were estimated using odds ratios (ORs) and corresponding statistical significance for 36 variables, derived from univariable and multivariable logistic regression models. Missing data were handled using multiple imputation. Non-linear associations were explored using fractional polynomials.ResultsDuring 317 participant-seasons, 138 I-IMIs were recorded. Univariable associations were determined for previous calf IMI frequency (OR 1.80, 95% CI 1.09 to 2.97), hamstring IMI frequency (OR 1.56, 95% CI 1.17 to 2.09), if the most recent hamstring IMI occurred >12 months but <3 years prior to PHE (OR 2.95, 95% CI 1.51 to 5.73) and age (OR 1.12 per 1-year increase, 95% CI 1.06 to 1.18). Multivariable analyses showed that if a player’s most recent previous hamstring IMI was >12 months but <3 years prior to PHE (OR 2.24, 95% CI 1.11 to 4.53), this was the only variable with added prognostic value over and above age, which was a confirmed prognostic factor (OR 1.12 per 1-year increase, 95% CI 1.05 to 1.18). Allowing non-linear associations conferred no advantage over linear associations.ConclusionPHE has limited use for injury risk prediction. Most variables did not add prognostic value over and above age, other than if a player experienced a hamstring IMI >12 months but <3 years prior to PHE. However, the precision of this prognostic association should be confirmed in future.Trial registration numberNCT03782389.
International consensus recommendations for the optimal prioritisation and distribution of surgical services in low-income and middle-income countries: a modified Delphi process
Authors: Henry Jaymie A , Reyes Ana M , Ameh Emmanuel , Yip Cheng-Har , Nthumba Peter , Mehes Mira , Lelchuk Ashley , Hollier Larry , Waqainabete Ifereimi , Abdullah Noor Hisham , Alliance The , Hill Andrew , Ferguson Mark K 
Published: January 2023

ObjectivesTo develop consensus statements regarding the regional-level or district-level distribution of surgical services in low and middle-income countries (LMICs) and prioritisation of service scale-up.DesignThis work was conducted using a modified Delphi consensus process. Initial statements were developed by the International Standards and Guidelines for Quality Safe Surgery and Anesthesia Working Group of the Global Alliance for Surgical, Obstetric, Trauma and Anesthesia Care (G4 Alliance) and the International Society of Surgery based on previously published literature and clinical expertise. The Guidance on Conducting and REporting DElphi Studies framework was applied.SettingThe Working Group convened in Suva, Fiji for a meeting hosted by the Ministry of Health and Medical Services to develop the initial statements. Local experts were invited to participate. The modified Delphi process was conducted through an electronically administered anonymised survey.ParticipantsExpert LMIC surgeons were nominated for participation in the modified Delphi process based on criteria developed by the Working Group.Primary outcome measuresThe consensus panel voted on statements regarding the organisation of surgical services, principles for scale-up and prioritisation of scale-up. Statements reached consensus if there was ≥80% agreement among participants.ResultsFifty-three nominated experts from 27 LMICs voted on 27 statements in two rounds. Ultimately, 26 statements reached consensus and comprise the current recommendations. The statements covered three major themes: which surgical services should be decentralised or regionalised; how the implementation of these services should be prioritised; and principles to guide LMIC governments and international visiting teams in scaling up safe, accessible and affordable surgical care.ConclusionsThese recommendations represent the first step towards the development of international guidelines for the scaling up of surgical services in LMICs. They constitute the best available basis for policymaking, planning and allocation of resources for strengthening surgical systems.
Computer-assisted analysis of routine electroencephalogram to identify hidden biomarkers of epilepsy: protocol for a systematic review
Authors: Lemoine Émile , Neves Briard Joel , Rioux Bastien , Podbielski Renata , Nauche Bénédicte , Toffa Denahin , Keezer Mark , Lesage Frédéric , Nguyen Dang K , Bou Assi Elie 
Published: January 2023

