bluuebunny/crossref_metadata_2025_split huggingface dataset:
Improving the patient-reported outcome sections of clinical trial protocols: a mixed methods evaluation of educational workshops
Authors: King Madeleine , Tait Margaret-Ann , Campbell Rachel , Müller Fabiola , Rutherford Claudia , Beckmore Corinna , Chima Sophie , Langbecker Danette , Shaw Joanne , Mercieca-Bebber Rebecca 
Published: August 2021

Abstract
IntroductionFailure to incorporate key patient-reported outcome (PRO) content in trial protocols affects the quality and interpretability of the collected data, contributing to research waste. Our group developed evidence-based training specifically addressing PRO components of protocols. We aimed to assess whether 2-day educational workshops improved the PRO completeness of protocols against consensus-based minimum standards provided in the SPIRIT-PRO Extension in 2018.MethodAnnual workshops were conducted 2011–2017. Participants were investigators/ trialists from cancer clinical trials groups. Although developed pre-2018, workshops covered 15/16 SPIRIT-PRO items. Participant feedback immediately post-workshop and, retrospectively, in November 2017 was summarised descriptively. Protocols were evaluated against SPIRIT-PRO by two independent raters for workshop protocols (developed post-workshop by participants) and control protocols (contemporaneous non-workshop protocols). SPIRIT-PRO items were assessed for completeness (0 = not addressed, 10 = fully addressed). Mann-Whitney U-tests assessed whether workshop protocols scored higher than controls by item and overall.ResultsParticipants (n = 107) evaluated the workshop positively. In 2017, 16/41 survey responders (39%) reported never applying in practice; barriers included role restrictions (14/41, 34%) and lack of time (5/41, 12%). SPIRIT-PRO overall scores did not differ between workshop (n = 16, mean = 3.84 (standard deviation = 1.86)) and control protocols (n = 6, 2.46 (1.35)), (p = 0.09). Workshop protocols scored higher than controls on two items: ‘specify PRO concepts/domains’ (p = 0.035); ‘specify analysis methods’ (p = 0.011).ConclusionAlthough participants were highly satisfied with these workshops, the completeness of PRO protocol content improved only slightly. Additional knowledge translation efforts are needed to assist protocol writers address SPIRIT-PRO guidance and avoid research waste that may eventuate from sub-optimal PRO protocol content.
Genetic Characterisation of Spring Viraemia of Carp Virus Strains in Russia
Authors: Perchun Aleksey , Pavlov Dmitry , Melnikov Vladimir , Antonychev Aleksey , Zinyakov Nikolay , Korennoy Fedor , Moroz Natalya , Chvala Ilya , Metlin Artem 
Published: August 2021

Abstract
The paper presents genetic characteristics of two strains of the spring viraemia of carp virus strains Kirov/08 and Orenburg/14 isolated in the Kirov and Orenburg Oblasts of the Russian Federation, respectively. The nucleotide sequence analysis of the 516-bp fragment of Kirov/08 and Orenburg/14 G gene showed 9.5% difference. The phylogenetic analysis demonstrated a high level of homology of these strains to SVC viruses, isolated earlier in Russia, Ukraine and the Republic of Moldova.
Beauveria Bassiana as Fungal Endophyte for the Potential Control of the Potato Tuber Moth Phthorimaea Operculella on Potatoes
Authors: Zhang Mengdi , Yan Junjie , Reitz Stuart , Wu Shengyong , Gao Yulin 
Published: August 2021

Abstract
The potato tuber moth, Phthorimaea operculella, is the most damaging potato pest in the world and is difficult to control as the larvae are internal feeders in the foliage or tubers. Entomopathogenic fungi (EPF) which colonize plants as endophytes, have lethal and sublethal pathological effects on insect pests. Experiments showed that Beauveria bassiana colonized the aerial parts of potato plants endophytically after inoculation through soil drenching. The colonization rate reached 100% for both upper and lower foliage parts one day after inoculation, and endophytic B. bassiana remained present for more than 21-day post inoculation. Mortality experiments indicated that B. bassiana and B. bassiana-inoculated potato plants were pathogenic against 2nd instar larvae of P. operculella. Development experiments showed that the weight of P. operculella pupae reared on B. bassiana-colonized potato leaves (4.25 mg) was significantly lighter than of those reared on uninoculated control plants (8.89 mg). Sublethal experiments indicated that B. bassiana negatively affected the growth, development and reproduction of P. operculella. Compared to newly eclosed larvae fed on control plants, those fed on B. bassiana-inoculated plants had significantly lower survival, with only 17.8% developing to the adult stage. Oviposition of P. operculella females reared on B. bassiana endophytically-colonized plants was significantly lower (35 eggs/per female) than of those reared on uninoculated plants (115 eggs/per female). This study demonstrates that endophytic B. bassiana can be a potential biological agent for the control and management of P. operculella.
Diagnostic Utility of Next-Generation Sequencing-Based Panel Testing in 543 Patients with Suspected Skeletal Dysplasia
Authors: Scocchia Alicia , Kangas-Kontio Tiia , Irving Melita , Hero Matti , Saarinen Inka , Pelttari Liisa , Gall Kimberly , Valo Satu , Huusko Johanna M. , Tallila Jonna , Sistonen Johanna , Koskenvuo Juha , Alastalo Tero-Pekka 
Published: August 2021

