bluuebunny/crossref_metadata_2025_split huggingface dataset:
Clinical Value of Liquid Biopsy in Patients with FGFR2 Fusion–Positive Cholangiocarcinoma During Targeted Therapy
Authors: González-Medina Alberto , Vila-Casadesús Maria , Gomez-Rey Marina , Fabregat-Franco Carles , Sierra Alexandre , Tian Tian V. , Castet Florian , Castillo Gloria , Matito Judit , Martinez Paola , Miquel Josep M. , Nuciforo Paolo , Pérez-López Raquel , Macarulla Teresa , Vivancos Ana 
Published: July 2024

Abstract

Purpose:
FGFR2 fusions occur in 10% to 15% of patients with intrahepatic cholangiocarcinoma (iCCA), potentially benefiting from FGFR inhibitors (FGFRi). We aimed to assess the feasibility of detecting FGFR2 fusions in plasma and explore plasma biomarkers for managing FGFRi treatment.

Experimental Design:
We conducted a retrospective study in 18 patients with iCCA and known FGFR2 fusions previously identified in tissue samples from prior FGFRi treatment. Both tissue and synchronous plasma samples were analyzed using a custom hybrid capture gene panel with next-generation sequencing (VHIO-iCCA panel) and validated against commercial vendor results. Longitudinal plasma analysis during FGFRi was performed. Subsequently, we explored the correlation between plasma biomarkers, liver enzymes, tumor volume, and clinical outcomes.

Results:
Sixteen patients (88.9%) were positive for FGFR2 fusion events in plasma. Remarkably, the analysis of plasma suggests that lower levels of ctDNA are linked to clinical benefits from targeted therapy and result in improved progression-free survival and overall survival. Higher concentrations of cell-free DNA before FGFRi treatment were linked to worse overall survival, correlating with impaired liver function and indicating compromised cell-free DNA removal by the liver. Additionally, increased ctDNA or the emergence of resistance mutations allowed earlier detection of disease progression compared with standard radiologic imaging methods.

Conclusions:
VHIO-iCCA demonstrated accurate detection of FGFR2 fusions in plasma. The integration of information from various plasma biomarkers holds the potential to predict clinical outcomes and identify treatment failure prior to radiologic progression, offering valuable guidance for the clinical management of patients with iCCA.
Effect of Comprehensive Rehabilitation Training Based on Balance Function on Postoperative Recovery and Function of Hip Fracture in the Elderly: A Systematic Review and Meta-Analysis
Authors: Chang Hai , Luan Chunliang , Li Chen 
Published: July 2024

Introduction In China, the proportion of the elderly population is gradually increasing, followed by the increasing medical demands of elderly patients. Hip fracture is a common fracture in the elderly. The elderly are prone to serious postoperative complications, resulting in failure to restore normal hip function, which seriously affects patients’ quality of life and further increases their mortality rate. Thus, hip fracture represents a remarkable public health issue within the realm of geriatric medical care. Significance This study systematically evaluated the impact of comprehensive rehabilitation training, with a focus on balance function, on elderly individuals with hip fractures’ postoperative recovery and functional outcomes. Result Results showed a significant difference in BBS scores favoring comprehensive rehabilitation training based on balance function over conventional intervention. Similarly, AM-PAC scores favored the balance-focused training. TUTG meta-analysis indicated its adoption in comprehensive rehabilitation training. FIM scores showed improvement with balance-focused training. Harris score meta-analysis also favored this approach. A funnel plot analysis revealed potential publication bias, likely due to study heterogeneity and limited publications. Conclusions In conclusion, comprehensive rehabilitation training centered around balance function displayed clinical efficacy in enhancing postoperative hip joint function in elderly hip fracture patients. This approach improved balance, coordination, and posture control, facilitating lower limb function recovery and overall prognosis. It holds promise as a valuable treatment approach.
Management of Uveitis Patients on Anti-TNF Agents Who Develop Demyelinating Disease – A Case Series
Authors: Hamdan Abel , Sharma Sumit , Baynes Kimberly , Hajj Ali Rula A. , Lowder Careen Y. , Srivastava Sunil K. 
Published: July 2024

Abstract
Background/Aims
Anti-tumor necrosis factor (Anti-TNF) agents have proven beneficial for the treatment of chronic non-infectious uveitis, yet rare neurological complications and demyelinating disease can occur with their use. Management of uveitis and neurological disease after developing these rare complications is not well understood. We sought to identify these specific cases and their outcomes through a retrospective observational case series.

