bluuebunny/crossref_metadata_2025_split huggingface dataset:
Detection of ISUP ≥2 prostate cancers using multiparametric MRI: prospective multicentre assessment of the non-inferiority of an artificial intelligence system as compared to the PI-RADS V.2.1 score (CHANGE study)
Authors: Rouvière Olivier , Souchon Rémi , Lartizien Carole , Mansuy Adeline , Magaud Laurent , Colom Matthieu , Dubreuil-Chambardel Marine , Debeer Sabine , Jaouen Tristan , Duran Audrey , Rippert Pascal , Riche Benjamin , Monini Caterina , Vlaeminck-Guillem Virginie , Haesebaert Julie , Rabilloud Muriel , Crouzet Sébastien 
Published: February 2022

IntroductionProstate multiparametric MRI (mpMRI) has shown good sensitivity in detecting cancers with an International Society of Urological Pathology (ISUP) grade of ≥2. However, it lacks specificity, and its inter-reader reproducibility remains moderate. Biomarkers, such as the Prostate Health Index (PHI), may help select patients for prostate biopsy. Computer-aided diagnosis/detection (CAD) systems may also improve mpMRI interpretation. Different prototypes of CAD systems are currently developed under the Recherche Hospitalo-Universitaire en Santé / Personalized Focused Ultrasound Surgery of Localized Prostate Cancer (RHU PERFUSE) research programme, tackling challenging issues such as robustness across imaging protocols and magnetic resonance (MR) vendors, and ability to characterise cancer aggressiveness. The study primary objective is to evaluate the non-inferiority of the area under the receiver operating characteristic curve of the final CAD system as compared with the Prostate Imaging-Reporting and Data System V.2.1 (PI-RADS V.2.1) in predicting the presence of ISUP ≥2 prostate cancer in patients undergoing prostate biopsy.MethodsThis prospective, multicentre, non-inferiority trial will include 420 men with suspected prostate cancer, a prostate-specific antigen level of ≤30 ng/mL and a clinical stage ≤T2 c. Included men will undergo prostate mpMRI that will be interpreted using the PI-RADS V.2.1 score. Then, they will undergo systematic and targeted biopsy. PHI will be assessed before biopsy. At the end of patient inclusion, MR images will be assessed by the final version of the CAD system developed under the RHU PERFUSE programme. Key secondary outcomes include the prediction of ISUP grade ≥2 prostate cancer during a 3-year follow-up, and the number of biopsy procedures saved and ISUP grade ≥2 cancers missed by several diagnostic pathways combining PHI and MRI findings.Ethics and disseminationEthical approval was obtained from the Comité de Protection des Personnes Nord Ouest III (ID-RCB: 2020-A02785-34). After publication of the results, access to MR images will be possible for testing other CAD systems.Trial registration numberNCT04732156.
Changes in QTc interval after hydroxychloroquine therapy in patients with COVID-19 infection: a large, retrospective, multicentre cohort study
Authors: El Kadri Moutaz , Al Falasi Omar , Ahmed Rizwan , Al Awadhi Ahlam , Altaha Zainab , Hillis Amany , Panikkaveetil Basheer , Abdalla Sara , Ansel Benette Honey , Almubarak Adhba , Saifuddin Mohammed , Alattar Yousef , Oulhaj Abderrahim , AlKaabi Salem 
Published: February 2022

