bluuebunny/crossref_metadata_2025_split huggingface dataset:
Mid-German Sepsis Cohort (MSC): a prospective observational study of sepsis survivorship
Authors: Fleischmann-Struzek Carolin , Kesselmeier Miriam , Ouart Dominique , Hartog Christiane S. , Bauer Michael , Bercker Sven , Bucher Michael , Meier-Hellmann Andreas , Petros Sirak , Schreiber Torsten , Simon Philipp , Weidhase Lorenz , Born Sebastian , Braune Anke , Chkirni Hicham , Eichhorn Cornelia , Fiedler Sandra , Gampe Christin , König Christian , Platzer Stephanie , Romeike Heike , Töpfer Kristin , Reinhart Konrad , Scherag André 
Published: March 2021

PurposeThe Mid-German Sepsis Cohort (MSC) aims to investigate mid-term and long-term functional disabilities in sepsis survivors from intensive care unit (ICU) discharge until 1 year after. Secondary, post-acute mortality and morbidity, health-related quality of life and healthcare utilisation will be investigated.ParticipantsThe MSC comprises adult (aged ≥18 years) patients who were treated for (severe) sepsis or septic shock on ICU. The participants were recruited between 15 April 2016 and 30 November 2018 from five German centres. Three thousand two hundred and ten patients with sepsis were identified, of which 1968 survived their ICU stay and were eligible for enrolment in the follow-up cohort. Informed consent for follow-up assessment was provided by 907 patients (46.1% of eligible patients).Findings to dateThe recruitment of the participants for follow-up assessments and the baseline data collection is completed. Incidence of sepsis was 116.7 patients per 1000 ICU patients. In this cohort profile, we provide an overview of the demographics and the clinical characteristics of both the overall sepsis cohort and the ICU survivors who provided informed consent for follow-up assessment (907 out of 1968 ICU survivors (46.1%)).Future plansThe follow-ups are conducted 3, 6 and 12 months after ICU discharge. Another yearly follow-up up to 5 years after ICU discharge is pursued. Several cooperation and satellite projects were initiated. This prospective cohort offers a unique resource for research on long-term sequelae of sepsis survivors.Trial registration numberGerman Clinical Trials Registry (DRKS00010050).
International multicentre observational study to evaluate the association between perioperative red blood cell transfusions and 1-year mortality after major cancer surgery (ARCA-1): study design, statistical analysis plan and study protocol
Authors: Cata Juan , Ramirez Maria , Forget Patrice , Chen Lee-Lynn , Diaz-Cambronero Oscar , Chen Wankun , Warner Matthew A , Knopfelmacher Couchonal Adriana , Pelosi Paolo , Cuellar Luis , Corrales German , Romero Carlos , Lobo Francisco , Saager Leif , Castro Tapia Jorge , Kiberenge Roy , Feng Lei , Serpa Neto Ary 
Published: March 2021

IntroductionBlood transfusion is still common in patients undergoing major cancer surgery. Blood transfusion can be associated with poor prognosis in patients with cancer. Perioperative Care in the Cancer Patient -1 (ARCA-1) aims to assess in a large cohort of patients the current incidence, pattern of practice and associations between perioperative blood transfusions and 1-year survival in patients undergoing major cancer surgery.Methods and analysisARCA-1 is a prospective international multicentre observational study that will include adult patients scheduled to have major cancer surgical procedures with the intention to cure, and an overnight planned hospital admission. The study will be opened for 1 year for enrolment (7 January 2020–7 February 2021). Each centre will enrol patients for 30 days. The primary endpoint of this study is all-cause mortality 1 year after major cancer surgery. Secondary endpoints are rate of perioperative blood product use, cancer-specific mortality at 1 year and PFSs and 30-day morbidity and mortality.Ethics and disseminationThis study was approved by the Institutional Review Board at The University of Texas—MD Anderson Cancer Center. The study results will be published in peer-reviewed journals and disseminated at international conferences.Trial registration numberNCT04491409.
Urgent assessment and ongoing care for infection in community-dwelling older people: a qualitative study of patient experience
Authors: Moore Abigail , McKelvie Sara , Glogowska Margaret , Lasserson Daniel S , Hayward Gail 
Published: March 2021

