bluuebunny/crossref_metadata_2025_split huggingface dataset:
An amplicon-based sequencing approach for Usutu virus characterization
Authors: Ndione Marie Henriette Dior , Diagne Moussa Moïse , Mencattelli Giulia , Diallo Amadou , Ndiaye El Hadji , Di Domenico Marco , Diallo Diawo , Kane Mouhamed , Curini Valentina , Top Ndeye Marieme , Marcacci Maurilia , Sankhe Safiétou , Ancora Massimo , Secondini Barbara , Di Lollo Valeria , Teodori Liana , Leone Alessandra , Puglia Ilaria , Gaye Alioune , Sall Amadou Alpha , Loucoubar Cheikh , Rosà Roberto , Diallo Mawlouth , Monaco Federica , Faye Ousmane , Cammà Cesare , Rizzoli Annapaola , Savini Giovanni , Faye Oumar 
Published: July 2024

AbstractUsutu virus (USUV), an arbovirus from the Flaviviridae family, genus Flavivirus, has recently gained increasing attention because of its potential for emergence. After his discovery in South Africa, USUV spread to other African countries, then emerged in Europe where it was responsible for epizootics. The virus has recently been found in Asia. USUV infection in humans is considered to be most often asymptomatic or to cause mild clinical signs. However, a few cases of neurological complications such as encephalitis or meningo-encephalitis have been reported in both immunocompromised and immunocompetent patients. USUV natural life cycle involves Culex mosquitoes as its main vector, and multiple bird species as natural viral reservoirs or amplifying hosts, humans and horses can be incidental hosts. Phylogenetic studies carried out showed eight lineages, showing an increasing genetic diversity for USUV. This work describes the development and validation of a novel whole-genome amplicon-based sequencing approach to Usutu virus. This study was carried out on different strains from Senegal and Italy. The new approach showed good coverage using samples derived from several vertebrate hosts and may be valuable for Usutu virus genomic surveillance to better understand the dynamics of evolution and transmission of the virus.
Comparative efficacy of platelet-rich plasma (PRP) injection versus PRP combined with vitamin C injection for partial-thickness rotator cuff tears: a randomized controlled trial
Authors: Mohammadivahedi Fatemeh , Sadeghifar Amirreza , Farsinejad Alireza , Jambarsang Sara , Mirhosseini Hamid 
Published: July 2024

Abstract
Background
The optimal approach for managing partial-thickness rotator cuff tears (PTRCT) remains controversial. Recent studies related to PTRCTs have shown that platelet-rich plasma (PRP) injection might be an effective treatment option. Despite the role of vitamin C in collagen synthesis and its antioxidant properties, the effects of combined PRP and vitamin C treatment on rotator cuff repair are not well understood. This study investigated the effect of combined treatment of PRP and vitamin C treatment on PTRCTs.

Methods
One hundred-ten patients with PTRCTs were randomly allocated to two groups and underwent subacromial injections of either (A) normal saline and platelet-rich plasma or (B) vitamin C and platelet-rich plasma. The Constant score, American Shoulder and Elbow Surgeons (ASES) score, and visual analog scale were used to evaluate the outcomes before, 1 month after, and 3 months after injection.

Results
At the 3-month follow-up, no statistically significant differences were observed between the two groups in terms of ASES and Constant scores. Although a slight difference favoring group B was noted in functional scores and pain reduction, this difference was not statistically significant. However, both groups demonstrated significant pain reduction over time (p-value < 0.001). Additionally, the enhancement of ASES and Constant scores in both groups was statistically significant (p-value < 0.001).

Conclusions
In conclusion, both PRP injection alone and PRP combined with vitamin C led to significant reductions in pain and enhancements in function scores over time (p < 0.001), suggesting the effectiveness of PRP as a non-surgical treatment for PTRCTs within 3 months. While PRP alone showed significant benefits, further research is required to ascertain if the combination therapy offers statistically significant advantages over PRP alone.