Methods
Electronic Medical Record (EMR) chart review of 394 non-infectious uveitis patients on anti-TNF therapy focused on identifying patients seen by uveitis specialists at a single institution who were on anti-TNF therapy and had developed neurological symptoms. Cases were reviewed for subsequent management and outcomes of both their neurologic and ocular inflammatory disease.

Results
Five (5) patients were included following complaints of neurological symptoms while on anti-TNF therapy. Subsequent demyelinating diagnosis, acute treatment, and long-term course were described. All five patients continue to be inactive at around three years of anti-TNF discontinuation.

Conclusion
Unidentified rare neurological symptoms and demyelinating disease associated with the use of anti-TNF agents can be detrimental to patient treatment outcomes. Emphasis is given on possible avoidance and early identification of exacerbating underlying disease through a detailed neurologic history and use of imaging when suspicion is high. Patients may have no evidence of higher neurological risk prior to starting an anti-TNF treatment. Discontinuation of an anti-TNF agent and subsequent control of disease is possible with alternative immunosuppressive treatments.
The impact of heterogeneity on the analysis of platform trials with normally distributed outcomes
Authors: Lee Kim May , Emsley Richard 
Published: July 2024

Abstract
Background
A platform trial approach allows adding arms to on-going trials to speed up intervention discovery programs. A control arm remains open for recruitment in a platform trial while intervention arms may be added after the onset of the study and could be terminated early for efficacy and/or futility when early stopping is allowed. The topic of utilising non-concurrent control data in the analysis of platform trials has been explored and discussed extensively. A less familiar issue is the presence of heterogeneity, which may exist for example due to modification of enrolment criteria and recruitment strategy.

Method
We conduct a simulation study to explore the impact of heterogeneity on the analysis of a two-stage platform trial design. We consider heterogeneity in treatment effects and heteroscedasticity in outcome data across stages for a normally distributed endpoint. We examine the performance of some hypothesis testing procedures and modelling strategies. The use of non-concurrent control data is also considered accordingly. Alongside standard regression analysis, we examine the performance of a novel method that was known as the pairwise trials analysis. It is similar to a network meta-analysis approach but adjusts for treatment comparisons instead of individual studies using fixed effects.

Results
Several testing strategies with concurrent control data seem to control the type I error rate at the required level when there is heteroscedasticity in outcome data across stages and/or a random cohort effect. The main parameter of treatment effects in some analysis models correspond to overall treatment effects weighted by stage wise sample sizes; while others correspond to the effect observed within a single stage. The characteristics of the estimates are not affected significantly by the presence of a random cohort effect and/ or heteroscedasticity.

Conclusion
In view of heterogeneity in treatment effect across stages, the specification of null hypotheses in platform trials may need to be more subtle. We suggest employing testing procedure of adaptive design as opposed to testing the statistics from regression models; comparing the estimates from the pairwise trials analysis method and the regression model with interaction terms may indicate if heterogeneity is negligible.
Comparison between asymptotic and re-randomisation tests under non-proportional hazards in a randomised controlled trial using the minimisation method
Authors: Kimura Ryusei , Nomura Shogo , Nagashima Kengo , Sato Yasunori 
Published: July 2024

Abstract
Background
Pocock-Simon’s minimisation method has been widely used to balance treatment assignments across prognostic factors in randomised controlled trials (RCTs). Previous studies focusing on the survival outcomes have demonstrated that the conservativeness of asymptotic tests without adjusting for stratification factors, as well as the inflated type I error rate of adjusted asymptotic tests conducted in a small sample of patients, can be relaxed using re-randomisation tests. Although several RCTs using minimisation have suggested the presence of non-proportional hazards (non-PH) effects, the application of re-randomisation tests has been limited to the log-rank test and Cox PH models, which may result in diminished statistical power when confronted with non-PH scenarios. To address this issue, we proposed two re-randomisation tests based on a maximum combination of weighted log-rank tests (MaxCombo test) and the difference in restricted mean survival time (dRMST) up to a fixed time point $$\tau$$
τ
, both of which can be extended to adjust for randomisation stratification factors.

