bluuebunny/crossref_metadata_2025_split huggingface dataset:
Safety surveillance and challenges in accelerated COVID-19 vaccine development
Authors: Cole Abimbola , Webster Peggy , Van Liew Denny , Salas Maribel , Aimer Omar , Malikova Marina A. 
Published: September 2022

The COVID-19 pandemic, caused by a novel type of coronavirus, continues to infect people, increasing morbidity and mortality across the globe. Measures to slow the transmission of the virus have had limited impact, and people, businesses, and economies have suffered. The disease has disproportionally impacted elderly and individuals with certain pre-existing conditions and has highlighted health and social inequities in some racial and ethnic minority groups. The majority of those who contract the disease recover completely, but some experience long-lasting complications. Vaccines have the potential to end the pandemic, and through the intense collaboration of scientists in government and private sectors, more than 200 COVID-19 candidate vaccines have been or are being developed, using known platforms and previous experiences with severe acute respiratory syndrome (SARS), at unprecedented speed. The expectations for vaccine safety and quality in the setting of accelerated development are the same as during non-emergency times; however, challenges inherent with the circumstances of the pandemic situation provide opportunities to improve clinical trial conduct and strengthen pharmacovigilance systems. We have reviewed and analyzed existing PV guidelines and recommendations throughout the lifecycle of vaccine development with a focus on developing a global/worldwide effort for post-marketing vaccine safety surveillance. Plain Language Summary The Important Role of Pharmacovigilance in Accelerated COVID-19 Vaccine Development This is an extensive review that intends to address important aspects of COVID-19 vaccines’ accelerated development and safety surveillance. It is focused on regulatory requirements for long-term safety monitoring, practical applications, and current global efforts in developing robust pharmacovigilance systems for post-authorization surveillance. Notably, different perspectives of authors from industry, academic institutions, and contract research organizations involved in drug safety were incorporated to reflect on various regulatory requirements and new developments in vaccine safety. All co-authors are current members of International Society of Pharmacovigilance (ISoP).
Promoting Well-Being and Responsiveness in Pre-Service Teachers Using Dialectical Behavior Therapy Skills: A Mixed-Methods Study
Authors: Zieher Almut K. , Armstrong Jan 
Published: September 2022

Mindfulness trainings are a promising approach for mitigating teacher burnout and promoting well-being and effective teaching, yet few studies with pre-service teachers employ this approach for prevention purposes, and only one has used dialectical behavior therapy (DBT) skills. In this study, 12 pre-service teachers were taught DBT skills in eight 1-hour weekly sessions to promote their mindfulness and well-being. Using mixed methods, we investigated how pre-service teachers used DBT skills and evaluated training effects and feasibility. Findings from 81 days of daily survey data indicated that pre-service teachers’ mindfulness and positive affect were significantly higher the evening after training sessions and that their positive affect remained elevated through the next evening. Completed homework sheets, researcher journals, and interviews provided evidence of how the pre-service teachers used DBT skills to navigate challenges and support their students. We identified the need for more frequent sessions and additional structures to promote practice of DBT skills in daily life. The results from this study point to the feasibility of using DBT skills in a preventative capacity as part of teacher preparation programming to support teachers’ ongoing well-being and effective teaching.
Identification of COX4I2 as a hypoxia-associated gene acting through FGF1 to promote EMT and angiogenesis in CRC
Authors: Li Jie-pin , Liu Yuan-jie , Zeng Shu-hong , Gao Hai-jian , Chen Yu-gen , Zou Xi 
Published: September 2022

AbstractBackgroundCurrent evidence suggests that the hypoxic tumor microenvironment further aggravates tumor progression, leading to poor therapeutic outcomes. There is as yet no biomarker capable of evaluating the hypoxic state of the tumor. The cytochromecoxidase (COX) subunit is crucial to the mitochondrial respiratory chain.MethodsWe investigated the potential oncogenic role of COX subunit 4 isoform 2 gene (COX4I2) in colorectal cancer (CRC) by least absolute shrinkage and selection operator (LASSO) and COX regression analysis to examine whetherCOX4I2overexpression can predict colorectal cancer (CRC) prognosis. The association ofCOX4I2levels with clinical features and its biological actions were evaluated both in vitro and in vivo.ResultsOur analysis showed that elevatedCOX4I2levels were correlated with poor clinical outcomes. We also observed that thatCOX4I2may be involved in epithelial-mesenchymal transition, activation of cancer-related fibroblasts and angiogenesis in relation to fibroblast growth factor 1.ConclusionsTheCOX4I2level may be a predictor of outcome in CRC and may represent a novel target for treatment development.Graphical Abstract
Characterisation and analysis of key studies used to restrict substances under REACH
Authors: Borchert Flora , Beronius Anna , Ågerstrand Marlene 
Published: September 2022