Abstract
Background: Skeletal dysplasia is typically diagnosed using a combination of radiographic imaging, clinical examinations, and molecular testing. Identifying a molecular diagnosis for an individual with a skeletal dysplasia can lead to improved clinical care, guide future medical management and treatment, and inform assessment of risk for familial recurrence. The molecular diagnostic utility of multi-gene panel testing using next-generation sequencing (NGS) has not yet been characterized for an unselected population of individuals with suspected skeletal dysplasia. In this study, we retrospectively reviewed patient reports to assess the diagnostic yield, reported variant characteristics, impact of copy number variation, and performance in prenatal diagnostics of panel tests for variants in genes associated with skeletal dysplasia and growth disorders. Results: Clinical reports of consecutive patients with a clinical indication of suspected skeletal dysplasia who underwent panel testing were examined. The 543 patients included in the study submitted samples for diagnostic genetic testing with an indication of suspected skeletal dysplasia or growth disorder and received one of three nested panel tests. A molecular diagnosis was established in 42.0% of patients (n=228/543). Diagnostic variants were identified in 71 genes, nearly half of which (n=35, 49.3%) contributed uniquely to a molecular diagnosis for a single patient in this cohort. Diagnostic yield was significantly higher among fetal samples (58.0%, n=51/88) than postnatal samples (38.9%, n=177/455; z=3.32, p<0.0009). Diagnostic variants in fetal cases were identified across 18 genes. Thirteen diagnostic CNVs were reported, representing 5.7% of diagnostic findings and ranging in size from 241-bp to whole chromosome aneuploidy. Additionally, 11.4% (36/315) of non-diagnostic patient reports had suspicious variants of unknown significance (VUS), in which additional family studies that provide segregation data and/or functional characterization may result in reclassification to likely pathogenic. Conclusions: These findings demonstrate the utility of panel testing for individuals with a suspected skeletal dysplasia or growth disorder, with a particularly high diagnostic yield seen in prenatal cases. Pursuing comprehensive panel testing with high-resolution CNV analysis can provide a diagnostic benefit, given the considerable phenotype overlap amongst skeletal dysplasia conditions.
Prognostic Role of Ultrasound Imaging in Desmoplastic Small Round Cell Tumor: A Retrospective Study and Literature Review
Authors: Zhang Jing , Cheng Xueqing , Liu Juxian , Liu Jiakai , Lu Qiang , Yan Feng , Xu Jinshun , Peng Yulan 
Published: August 2021

Abstract
Background: Desmoplastic small round cell tumor (DSRCT) mostly arose in the abdominopelvic cavity is an aggressive sarcoma with poor prognosis. The purpose of this study is to analyze ultrasonographic performance in prediction of prognosis of DSRCT.Method: Between March 1999 and October 2019, a total of 27 patients with pathologically confirmed DSRCT in our hospital were conducted. Clinical and ultrasonographic characterizations, including age, sex, symptoms, tumor size, number, location, shape, margin, echogenicity, homogeneity, vascularity, and metastases were recorded and analyzed with overall survival (OS) by using univariate analysis.Result: Ultrasonographic performance of DSRCT were irregular (74%), posterior echo enhancement (63%), calcification (51.9%), and liquefaction (55.6%) in tumors companied with ascites (63%), hydronephrosis (59%) and metastases (63%). The median OS was 22 months (range 7–36 months) and 5-year OS rate was 19.6%. Using univariate analysis, a higher hazard ratio (HR) of mortality was associated with liquefaction (HR: 3.09, 95% CI:1.23-7.76, p=0.016) and bone metastasis (HR: 2.95, 95%CI: 1.16-7.49, p=0.023). According to a risk staging system developed by selected predictors (low = neither liquefaction nor bone involvement; moderate = either liquefaction or bone involvement; high = both liquefaction and bone involvement), 40%, 10%, and 0 of 3-year survival were found in the low, moderate, and high risk patients, respectively.Conclusion: Ultrasound imaging is effective to evaluate prognosis of DSRCT. Findings of liquefaction and bone involvement in the ultrasonography may predict a poor prognosis of DSRCT patients.
Building a Cancer Coalition: A co-design framework for evaluating regionalism in the South Pacific
Authors: Hyatt Amelia , Chan Belinda , Moodie Rob , Varlow Megan , Bates Chris , Folaki Sunia , Palafox Neal , Burich Shelley , Aranda Sanchia 
Published: August 2021

