bluuebunny/crossref_metadata_2025_split huggingface dataset:
Mixed methods study of attitudes on location of gynaecological oncology outpatient care: a patient and healthcare professional questionnaire
Authors: Newhouse Rebecca , Cullimore Victoria , Hotton Emily , Maxwell Hilary , Jones Eleanor , Morrison Jo 
Published: January 2024

ObjectiveGynaecological oncology place of care is often based on evolution of services, along historical professional boundaries, rather than user needs or preferences. We aimed to assess existing evidence, gather views of patients in the UK on their preferred place of outpatient care for gynaecological malignancies and evaluate alignment with preferences of healthcare professionals (HCP).MethodsWe performed a mixed methods study, including a scoping review, a patient survey and a healthcare practitioner questionnaire. We collected quantitative and qualitative data, performing content analysis to determine current practice and impact on patients.ResultsNo studies were identified in our scoping review. We received responses from 159 patients and 54 gynaecological oncology HCPs. There was a strong preference for a dedicated gynaecological oncology setting (89% somewhat or very happy) (p<0.0001). Fifty-three percent of patients were somewhat or very unhappy to have care colocated with general obstetrics and gynaecology services. Specifically, two key themes were identified through content analysis of qualitative data from patients: ‘environment and getting this right is vital’; and ‘our cancer should be the priority’. HCPs underestimated the strong patient preference to be seen in dedicated units. Of those who see patients within general obstetrics and gynaecology, only 50% said patients were seen at separate times/locations from obstetric patients.ConclusionThis study demonstrates the significant impact of place of care on gynaecological oncology patients, which may be underestimated by HCPs.
Normal saline for children with bronchiolitis: study protocol for a randomised controlled non-inferiority trial
Authors: Schmidt Marika Nathalie , Daugberg Rie , Nygaard Ulrikka , Nielsen Xiaohui Chen , Chawes Bo , Rytter Maren Heilskov , Schoos Ann-Marie Malby 
Published: January 2024

IntroductionBronchiolitis is one of the most common reasons for hospital admissions in early childhood. As supportive treatment, some treatment guidelines suggest using nasal irrigation with normal saline (NS) to facilitate clearance of mucus from the airways. In addition, most paediatric departments in Denmark use nebulised NS for the same purpose, which can mainly be administered as inpatient care. However, no studies have ever directly tested the effect of saline in children with bronchiolitis.Methods and analysisThe study is an investigator-initiated, multicentre, open-label, randomised, controlled non-inferiority trial and will be performed at six paediatric departments in eastern Denmark. We plan to include 300 children aged 0–12 months admitted to hospital with bronchiolitis. Participating children are randomised 1:1:1 to nebulised NS, nasal irrigation with NS or no saline therapy. All other treatment will be given according to standard guidelines.The primary outcome is duration of hospitalisation, analysed according to intention-to-treat analysis using linear regression and Cox regression analysis. By including at least 249 children, we can prove non-inferiority with a limit of 12 hours admission, alpha 2.5% and a power of 80%. Secondary outcomes are need for respiratory support with nasal continuous positive airway pressure or high-flow oxygen therapy and requirement of fluid supplements (either by nasogastric tube or intravenous).Ethics and disseminationThis study may inform current practice for supportive treatment of children with bronchiolitis. First, if NS is found to be helpful, it may be implemented into global guidelines. If no effect of NS is found, we can stop spending resources on an ineffective treatment. Second, if NS is effective, but nasal irrigation is non-inferior to nebulisation, it may reduce the workload of nurses, and possible duration of hospitalisation because the treatment can be delivered by the parents at home.Trial registration numberNCT05902702.
Initial intravenous immunoglobulin therapy without aspirin for acute Kawasaki disease: a retrospective cohort study with a Bayesian inference
Authors: Hayashi Ken , Miyakoshi Chisato , Hoshino Shinsuke , Kobayashi Naho , Nakajima Ryo , Sagawa Hironori , Hayashiya Toshikazu , Suzuki Atsushi , Aota Chie , Nishijima Setsuko , Shimizu Yasuyo , Yamakawa Masaru , Tsuda Etsuko 
Published: January 2024

