bluuebunny/crossref_metadata_2025_split huggingface dataset:
Ganglioside-monosialic acid (GM1) for prevention of chemotherapy-induced peripheral neuropathy: a meta-analysis with trial sequential analysis
Authors: Wu Shaoyong , Bai Xiaohui , Guo Caixia , Huang Zhimei , Ouyang Handong , Huang Jingxiu , Zeng Weian 
Published: November 2021

Abstract
Background
Chemotherapy-induced peripheral neuropathy (CIPN) is a dose-limiting side effect that largely remains an unresolved clinical issue, leading to long-term morbidity. This meta-analysis aimed to evaluate the efficacy and safety of Ganglioside-monosialic acid (GM1) in preventing CIPN.

Methods
Systematic literature searches of PubMed, Web of Science, Embase, the Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov were performed to identify randomized controlled trials and cohort studies that evaluated the efficacy of GM1 for preventing CIPN. Conventional meta-analysis with a random-effects model and trial sequential analysis (TSA) were performed.

Results
A total of five studies involving 868 participants were included. The results showed that GM1 did not reduce the overall incidence of grade ≥ 2 CIPN when the common terminology criteria for adverse events (CTCAE) was used (OR 0.34, 95% CI 0.34–1.11). Subgroup analyses showed that GM1 could not reduce the risk of CTCAE grade ≥ 2 CIPN (OR 0.63, 95% CI 0.35–1.13) and neurotoxicity criteria of Debiopharm (DEB-NTC) grade ≥ 2 CIPN (OR 0.25, 95% CI 0.01–7.10) in oxaliplatin-treated patients, despite that GM1 was associated with a reduced risk of CTCAE grade ≥ 2 CIPN in the taxane subgroup of one study (OR 0.003, 95% CI 0.00–0.05). These results were confirmed by the sub-analysis of randomized controlled trials (RCTs). In TSA, the z-curve for the taxane subgroup crossed the upper trial sequential monitoring boundary (TSMB) but do not reach the required information size (RIS). The z-curves for the oxaliplatin subgroup remained in the nonsignificant area and did not reach the RIS. Further, GM1 did not influence the rate of response to chemotherapy and CTCAE grade ≥ 2 adverse events such as fatigue, nausea, diarrhea, and rash.

Conclusions
GM1 seemed to be well-tolerated and did not influence the anti-cancer effects of chemotherapeutic agents. Although the data did not confirm the effectiveness of GM1 in preventing oxaliplatin-induced peripheral neuropathy, GM1 might be able to prevent taxane-induced peripheral neuropathy. More studies are required in different ethnic populations receiving taxane-based chemotherapy to confirm these findings.
Phase II trial of nab-paclitaxel in metastatic breast cancer patients with visceral metastases
Authors: Xie Yizhao , Gong Chengcheng , Zhang Jian , Wang Leiping , Cao Jun , Tao Zhonghua , Li Ting , Zhao Yannan , Li Yi , Hu Shihui , Wang Biyun , Hu Xichun 
Published: November 2021

Abstract
Background
Visceral metastases account for 48–67% of metastatic breast cancer (MBC) patients and presage a worse overall survival. Previous study suggested potential effect of nab-paclitaxel on patients with visceral metastases subgroups. This phase II trial was conducted to explore the efficacy and safety of nab-paclitaxel in such a high-risk group of patients.

Methods
In this prospective, single-center, open-label, phase II study, MBC patients with visceral metastases (N = 80) received nab-paclitaxel (Abraxane, 125 mg/m2, D1, D8, D15 every 28 days).

Results
The median PFS was 5.1 months (95% CI: 4.2–6.0 months), with an ORR of 33.8% (95% CI 21.3–43.8%) and CBR of 66.2% (95% CI 56.3–75.0%). In univariate analysis, patients with premenopausal status had a trend of better treatment outcome. Multivariate analysis demonstrated non brain metastasis (adjusted HR 0.31, 95% CI 0.12–0.83, P = 0.019) and first line treatment (adjusted HR 0.37, 95% CI 0.17–0.81, P = 0.013) as independent predictors of longer PFS. The overall safety was acceptable with most common treatment-related, grade ≥ 3 toxicities of neutropenia (16.3%) and sensory neuropathy (3.7%).

Conclusions
This phase II trial documented satisfactory efficacy and safety of nab-paclitaxel in MBC patients with visceral metastases, providing evidence for relative clinical practice. Patients in first line therapy had better treatment outcome. For patients with premenopausal status or brain metastasis, further alternatives (for example, combined chemotherapy or targeting therapy) might be required. This study also demonstrated the efficacy and safety of 125 mg/m2 nab-paclitaxel among Asian patients.