Abstract
Background

Cancer is a significant problem for the South Pacific region due to a range of complex and unique health challenges caused by shared social, environmental and economic factors. Currently gaps in diagnosis, treatment and palliative care are significant, and while governmental commitment is strong, economic constrains limit health system strengthening. Collaboration, alliances and partnerships in cancer control have been successful in resource constrained settings. A regional approach has therefore been recommended as an effective solution to addressing many of the challenges for cancer control in the South Pacific. However, comprehensive and appropriate information detailing how to effectively scope and establish a multi-national or regional coalition is scarce. This study therefore aimed to 1) create a Coalition Development Framework, and 2) use the Framework to co-design a South Pacific Cancer Control Coalition through consultation with key cancer control stakeholders working within Fiji, New Caledonia, Papua New Guinea, Samoa and Tonga.
Results

Analysis of the consultations with key cancer control stakeholders identified overwhelming appetite and support for a South Pacific Cancer Control Coalition. This paper details the following six coalition development outputs: coalition design and purpose, strategic imperatives, structure, South Pacific foundations, barriers and facilitators to coalition establishment and ongoing operations, priorities for action. Concurrent evaluation of the Coalition Development Framework using theory of change revealed the framework to be an effective mechanism to drive engagement, discovery, unification and action in alliance-building.
Conclusions

A regional Coalition to drive cancer control in the South Pacific has significant support among key Pacific stakeholders. Likewise, design and scope of the Coalition has been synthesised and mapped to guide feasible and appropriate establishment. Importantly our results also describe the effective implementation of a Coalition Development Framework in an applied setting, to guide future use. If momentum is continued, and a regional South Pacific Coalition established, the benefits in reducing the burden of cancer within the region will be substantial.
Is waist-to-height ratio the best predictive indicator of cardiovascular disease incidence in hypertensive adults? A cohort study
Authors: Sun Yingxian , Zhang Shu , Fu Xin , Du Zhi , Guo Xiaofan , Sun Guozhe , Li Zhao , Zhou Ying , Yang Hongmei , Yu Shasha , Zheng Liqiang 
Published: August 2021

Abstract
Background

Cardiovascular disease (CVD) brings high mortality and economic burden to patients, especially in rural areas. Simple, low-cost abdominal adiposity measures may help identify individuals with increased CVD risk. It is unclear that which obesity indice is the best to predict CVD in hypertensive people.
Methods

NCRCHS is a prospective cohort study in a general population in Northeast China. The study examined the cardiovascular health from 2013–2015, and follow-up captured the CVD incidence in 2018. Baseline waist-to-height ratio (WHtR), body mass index (BMI),waist-to-hip(WHR)and waist circumference (WC) were calculated and analyzed in relation to the CVD incidence.
Results

A total of 4244 hypertensive adults without pre-existing CVD at baseline were included in this analysis (age 35–92 years; 2108 men). Over a median follow-up of 4.66 years, a total of 290 CVD cases (6.83%) were documented during the follow-up. Baseline WHtR showed a significant positive association with CVD incidence, even after adjusting for age, sex, diabetes, drinking, smoking, SBP, DBP, Triglyceride, HDL-C, LDL-C, and TC (Hazard Ratios per SD of WHtR ranging from 1.03 to 1.31, p = 0.017). Reclassification and discrimination analyses indicated WHtR addition could improve the conventional model for predicting adverse outcomes within 4 years. Moreover, WHtR predicted the CVD incidence better than other obesity indices (BMI, WC, WHR).
Conclusion

These findings support a positive association between WHtR and CVD incidence in CVD-free hypertensive adults. WHtR may be useful in predicting CVD incidence in hypertensive adults.
A secondary data analysis of qualitative study of individualized treatment regimen for North Indians living with human immunodeficiency virus-1
Authors: Barik Sushanta Kumar , Bansal Avi Kumar , Yadav Ashwini , Tripathy Srikanth Prasad , Singh Tej Pal , Jena Srikanta , Patil Shripad A , Mohanty Keshar Kunja 
Published: August 2021

