bluuebunny/crossref_metadata_2025_split huggingface dataset:
Pre-diabetes virtual health management community (VHMC) intervention and group interaction management model in China: a randomised clinical trial protocol
Authors: Wang Yifan , Hu Xiling , Cheng Li , Guo Xiaodi , Cai Mengyin , Liu Shuhong , Zhang Yao 
Published: December 2024

IntroductionIndividuals with pre-diabetes are at high risk for developing type 2 diabetes mellitus (T2DM), which makes them prone to serious complications such as stroke, kidney failure, blindness and lower-limb amputation. Pre-diabetes can be reversed, and lifestyle modification is considered the best intervention method for diabetes prevention. However, it is difficult for individuals with pre-diabetes to maintain a long-term modified healthy lifestyle owing to psychological burnout in daily management over time due to poor adherence. We developed a novel virtual health management community (VHMC) model based on group interaction management. We present the protocol for the VHMC model applied to the pre-diabetic population—a randomised controlled trial (RCT).Methods and analysisThis study will be conducted to determine the effectiveness of the pre-diabetes VHMC–group interaction management model on improving long-term lifestyle intervention adherence to reduce the incidence of T2DM in China. We will conduct a prospective, multicentre, single-blinded, two-arm, RCT, and a total of 706 patients will be recruited. Those randomly assigned to the intervention group will receive group interaction management based on the VHMC platform. Measures of incidence of T2DM, diabetes outcomes, lifestyle modification and psychosocial outcomes will be assessed at baseline, 3, 6, 12, 24 and 36 months. If the VHMC–group interaction management model shows efficacy in improving the self-management of pre-diabetes or metabolic control, similar interventions may be applied to other chronic conditions. The cost-utility analysis of this model may indicate that this platform could be a potentially cost-effective and efficient way to integrate the VHMC platform into the health management of patients with pre-diabetes.Ethics and disseminationThe Ethics Committee of the Third Affiliated Hospital of Sun Yat-sen University approved this study (No. RG2023-262-02). The results of this study will be disseminated through conference presentations and peer-reviewed publications.Trial registration numberChiCTR2400081268. Study start: 1 July 2024, completion: 1 December 2026.
HINODE study: haemophilia A in infancy and newborns – protocol for a prospective, multicentre, observational study evaluating the coagulation potential and safety of emicizumab prophylaxis
Authors: Ohga Shouichi , Takeyama Masahiro , Ishimura Masataka , Inoue Hirosuke , Nosaka Daisuke , Iwasaki Keisuke , Mitsui Chika , Nogami Keiji 
Published: December 2024

IntroductionEmicizumab prophylaxis is approved for people of all ages with haemophilia A (HA) including infants and children. Although previous studies have demonstrated the efficacy and tolerability of emicizumab in infants with HA, real-world data on emicizumab use in infants are limited. The Haemophilia A in Infancy and NewbOrns: multi-instituional prospective observational study to assess the efficacy anD safety of Emicizumab (HINODE) study aims to evaluate the coagulation potential and safety of emicizumab prophylaxis in infants with congenital HA from birth to <12 months of age.Methods and analysisThis is a multicentre, observational study conducted in Japan in infants with congenital HA aged <12 months who are receiving or are scheduled to receive prophylactic emicizumab at an approved dosing regimen: 1.5 mg/kg weekly, 3 mg/kg every 2 weeks or 6 mg/kg every 4 weeks. The target inclusion is 50 infants. The primary endpoint is to evaluate the relationship between global coagulation test parameters (using clot waveform analysis and thrombin generation assay) and plasma emicizumab concentrations in infants aged from 6 to <12 months. Secondary endpoints include evaluating coagulation profiles in infants aged <6 months and changes between the age of <6 and 6 to <12 months. Additionally, coagulation parameters will be evaluated with the in vitro addition of anti-idiotype antibodies against emicizumab or the addition of a factor VIII product in infants aged from 6 to <12 months. The study will also evaluate adverse events and bleeds.Ethics and disseminationThe study was approved by the MINS Clinical Trial Review Committee (no. 230214) and will be conducted in compliance with the Declaration of Helsinki, the Act on the Protection of Personal Information and the Guidance of Ethical Guidelines for Medical and Biological Research Involving Human Subjects. Written informed consent for participation in the study will be obtained from a legally acceptable representative. Results will be published in scientific/medical journals and presented at international congresses.Trial registration numberJapan Registry of Clinical Trials; jRCT1031230264.
Nursing home staff’s experiences with the implementation of an automated blister packaging system for solid, orally ingestible drugs: a qualitative study in Northern Italy
Authors: Tappeiner Waltraud , Wieser Heike , Obkircher Rita , Pigneter Jessica , Roth Jacob , Ausserhofer Dietmar 
Published: December 2024