Trial registration
Clinical trial registration code: IRCT20230821059205N1.
Validation of the Portuguese version of the diabetes self-management questionnaire-revised (DSMQ-R) in people with type 2 diabetes mellitus
Authors: Oliveira Dulce , Costa Andreia , Henriques Adriana , Curado Maria Alice , Schmitt Andreas , Nogueira Paulo 
Published: July 2024

Abstract
Background
Reflecting people with diabetes’ self-management activities is often required in both research and clinical practice. This study evaluated the measurement properties of the Portuguese version of the Diabetes Self-Management Questionnaire-Revised (DSMQ-R) on a sample of people with type 2 diabetes mellitus (T2DM).

Methods
Translation and cultural adaptation were conducted according to guidelines for cross-cultural adaptation and validation of healthcare measurement instruments. A cross-sectional study was performed including 365 people with T2DM in primary care. Reliability, construct validity, and criterion validity were analyzed.

Results
The total scale of the translated DSMQ-R revealed sufficient internal consistency (alpha = 0.82), and most of the subscales performed adequately. The exploratory factor structure was robust, and confirmatory analysis showed a good model fit with the scale structure of the original scale. The scale scores correlated with the participants’ last HbA1c estimates, supporting convergent validity, and convergence was confirmed by the adequate average variance extracted.

Conclusions
The Portuguese version of the DSMQ-R is a reliable and valid tool for gauging self-management behaviors in people with T2DM and their relationship with glycemic values.
Regression of cardiac angiosarcoma in a 17-year-old: a percutaneous biopsy effect
Authors: Sharrack Noor , Parent Martine , Lethaby Christopher , Rosendahl Ulrich , Lyon Alexander R , Farooq Maryum , Jamil Haqeel , Greenwood John P. , Plein Sven , Kidambi Ananth 
Published: July 2024

Abstract
Background
Cardiac angiosarcoma is a very rare and aggressive primary cardiac tumor associated with poor prognosis. Diagnosis is often delayed due to non-specific symptoms, with most cases involving metastases at the time of diagnosis. We describe a unique case of apparent tumor regression of cardiac angiosarcoma post percutaneous biopsy.

Case Presentation
A young male was admitted with suspected pericarditis. Echocardiogram revealed a pericardial mass. Cardiovascular magnetic resonance (CMR) suggested primary cardiac malignancy. Percutaneous biopsy was inconclusive, with subsequent CMR demonstrating apparent tumor regression. Interval imaging revealed further tumor growth, and surgical biopsy revealed primary cardiac angiosarcoma (PCAS). Causes of tumor regression following percutaneous biopsy are discussed.

Conclusions
Cases of suspected primary cardiac malignancy require careful follow up with serial multimodality imaging. Percutaneous biopsy effects should be considered in cases of tumor regression, and serial imaging should be planned afterwards.
Advancements in the application of nanotechnology for the management of epileptic seizures
Authors: Ping Honglu , Ding Ding , Zhu Guoxing , Wang Jianhong , Zhang Jun 
Published: July 2024

AbstractEpilepsy is a common yet complex neurological disorder. Historically, antiseizure medications (ASMs) have faced challenges in crossing the blood-brain barrier (BBB) and targeting the epileptogenic zone, creating a bottleneck in seizure management. Certain nanomaterials can facilitate drug penetration through the BBB and enable stimulus-responsive drug release, thereby enhancing targeted and efficient drug utilization while reducing adverse reactions in other brain tissues and peripherally. This article reviews the current researches on stimulus-responsive nanosystems applicable in antiepileptic therapy, as well as nanotechnology applications that improve the brain delivery of ASMs.
Efficacy and safety of disitamab vedotin (RC48) in HER2-expressing breast cancer: A multicenter retrospective study.
Authors: Yang Can , Chang Jianying , Li Taolang , Liu Yuncong , Zhang Hanqun , Luo Xiaoqing , Xiang Yang , Zhang Cui , Huang Yisidan , Hou Jing , Wang Guanghui , Li Yong 
Published: July 2024

