bluuebunny/crossref_metadata_2025_split huggingface dataset:
Effectiveness of ertugliflozin during Ramadan fasting in patients with type 2 diabetes mellitus: a real-world study (ErtuRamadan study)
Authors: Pathan Md Faruque , Akter Nazma , Mustari Marufa , Saifuddin M. , Sharifuzzaman Mirza , Rahman Mohammad Motiur , Ripon Mohammed , Mohiuddin S. M. , Kamrul-Hasan A. B. M. , Hannan Mohammad Abdul , Alam Muhammad Shah , Mahjabeen Samira , Afsana Faria , Bakar Muhammed Abu , Haq Tahniyah , Ahammed Afsar , Talukder Samir Kumar , Sarkar Sourav , Selim Shahjada 
Published: February 2025

BackgroundManagement of type 2 diabetes mellitus (T2DM) during Ramadan fasting presents unique challenges due to prolonged fasting periods, irregular meal schedules, and altered medication timing, potentially impacting glycemic control. Ertugliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, has been shown to improve glycemic control in T2DM effectively. However, the effectiveness of ertugliflozin during Ramadan fasting, a period with unique glycemic challenges, has not been studied extensively.MethodsThis study was a multicenter, real-life experience study involving 1373 adult patients with known T2DM for at least one year, an HbA1c level of less than 10%, and who intended to fast during Ramadan. Participants were divided into two groups: the Ertu group (n=703), consisting of patients who had been on a stable dose of ertugliflozin for at least three months before Ramadan, and the non-Ertu group (n=670), which included patients receiving other oral antihyperglycemic drugs (OADs) except ertugliflozin. Patients attended a baseline visit one month before the first day of Ramadan and a follow-up visit within one month after the last day of Ramadan. Both visits included history taking, physical examinations, and laboratory tests. The primary endpoints were changes in HbA1c levels, body weight, body mass index (BMI), and the incidence of hypoglycemia during Ramadan fasting.ResultsThe mean age of the study participants was 50.37 ± 11.14 (SD) years, with 40.6% male and 58.7% female. Patients receiving ertugliflozin showed significant reduction in HbA1C (-0.65 ± 0.67% vs. -0.22 ± 0.64%, p&lt;0.001), body weight (-1.24 ± 2.58 kg vs. -0.36 ± 3.41 kg, p&lt;0.001), and BMI (-0.48 ± 1.03 kg/m² vs. -0.11 ± 1.33 kg/m², p&lt;0.001) compared to the non-Ertu group. Hypoglycemia was reported in 0.3% of the ertugliflozin group and 0.7% of the other group, with comparable adverse events (p=.23; ≥0.05), indicating a favorable safety profile for ertugliflozin during fasting.ConclusionThis study demonstrates that ertugliflozin is effective and safe for patients with T2DM during Ramadan fasting.
Exploration of the relationship between primary dysmenorrhea, pain perception, and menstruation-related quality of life in young women: a cross-sectional observational study
Authors: Del Prado Rebeca , García-Arrabé María , González-de-la-Flor Ángel , De La Plaza San Frutos Marta , Almazán Polo Jaime , Guérineau Fabien , Estrada-Barranco Cecilia 
Published: February 2025

BackgroundThis study explores the relationship between primary dysmenorrhea (PD), pain, pain catastrophizing, and menstruation-related quality of life in young women.MethodsA cross-sectional study was conducted involving 44 young women, both with and without PD. Various variables including pain intensity, pain catastrophizing, and menstruation-related quality of life were assessed using validated questionnaires. Correlation and regression analyses were performed to examine the relationships between the variables.ResultsSignificant associations were found between the presence of PD, tendency to catastrophize pain, and decreased menstruation-related quality of life. A high correlation was observed between pain intensity and catastrophizing, indicating mutual influence between these variables. Menstruation-related quality of life was affected in terms of health perception, psychological aspect, and symptoms among women with PD. The linear regression model demonstrated that catastrophizing explained 42.8% of the variance in menstruation-related quality of life.ConclusionsThese findings underscore the importance of addressing dysmenorrhea in young women, as it significantly impacts their quality of life related to menstruation. Understanding the factors contributing to dysmenorrhea and its effects on quality of life can inform more effective, patient-centered treatment strategies.
Advancing risk stratification in kidney transplantation: integrating HLA-derived T-cell epitope and B-cell epitope matching algorithms for enhanced predictive accuracy of HLA compatibility
Authors: Niemann Matthias , Matern Benedict M. , Gupta Gaurav , Tanriover Bekir , Halleck Fabian , Budde Klemens , Spierings Eric 
Published: February 2025

