bluuebunny/crossref_metadata_2025_split huggingface dataset:
A prospective CSFV-PCV2 bivalent vaccine effectively protects against classical swine fever virus and porcine circovirus type 2 dual challenge and prevents horizontal transmission
Authors: Chen Jing-Yuan , Wu Chi-Ming , Chia Min-Yuan , Huang Chienjin , Chien Maw-Sheng 
Published: July 2023

AbstractClassical swine fever virus (CSFV) infection leading to CSF outbreaks is among the most devastating swine diseases in the pig industry. Porcine circovirus type 2 (PCV2) infection, resulting in porcine circovirus-associated disease (PCVAD), is also a highly contagious disease affecting pig health worldwide. To prevent and control disease occurrence, multiple-vaccine immunization is necessary in contaminated areas or countries. In this study, a novel CSFV-PCV2 bivalent vaccine was constructed and demonstrated to be capable of eliciting humoral and cellular immune responses against CSFV and PCV2, respectively. Moreover, a CSFV-PCV2 dual-challenge trial was conducted on specific-pathogen-free (SPF) pigs to evaluate vaccine efficacy. All of the vaccinated pigs survived and showed no clinical signs of infection throughout the experimental period. In contrast, placebo-vaccinated pigs exhibited severe clinical signs of infection and steeply increased viremia levels of CSFV and PCV2 after virus challenge. Additionally, neither clinical signs nor viral detections were noted in the sentinel pigs when cohabitated with vaccinated-challenged pigs at three days post-inoculation of CSFV, indicating that the CSFV-PCV2 bivalent vaccine completely prevents horizontal transmission of CSFV. Furthermore, conventional pigs were utilized to evaluate the application of the CSFV-PCV2 bivalent vaccine in field farms. An adequate CSFV antibody response and a significant decrease in PCV2 viral load in the peripheral lymph nodes were observed in immunized conventional pigs, suggesting its potential for clinical application. Overall, this study demonstrated that the CSFV-PCV2 bivalent vaccine effectively elicited protective immune responses and the ability to prevent horizontal transmission, which could be a prospective strategy for controlling both CSF and PCVAD in commercial herds.
Polyvinyl alcohol coating releasing fungal blastospores improves kill effect of attract-and-kill beads
Authors: Hermann Katharina M. , Grünberger Alexander , Patel Anant V. 
Published: July 2023

AbstractPolyvinyl alcohol (PVA) is a biodegradable, water-soluble polymer with excellent film forming properties, commonly studied or used as tablet coating, food packaging or controlled release fertilizers. Attract-and-kill (AK) beads are sustainable, microbial alternatives to synthetic soil insecticides, whose onset of lethal effect largely depend on how fast the encapsulated entomopathogenic fungus forms virulent conidia. Therefore, the objective of this study was to develop a water-soluble coating accelerating the kill effect of AK beads by immediately releasing virulent Metarhizium brunneum CB15-III blastospores. We assessed three PVA types (PVA 4-88, 8-88, 10-98) which differed in their degree of hydrolysis or molecular weight for their ability to release viable blastospores from thin films after drying at 60–40 °C, and examined how polyethylene glycol and soy-lecithin impact the blastospore survival. Finally, we evaluated the effectiveness of coated AK beads in a bioassay against Tenebrio molitor larvae. The blastospore release rate quadrupled within the first 5 min with decreasing molecular weight and degree of hydrolysis, with PVA 4-88 releasing 79 ± 19% blastospores. Polyethylene glycol and soy-lecithin significantly increased the blastospore survival to 18–28% for all three PVA types. Coated beads exhibited a uniform, 22.4 ± 7.3 µm thin coating layer, with embedded blastospores, as confirmed by scanning electron microscopy. The blastospore coating increased the mortality rate of T. molitor larvae over uncoated AK beads, decreasing the median lethal time from 10 to 6 days. Consequently, the blastospore coating accelerated the kill effect of regular AK beads. These findings pave the way to enhanced pest control efficacy from coated systems such as beads or seeds.
Graphical Abstract
Can routinely collected administrative data effectively be used to evaluate and validate endpoints used in breast cancer clinical trials? Protocol for a scoping review of the literature
Authors: Shah Hely , Wolfe Dianna , Clemons Mark , Liu Michelle , Thavorn Kednapa , Veroniki Areti-Angeliki , Lunny Carole , Pond Greg , McGee Sharon , Skidmore Becky , Arnaout Angel , Hutton Brian 
Published: July 2023

Abstract
Background
Randomized controlled trials (RCTs) are a critical component of evidence-based medicine and the evolution of patient care. However, the costs of conducting a RCT can be prohibitive. A promising approach toward reduction of costs and lessening of the burden of intensive and lengthy patient follow-up is the use of routinely collected healthcare data (RCHD), commonly called real-world data. We propose a scoping review to identify existing RCHD case definitions of breast cancer progression and survival and their diagnostic performance.

