bluuebunny/crossref_metadata_2025_split huggingface dataset:
Phase 2, randomized, placebo-controlled trial of dapirolizumab pegol in patients with moderate-to-severe active systemic lupus erythematosus
Authors: Furie Richard A , Bruce Ian N , Dörner Thomas , Leon Manuel Gustavo , Leszczyński Piotr , Urowitz Murray , Haier Birgit , Jimenez Teri , Brittain Claire , Liu Jiajun , Barbey Catherine , Stach Christian 
Published: May 2021

Abstract

Objective
To evaluate the dose–response, efficacy and safety of dapirolizumab pegol (DZP) in patients with SLE.

Methods
Adults with moderately to severely active SLE (SLEDAI-2K score ≥6 and ≥1 BILAG A or ≥2 BILAG B domain scores), receiving stable CS (≤40 mg/day prednisone-equivalent), antimalarial or immunosuppressant drugs were included. Patients with stable LN (proteinuria ≤2 g/day) not receiving high-dose CS or CYC were permitted entry. Randomized patients received placebo or i.v. DZP (6/24/45 mg/kg) and standard-of-care (SOC) treatment every 4 weeks to week 24, after which patients received only SOC to week 48. The primary objective was to establish a dose–response relationship based on week 24 BILAG-Based Composite Lupus Assessment (BICLA) responder rates.

Results
All DZP groups exhibited improvements in clinical and immunological outcomes vs placebo at week 24; however, BICLA responder rates did not fit pre-specified dose–response models [best-fitting model (Emax): P = 0.07]. Incidences of serious treatment-emergent adverse events across DZP groups were low and similar to placebo. Following DZP withdrawal, SLEDAI-2K, physician’s global assessment (PGA), BILAG, and Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) scores stabilized; BICLA and SLE Responder Index (SRI-4) responder rates declined (likely due to interventions with disallowed escape medications), BILAG flares increased, and immunologic parameters returned towards baseline.

Conclusions
Although the primary objective was not met, DZP appeared to be well tolerated, and patients exhibited improvements across multiple clinical and immunological measures of disease activity after 24 weeks relative to placebo. The potential clinical benefit of DZP warrants further investigation.
Effects of compassion training on brain responses to suffering others
Authors: Ashar Yoni K , Andrews-Hanna Jessica R , Halifax Joan , Dimidjian Sona , Wager Tor D 
Published: May 2021

Abstract
Compassion meditation (CM) is a promising intervention for enhancing compassion, although its active ingredients and neurobiological mechanisms are not well-understood. To investigate these, we conducted a three-armed placebo-controlled randomized trial (N = 57) with longitudinal functional magnetic resonance imaging (fMRI). We compared a 4-week CM program delivered by smartphone application with (i) a placebo condition, presented to participants as the compassion-enhancing hormone oxytocin, and (ii) a condition designed to control for increased familiarity with suffering others, an element of CM which may promote compassion. At pre- and post-intervention, participants listened to compassion-eliciting narratives describing suffering others during fMRI. CM increased brain responses to suffering others in the medial orbitofrontal cortex (mOFC) relative to the familiarity condition, p &lt; 0.05 family-wise error rate corrected. Among CM participants, individual differences in increased mOFC responses positively correlated with increased compassion-related feelings and attributions, r = 0.50, p = 0.04. Relative to placebo, the CM group exhibited a similar increase in mOFC activity at an uncorrected threshold of P &lt; 0.001 and 10 contiguous voxels. We conclude that the mOFC, a region closely related to affiliative affect and motivation, is an important brain mechanism of CM. Effects of CM on mOFC function are not explained by familiarity effects and are partly explained by placebo effects.
PULSATILE FILLING OF DILATED CHOROIDAL VESSELS IN MACULAR WATERSHED ZONES
Authors: Gemmy Cheung Chui Ming , Teo Kelvin Yi Chong , Spaide Richard F. 
Published: May 2021

Purpose:
To describe pulsatile filling of dilated choroidal veins in the watershed zones and propose an alteration in choroidal perfusion pressure.

Methods:
Retrospective review of original and digital subtraction indocyanine green angiography.

Results:
We observed pulsating blood flow within choroidal vein segments in the posterior pole in 14 eyes (diagnosis of polypoidal choroidal vasculopathy, central serous chorioretinopathy, or neovascular age-related macular degeneration). Pulsating dye front was observed in single or multiple large choroidal vein(s) in a location that is ordinarily a watershed zone between the segmental areas of venous drainage, and vessels proximal and distal were often dilated. The pulsatile venous segments filled more slowly than the neighboring veins. In digital subtraction indocyanine green angiography, the dye front advanced in an incremental fashion or oscillated in a back-and-forth manner during several cardiac cycles during the filling of these larger choroidal veins. With indocyanine green angiography, we observed dilated choroidal veins that violated the macula watershed zone, localized bulbous dilations, and arteriole-over-vein crossings with apparent compression.