ObjectiveTo evaluate the extent of hydroxychloroquine-induced corrected QT (QTc) prolongation and its relation to COVID-19 infection severity and incidence of polymorphic ventricular arrhythmias and sudden arrhythmic deaths.DesignA large-scale cohort study with retrospective analysis of baseline and on-therapy QT interval corrected using Bazett and Fridericia formulas.SettingA multicentre study involving eight secondary and tertiary care hospitals of the Abu Dhabi Health Services Company (SEHA), United Arab Emirates.Participants2014 patients consecutively admitted with PCR-confirmed SARS-CoV-2 infection between 1 March 2020 and 1 June 2020.InterventionsTreatment with hydroxychloroquine alone or in combination with azithromycin for at least 24 hours and with a baseline ECG and at least one ECG after 24 hours of therapy.Main outcome measuresMaximal QTc interval prolongation and its relationship to clinical severity, polymorphic ventricular tachycardia and sudden arrhythmic death while on treatment.ResultsThe baseline QTc(Bazett) was 427.6±25.4 ms and the maximum QTc(Bazett) during treatment was 439.2±30.4 ms (p<0.001). Severe QTc prolongation (QTc ≥500 ms) was observed in 1.7%–3.3% of patients (Fridericia and Bazett, respectively). There were no cases of polymorphic ventricular arrhythmia or hydroxychloroquine-related arrhythmic death. QTc prolongation was more pronounced in combination therapy compared with hydroxychloroquine alone (22.2 ms vs 11.0 ms, p<0.001) and in patients with higher COVID-19 clinical severity (asymptomatic: 428.4±25.4 ms, severe COVID-19 infection: 452.7±35.7 ms, p<0.001). The overall in-hospital mortality was 3.97% and deceased patients had longer on-therapy QTc(Bazett) than survivors (459.8±21.4 ms vs 438.4±29.9 ms, p<0.001).ConclusionsThe incidence of severe QTc prolongation with hydroxychloroquine was low and not associated with ventricular arrhythmia. The safety concerns surrounding the use of hydroxychloroquine may have been overestimated; however, caution should be exercised when using hydroxychloroquine in patients with risk factors for QT prolongation.
Incidence of venous thrombotic events and events of special interest in a retrospective cohort of commercially insured US patients
Authors: Weller Susan C , Porterfield Laura , Davis John , Wilkinson Gregg S , Chen Lu , Baillargeon Jacques 
Published: February 2022

ObjectiveTo estimate the US incidence of thrombotic events and related rare diagnoses.DesignClaims-based retrospective cohort study of incidence.SettingUS commercial health insurance administrative claims database.ParticipantsAdults 25–64 years of age between 2015 and 2019 with a minimum of 12 consecutive thrombosis-free months of continuous enrolment beginning 2014 were selected.Main outcomesAge (10-year intervals) and sex stratum-specific incidence rates per 100 000 person-years were determined for venous thromboembolism (VTE), cerebral venous thrombosis (CVT) and other major venous thrombotic events, and events of special interest, including immune thrombocytopenic purpura (ITP), haemolytic-uremic syndrome (HUS) and heparin-induced thrombocytopenia (HIT).ResultsOf 13 249 229 enrollees (half female/male), incidence of venous thromboembolic events (deep vein thrombosis (DVT), pulmonary embolism (PE), CVT or other major venous thrombotic conditions) was 247.89 per 100 000 person-years (95% CI: 245.96 to 249.84). Incidence of VTE was 213.79 with ICD codes alone (95% CI: 211.99 to 215.59) and 129.34 (95% CI: 127.95 to 130.75) when also requiring a filled anticoagulation prescription or an inferior vena cava (IVC) filter. Incidence was 6.37 for CVT (95% CI: 6.07 to 6.69), 26.06 for ITP (95% CI: 25.44 to 26.78), 0.94 for HUS (95% CI: 0.82 to 1.06) and 4.82 for HIT (95% CI: 4.56 to 5.10). The co-occurrence of CVT with either ITP or HIT (diagnoses within 14 days of one another) was 0.090 (95% CI: 0.06 to 0.13). Incidence tended to increase with age and was higher for women under 55. Incidence for CVT, HUS and CVT with ITP or HIT was higher for women in all age groups. Incidence of PE and CVT increased significantly over the 5-year period, while DVT rates decreased.ConclusionsThese results are the first US estimates for the incidence of thrombotic and rare events of interest in a large, commercially insured US population. Findings provide a critically important reference for determining excess morbidity associated with COVID-19 and more generally for vaccine pharmacovigilance.
FSTL1 promotes liver fibrosis by reprogramming macrophage function through modulating the intracellular function of PKM2
Authors: Rao Jianhua , Wang Hao , Ni Ming , Wang Zeng , Wang Ziyi , Wei Song , Liu Mu , Wang Peng , Qiu Jiannan , Zhang Lei , Wu Chen , Shen Hongbing , Wang Xuehao , Cheng Feng , Lu Ling 
Published: February 2022