e13011 Background: RC48 is an Antibody-Drug Conjugate (ADC) that integrates a humanized monoclonal antibody targeting human epidermal growth factor receptor 2 (HER2) linked to the microtubule inhibitor monomethyl auristatin E (MMAE). This study reports real-world data using RC48 monotherapy in HER2-expressing advanced breast cancer (ABC). Methods: The study reviewed patients with HER2-expressing ABC who received RC48 monotherapy at three hospitals in China between September 2021 and June 2022. The electronic medical record was used to collect the clinical characteristics of the patient and to evaluate the antitumor activity and safety. The primary outcome was real-world progression-free survival (rwPFS). Results: A total of 15 patients were included, of whom 9(60%) were HER2-positive and 6(40%) had HER2 low expression (IHC 1+ or IHC 2+/ISH-).11 patients (73.3%) had visceral metastases, 40% of patients (6/15) had central nervous system (CNS) metastases at baseline. 6 patients (40%) had ≥3 metastatic lesions, and 13(86.7%) of patients received RC48 as third-line treatment or higher. Progression-free survival (PFS), overall survival (OS), and response can be assessed in all patients. The median follow-up was 10 months and the median rwPFS was 8.0 months (95% CI, 4.897-11.103), while the median OS was not reached. Objective response rate (ORR) and disease control rate (DCR) were 46.7% and 80% respectively. Partial response (PR) was achieved in 46.7% of the patients (7/15). patients with HER2-positive and HER2 low expression, the median rwPFS was 8.77 and 4.63 months, respectively (HR = 0.49,95% Cl, 0.13-1.80, P = 0.196), and in 6 patients with CNS metastases, the median rwPFS was 7.5 months (95% CI, 2.82-18.28). The most common treatment-related adverse events (TRAEs) were elevated transaminase (33.3%) and Leukopenia (33.3%), most of which were grade 1-2, No serious adverse events related to treatment were observed. Conclusions: The novel HER2-targeted ADC, RC48, demonstrated promising preliminary antitumor activity in patients with HER2-expressing ABC, patient with brain metastases could also benefit, with tolerable toxicities.
Real-world analysis of inetetamab combined with pyrotinib plus chemotherapy for the treatment of HER2-positive advanced breast cancer: A multi-center retrospective study.
Authors: Zhou Huanhuan , Chen Zhanhong , Deng Chao , Gan LU , Li Fan , Xu Xuefeng , Fang YanMan , Qi Xiaowei , Bian Wei Gang , Yu Zeshun , Wang Xiaojia 
Published: July 2024

e13012 Background: Inetetamab combined with tyrosine kinase inhibitors exhibited stronger antitumor effects than inetetamab alone. At present, there was few studies on the efficacy and safety of inetetamab combined with pyrotinib in the treatment of advanced breast cancer (ABC) patients. The study aims to investigate the efficacy and safety of inetetamab combined with pyrotinib plus chemotherapy for HER2-positive ABC patients. Methods: We retrospectively investigated the medical records of eligible women who aged 18 years or older with pathologically confirmed HER2-positive recurrent or metastatic invasive breast cancer, and received at least two cycles of inetetamab combined with pyrotinib plus chemotherapy treatment regimens in multicenters in China between July 2020 and December 2022. The primary endpoint was progression-free survival (PFS) estimated by the Kaplan-Meier method. The secondary endpoints were the objective response rate (ORR), disease control rate (DCR), and safety. Cox regression model was used to identify predictive factors for PFS. Results: A total of 99 patients were included. Overall patient's median PFS was 12.3 (95% CI: 10.9-13.6) months. Of 99 evaluable patients, 53 (53.5%) patients achieved objective response, including 9 (9.1%) complete response and 44 (44.4%) partial response. The remaining 45 patients achieved stable disease as the best response, thus, the DCR was 99.0%. Patients who received Inetetamab combined with pyrotinib plus chemotherapy as first-line treatment (15.0 months [95% CI: 13.6-15.8]) provided longer median PFS than that as second-line treatment (10.3 months [95% CI:9.6-10.9], p<0.001). Furtherly, the Cox multivariate regression analysis indicated that patients who received inetetamab combined with pyrotinib plus albumin-bound paclitaxel for first-line treatment achieved longer median PFS. Grade 1-2 diarrhea (59.6%), vomiting (29.3%) and nausea (28.3%), hand-foot syndrome (23.2%) were the top four most common adverse events (AEs). The most common grade ≥3 AEs were leukopenia (19.2%), diarrhea (18.2%), myelosuppression (7.1%) and neutromenia (4.0%). Conclusions: The first-line treatment of inetetamab combined with pyrotinib plus chemotherapy was an effective and safe treatment for HER2-positive ABC patients. Inetetamab combined with pyrotinib plus albumin-bound paclitaxel might be the most effective combination therapies. All AEs were controllable and tolerable.
Efficacy and safety of inetetamab-containing regimens in patients with HER2-positive metastatic breast cancer in first-line/second-line setting.
Authors: Mu Yuxin , Meng Yanchun , Zhang Jian 
Published: July 2024