ObjectiveTo clarify the necessity of acetylsalicylic acid (ASA) administration combined with intravenous immunoglobulin (IVIG) therapy in the treatment of acute Kawasaki disease.DesignRetrospective cohort study.SettingMulticentre.ParticipantsThis study included 735 patients with Kawasaki disease aged ≤10 years and hospitalised between 4 and 10 days of illness in eight Japanese hospitals from January 2016 to December 2020.ExposuresHigh-dose (HD) ASA was administered with initial IVIG to 333 patients in 6 hospitals (HD group). ASA was not administered routinely to 402 patients in the other two hospitals, and low-dose ASA was only administered when patients developed coronary artery lesions or pericardial effusion (non-HD group).Primary and secondary outcome measuresThe primary outcome was the presence of coronary artery lesions, defined as a coronary artery diameter >+2.5 SD of body surface area within 1 month of onset. The secondary outcome was responsiveness to the initial IVIG therapy. Adjusted risk ratios for the outcomes were calculated using modified Poisson regression models. Bayesian analysis was conducted to estimate the posterior probability of the treatment effect of HD ASA under several prior distributions.ResultsThe incidence of coronary artery lesions was not significantly higher in the HD group than in the non-HD group (12/333 (3.6%) vs 15/402 (4.0%)). The proportion of non-responders to initial IVIG was similar between the two groups (HD group: 78/333 (23%); non-HD group: 83/402 (22%)). In the Bayesian analysis, considering a difference of ≤2% to be of no clinical importance, there was only a 9.3% chance of reduced risk of coronary artery lesions in the HD group compared with the non-HD group even with a strongly enthusiastic prior for HD treatment.ConclusionsCompared with HD ASA treatment, treatment without ASA in the acute phase of Kawasaki disease was not associated with increased complications from Kawasaki disease.
Comparison of efficacy discrepancy between early-phase clinical trials and phase III trials of PD-1/PD-L1 inhibitors
Authors: Li Xiang , Zhou Yangzhong , Xu Bing , Qin Yunhe , Zhao Jiuliang , Li Mengtao , Xu Jiachen , Li Guanqiao 
Published: January 2024

BackgroundPhase III clinical trials are pivotal for evaluating therapeutics, yet a concerning failure rate has been documented, particularly impacting oncology where accelerated approvals of immunotherapies are common. These failures are predominantly attributed to a lack of therapeutic efficacy, indicating overestimation of results from phase II studies. Our research aims to systematically assess overestimation in early-phase trials involving programmed cell death-1 (PD-1)/programmed cell death-ligand 1(PD-L1) inhibitors compared with phase III trials and identify contributing factors.MethodsWe matched 51 pairs of early-phase and phase III clinical trials from a pool of over 9,600 PD-1/PD-L1 inhibitor trials. The matching criteria included identical treatment regimens, cancer types, treatment lines, and biomarker enrichment strategies. To assess overestimation, we compared the overall response rates (ORR) between early-phase and phase III trials. We established independent variables related to eligibility criteria, and trial design features of participants to analyze the factors influencing the observed discrepancy in efficacy between the two phases through univariable and multivariable logistic analyses.ResultEarly-phase trial outcomes systematically overestimated the subsequent phase III results, yielding an odds ratio (OR) comparing ORR in early-phase versus phase III: 1.66 (95% CI: 1.43 to 1.92, p<0.05). This trend of inflated ORR was consistent across trials testing PD-1/PD-L1 monotherapies and combination therapies involving PD-1/PD-L1. Among the examined factors, the exclusion of patients with autoimmune diseases was significantly associated with the disparity in efficacy between early-phase trials and phase III trials (p=0.023). We calculated a Ward statistic of 2.27 to validate the effectiveness of the model.ConclusionThese findings underscore the tendency of overestimation of efficacy in early-phase trials involving immunotherapies. The observed differences could be attributed to variations in the inclusion of patients with autoimmune disorders in early-phase trials. These insights have the potential to inform stakeholders in the future development of cancer immunotherapies.
Lower frequencies of circulating suppressive regulatory T cells and higher frequencies of CD4+naïve T cells at baseline are associated with severe immune-related adverse events in immune checkpoint inhibitor-treated melanoma
Authors: Kovacsovics-Bankowski Magdalena , Sweere Johanna M , Healy Connor P , Sigal Natalia , Cheng Li-Chun , Chronister William D , Evans Shane A , Marsiglio John , Gibson Berit , Swami Umang , Erickson-Wayman Alyssa , McPherson Jordan P , Derose Yoko S , Eliason Annaleah Larson , Medina Carlos O , Srinivasan Ramji , Spitzer Matthew H , Nguyen Ngan , Hyngstrom John , Hu-Lieskovan Siwen 
Published: January 2024