IntroductionThe diagnosis of epilepsy frequently relies on the visual interpretation of the electroencephalogram (EEG) by a neurologist. The hallmark of epilepsy on EEG is the interictal epileptiform discharge (IED). This marker lacks sensitivity: it is only captured in a small percentage of 30 min routine EEGs in patients with epilepsy. In the past three decades, there has been growing interest in the use of computational methods to analyse the EEG without relying on the detection of IEDs, but none have made it to the clinical practice. We aim to review the diagnostic accuracy of quantitative methods applied to ambulatory EEG analysis to guide the diagnosis and management of epilepsy.Methods and analysisThe protocol complies with the recommendations for systematic reviews of diagnostic test accuracy by Cochrane. We will search MEDLINE, EMBASE, EBM reviews, IEEE Explore along with grey literature for articles, conference papers and conference abstracts published after 1961. We will include observational studies that present a computational method to analyse the EEG for the diagnosis of epilepsy in adults or children without relying on the identification of IEDs or seizures. The reference standard is the diagnosis of epilepsy by a physician. We will report the estimated pooled sensitivity and specificity, and receiver operating characteristic area under the curve (ROC AUC) for each marker. If possible, we will perform a meta-analysis of the sensitivity and specificity and ROC AUC for each individual marker. We will assess the risk of bias using an adapted QUADAS-2 tool. We will also describe the algorithms used for signal processing, feature extraction and predictive modelling, and comment on the reproducibility of the different studies.Ethics and disseminationEthical approval was not required. Findings will be disseminated through peer-reviewed publication and presented at conferences related to this field.PROSPERO registration numberCRD42022292261.
‘The way that we are collecting and using data has evolved’ evaluating the Australian National Stroke Audit programme to inform strategic direction
Authors: Lynch Elizabeth , Laver Kate , Levy Tamina , Schultz Timothy 
Published: January 2023

BackgroundThe National Stroke Audit has been used to audit and provide feedback to health professionals and stroke care services in Australia since 2007. The Australian Stroke Clinical Registry was piloted in 2009 and numbers of hospitals participating in the registry are increasing. Considering the changing data landscape in Australia, we designed this study to evaluate the stroke audit and to inform strategic direction.MethodsWe conducted a rapid review of published literature to map features of successful data programmes, followed by a mixed-methods study, comprising national surveys and interviews with clinicians and administrators about the stroke audit. We analysed quantitative data descriptively and analysed open-ended survey responses and interview data using qualitative content analysis. We integrated data from the two sources.ResultsWe identified 47 Australian data programs, successful programs were usually funded by government sources or professional associations and typically provided twice yearly or yearly reports.106 survey participants, 14 clinician and 5 health administrator interview participants were included in the evaluation. The Stroke Audit was consistently perceived as useful for benchmarking, but there were mixed views about its value for local quality improvement. Time to enter data was the most frequently reported barrier to participation (88% of survey participants), due to the large number of datapoints and features of the audit software.Opportunities to improve the Stroke Audit included refining Audit questions, developing ways to automatically export data from electronic medical records and capturing accurate data for patients who transferred between hospitals.ConclusionWhile the Stroke Audit was not perceived by all users to be beneficial for traditional quality improvement purposes, the ability to benchmark national stroke services and use these data in advocacy activities was a consistently reported benefit. Modifications were suggested to improve usability and usefulness for participating sites.
Futile reperfusion of endovascular treatment for acute anterior circulation large vessel occlusion in the ANGEL-ACT registry
Authors: Yang XinGuang , Sun Dapeng , Huo Xiaochuan , Raynald Raynald , Jia BaiXue , Tong Xu , Wang Anxin , Ma Ning , Gao Feng , Mo Dapeng , Miao Zhongrong 
Published: January 2023

BackgroundSome patients with large vessel occlusion (LVO) still cannot achieve functional independence despite successful reperfusion after endovascular treatment (EVT), named futile reperfusion. We aimed to explore the incidence and predictors of futile reperfusion of EVT for anterior circulation LVO in the Chinese population based on a nationwide prospective multicenter registry.MethodsWe selected patients from the ANGEL-ACT (Endovascular Treatment Key Technique and Emergency Workflow Improvement of Acute Ischemic Stroke) registry. Successful reperfusion was defined as modified Treatment In Cerebral Ischemia (mTICI) 2b-3 after EVT, and functional independence was defined as 90-day modified Rankin Scale (mRS) 0–2. A multivariable regression model was performed to identify the independent predictors of futile reperfusion in anterior circulation LVO patients.ResultsA total of 1158 anterior circulation LVO patients were included in our study. 600 of the 1158 patients (51.8%) suffered futile reperfusion. Age ≥69 (adjusted OR (aOR) 1.69, 95% CI 1.21 to 2.35, P=0.002), baseline National Institutes of Health Stroke Scale (NIHSS) ≥14 (aOR 2.36, 95% CI 1.71 to 3.27, P<0.001), baseline serum glucose ≥6.5 mmol/L (aOR 1.73, 95% CI 1.27 to 2.36, P=0.001), drip and ship (aOR 1.56, 95% CI 1.11 to 2.18, P=0.011), and general anesthesia (aOR 2.28, 95% CI 1.66 to 3.14, P<0.001) were associated with a high risk of futile reperfusion in the anterior LVO patients after EVT, whereas baseline Alberta Stroke Program Early CT Score (ASPECTS) ≥8 (aOR 0.65, 95% CI 0.47 to 0.91, P=0.011) and complete reperfusion (aOR 0.62, 95% CI 0.43 to 0.89, P=0.010) were associated with a low risk of futile reperfusion in the anterior LVO patients after EVT.ConclusionsIn the ANGEL-ACT registry, 51.8% of anterior circulation LVO patients suffered futile reperfusion after EVT. Age ≥69 years, baseline NIHSS ≥14, baseline serum glucose ≥6.5 mmol/L, drip and ship, general anesthesia, baseline ASPECTS <8, and incomplete reperfusion were the independent predictors of futile reperfusion.
Effectiveness of early cycles of fast-acting treatment in generalised myasthenia gravis
Authors: Uzawa Akiyuki , Suzuki Shigeaki , Kuwabara Satoshi , Akamine Hiroyuki , Onishi Yosuke , Yasuda Manato , Ozawa Yukiko , Kawaguchi Naoki , Kubota Tomoya , Takahashi Masanori P , Suzuki Yasushi , Watanabe Genya , Kimura Takashi , Sugimoto Takamichi , Samukawa Makoto , Minami Naoya , Masuda Masayuki , Konno Shingo , Nagane Yuriko , Utsugisawa Kimiaki 
Published: January 2023