ObjectivesTo explore nursing home (NH) staff’s experiences implementing an automated blister packaging system for solid, orally ingestible drugs.DesignThis was a descriptive qualitative study. Semistructured interviews were used for data collection, and qualitative content analysis was applied for data analysis.SettingFour NHs in a region in Northern Italy participated in the piloting of an automated blister packaging system.ParticipantsThe purposive sample comprised 40 NH staff (seven registered nurses, 11 certified nursing assistants, three nursing aids, seven nursing managers, four directors and eight physicians)ResultsSix main categories emerged from the data analysis: (1) impacting safety, including improved medication process, perceived insecurities and remaining error sources; (2) creating free spaces, including time, individualised care and drug storage and logistics; (3) serving residents, (4) meeting expectations, including met and unmet expectations; (5) generating efforts and (6) producing waste. They all merged into one theme ‘It pays off!’ConclusionsAs experienced by NH staff, the automated blister packaging system improved medication safety and reduced the workload of registered nurses, but it is not an ‘all-around carefree package’. Continuous quality improvement and risk management strategies are recommended to accompany and sustain implementation, as well as further clarification of roles and duties among the different care workers involved in medication management. Further research is needed to gain a better understanding of the impact of an automated blister packaging system on registered nurses’ competencies in NHs regarding medication management and residents’ therapies and safety.
TOURISM study (Treatment Outcomes in UteRIne SarcoMa): a 10-year retrospective evaluation of practice in the UK
Authors: Mactier Karen E , Baxter Mark A , Peters Adam L , Fair Katherine , Hannington Laura , Robertson James , Wood Georgina E , Sarwar Asma , Bishr Mai K , Webb Rebekah , Al-Zubaidi Mohammed , Eastlake Leonie , Lankester Katharine , McInerney Samuel , Creedon Helen , Stillie Alison L , Purshouse Karin 
Published: December 2024

BackgroundAlthough rare, uterine sarcomas account for a high proportion of uterine cancer mortality. Treatment options and robust trial data are limited.ObjectivesThe TOURISM study (Treatment Outcomes in UteRIne SarcoMa) is a UK-wide study by the National Oncology Trainees Collaborative for Healthcare Research which aimed to characterise this patient cohort.DesignA retrospective descriptive cohort study. Patients with carcinosarcomas/mixed Mullerian tumours, non-uterine gynaecological sarcomas and uterine metastases were excluded. Routine clinical data, including general patient demographics, diagnosis, treatment and outcomes, were collated and pseudonymised.SettingPatients diagnosed with uterine sarcoma in the UK National Health Service between 1 January 2008 and 31 December 2017 were identified from electronic records.ParticipantsA total of 406 patients from eight centres were eligible for inclusion.ResultsThe median age at diagnosis was 56 years, with leiomyosarcoma the most common diagnosis (54.4%). The majority (57.9%) were diagnosed at the International Federation of Gynecology and Obstetrics stage I, with 19.7% diagnosed at stage IV. Nearly half (45.2%) of the patients received at least one line of chemotherapy, of which most (81.0%) received doxorubicin first-line. In the stage I group 7.4% received adjuvant chemotherapy and 15.0% received adjuvant radiotherapy. Median overall survival was 37 months; however, survival varied significantly by stage at diagnosis (stage I: 105 months; stage II: 33 months; stage III: 19 months; stage IV: 14 months).ConclusionsOur data highlight the diversity in patient management in uterine sarcoma and a marked survival advantage for patients diagnosed with stage I disease. These data highlight the importance of a multidisciplinary approach and describe real-world trends in systemic therapies, radiotherapy and surgical treatment in this rare cancer type.
High peripheral T cell diversity is associated with lower risk of toxicity and superior response to dual immune checkpoint inhibitor therapy in patients with metastatic NSCLC
Authors: Altan Mehmet , Li Ruoxing , Li Ziyi , Chen Runzhe , Sheshadri Ajay , Tran Hai T , Little Latasha , Baguley Joshua , Sinson Jefferson , Vokes Natalie , Gandhi Saumil , Antonoff Mara B , Swisher Stephen G , Lizee Greg , Reuben Alexandre , Heymach John V , Zhang Jianjun 
Published: December 2024