BackgroundImmune-related adverse events (irAEs) are major barriers of clinical management and further development of immune checkpoint inhibitors (ICIs) for cancer therapy. Therefore, biomarkers associated with the onset of severe irAEs are needed. In this study, we aimed to identify immune features detectable in peripheral blood and associated with the development of severe irAEs that required clinical intervention.MethodsWe used a 43-marker mass cytometry panel to characterize peripheral blood mononuclear cells from 28 unique patients with melanoma across 29 lines of ICI therapy before treatment (baseline), before the onset of irAEs (pre-irAE) and at the peak of irAEs (irAE-max). In the 29 lines of ICI therapy, 18 resulted in severe irAEs and 11 did not.ResultsUnsupervised and gated population analysis showed that patients with severe irAEs had a higher frequency of CD4+naïve T cells and lower frequency of CD16+natural killer (NK) cells at all time points. Gated population analysis additionally showed that patients with severe irAEs had fewer T cell immunoreceptor with Ig and ITIM domain (TIGIT+) regulatory T cells at baseline and more activated CD38+CD4+central memory T cells (TCM) and CD39+and Human Leukocyte Antigen-DR Isotype (HLA-DR)+CD8+TCM at peak of irAEs. The differentiating immune features at baseline were predominantly seen in patients with gastrointestinal and cutaneous irAEs and type 1 diabetes. Higher frequencies of CD4+naïve T cells and lower frequencies of CD16+NK cells were also associated with clinical benefit to ICI therapy.ConclusionsThis study demonstrates that high-dimensional immune profiling can reveal novel blood-based immune signatures associated with risk and mechanism of severe irAEs. Development of severe irAEs in melanoma could be the result of reduced immune inhibitory capacity pre-ICI treatment, resulting in more activated TCM cells after treatment.
Comparison of a covered stent and pipeline embolization device in intracranial aneurysm: a propensity score matching analysis
Authors: Tong Xin , Xue Xiaopeng , Sun Mingjiang , Han Mingyang , Jiang Peng , Liu Aihua 
Published: January 2024

Background
The Willis covered stent (WCS) and pipeline embolization device (PED) have partly overlapping therapeutic indications. However, the differences of effect between these two treatments remain unclear.

Objective
To compare clinical outcome, angiographic outcome, and complications following treatment with a WCS versus PED.

Methods
Patients with intracranial aneurysms treated by a WCS or PED between January 2015 and December 2020 were included. The primary outcomes were complications, clinical outcome (modified Rankin Scale score >2), and angiographic outcome (incomplete aneurysm occlusion). Propensity score matching was conducted to adjust for potential confounding factors.

Results
A total of 94 aneurysms treated by WCS and 698 aneurysms by PED were included. Compared with the PED group, patients in the WCS group are younger, a greater number have a poor condition at admission, a larger proportion of ruptured, non-saccular, and anterior circulation aneurysms, a smaller aneurysm neck width, and less coiling assistance is required. A total of 42 (44.7%) branches were covered by WCS. After adjustment for age, sex, aneurysm type, rupture status, neck size, aneurysm location, and coiling, 50 WCS and PED pairs were examined for internal carotid artery aneurysms. No significant differences were observed in clinical (10.4% vs 2.1%, P=0.206) and angiographic outcomes (12.8% vs 18.2%, P=0.713). However, 27 branches covered by WCS, including 22 ophthalmic arteries and five posterior communicating arteries. Patients in the WCS group had a higher intraoperative complication rate than those in the PED group (28% vs 6%, P=0.008), especially in the occlusion rate of covered branches (51.9% vs 11.1%, P<0.001).

Conclusion
The comparable clinical and angiographic outcomes of WCS or PED demonstrate the therapeutic potential of WCS as a viable alternative for aneurysms. However, the complication of occlusion of covered branches might not be negligible.
Cardiology researchers’ practices and perceived barriers to open science: an international survey
Authors: Cobey Kelly D , Alayche Mohsen , Saba Sara , Barnes Nana Yaa , Ebrahimzadeh Sanam , Alarcón Emilio , Hibbert Benjamin , Moher David 
Published: January 2024

