bluuebunny/crossref_metadata_2025_split huggingface dataset:
The safety of COVID‐19 convalescent plasma donation: A multi‐institutional donor hemovigilance study
Authors: Cho Joseph H. , Rajbhandary Srijana , van Buren Nancy L. , Fung Mark K. , Al‐Ghafry Maha , Fridey Joy L. , Dy Beth A. , Ziman Alyssa , Schreiber George B. , Gammon Richard R. , Reik Rita , Stubbs James R. , van Buskirk Camille M. , Kamel Hany , Townsend Mary J. , Zeller Michelle P. , Gottschall Jerome L. 
Published: July 2021

AbstractBackgroundAlthough the safety and therapeutic efficacy of COVID‐19 convalescent plasma (CCP) has been extensively evaluated, the safety of CCP donation has not been explored in a multi‐institutional context.Study design and methodsNine blood collection organizations (BCOs) participated in a multi‐institutional donor hemovigilance effort to assess the safety of CCP donation. Donor adverse events (DAEs) were defined according to the Standard for Surveillance of Complications Related to Blood Donation, and severity was assessed using the severity grading tool. Multivariate analysis was performed to determine attributes associated with DAE severity.ResultsThe overall DAE rate was 37.7 per 1000 donations. Repeat apheresis and apheresis‐naïve donors experienced adverse event rates of 19.9 and 49.8 per 1000 donations, respectively. Female donors contributed 51.9% of CCP donations with a DAE rate of 49.4 per 1000 donations. The DAE rate for male donors was 27.4 per 1000 donations. Vasovagal reactions accounted for over half of all reported DAEs (51.1%). After adjustment, volume of CCP donated was associated with vasovagal reaction severity (odds ratio [OR] 6.5, 95% confidence interval [CI] 2.5–17.1). Donor age and donation history were also associated with DAE severity. Considerable differences in DAE types and rates were observed across the participating BCOs despite the use of standardized hemovigilance definitions.ConclusionThe safety of CCP donation appears comparable to that of conventional apheresis plasma donation with similar associated risk factors for DAE types and severity.
An unusual case of anti‐D detection in two consecutive D+ patient samples: Antibody carryover on an automated gel platform
Authors: Gabert Kimberly , Seheult Jansen N. , Meyer Michael P. , Triulzi Darrell J. , Kaplan Alesia 
Published: July 2021

AbstractBackgroundLaboratory results can be affected by sample to sample carryover. Carryover of different analytes occurring in automated clinical chemistry, immunology, hematology, and molecular laboratories is well described. However, carryover in a transfusion service laboratory is not reported in medical literature.Materials and methodsImmunohematology testing results, demographic data, and clinical data were reviewed on three patients retrospectively from 2015 to 2019.ResultsType and screen samples tested on automated gel platform from two D+ patients were affected by anti‐D carryover from a patient sample with a very high‐titer anti‐D. Additional immunohematology and molecular testing confirmed that anti‐D in samples of two D+ patients was due to carryover.ConclusionA case of anti‐D carryover caused false detection of anti‐D in two D+ patients. Carryover can have implications for patient management. Transfusion laboratory staff need to be aware of it and investigate any unexpected results further.
Generation of glycans depleted decellularized porcine pericardium, using digestive enzymatic supplements and enzymatic mixtures for food industry
Authors: Morticelli Lucrezia , Magdei Mikhail , Tschalaki Negin , Petersen Björn , Haverich Axel , Hilfiker Andres 
Published: July 2021

