bluuebunny/crossref_metadata_2025_split huggingface dataset:
COVID-19 vaccine effectiveness among healthcare workers in Albania (COVE-AL): protocol for a prospective cohort study and cohort baseline data
Authors: Sridhar Shela , Fico Albana , Preza Iria , Hatibi Iris , Sulo Jonilda , Kissling Esther , Daja Rovena , Ibrahim Rawi , Lemos Diogo , Rubin-Smith Julia , Schmid Alexis , Vasili Adela , Valenciano Marta , Jorgensen Pernille , Pebody Richard , Lafond Kathryn E. , Katz Mark A. , Bino Silvia 
Published: March 2022

IntroductionCritical questions remain about COVID-19 vaccine effectiveness (VE) in real-world settings, particularly in middle-income countries. We describe a study protocol to evaluate COVID-19 VE in preventing laboratory-confirmed SARS-CoV-2 infection in health workers (HWs) in Albania, an upper-middle-income country.Methods and analysisIn this 12-month prospective cohort study, we enrolled HWs at three hospitals in Albania. HWs are vaccinated through the routine COVID-19 vaccine campaign. Participants completed a baseline survey about demographics, clinical comorbidities, and infection risk behaviours. Baseline serology samples were also collected and tested against the SARS-CoV-2 spike protein, and respiratory swabs were collected and tested for SARS-CoV-2 by RT-PCR. Participants complete weekly symptom questionnaires and symptomatic participants have a respiratory swab collected, which is tested for SARS-CoV-2. At 3, 6, 9 months and 12 months of the study, serology will be collected and tested for antibodies against the SARS-CoV-2 nucleocapsid protein and spike protein. VE will be estimated using a piecewise proportional hazards model (VE=1−HR).Baseline dataFrom February to May 2021, 1504 HWs were enrolled. The median age was 44 (range: 22–71) and 78% were female. At enrolment, 72% of participants were seropositive for SARS-CoV-2. 56% of participants were vaccinated with one dose, of whom 98% received their first shot within 4 days of enrolment. All HWs received the Pfizer BNT162b2 mRNA COVID-19 vaccine.Ethics and disseminationThe study protocol and procedures were reviewed and approved by the WHO Ethical Review Board, reference number CERC.0097A, and the Albanian Institute of Public Health Ethical Review Board, reference number 156. All participants have provided written informed consent to participate in this study. The primary results of this study will be published in a peer-reviewed journal at the time of completion.Trial registration numberNCT04811391.
Late pregnancy ultrasound parameters identifying fetuses at risk of adverse perinatal outcomes: a protocol for a systematic review of systematic reviews
Authors: Aderoba Adeniyi Kolade , Nasir Naima , Quigley Maria , Impey Lawrence , Rivero-Arias Oliver , Kurinczuk Jennifer J 
Published: March 2022

IntroductionStillbirths and neonatal deaths are leading contributors to the global burden of disease and pregnancy ultrasound has the potential to help decrease this burden. In the absence of high-Grading of Recommendations Assessment, Development and Evaluation (GRADE) evidence on universal obstetric ultrasound screening at or close to term, many different screening strategies have been proposed. Systematic reviews have rapidly increased over the past decade owing to the diverse nature of ultrasound parameters and the wide range of possible adverse perinatal outcomes. This systematic review will summarise the evidence on key ultrasound parameters in the published literature to help develop an obstetric ultrasound protocol that identifies pregnancies at risk of adverse perinatal outcomes at or close to term.MethodsThis study will follow the recent Cochrane guidelines for a systematic review of systematic reviews. A comprehensive literature search will be conducted using Embase (OvidSP), Medline (OvidSP), CDSR, CINAHL (EBSCOhost) and Scopus. Systematic reviews evaluating at least one ultrasound parameter in late pregnancy to detect pregnancies at risk of adverse perinatal outcomes will be included. Two independent reviewers will screen, assess the quality including the risk of bias using the ROBIS tool, and extract data from eligible systematic reviews that meet the study inclusion criteria. Overlapping data will be assessed and managed with decision rules, and study evidence including the GRADE assessment of the certainty of results will be presented as a narrative synthesis as described in the Cochrane guidelines for an overview of reviews.Ethics and disseminationThis research uses publicly available published data; thus, an ethics committee review is not required. The findings will be published in a peer-reviewed journal.PROSPERO registration numberCRD42021266108.
Protocol for GUo’s renovisceral Artery reconstruction-1: a prospective, multicentre, single-arm clinical trial to evaluate the safety and efficacy of a multibRANched sTEnt graft systEm for thoracoabdominal aortic aneurysm (GUARANTEE study)
Authors: Ge Yangyang , Zhang Hongpeng , Rong Dan , Liu Feng , Jia Xin , Xiong Jiang , Ma Xiaohui , Wang Lijun , Fan Tingting , Guo Wei 
Published: March 2022