Methods
We compared the performance of asymptotic and re-randomisation tests using the MaxCombo test, dRMST, log-rank test, and Cox PH models, assuming various non-PH situations for RCTs using minimisation, with total sample sizes of 50, 100, and 500 at a 1:1 allocation ratio. We mainly considered null, and alternative scenarios featuring delayed, crossing, and diminishing treatment effects.

Results
Across all examined null scenarios, re-randomisation tests maintained the type I error rates at the nominal level. Conversely, unadjusted asymptotic tests indicated excessive conservatism, while adjusted asymptotic tests in both the Cox PH models and dRMST indicated inflated type I error rates for total sample sizes of 50. The stratified MaxCombo-based re-randomisation test consistently exhibited robust power across all examined scenarios.

Conclusions
The re-randomisation test is a useful alternative in non-PH situations for RCTs with minimisation using the stratified MaxCombo test, suggesting its robust power in various scenarios.
The effect of education of self-care behaviors on the quality of life and resilience of multiple sclerosis patients
Authors: Rakhshani Tayebeh , Afroozeh Shohreh , Kashfi Seyyed Mansour , Kamyab Amirhossein , Khani Jeihooni Ali 
Published: July 2024

Abstract
Background
Multiple sclerosis (MS) is one of the most common causes of non-traumatic disability in young adults. Typically, doctors diagnose MS between the ages of 20 and 50. This study aims to determine the effect of educational intervention on self-care behaviors on MS patients’ quality of life and resilience in Shiraz, Iran.

Methods
This interventional study included 90 individuals, aged 15 to 50, who were members of the support association for MS patients in Shiraz city, Iran. The study employed a convenient sampling method. Patients were randomly assigned to two experimental and control groups, and the self-care educational program was conducted during six educational sessions. The quality of life and resilience of the patients were measured before and after the study. Information was collected by completing the questionnaires before and three months after the intervention. To analyze the data, SPSS 23 was used. To describe the data, frequency, percentage, mean, and standard deviation indicators were used, and for analysis, independent t-tests and paired t-tests were used.

Results
This study examined a total of 90 MS patients. 50.4% of the people in the study were married, 40% of them had a high school diploma, and 78.5% were unemployed. The results of the t-test showed that there was a significant difference between all the components of self-care, quality of life, and resilience before and after the intervention (P < 0.05).

Conclusion
By accepting the responsibility of self-care, patients would improve the inadequacies and disabilities resulting from the disease, use the power of self-care to solve problems, and improve their quality of life and resilience.
Association between watching eating broadcasts like mukbang and cookbang and generalized anxiety disorder among Korean adolescents
Authors: Kim Jung-Hwan , Kim Jinhyun , Jang Suk-Yong , Park Eun-Cheol 
Published: July 2024

Abstract
Background
Anxiety disorders are common during adolescence; therefore, detecting anxiety disorders among adolescents and providing appropriate treatment are crucial. Studies have suggested that watching online audiovisual broadcasts like mukbang and cookbang (hereafter mukbang), where hosts eat or cook food, may influence anxiety disorders. However, there is insufficient research on the association between watching mukbang and generalized anxiety disorder (GAD). Therefore, we investigated the association between watching mukbang and GAD among Korean adolescents.

Methods
We analyzed 51,764 adolescents who participated in the 2020 Korea Youth Risk Behavior Web-Based Survey (KYRBS). The participants were asked how frequently they watched mukbang per week over the past 12 months. Anxiety disorders were assessed using the generalized anxiety disorder-7 (GAD-7) questionnaire. A multiple logistic regression analysis was performed after adjusting for confounding variables.