Abstract
Background
Understanding how scientific studies are used in regulatory risk assessments is important since it influences the outcome of an assessment, and thus the level of protection of human health and the environment. Within the REACH legislation (Registration, Evaluation, Authorisation and Restriction of Chemicals, EC Nr. 1907/2006) hazard information on clearly defined (eco-)toxicological endpoints are submitted for the registration of substances, and this information is intended for concluding on potential hazards and risk as well as subsequent risk management measures such as restrictions. The present study aimed to (1) characterise key studies used by the European Chemicals Agency’s Committee for Risk Assessment to restrict hazardous substances; (2) analyse if the REACH registration database provided the key studies used in these restrictions, and (3) investigate potential expert disagreements related to the use of non-standard studies in the restrictions.

Results
Our analysis showed that 58% of the 53 scrutinised key studies were non-standard studies, all available by paying a fee or through open access. Sixteen (30%) of the key studies were consulted from external sources outside the REACH registration database by the Committee for Risk Assessment. Only one study of the 16 external key studies was a standard study. Further, 9% (5/53) of the key studies used by the Committee for Risk Assessment were inaccessible to third parties, all were standard studies. The uses of non-standard studies were (unsuccessfully) challenged for five substances during the public consultation.

Conclusions
These results suggest that non-standard studies contributed to the identification and management of substances of concern, that the REACH registration database may not be sufficient for the identification and management of uncontrolled hazards and risks, and that the transparency of the decisions made by the Committee for Risk Assessment was partially hampered due to the use of standard studies inaccessible to third parties.
Dignity and psychosocial related variables in elderly advanced cancer patients
Authors: Martín-Abreu Carla M. , Hernández Raquel , Cruz-Castellanos Patricia , Fernández-Montes Ana , Lorente-Estellés David , López-Ceballos Helena , Ostios-Garcia Lorena , Antoñanzas Mónica , Jiménez-Fonseca Paula , García-García Teresa , Calderon Caterina 
Published: September 2022

Abstract
Introduction
Most cancers occur in older individuals, who are more vulnerable due to functional impairment, multiple comorbidities, cognitive impairment, and lack of socio-familial support. These can undermine patients’ sense of dignity. This study seeks to compare dignity scores in older patients with advanced cancer on sociodemographic and clinical variables and analyze the predictive value of anxiety, depression, functional limitations, and social support on dignity scores.

Methods
A prospective, multicenter, observational study conducted with participation of 15 hospitals in Spain from February 2020 to October 2021. Patients with newly-diagnosed, advanced cancer completed the dignity (PPDS), anxiety and depression (BSI), Social Support (Duke–UNC-11), and functional limitations (EORTC-C30) scales. Lineal regression analyses explored the effects of anxiety, depression, functional status, and social support on dignity, adjusting for sociodemographic and clinical variables.

Results
A total of 180 subjects participated in this study. The results of the correlation analysis revealed that dignity correlated negatively with anxiety, depression, and sex, and positively with social support, functional status, and longer estimated survival. Thus, women, and more anxious and depressed individuals scored lower on the dignity scale, whereas patients with more social support, fewer functional limitations, and longer estimated survival scored higher.

Conclusion
In conclusion, being female, having a lower educational level, lower estimated survival, depression, anxiety, less social support, and limited functionality are correlated with less dignity in the elderly with advanced cancer. It is a priority to manage both physical and psychological symptoms in patients with unresectable advanced cancer to mitigate psychological distress and increase their sense of dignity.
Using pre-operative radiomics to predict microvascular invasion of hepatocellular carcinoma based on Gd-EOB-DTPA enhanced MRI
Authors: Lu Xin-Yu , Zhang Ji-Yun , Zhang Tao , Zhang Xue-Qin , Lu Jian , Miao Xiao-Fen , Chen Wei-Bo , Jiang Ji-Feng , Ding Ding , Du Sheng 
Published: September 2022

Abstract
Objectives
We aimed to investigate the value of performing gadolinium-ethoxybenzyl-diethylenetriamine pentaacetic acid (Gd-EOB-DTPA) enhanced magnetic resonance imaging (MRI) radiomics for preoperative prediction of microvascular invasion (MVI) of hepatocellular carcinoma (HCC) based on multiple sequences.