Abstract
Background
A correlation between the CD4 counts and viral loads of HIV-1 infected North Indian patients with first line ART was reported. The follow up of fifty-seven patients were conducted after a confirmation genotypic test. The secondary data analysis was done on the data available to observe the correlation between the CD4 counts and viral loads (markers of clinical outcome) of HIV-1 Subtype C infected North Indian patients.
Methods
After analysis of the drug resistance mutations in individual patients through the drug resistance database, Stanford University, the data of resistance associated drugs, CD4 counts, viral load of individuals were compiled and analysed using Microsoft Excel 2016 and SPSS Version 22. Normality of data was checked by Shapiro-Wilk test (p < 0.05).
Results
Starting and study end point data on CD4 count, viral load and drug resistance pattern associated with multiple first line ART was available for 24 North Indian patients. Starting and study end point data on CD4 count and drug resistance pattern associated with multiple first line ART was available for 33 North Indian patients.
Conclusion
Our findings are categorically indicative that policy recommendation to provide tailor-made individualized regimen based on molecular drug resistance testing to HIV patients under AIDS control program requires robust evidence before implementation.
Natural Glycoside Salidroside Ameliorates Orthopedic Surgery-Induced Cognitive Dysfunction Through Activating Adenosine 5‘-Monophosphate-Activated Protein Kinase Signaling in Mice
Authors: Pan Cai-Long , Dai Guo-Liang , Zhang Hui-Wen , Zhang Chen-Yang , Meng Qing-Hai , Xu Lu , Xu Ning , Liu Xue , Zhang Zhiren , Zhang Yong , Tan Qi-Lian , Wang Xiao-Liang , Zhang Zhi-Yuan 
Published: August 2021

Abstract
Background: Perioperative neurocognitive disorders (PND) are the most common postoperative complications with few therapeutic options. Salidroside, a plant-derived compound, has gained increased attention as treatment for various neurological diseases and particularly modifier of microglia-mediated neuroinflammation. However, the effect of salidroside on orthopedic surgery-induced cognitive dysfunction and the underlying mechanisms are largely unknown.Methods: The Morris water maze test was used to investigate potential effects of salidroside in the animal model of tibia fracturing with intramedullary fixation. Therapeutic mechanism and related signaling pathways of salidroside in PND were further investigated with animal tissues and microglial cultures in vitro by molecular biology tests.Results: Here we found that salidroside greatly attenuated cognitive impairment in mice after orthopedic surgery. Neuroinflammation in mouse hippocampus were also attenuated by salidroside. Meanwhile, salidroside treatment induced a switch in microglia polarization to the anti-inflammatory phenotype. In vitro, salidroside suppressed the expression of pro-inflammatory cytokines and induced a switch in microglial phenotype to the anti-inflammatory phenotype. Mechanically, molecular docking studies revealed potential AMPK activation activity of salidroside. And salidroside did up-regulated the AMPK pathway proteins. Moreover, AMPK antagonist abolished the effects of salidroside in vivo and in vitro.Conclusions: Taken together, our results demonstrated that salidroside effectively suppressed PND by suppressing microglia-mediated neuroinflammation through activating AMPK pathway, and it might be a novel therapeutic approach for PND.
Association Between the Triglyceride Glucose Index and Alanine Aminotransferase Levels: a Cross-sectional Study
Authors: Hua Yu , Yu Haiyue , Chen Shuang , Zhang Xueyao , Zhang Xingang , Sun Yingxian 
Published: August 2021