ObjectiveOpen science is a movement and set of practices to conduct research more transparently. Implementing open science will significantly improve public access and supports equity. It also has the potential to foster innovation and reduce duplication through data and materials sharing. Here, we survey an international group of researchers publishing in cardiovascular journals regarding their perceptions and practices related to open science.MethodsWe identified the top 100 ‘Cardiology and Cardiovascular Medicine’ subject category journals from the SCImago journal ranking platform. This is a publicly available portal that draws from Scopus. We then extracted the corresponding author’s name and email from all articles published in these journals between 1 March 2021 and 1 March 2022. Participants were sent a purpose-built survey about open science. The survey contained primarily multiple choice and scale-based questions for which we report count data and percentages. For the few text-based responses we conducted thematic content analysis.Results198 participants responded to our survey. Participants had a mean response of 6.8 (N=197, SD=1.8) on a 9-point scale with endpoints, not at all familiar (1) and extremely familiar (9), when indicating how familiar they were with open science. When asked about where they obtained open science training, most participants indicated this was done on the job self-initiated while conducting research (n=103, 52%), or that they had no formal training with respect to open science (n=72, 36%). More than half of the participants indicated they would benefit from practical support from their institution on how to perform open science practices (N=106, 54%). A diversity of barriers to each of the open science practices presented to participants were acknowledged. Participants indicated that funding was the most essential incentive to adopt open science.ConclusionsIt is clear that policy alone will not lead to the effective implementation of open science. This survey serves as a baseline for the cardiovascular research community’s open science performance and perception and can be used to inform future interventions and monitoring.
Colchicine in acute myocardial infarction: cardiovascular events at 1-year follow up
Authors: Bouleti Claire , Viscogliosi Simon , Bresson Didier , Leboube Simon , Bochaton Thomas , El-Jonhy Naoual , AMAZ Camille , Prunier Fabrice , Bidaux Gabriel , Roubille Francois , Angoulvant Denis , Mewton Nathan 
Published: January 2024

ObjectiveIn the COVERT-MI randomised placebo-controlled trial, oral administration of high-dose colchicine at the time of reperfusion and for 5 days in acute ST-elevated myocardial infarction did not reduce infarct size but was associated with a significant increase in left ventricular thrombus (LVT) in comparison to placebo. We aimed to assess the 1-year clinical outcomes of the study population.MethodsThis study is a follow-up analysis of the COVERT-MI study on prespecified secondary clinical endpoints at 1 year. The primary endpoint of this study was a composite of major adverse cardiovascular events (MACEs), including all-cause death, acute coronary syndromes, heart failure events, ischaemic strokes, sustained ventricular arrhythmias and acute kidney injury at 1-year follow-up. The quality of life (QOL) and the drug therapy prescription were also assessed.ResultsAt 1 year, 192 patients (101 patients in the colchicine group, 91 in the placebo group) were followed up. Seventy-six (39.6%) MACEs were reported in the study population. There was no significant difference regarding the number of MACEs between groups: 36 (35.6%) in the colchicine group and 40 (44.1%) in the placebo group (p=0.3). There were no differences in the occurrence of ischaemic strokes between the colchicine group and the control group (3 (3%) vs 2 (2.2%), respectively, p=0.99). There was a trend towards fewer heart failure events in the colchicine group compared with the placebo group (12 (11.9%) vs 18 (19.8%), p=0.20). There was no significant difference in QOL scores at 1 year (75.8±15.7 vs 72.7±16.2 respectively, p=0.18).ConclusionsThere was no significant difference between the colchicine and placebo groups at 1 year regarding MACEs, especially concerning deaths or ischaemic strokes. No excess of ischaemic adverse events was observed despite the initial increase in LVT in the colchicine group.Trial registration numberNCT0315681.
PD-1/PD-L1 governed cross-talk of exhausted CD8+T and memory B cells in systemic lupus erythematosus
Authors: Wang Kaiwen , Zhao Jiangfeng , Feng Xuemei , He Shuangjun , Li Jia , Sun Fangfang , Xu Zhangling , Yang Haiting , Ye Jiaer , Cao Liou , Ye Shuang 
Published: January 2024

BackgroundIndeterminate readout of the quantitative interferon-γ release test (QFT) forMycobacterium tuberculosisscreening is a specific laboratory finding for systemic lupus erythematosus (SLE), which may be due to T-cell exhaustion and abnormal programmed death receptor 1 (PD-1)/programmed death-ligand 1 (PD-L1) signalling.MethodsWe enrolled 104 patients with SLE and 225 with other rheumatic musculoskeletal diseases (RMDs) who presented to the outpatient clinic between 2020 and 2023. Twenty healthy donors served as the controls. The QFT was performed in all participants, and those with indeterminate results were compared among the groups. Immunophenotyping and functional assays were performed using blood mononuclear cells. Interferon (IFN)-γ was detected in vitro and ex vivo in patients with SLE with indeterminate or negative QFT results, before or after rituximab therapy.Results104 patients with SLE had a significantly higher rate of indeterminate QFT results was significantly higher (17.31%) than that of 225 patients with RMD (3.56%). Patients with SLE with indeterminate QFT had more active disease (SLEDAI-2K, mean 10.94 vs 4.02, p<0.0001), including a higher incidence of active nephritis (55.56% vs 29.07%). Indeterminate QFT in SLE is mainly caused by an insufficient IFN-γ response in CD8+T cells with exhausted immunophenotypes. The abnormal interaction between exhausted PD-1 high CD8+T cells and activated PD-L1 low memory B cells in SLE can be reversed with a PD-1 agonist or increased PD-L1 expression. Rituximab treatment indirectly reversed this IFN-γ response.ConclusionThe PD-1/PD-L1 signalling pathway, which governs the crosstalk between exhausted CD8+T cells and activated memory B cells, is a mechanistic explanation for insufficient interferon-γ response in patients with SLE.
Exploring a new approach to hadronic parity violation from lattice QCD
Authors: Petschlies Marcus , Schlage Nikolas , Sen Aniket , Urbach Carsten 
Published: January 2024