ObjectivesTo explore the experience of infection from the perspective of community-dwelling older people, including access and preferences for place of care.DesignQualitative interview study, carried out between March 2017 and August 2018.SettingAmbulatory care units in Oxfordshire, UK.ParticipantsAdults >70 years with a clinical diagnosis of infection.MethodsSemistructured interviews based on a flexible topic guide. Participants were given the option to be interviewed with their caregiver. Thematic analysis was facilitated by NVivo V.11.ResultsParticipants described encountering several barriers when accessing an urgent healthcare assessment which were hard to negotiate when they felt unwell. They valued home comforts and independence if they received care for their infection at home, though were worried about burdening their family. Most talked about hospital admission being a necessity in the context of more severe illness. Perceived advantages included monitoring, availability of treatments and investigations. However, some recognised that admission put them at risk of a hospital-acquired infection. Ambulatory care was felt to be convenient if local, but daily transport was challenging.ConclusionsProviders may need to think about protocols and targeted advice that could improve access for older people to urgent healthcare when they feel unwell. General practitioners making decisions about place of care may need to better communicate risks associated with the available options and think about balancing convenience with facilities for care.
Association of outpatient ACE inhibitors and angiotensin receptor blockers and outcomes of acute respiratory illness: a retrospective cohort study
Authors: Jeffery Molly Moore , Cummins Nathan W , Dempsey Timothy M , Limper Andrew H. , Shah Nilay D , Bellolio Fernanda 
Published: March 2021

ObjectivesEvaluate associations between ACE inhibitors (ACEis) and angiotensin receptor blockers (ARBs) and clinical outcomes in acute viral respiratory illness (AVRI).DesignRetrospective cohort analysis of claims data.SettingThe USA; 2018–2019 influenza season.ParticipantsMain cohort: people with hypertension (HTN) taking an ACEi, ARB or other HTN medications, and experiencing AVRI. Falsification cohort: parallel cohort receiving elective knee or hip replacement.Main outcome measuresMain cohort: hospital admission, intensive care unit, acute respiratory distress (ARD), ARD syndrome and all-cause mortality. Falsification cohort: complications after surgery and all-cause mortality.ResultsThe main cohort included 236 843 episodes of AVRI contributed by 202 629 unique individuals. Most episodes were in women (58.9%), 81.4% in people with Medicare Advantage and 40.3% in people aged 75+ years. Odds of mortality were lower in the ACEi (0.78 (0.74 to 0.83)) and ARB (0.64 (0.61 to 0.68)) cohorts compared with other HTN medications. On all other outcomes, people taking ARBs (but not ACEis) had a >10% reduction in odds of inpatient stays compared with other HTN medications.In the falsification analysis (N=103 353), both ACEis (0.89 (0.80 to 0.98)) and ARBs (0.82 (0.74 to 0.91)) were associated with decreased odds of complications compared with other HTN medications; ARBs (0.64 (0.47 to 0.87)) but not ACEis (0.79 (0.60 to 1.05)) were associated with lower odds of death compared with other HTN medications.ConclusionsOutpatient use of ARBs was associated with better outcomes with AVRI compared with other medications for HTN. ACEis were associated with reduced risk of death, but with minimal or no reduction in risk of other complications. A falsification analysis conducted to provide context on the possible causal implications of these findings did not provide a clear answer. Further analysis using observational data will benefit from additional approaches to assess causal relationships between these drugs and outcomes in AVRI.
Lifelines COVID-19 cohort: investigating COVID-19 infection and its health and societal impacts in a Dutch population-based cohort
Authors: Mc Intyre Katherine , Lanting Pauline , Deelen Patrick , Wiersma Henry H , Vonk Judith M , Ori Anil P S , Jankipersadsing Soesma A , Warmerdam Robert , van Blokland Irene , Boulogne Floranne , Dijkema Marjolein X L , Herkert Johanna C , Claringbould Annique , Bakker Olivier , Lopera Maya Esteban A , Bültmann Ute , Zhernakova Alexandra , Reijneveld Sijmen A , Zijlstra Elianne , Swertz Morris A , Brouwer Sandra , van Ooijen Raun , Angelini Viola , Dekker Louise H , Sijtsma Anna , Scherjon Sicco A , Wijmenga Cisca , Dekens Jackie A M , Mierau Jochen , Boezen H Marike , Franke Lude 
Published: March 2021