AbstractBackgroundXenogeneic pericardium has been used largely for various applications in cardiovascular surgery. Nevertheless, xenogeneic pericardial patches fail mainly due to their antigenic components. The xenoantigens identified as playing a major role in recipient immune response are the Galα1‐3Gal (α‐Gal) epitope, the non‐human sialic acid N‐glycolylneuraminic acid (Neu5Gc), and the porcine SDa antigen, associated with both proteins and lipids. The reduction in glycans from porcine pericardium might hinder or reduce the immunogenicity of xenogeneic scaffolds.MethodsDecellularized porcine pericardia were further treated at different time points and dilutions with digestive enzymatic supplements and enzymatic mixtures applied for food industry, for the removal of potentially immunogenic carbohydrates. Carbohydrates removal was investigated using up to 8 different lectin stains for the identification of N‐ and O‐glycosylations, as well as glycolipids. Histoarchitectural changes in the ECM were assessed using Elastica van Gieson stain, whereas changes in mechanical properties were investigated via uniaxial tensile test and burst pressure test.ResultsTissues after enzymatic treatments showed a dramatic decrease in lectin stainings in comparison to tissues which were only decellularized. Histological assessment revealed cell‐nuclei removal after decellularization. Some of the enzymatic treatments induced elastic lamellae disruption. Tissue strength decreased after enzymatic treatment; however, treated tissues showed values of burst pressure higher than physiological transvalvular pressures.ConclusionsThe application of these enzymatic treatments for tissue deglycosylation is totally novel, low cost, and appears to be very efficient for glycan removal. The immunogenic potential of treated tissues will be further investigated in subsequent studies, in vitro and in vivo.
Heat Transfer Enhancement Feature of the Non-Fourier Cattaneo–Christov Heat Flux Model
Authors: Turkyilmazoglu Mustafa 
Published: July 2021

Abstract
Cattaneo–Christov heat flux model was proposed to remedy the weakness of the traditional Fourier heat flux model to maintain the finite travel time of heat. The literature is replete with numerical studies to understand the heat transfer enhancement property. The present effort is to provide a mathematical rigor and to analytically demonstrate why the new model should act toward cooling and thus, in the way of enhancing the heat transfer rate from the surfaces. The derived and presented formulae here prove this assertion through comparison with a few selected examples from the open literature.
Heat Transfer Analysis of Supercritical Methane on a Cooling Channel of Electromechanical Actuator Under Various Flight Acceleration Overloads
Authors: Gao Zhigang , Zhou Jun , Wang Tianhu , Li Peng 
Published: July 2021

Abstract
The crucial distinction of heat transfer between the earth environment and the high acceleration overloads of flight vehicle is the secondary flow resulting from the gravitational buoyancy force and centrifugal one, which influences the heat transfer of supercritical fluid significantly. Hence, in this work, the effect of various flight acceleration overloads on turbulent convection heat transfer in the cooling channel of flight vehicle electromechanical actuator (EMA) is investigated numerically. The cooling channel is constructed from a helically coiled tube with an inner diameter of 8 mm, coil diameter of 74 mm, and screw pitch of 10 mm, the operation pressure covers the range of 5–9 MPa, and the gravity ranges from 1 g to 50 g. Based on this model, the heat transfer characteristics of supercritical methane in the cooling channel of flight vehicle EMA under various acceleration overloads are studied, aiming to obtain a deep understanding of flow and heat transfer mechanism and thermal performance of supercritical methane in the cooling channel under the conditions of actual flight. The simulation result indicates that with the high-g overload, the heat transfer enhancement becomes obvious and the effect of secondary flow caused by the flight acceleration exhibits the non-negligible influence. The secondary flow caused by flight acceleration overloads disturbs the flow acceleration of the main stream that weakens the suppression of heat transfer. However, the effect of gravitational buoyancy does not dominate on forced convection heat transfer even under the high acceleration overload.
Butyrylcholinesterase as a perioperative complication marker in patients after transcatheter aortic valve implantation: a prospective observational study
Authors: Michels Bernhard , Holzamer Andreas , Graf Bernhard M , Bredthauer Andre , Petermichl Walter , Müller Anika , Zausig York Alexander , Bitzinger Diane Inge 
Published: July 2021