IntroductionThe immune-mediated rejection of transplanted organs is a complex interplay between T cells and B cells, where the recognition of HLA-derived epitopes plays a crucial role. Several algorithms of molecular compatibility have been suggested, each focusing on a specific aspect of epitope immunogenicity.MethodsConsidering reported death-censored graft survival in the SRTR dataset, we evaluated four models of molecular compatibility: antibody-verified Eplets, Snow, PIRCHE-II and amino acid matching. We have statistically evaluated their co-dependency and synergistic effects between models systematically on 400,935 kidney transplantations using Cox proportional hazards and XGBoost models.ResultsMultivariable models of histocompatibility generally outperformed univariable predictors, with a combined model of HLA-A, -B, -DR matching, Snow and PIRCHE-II yielding highest AUC in XGBoost and lowest BIC in Cox models. Augmentation of a clinical prediction model of pre-transplant parameters by molecular compatibility metrics improved model performance particularly considering long-term outcomes.DiscussionOur study demonstrates that the use of multiple specialized molecular HLA matching predictors improves prediction performance, thereby improving risk classification and supporting informed decision-making in kidney transplantation.
Requirements and special considerations for drug trials with children across six jurisdictions: 2. Ethics review in the regulatory approval process
Authors: Stewart Breanne , Lepola Pirkko , Egger Gunter F. , Ali Fahimeda , Allen Albert J. , Croker Alysha K. , Davidson Andrew J. , Dicks Pamela , Faust Saul N. , Green Dionna , Hovinga Collin , Klein Agnes V. , Langham Robyn , Nakamura Hidefumi , Pioppo Laura , Ramroop Shiva , Sakiyama Michiyo , Sanchez Vigil de la Villa Isabel , Sato Junko , Snyder Donna L. , Turner Mark A. , Zaidi Sarah , Zimmerman Kanecia , Lacaze-Masmonteil Thierry 
Published: February 2025

BackgroundConducting clinical drug trials (CTs) with children presents several challenges. A major challenge is the need to enroll participants at multiple sites across different jurisdictions. Recruiting the required number of children within a reasonable timeframe requires the study to be reviewed by Research Ethics Boards (REB) or Institutional Review Boards (IRB) at multiple sites across various jurisdictions. This work, undertaken by the Working Group (WG) on International Collaborations at the European Network of Pediatric Research at the European Medicines Agency (Enpr-EMA) aims to describe the research ethics review requirements including any pediatric specific requirements, as well as current or upcoming changes across six jurisdictions – the European Union (EU), United Kingdom (UK), United States of America (USA), Canada, Japan, and Australia.MethodsAn open questionnaire developed by the WG and directed at both the Competent Authorities (CA) and the national pediatric clinical trial networks arranged by jurisdictions.ResultsA synopsis of the current regulatory requirements covers centralized versus independent review, comparisons between investigator initiated and industry sponsored clinical trials, timelines, review board members requirements and the consenting/assent process for clinical trial (CT) applications, application submission processes and application requirements for each of the six jurisdictions. It also describes changes currently or soon to be implemented in some jurisdictions.ConclusionThis environmental scan highlights the differences in ethics review for CTs in pediatric medicine development across six jurisdictions. While there is a growing trend for centralized ethics review, it is not universally permitted due to institutional, state/provincial, or national policies. Even where central review is allowed, local review may still be required for vulnerable populations like children. Harmonized and centralized ethics reviews offer advantages such as expert pediatric reviewers and efficient and consistent evaluations.
Large-scale screening of HIV-1 T-cell epitopes restricted by 12 prevalent HLA-A allotypes in Northeast Asia and universal detection of HIV-1-specific CD8+ T cells
Authors: Ding Yan , Yan Jialai , Huang Ling , Yu Jinhong , Wu Yandan , Shen Chuanlai , Fang Anning 
Published: February 2025

