bluuebunny/crossref_metadata_2025_split huggingface dataset:
Early estimates of COVID-19 infections in small, medium and large population clusters
Authors: Siraj Amir , Worku Alemayehu , Berhane Kiros , Aregawi Maru , Eshetu Munir , Mirkuzie Alemnesh , Berhane Yemane , Siraj Dawd 
Published: September 2020

IntroductionSince its emergence in late December 2019, COVID-19 has rapidly developed into a pandemic in mid of March with many countries suffering heavy human loss and declaring emergency conditions to contain its spread. The impact of the disease, while it has been relatively low in the sub-Saharan Africa (SSA) as of May 2020, is feared to be potentially devastating given the less developed and fragmented healthcare system in the continent. In addition, most emergency measures practised may not be effective due to their limited affordability as well as the communal way people in SSA live in relative isolation in clusters of large as well as smaller population centres.MethodsTo address the acute need for estimates of the potential impacts of the disease once it sweeps through the African region, we developed a process-based model with key parameters obtained from recent studies, taking local context into consideration. We further used the model to estimate the number of infections within a year of sustained local transmissions under scenarios that cover different population sizes, urban status, effectiveness and coverage of social distancing, contact tracing and usage of cloth face mask.ResultsWe showed that when implemented early, 50% coverage of contact tracing and face mask, with 33% effective social distancing policies can bringing the epidemic to a manageable level for all population sizes and settings we assessed. Relaxing of social distancing in urban settings from 33% to 25% could be matched by introduction and maintenance of face mask use at 43%.ConclusionsIn SSA countries with limited healthcare workforce, hospital resources and intensive care units, a robust system of social distancing, contact tracing and face mask use could yield in outcomes that prevent several millions of infections and thousands of deaths across the continent.
Prevalence of psychoactive substance use among acutely hospitalised patients in Oslo and Moscow: a cross-sectional, observational study
Authors: Gamboa Danil , Jørgenrud Benedicte , Bryun Evgeny A , Vindenes Vigdis , Koshkina Evgenya A , Nadezhdin Aleksei V , Kabashi Saranda , Tetenova Elena J , Berg Thomas , Nyman Anna Armika Tussilago , Kolgashkin Alexey J , Petukhov Aleksei E , Perekhodov Sergey N , Davydova Elena N , Lerdal Anners , Nordby Gudmund , Bogstrand Stig Tore 
Published: September 2020

ObjectivesThe use of psychoactive prescription medication is increasing in the general population. This is a cause for concern, particularly among the elderly, where physiological changes related to senescence increase the risk for adverse effects. While previous studies regarding psychoactive substance use have generally been population based, we sought to determine the frequency of such use among acutely hospitalised patients.SettingTwo emergency departments (EDs), one in Oslo and one in Moscow, admitting patients to Departments of Internal Medicine.Participants5583 patients aged ≥18 years participated, distributed evenly between genders and study locations. Patients unable to give informed consent were excluded. The study sites did not admit patients with surgical conditions and/or injuries.Primary and secondary outcomesThe presence of psychoactive substances was determined through blood analysis using liquid chromatography-mass spectrometry. Secondary outcomes comprised demographic data (including age, gender, employment and marital status), degree of psychological distress, concurrent alcohol use, and self-reported alcohol, psychoactive drug and illicit substance use.Results32.3% in Oslo and 12% in Moscow were positive for one or more psychoactive medicinal drugs (benzodiazepines, z-hypnotics, opioids or barbiturates). In Oslo, medicinal drug use was associated with being aged 61 to 70 years (OR 2.40, 95% CI 1.61 to 3.58) compared with 18 to 40 years, and psychological distress (OR 2.61, 95% CI 2.06 to 3.30). In Moscow, psychoactive medicinal drug use was also associated with psychological distress (OR 1.68, 95% CI 1.18 to 2.39), and was less common among patients aged 41 to 60 years (OR 0.62, 95% CI 0.43 to 0.88) than among patients aged 18 to 40 years.ConclusionA significant proportion of admitted patients used one or more psychoactive medicinal drugs, in particular benzodiazepines (Oslo and Moscow) and opiates (Oslo). We suggest formalised screening for inappropriate prescription drug use and increased adherence to clinical prescription guidelines.
Bedside hyperspectral imaging for the evaluation of microcirculatory alterations in perioperative intensive care medicine: a study protocol for an observational clinical pilot study (HySpI-ICU)
Authors: Dietrich Maximilian , Marx Sebastian , Bruckner Thomas , Nickel Felix , Müller-Stich Beat Peter , Hackert Thilo , Weigand Markus A , Uhle Florian , Brenner Thorsten , Schmidt Karsten 
Published: September 2020