Abstract
Background: The triglyceride glucose index (TyG) has been proposed as a marker of insulin resistance or type 2 diabetes mellitus (T2DM). Risk of serum alanine aminotransferase (ALT) levels is increased in T2DM patients. We aimed to evaluate the association between TyG index and elevated ALT. Methods: A multicenter, cross-sectional study was conducted in China from Northeast China Rural Cardiovascular Health Study (NCRCHS), and 11,573 adults with complete data were included in our final analysis.Results: TyG index was positively associated with the prevalence of elevated ALT. Frequency of elevated ALT increased from the lowest to the top quartile of TyG in both sexes (p for trend <0.001). Compared with the participants in the lowest quartile of TyG, the adjusted odds ratio and 95% CIs for elevated ALT were 1.71 (1.32-2.21) and 2.46 (1.90-3.19) for those in the third and the fourth quartile of TyG (p<0.001). Compared with the first quartile of TyG, participants in the top quartile of TyG had more than 2 times risk for elevated ALT (2.38-times for men and 2.22-times for women, respectively, p<0.001). According to the ROC analysis, the optimal cut-off point of TyG for elevated ALT was 8.69 and 8.96 for men and women, respectively. Conclusions: TyG index is effective to identify individuals at risk for elevated ALT. TyG thresholds of 8.69 for men and 8.96 for women was highly sensitive for detecting elevated ALT subjects. Findings from this study underscore that TyG index may be suitable as a surrogate marker for abnormal liver enzymes in Chinese adults.
Overexpression of Calreticulin Promotes Cardiac Fibroblasts Activation Via Regulating IRE1 Pathway
Authors: zhiyue liu , Liu Zhiyue , Zhang Wen , Li Junli , Xiao Lei , Huang He 
Published: August 2021

Abstract
Calreticulin (CRT) is an endoplasmic reticulum (ER) chaperone involved in cardiac fibroblasts (CFs) activation. It has been reported that the expression of CRT increased in the process of CFs activation. However, the role of CRT in CFs activation and the mechanism is not yet fully elucidated. Therefore, we aimed to verify whether CRT was involved in CFs activation and the possible mechanism underlying this process. We found that CRT protein level was elevated in AngⅡ-induced CFs activation. Knocking down CRT by its siRNA could decrease the protein expression of connective tissue growth factor (CTGF), α-smooth muscle actin (α-SMA), and transforming growth factor-β (TGF-β), and meanwhile attenuate proliferation and migration ratio of CFs. Moreover, the proliferation and migration rates of CFs were promoted and the expression of CTGF, α-SMA and TGF-β were increased when transfection with high-titer adenovirus of CRT. In AngⅡ-induced CFs, inositol-requiring enzyme 1(IRE-1), one of the main ER pathways, was inhibited through CRT silence and activated through CRT overexpression. Overall, this study demonstrates that CRT overexpression could promote AngⅡ induced-CFs activation by activating IRE1 pathway, which could be a potential target for CFs activation.
Femur-tibia Angle and Patella-tibia Angle: New Indicators for Diagnosing Anterior Cruciate Ligament Tears in Magnetic Resonance Imaging
Authors: Li Zeng , Li Mengyuan , Du Yan , Jiang Hai , Ma Yuanchen , Zheng Qiujian 
Published: August 2021

Abstract
Background: Torn anterior cruciate ligament (ACL) contributes to internal rotation of tibia. However, there is no indicator in MRI to reflect the rotation of knee joint. So the purpose of this study is to introduce two new measurements in MRI, femur-tibia angle (FTA) and patella-tibia angle (PTA), which reflect the rotation of knee joint and assess their role in diagnosing ACL tears.Methods: Present study retrospectively reviewed the cases of primary arthroscopic knee surgery from January 2018 to December 2019 from the Arthroscopy Database at Guangdong Provincial People's Hospital. Firstly, comparisons of different measurements were conducted between the ACL tears group and isolated meniscus injury group. Then, the measurements were tested in diagnosing complete or partial ACL tears. Diagnostic performance of different measurements was assessed by area under the curve (AUC) of receiver operating characteristic (ROC) curve and cutoff values were determined by Youden index. Results: FTA and PTA in ACL tears group had 4.79 and 7.36 degrees more than that of control group (p = 0.022 and < 0.001, respectively). Besides, ACL angle and distance of anterior tibial subluxation (D) also showed significant differences (p<0.05). In distinguishing complete ACL tear with intact ACL, the ROC curves indicated that ACL angle had the highest AUC of 0.906 (95% CI: 0.833-0.978) while AUC of PTA was 0.849 (95% CI: 0.763-0.936) and AUC of FTA was 0.809 (95% CI: 0.710-0.908). In distinguishing partial ACL tear with intact ACL, the ROC curves showed that FTA and PTA had the highest AUCs of 0.847 and 0.813 with 95% CI of 0.737-0.957 and 0.680-0.947, respectively. In contrast, the AUCs of ACL angle and D were only 0.519 and 0.387 with 95% CI of 0.292-0.745 and 0.227-0.546.Conclusion: Present study introduced two new quantitative parameters, FTA and PTA, to assess the rotation of knee joint. FTA and PTA increased when ACL tears and they might be valuable in diagnosing ACL tears, especially in distinguishing partial ACL tear with intact ACL which was poorly diagnosed in MRI.