ObjectiveFollistatin-like protein 1 (FSTL1) is widely recognised as a secreted glycoprotein, but its role in modulating macrophage-related inflammation during liver fibrosis has not been documented. Herein, we aimed to characterise the roles of macrophage FSTL1 in the development of liver fibrosis.DesignExpression analysis was conducted with human liver samples obtained from 33 patients with liver fibrosis and 18 individuals without fibrosis serving as controls. Myeloid-specific FSTL1-knockout (FSTL1M-KO) mice were constructed to explore the function and mechanism of macrophage FSTL1 in 3 murine models of liver fibrosis induced by carbon tetrachloride injection, bile duct ligation or a methionine-deficient and choline-deficient diet.ResultsFSTL1 expression was significantly elevated in macrophages from fibrotic livers of both humans and mice. Myeloid-specific FSTL1 deficiency effectively attenuated the progression of liver fibrosis. In FSTL1M-KOmice, the microenvironment that developed during liver fibrosis showed relatively less inflammation, as demonstrated by attenuated infiltration of monocytes/macrophages and neutrophils and decreased expression of proinflammatory factors. FSTL1M-KOmacrophages exhibited suppressed proinflammatory M1 polarisation and nuclear factor kappa B pathway activation in vivo and in vitro. Furthermore, this study showed that, through its FK domain, FSTL1 bound directly to the pyruvate kinase M2 (PKM2). Interestingly, FSTL1 promoted PKM2 phosphorylation and nuclear translocation, reduced PKM2 ubiquitination to enhance PKM2-dependent glycolysis and increased M1 polarisation. Pharmacological activation of PKM2 (DASA-58) partially countered FSTL1-mediated glycolysis and inflammation.ConclusionMacrophage FSTL1 promotes the progression of liver fibrosis by inducing M1 polarisation and inflammation based on the intracellular PKM2 reprogramming function of macrophages.
Gut microbiota composition is associated with SARS-CoV-2 vaccine immunogenicity and adverse events
Authors: Ng Siew C , Peng Ye , Zhang Lin , Mok Chris KP , Zhao Shilin , Li Amy , Ching Jessica YL , Liu Yingzhi , Yan Shuai , Chan Dream L S , Zhu Jie , Chen Chunke , Fung Adrian CH , Wong Kenneth KY , Hui David SC , Chan Francis KL , Tun Hein M 
Published: February 2022

ObjectiveThe gut microbiota plays a key role in modulating host immune response. We conducted a prospective, observational study to examine gut microbiota composition in association with immune responses and adverse events in adults who have received the inactivated vaccine (CoronaVac; Sinovac) or the mRNA vaccine (BNT162b2; BioNTech; Comirnaty).DesignWe performed shotgun metagenomic sequencing in stool samples of 138 COVID-19 vaccinees (37 CoronaVac and 101 BNT162b2 vaccinees) collected at baseline and 1 month after second dose of vaccination. Immune markers were measured by SARS-CoV-2 surrogate virus neutralisation test and spike receptor-binding domain IgG ELISA.ResultsWe found a significantly lower immune response in recipients of CoronaVac than BNT162b2 vaccines (p<0.05).Bifidobacterium adolescentiswas persistently higher in subjects with high neutralising antibodies to CoronaVac vaccine (p=0.023) and their baseline gut microbiome was enriched in pathways related to carbohydrate metabolism (linear discriminant analysis (LDA) scores >2 and p<0.05). Neutralising antibodies in BNT162b2 vaccinees showed a positive correlation with the total abundance of bacteria with flagella and fimbriae includingRoseburia faecis(p=0.028). The abundance ofPrevotella copriand twoMegamonasspecies were enriched in individuals with fewer adverse events following either of the vaccines indicating that these bacteria may play an anti-inflammatory role in host immune response (LDA scores>3 and p<0.05).ConclusionOur study has identified specific gut microbiota markers in association with improved immune response and reduced adverse events following COVID-19 vaccines. Microbiota-targeted interventions have the potential to complement effectiveness of COVID-19 vaccines.
Gut microbiota and obesity: an overview of microbiota to microbial-based therapies
Authors: Sheykhsaran Elham , Abbasi Amin , Ebrahimzadeh Leylabadlo Hamed , Sadeghi Javid , Mehri Samaneh , Naeimi Mazraeh Fariba , Feizi Hadi , Bannazadeh Baghi Hossein 
Published: February 2022