IntroductionNormalisation of macrocirculatory parameters during resuscitation therapy does not guarantee the restoration of microcirculatory perfusion in critical illness due to haemodynamic incoherence. Persistent microcirculatory abnormalities are associated with severity of organ dysfunction and mandate the development of bedside microcirculatory monitoring. A novel hyperspectral imaging (HSI) system can visualise changes in skin perfusion, oxygenation and water content at the bedside. We aim to evaluate the effectiveness of HSI for bedside monitoring of skin microcirculation and the association of HSI parameters with organ dysfunction in patients with sepsis and major abdominal surgery.Methods and analysisThree independent groups will be assessed and separately analysed within a clinical prospective observational study: (1) 25 patients with sepsis or septic shock (according to sepsis-3 criteria), (2) 25 patients undergoing pancreatic surgery and (3) 25 healthy controls. Patients with sepsis and patients undergoing pancreatic surgery will receive standard therapy according to local protocols derived from international guidelines. In addition, cardiac output of perioperative patients and patients with sepsis will be measured. Healthy controls undergo one standardised evaluation. The TIVITA Tissue System is a novel HSI system that uses the visible and near-infrared spectral light region to determine tissue microcirculatory parameters. HSI analysis (hand/knee) will be done in parallel to haemodynamic monitoring within defined intervals during a 72-hour observation period. HSI data will be correlated with the Sequential Organ Failure Assessment score, global haemodynamics, inflammation and glycocalyx markers, surgical complications and 30-day outcome.Ethics and disseminationThe protocol has been approved by the local ethics committee of the University of Heidelberg (S-148/2019). Study results will be submitted to peer-reviewed journals and medical conferences.Trial registration numberDRKS00017313; Pre-results.
Effect of visit-to-visit blood pressure variability on cardiovascular events in populations with different body mass indexes: a prospective cohort study
Authors: Chen Haojia , Chen Youren , Wu Weiqiang , Huang Jianhuan , Chen Zekai , Chen Zhichao , Yan Xiuzhu , Wu Shouling 
Published: September 2020

ObjectiveThis study was performed to explore the effects of visit-to-visit blood pressure variability (BPV) on cardiovascular events (CVEs) in people with various body mass indexes (BMIs).DesignProspective cohort study.SettingThe average real variability of systolic blood pressure (ARVSBP) was the indicator for visit-to-visit BPV. The participants were divided into three groups: normal weight, overweight and obesity. We further divided these groups into four subgroups based on the ARVSBP. A Cox regression model was used to calculate the HRs of the ARVSBP on CVEs in the same and different BMI groups. Additionally, a competitive risk model was used to calculate the HRs of the ARVSBP on CVEs in the same BMI group.ParticipantsIn total, 41 043 individuals met the inclusion criteria (no historical CVEs or tumours, no incidence of CVEs or tumours and no death during the four examinations) and had complete systolic blood pressure and BMI data.ResultsA total of 868 CVEs occurred. The cumulative incidence of CVEs increased as ARVSBP rose in both the normal weight and overweight groups. In same BMI groups, the risk of CVEs significantly increased as ARVSBP increased only in the normal weight group (highest quartiles of ARVSBP: HR (95% CI) 2.20 (1.46–3.31)). In the different BMI groups, the risk of CVEs in the ARVSBP subgroup in each BMI group was higher than that the least quintile of ARVSBP in the normal weight group (highest quartiles of ARVSBP in obesity: HR (95% CI) 2.28 (1.47–3.55)). The result of the competitive risk model did not change.ConclusionsAs BMI and ARVSBP increase, the risk of CVEs increases. However, the risk of visit-to-visit BPV on CVEs varies in different BMI groups, especially in people of normal weight.Trial registration numberCHiCTR-TNC1100 1489.
Voluntary disclosures of payments from pharmaceutical companies to healthcare professionals in Germany: a descriptive study of disclosures in 2015 and 2016
Authors: Stoll Marlene , Hubenschmid Lara , Koch Cora , Lieb Klaus 
Published: September 2020