Results
The prevalence of GAD was higher among adolescents who watched mukbang compared to those who did not (aOR: 1.100, 95% CI: 1.026–1.180, P = 0.008 in male participants; aOR: 1.090, 95% CI: 1.003–1.185, P = 0.042 in female participants). The frequency of watching mukbang showed a dose-dependent relationship with a greater likelihood of GAD in female adolescents.

Conclusion
This study’s results showed that watching mukbang is associated with GAD in Korean adolescents. Proper interventions for mental health are needed for adolescents who watch mukbang.
Pattern of sleep disorders among children with autism spectrum disorder
Authors: Mohammed Muaath Ahmed , Abdalkhalig Elham Mohammed , Ali Ibrahim Abdelrhim , Hassan Salma Shakir , Osman Hayat 
Published: July 2024

Abstract
Background
Sleep disorders (SDs) are among many co-morbid medical conditions that affect children with autism spectrum disorder (ASD). Raising awareness and improving the standard of care for children diagnosed with ASD may result from identifying SDs among them. This study aims to evaluate patterns of SDs among Sudanese children diagnosed with ASD.

Method
Using the Childhood Sleep Habit Questionnaire (CSHQ) to gather data on sleep disorders and SPSS version 26.0 for data analysis, a descriptive cross-sectional study was carried out in the five main autistic centres in Khartoum state covering all registered patients with ASD between April and June 2022. Ninety-two children diagnosed with ASD were enrolled in this study after the purpose of the research was explained and consent was obtained from their guardians. A p-value < 0.05 was considered to indicate statistical significance.

Results
The mean age was 6.90 (± 2.6) years with a boys-to-girls ratio of 2.17:1. The prevalence of SDs (at least one sleep condition almost daily) was 95.65%. Sleep onset 71 (77.2%), limit setting 32 (32.6%), resistant onset to sleep 48 (52.2%), and combined 52 (56.5%) insomnia affected the majority of children. Additionally, there were significant associations between sex and Limit-setting insomnia, advanced sleep phase disorder, and narcolepsy type 2 (P values = 0.033, 0.009, and 0.037, respectively). Additionally, there was a significant association between age and sleep-related breathing disorders-snoring (p value = 0.031).

Conclusion
The frequency of SDs is significant among children diagnosed with ASD from Sudan, and certain SDs are associated with age and sex. Subsequent studies are required to develop national guidelines for the prevalence, presentation, screening, and treatment of SDs in children diagnosed with ASD.
Drug supply and assurance: a cross-sectional study of drug shortage monitoring varieties in China
Authors: Lan Yipeng , Lin Xiaofeng , Chen Qiannan , Wang Li , Sun Lihua , Huang Zhe 
Published: July 2024

Abstract
Background
Drug shortage is a worldwide problem that seriously threatens public health. China released the most comprehensive list of key drug shortage monitoring varieties ever in 2022. We aim to analyze the attributes and characteristics of the medicines within the list to provide a reference for improving China’s supply security of shortage drugs.

Methods
We used public data to extract information on drug types, dosage forms, indications, classification of clinical uses, whether they were included in medical catalogs such as the National Essential Drugs, and the number of drug and active pharmaceutical ingredient (API) manufacturers. A descriptive statistical analysis was used.

Results
Of the 980 drugs on the list, 99.59% were chemicals and 92.65% were injectables. Drugs for blood and hematopoietic organs, the cardiovascular system, and the digestive tract and metabolism ranked among the top three shortages. Verification of the medical catalogs showed that 90.41% of the drugs belonged to the national essential drugs, 95.10% were medicare drugs, 2.55% were volume-based procurement drugs, and 14.70% were for rare diseases, and 42.04% were for children. In terms of drug supply capacity, 21.33% of drug approvals are less than 10, and there were even 26 drugs for exclusive production, close to 90% of manufacturers need to purchase APIs from outside. Among the 256 APIs included in the list, 152 APIs had less than 10 manufacturers, and there were even 5 APIs produced by only one enterprise nationwide.