e13013 Background: Inetetamab is a novel recombinant humanized anti-human epidermal growth factor receptor-2 (HER-2) monoclonal antibody. This real-world retrospective study assessed the efficacy and safety of inetetamab-based combination regimens in first-line/second-line treatment of HER2-positive metastatic breast cancer (MBC). Methods: This study retrospectively recruited HER2-positive MBC patients who received inetetamab-based combination regimens from June 2020 to May 2023. The outcomes included progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and disease control rate (DCR). Results: A total of 329 patients were enrolled and included in the efficacy analysis. The most frequently used treatment strategy was inetetamab plus pyrotinib-contained regimens (205/329, 62.3%). Patients treated with first-line regimens benefited the most, with a median PFS of 14.5 versus (vs.) 10.0 months (first-line- vs. second-line combination therapy of inetetamab, pyrotinib and chemotherapy, p <0.001), 18.0 vs. 17.0 months (first-line- vs. second-line combination therapy of inetetamab, pertuzumab and chemotherapy, p=0.096), and 14.0 vs. not applicable months (first-line- vs. second-line inetetamab plus chemotherapy, p=0.229). The complete response (CR) was observed in 14 (4.3%) patients. The ORR was 54.4% (95%CI, 49.0%-59.7%), and the DCR was 99.4% (95%CI, 97.8%-99.8%). Diarrhea (39.2%) and white blood cell count decreased (33.0%) were the most common adverse events (AEs). The grade 3 and higher AEs were observed in 29.5% of the whole study cohort. Conclusions: Inetetamab-based combinations therapy demonstrated promising clinical activity and a manageable safety profile in patients with HER2-positive MBC, especially in the first-line setting.
Can elective neck dissection for oral cancers be planned based on depth of invasion?
Authors: Majumdar Kinjal Shankar , Kottayasamy Seenivasagam Rajkumar , Malhotra Manu , Thaduri Abhinav , Panuganti Achyuth 
Published: July 2024