ObjectiveTo analyse voluntary payment reports of pharmaceutical companies to German healthcare professionals (HCPs) in 2015 and 2016 based on an industry-self-regulating transparency codex.Design and participantsCohort study of all German HCPs who voluntarily agreed that at least one payment they received in 2015 and 2016 from pharmaceutical companies is disclosed.Main outcome measuresNumber of HCPs who disclosed at least one payment in the database; separated by year of disclosure and whether they disclosed once or repeatedly. Amount of disclosed payments and distribution parameters of disclosed annual payment sums per person; separated by year of disclosure und whether they disclosed once or repeatedly.Results28 230 HCPs agreed to the disclosure of at least one payment in the database. In 2015, 19 905 HCPs agreed to the disclosure, decreasing to 15 782 HCPs in 2016. Whereas 7457 disclosed payments in both years, 12 448 disclosed only in 2015 and 8325 only in 2016. Payments of €32 426 721 in 2015 and €23 289 343 in 2016 were disclosed, that is, 27% and 23% of the total amounts spent on HCPs, respectively. Distribution of annual payments was skewed: the top 1% of HCPs disclosed annual payment sums between €17 049 and €200 194, while the median disclosed annual payment sum per person was €536 (IQR €1092). Disclosed payments were higher in male physicians and in physicians with higher academic degree.ConclusionsIf voluntary, disclosure rates of payments are low and therefore only provide a fragmented picture of interactions between HCPs and pharmaceutical companies. Efforts must be intensified to ensure obligatory disclosure of all payments worldwide.
Evaluation of outcome relevance of quality indicators in the emergency department (ENQuIRE): study protocol for a prospective multicentre cohort study
Authors: Drynda Susanne , Schindler Wencke , Slagman Anna , Pollmanns Johannes , Horenkamp-Sonntag Dirk , Schirrmeister Wiebke , Otto Ronny , Bienzeisler Jonas , Greiner Felix , Drösler Saskia , Lefering Rolf , Hitzek Jennifer , Möckel Martin , Röhrig Rainer , Swart Enno , Walcher Felix 
Published: September 2020

IntroductionQuality of emergency department (ED) care affects patient outcomes substantially. Quality indicators (QIs) for ED care are a major challenge due to the heterogeneity of patient populations, health care structures and processes in Germany. Although a number of quality measures are already in use, there is a paucity of data on the importance of these QIs on medium-term and long-term outcomes. The evaluation of outcome relevance of quality indicators in the emergency department study (ENQuIRE) aims to identify and investigate the relevance of QIs in the ED on patient outcomes in a 12-month follow-up.Methods and analysisThe study is a prospective non-interventional multicentre cohort study conducted in 15 EDs throughout Germany. Included are all patients in 2019, who were ≥18 years of age, insured at the Techniker Krankenkasse (statutory health insurance (SHI)) and gave their written informed consent to the study.The primary objective of the study is to assess the effect of selected quality measures on patient outcome. The data collected for this purpose comprise medical records from the ED treatment, discharge (claims) data from hospitalised patients, a patient questionnaire to be answered 6–8 weeks after emergency admission, and outcome measures in a 12-month follow-up obtained as claims data from the SHI.Descriptive and analytical statistics will be applied to provide summaries about the characteristics of QIs and associations between quality measures and patient outcomes.Ethics and disseminationApproval of the leading ethics committee at the Medical Faculty of the University of Magdeburg (reference number 163/18 from 19 November 2018) has been obtained and adapted by responsible local ethics committees.The findings of this work will be disseminated by publication of peer-reviewed manuscripts and presentations as conference contributions (abstracts, poster or oral presentations).Moreover, results will be discussed with clinical experts and medical associations before being proposed for implementation into the quality management of EDs.Trial registration numberGerman Clinical Trials Registry (DRKS00015203); Pre-results.
Impact of hearing loss and vestibular decline on cognition in Alzheimer’s disease: a prospective longitudinal study protocol (Gehoor, Evenwicht en Cognitie, GECkO)
Authors: Bosmans Joyce , Jorissen Cathérine , Cras Patrick , Van Ombergen Angelique , Engelborghs Sebastiaan , Gilles Annick , Princen Eline , Moyaert Julie , Mertens Griet , Van Rompaey Vincent 
Published: September 2020