BackgroundEarly fast-acting treatment (EFT) is the aggressive use of fast-acting therapies such as plasmapheresis, intravenous immunoglobulin and/or intravenous high-dose methylprednisolone (IVMP) from the early phases of treatment. EFT is reportedly beneficial for early achievement of minimal manifestations (MM) or better status with ≤5 mg/day prednisolone (MM5mg), a practical therapeutic target for myasthenia gravis (MG).ObjectiveThe current study aimed to clarify which specific EFT regimen is efficacious and the patient characteristics that confer sensitivity to EFT.MethodsWe recruited a total of 1710 consecutive patients with MG who enrolled in the Japan MG Registry for this large-cohort study. Among them, 1066 with generalised MG who had received immunotherapy were analysed. Prognostic background factors were matched in a 1:1 ratio using propensity score matching analysis between patients treated with EFT (n=350) and those treated without EFT (n=350). The clinical course and time to first achieve MM5mg after starting immunotherapy was analysed in relation to treatment combinations and patient characteristics.ResultsKaplan-Meier analyses showed that EFT had a significant effect on the achievement of MM5mg (p<0.0001, log-rank test; HR 1.82, p<0.0001). Notably, EFT was efficacious for any type of MG, and the inclusion of IVMP resulted in earlier and more frequent achievement of MM5mg (p=0.0352, log-rank test; HR 1.46, p=0.0380). In addition, early administration of calcineurin inhibitors also promoted MM5mg achievement.ConclusionEarly cycles of intervention with EFT and early use of calcineurin inhibitors provides long-term benefits in terms of achieving therapeutic targets for generalised MG, regardless of clinical subtype.
Ocrelizumab concentration and antidrug antibodies are associated with B-cell count in multiple sclerosis
Authors: Toorop Alyssa A , Hogenboom Laura , Bloem Karien , Kocyigit Merve , Commandeur Nadine W M , Wijnants Anne , Lissenberg-Witte Birgit I , Strijbis Eva M M , Uitdehaag Bernard M J , Rispens Theo , Killestein Joep , van Kempen Zoé L E 
Published: January 2023

BackgroundThe majority of patients with multiple sclerosis on ocrelizumab have B-cell depletion after standard interval dosing of 26 weeks. With B-cell-guided dosing patients receive their next dose when B-cell repopulation occurs. Prediction of B-cell repopulation using ocrelizumab concentrations could aid in personalising treatment regimes. The objectives of this study were to evaluate the association between ocrelizumab drug concentration, antidrug antibodies (ADAs) and CD19 B-cell count, and to define a cut-off ocrelizumab concentration for start of B-cell repopulation (defined by ≥10 CD19+ B cells/µL).MethodsIn this investigator-initiated prospective study, blood samples at various time points during ocrelizumab treatment were collected from a biobank. Serum ocrelizumab concentrations and ADAs were measured with two different assays developed for this study. Data were analysed using linear mixed effect models. An receiver operating characteristic (ROC) curve was used to determine a cut-off ocrelizumab concentration for start of B-cell repopulation (defined by ≥10 cells/µL).ResultsA total of 452 blood samples from 72 patients were analysed. Ocrelizumab concentrations were detectable up until 53.3 weeks after last infusion and ranged between <0.0025 and 204 µg/mL after 1–67 weeks. Ocrelizumab concentration was negatively associated with B-cell count, with body mass index identified as effect modifier. We found a cut-off value of 0.06 µg/mL for start of B-cell repopulation of ≥10 cells/µL. Ocrelizumab ADAs were detectable in four patients (5.7%) with corresponding low ocrelizumab concentrations and start of B-cell repopulation.ConclusionsSerum ocrelizumab concentration was strongly associated with B-cell count. Measurement of ocrelizumab drug concentrations and ADAs could play an important role to further personalise treatment and predict the start of B-cell repopulation.
Standard Model predictions for rare K and B decays without new physics infection
Authors: Buras Andrzej J. 
Published: January 2023