Conclusions
The situation of drug shortages in China was severe and complex, with serious shortages of medicines adapted to basic medical and healthcare needs and clinically necessary medicines, and a need to improve the production capacity of drugs and the ability to supply APIs. We recommend strengthening drug monitoring and stockpiling and accelerating the approval of shortage drugs to improve drug supply security.
Dietary intake of luteolin is negatively associated with all-cause and cardiovascular mortality in chronic kidney disease patients
Authors: Yao Xiaotian , Zhou Zhengxi 
Published: July 2024

Abstract
Background
Luteolin (Lut), a flavonoid present in the daily diet, exhibits potent anti-inflammatory and renoprotective effects. However, the association between Lut and chronic kidney disease (CKD) remains uncertain. The objective of this study is to explore the potential correlation.

Methods
A total of 2,393 CKD patients were enrolled in a prospective cohort in the National Health and Nutrition Examination Survey (NHANES). A 24-h dietary recall was utilized to estimate the intake of dietary Lut based on the type and amount of food consumed. The National Death Index mortality data was utilized to ascertain all-cause and cardiac mortality (as of December 27, 2023). Cox proportional hazards model was used to estimate the relationship between Lut intake and mortality risk.

Results
The median Lut intake was 0.305 mg/day, with interquartile range was 0.105–0.775 mg/day. During the follow-up period (median, 93 months), 682 all-cause deaths (217 cardiovascular disease [CVD] deaths) were recorded. Per unit increase in Lut intake reduced all-cause mortality by 27% (P < 0.001) and cardiac mortality by 34% (P = 0.01) in CKD patients. There was an inverse dose–response association between Lut intake (range: 0–8.945 mg/day) and mortality risk. Consistent results were also shown when stratified by age, sex, race, marital status, body mass index, CKD stage, urine protein creatinine ratio strata, CKD progression risk, hypertension, and CVD.

Conclusion
Dietary Lut intake is associated with a reduction in all-cause and cardiac mortality among CKD patients, potentially attributable to the anti-inflammatory characteristics of Lut.
The Chinese version of rating scale of pain expression during childbirth (ESVADOPA): reliability and validity assessment
Authors: Wu Yu , Chu Yanxin , Zhao Xin , Wang Xiaoli , Chen Liyuan , Duan Ruihan , Li Yunfeng , Liu Xia 
Published: July 2024

Abstract
Background
Childbirth pain is a physiological phenomenon during the delivery process, the intense pain of childbirth could bring harmful effects to pregnant women and their babies. Assessment of childbirth pain is the first step in childbirth pain intervention. Some pain assessment scales have shortcomings such as interfering in the birthing process and affecting pain perception during delivery, while the Rating Scale of Pain Expression during Childbirth (ESVADOPA) could be used as an auxiliary scale to compensate for these shortcomings. The purpose of this study was to introduce the ESVADOPA and adapt it among Chinese pregnant women to check on the psychometric properties of the translated version of ESVADOPA.

Methods
A new translation model based on Brislin’s classical back translation model was used to translate and cross-cultural adapt the ESVADOPA. During June 2021 and June 2022, pregnant women at Shandong Provincial Hospital Affiliated to Shandong First Medical University were invited. In the stage of translation and cross-culturally adaptation, 18 midwives and 30 pregnant women were invited to participate in the first round of pre-experiment. And in the second round of pre-experiment, 15 midwives and 20 pregnant women were invited to participate. The Chinese version of ESVADOPA was tested on a group of pregnant women (N = 487). Construct validity was evaluated by exploratory factor analysis, confirmatory factor analysis and criterion-related validity. Reliability was assessed by Cronbach’s α coefficient, McDonald Omega, Spearman-Brown split-half reliability and Guttman split-half reliability.

Results
The item statistical analysis and construct validity resulted in six items and one factor that explained 61.064% of the total variance. Confirmatory factor analysis showed that the data fit the one-factor structure. Criterion-related validity indicated that the scale is significantly and positively correlated with the Numeric Rating Scale (NRS). Cronbach’s α coefficient, McDonald Omega, Spearman-Brown split-half reliability, and Guttman split-half reliability of the Chinese version of ESVADOPA were 0.868, 0.896, 0.845, 0.842, respectively.

Conclusion
The Chinese version of the ESVADOPA with good reliability and validity data could be used to assess the pain rating of pregnant women during childbirth without interfering in the birthing process.