Abstract
The increasing prevalence of obesity and overweight is a significant public concern throughout the world. Obesity is a complex disorder involving an excessive amount of body fat. It is not just a cosmetic concern. It is a medical challenge that increases the risk of other diseases and health circumstances, such as diabetes, heart disease, high blood pressure and certain cancers. Environmental and genetic factors are involved in obesity as a significant metabolic disorder along with diabetes. Gut microbiota (GM) has a high potential for energy harvesting from the diet. In the current review, we aim to consider the role of GM, gut dysbiosis and significant therapies to treat obesity. Dietary modifications, probiotics, prebiotics, synbiotics compounds, using faecal microbiota transplant, and other microbial-based therapies are the strategies to intervene in obesity reducing improvement. Each of these factors serves through various mechanisms including a variety of receptors and compounds to control body weight. Trial and animal investigations have indicated that GM can affect both sides of the energy-balancing equation; first, as an influencing factor for energy utilisation from the diet and also as an influencing factor that regulates the host genes and energy storage and expenditure. All the investigated articles declare the clear and inevitable role of GM in obesity. Overall, obesity and obesity-relevant metabolic disorders are characterised by specific modifications in the human microbiota’s composition and functions. The emerging therapeutic methods display positive and promising effects; however, further research must be done to update and complete existing knowledge.
IQOS marketing strategies at point-of-sales: a cross-sectional survey with retailers
Authors: Bar-Zeev Yael , Berg Carla J , Khayat Amal , Romm Katelyn F , Wysota Chritina N , Abroms Lorien C , Elbaz Daniel , Levine Hagai 
Published: February 2022

BackgroundThe point-of-sale (POS) is adapting to marketing restrictions, societal changes and the inclusion of new products, such as heated tobacco products (eg, Philip Morris International’s (PMI) IQOS device and HEETS sticks). We aimed to assess (1) PMI’s influences on IQOS/HEETS POS marketing and (2) the implications of the new legislation (POS display ban and plain packaging) for retailers.MethodsA cross-sectional survey of 43 IQOS/HEETS POS owners/managers in five Israeli cities assessed POS and participant characteristics, marketing strategies, attitudes towards IQOS, and POS implications of the legislation and COVID-19, including industry reactions. Bivariate analysis explored differences between POS selling of the IQOS device versus POS selling of HEETS only.ResultsA higher proportion of those carrying IQOS (n=15) (vs HEETS only) had special displays (100% vs 17.9%, p<0.001) and interacted with specific IQOS salespersons (73.3% vs 28.6%, p=0.013). Common promotions were financial incentives based on HEETS sales for retailers (37.5%) and price discounts on HEETS for customers (48.7%). Most indicated positive attitudes towards IQOS (72.1%; eg, ‘less harmful’), opposition to the legislation (62.7%), limited government assistance to implement the legislation (62.8%), and industry provision of display cases and/or signage to comply with the legislation (67.4%).ConclusionPMI uses similar tactics to promote IQOS at POS as they previously used for combustible products, including direct promotional activities with retailers, and circumvented legislation by using special displays and signage. Governments need to ban these measures and support retailers with clear practical guidance regarding the implementation of marketing restrictions at POS.
Warm Higgs–Starobinsky inflation
Authors: Samart Daris , Ma-adlerd Patinya , Channuie Phongpichit 
Published: February 2022

AbstractIn this work, we investigate the Higgs–Starobinsky (HS) model in the context of warm inflation scenario. The dissipative parameter as a linear form of temperature of warm inflation is considered with strong and weak regimes. We study the HS model in the Einstein frame using the slow-roll inflation framework. The inflationary observables are computed and then compared with the Plank 2018 data. With the sizeable number of e-folds and proper choices of parameters, we discover that the predictions of warm HS model present in this work are in very good agreement with the latest Planck 2018 results. More importantly, the parameters of the HS model are also constrained by using the data in order to make warm HS inflation successful.
Corticosteroid Injection for the Treatment of Trigger Finger: A Meta-Analysis of Randomised Control Trials
Authors: PATHAK Subodh Kumar , SALUNKE Abhijeet Ashok , MENON Prem Haridas , THIVARI Praveen , NANDY Kunal , Yongsheng CHEN 
Published: February 2022