Methods
We will search MEDLINE, EMBASE, and CINAHL to identify primary studies of women with either early-stage or metastatic breast cancer, managed with established therapies, that evaluated the diagnostic accuracy of one or more RCHD-based case definitions or algorithms of disease progression (i.e., recurrence, progression-free survival, disease-free survival, or invasive disease-free survival) or survival (i.e., breast-cancer-free survival or overall survival) compared with a reference standard measure (e.g., chart review or a clinical trial dataset). Study characteristics and descriptions of algorithms will be extracted along with measures of the diagnostic accuracy of each algorithm (e.g., sensitivity, specificity, positive predictive value, negative predictive value), which will be summarized both descriptively and in structured figures/tables.

Discussion
Findings from this scoping review will be clinically meaningful for breast cancer researchers globally. Identification of feasible and accurate strategies to measure patient-important outcomes will potentially reduce RCT budgets as well as lessen the burden of intensive trial follow-up on patients.

Systematic review registration
Open Science Framework (https://doi.org/10.17605/OSF.IO/6D9RS)
An ECC-based mutual data access control protocol for next-generation public cloud
Authors: Khan Naveed , Jianbiao Zhang , Lim Huhnkuk , Ali Jehad , Ullah Intikhab , Salman Pathan Muhammad , Chaudhry Shehzad Ashraf 
Published: July 2023

AbstractThrough the broad usage of cloud computing and the extensive utilization of next-generation public clouds, people can share valuable information worldwide via a wireless medium. Public cloud computing is used in various domains where thousands of applications are connected and generate numerous amounts of data stored on the cloud servers via an open network channel. However, open transmission is vulnerable to several threats, and its security and privacy are still a big challenge. Some proposed security solutions for protecting next-generation public cloud environments are in the literature. However, these methods may not be suitable for a wide range of applications in a next-generation public cloud environment due to their high computing and communication overheads because if security protocol is strengthened, it inversely impacts performance and vice versa. Furthermore, these security frameworks are vulnerable to several attacks, such as replay, denial-of-service (DoS), insider, server spoofing, and masquerade, and also lack strong user anonymity and privacy protection for the end user. Therefore, this study aims to design an elliptic curve cryptographic (ECC) based data access control protocol for a public cloud environment. The security mechanism of the proposed protocol can be verified using BAN (Burrows-Abadi-Needham) logic and ProVerif 2.03, as well as informally using assumptions and pragmatic illustration. In contrast, in the performance analysis section, we have considered the parameters such as the complexity of storage overheads, communication, and computation time. As per the numerical results obtained in the performance analysis section, the proposed protocol is lightweight, robust, and easily implemented in a practical next-generation cloud computing environment.
High risk of bloodstream infection of carbapenem-resistant enterobacteriaceae carriers in neutropenic children with hematological diseases
Authors: Liu Li-Peng , Lin Qing-Song , Yang Wen-Yu , Chen Xiao-Juan , Liu Fang , Chen Xia , Ren Yuan-Yuan , Ruan Min , Chen Yu-Mei , Zhang Li , Zou Yao , Guo Ye , Zhu Xiao-Fan 
Published: July 2023

Abstract
Background
Neutropenic children with hematological diseases were associated with higher morbidity of carbapenem-resistant enterobacteriaceae (CRE) blood-stream infection (BSI) or colonization. But it was still murky regarding clinical characteristics, antimicrobial susceptibility, and outcomes of CRE-BSI in these patients. We aimed to identify the potential risk factors for subsequent bacteremia and clinical outcome caused by CRE-BSI.

Methods
Between 2008 and 2020, 2,465 consecutive neutropenic children were enrolled. The incidence and characteristics of CRE-BSI were explored in CRE-colonizers versus non-colonizers. Survival analysis was performed and risk factors for CRE-BSI and 30-day mortality were evaluated.

