bluuebunny/crossref_metadata_2025_split huggingface dataset:
Effects of empagliflozin on cardiac structure, function and biomarkers in patients with heart failure with preserved ejection fraction: study protocol for a randomised, placebo-controlled prospective trial
Authors: Chai Ke , Luo Yao , Zhang Min , Liu Yujia , Li Yingying , Cheng Yalin , Zhu Wanrong , Meng Chen , Yang Jiefu , Wang Hua 
Published: August 2023

IntroductionHeart failure (HF) with preserved ejection fraction (HFpEF) has become the main type of HF worldwide. Although large randomised controlled studies have demonstrated the beneficial effects of sodium–glucose cotransporter 2 inhibitors among patients with HFpEF, the mechanisms remain unclear. Basic research suggests that empagliflozin inhibits myocardial fibrosis. Myocardial extracellular volume (ECV) can be calculated using cardiac MRI (CMRI), which can reflect the degree of diffuse myocardial fibrosis. Studies show that empagliflozin can reduce ECV and left ventricular mass (LVM) assessed by CMRI in patients with diabetes with coronary heart disease and patients without diabetes with HF with reduced ejection fraction. However, whether empagliflozin reduces ECV and LVM among patients with HFpEF is unclear. This study intends to use CMRI to evaluate ECV and LVM, combined with echocardiography and an assessment of related biomarkers, to determine whether empagliflozin can improve myocardial fibrosis and left ventricular remodelling in patients with HFpEF.Methods and analysisThis report describes the study design of a prospective, multicentre, randomised, double-blind, placebo-controlled and parallel-group clinical study. A total of 180 participants with HFpEF aged 40–80 years old who meet the inclusion and exclusion criteria will be randomly divided into an empagliflozin treatment group or a placebo control group. The empagliflozin treatment group will receive 10 mg of empagliflozin per day for 6 months in addition to guideline-directed medical treatment, while the control group will receive placebo oral administration with guideline-directed medical therapy for 6 months. The primary outcomes are ECV and LVM changes measured by CMRI after 6 months of treatment.Ethics and disseminationThe study design is approved by the ethical committee of Beijing Hospital (2022BJYYEC-070-02). The trial is registered at the Chinese Clinical Trial Registry (http://www.chictr.org.cn). The trial results will be published in peer-reviewed journals and conferences.Trial registration numberChinese Clinical Trial Registry (ChiCTR2200060862).
Development and content of a community-based reablement programme (I-MANAGE): a co-creation study
Authors: Mouchaers Ines , Verbeek Hilde , Kempen Gertrudis I J M , van Haastregt Jolanda C M , Vlaeyen Ellen , Goderis Geert , Metzelthin Silke F 
Published: August 2023

ObjectivesAs age increases, people generally start experiencing problems related to independent living, resulting in an increased need for long-term care services. Investing in sustainable solutions to promote independent living is therefore essential. Subsequently, reablement is a concept attracting growing interest. Reablement is a person-centred, holistic approach promoting older adults’ active participation through daily, social, leisure and physical activities. The aim of this paper is to describe the development and content of I-MANAGE, a model for a reablement programme for community-dwelling older adults.DesignThe development of the programme was performed according to the Medical Research Council framework as part of the TRANS-SENIOR international training and research network. A co-creation design was used, including literature research, observations, interviews, and working group sessions with stakeholders.Setting and participantsThe interviews and working group sessions took place in the Dutch long-term home care context. Stakeholders invited to the individual interviews and working group sessions included care professionals, policymakers, client representatives, informal caregiver representatives, informal caregivers, and scientific experts.ResultsThe co-creation process resulted in a 5-phase interdisciplinary primary care programme, called I-MANAGE. The programme focuses on improving the self-management and well-being of older adults by working towards their meaningful goals. During the programme, the person’s physical and social environment will be put to optimal use, and sufficient support will be provided to informal caregivers to reduce their burden. Lastly, the programme aims for continuity of care and better communication and coordination.ConclusionThe I-MANAGE programme can be tailored to the local practices and resources and is therefore suitable for the use in different settings, nationally and internationally. If the programme is implemented as described, it is important to closely monitor the process and results.
Exploring usual care for patients with low back pain in primary care: a cross-sectional study of general practitioners, physiotherapists and chiropractors
Authors: Madsen Simon Dyrløv , Morsø Lars , Vach Werner , Andersen Merethe Kirstine , Lykkegaard Jesper , Schiøttz-Christensen Berit , Stochkendahl Mette Jensen 
Published: August 2023