AbstractThe long-range, parity-odd nucleon interaction generated by single-pion exchange is captured in the parity-odd pion–nucleon coupling $$h^{1}_{\pi }$$

h
π
1

. Its calculation in lattice QCD requires the evaluation of four-quark operator nucleon three-point functions. We investigate a new numerical approach to compute $$h^{1}_{\pi }$$

h
π
1

based on nucleon matrix elements of parity-even four-quark operators and related to the parity-violating electroweak theory by partial conservation of axial current (PCAC) and chiral perturbation theory. This study is performed with 2+1+1 dynamical flavors of twisted mass fermions at pion mass $$m_{\pi } \approx 260 \,\text {MeV}$$

m
π

≈
260

MeV

in a lattice box of $$L \approx 3 \,\text {fm}$$

L
≈
3

fm

and with lattice spacing of $$a \approx 0.091 \,\text {fm}$$

a
≈
0.091

fm

. From a calculation excluding fermion loop diagrams we find a bare coupling of $$h^{1}_{\pi }= 8.08 \,(98) \cdot 10^{-7}$$

h
π
1

=
8.08

(
98
)

·

10

-
7

.
Structural, magnetic, and optoelectronic properties of rock salt MgO co-doped with Eu-TM (TM = Cu, Ag, and Au) for spintronic and UV detector applications: SP-DFT investigations
Authors: Tayeb Halais Wissem , Doghmane Malika , Bouhlala Aicha , Chettibi Sabah 
Published: January 2024

This study analyzes how adding europium and transition metals (Cu, Ag, and Au) at a 12.5% concentration to magnesium oxide (MgO) affects its physical characteristics and potential uses. To do so, the full potential linearized augmented plane wave (FP-LAPW) method, based on spin-polarized density functional theory (SP-DFT), is used to derive the results. Wu and Cohen’s generalized gradient approximation (GGA-WC) described the exchange-correlation potential. The modified Becke-Johnson exchange potential (TB-mBJ) was also used to improve the findings of optoelectronic properties. When Eu and TM (Cu, Ag, and Au) impurities are co-doped into the nonmagnetic (NM) semiconductor MgO, the structural optimization results show that the lattice constants increase, and the bulk modulus decreases with increasing the atomic number of transition metals. The resulting dilute magnetic oxides (DMOs) are stable in the spin-polarized ferromagnetic (FM) phase, and the formation energy values confirm their stability in the [Formula: see text] cubic structure, with the lowest value belonging to Eu[Formula: see text]TM[Formula: see text]Mg[Formula: see text]O. Similarly, calculations of electronic properties using the WC-mBJ functional demonstrate that all compounds have an indirect half-metallic bandgap at L-[Formula: see text] equal to 2.53, 2.49, and 1.39 eV for Eu[Formula: see text]Cu[Formula: see text]Mg[Formula: see text]O, Eu[Formula: see text]Ag[Formula: see text]Mg[Formula: see text]O, and Eu[Formula: see text]Au[Formula: see text]Mg[Formula: see text]O, respectively. They have an integer magnetic moment of 6 [Formula: see text]. The density of states shows that at the Fermi level, the 4f-Eu, d-TM, and p-O states give rise to new energy levels. This indicates that the f–p–d hybridization provides this system with its FM properties. Also, these compounds’ dielectric function and absorption spectra are calculated and analyzed to learn more about their optical properties. The results provide insight into the optical behavior of the materials. It is observed that the co-doped compounds exhibit greater optical absorbance than their un-doped MgO counterparts do. This theoretical investigation opens the way to preparing high magnetic moment DMOs using TM and rare earth as dopants suitable for spintronic and UV devices.