PurposeThe Lifelines COVID-19 cohort was set up to assess the psychological and societal impacts of the COVID-19 pandemic and investigate potential risk factors for COVID-19 within the Lifelines prospective population cohort.ParticipantsParticipants were recruited from the 140 000 eligible participants of Lifelines and the Lifelines NEXT birth cohort, who are all residents of the three northern provinces of the Netherlands. Participants filled out detailed questionnaires about their physical and mental health and experiences on a weekly basis starting in late March 2020, and the cohort consists of everyone who filled in at least one questionnaire in the first 8 weeks of the project.Findings to date>71 000 unique participants responded to the questionnaires at least once during the first 8 weeks, with >22 000 participants responding to seven questionnaires. Compiled questionnaire results are continuously updated and shared with the public through the Corona Barometer website. Early results included a clear signal that younger people living alone were experiencing greater levels of loneliness due to lockdown, and subsequent results showed the easing of anxiety as lockdown was eased in June 2020.Future plansQuestionnaires were sent on a (bi)weekly basis starting in March 2020 and on a monthly basis starting July 2020, with plans for new questionnaire rounds to continue through 2020 and early 2021. Questionnaire frequency can be increased again for subsequent waves of infections. Cohort data will be used to address how the COVID-19 pandemic developed in the northern provinces of the Netherlands, which environmental and genetic risk factors predict disease susceptibility and severity and the psychological and societal impacts of the crisis. Cohort data are linked to the extensive health, lifestyle and sociodemographic data held for these participants by Lifelines, a 30-year project that started in 2006, and to data about participants held in national databases.
A randomised, open-label trial to assess the optimal treatment strategy in early diffuse cutaneous systemic sclerosis: the UPSIDE study protocol
Authors: Spierings Julia , van Rhenen Anna , Welsing Paco MW , Marijnissen Anne CA , De Langhe Ellen , Del Papa Nicoletta , Dierickx Daan , Gheorghe Karina R , Henes Joerg , Hesselstrand Roger , Kerre Tessa , Ljungman Per , van de Loosdrecht Arjan A , Marijt Erik WAF , Mayer Miro , Schmalzing Marc , Schroers Roland , Smith Vanessa , Voll Reinhard E , Vonk Madelon C , Voskuyl Alexandre E , de Vries-Bouwstra Jeska K , Walker Ulrich A , Wuttge Dirk M , van Laar Jacob M 
Published: March 2021

IntroductionSystemic sclerosis (SSc) is a chronic, autoimmune connective tissue disease associated with high morbidity and mortality, especially in diffuse cutaneous SSc (dcSSc). Currently, there are several treatments available in early dcSSc that aim to change the disease course, including immunosuppressive agents and autologous haematopoietic stem cell transplantation (HSCT). HSCT has been adopted in international guidelines and is offered in current clinical care. However, optimal timing and patient selection for HSCT are still unclear. In particular, it is unclear whether HSCT should be positioned as upfront therapy or rescue treatment for patients refractory to immunosuppressive therapy. We hypothesise that upfront HSCT is superior and results in lower toxicity and lower long-term medical costs. Therefore, we propose this randomised trial aiming to determine the optimal treatment strategy for early dcSSc by comparing two strategies used in standard care: (1) upfront autologous HSCT versus (2) immunosuppressive therapy (intravenous cyclophosphamide pulse therapy followed by mycophenolate mofetil) with rescue HSCT in case of treatment failure.Methods and analysisThe UPSIDE (UPfront autologous hematopoieticStem cell transplantation vsImmunosuppressive medication in earlyDiffusEcutaneous systemic sclerosis) study is a multicentre, randomised, open-label, controlled trial. In total, 120 patients with early dcSSc will be randomised. The primary outcome is event-free survival at 2 years after randomisation. Secondary outcomes include serious adverse events, functional status and health-related quality of life. We will also evaluate changes in nailfold capillaroscopy pattern, pulmonary function, cardiac MR and high-resolution CT of the chest. Follow-up visits will be scheduled 3-monthly for 2 years and annually in the following 3 years.Ethics and disseminationThe study was approved by the Dutch Central Committee on Research Concerning Human Subjects (NL72607.041.20). The results will be disseminated through patient associations and conventional scientific channels.Trial registration numbersNCT04464434; NL 8720.
COVID-19 symptom surveillance in immunocompromised children and young people in the UK: a prospective observational cohort study
Authors: Shaunak Meera , Patel Ravin , Driessens Corine , Mills Lynne , Leahy Alice , Gbesemete Diane , Owens Daniel R , Lucas Jane S , Faust Saul N , de Graaf Hans 
Published: March 2021