Trial registration
This research is registered under clinicaltrials.gov (NCT 02687490, February 22, 2016).
Loneliness and mental health among the elderly in Poland during the COVID-19 pandemic
Authors: Dziedzic Beata , Idzik Anna , Kobos Ewa , Sienkiewicz Zofia , Kryczka Tomasz , Fidecki Wiesław , Wysokiński Mariusz 
Published: November 2021

Abstract
Background
The unexpected changes caused by the COVID-19 pandemic related to the fear of developing the disease, and the need for social distancing and isolation have had an effect on people’s mental health. These drastic changes can result in the development of anxiety, depressive symptoms and sense of loneliness. Elderly and chronically ill individuals are at a particularly high risk of developing COVID-19, suffering severe illness and dying as a result of it.

Aim of the study
The aim of the study was to assess the prevalence of anxiety, depressive symptoms, irritability and loneliness in the elderly aged 60 years and older as a group exposed to the negative impact of the COVID-19 pandemic, and to analyze the relationships between loneliness and mental health of the respondents and sociodemographic variables and chronic diseases.

Materials and methods
The study was conducted in Poland among 221 individuals aged 60+. The study material was collected using a sociodemographic questionnaire, Hospital Anxiety and Depression Scale (HADS-M) and a revised University of California Los Angeles loneliness scale (R-UCLA). Women accounted for 47.51% and men for 52.49% of study participants; the mean age was 65.18 (SD = 4.06).

Results
In total, according to HADS-M, depressive symptoms were present in 19.15% of the participants and borderline states in 14.18% of them. Based on R-UCLA, moderate and moderately high sense of loneliness was present in 58.83% of the participants. Sense of loneliness was significantly correlated with the prevalence of depressive symptoms (p < 0.001).

Conclusions
In this study, one in five participants experienced anxiety and depressive symptoms. Two out of three participants experienced a moderate sense of loneliness. Individuals who displayed a higher level of loneliness also had a higher severity of anxiety level depressive symptoms and irritability. Elderly individuals should be under special care due to their high risk of experiencing physical and mental effects of the COVID-19 pandemic.
Comparison of a ceiling-mounted 3D flat panel detector vs. conventional intraoperative 2D fluoroscopy in plate osteosynthesis of distal radius fractures with volar locking plate systems
Authors: Seuthe Raphael , Seekamp Andreas , Kurz Bodo , Pfarr Julian , Schaefer Jost Philipp , Peh Simon , Lippross Sebastian 
Published: November 2021

Abstract
Objectives
To compare intraoperative 3D fluoroscopy with a ceiling-mounted flat panel detector in plate osteosynthesis of distal radius fractures (AO/OTA 2R3C1.2) with volar locking plate systems to conventional 2D fluoroscopy for detection of insufficient fracture reduction, plate misplacement and protruding screws.

Methods
Using a common volar approach on 12 cadaver forearms, total intraarticular distal radius fractures were induced, manually reduced and internally fixated with a 2.4 distal radius locking compression plate. 2D (anterior-posterior and lateral) and 3D (rotational) fluoroscopic images were taken as well as computed tomographies. Fluoroscopic images, Cone Beam CT (CBCT), 360° rotating sequences (so called “Movies”) and CT scans were co-evaluated by a specialist orthopedic surgeon and a specialist radiologist regarding quality of fracture reduction, position of plate, position of the three distal locking screws and position of the three diaphyseal screws. In reference to gold standard CT, sensitivity and specifity were analyzed.

Results
“Movie” showed highest sensitivity for detection of insufficient fracture reduction (88%). Sensitivity for detection of incorrect position of plate was 100% for CBCT and 90% for “Movie.” For intraarticular position of screws, 2D fluoroscopy and CBCT showed highest sensitivity and specifity (100 and 91%, respectively). Regarding detection of only marginal intraarticular position of screws, sensitivity and specifity of 2D fluoroscopy reached 100% (CBCT: 100 and 83%). “Movie” showed highest sensitivity for detection of overlapping position of screws (100%). When it comes to specifity, CBCT achieved 100%. Regarding detection of only marginal overlapping position of screws, 2D fluoroscopy and “Movie” showed highest sensitivity (100%). CBCT achieved highest specifity (100%).