IntroductionThe multibranched off-the-shelf stent graft is a promising treatment option for thoracoabdominal aortic aneurysm (TAAA). A commercially available, multibranched, off-the-shelf endograft called the t-Branch stent graft has demonstrated favourable midterm outcomes. Another two investigational off-the-shelf endografts, the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis and E-nside multibranch stent graft system, are still being developed. However, these three endografts have an unsatisfactory anatomic feasibility rate in patients with TAAA. Based on the concept of Guo’s renovisceral artery reconstruction-1, a novel, multibranched, off-the-shelf endograft with different configurations has been developed.Methods and analysisThis prospective, multicentre, single-arm, cohort study will enrol 73 patients with TAAA. Preoperative and postoperative clinical data, as well as CT angiography images at each follow-up timepoint, will be analysed to evaluate the safety and efficacy of this novel, multibranched, off-the-shelf endograft for the treatment of TAAA. The primary safety end point is the major adverse event rate within 30 days after index endovascular aortic repair, including all-cause death, hepatic failure, bowel necrosis, renal failure, stroke, permanent paraplegia, cardiac infarction and respiratory failure. The primary efficacy end point is the successful treatment rate within 12 months after procedure, which is a composite of immediate technical success and no secondary surgical intervention related to TAAA within 12 months after the procedure.Ethics and disseminationThe protocol has been reviewed and approved by the ethics committee of Chinese PLA General Hospital (reference number: 2021-NO.-007) and each participating hospital. The findings of this study will be disseminated through conference presentations, peer-reviewed journal publications and social media.Trial registration numberNCT05054985.
Feasibility of establishing a Canadian Obstetric Survey System (CanOSS) for severe maternal morbidity: a study protocol
Authors: D’Souza Rohan , Seymour Rebecca J , Knight Marian , Dzakpasu Susie , Joseph K S , Thorne Sara , Ospina Maria B , Barrett Jon , Cook Jocelynn , Fell Deshayne B , Scott Heather , Metcalfe Amy , van den Akker Thomas , Lapinsky Stephen , Skeith Leslie , Murray-Davis Beth , Shah Prakesh , Forte Milena , Ashraf Rizwana , Chundamala Josie , Hutchinson Sarah A , Chen Kenneth K , Malhamé Isabelle 
Published: March 2022

IntroductionSevere maternal morbidity (SMM)—an unexpected pregnancy-associated maternal outcome resulting in severe illness, prolonged hospitalisation or long-term disability—is recognised by many, as the preferred indicator of the quality of maternity care, especially in high-income countries. Obtaining comprehensive details on events and circumstances leading to SMM, obtained through maternity units, could complement data from large epidemiological studies and enable targeted interventions to improve maternal health. The aim of this study is to assess the feasibility of gathering such data from maternity units across Canadian provinces and territories, with the goal of establishing a national obstetric survey system for SMM in Canada.Methods and analysisWe propose a sequential explanatory mixed-methods study. We will first distribute a cross-sectional survey to leads of all maternity units across Canada to gather information on (1) Whether the unit has a system for reviewing SMM and the nature and format of this system, (2) Willingness to share anonymised data on SMM by direct entry using a web-based platform and (3) Respondents’ perception on the definition and leading causes of SMM at a local level. This will be followed by semistructured interviews with respondent groups defined a priori, to identify barriers and facilitators for data sharing. We will perform an integrated analysis to determine feasibility outcomes, a narrative description of barriers and facilitators for data-sharing and resource implications for data acquisition on an annual basis, and variations in top-5 causes of SMM.Ethics and disseminationThe study has been approved by the Mount Sinai and Hamilton Integrated Research Ethics Boards. The study findings will be presented at annual scientific meetings of the Society of Obstetricians and Gynaecologists of Canada, North American Society of Obstetric Medicine, and International Network of Obstetric Survey Systems and published in an open-access peer-reviewed Obstetrics and Gynaecology or General Internal Medicine journal.
Diagnostic performance of anterior segment optical coherence tomography in detecting plateau iris
Authors: Wanichwecharungruang Boonsong , Pattanapongpaiboon Warisara , Kongsomboon Kittipong , Parivisutt Nucharee , Annopawong Kornkamol , Seresirikachorn Kasem 
Published: March 2022