ObjectivesTo describe the frequency of symptoms compatible with SARS-CoV-2 infection in immunocompromised children and young people in the UK during the SARS-CoV-2 pandemic. To describe patient/parent anxiety regarding SARS-CoV-2 infection in this cohort.DesignA prospective observational cohort study.Setting46 centres across the UK between 16 March and 4 July 2020. A weekly online questionnaire based on the International Severe Acute Respiratory and emerging Infections Consortium-WHO Case Report Form was used to collect participant reported data on symptoms, test results, National Health Service attendance, hospital admission and impact on daily life.Participants1490 immunocompromised children, defined as those requiring an annual influenza vaccination due to their underlying condition or medication.Main outcome measuresIncidence of SARS-CoV-2-like symptoms and patient/parent anxiety score.ResultsOver 16 weeks during the first wave of the pandemic, no SARS-CoV-2 infection was diagnosed in this large immunocompromised paediatric cohort (median age 11 years, 54.4% female). 110 symptomatic participants underwent a test for SARS-CoV-2; all were negative. 922 (67.4%) participants reported at least one symptom consistent with suspected SARS-CoV-2 infection over the study period. 476 (34.8%) reported three or more symptoms. The most frequently reported symptoms included joint pain, fatigue, headache, nausea and muscle pain. SARS-CoV-2 testing during this period was performed on admitted patients only. 137 participants had their medication suspended or changed during the study period due to assumed COVID-19 disease risk. 62% reported high levels of anxiety (scores of 7–10 out of 10) at the start of the study, with anxiety levels remaining high throughout the study period.ConclusionsAlthough symptoms related to SARS-CoV-2 infection in children were common, there were no positive tests in this large immunocompromised cohort. Symptom-based screening to facilitate early detection of SARS-CoV-2 infection may not be helpful in these individuals. Patient/parent anxiety about SARS-CoV-2 infection was high.Trial registration numberNCT04382508.
Patient and public involvement in numerical aspects of trials: a mixed methods theory-informed survey of trialists’ current practices, barriers and facilitators
Authors: Goulao Beatriz , Poisson Camille , Gillies Katie 
Published: March 2021

ObjectiveWe aimed to find out if trialists involve patients and the public in numerical aspects of trials, how and what are the barriers and facilitators to doing it.DesignWe developed a survey based on the Theoretical Domains Framework. We used a mixed methods approach to analyse the data and to identify important domains.SettingOnline survey targeting UK-based trial units.ParticipantsStakeholders working in UK-based clinical trials, 18 years old or over, understand English and agree to take part in the study.Outcome measuresTrialists’ behaviour of involving patients and the public in numerical aspects of trials and its determinants.ResultsWe included 187 respondents. Majority were female (70%), trial managers (67%) and involved public and patient partners in numerical aspects of trials (60%). We found lack of knowledge, trialists’ perception of public and patient partners’ skills, capabilities and motivations, scarce resources, lack of reinforcement, and lack of guidance were barriers to involving public and patient partners in numerical aspects of trials. Positive beliefs about consequences were an incentive to doing it.ConclusionsMore training, guidance and funding can help trialists involve patient and public partners in numerical aspects, although they were uncertain about public and patient partners’ motivation to be involved. Future research should focus on identifying public and patient partners’ motivations and develop strategies to improve the communication of numerical aspects.
Prospective observational study of SARS-CoV-2 infection, transmission and immunity in a cohort of households in Liverpool City Region, UK (COVID-LIV): a study protocol
Authors: Setiabudi Wega , Hungerford Daniel , Subramaniam Krishanthi , Vaselli Natasha Marcella , Shaw Victoria E , Wilton Moon , Vivancos Roberto , Aston Stephen , Platt Gareth , Moitt Tracy , Jones Ashley P , Gabbay Mark , Buchan Iain , Carrol Enitan D , Iturriza-Gomara Miren , Solomon Tom , Greenhalf William , Naisbitt Dean J , Adams Emily R , Cunliffe Nigel A , Turtle Lance , French Neil 
Published: March 2021