IntroductionDementia is a prevalent disease affecting a growing number of the ageing population. Alzheimer’s disease (AD) is the most common cause of dementia. Previous research investigated the link between hearing loss and cognition, and the effect of vestibular dysfunction on cognition. Hearing loss and, to a lesser extent, vestibular decline both result in a decreasing cognitive function. However, their interaction should not be underestimated. The aim of this study is to assess the effect of hearing loss, vestibular decline and their interaction on cognition in people suffering from mild cognitive impairment (MCI) and dementia due to AD (ADD).Methods and analysisWe designed a prospective longitudinal study to assess the effect of hearing loss and vestibular decline on cognition. A total of 100 cognitively impaired elderly (between 55 and 84 years of age), consisting of 60 patients with MCI due to AD and 40 patients with ADD will be included. The control group will consist of individuals with preserved cognition group-matched based on age, hearing level and vestibular function. A comprehensive assessment is performed at baseline, 12-month and 24-month follow-ups. The primary outcome measure is the change in the Repeatable Battery for the Assessment of Neuropsychological Status adjusted for Hearing-impaired individuals total score, a cognitive test battery assessing different cognitive domains. Secondary outcome measures include additional neuropsychological assessments, cortical auditory-evoked potentials, and evaluation of general and disease-specific health-related quality of life. Variables include cognitive, audiological and vestibular evaluation. Variance analyses will assess the effect of hearing loss and vestibular decline on cognition. More precisely, the link between hearing loss and non-spatial cognitive functioning, the effect of vestibular decline on spatial cognition and the impact of both factors on the rate of conversion from MCI due to AD to ADD will be investigated.Ethics and disseminationThe study protocol was approved by the ethical committee of the Antwerp University Hospital on 4 February 2019 with protocol number B300201938949. The findings will be disseminated through peer-reviewed publications and conference presentations.Trial registration numberClinicalTrials.gov Registry (NCT04385225).
Characteristics of COVID-19 clinical trials registered with ClinicalTrials.gov: cross-sectional analysis
Authors: Jones Christopher W , Woodford Ashley L , Platts-Mills Timothy F 
Published: September 2020

ObjectivesTo characterise current COVID-19-related research activities.DesignCross-sectional analysis.SettingClinical trials registered with ClinicalTrials.gov testing interventions relevant to COVID-19.Data sourcesClinicalTrials.gov was searched for COVID-19 and related terms to identify trials registered between 1 December 2019 and 1 May 2020 that test interventions related to the COVID-19 pandemic.Main outcome measuresWe classified trials according to intervention type, and report key trial characteristics including recruitment status, location, funder type, target enrolment number, intervention model (single group, randomised or sequential assignment) and projected completion date.ResultsOf the 630 identified clinical trials related to COVID-19, 509 (81%) involved the study of drugs or biological agents. Of these trials of drugs and biologics, 305 (60%) use an open-label design, 43 (8%) are single blinded (participant only) and 161 (32%) are double blinded (participant and investigator). 94 (18%) of the drug/biological trials are non-randomised. Either hydroxychloroquine or chloroquine is administered as part of the study protocol in 152 (30%) of the drug/biological trials. The total planned enrolment for these hydroxychloroquine/chloroquine trials is over 200 000 participants, which represents 65% of the total planned enrolment for all registered trials of drugs or biologics. There are also at least 25 registered trials of azithromycin (n=53), convalescent plasma (n=38), lopinavir/ritonavir (n=30), stem cell treatments (n=29) and tocilizumab (n=25). 142 trials were registered in the first 3 months of 2020, and 488 trials were registered between 1 April and 1 May 2020.ConclusionsThese findings demonstrate a robust research response to the COVID-19 pandemic, though many of the currently planned and ongoing trials focus on a small number of potential therapies, and many also lack essential design features and power necessary to provide accurate treatment effect estimates.
Differential gene expression of tumor-infiltrating CD8+T cells in advanced versus early-stage colorectal cancer and identification of a gene signature of poor prognosis
Authors: Saleh Reem , Sasidharan Nair Varun , Toor Salman M , Taha Rowaida Z , Murshed Khaled , Al-Dhaheri Mahmood , Khawar Mahwish , Petkar Mahir Abdulla , Abu Nada Mohamed , Al-Ejeh Fares , Elkord Eyad 
Published: September 2020