AbstractThe Standard Model (SM) does not contain by definition any new physics (NP) contributions to any observable but contains four CKM parameters which are not predicted by this model. We point out that if these four parameters are determined in a global fit which includes processes that are infected by NP and therefore by sources outside the SM, the resulting so-called SM contributions to rare decay branching ratios cannot be considered asgenuineSM contributions to the latter. On the other handgenuineSM predictions, that arefreefrom the CKM dependence, can be obtained for suitable ratios of theKandBrare decay branching ratios to$$\Delta M_s$$ΔMs,$$\Delta M_d$$ΔMdand$$|\varepsilon _K|$$|εK|, all calculated within the SM. These three observables contain by now only small hadronic uncertainties and are already well measured so that rather precise SM predictions for the ratios in question can be obtained. In this context therapid testof NP infection in the$$\Delta F=2$$ΔF=2sector is provided by a$$|V_{cb}|-\gamma $$|Vcb|-γplot that involves$$\Delta M_s$$ΔMs,$$\Delta M_d$$ΔMd,$$|\varepsilon _K|$$|εK|, and the mixing induced CP-asymmetry$$S_{\psi K_S}$$SψKS. As with the present hadronic matrix elements this test turns out to benegative, assuming negligible NP infection in the$$\Delta F=2$$ΔF=2sector and setting the values of these four observables to the experimental ones, allows to obtain SM predictions for allKandBrare decay branching ratios that are most accurate to date and as a byproduct to obtain the full CKM matrix on the basis of$$\Delta F=2$$ΔF=2transitionsalone.Using this strategy we obtain SM predictions for 26 branching ratios for rare semileptonic and leptonicKandBdecays with the$$\mu ^+\mu ^-$$μ+μ-pair or the$$\nu {\bar{\nu }}$$νν¯pair in the final state. Most interesting turn out to be the anomalies in the low$$q^2$$q2bin in$$B^+\rightarrow K^+\mu ^+\mu ^-$$B+→K+μ+μ-($$5.1\sigma $$5.1σ) and$$B_s\rightarrow \phi \mu ^+\mu ^-$$Bs→ϕμ+μ-($$4.8\sigma $$4.8σ).
Tetrandrine Inhibits Cancer Stem Cell Characteristics and Epithelial to Mesenchymal Transition in Triple-Negative Breast Cancer via SOD1/ROS Signaling Pathway
Authors: Liu Ting , Li Kangdi , Zhang Zhenxing , Peng Jinghui , Yang Jingzhao , Law Betty Yuen Kwan , Liu Xin , Li Wenhua 
Published: January 2023

Targeting the stemness of triple-negative breast cancer (TNBC) is a potential therapeutic approach for treating TNBC. Tetrandrine, a natural plant alkaloid, has several anticancer effects. Here, we aimed to evaluate the efficacy of tetrandrine in cancer stemness and epithelial to mesenchymal transition (EMT) in TNBC, and to explore the underlying mechanisms. The effects of tetrandrine on cell growth, cell viability, cell stemness capacity, cell migration, and cell invasion, as well as the molecules involved in these processes, were investigated in a cell culture system. An in vivo xenograft tumor and lung metastasis study was performed using nude mice to verify the effects and mechanisms of tetrandrine. Tetrandrine exhibited antiproliferative and cell cycle arrest activities in TNBC cell lines, significantly reduced aldehyde dehydrogenase and CD44[Formula: see text]CD24[Formula: see text] characteristic subpopulation, and successfully prevented mammosphere formation. It suppressed migration and invasion, enhanced anoikis, and regulated the expression of proteins involved in the EMT, including E-cadherin, Vimentin, and Occludin, in both TNBC cells and MDA-MB-231 spheroid cells. Further studies revealed that tetrandrine downregulated the expression of superoxide dismutase 1 (SOD1) and catalase and induced reactive oxygen species (ROS) production, which subsequently contributed to the inhibition of cell EMT and stemness. The in vivo studies also showed that tetrandrine inhibited tumor growth and metastasis of both adherent normal cells, and flow cytometry sorted specific CD44[Formula: see text]CD24[Formula: see text] breast cancer stem cells, which could be rescued by SOD1 overexpression. The results of this study suggest that tetrandrine could effectively inhibit breast cancer stem cell characteristics and the EMT process via the SOD1/ROS signaling pathway. Therefore, tetrandrine can be considered a promising anti-TNBC agent.