Methods
We randomly allocated 165 patients with HCC who underwent partial hepatectomy to training and validation sets. Stepwise regression and the least absolute shrinkage and selection operator algorithm were used to select significant variables. A clinicoradiological model, radiomics model, and combined model were constructed using multivariate logistic regression. The performance of the models was evaluated, and a nomogram risk-prediction model was built based on the combined model. A concordance index and calibration curve were used to evaluate the discrimination and calibration of the nomogram model.

Results
The tumour margin, peritumoural hypointensity, and seven radiomics features were selected to build the combined model. The combined model outperformed the radiomics model and the clinicoradiological model and had the highest sensitivity (90.89%) in the validation set. The areas under the receiver operating characteristic curve were 0.826, 0.755, and 0.708 for the combined, radiomics, and clinicoradiological models, respectively. The nomogram model based on the combined model exhibited good discrimination (concordance index = 0.79) and calibration.

Conclusions
The combined model based on radiomics features of Gd-EOB-DTPA enhanced MRI, tumour margin, and peritumoural hypointensity was valuable for predicting HCC microvascular invasion. The nomogram based on the combined model can intuitively show the probabilities of MVI.
Clinical and immunohistochemical analysis of the verrucous and non-verrucous divided nevus of the eyelids
Authors: Deng Yuan , Li Zhengkang , Zhang Leilei 
Published: September 2022

Abstract
Purpose
Divided nevus with verrucous hyperplasia will always recur after surgery but non-verrucous divided eyelid nevus rarely recur. This study analyzed the differential expression of Ki-67, S100, Melan A and HMB45 and identified the correlation between the clinical and histopathological features of verrucous and non-verrucous divided eyelid nevus.

Methods
This study included 29 patients, of whom 8 patients had verrucous divided nevus. Immunohistochemistry labeling was used to assess the expression of Ki-67, S100, Melan A and HMB45 after excision. The difference between verrucous and non-verrucous divided eyelid nevus was analyzed.

Results
The patients’ ages ranged from 2 to 59 years, with a mean age of 19 years. The lesion size ranged from 1.5 to 2.0 cm in diameter and invaded the eyelid margins and the posterior lamella of the eyelids. Immunohistochemistry labeling showed strong positivity for approximately 98.5% of S100 and positive staining for approximately 27.6% of Ki-67, 72.4% of Melan A and 6.8% of HMB45. However, Ki-67 was significantly upregulated in verrucous divided nevus of the eyelids compared with non-verrucous divided nevus, with approximately 38.8% upregulation in verrucous and 18.3% upregulation in non-verrucous nevus.

Conclusions
This study correlated the clinic-pathologic features of verrucous divided eyelid nevus by means of statistically analyzing the varied clinical features and pathological impressions. The significant over-expression of S100 may be used as an indicator of divided nevus of the eyelids, and the over-expressed Ki-67 may contribute to the recurrence of verrucous divided nevus. High expression of HMB45 and Melan A may represent malignant transformation.
The effect of the combined use of complex decongestive therapy with electrotherapy modalities for the treatment of breast cancer-related lymphedema: a randomized clinical trial
Authors: Hemmati Mahboobeh , Rojhani-Shirazi Zahra , Zakeri Zeinab Sadat , Akrami Majid , Salehi Dehno Nasrin 
Published: September 2022

Abstract
Background
We evaluated the effects of combined complex decongestive therapy (CDT) with electrotherapy modalities (ultrasound and faradic currents) in patients with breast cancer-related lymphedema (BCRL), investigating upper extremity circumference, volume, pain, and functional disability.

Methods
Thirty-nine patients with unilateral BCRL were randomly allocated to three groups (n = 13) as the following: The control group received CDT, the ultrasound group received CDT and therapeutic ultrasound, and the faradic group received CDT and faradic current. All the participants underwent treatment for 10 sessions. The outcomes including volume, circumference (measured at five points), pain intensity, and functional disability of the affected upper extremity were evaluated at baseline and after the treatment.