IntroductionThe emergence and rapid spread of COVID-19 have caused widespread and catastrophic public health and economic impact, requiring governments to restrict societal activity to reduce the spread of the disease. The role of household transmission in the population spread of SARS-CoV-2, and of host immunity in limiting transmission, is poorly understood. This paper describes a protocol for a prospective observational study of a cohort of households in Liverpool City Region, UK, which addresses the transmission of SARS-CoV-2 between household members and how immunological response to the infection changes over time.Methods and analysisHouseholds in the Liverpool City Region, in which members have not previously tested positive for SARS-CoV-2 with a nucleic acid amplification test, are followed up for an initial period of 12 weeks. Participants are asked to provide weekly self-throat and nasal swabs and record their activity and presence of symptoms. Incidence of infection and household secondary attack rates of COVID-19 are measured. Transmission of SARS-CoV-2 will be investigated against a range of demographic and behavioural variables. Blood and faecal samples are collected at several time points to evaluate immune responses to SARS-CoV-2 infection and prevalence and risk factors for faecal shedding of SARS-CoV-2, respectively.Ethics and disseminationThe study has received approval from the National Health Service Research Ethics Committee; REC Reference: 20/HRA/2297, IRAS Number: 283 464. Results will be disseminated through scientific conferences and peer-reviewed open access publications. A report of the findings will also be shared with participants. The study will quantify the scale and determinants of household transmission of SARS-CoV-2. Additionally, immunological responses before and during the different stages of infection will be analysed, adding to the understanding of the range of immunological response by infection severity.
Characteristics of Cubitus Varus Deformity after Lateral Condylar Fracture of the Humerus
Authors: Takagi Takehiko , Bessho Yuki , Seki Atsuhito , Takayama Shinichiro 
Published: March 2021

Background: Lateral humeral condylar fractures often heal with some residual elbow deformity. However, details of angulation or tilting angle of the lateral condyle after the fracture have not been evaluated so far. Methods: Between 2008 and 2016, we followed up 80 mild fractures of the lateral humeral condyle for more than a year. Thirty fractures were treated by open reduction and internal fixation (ORIF) with Kirschner wires. Fifty cases were treated with a long arm splint for 3 weeks (Fig. 1). The average age of the patients at the time of the injury was 5.5 years. The humerus-elbow-wrist angle (HEWA), Baumann’s angle (BA), and tilting angle (TA) were measured on the radiographs. The active range of motion (ROM) was clinically assessed at unaffected and affected sides at the final follow-up. Results: No significant differences were detected between the sides about TA or ROM at the final follow-up. However, HEWA/ BA showed more significant loss of correction. There were significant differences in BA at the affected side between the ORIF and splint groups. Conclusions: Cubitus varus deformity after lateral humeral condylar fracture is not accompanied by a change in TA or ROM, unlike the deformity after supracondylar or distal epiphyseal fracture of the humerus (Fig. 2). Operative treatment to precisely correct and fix the lateral condylar fracture still retained some cubitus varus deformity, although it might lessen or prevent the deformity when compared to conservative treatment with a splint.
Who Is the Demiurge, According to Plutarch? The Cosmic Soul in the iv Platonic Question
Authors: Delle Donne Carlo 
Published: March 2021

Abstract
According to Plutarch, who is responsible for the ordering of the indeterminate precosmic matter? Is this activity imputable to the divine demiurgic intellect? Or are we to consider the Cosmic Soul as the force which firstly gave shape to the precosmic chora/hyle? By means of examining the iv Platonica Quaestio, I set out to maintain that, at a certain moment of his philosophical career, Plutarch thought it better to relieve the divine intellect from the task of firstly ordering the material substratum; this duty had to fall upon the Cosmic Soul. Thus, he would keep the divine intellect from any engagement in activities concerning the hyle.
Ethnic Diversity and the Nation-State in the 21st Century
Authors: Kok Wah Loh Francis 
Published: March 2021

Abstract
The cause of conflict in multi-ethnic and multi-religious societies is not diversity in and of itself. Instead, it is one’s attitude towards diversity. Do we share political power and economic development with the regions and minority communities? Do we respect and recognise the cultural identities of minorities? This requires that the nation-state building process be imagined in more inclusive civic territorial lines rather than exclusive ethnic-genealogical lines. With the above as a backdrop, the article explores the status of the Christian minority in Malay-Islamic majority Malaysia and the plight of the Rohingyas in Bamar-Buddhist majority Myanmar.