Results
CRE-carriers were identified in 59/2465 (2.39%) neutropenic children and19/59 (32.2%) developed CRE-BSI, while 12/2406 (0.5%) of non-carriers developed CRE-BSI (P < 0.001). The 30-day survival probability was significantly lower in patients with CRE-BSI than in non-BSI (73.9% vs. 94.9%, P = 0.050). Moreover, the 30-day survival probability of patients with CRE-BSI was also poorer in CRE-carriers versus non-carriers (49.7% vs. 91.7%, P = 0.048). Tigecycline and amikacin exhibited satisfactory antimicrobial activity against all isolated strains. Fluoroquinolone sensitivity was lower in E. coli (26.3%) strains versus satisfactory susceptibility of E. cloacae and other CRE-strains (91.2%). CRE-BSI accompanying intestinal mucosal damage were independent risk factors for 30-day survival probability (both P < 0.05), while combined antibiotic therapy and longer duration of neutropenia were more prone to developed CRE-BSI (P < 0.05).

Conclusion
CRE-colonizers were prone to subsequent BSI and CRE-BSI was regarded as an independent predictor predisposing to high mortality in neutropenic children. Moreover, individualized antimicrobial therapy should be adopted due to different features of patients with separate CRE strains.
Anterior mediastinal tracheostomy for severe tracheal stenosis in a child with severe motor and intellectual disabilities: a case report
Authors: Iwanaka Tsuyoshi , Shiraishi Takeshi , Hirose Ryuichiro , Sato Toshihiko 
Published: July 2023

Abstract
Background
Owing to recurrent aspiration pneumonia and airway stenosis secondary to thoracic deformities, tracheostomy or laryngotracheal separation are often necessary in children with severe motor and intellectual disabilities. However, these procedures are associated with the risks of tracheal stenosis due to tracheal granulation and tracheoinnominate artery fistula formation. We report a case of a child with severe motor and intellectual disabilities treated with an anterior mediastinal tracheostomy.

Case presentation
The patient was a 15-year-old boy with severe motor and intellectual disabilities due to intractable epilepsy. Due to thoracic deformity and tracheomalacia, the patient had a flattened and narrowed trachea. Accordingly, laryngotracheal separation was performed 4 months before admission to avoid aspiration pneumonia. Due to a common cold, the patient required frequent sputum suctioning, which exacerbated the tracheal stenosis. Bronchoscopy revealed tracheal stenosis 4–5 cm caudal to the tracheostomy site, tracheal mucosal ulcers, and pulsation of the innominate artery on the anterior wall of the trachea. We performed an anterior mediastinum tracheostomy to release the tracheal stenosis and prevent tracheoinnominate artery fistula formation.

Conclusions
Anterior mediastinal tracheostomy has several advantages. Including sufficient release of bony compression, release of tracheal hyperextension, and relief of tracheal and innominate artery contact ensures a cannula-free tracheostomy, and there is no need to dissect the brachiocephalic artery. It is the procedure of choice in cases of head and neck malignancies requiring extensive tracheal resection and could be a good surgical option for severe tracheal stenosis and tracheoinnominate artery fistula in children with severe motor and intellectual disabilities.
Protocol for a multi-site randomised controlled feasibility study investigating intermittently scanned blood continuous glucose monitoring use for gestational diabetes: the RECOGNISE study
Authors: Davies Anna , Lenguerrand Erik , Scott Eleanor , Kandiyali Rebecca , Douek Isabelle , Norman Jane , Loose Abi , Sawyer Lynn , Timlin Laura , Burden Christy 
Published: July 2023