e18042 Background: Elective neck dissection (END) is the standard of care for oral squamous cell carcinoma (OSCC). Literature suggests END may be avoided in primaries with depth of invasion (DOI) less than 4 mm. The present study evaluates the accuracy of DOI in predicting nodal metastases in OSCC. Methods: This retrospective study, approved by the Institutional Ethics Committee, includes all the patients with OSCC who underwent surgical excision. All tumors were classified and DOI was measured microscopically on resected specimens according to the AJCC TNM 8th ed. Statistical analysis was performed using IBM SPSS for Windows version 26. Pathological N-classification (pN) was correlated with DOI (in mm) using Spearman’s rank-order (pN1-3) and point-biserial (pN0 vs pN+) correlation statistics. Receiver operating characteristic (ROC) curve with area under the curve (AUC) were analyzed to determine the accuracy of DOI in predicting nodal metastases (pN+). Primaries were classified into three groups based on the range of DOI (≤5 mm; >5 mm and ≤10 mm; >10 mm) according to the AJCC TNM 8th ed. Chi-square statistic was used to measure the association between DOI groups and pN status (pN0; pN+). ANOVA with post hoc Bonferroni statistics were used to compare between three DOI groups. Results: Three hundred and thirty-seven (n=337) patients were screened for inclusion. After adjusting for missing data, 254 patients were included in the final analysis. Median age at presentation, DOI and nodal yield were 46 (24-82) years, 11 (1-40) mm, and 35 (1-121), respectively. Depth of invasion failed to demonstrate a strong positive correlation with pN classification (ρ=0.31; p<0.001). DOI did not show a strong correlation with pN status (pN0 vs pN+) either (rpb=0.27; p<0.001). ROC curve analysis suggested a poor accuracy of DOI in predicting nodal metastases (AUC=0.67; 95% CI 0.6-0.73). There was a statistically significant association between DOI groups and pN status (Chi-square=26.67; p<0.001). ANOVA with post hoc Bonferroni showed statistical significance only for DOI >10 mm group (p<0.001 for DOI ≤5 mm; p=0.02 for DOI >5 mm and ≤10 mm). However, the sensitivity and specificity achieved by the ROC analysis for DOI cut-off value of 10mm in the present cohort were merely 69.3% and 57.9%, respectively. Conclusions: DOI alone is a poor predictor of nodal metastases in OSCC. Though all correlations in the present study achieved statistical significance, none demonstrated a strong association or an accuracy credible enough of clinical importance. END should remain the standard-of-care for all OSCC, including early primaries with DOI <4 mm.
Association between heavy metal concentrations and chemotherapy-related acute adverse events in the patients with nasopharyngeal carcinoma: A prospective, longitudinal, observational study.
Authors: Chen Xi , Gao Tian-Rui , Qian Chao-Nan , Lv Xing , Guo Xiang , Peng Li-Xia 
Published: July 2024

e18045 Background: Chronic exposure to heavy metals may cause chronic burden on liver, kidney, bone marrow and other organs. To determine whether the accumulation of heavy metals prior to treatment was related to the occurrence of acute adverse events in patients with nasopharyngeal carcinoma (NPC) receiving platinum-based chemotherapy, we conducted a single-center, prospective, longitudinal study. Methods: The heavy metal concentrations of pretreatment whole blood samples and the pretreatment and posttreatment morning urine samples for 140 NPC patients were measured, which were classified into low and high levels based on the 75% quartile. The highest grades of acute adverse events for every cycle of platinum-based chemotherapy were recorded according to the Common Terminology Criteria for Adverse Events (version 4.03). Wilcoxon rank-sum test was used to compare the difference in the distribution of acute adverse events between two levels. To illustrate the potential relationship of metal between in blood and urine, the spearman’s correlation coefficient of metal concentration in blood and urine adjusted by creatinine was calculated. The kendal's correlation coefficients were calculated to characterize the correlation between heavy metal levels and acute adverse events. Finally, the study developed multivariable adjusted logistic regression models to calculate odds ratios (OR) and 95% CIs of the association between various heavy metals and risk of chemotherapy-related acute adverse events, respectively. Results: The study enrolled 140 patients with stage II (n=2, 1.4%), III (n=76, 54.3%), and IVa (n=62, 44.3%) NPC. A total of 13 heavy metals of both blood and urine samples were measured, with Cd, Pb, Hg, As, Pt, Mg, Ca, Cr, Co, Ni, Cu, Zn, and Se included. The concentrations of the same metals in blood and urine (including Cd, Pb, Hg, As, Pt, Co and Se) had a moderate correlation (0.2 < correlation coefficient < 0.7). High level patients were prone to experiencing acute adverse events ( p<0.05). In multivariable adjusted logistic regression, patients with impaired liver function had higher BCd (Cd in blood) level (OR, 3.65; 95% CI, 1.38–9.64; p=0.009). Patients with thrombocytopenia had higher UCr (Cr in urine) level (OR, 5.63; 95% CI, 1.60–19.87; p=0.007). And UPb (OR, 3.16; 95% CI, 1.26–7.92; p=0. 014) and UZn (OR, 2.69; 95% CI, 1.10–6.59; p=0. 030) were found significantly higher in patients with abnormal blood glucose. Conclusions: NPC patients with chronic accumulation of BCd had tendency to have impaired liver function when receiving platinum-based chemotherapy. Similar correlations were also observed in the thrombocytopenia with UCr, and the abnormal blood glucose with UPb and UZn.
Neoadjuvant docetaxel-cisplatin followed by concurrent chemoradiotherapy and adjuvant tislelizumab for locally advanced nasopharyngeal carcinoma: A multicenter, single-arm, phase II trial.
Authors: Yuan Yawei , Tian Yunhong , Zhong Huang , Zheng Ronghui , Jie Lin , Zhang Jian , Liao Kai , Deng Jin , Yu Yi , Qiu Wenze , Bu Junguo , Zheng Rong , Xu Benhua , Chen Yong 
Published: July 2024