ObjectiveTo evaluate the diagnostic performance of manual grading of anterior segment optical coherence tomography (AS-OCT) in detection of plateau iris configuration (PIC) based on the presence of standardised ultrasound biomicroscopy (UBM) criteria in at least two quadrants; namely, clinical diagnosis of PIC (DxPIC).Methods and analysisIn this cross-sectional study, paired AS-OCT and UBM images were evaluated by three glaucoma specialists. AS-OCT was classified into two mechanisms, PIC versus non-PIC, of primary angle closure disease (PACD) and AS-OCT-PIC diagnostic performance was tested with DxPIC.ResultsOne hundred and seventy-nine eyes of 142 patients were enrolled for analysis, and DxPIC was found in 85 eyes (47.49%). Intraobserver agreement rates of AS-OCT classification by the graders were 0.77, 0.701 and 0.742 (all p<0.001), and interobserver agreement rates, between a senior glaucoma specialist and the other two glaucoma specialists, were 0.68 and 0.702 (all p<0.001). Plateau iris was classified in AS-OCT images by the three graders, rated 32.96%–39.1% and 24.58%–34.08% in the horizontal and vertical axes, respectively. Diagnostic performance was analysed, yielding sensitivity ranging from 56.47% to 77.78%, and specificity of 48.94% to 64.29%. We applied disease prevalence of 30%, revealing positive predictive values varying from 32.16% to 44.44%, and negative predictive values of 72.4% to 85.71%. Accuracy ranged from 51.2% to 65%. Agreement between the two devices was fair, kappa range 0.31–0.351.ConclusionPerformance of manual grading of AS-OCT in detection of DxPIC was relatively poor; therefore, unadjusted AS-OCT does not appear to be good for manual PIC screening in PACD patients and cannot serve as a substitute for UBM in PIC detection.
Pain management in children and young adults with minor injury in emergency departments in the UK and Ireland: a PERUKI service evaluation
Authors: Hartshorn Stuart , Durnin Sheena , Lyttle Mark D , Barrett Michael 
Published: March 2022

BackgroundManagement of acute pain should commence at the earliest opportunity, as it has many short-term and long-term consequences. A research priority of Paediatric Emergency Research in the UK and Ireland (PERUKI) was to examine paediatric pain practices.ObjectiveTo describe the outcomes for paediatric pain management of minor injuries presenting to emergency departments (EDs) across PERUKI.MethodsA retrospective service evaluation was performed over a 7-day period in late 2016/early 2017 across PERUKI sites, and analysis performed using an adapted Donabedian framework. Patients under 16 years presenting with minor trauma were eligible, and data were collected on prehospital management, pain assessment, analgesia administered and injury diagnosed.ResultsThirty-one sites submitted data on 3888 patients. There were 111 missed cases (missed rate 3.6%). The most common injuries were sprains, lacerations, contusions/abrasions and fractures. Documentation of receiving analgesia before arrival in ED occurred in 21% of patients (n=818). A pain assessment was documented in 57.5% of patients (n=2235) during their ED visit, and 3.5% of patients had their pain reassessed (n=138). Of the patients who presented in severe pain (pain score 7–10 or rated severe), 11% were reassessed. Site variability of initial pain assessment ranged from 1.4% to 100% (median 62%). The characteristics of the top quartile performing centres against the bottom quartile performing centres based on completion rate of initial pain scores were identified.ConclusionPain assessment was documented in under 60% of children with minor injury, re-assessment of pain was almost completely absent, data and outcomes were missing in a substantial volume of patients, indicating that pain management and the associated outcomes have not been adequately addressed and prioritised within existing network structures and processes.
Therapeutic hypothermia for neonatal encephalopathy with sepsis: a retrospective cohort study
Authors: Sibbin Kristina , Crawford Tara M , Stark Michael , Battin Malcolm 
Published: March 2022