ObjectivesTranscatheter aortic valve implantation (TAVI) is performed in elderly patients with severe aortic valve stenosis and increased operative risks. We tested the hypothesis that acetylcholinesterase (AChE) and butyrylcholinesterase (BChE) have a predictive value for prevalent complications after TAVI and could serve as indicators of systemic inflammation in the early postoperative period.DesignProspective observational study.SettingThis study is a secondary analysis of multicentre CESARO- study.Participants48 patients with TAVI were included and 43 obtained the complete assessment.Primary and secondary outcome measuresPatients’ clinical parameters, demographic data, peripheral AChE and BChE activities and routine blood markers were assessed throughout the perioperative period using bedside point-of-care measurements for AChE and BChE. Postoperative complication screening was conducted up to the third postoperative day and included infections, delirium and heart-rhythm disturbances. After assessment, the patients were divided into complication and noncomplication group.ResultsOf 43 patients, 24 developed postsurgical complications (55.8%). Preoperative assessment showed no significant differences regarding demographic data and laboratory markers, but preoperative BChE levels were significantly lower in patients who developed postoperative complications (complication group 2589.2±556.4 vs noncomplication group 3295.7±628.0, Cohen’s r=0.514, p<0.001). In complication group, we observed an early, sustained reduction in BChE activity from preoperative to postoperative period. In complication group, BChE levels were significantly lower at each time point compared with noncomplication group. AChE activity showed no significant difference between both groups. Complication group also had longer stay in hospital overall.ConclusionBChE could be a useful perioperative biomarker to identify patients with a higher risk for postoperative complications after TAVI. By using point-of-care measurements, the levels of BChE are fast available and can lead to an early targeted therapy. Predicting the length of the hospital stay might play an important role in staff and resource management for these patients.Trial registration numberNCT01964274; Post-results.
Risk factors associated with day-30 mortality in patients over 60 years old admitted in ICU for severe COVID-19: the Senior-COVID-Rea Multicentre Survey protocol
Authors: Falandry Claire , Malapert Amélie , Roche Mélanie , Subtil Fabien , Berthiller Julien , Boin Camille , Dubreuil Justine , Ravot Christine , Bitker Laurent , Abraham Paul , Collange Vincent , Balança Baptiste , Goutte Sylvie , Guichon Céline , Gadea Emilie , Argaud Laurent , Dayde David , Jallades Laurent , Lepape Alain , Pialat Jean-Baptiste , Friggeri Arnaud , Thiollière Fabrice 
Published: July 2021

IntroductionWith the spread of COVID-19 epidemic, health plans must be adapted continuously. There is an urgent need to define the best care courses of patients with COVID-19, especially in intensive care units (ICUs), according to their individualised benefit/risk ratio. Since older age is associated with poorer short-term and long-term outcomes, prediction models are needed, that may assist clinicians in their ICU admission decision. Senior-COVID-Rea was designed to evaluate, in patients over 60 years old admitted in ICU for severe COVID-19 disease, the impact of age and geriatric and paraclinical parameters on their mortality 30 days after ICU admission.Methods and analysisThis is a multicentre survey protocol to be conducted in seven hospitals of the Auvergne-Rhône-Alpes region, France. All patients over 60 years old admitted in ICU for severe COVID-19 infection (or their legally acceptable representative) will be proposed to enter the study and to fill in a questionnaire regarding their functional and nutritional parameters 1 month before COVID-19 infection. Paraclinical parameters at ICU admission will be collected: lymphocytes and neutrophils counts, high-fluorescent lymphoid cells and immature granulocytes percentages (Sysmex data), D-dimers, C-reactive protein, lactate dehydrogenase (LDH), creatinine, CT scan for lung extension rate as well as clinical resuscitation scores, and the delay between the first signs of infection and ICU admission. The primary outcome will be the overall survival at day 30 post-ICU admission. The analysis of factors predicting mortality at day 30 will be carried out using univariate and multivariate logistic regressions. Multivariate logistic regression will consider up to 15 factors.The ambition of this trial, which takes into account the different approaches of geriatric vulnerability, is to define the respective abilities of different operational criteria of frailty to predict patients’ outcomes.Ethics and disseminationThe study protocol was ethically approved. The results of the primary and secondary objectives will be published in peer-reviewed journals.Trial registration numberNCT04422340.
COpenhagen Neuroplastic TRaining Against Contractures in Toddlers (CONTRACT): protocol of an open-label randomised clinical trial with blinded assessment for prevention of contractures in infants with high risk of cerebral palsy
Authors: Willerslev-Olsen Maria , Lorentzen Jakob , Røhder Katrine , Ritterband-Rosenbaum Anina , Justiniano Mikkel , Guzzetta Andrea , Lando Ane Vibeke , Jensen Anne-Mette Bæk , Greisen Gorm , Ejlersen Sofie , Pedersen Line Zacho , Andersen Britta , Lipthay Behrend Patricia , Nielsen Jens Bo 
Published: July 2021