Conclusion
As for assessment of quality of fracture reduction and detection of incorrect position of plate as well as overlapping position of the three diaphyseal screws CBCT and “Movie” are comparable to CT – especially when combined. Particularly sensitivity is high compared to standard 2D fluoroscopy.
Prevalence and characteristics of the aberrant anterior tibial artery: a single-center magnetic resonance imaging study and scoping review
Authors: Marin-Concha Julio , Rengifo Pablo , Tapia Pedro , Kaiser Daniel , Siepmann Timo 
Published: November 2021

Abstract
Background
Planning surgical procedures of the lower leg benefits from considering the possibility of an aberrant anterior tibial artery (AATA), but previously published data on the frequency of this anatomic variant shows heterogeneity. We assessed the prevalence of AATA in a Latin American cohort using magnetic resonance imaging (MRI) and compared these with other studies reported in the literature.

Methods
We retrospectively included consecutive patients who had undergone multiplanar knee MRI at a radiology department in Lima, Peru. The MRI protocol included coronal T1 weighted, axial, sagittal and coronal proton density fat-saturated (PDFS) and sagittal T2 weighted images.
Two experienced radiologists assessed all images and were blinded to each other’s findings. The frequency of the AATA was compared to previous cohorts. A scoping review was undertaken to provide an overview of previously published data on the prevalence of ATAA.

Results
We analyzed 280 knee MRI examinations of 253 patients (median age 41 years (IQR 31–52), 53.8% male). The aberrant anterior tibial artery variant was present in 8 of 280 (2.9%) evaluated knees, resulting in a prevalence of 3.2% in our study population. The PDFS sequence in the axial or sagittal orientation was most effective to identify AATA. The frequency of AATA in the reviewed literature using different radiological modalities ranged from 0.4 to 6% (median 1%, IQR (0.5–2.3%).

Conclusions
The AATA is a frequent vascular variant that can be detected by MRI in the preparation of invasive interventions of the lower leg.
Medical students in Russia evaluate the training during the COVID-19 pandemic: a student survey
Authors: Mukharyamova Laysan , Ziganshina Arina , Zhidjaevskij Aleksandr , Galimova Liana , Kuznetsov Maksim 
Published: November 2021

Abstract
Background
The aim of the study was to obtain feedback from medical students in Russia regarding their e-learning experience during COVID-19 Pandemic.

Methods
Thirteen thousand forty students from 46 Medical Schools in Russia completed an original evaluation form validated by 6 experts. Criterion and construct validity were determined in a pilot study (n = 46). The study design was based on the use of Google Forms. Participants used the Visual Analog Scale from 1 to 10 to assess the level of knowledge acquired.

Results
95.31% of medical schools in Russia switched to e-learning during the Pandemic. 39.8% of the students stated that the time to prepare for the class has doubled. For 19.9% of them, it increased by one third, while 26.6% did not report any changes. 38,4% of the participants are satisfied with particular elements of e-learning, 27.5% like such a format, 22.9% do not like it, and 11.2% could not answer the question. The average scores for the knowledge assessment were 5.9 for the humanities, 6.1 for fundamental science, and 6.0 for clinical training.

Conclusions
The most important findings are increased self-instruction time, insufficient knowledge gained and territorial and socio-economic inequalities within the country. Meanwhile, most students favor distance learning or its particular elements. Consequently, medical education leaders in Russia should consider the implementation of blended training in medicine taking into account specific regional factors, ensuring its effectiveness at all stages.
Resilience level and its relationship with hypochondriasis in nurses working in COVID-19 reference hospitals
Authors: Yusefi Ali Reza , Daneshi Salman , Davarani Esmat Rezabeigi , Nikmanesh Parnian , Mehralian Gholamhossein , Bastani Peivand 
Published: November 2021

Abstract
Introduction
A new coronavirus, called COVID-19, is an acute respiratory disease, which may arouse many psychological disorders since there is no specialized knowledge about it. The present study aimed to investigate the level of resilience and its relationship with hypochondriasis in nurses working in a COVID-19 reference hospital in south of Iran.

Methods
This cross-sectional study was conducted in 2020, in which 312 nurses participated using the census method. Data collection tools were the Conker-Davidson standard resilience scale (CD-RISC) and the Evans Hypoglycaemia Awareness Questionnaire. Data were analyzed using t-test, ANOVA, Pearson correlation coefficient, and multiple linear regression using SPSS software version 23.