ObjectiveNeonatal encephalopathy remains a major cause of infant mortality and neurodevelopmental impairment. Infection may exacerbate brain injury and mitigate the effect of therapeutic hypothermia (TH). Additionally, infants with sepsis treated with TH may be at increased risk of adverse effects. This study aimed to review the clinical characteristics and outcomes for infants with sepsis treated with TH.Design and settingRetrospective cohort study of infants treated with TH within Australia and New Zealand.Patients1522 infants treated with TH, including 38 with culture-positive sepsis from 2014 to 2018.InterventionAnonymised retrospective review of data from Australian and New Zealand Neonatal Network. Infants with culture-positive sepsis within 48 hours were compared with those without sepsis.Main outcome measuresKey outcomes include in-hospital mortality, intensive care support requirements and length of stay.ResultsOverall the rate of mortality was similar between the groups (13% vs 13%). Infants with sepsis received a higher rate of mechanical ventilation (89% vs 70%, p=0.01), high-frequency oscillatory ventilation (32% vs 13%, p=0.003) and inhaled nitric oxide for persistent pulmonary hypertension (38% vs 16%, p<0.001). Additionally, the sepsis group had a longer length of stay (20 vs 11 days, p<0.001).ConclusionInfants with sepsis treated with TH required significantly more respiratory support and had a longer length of stay. Although this may suggest a more severe illness the rate of mortality was similar. Further research is warranted to review the neurodevelopmental outcomes for these infants.
Multicentre study to improve clinical interpretation of rheumatoid factor and anti-citrullinated protein/peptide antibodies test results
Authors: Van Hoovels Lieve , Vander Cruyssen Bert , Sieghart Daniela , Bonroy Carolien , Nagy Eszter , Pullerits Rille , Čučnik Saša , Dahle Charlotte , Heijnen Ingmar , Bernasconi Luca , Benkhadra Farid , Bogaert Laura , Van Den Bremt Stefanie , Van Liedekerke Ann , Vanheule Geert , Robbrecht Johan , Studholme Lucy , Wirth Claudine , Müller Rüdiger , Kyburz Diego , Sjöwall Christopher , Kastbom Alf , Ješe Rok , Jovancevic Boja , Kiss Emese , Jacques Peggy , Aletaha Daniel , Steiner Guenter , Verschueren Patrick , Bossuyt Xavier 
Published: March 2022

BackgroundRheumatoid factor (RF) and anti-citrullinated protein/peptide antibodies (ACPA) are important biomarkers for diagnosis of rheumatoid arthritis (RA). However, there is poor harmonisation of RF and ACPA assays. The aim of this study was to refine RF and ACPA interpretation across commercial assays.Materials and methodsSix total RF isotype-non-specific assays, 3 RF IgM isotype-specific assays and 9 ACPA immunoglobulin G assays of 13 different companies were evaluated using 398 diagnostic samples from patients with RA and 1073 disease controls.ResultsUsing cut-offs proposed by the manufacturer, there was a large variability in diagnostic sensitivity and specificity between assays. Thresholds of antibody levels were determined based on predefined specificities and used to define test result intervals. Test result interval-specific likelihood ratios (LRs) were concordant across the different RF and ACPA assays. For all assays, the LR for RA increased with increasing antibody level. Higher LRs were found for ACPA than for RF. ACPA levels associated with LRs >80 were found in a substantial fraction (>22%) of patients with RA.ConclusionDefining thresholds for antibody levels and assigning test result interval-specific LRs allows alignment of clinical interpretation for all RF and ACPA assays.
Modeling of dielectric behavior of polymers nanocomposites using adaptive neuro-fuzzy inference system (ANFIS)
Authors: Mohamed R. A. 
Published: March 2022