ObjectivesTo explore the elements and composition of care provided by general practitioners (GPs), physiotherapists (PTs) and chiropractors (DCs) to patients with low back pain (LBP).DesignObservational study.SettingPrimary care setting, Denmark.ParticipantsPrimary care clinicians (GPs, PTs and DCs) in the Region of Southern Denmark were invited to register consecutive adult patient visits with LBP as the primary complaint.Primary outcome measuresClinicians reported care elements provided to patients with LBP. Elements varied due to professional differences (eg, prescriptive rights). Data were descriptively analysed, on group and individual levels, for frequency and combination of care elements, and practice patterns were explored with latent class analysis.ResultsThe clinicians (33 GPs, 67 PTs and 43 DCs with a median experience of 15 years and 59% were females) registered 3500 patient visits. On average, the visits involved patients aged 51 years, and 51% were with females. The frequencies of common care elements across professions were information (42%–56% of visits between professions) and advice (56%–81%), while other common elements for GPs were pain medication (40%) and referrals to PTs (36%), for PTs, use of exercises (81%) and for DCs, use of manual therapy (96%). Substantial variation was observed within professions and distinct practice patterns, with different focuses of attention to information and advice versus exercise and manual therapy, were identified for PTs and DCs.ConclusionsThese data indicate substantial variation in the care elements provided by GPs, PTs and DCs to LBP patients. The compositions of care and practice patterns identified challenge the understanding of usual care as a uniform concept and professions as homogeneous groups. Strategic use of particular care elements in different parts of treatment courses is indicated. Longitudinal data and qualitative enquiry are needed to assess if or how care is tailored to individual patients.
Health risk perceptions of household air pollution and perceived benefits of improved stoves among pregnant women in rural Ethiopia: a mixed method study
Authors: Habtamu Demelash , Abebe Beyene , Seid Tiku 
Published: August 2023

ObjectiveSince community perceptions of the risk of biomass smoke and the benefits of improved stoves play a critical role in behaviour change to the uptake and sustainable utilisation of improved stoves, we aimed to assess the level of health risk perception on kitchen smoke and benefits of using improved stoves among pregnant women.DesignA community-based cross-sectional mixed method study.SettingIn six kebeles of a low-income rural community of South Gondar Zone, Northwestern Ethiopia.ParticipantsAll 455 households with pregnant women aged 18–38 years, in their first-trimester or second-trimester gestation, exclusively use traditional biomass-fuelled or locally modified mud stoves, and the primary cook in her household were included. But completed data were obtained only from 422 households.ResultFrom 422 completed data, more than half, 63% (95% CI 58% to 68%) had high-level health risk perception of household air pollution, and nearly three-fourths, 74% (95% CI 70% to 79%) of the respondents perceived that using improved stove had benefits for their families. Participants in the 32–38 years age group, rich in asset index, presence of under-five children, being a member of any women group and large family size were positively associated with high-level health risk perception. Whereas respondents in the 18–24 years age group, presence of under-five children, husbands of primary or higher education, high health risk perception and not happy with the current stove were positively associated with perceived benefits of using an improved stove.ConclusionThe observed level of health risk perception of biomass smoke and the benefits of using improved stoves may help to adopt effective intervention measures. This study also suggests that for successful intervention, clean cooking programmes and policies must consider many local factors influencing health risk perception and benefits of using improved stoves.Trial registration numberACTR202111534227089.
Trends in renal function in Northern Sweden 1986–2014: data from the seven cross-sectional surveys within the Northern Sweden MONICA study
Authors: de Man Lapidoth Julia , Hultdin Johan , Jonsson P Andreas , Eriksson Svensson Maria , Wennberg Maria , Zeller Tanja , Söderberg Stefan 
Published: August 2023