Results
The mean scores of resilience and hypochondriasis were 72.38 ± 7.11 and 49.75 ± 8.13, respectively, indicating the moderate level of these two variables among nurses. Hypochondriasis in 18.91, 61.22, and 1.28% of the nurses was mild, moderate, and severe, respectively. There was a significant negative correlation between resilience and hypochondriasis (r = − 0.214 and P < 0.001). In this regard, control (P < 0.001), positive acceptance of change (P < 0.001), spiritual effects (P = 0.001), trust in individual instincts (P = 0.001), and perception of competence (P = 0.002) were detected as the predictors of nurses’ hypochondriasis.

Conclusion
The nurses had moderate levels of resilience and hypochondriasis. Promoting knowledge about COVID-19and increasing information on how to protect oneself and others against the disease along with supportive packages from their managers are thus recommended.
Rehabilitation of executive function in chronic paediatric brain injury: a randomized controlled trial
Authors: Brandt Anne E. , Finnanger Torun G. , Hypher Ruth E. , Rø Torstein B. , Skovlund Eva , Andersson Stein , Risnes Kari , Stubberud Jan 
Published: November 2021

Abstract
Background
Impaired executive functions (EFs, i.e., purposeful, goal-directed behaviour) cause significant disability after paediatric acquired brain injury (pABI) warranting efficient interventions. Goal Management Training (GMT) is a metacognitive protocol proven effective for executive dysfunction in adults. This pre-registered, blinded, parallel-randomized controlled trial evaluated efficacy of a paediatric adaptation (pGMT) compared to a psychoeducative control (paediatric Brain Health Workshop, pBHW) to improve EF.

Methods
Children aged 10 to 17 years with pABI (e.g., traumatic brain injury, brain tumour), ≥ 1 year post-onset or ended treatment, with parent-reported EF complaints were eligible. Participants were randomized (computer-algorithm) to either group-based pGMT (n = 38) or pBHW (n = 38). The active control was tailored to keep non-specific factors constant. Thus, both treatments comprised of 7 sessions at hospitals over 3 consecutive weeks, followed by 4 weeks of telephone counselling of participants, parents, and teachers. Parent-reported daily life EF, assessed by the questionnaire Behavior Rating Inventory of Executive Function (BRIEF; Behavioral Regulation Index (BRI) and Metacognition Index (MI)), were co-primary outcomes 6 months post-intervention. Secondary outcomes included neuropsychological tests and a complex naturalistic task (Children’s Cooking Task).

Results
Seventy-three participants (96%) completed allocated interventions and 71 (93%) attended the 6-month follow-up. The results demonstrated no significant difference in effectiveness for the two interventions on parent-reported EF: For BRIEFBRI, mean (SD) raw score for pGMT was 42.7 (8.8) and 38.3 (9.3) for pBHW. Estimated difference was − 2.3 (95% CI − 5.1 to 0.6). For BRIEFMI, the corresponding results were 80.9 (20.4) for GMT and 75.5 (19.3) for pBHW. Estimated difference was − 1.4 (95% CI −8.5 to 5.8). In performance-based tests, pGMT was associated with improved inhibition and executive attention, while pBHW was associated with fewer errors in the naturalistic task.

Conclusions
In pABI, metacognitive training (pGMT) did not demonstrate additional effectiveness on parent-reported daily life EF at 6-month follow-up, when compared to a psychoeducative control. Both interventions were well-tolerated and demonstrated distinct improvements at different EF assessment levels. To conclude on pGMT efficacy, larger studies are needed, including further investigation of appropriate assessment levels and possible differences in effect related to treatment duration, developmental factors, and injury characteristics.

Trial registration
ClinicalTrials.gov, NCT0321534211, 11 July 2017
Immune checkpoint blockade in the treatment of malignant tumor: current statue and future strategies
Authors: Yang Wenwen , Lei Caining , Song Shaoming , Jing Wutang , Jin Chuanwei , Gong Shiyi , Tian Hongwei , Guo Tiankang 
Published: November 2021