BackgroundAlthough the immune response of host T cells to human immunodeficiency virus (HIV) significantly influences the progression of the infection, the development of T-cell-based vaccines and therapies, as well as the clinical evaluation of specific T-cell functions, is currently markedly hindered by the absence of broad-spectrum, functionally validated HIV T-cell epitopes that account for the polymorphisms of the human leukocyte antigen (HLA) within an indicated geographic population. This study aimed to identify T-cell epitopes derived from the GP160, GAG, and POL proteins of the HIV-1 strain, specifically linked to 12 prevalent HLA-A allotypes, that collectively represent approximately 91% of the total gene frequency in Northeast Asian populations.MethodsA total of 134 epitopes were predicted in silico and selected as potential candidates for further validation. Subsequently, peripheral blood mononuclear cells (PBMCs) were collected from 96 individuals with HIV-1 and cocultured ex vivo with each epitope candidate peptide, followed by the detection of activated CD8+ T cells. Peripheral blood mononuclear cells (PBMCs) were collected from 96 individuals with HIV-1 and cocultured ex vivo with each candidate peptide epitope, followed by the detection of activated CD8+ T cells. A total of 69 epitopes were validated as real-world HIV T-cell epitopes presented by 12 dominant HLA-A allotypes. Furthermore, the HLA-A cross-restriction for each epitope candidate was identified through peptide competitive binding assays using 12 transfected HMy2.CIR cell lines.ResultsA total of 45 epitopes demonstrated high affinity, while 31 epitopes displayed intermediate affinity. A broad-spectrum CD8+ T-cell epitope library containing 141 validated epitope peptides was used to universally detect HIV-1-specific CD8+ T cells via peptide-PBMC ex vivo coculture and intracellular IFN-γ staining. In 52 people with HIV-1, the number of reactive HIV-1 specific CD8+ T cells was significantly higher in the CD4+ T-cell-high patient group compared to the CD4+ T-cell-low patient group, and it correlated with the CD4+ T-cell-low patient group (&lt;200/μL).ConclusionThis study provides a broad-spectrum CD8+ T-cell epitope library aimed at developing a T-cell-directed HIV vaccine that offers high population coverage in Northeast Asia. In addition, it establishes a universal detection method for the clinical assessment of HIV-1-specific CD8+ T-cell responses.
Relationships between the menstrual cycle and neuropsychiatric and physical symptoms in females with Tourette syndrome
Authors: Noriega-Makarskyy Daisy T. , Realbuto Evan , Kaylor Ariadne , Osiecki Lisa , Essa Angela , Yu Dongmei , Illmann Cornelia , Mathews Carol A. , Scharf Jeremiah M. 
Published: February 2025

BackgroundThe effects of the menstrual cycle on neuropsychiatric and physical symptoms have been examined in multiple psychiatric illnesses, but research on Tourette syndrome (TS) and menstruation is limited and inconclusive. One study published in 1992 reported that 34% of female respondents experienced tic fluctuations with their menstrual cycles; however, a subsequent 2001 study found no significant relationship between menstrual cycle-related hormonal changes and tic symptoms across participants. There has been no further published exploration of this topic in the intervening 20+ years, and thus these discrepant results have not been reconciled. The current study aimed to assess tic changes across the menstrual cycle and to explore clinical predictors of tic fluctuations in adult females with TS.MethodsAn online survey was completed by 112 of 315 eligible female adults with TS. Respondents were asked to share their age of TS symptom onset, history of OCD and ADHD diagnoses, and current tic symptoms and severity. Participants also retrospectively reported their experiences with fluctuations in tics and other physical and psychiatric symptoms over the course of the menstrual cycle.Results26% of the 112 respondents endorsed tic changes in relation to their menstrual cycles. Univariable and multivariable logistic regression demonstrated that higher current tic severity and impairment as well as co-occurring cycle-related mood and anxiety changes significantly predicted the presence of self-reported tic fluctuations during the menstrual cycle.DiscussionResults suggest that some females with TS experience changes in tic symptoms during their menstrual cycles, although future research is required to clarify the complex relationships between the menstrual cycle, tics, and other psychiatric symptoms. The low response rate, retrospective recall of symptoms, and lack of information about hormonal influences such as contraceptives and menopause are notable study limitations.
A novel paradigm for fast training data generation in asynchronous movement-based BCIs
Authors: Crell Markus R. , Kostoglou Kyriaki , Sterk Kathrin , Müller-Putz Gernot R. 
Published: February 2025