AbstractBackgroundIncidence of gestational diabetes mellitus (GDM) is increasing and is associated with adverse perinatal outcomes including macrosomia, pre-eclampsia, and pre-term delivery. Optimum glycaemic control can reduce these adverse perinatal outcomes. Continuous glucose monitoring (CGM) informs users about interstitial glucose levels allowing early detection of glycaemic excursions and pharmacological or behavioural intervention. Few adequately powered RCTs to evaluate the impact of using CGM in women with GDM on perinatal outcomes have been undertaken.We aim to establish the feasibility of a multi-site RCT to evaluate the clinical- and cost-effectiveness of an intermittently scanned continuous glucose monitor (isCGM) compared with self-monitored blood glucose (SMBG) in women with GDM for reducing fetal macrosomia and improving maternal and fetal outcomes. We will evaluate recruitment and retention rates, adherence to device requirements, adequacy of data capture and acceptability of trial design and isCGM devices.MethodsOpen-label multicentre randomised controlled feasibility trial. Inclusion criteria: pregnant women, singleton pregnancy, recent diagnosis of GDM (within 14 days of commencing medication, up to 34 weeks gestation) prescribed metformin and/or insulin. Women will be consecutively recruited and randomised to isCGM (FreestyleLibre2) or SMBG. At every antenatal visit, glucose measurements will be evaluated. The SMBG group will use blinded isCGM for 14 days at baseline (~ 12–32 weeks) and ~ 34–36 weeks. The primary outcome is the recruitment rate and absolute number of women participating. Clinical assessments of maternal and fetal/infant health will be undertaken at baseline, birth, up to ~ 13 weeks post-natal. Psychological, behavioural and health economic measures will be assessed at baseline and ~ 34–36 weeks gestation. Qualitative interviews will be undertaken with study decliners, participants, and professionals to explore trial acceptability, of using isCGM and SMBG.DiscussionGDM can be associated with adverse pregnancy outcomes. isCGM could offer a timely, easy-to-engage-with intervention, to improve glycaemic control, potentially reducing adverse pregnancy, birth and long-term health outcomes for mother and child. This study will determine the feasibility of conducting a large-scale multisite RCT of isCGM in women with GDM.Trial registrationThis study has been registered with the ISRCTN (reference:ISRCTN42125256, Date registered: 07/11/2022).
Patient and public involvement in health research in Norway: a survey among researchers and patient organisations
Authors: Aas Sigve Nyvik , Distefano Marita Borg , Pettersen Ingvild , Gravrok Berit , Nordvoll Laila Yvonne , Bjaastad Jon Fauskanger , Grimsgaard Sameline 
Published: July 2023

Abstract
Background
Patient and public involvement (PPI) in health research may improve both the relevance and quality of the research. There is however a lack of research investigating the experiences, attitudes and barriers towards PPI in clinical research in Norway. The Norwegian Clinical Research Infrastructure Network therefore conducted a survey among researchers and PPI contributors aiming to investigate experiences with PPI and identify current challenges for successful involvement.

Methods
Two survey questionnaires were developed and distributed in October and November 2021. The survey targeting 1185 researchers was distributed from the research administrative system in the Regional Health Trusts. The survey targeting PPI contributors was distributed through Norwegian patient organisations, regional and national competence centers.

Results
The response rate was 30% among researchers and was unobtainable from PPI contributors due to the survey distribution strategy. PPI was most frequently used in the planning and conduct of the studies, and less utilized in dissemination and implementation of results. Both researchers and user representatives were generally positive to PPI, and agreed that PPI might be more useful in clinical research than in underpinning research. Researchers and PPI contributors who reported that roles and expectations were clarified in advance, were more likely to experience a common understanding of roles and responsibilities in the research project. Both groups pointed to the importance of earmarked funding for PPI activities. There was a demand for a closer collaboration between researchers and patient organisations to develop accessible tools and effective models for PPI in health research.

Conclusions
Surveys among clinical researchers and PPI contributors indicate overall positive attitudes towards PPI in clinical research. However, more resources, such as budget, time, and accessible tools, are needed. Clarifying roles and expectations, and creating new PPI models under resource constraints can enhance its effectiveness. PPI is underutilized in disseminating and implementing research results, presenting an opportunity for improving healthcare outcomes.
Neutralizing Antibody Validation Testing and Reporting Harmonization
Authors: Myler Heather , Pedras-Vasconcelos João , Lester Todd , Civoli Francesca , Xu Weifeng , Wu Bonnie , Vainshtein Inna , Luo Linlin , Hassanein Mohamed , Liu Susana , Ramaswamy Swarna Suba , Mora Johanna , Pennucci Jason , McCush Fred , Lavelle Amy , Jani Darshana , Ambakhutwala Angela , Baltrukonis Daniel , Barker Breann , Carmean Rebecca , Chung Shan , Dai Sheng , DeWall Stephen , Dholakiya Sanjay L. , Dodge Robert , Finco Deborah , Yan Haoheng , Hays Amanda , Hu Zheng , Inzano Cynthia , Kamen Lynn , Lai Ching-Ha , Meyer Erik , Nelson Robert , Paudel Amrit , Phillips Kelli , Poupart Marie-Eve , Qu Qiang , Abhari Mohsen Rajabi , Ryding Janka , Sheldon Curtis , Spriggs Franklin , Warrino Dominic , Wu Yuling , Yang Lin , Pasas-Farmer Stephanie 
Published: July 2023