AbstractThe research presents a theoretical study on modeling of dielectric properties of polymer nanocomposites based on adaptive neuro-fuzzy inference system (ANFIS). The research contributes a better utilizing of ANFIS model in the prediction of dielectric behavior of polymers nanocomposites. In this respect, three different samples are trained (Mg1−xCuxO/PMMA, PPy-DBSA-Y2O3 and PVC/PEMA with [Zn(CF3SO3)2]). Inputs are obtained from earlier experimental studies. ANFIS Takagi–Sugeno type is trained. The model is applied based on weighted average as a defuzzification method. The optimal network structures, which produce the most acceptable results, are implemented in MATLAB. Six ANFIS networks are trained to simulate and predict dielectric permittivity and dielectric loss in terms of nanocomposite weight % (0–0.2%, 0–8% and 10–30% for each sample, respectively) and frequency (10−2–103 kHz). ANFIS simulation results are very close to their targets. Predictions of dielectric properties at nanocomposite weights % that are measured experimentally as a testing step and predictions of other values that are not implicated in the experimental data extent are achieved. Also, predictions of individual points are processed using ANFIS rule viewer. It is found that ANFIS predictions provide excellent results. Three-dimensional illustrations that represent the mapping from frequency and nanocomposite weight% to the dielectric permittivity and dielectric loss are obtained using MATLAB surface viewer. Histogram error plot is obtained to indicate the degree of noisy. Mean error, mean squared error, root-mean-squared error and standard division error are calculated. Their values improve the efficiency of the modeling process. A key goal of this paper is to develop a mechanism to predict the dielectric properties of polymers nanocomposites. In accordance with the modeling results, the ANFIS technique achieves the purpose. It can also form a great link between practical and theoretical domains.
A Multispecific Anti-CD40 DARPin Construct Induces Tumor-Selective CD40 Activation and Tumor Regression
Authors: Rigamonti Nicolò , Veitonmäki Niina , Domke Clara , Barsin Sophie , Jetzer Sarah , Abdelmotaleb Omar , Bessey Ralph , Lekishvili Tamara , Malvezzi Francesca , Gachechiladze Mariam , Behe Martin , Levitsky Victor , Trail Pamela A. 
Published: March 2022

Abstract

The CD40 receptor is an attractive target for cancer immunotherapy. Although a modest pharmacodynamic effect is seen in patients following administration of CD40-targeting monoclonal antibodies (mAb), the doses that could be safely administered do not result in a meaningful clinical response, most likely due to the limited therapeutic window associated with systemic CD40 activation. To overcome this issue, we developed a multispecific DARPin construct, α-FAPxCD40, which has conditional activity at the site of disease. α-FAPxCD40 activation of CD40 depends on binding to fibroblast activation protein (FAP), a cell-surface protease overexpressed in the stroma of solid tumors. In vitro studies demonstrated that α-FAPxCD40 potently activates human antigen-presenting cells in the presence, but not in the absence, of FAP-positive cells. After intravenous injection, a murine surrogate construct (α-mFAPxCD40) accumulated in FAP-positive tumors, elicited rejection of 88% of these tumors, and induced memory antitumor immunity. Importantly, in contrast to the mouse anti-CD40 tested in parallel, the in vivo antitumor activity of α-mFAPxCD40 was associated neither with elevated blood cytokines nor with hepatotoxicity, both of which contribute to the clinical dose-limiting toxicities of several CD40 mAb. This study demonstrates that α-(m)FAPxCD40 engages CD40 in an FAP-restricted manner, leading to tumor eradication without signs of peripheral toxicity. This distinct preclinical profile suggests that a favorable therapeutic index may be achieved in humans. It further supports the development of α-FAPxCD40, currently tested in a first-in-human clinical study in patients with solid tumors (NCT05098405).