Results
Following the treatment, an improvement was noted in lymphedema volume, pain, and functional disability in all the three groups and there was a significant difference between the groups (P < 0.05). However, changes in limb circumference at the end of the treatment were not significantly different among the three groups in any sites (P > 0.05).

Conclusion
The combination of electrotherapy modalities, faradic current or ultrasound, with CDT can result in a greater reduction in lymphedema volume, pain, and functional disability in patients with BCRL.

Trial registration
IRCT, IRCT201310292391N14, registered 03/01/2016.
Sex differences in factors associated with neck pain among undergraduate healthcare students: a cross-sectional survey
Authors: Zheng Bi’e , Zheng Lifeng , Li Ming , Lin Jianping , Zhu Yuxiang , Jin Liuzhisheng , You Roushi , Gao Yifang , Liu Xia , Wang Shizhong 
Published: September 2022

Abstract
Background
Neck pain is widespread among students in healthcare-related fields. Although neck pain is more prevalent in females, since most research involves mixed-sex samples we know very little about sex differences in contributors to neck pain. Thus, this study sought to explore sex differences in the risk factors for neck pain in this high-risk population.

Methods
This cross-sectional study was conducted in China in 2021 and included a sample of 1921 undergraduate healthcare students (693 males, 1228 females) from 7 health professional schools at Fujian Medical University. We collected data on neck pain symptoms, demographics, behavioral and psychological factors. Multiple regression analysis was conducted to examine sex differences in the risk factors of neck pain.

Results
The overall prevalence of neck pain was 41.6% with female students having a higher prevalence than male students (44.4% vs. 36.7%, respectively). The adjusted analyses showed that self-study time ≥ 6 h/day (OR = 1.44, 95% CI:1.13-1.83), flexed neck posture >20 degrees (OR = 2.19, 95% CI: 1.28-3.74), static duration posture >2 h (OR = 1.42, 95% CI: 1.02-1.97), and psychological distress (high: OR = 2.04, 95% CI:1.42-2.94; very high: OR = 2.50, 95% CI:1.57-3.74; respectively) were independent factors for neck pain in females. Among males, self-study time ≥ 6 h/day (OR = 1.43, 95% CI: 1.02-2.01) and psychological distress (moderate: OR = 2.04, 95% CI:1.28-3.25; high: OR = 2.37, 95% CI:1.49-3.79; very high: OR = 2.97, 95% CI:1.75-5.02; respectively) were significant risk factors for neck pain.

Conclusions
These findings suggest that the risk profiles of neck pain differ between females and males. The modifiable risk factors for neck pain, such as prolonged self-study time and elevated psychological distress, as well as poor posture among females, could be targeted through health promotion interventions in university settings.
A systematic review of chiropractic care for fall prevention: rationale, state of the evidence, and recommendations for future research
Authors: Grabowska Weronika , Burton Wren , Kowalski Matthew H. , Vining Robert , Long Cynthia R. , Lisi Anthony , Hausdorff Jeffrey M. , Manor Brad , Muñoz-Vergara Dennis , Wayne Peter M. 
Published: September 2022

Abstract
Background
Falls in older adults are a significant and growing public health concern. There are multiple risk factors associated with falls that may be addressed within the scope of chiropractic training and licensure. Few attempts have been made to summarize existing evidence on multimodal chiropractic care and fall risk mitigation. Therefore, the broad purpose of this review was to summarize this research to date.

Body
Systematic review was conducted following PRISMA guidelines. Databases searched included PubMed, Embase, Cochrane Library, PEDro, and Index of Chiropractic Literature. Eligible study designs included randomized controlled trials (RCT), prospective non-randomized controlled, observational, and cross-over studies in which multimodal chiropractic care was the primary intervention and changes in gait, balance and/or falls were outcomes. Risk of bias was also assessed using the 8-item Cochrane Collaboration Tool. The original search yielded 889 articles; 21 met final eligibility including 10 RCTs. One study directly measured the frequency of falls (underpowered secondary outcome) while most studies assessed short-term measurements of gait and balance. The overall methodological quality of identified studies and findings were mixed, limiting interpretation regarding the potential impact of chiropractic care on fall risk to qualitative synthesis.