Abstract
Evolving immunogenicity assay performance expectations and a lack of harmonized neutralizing antibody validation testing and reporting tools have resulted in significant time spent by health authorities and sponsors on resolving filing queries. A team of experts within the American Association of Pharmaceutical Scientists’ Therapeutic Product Immunogenicity Community across industry and the Food and Drug Administration addressed challenges unique to cell-based and non-cell-based neutralizing antibody assays. Harmonization of validation expectations and data reporting will facilitate filings to health authorities and are described in this manuscript. This team provides validation testing and reporting strategies and tools for the following assessments: (1) format selection; (2) cut point; (3) assay acceptance criteria; (4) control precision; (5) sensitivity including positive control selection and performance tracking; (6) negative control selection; (7) selectivity/specificity including matrix interference, hemolysis, lipemia, bilirubin, concomitant medications, and structurally similar analytes; (8) drug tolerance; (9) target tolerance; (10) sample stability; and (11) assay robustness.
Graphical Abstract
Contemporary Techniques and Potential Transungual Drug Delivery Nanosystems for The Treatment of Onychomycosis
Authors: Abd-Elsalam Wessam H. , Abouelatta Samar M. 
Published: July 2023

AbstractThe humanoid nail is considered an exceptional protective barrier that is formed mainly from keratin. Onychomycosis is the cause of 50% of nail infections that is generally caused by dermatophytes. Firstly, the infection was regarded as a cosmetic problem but because of the tenacious nature of onychomycosis and its relapses, these infections have attracted medical attention. The first line of therapy was the oral antifungal agents which were proven to be effective; nevertheless, they exhibited hepato-toxic side effects, alongside drug interactions. Following, the opportunity was shifted to the topical remedies, as onychomycosis is rather superficial, yet this route is hindered by the keratinized layers in the nail plate. A potential alternative to overcome the obstacle was applying different mechanical, physical, and chemical methods to boost the penetration of drugs through the nail plate. Unfortunately, these methods might be expensive, require an expert to be completed, or even be followed by pain or more serious side effects. Furthermore, topical formulations such as nail lacquers and patches do not provide enough sustaining effects. Recently, newer therapies such as nanovesicles, nanoparticles, and nanoemulsions have emerged for the treatment of onychomycosis that provided effective treatment with possibly no side effects. This review states the treatment strategies such as mechanical, physical, and chemical methods, and highlights various innovative dosage forms and nanosystems developed in the last 10 years with a focus on advanced findings regarding formulation systems. Furthermore, it demonstrates the natural bioactives and their formulation as nanosystems, and the most relevant clinical outcomes.
Graphical Abstract
Frequency-dependent avoidance movement of glass catfish in response to sinusoidal electrical stimulation and associated spiking patterns of electroreceptors
Authors: Adachi Yu , Tateno Katsumi 
Published: July 2023

ABSTRACT
The glass catfish is a freshwater fish with electroreceptors on its body surface. In this study, we investigated its behavioral response to sinusoidal electrical stimulation with a dipole wider than its body length and the spiking patterns of its electroreceptors. We observed that sinusoidal electric stimulation with a large dipole distance elicited in the glass catfish an avoidance movement whose frequency range is frequency-dependent. The movements were prominent in the frequency range between 10–20 Hz. When the stimulation strength increased, the movements were also found in the low-frequency range. In electrophysiological experiments, periodic interspike intervals of the electroreceptors were modulated by sinusoidal electrical stimuli. The stimulation introduced irregularity in the spiking patterns. The local variability of the spike modulations was significantly higher in the frequency range of 4–40 Hz and was particularly sensitive at 20 Hz. The avoidance movements and an increase in the local variability in the spike patterns were found around 20 Hz. Our results indicate that the glass catfish avoids sinusoidal electrical stimulation in a frequency-dependent manner, and this is associated with local modulations in the spiking patterns of the electroreceptors.