IntroductionMovement-based brain-computer interfaces (BCIs) utilize brain activity generated during executed or attempted movement to provide control over applications. By relying on natural movement processes, these BCIs offer a more intuitive control compared to other BCI systems. However, non-invasive movement-based BCIs utilizing electroencephalographic (EEG) signals usually require large amounts of training data to achieve suitable accuracy in the detection of movement intent. Additionally, patients with movement impairments require cue-based paradigms to indicate the start of a movement-related task. Such paradigms tend to introduce long delays between trials, thereby extending training times. To address this, we propose a novel experimental paradigm that enables the collection of 300 cued movement trials in 18 min.MethodsBy obtaining measurements from ten participants, we demonstrate that the data produced by this paradigm exhibits characteristics similar to those observed during self-paced movement.Results and discussionWe also show that classifiers trained on this data can be used to accurately detect executed movements with an average true positive rate of 31.8% at a maximum rate of 1.0 false positives per minute.
Combined morphology and radiomics of intravoxel incoherent movement as a predictive model for the pathologic complete response before neoadjuvant chemotherapy in patients with breast cancer
Authors: Zheng Yunyan , Zhang Hui , Chen Huijian , Song Yang , Lu Ping , Ma Mingping , Lin Mengbo , He Muzhen 
Published: February 2025

BackgroundTo develop a predictive model using baseline imaging of morphology and radiomics derived from intravoxel incoherent motion diffusion-weighted imaging (IVIM-DWI) to determine the pathologic complete response (pCR) to neoadjuvant chemotherapy (NACT) in breast cancer patients.MethodsA total of 265 patients who underwent 3.0 T MRI scans before NACT were examined. Among them, 113 female patients with stage II–III breast cancer were included. The training data set consisted of 79 patients (31/48=pCR/Non-PCR, npCR), while the remaining 34 cases formed the validation cohort (13/21=pCR/npCR). Radiomics and conventional magnetic resonance imaging features analysis were performed. To build a nomogram model that integrates the radiomics signature and conventional imaging, a logistic regression method was employed. The performance evaluation of the nomogram involved the area under the receiver operating characteristic curve (AUC), a decision curve analysis, and the calibration slope.ResultsIn an assessment for predicting pCR, the radiomics model displayed an AUC of 0.778 and 0.703 for the training and testing cohorts, respectively. Conversely, the morphology model exhibited an AUC of 0.721 and 0.795 for the training and testing cohorts, respectively. The nomogram displayed superior predictive discrimination with an AUC of 0.862 for the training cohort and 0.861 for the testing cohort. Decision curve analyses indicated that the nomogram provided the highest clinical net benefit.ConclusionPerforming a nomogram consisting of integrated morphology and radiomics assessment using IVIM-DWI before NACT enables effective prediction of pCR in breast cancer. This predictive model therefore can facilitate medical professionals in making individualized treatment decisions.
Co-modulation of a circular form of PCDH11Y during neuroendocrine differentiation of prostate cancer
Authors: Pecoraro Giovanni , Leone Ilaria , Nuzzo Silvia , Negueruela Santiago , Smaldone Giovanni , Buono Lorena 
Published: February 2025

IntroductionProstate cancer (PC) is a leading cause of cancer-related deaths among men, often progressing to castration-resistant prostate cancer (CRPC) after androgen deprivation therapy (ADT). A subset of CRPC evolves into treatment-emergent neuroendocrine prostate cancer (t-NEPC), an aggressive form characterized by poor prognosis. Currently, there is no reliable biomarker for early detection of t-NEPC. Circular RNAs (circRNAs) have emerged as potential biomarkers due to their stability and tissue-specific expression.MethodsIn this study, we investigated the circRNA landscape during neuroendocrine transdifferentiation (NED) of PC cells using the androgen-sensitive LNCaP and androgen-insensitive DU145 cell lines. To achieve that, we applied CirComPara2 pipeline to publicly available datasets to identify the differently expressed circRNAs in the LNCaP cell lines pre- and post-transdifferentiation. After that, validation and functional analysis by RNA-interference was applied to a selected circRNA to explore its role during NED. ResultsWe identified over 6,200 circRNAs, of which 33 were differentially expressed during NED. Among them, a novel circRNA, circPCDH11Y, was highly upregulated during the transition of LNCaP cells from an epithelial to neuroendocrine phenotype, while its levels remained unchanged in DU145 cells. Functional assays demonstrated that circPCDH11Y plays a role in regulating the expression of key neuroendocrine markers, including synaptophysin (SYP), neuron-specific enolase (ENO2), prostate-specific antigen (PSA), Brain-Specific Homeobox/POU Domain Protein 2 (BRN2) and the linear form of Protocadherin 11 Y-Linked (PCDH11Y). Silencing circPCDH11Y delayed the expression of SYP, ENO2 and PCDH11Y, while increasing PSA and BRN2 transcriptional levels, indicating its involvement in promoting neuroendocrine differentiation. Additionally, circPCDH11Y was detected in extracellular vesicles (EVs) secreted by LNCaP cells post-NED, suggesting its potential as a circulating biomarker. DiscussionThese findings highlight circPCDH11Y as a promising candidate for early detection of t-NEPC and provide new insights into the molecular mechanisms underlying prostate cancer progression. Further validation in clinical samples is required to establish its diagnostic and therapeutic potential, which could significantly improve the management of treatment-resistant prostate cancer.
Primary leiomyosarcoma of the scalp: a case report and review of the literature
Authors: Gao Shuo , Liu Pule , Liu Jixing , Yang Wenzhen , Yang Shude 
Published: February 2025