IntroductionContractures are frequent causes of reduced mobility in children with cerebral palsy (CP) already at the age of 2–3 years. Reduced muscle use and muscle growth have been suggested as key factors in the development of contractures, suggesting that effective early prevention may have to involve stimuli that can facilitate muscle growth before the age of 1 year. The present study protocol was developed to assess the effectiveness of an early multicomponent intervention, CONTRACT, involving family-oriented and supervised home-based training, diet and electrical muscle stimulation directed at facilitating muscle growth and thus reduce the risk of contractures in children at high risk of CP compared with standard care.Methods and analysisA two-group, parallel, open-label randomised clinical trial with blinded assessment (n=50) will be conducted. Infants diagnosed with CP or designated at high risk of CP based on abnormal neuroimaging or absent fidgety movement determined as part of General Movement Assessment, age 9–17 weeks corrected age (CA) will be recruited. A balanced 1:1 randomisation will be made by a computer. The intervention will last for 6 months aiming to support parents in providing daily individualised, goal-directed activities and primarily in lower legs that may stimulate their child to move more and increase muscle growth. Guidance and education of the parents regarding the nutritional benefits of docosahexaenic acid (DHA) and vitamin D for the developing brain and muscle growth will be provided. Infants will receive DHA drops as nutritional supplements and neuromuscular stimulation to facilitate muscle growth. The control group will receive standard care as offered by their local hospital or community. Outcome measures will be taken at 9, 12, 18, 24, 36 and 48 months CA. Primary and secondary outcome measure will be lower leg muscle volume and stiffness of the triceps surae musculotendinous unit together with infant motor profile, respectively.Ethics and disseminationFull approval from the local ethics committee, Danish Committee System on Health Research Ethics, Region H (H-19041562). Experimental procedures conform with the Declaration of Helsinki.Trial registration numberNCT04250454.Expected recruitment period1 January 2021–1 January 2025.
Introducing the non-invasive prenatal testing for detection of Down syndrome in China: a cost-effectiveness analysis
Authors: Shang Wenru , Wan Yang , Chen Jianan , Du Yanqiu , Huang Jiayan 
Published: July 2021

ObjectiveThis study aimed to compare the health economic value of a non-invasive prenatal testing (NIPT) strategy against a second-trimester triple screening (STS) strategy for the detection of Down syndrome based on real-world data from China.DesignA decision-analytical model was developed to compare the cost-effectiveness of five strategies from a societal perspective. Cost and probability input data were obtained from the real-world surveys and published sources.SettingChina.ParticipantsWomen with a singleton pregnancy.InterventionsThe five strategies for screening were: (A) maternal age with STS (no NIPT); (B) STS plus NIPT screening; (C) age-STS plus NIPT screening (the currently referral strategy in China); (D) maternal age with NIPT screening and (E) universal NIPT screening.Main outcome measuresIncremental cost-effectiveness ratios (ICERs) per additional Down syndrome case terminated, univariate and probabilistic sensitivity analysis and cost-effectiveness acceptability curves were obtained.ResultsStrategy A detected the least number of Down syndrome cases. Compared with the cheapest Strategy B, Strategy D had the lowest ICER (incremental cost, US$98 944.85 per additional Down syndrome case detected). Strategy D had the highest probability of being cost-effective at the willingness-to-pay level between US$110 000.00 and US$535 000.00 per additional Down syndrome case averted. Strategy E would not be cost-effective unless the unit cost of the NIPT could be decreased to US$60.50.ConclusionIntroducing NIPT screening strategies was beneficial over the use of STS strategy alone. Evaluating maternal age in combination with the NIPT screening strategy performs better than China’s currently referral strategy in terms of cost-effectiveness and safety. Lowering the price of NIPT and optimising payment methods are effective measures to promote universal NIPT strategies in China.
Randomised, controlled, open label, multicentre clinical trial to explore safety and efficacy of hyperbaric oxygen for preventing ICU admission, morbidity and mortality in adult patients with COVID-19
Authors: Kjellberg Anders , Douglas Johan , Pawlik Michael T , Kraus Michael , Oscarsson Nicklas , Zheng Xiaowei , Bergman Peter , Frånberg Oskar , Kowalski Jan H , Nyren Sven Paul , Silvanius Mårten , Skold Magnus , Catrina Sergiu-Bogdan , Rodriguez-Wallberg Kenny A , Lindholm Peter 
Published: July 2021