e18047 Background: Patients with locoregionally advanced nasopharyngeal carcinoma (LA-NPC) have a high risk of distant metastasis or recurrence despite the current standard of neoadjuvant chemotherapy and concurrent chemoradiation (CCRT), indicating the need of more comprehensive treatment. Due to good compliance and convenient adverse event management, the TP (docetaxel and cisplatin) regimen is more widely accepted and commonly used as a neoadjuvant chemotherapy for LA-NPC in the real world. Immune checkpoint blockade therapy plus chemotherapy has been shown to improve the survival in recurrent or metastatic NPC. We investigated the efficacy and safety of tislelizumab, an anti-PD-1 monoclonal antibody, as adjuvant treatment in patients with LA-NPC that had the neoadjuvant TP chemotherapy and CCRT. Methods: This multicenter, open label, single arm, phase II clinical trial was done at four hospitals in China. Patients (aged 18-65 years) with histologically confirmed, LA-NPC (T4N1 and T1-4N2-3) were enrolled and treated with neoadjuvant chemotherapy for 3 cycles (docetaxel 75 mg/m2 D1, cisplatin 75 mg/m2 D1) followed by concurrent cisplatin (100mg/m2, D1 and D22) during intensity-modulated radiation (IMRT). Four weeks post-RT, tislelizumab (200 mg) was given intravenously once every 3 weeks for up to 12 cycles. By Fleming one-stage design (type I error 0.05, power 0.80, 10% drop out), planned sample size is 100. Primary endpoint is 3-year (yr) progression free survival (PFS). Secondary endpoints include safety and tolerability. Results: From June 2021 to January 2024, a total of 100 patients (median age 53y, 73.0% male) were recruited at four study sites. This protocol specified analysis included 78 subjects with >12 months post-treatment follow up (median 26.2 months, 95% CI 21.3-30.1). Overall compliance rate: neoadjuvant cisplatin + docetaxel 97.5%, concurrent cisplatin 80.8%, adjuvant tislelizumab 78.2%, IMRT 99.7% (69.96 Gy). Treatment related adverse events (AEs, ≥grade 3, >10%): dysphagia (30.5%), mucositis (26.2%), neutropenia(26.7%), radiation dermatitis (23.7%), anemia (16.2%). No ≥grade 4 mucositis/dermatitis. In addition, the incidence of immune-related adverse events (irAEs) of grade 3 or 4 was 5.2%, and all were thyroid toxicity and skin rash. The 2-yr PFS and 2-yr overall survival were 89.6% (95% CI 53.8 - 88.5%) and 100%, respectively. 3-yr PFS and long-term efficacy are awaited. Conclusions: Tislelizumab adjuvant therapy after neoadjuvant docetaxel -cisplatin followed by CCRT is safe with promising results for LA-NPC. However, further follow-up is needed to confirm the long-term efficacy. Clinical trial information: NCT04870905 .