Background and importanceLeiomyosarcoma is a rare and aggressive malignant tumor with a high potential for relapse and metastasis. Correct and timely diagnosis is critical for effective treatment, yet it is often challenging due to the diverse clinical presentations. This case report highlights the significance of early identification and the consequences of delayed diagnosis in scalp leiomyosarcoma.Clinical presentationWe present the case of a 39-year-old woman with a scalp neoplasm. Initially, the diagnosis was missed, leading to a delay in surgical intervention. The tumor demonstrated a locally aggressive course, infiltrating the skull and dura mater. Upon admission, the scalp tumor was promptly excised. This case provides valuable insights into the varied symptoms and presentations of scalp leiomyosarcoma, which can aid in the recognition of this condition.ConclusionThis report underscores the importance of considering leiomyosarcoma in the differential diagnosis of scalp masses, particularly when the etiology is unclear. Early recognition and intervention are essential to prevent locally invasive growth and potential metastasis, emphasizing the need for a high index of suspicion among healthcare professionals.
Association of blood manganese and selenium levels with hepatic steatosis among adolescents: a nationwide cross-sectional analysis
Authors: You Bin , Chen Zhiyuan 
Published: February 2025

ObjectiveThis study aimed to investigate the association between blood manganese and selenium levels and hepatic steatosis among adolescents, using data from the National Health and Nutrition Examination Survey (NHANES) 2017–2023.MethodsA cross-sectional analysis was conducted using data from 2,459 adolescents (aged 12–19 years) with complete data on liver ultrasound transient elastography, blood manganese, and selenium levels. Hepatic steatosis was defined as a controlled attenuation parameter (CAP) score of ≥248 dB/m, a measure of liver steatosis, which is a primary characteristic and a less severe stage of hepatic steatosis, assessed by vibration-controlled transient elastography (VCTE). Multivariate logistic regression models were used to assess the associations between blood manganese and selenium levels and hepatic steatosis, while restricted cubic splines (RCS) were employed to examine the dose-response relationships.ResultsThe mean age of the participants was 15.37 years, with 52.22% boy. Higher blood manganese and selenium levels were significantly associated with an increased prevalence of hepatic steatosis. In the fully adjusted model, adolescents in the highest quartile of blood manganese had more than twice the odds of hepatic steatosis compared to those in the lowest quartile (OR = 2.41, 95% CI: 1.55–3.75, P &lt; 0.01). Similarly, the highest quartile of blood selenium was associated with a 57% increase in hepatic steatosis prevalence compared to the lowest quartile (OR = 1.57, 95% CI: 1.19–2.08, P &lt; 0.01). RCS analysis confirmed a linear association between both blood manganese and selenium levels and hepatic steatosis prevalence. Subgroup analyses did not reveal statistically significant interactions by age, sex, or obesity status, although associations appeared stronger in younger adolescents.ConclusionElevated blood manganese and selenium levels are associated with a higher prevalence of hepatic steatosis in adolescents. These findings suggest a potential role of trace elements in the development of hepatic steatosis, highlighting the need for further research to better understand the underlying mechanisms involved in liver fat accumulation in this population.