IntroductionDespite significant successes, immune checkpoint blockade fails to achieve clinical responses in a significant proportion of patients, predictive markers for responses are imperfect and immune-related adverse events (irAEs) are unpredictable. We used T-cell receptor (TCR) sequencing to systematically analyze prospectively collected patient blood samples from a randomized clinical trial of dual immune checkpoint inhibitor therapy to evaluate changes in the T-cell repertoire and their association with response and irAEs.MethodsPatients with immunotherapy-naïve metastatic non-small cell lung cancer (NSCLC) were treated with ipilimumab and nivolumab according to trial protocol (LONESTAR,NCT03391869). Blood samples were systematically obtained at baseline (n=107), after 12 weeks of ipilimumab and nivolumab (n=91), and at the time of grade ≥2 irAEs (n=77). For analysis of T-cell repertoire, we performed immunoSEQ to assess the complementary determining region 3β region of the TCR involved in antigen binding.ResultsA total of 250 samples from 119 patients were analyzed. Patients who had a response to therapy exhibited greater T-cell diversity at baseline. Interestingly, patients with irAEs demonstrated lower T-cell richness at the time of toxicity compared with those without irAEs.ConclusionOur study highlights the potential impact of peripheral blood T-cell repertoire on clinical response and toxicities from the combination of ipilimumab and nivolumab in patients with metastatic NSCLC. These findings suggest that analysis of peripheral blood T-cell repertoire may help to guide patient selection for treatment with ipilimumab and nivolumab.Trial registration numberNCT03391869.
Inhaled corticosteroids and major cardiovascular events in people with chronic obstructive pulmonary disease
Authors: Ioannides Anne E , Kallis Constantinos , Whittaker Hannah R , Quint Jennifer K 
Published: December 2024

BackgroundWhether inhaled corticosteroids (ICSs) reduce major adverse cardiovascular events (MACEs) in people with chronic obstructive pulmonary disease (COPD) is debated.ObjectivesTo establish, within people with COPD, (1) whether ICS reduced MACE rates (acute coronary syndrome (ACS), heart failure (HF), ischaemic strokes or cardiovascular-specific death) compared with long-acting bronchodilators; and (2) whether drug class, incident usership or patient cardiovascular history influenced the ICS-MACE relationship.MethodsWe conducted a cohort study including patients with COPD in England, using Clinical Practice Research Datalink Aurum data, linked with Hospital Episode Statistics and Office of National Statistics death data, between 1 January 2010 and 31 December 2019. We implemented Cox proportional hazard regressions, adjusting for time interactions or using propensity score-adjusted models, as necessary. Our exposures included prescriptions of any ICS (vs any long-acting bronchodilators) and triple therapy (vs combination long-acting bronchodilators), determined during the year prior to follow-up. The outcomes of interest were MACE collectively and individual MACE subtypes.Measurements and main resultsAmong 113 353 people with COPD (mean age 67.9 years old, 53.3% male), ICS prescription was not associated with MACE (adjusted HR (95% CI)=0.98 (0.95, 1.02), p=0.41) but was associated with reduced HF, specifically, until year 6 of follow-up (average adjusted HR (95% CI)=0.91 (0.86, 0.96), p<0.001). HF reduction was driven by the ICS group containing mometasone furoate, beclomethasone, budesonide or ciclesonide (HR (95% CI)=0.89 (0.84, 0.94), p<0.001). Incident ICS use was associated with increased ACS (HR (95% CI)=1.27 (1.09, 1.47), p<0.001) but was not sustained beyond incident use. There was no association between triple therapy and MACE. Results did not differ by cardiovascular history.ConclusionsICS did not reduce MACE, except HF, likely by reducing misclassified COPD exacerbations.
Strong-field QED effects on polarization states in dipole and quadrudipole pulsar emissions
Authors: Kim Dong-Hoon , Kim Chul Min , Kim Sang Pyo 
Published: December 2024

Abstract
Highly magnetized neutron stars have quantum refraction effects on pulsar emission due to the non-linearity of the quantum electrodynamics (QED) action. In this paper, we investigate the evolution of the polarization states of pulsar emission under the quantum refraction effects, combined with the dependence on the emission frequency, for dipole and quadrudipole pulsar models; we solve a system of evolution equations of the Stokes vector, where the birefringent vector, in which such effects are encoded, acts on the Stokes vector. At a fixed emission frequency, depending on the magnitude of the birefringent vector, dominated mostly by the magnetic field strength, the evolution of the Stokes vector largely exhibits three different patterns: (i) monotonic, or (ii) half-oscillatory, or (iii) highly oscillatory behaviors. These features are understood and confirmed by means of approximate analytical solutions to the evolution equations. Also, the evolution patterns are shown to differ between dipole and quadrudipole pulsar models, depending on the magnetic field strength.
A model-independent compact dynamical system formulation for exploring bounce and cyclic cosmological evolutions in $$f\, (R)$$ gravity
Authors: Chakraborty Saikat , Louw Charlotte , S. Agrawal A. , Dunsby Peter K. S. 
Published: December 2024