ObjectiveThe prevalence of chronic kidney disease (CKD) is increasing globally, and CKD is closely related to cardiovascular disease (CVD). CKD and CVD share several risk factors (RF), such as diabetes, hypertension, obesity and smoking, and the prevalence of these RF has changed during the last decades, and we aimed to study the effect on renal function over time.DesignRepeated cross-sectional population-based studies.SettingThe two Northern counties (Norr- and Västerbotten) in Sweden.ParticipantsWithin the MONitoring Trends and Determinants of CArdiovascular Disease (MONICA) study, seven surveys were performed between 1986 and 2014, including participants aged 25–64 years (n=10 185).InterventionsNone.MeasuresInformation on anthropometry, blood pressure and cardiovascular risk factors was collected. Creatinine and cystatin C were analysed in stored blood samples and the estimated glomerular filtration rate (eGFR) calculated using the creatinine-based Lund–Malmö revised and Chronic Kidney Disease Epidemiology Collaboration (eGFRcrea) equations as well as the cystatin C-based Caucasian, Asian, Paediatric and Adult cohort (CAPA) equation (eGFRcysC). Renal function over time was analysed using univariable and multivariable linear regression models.ResultsRenal function, both eGFRcreaand eGFRcysC, decreased over time (both p<0.001) and differed between counties and sexes. In a multivariable analysis, study year remained inversely associated with both eGFRcreaand eGFRcysC(both p<0.001) after adjustment for classical cardiovascular RF.ConclusionRenal function has deteriorated in Northern Sweden between 1986 and 2014.
Prevalence of Chinese pregnant women meeting physical activity recommendation and its influencing factors: a protocol for systematic review and meta-analysis
Authors: Zhang Wei , Zhang Le , Wang Xiaojuan , Xu Ping , Guo Pingping , Mao Minna , Zhao Rujia , Feng Suwen 
Published: August 2023

IntroductionRegular physical activity during pregnancy is effective in preventing diseases and promoting the health outcomes of mothers and babies. However, the level of physical activity among them is not ideal. Especially in China, the proportion of pregnant women who meet the recommendation of physical activity in the guidelines is even lower. Thus, we aim to evaluate the prevalence of meeting physical activity recommendation and its influencing factors during pregnancy in China.Methods and analysisThis protocol is developed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols guidelines. PubMed, Web of Science, Scopus, CINAHL, MEDLINE, PsycINFO, EMBASE, China National Knowledge Infrastructure (CNKI), China Science and Technology Journal Database (Weipu) and WanFang Data will be comprehensively searched by two reviewers. Studies that report the prevalence of Chinese pregnant women meeting physical activity recommendation will be included. Two reviewers will independently assess eligibility, extract data and evaluate methodological quality. Data including authors, publication years, language, geographical region, tools, trimesters, prevalence and influence factors will be extracted. Data will be analysed by Stata V.11 statistical software.Ethics and disseminationNo formal ethics approval is required for this protocol and no primary data are to be collected. Findings from this review may be useful to develop interventions for the physical activity of pregnant women in China. The results will be disseminated through peer-reviewed journals, conference presentations and public events.PROSPERO registration numberCRD42022372722
Optimal antiplatelet strategy following coronary artery bypass grafting: a meta-analysis
Authors: Agrawal Ankit , Kumar Ashwin , Majid Muhammad , Badwan Osamah , Arockiam Aro Daniela , El Dahdah Joseph , Syed Alveena B , Schleicher Mary , Reed Grant W , Cremer Paul C , Griffin Brian P , Menon Venu , Wang Tom Kai Ming 
Published: August 2023