AbstractAfter being stagnant for decades, there has finally been a paradigm shift in the treatment of cancer with the emergence and application of immune checkpoint inhibitors (ICIs). The most extensively utilized ICIs are targeting the pathways involving programmed death-1 (PD-1) and cytotoxic T-lymphocyte associated protein 4 (CTLA-4). PD-1, as an crucial immune inhibitory molecule, by and large reasons the immune checkpoint response of T cells, making tumor cells get away from immune surveillance. Programmed cell death ligand-1 (PD-L1) is exceptionally expressed in most cancers cells and approves non-stop activation of the PD-1 pathway in the tumor microenvironment. PD-1/PD-L1 inhibitors can block the combination of PD-1 and PD-L1, inhibit hostile to regulatory signals, and restore the activity of T cells, thereby bettering immune response. The current researchers assume that the efficacy of these drugs is related to PD-L1 expression in tumor tissue, tumor mutation burden (TMB), and other emerging biomarkers. Although malignant tumors can benefit from the immunotherapy of PD-1/PD-L1 inhibitors, formulating a customized medication model and discovering biomarkers that can predict efficacy are the new trend in the new era of malignant tumor immunotherapy. This review summarizes the mechanism of action of PD-1/PD-L1 inhibitors, their clinical outcomes on various malignant tumors, their efficacy biomarkers, as well as predictive markers of irAEs.
Instruments to assess quality of life in people with mental health problems: a systematic review and dimension analysis of generic, domain- and disease-specific instruments
Authors: van Krugten F. C. W. , Feskens K. , Busschbach J. J. V. , Hakkaart-van Roijen L. , Brouwer W. B. F. 
Published: November 2021

Abstract
Objectives
The importance of economic evaluations of mental healthcare interventions is increasingly recognized. Despite the multitude of available quality of life instruments, concerns have been raised regarding the content validity of these instruments, and hence suitability for use in mental health. The aim of this paper, therefore, was to assess the content validity and the suitability of existing quality of life instruments for use in economic evaluations in mental health problems.

Methods
In order to identify available quality of life instruments used in people with mental health problems, a systematic review was performed using the Embase, Medline and PsycINFO databases (time period January 2012 to January 2018). Two reviewers independently assessed study eligibility and executed data extraction. The evaluation framework of Connell and colleagues was used to assess whether the identified quality of life instruments cover the dimensions valued highly by people with mental health problems. Two reviewers independently mapped the content of each identified instrument onto the evaluation framework and indicated the extent to which the instrument covered each of the dimensions of the evaluation framework.

Results
Searches of databases yielded a total of 5727 references. Following duplicate removal and double-independent screening, 949 studies were included in the qualitative synthesis. A total of 44 unique quality of life instruments were identified, of which 12 were adapted versions of original instruments. The best coverage of the dimensions of the evaluation framework of Connell and colleagues was by the WHOQOL-100, S-QoL, SQLS, EDQoL, QLI and the IMHQOL, but none fully covered all dimensions of the evaluation framework.

Conclusions
The results of this study highlight the multitude of available quality of life instruments used in people with mental health problems and indicate that none of the available quality of life instruments fully cover the dimensions previously found to be important in people with mental health problems. Future research should explore the possibilities of refining or expanding existing instruments as well as the development and testing of new quality of life instruments to ensure that all relevant quality of life dimensions for people with mental health problems are covered in evaluations.
Accelerated coronary calcium burden in breast cancer patients after radiotherapy: a comparison with age and race matched healthy women
Authors: Lai Yu-Hsuan , Chen Helen H. W. , Tsai Yi-Shan 
Published: November 2021

Abstract
Background
Radiotherapy (RT) might lead to atherosclerotic plaque buildup and coronary artery stenosis of breast cancer (BC) survivors, and coronary artery calcium (CAC) might be a sign of preclinical atherosclerosis. This study explores possible determinants affecting the acceleration of CAC burden in BC patients after adjuvant RT.

Methods
Female BC patients receiving adjuvant RT from 2002 to 2010 were included. All patients received noncontrast computed tomography (NCCT) of thorax before and after adjuvant RT. Their CAC burden was compared with healthy controls from the Multi-Ethnic Study of Atherosclerosis (MESA) cohort. The progression of the CAC burden was manifested by the increment of CAC percentiles (%CACinc).

Results
Ninety-four patients, including both left- and right-side BC, were enrolled in this study. From undergoing the first to second NCCT, the %CACinc in BC patients significantly increased rather than non-BC women. In addition, the %CACinc was significantly higher in left-side than right-side BC patients (p < 0.05), and significant differences in most heart outcomes were found between the two groups. Besides, the lower the mean right coronary artery (RCA) dose, the lower the risks of CAC percentiles increase ≥ 50% after adjusting the disease's laterality.

Conclusions
A significantly higher accelerated CAC burden in BC patients than non-BC women represents that BC could affect accelerated CAC. A higher risk of accelerated CAC burden was found in left-side than right-side BC patients after adjuvant RT. A decrease of the mean RCA dose could reduce more than 50% of the risk of accelerated CAC burden in BC patients.