Abstract
Using the dynamical systems approach together with the cosmographic parameters, we present a model-independent dynamical system formulation for cosmology in f(R) gravity. The formulation is model-independent in the sense that one needs to specify not a particular functional form of f(R) a-priori, but rather a particular cosmological evolution, which fixes the cosmography. In a sense, our approach is the way around the reconstruction method. This is shown using both non-compact and compact dynamical variables. The focus in this paper is on the compact analysis since we demonstrate the applicability of this formulation using examples of bouncing and cyclic cosmology. In particular, our analysis reveals, in a model-independent manner, the problem of achieving such cosmologies when the universe is globally spatially flat and devoid of matter.
Vortical waves in a quantum fluid with vector, axial, and helical charges. I. Non-dissipative transport
Authors: Morales-Tejera Sergio , Ambruş Victor E. , Chernodub Maxim N. 
Published: December 2024

Abstract
Due to the spin-orbit coupling, Dirac fermions, submerged in a thermal bath with finite macroscopic vorticity, exhibit a spin polarisation along the direction parallel to the vorticity vector

$$\varvec{\Omega }$$

Ω

. Due to the symmetries of the Lagrangian for free massless Dirac particles, there are three independent and classically conserved currents corresponding to the vector, axial, and helical charges. The constitutive relations for the charge currents and the stress-energy tensor at thermal equilibrium, derived in the framework of quantum field theory at finite temperature, reveal vorticity-induced contributions that deviate from the perfect fluid form. In this paper, we consider the mode structure of the corresponding hydrodynamical theory and derive collective excitations associated with coherent fluctuations of all three charges. We show that the chirally imbalanced rotating fluid should possess non-reciprocal gapless waves that propagate with different velocities along and opposite to the vorticity vector. We also uncover a strictly unidirectional mode, which we call the axial vortical wave, propagating in the background of the axial charge density. The emergence of this wave can be traced back to earlier studies of vortical chiral fluids in a hydrodynamic approach. We also point out an unexpected instability in the limit of degenerate matter and discuss possible solutions when helicity and axial charge non-conservation are taken into account.
Neuropathic Component Characteristics in Chronic Secondary Musculoskeletal Pain After Postmenopausal Osteoporotic Fractures: A Pilot Cross‐Sectional Study
Authors: Pickering Marie-Eva , Perrot Serge , Christian Dualé , Morel Véronique , Macian Nicolas , Pereira Bruno 
Published: December 2024

Background: The neuropathic characteristics of pain occurring after an osteoporosis (OP)‐related fracture are often under‐recognized. The aim of this pilot study is to identify, in patients suffering from pain localized on the site of a previous osteoporotic fracture, the presence of neuropathic characteristics, their medical management, and their impact on quality of life.Methods: This pilot cross‐sectional study on consecutive patients in University Hospital, Rheumatology Department, Clermont‐Ferrand, France, was approved by the Ethics Committee (IRB number 2023‐CF34). Pain was evaluated with the Numeric Pain Rating Scale (NPRS), Neuropathic Component of Chronic pain (NCCP) was screened with the DN4 questionnaire, and sleep was assessed with the Pittsburg questionnaire. Depression, anxiety, quality of life, and concomitant treatment were also evaluated. Results were expressed using effect sizes (ESs) and 95% confidence intervals.Results: Fifty new patients with a history of at least one fully documented fragility vertebral fracture (VF) or nonvertebral fracture (NVF) due to osteoporosis, in the last 2 years minus the previous 6 months, were included. Findings show that 21% patients with VF and 28% patients with NVF reported NCCP (DN ≥ 4). NCCP patients had more intense pain (NPRS = 5.1 ± 2.9 vs. 2.9 ± 2.7, ES = 0.82 [0.18; 1.44], p = 0.019) and impaired sleep compared to patients without NCCP (ES = 0.71 [0.08; 1.33], p = 0.043). A remarkable point was that patients had no specific oral or topical treatment for NCCP and were only taking on demand paracetamol and nonsteroidal anti‐inflammatory drugs.Conclusions: Future research should focus on the neuropathic characteristics of pain patients with OP, in order to better manage OP‐related pain.
High Shear Stress Reduces ERG Causing Endothelial-Mesenchymal Transition and Pulmonary Arterial Hypertension
Authors: Shinohara Tsutomu , Moonen Jan-Renier , Chun Yoon Hong , Lee-Yow Yannick C. , Okamura Kenichi , Szafron Jason M. , Kaplan Jordan , Cao Aiqin , Wang Lingli , Guntur Divya , Taylor Shalina , Isobe Sarasa , Dong Melody , Yang Weiguang , Guo Katherine , Franco Benjamin D. , Pacharinsak Cholawat , Pisani Laura J. , Saitoh Shinji , Mitani Yoshihide , Marsden Alison L. , Engreitz Jesse M. , Körbelin Jakob , Rabinovitch Marlene 
Published: December 2024