ObjectiveCoronary artery bypass grafting (CABG) is an established revascularisation strategy for multivessel and left main coronary artery disease. Although aspirin is routinely recommended for patients with CABG, the optimal antiplatelet regimen after CABG remains unclear. We evaluated the efficacies and risks of different antiplatelet regimens (dual (DAPT) versus single (SAPT), and dual with clopidogrel (DAPT-C) versus dual with ticagrelor or prasugrel (DAPT-T/P)) after CABG.MethodsWe followed Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and performed a comprehensive literature search using PubMed, Ovid Medline, Ovid Embase and Cochrane Central Register of Controlled Trials. Data were extracted and pooled using random-effects models and Review Manager (V.5.4).ResultsAmong the 2970 article abstracts screened, 215 full-text articles were reviewed and 38 studies totaling 77 447 CABG patients were included for analyses. DAPT compared with SAPT was associated with significantly lower all-cause mortality (OR 0.65 with 95% CI 0.50 to 0.86; p=0.002), cardiovascular mortality (OR 0.53, 95% CI 0.33 to 0.84; p=0.008), and major adverse cardiac and cerebrovascular events (MACCE) (OR 0.68, 95% CI 0.51 to 0.91; p=0.01), but higher rates of major (OR 1.30, 95% CI 1.08 to 1.56; p=0.007) and minor bleeding (OR 1.87, 95% CI 1.28 to 2.74; p=0.001) after CABG. DAPT-T/P compared with DAPT-C was associated with significantly lower all-cause (OR 0.43, 95% CI 0.29 to 0.65; p≤0.0001) and cardiovascular mortality (OR 0.44, 95% CI 0.24 to 0.80; p=0.008), and no differences on other cardiovascular or bleeding outcomes after CABG.ConclusionIn patients with CABG, DAPT compared with SAPT and DAPT-T/P compared with DAPT-C were associated with reduction in all-cause and cardiovascular mortality, especially in patients with acute coronary syndrome. Additionally, DAPT was associated with reduction in MACCE, but higher rates of major and minor bleeding. An individualised approach to choosing antiplatelet regimen is necessary for patients with CABG based on ischaemic and bleeding risks.
Interrupted time series analysis of drug overdose fatalities in service-related industries versus non-service-related industries during the COVID-19 pandemic, 2018–2021
Authors: Bunn Terry L , Costich Julia F , Mirzaian Mira , Daniels Lara K , Wang Dandan , Quesinberry Dana 
Published: August 2023

BackgroundVariation among industries in the association between COVID-19-related closing or reopening orders and drug overdose deaths is unknown. The objectives of this study were to compare drug overdose decedent demographics, annual drug overdose fatality rates and monthly drug overdose fatality rates by specific industry within the service-related industry sector, and to perform an interrupted time series analysis comparing weekly drug overdose mortality counts in service-related and non-service-related industries, examining the COVID-19 pre-pandemic and pandemic phases by Kentucky closing and reopening orders.MethodsKentucky drug overdose death certificate and toxicology testing data for years 2018–2021 were analysed using Χ2and interrupted time series methods.ResultsBefore the pandemic, annual drug overdose fatality rates in service-related industries were higher than in non-service-related industries. However, these trends reversed during the pandemic. Both service-related and non-service-related industry groups experienced increased fatal drug overdoses at change points associated with the gubernatorial business closure orders, although the magnitude of the increase differed between the two groups. Young, female and black workers in service-related industries had higher frequencies of drug overdose deaths compared with decedents in the non-service-related industries.ConclusionSpikes in drug overdose mortality in both service-related and non-service-related industries during the pandemic highlight the need to consider and include industries and occupations, as well as worker populations vulnerable to infectious diseases, as integral stakeholder groups when developing and implementing drug overdose prevention interventions, and implementing infectious disease surveillance systems.
Should a borderline negative HER2 result in a core biopsy of invasive carcinoma of the breast have HER2 assessment repeated in the excision specimen?
Authors: Lee Andrew H S , Hodi Zsolt , Abbas Areeg , Wencyk Peter , Ellis Ian O , Rakha Emad 
Published: August 2023

AimThe 2015 UK guidelines for HER2 assessment in breast cancer recommended repeat assessment if the core biopsy was scored as 2+ on HER2 immunohistochemistry (IHC) with borderline negative in situ hybridisation (ratio of number of HER2 to chromosome 17 centromere copies of 1.8–1.99). This case series aimed to assess the value of such repeat assessment in the surgical specimen, in particular the proportion that were HER2 positive.MethodsDetails of biopsies with 2+ IHC and borderline negative in situ hybridisation were extracted from a database. The results of repeat HER2 testing in the surgical specimen for this cohort study were then obtained.Results112 patients with no preoperative treatment had repeat assessment: 4 were 3+ and 16 were 2+ amplified. Of 14 with preoperative chemotherapy, 1 was 3+ and 4 were 2+ amplified. All the 2+ amplified carcinomas had a HER2 to chromosome 17 ratio less than 4, in 50% the ratio was between 2.0 and 2.2, and in 50% the HER2 copy number was less than 4.ConclusionsRepeat assessment yielded 4% 3+ results and 14% 2+ amplified carcinomas but with low level amplification. These results suggest that retesting of borderline negative HER2 cases should be optional and no longer mandatory.
Triple jump for the optimal management of psoriatic arthritis: diet, sleep and exercise – a review
Authors: Lubrano Ennio , Scriffignano Silvia , de Vlam Kurt , Ronga Mario , Perrotta Fabio Massimo , Lories Rik 
Published: August 2023