Background: The purpose of this meta-analysis is to provide an evidence-based overview of the effectiveness of corticosteroid injection for the treatment of stenosing tenosynovitis (trigger digits). We have analysed only randomised control trials (RCTs) which compared the effectiveness of corticosteroid injections with control injections. Methods: The Cochrane Library, PubMed, Medline, Web of Science and Scopus were searched to identify relevant studies. The keywords for search in the database were (‘stenosing tenosynovitis’ OR ‘trigger finger’) AND injections. After screening titles and abstracts of these studies, full-text articles of studies that fulfilled the selection criteria were obtained. For the meta-analysis, we determined the pooled mean failure rate, odds ratio (OR), relative risk (RR) and 95% confidence intervals (CI) for the risk of failure rate between the corticosteroid injection group and the control group through the random-effects model. Results: Six RCTs were found that involved 368 participants. The corticosteroid injection group included 190 patients and 178 patients were included in the control group. The pooled estimate of successful treatment in the corticosteroid injections group was 63.68 ± 5.32% and that in the control group was 27.53 ± 11.52%. The pooled RR of treatment failure between the corticosteroid injection group and the control group was 0.49 (95% CI 0.40–0.60). The pooled OR of treatment failure between the corticosteroid injection group and the control group was 0.18 (95% CI 0.08–0.44). All the included studies reported either mild or no complications with corticosteroids or placebo injections. Conclusions: In the treatment of stenosing tenosynovitis, the corticosteroid injections have better outcomes compared to the control injections and this meta-analysis provides significant evidence of the effectiveness of corticosteroid injection for stenosing tenosynovitis with minimal adverse effects. Level of Evidence: Level II (Therapeutic)
A Systematic Review of the Outcomes of Microsurgical Toe Transfer for Metacarpal and Metacarpal-Like Hand Deformity
Authors: NAGRATH Nalin , DUGGAN Emily , THURLEY Neal , RODRIGUES Jeremy N. 
Published: February 2022

Background: Thumb and multiple finger amputations may result in a metacarpal and a metacarpal-like hand deformity. Toe-to-hand transfer is a recognised treatment strategy for this deformity but has risks and is resource intensive. The aim of this study is to conduct a systematic review of the outcomes of toe-to-hand transfer for traumatic metacarpal and metacarpal-like hand deformity in adult patients. Methods: Multi-database searching with index and free text terms, duplicate standardised screening and extraction, and quality assessment was performed. The inclusion and exclusion criteria were prespecified. We included any randomised controlled trials, cohort studies, case-control studies, as well as interrupted time series, before and after intervention studies. Results: Screening of 548 articles yielded 20 studies eligible that included 19 retrospective observational studies and one before and after intervention study. A total of 171 patients underwent 274 toe transfers for metacarpal and metacarpal-like hand deformity. No study compared toe-transfer to a control group or to a prosthesis. The before and after intervention study demonstrated significant improvement in activities of daily living, work, aesthetics and satisfaction. Additionally, no significant donor site morbidity occurred in the heterogenous sample. Outcomes from remaining studies at risk of bias suggest that those with a lesser severity of injury and at least two toe transfers score higher in functional tests and scoring systems. Conclusions: There is limited confidence in the effectiveness of toe transfer for metacarpal and metacarpal-like hand deformity. The available evidence indicates that toe transfer(s) may restore acceptable function permitting activities of daily living, return to original or sedentary occupation and affords satisfaction. Level of Evidence: Level III (Therapeutic)
An Anatomical Variant of the Palmar Cutaneous Branch of the Median Nerve: A Case Report
Authors: CHIEW Jean , SATKUNANANTHAM Mala , SECHACHALAM Sreedharan 
Published: February 2022

There is a risk of injury to the palmar cutaneous branch of the median nerve (PCBMN) during a volar approach to the carpus or the distal radius. Anatomic variations of the PCBMN increase this risk. We report an anatomic variant of the PCBMN that coursed superficial and radial to the flexor carpi radialis (FCR), reinforcing the need for meticulous subcutaneous dissection to protect the nerve during a volar approach to the distal radius. In this case, identification of the PCBMN variant warranted a modified surgical approach, ulnar to the FCR instead of radial in order to avoid iatrogenic injury. Level of Evidence: Level V (Therapeutic)
A review of Palaeolithic sites associated with gravel deposits in India
Authors: Kaur Anubhav Preet 
Published: February 2022

Abstract
Rivers and river-borne deposits have always been a major attraction for hominins as an important source of sustenance and settlements. Hence, fluvial deposits have long been an important source of evidence for early human occupation throughout the Old World. Apart from being an important palaeoclimatic marker, fluvial sequences have provided archaeologists with frameworks for correlation, along with Palaeolithic markers discovered within them. Moreover, given the influx of sediments eroded and deposited by Indian rivers, these could have acted as a centre of hominin activities. Palaeolithic research in India has been concentrated around some of its major river valleys, which have yielded a rich record of hominin occupation. So far, 305 Palaeolithic sites have been reported from a gravel context throughout the country, yielding Lower to Upper Palaeolithic, Mesolithic and Neolithic evidence. However, most of the derived evidence is secondary deposits and stands contested based on its contextuality. Nevertheless, its importance as a source of information about hominin activity cannot be underestimated. This review presents a provisional synthesis of all of the Indian Palaeolithic sites reported from gravel contexts, thereby presenting scope for future multidisciplinary research at these localities.