BACKGROUND:

Computational modeling indicated that pathological high shear stress (HSS; 100 dyn/cm
2
) is generated in pulmonary arteries (PAs; 100–500 µm) in congenital heart defects causing PA hypertension (PAH) and in idiopathic PAH with occlusive vascular remodeling. Endothelial-to-mesenchymal transition (EndMT) is a feature of PAH. We hypothesize that HSS induces EndMT, contributing to the initiation and progression of PAH.

METHODS:

We used the Ibidi perfusion system to determine whether HSS applied to human PA endothelial cells (ECs) induces EndMT when compared with physiological laminar shear stress (15 dyn/cm
2
). The mechanism was investigated and targeted to prevent PAH in a mouse with HSS induced by an aortocaval shunt.

RESULTS:
EndMT, a feature of PAH not previously attributed to HSS, was observed. HSS did not alter the induction of transcription factors KLF (Krüppel-like factor) 2/4, but an ERG (ETS-family transcription factor) was reduced, as were histone H3 lysine 27 acetylation enhancer-promoter peaks containing ERG motifs. Consequently, there was reduced interaction between ERG and KLF2/4, a feature important in tethering KLF and the chromatin remodeling complex to DNA. In PA ECs under laminar shear stress, reducing ERG by siRNA caused EndMT associated with decreased BMPR2 (bone morphogenetic protein receptor 2), CDH5 (cadherin 5), and PECAM1 (platelet and EC adhesion molecule 1) and increased SNAI1/2 (Snail/Slug) and ACTA2 (smooth muscle α2 actin). In PA ECs under HSS, transfection of ERG prevented EndMT. HSS was then induced in mice by an aortocaval shunt, causing progressive PAH over 8 weeks. An adeno-associated viral vector (AAV2-ESGHGYF) was used to replenish ERG selectively in PA ECs. Elevated PA pressure, EndMT, and vascular remodeling (muscularization of peripheral arteries) in the aortocaval shunt mice were markedly reduced by ERG delivery.

CONCLUSIONS:
Pathological HSS reduced lung EC ERG, resulting in EndMT and PAH. Agents that upregulate ERG could reverse HSS-mediated PAH and occlusive vascular remodeling resulting from high flow or narrowed PAs.
Synesthetic Interactions: Exploring the Multisensory Relationships Between Color and Scent in Human Perception
Authors: Barbara Anna , Faschi Vanessa , Gilchrist Anna , Magagnoli Carlotta , Sanchez Federica , Mikhail Reejy Atef Abdelatty 
Published: December 2024

Abstract
The article explores the intricate relationship between colors and odors through five experiments. These experiments were developed by researchers in the field of olfactory design and used in a public workshop held in Brescia titled Chromascent, as part of the event il Corpo Eterno, curated by Elena Abbiatici. The first experiment investigates the duration and characteristics of visual and olfactive memories, revealing a complex interplay between these sensory modalities. The second focuses on the influence of color on perceived fragrance purity, showing that color can affect the identification of pure scents. The third experiment examines the neurological connections between colors and smells, suggesting that congruent color-odor pairings enhance cognitive performance. The fourth study investigates the effect of color intensity on perceived scent intensity, yielding mixed results. The fifth experiment delves into the mental processing of a pleasant atmosphere, demonstrating the dominant role of visual stimuli and the significant impact of olfactory elements in shaping emotional responses and memories. This comprehensive study offers valuable insights into the multisensory nature of human perception, with practical applications for design fields including product design, packaging, educational environments, and interior design. These findings can inform the creation of multisensory experiences that are aesthetically pleasing and enhance cognitive function, emotional response, and memory formation.