Psoriatic arthritis (PsA) is a complex, multiform and chronic inflammatory disease characterised by the association of arthritis and psoriasis combined with other related conditions and comorbidities. Treatment of PsA has rapidly evolved by the introduction of new biological drugs and small molecules which allow to achieve disease remission or low disease activity in most of the patients. However, unmet treatment needs still persist for those patients with persistent disease activity or symptoms, impaired function, reduced quality of life or comorbidities. In this context, non-pharmacological approaches, including diet modifications, an adequate sleep quality and physical activity could provide additional benefits. In recent years, diet modifications, improvement of sleep quality and physical activity became an area of interest for researchers and some studies showed how a holistic non-pharmacological approach may ameliorate the quality of life of patients with PsA.The aim of this manuscript was to review the current evidence on the intriguing link and potential effects of diet, sleep and exercise in PsA patients. In particular, we reviewed the literature focusing on the possible benefits of a holistic approach to PsA patients considering lifestyle modifications.
Genomic Portraits: Reflections into a Tumor's Response to Therapy
Authors: Slovin Susan F. 
Published: August 2023

Summary
Well-annotated matched tissue specimens both before and after initiation of androgen receptor signaling inhibitors (ARSI) have revealed activation of unique signaling pathways and genomic signatures that identify a profile to guide therapy. A recent study represents the largest prospective biospecimen banking protocol to study mechanisms of resistance to ARSIs.
See related article by Menssouri et al., p. 4504
Targeting Aggressive B-cell Lymphomas through Pharmacological Activation of the Mitochondrial Protease OMA1
Authors: Schwarzer Adrian , Oliveira Matheus , Kleppa Marc-Jens , Slattery Scott D. , Anantha Andy , Cooper Alan , Hannink Mark , Schambach Axel , Dörrie Anneke , Kotlyarov Alexey , Gaestel Matthias , Hembrough Todd , Levine Jedd , Luther Michael , Stocum Michael , Stiles Linsey , Weinstock David M. , Liesa Marc , Kostura Matthew J. 
Published: August 2023

Abstract
DLBCL are aggressive, rapidly proliferating tumors that critically depend on the ATF4-mediated integrated stress response (ISR) to adapt to stress caused by uncontrolled growth, such as hypoxia, amino acid deprivation, and accumulation of misfolded proteins. Here, we show that ISR hyperactivation is a targetable liability in DLBCL. We describe a novel class of compounds represented by BTM-3528 and BTM-3566, which activate the ISR through the mitochondrial protease OMA1. Treatment of tumor cells with compound leads to OMA1-dependent cleavage of DELE1 and OPA1, mitochondrial fragmentation, activation of the eIF2α-kinase HRI, cell growth arrest, and apoptosis. Activation of OMA1 by BTM-3528 and BTM-3566 is mechanistically distinct from inhibitors of mitochondrial electron transport, as the compounds induce OMA1 activity in the absence of acute changes in respiration. We further identify the mitochondrial protein FAM210B as a negative regulator of BTM-3528 and BTM-3566 activity. Overexpression of FAM210B prevents both OMA1 activation and apoptosis. Notably, FAM210B expression is nearly absent in healthy germinal center B-lymphocytes and in derived B-cell malignancies, revealing a fundamental molecular vulnerability which is targeted by BTM compounds. Both compounds induce rapid apoptosis across diverse DLBCL lines derived from activated B-cell, germinal center B-cell, and MYC-rearranged lymphomas. Once-daily oral dosing of BTM-3566 resulted in complete regression of xenografted human DLBCL SU-DHL-10 cells and complete regression in 6 of 9 DLBCL patient-derived xenografts. BTM-3566 represents a first-of-its kind approach of selectively hyperactivating the mitochondrial ISR for treating DLBCL.