Conclusion
Little high-quality research has been published to inform how multimodal chiropractic care can best address and positively influence fall prevention. We propose strategies for building an evidence base to inform the role of multimodal chiropractic care in fall prevention and outline recommendations for future research to fill current evidence gaps.
Should adjacent asymptomatic lumbar disc herniation of L5-S1 isthmic spondylolisthesis be simultaneously rectified? Evaluation of postoperative spino-pelvic sagittal balance and functional outcomes
Authors: Deng Lei , Hua Xi , Wu Qian , Lv Nanning , Shao Xiaofeng , Zhou Quan , Liu Hao , Qian Zhonglai 
Published: September 2022

Abstract
Background
This study aimed to analyze the efficacy of the simultaneous rectification of adjacent asymptomatic lumbar disc herniation (asLDH) of L5-S1 isthmic spondylolisthesis (IS).

Methods
One hundred and forty-eight patients with L5-S1 IS, and simultaneous L4-5 asLDH, were recruited between January 2012 and December 2017, for this study. Group A: seventy-two patients received PLIF at L5-S1. Group B: seventy-six patients received PLIF at L4-S1. The radiographic outcomes were assessed via the lumbar lordosis (LL), segmental lordosis (SL), sacral slope (SS), pelvic incidence (PI), pelvic tilt (PT), PI-LL and slip degree (SD). The functional outcomes were evaluated via the visual analog scale (VAS), Oswestry disability index (ODI), and reoperation rate. The potential risk hazards for reoperation were identified using both uni- and multivariate logistic regression analyses.

Results
The postoperative LL, SL, PT, SS, SD, VAS, and ODI exhibited vast improvements (P < 0.05). Relative to Group A, Group B exhibited markedly better LL, SL, PT, PI-LL,VAS and ODI scores at the final follow-up (P < 0.05). Group B also achieved better SD values post surgery than Group A (P < 0.05). The reoperation rate was remarkably elevated in Group A, compared to Group B (P < 0.05). The multivariate logistic regression analysis showed the L4-5 asLDH grade was a stand-alone risk hazard for reoperation, whereas, pre-SL and pre-LL offered protection against reoperation (P < 0.05).

Conclusions
L4-S1 PLIF is recommended to correct asLDH in L5-S1 IS patients, with high-grade disc herniation and abnormal sagittal alignment.
A simple arthroscopic technique for treatment of displaced “hinged” type of posterior cruciate ligament avulsion fractures
Authors: Xu Zheshu , Dong Yunlong , Feng Yu-e , Xie Peng , Gu Juyuan , Kang Kai , Gao Shijun , Zheng Xiaozuo 
Published: September 2022

Abstract
Background
The surgical technique for treatment of tibial avulsion fractures of the posterior cruciate ligament (PCL) remains challenging due to the deep-located lesion and the complexity of the anatomy. The purpose of this study was to report preliminary results of an arthroscopic technique in patients with the “hinged” type PCL tibial avulsion fractures.

Methods
Twenty-eight patients with the displaced “hinged” fractures with elevation of the posterior aspect of the bony fragment were arthroscopically treated. The bony fragment was reducted and fixed with the sutures passing through only one single tibial tunnel. The clinical outcomes were assessed by Lysholm score, Tegner activity score, and the side-to-side differences of KT-1000 measurement. The reduction and union of the fracture were assessed by radiography of the knee.

Results
Patients were followed up for a mean of 19 (12 to 24) months. There were no surgery-related complications, and all patients regained normal range of motion of the knees at the last follow-up. The Lysholm score significantly increased from preoperative 14.78 ± 8.23 to postoperative 96.96 ± 3.62 (P = 0.000). The Tegner score was 6.78 ± 1.35 pre-injury and 6.48 ± 1.20 at the last follow-up with no statistical difference (P = 0.688). The KT-1000 side-to-side differences significantly decreased from 8.26(SD 1.86; 6 to 12) pre-operatively to 0.91 (SD 0.85; 0 to 3) (P = 0.000). X-rays showed that satisfactory reduction and solid union was achieved in all patients.

Conclusion
The arthroscopic suture fixation through single-tibial tunnel technique yielded good clinical and radiographic outcome for treatment of displaced “hinged” type of PCL avulsion fractures.