BackgroundCytotoxic CD8+T cell-mediated response is the most important arm of adaptive immunity, which dictates the capacity of the host immune response in eradicating tumor cells. Due to tumor intrinsic and/or extrinsic factors, the density and function of CD8+tumor-infiltrating lymphocytes (TILs) could be compromised, leading to poor prognosis and survival.MethodsUsing RNA-Seq, transcriptomes of sorted CD3+CD8+TILs from treatment-naïve colorectal cancer (CRC) patients at advanced stages (III and IV) were compared with those from patients with early stages (I and II). A signature referred to as ‘poor prognosis CD8 gene signature (ppCD8sig)’ was identified and analyzed in The Cancer Genome Atlas CRC dataset. Scores for the ppCD8sig were calculated and classified as high, intermediate and low, and its prognostic significance was assessed using multivariate analysis and Cox proportional hazard model. Densities of CD3+and CD8+T cell infiltration in tumors from patients with high and low ppCD8sig scores were assessed by flow cytometry and immunostaining.ResultsGenes related to epigenetic regulation and response to hypoxia were upregulated in CD8+TILs from patients with advanced stages, while genes related to T cell activation, cell proliferation and cell cycle were downregulated. Patients with high ppCD8sig score had poorer disease-specific survival (DSS) and shorter progression-free interval (PFI). The ppCD8sig was an independent prognostic indicator for DSS (HR 1.83, 95% CI 1.40 to 2.38, p<0.0001) and PFI (HR 1.42, 95% CI 1.04 to 1.93, p=0.026). Additionally, patients with high ppCD8sig score were more likely to have advanced stages (χ2p<0.0001) and residual disease after primary therapy (χ2p=0.046). Patients with high ppCD8sig score had reduced levels of CD3+and CD8+TILs and low Immunoscores (IS), compared to patients with low ppCD8sig score.ConclusionsOur data provided insights into the altered regulation of biological mechanisms and signaling pathways in CD8+TILs during CRC progression, and revealed a gene signature as an independent prognostic indicator. Patients with high ppCD8sig score had lower levels of TILs and low IS. These data further confirm the prognostic value of the identified ppCD8sig and potentially highlight its clinical relevance.
Methylated DNA Markers of Esophageal Squamous Cancer and Dysplasia: An International Study
Authors: Qin Yi , Taylor William , Bamlet William R. , Ravindran Adharsh , Buglioni Alessia , Cao Xiaoming , Foote Patrick H. , Slettedahl Seth W. , Mahoney Douglas W. , Albert Paul S. , Kim Sungduk , Hu Nan , Taylor Philip R. , Etemadi Arash , Sotoudeh Masoud , Malekzadeh Reza , Abnet Christian C. , Smyrk Thomas C. , Katzka David , Topazian Mark D. , Dawsey Sanford M. , Ahlquist David , Kisiel John B. , Iyer Prasad G. 
Published: September 2020

Abstract

Background:
Discovery of methylated DNA markers (MDM) of esophageal squamous cell carcinoma (ESCC) has sparked interest in assessing these markers in tissue. We evaluated MDMs in ESCC from three geographically and ethnically distinct populations, and explored the feasibility of assaying MDMs from DNA obtained by swallowed balloon devices.

Methods:
MDMs were assayed in ESCC and normal tissues obtained from the populations of United States, Iran, and China, and from exfoliative cytology specimens obtained by balloons in a Chinese population. Areas under the receiver operating curve (AUC) of MDMs discriminating ESCC from normal tissues were calculated. Random forest prediction models were built, trained on U.S. cases and controls, and calibrated to U.S.-only controls (model 1) and three-country controls (model 2). Statistical tests were used to assess the relationship between dysplasia and MDM levels in balloons.

Results:
Extracted DNA from 333 ESCC and 322 normal tissues was analyzed, in addition to archival DNA from 98 balloons. For ESCC, model 1 validated in Iranian and Chinese tissues with AUCs of 0.90 and 0.87, and model 2 yielded AUCs of 0.99, 0.96, and 0.94 in tissues from the United States, Iran, and China, respectively. In Chinese balloons, MDMs showed a statistically significant trend of increasing levels with increasing grades of dysplasia (P &lt; 0.004).

Conclusions:
MDMs accurately discriminate ESCC from normal esophagus in tissues obtained from high- and low-incidence countries. Preliminary data suggest that levels of MDMs assayed in DNA from swallowed balloon devices increase with dysplasia grade. Larger studies are needed to validate these results.

Impact:
MDMs coupled with minimally invasive collection methods have the potential for worldwide application in ESCC screening.