IntroductionCOVID-19 may cause severe pneumonitis and trigger a massive inflammatory response that requires ventilatory support. The intensive care unit (ICU)-mortality has been reported to be as high as 62%. Dexamethasone is the only of all anti-inflammatory drugs that have been tested to date that has shown a positive effect on mortality. We aim to explore if treatment with hyperbaric oxygen (HBO) is safe and effective for patients with severe COVID-19. Our hypothesis is that HBO can prevent ICU admission, morbidity and mortality by attenuating the inflammatory response. The primary objective is to evaluate if HBO reduces the number of ICU admissions compared with best practice treatment for COVID-19, main secondary objectives are to evaluate if HBO reduces the load on ICU resources, morbidity and mortality and to evaluate if HBO mitigates the inflammatory reaction in COVID-19.Methods and analysisA randomised, controlled, phase II, open label, multicentre trial. 200 subjects with severe COVID-19 and at least two risk factors for mortality will be included. Baseline clinical data and blood samples will be collected before randomisation and repeated daily for 7 days, at days 14 and 30. Subjects will be randomised with a computer-based system to HBO, maximum five times during the first 7 days plus best practice treatment or only best practice treatment. The primary endpoint, ICU admission, is defined by criteria for selection for ICU. We will evaluate if HBO mitigates the inflammatory reaction in COVID-19 using molecular analyses. All parameters are recorded in an electronic case report form. An independent Data Safety Monitoring Board will review the safety parameters.Ethics and disseminationThe trial is approved by The National Institutional Review Board in Sweden (2020-01705) and the Swedish Medical Product Agency (5.1-2020-36673). Positive, negative and any inconclusive results will be published in peer-reviewed scientific journals with open access.Trial registrationNCT04327505. EudraCT number: 2020-001349-37.
‘You can’t start a car when there’s no petrol left’: a qualitative study of patient, family and clinician perspectives on implantable cardioverter defibrillator deactivation
Authors: Standing Holly , Thomson Richard G , Flynn Darren , Hughes Julian , Joyce Kerry , Lobban Trudie , Lord Stephen , Matlock Dan D , McComb Janet M , Paes Paul , Wilkinson Chris , Exley Catherine 
Published: July 2021

ObjectiveTo explore the attitudes towards implantable cardioverter defibrillator (ICD) deactivation and initiation of deactivation discussions among patients, relatives and clinicians.DesignA multiphase qualitative study consisting of in situ hospital ICD clinic observations, and semistructured interviews of clinicians, patients and relatives. Data were analysed using a constant comparative approach.SettingOne tertiary and two district general hospitals in England.ParticipantsWe completed 38 observations of hospital consultations prior to ICD implantation, and 80 interviews with patients, family members and clinicians between 2013 and 2015. Patients were recruited from preimplantation to postdeactivation. Clinicians included cardiologists, cardiac physiologists, heart failure nurses and palliative care professionals.ResultsFour key themes were identified from the data: the current status of deactivation discussions; patients’ perceptions of deactivation; who should take responsibility for deactivation discussions and decisions; and timing of deactivation discussions. We found that although patients and doctors recognised the importance of advance care planning, including ICD deactivation at an early stage in the patient journey, this was often not reflected in practice. The most appropriate clinician to take the lead was thought to be dependent on the context, but could include any appropriately trained member of the healthcare team. It was suggested that deactivation should be raised preimplantation and regularly reviewed. Identification of trigger points postimplantation for deactivation discussions may help ensure that these are timely and inappropriate shocks are avoided.ConclusionsThere is a need for early, ongoing and evolving discussion between ICD recipients and clinicians regarding the eventual need for ICD deactivation. The most appropriate clinician to instigate deactivation discussions is likely to vary between patients and models of care. Reminders at key trigger points, and routine discussion of deactivation at implantation and during advance care planning could prevent distressing experiences for both the patient and their family at the end of life.