Conclusion:
These novel observations suggest the pressure gradient for flow in the affected veins varied from low gradients when the filling was slow to high gradients when the filling was faster. The vessels violated the physiological watershed zone and seem to function as anastomoses between the ordinarily segmented venous drainage of the choroid. The dilated segments may result in pooling of venous blood as part of venous outflow abnormalities that may be operative in these diseases.
Phacofragmentation as an Effective Tool for Removal of Silicone Oil Adherent to Posterior Chamber Intraocular Lenses
Authors: Klisovic Nicholas D. , Suelves-Cogollos Ana 
Published: May 2021

Background/Purpose:
To assess usefulness of phacofragmentation probe in the removal of silicone oil (SO) adherent to intraocular lenses (IOLs) during a SO removal procedure.

Methods:
A 20-gauge (G) phacofragmentation probe was used to emulsify and remove SO adherent to IOLs during 23-G vitrectomy for SO removal. The superotemporal 23-G cannula was removed, and 20-G sclerotomy was made by using a 20-G MVR blade.

Results:
In all cases used, SO adherent to the posterior surface of posterior capsule IOLs and anterior chamber IOLs was easily removed using a phacofragmentation probe. No intraoperative complications or IOL damage were noted.

Conclusion:
We describe a simple, quick and reliable method of SO removal from all types of IOLs by using a phacofragmentation probe during SO removal surgery. This simple method can prevent IOL removal and replacement due to adherent SO bubbles in pseudophakic eyes that were previously filled with SO.
Trauma Tertiary Survey: Trauma Service Medical Officers and Trauma Nurses Detect Similar Rates of Missed Injuries
Authors: Williamson Frances , Grant Kerena , Warren Jacelle , Handy Michael 
Published: May 2021

Background:
Trauma tertiary surveys (TTSs) can improve patient outcomes by identifying missed injuries following initial trauma reception and resuscitation. Most TTSs are conducted by medical officers despite the multidisciplinary team approach of modern trauma care.

Objective:
The study aim was to assess the accuracy of detecting missed injuries when the TTS was performed by specialist trauma nursing staff, rather than trauma service medical officers (TSMOs).

Methods:
A prospective, convenience sample of adult trauma patients admitted to a tertiary trauma center and attended by the trauma service between October 2015 and August 2018 was obtained. For this sample, a TTS was completed by both the TSMO and the trauma nurse (TN). The number of radiological investigations ordered and missed injuries identified were compared between the two clinicians. Additional injuries were graded using the Clavien–Dindo system.

Results:
The study sample consisted of 165 patients with a dual TTS, for which at least one team member requested 35 additional radiological investigations. There was fair agreement (κ = 0.36) between the TN and the TSMO in requesting additional radiological investigations. Ten missed injuries were identified by TN-initiated review (n = 24), and 4 missed injuries were identified by TSMO-initiated review (n = 21). Injuries identified following TTSs ranged in severity grading from 0 to 3.

Conclusions:
Performance of the TN on the TTS in the identification of missed injuries is similar to that of the TSMO. Trauma nurses use an appropriate and rationalized approach to ordering additional radiological investigations and contribute a valuable addition to trauma patient care.
Population Vaccine Effectiveness and its Implication for Control of the Spread of COVID-19 in the US
Authors: Hu Zixin , Ge Qiyang , Luo Li , Xu Tao , Zhang Kai , Lu Henry H , Li Wei , Boerwinkle Eric , Jin Li , Xiong Momiao 
Published: May 2021

AbstractRealized vaccine efficacy in population is highly different from the individual vaccine efficacy measured in clinical trial. The realized vaccine efficacy in population is substantially affected by the vaccine age-stratified prioritization strategy, population age-structure, non-pharmaceutical intervention (NPI). We proposed a population vaccine efficacy which integrated individual vaccine efficacy, vaccine prioritization strategy and NPI to measure and monitor the control of the spread of COVID-19. We found that 11 states in the US had low population vaccine efficacy and 20 states had high population efficacy. We demonstrated that although the proportion of the population who received at least one dose of COVID-19 vaccine across 11 low population vaccine efficacy states, in general, was greater than that in 20 high population vaccine efficacy states, the 11 low population vaccine efficacy states experienced the recent COVID-19 surge, while the number of new cases in the 20 high population vaccine efficacy states exponentially decreased. We demonstrated that the proportions of adults in the population across 50 states were significantly associated with the forecasted ending date of the COVID-19. We show that it was recent low proportion of adults vaccinated in Michigan that caused its COVID-19 surge. Using population vaccination efficacy, we forecasted that the earliest COVID-19 ending states were Hawaii, Arizona, Arkansas, and California (in the end of June, 2021) and the last COVID-19 ending states were Colorado, New York and Michigan (in the Spring, 2022).
Effect of commuting on the risk of COVID-19 and COVID-19-induced anxiety
Authors: Ando Hajime , Ikegami Kazunori , Nagata Tomohisa , Tateishi Seiichiro , Eguchi Hisashi , Tsuji Mayumi , Matsuda Shinya , Fujino Yoshihisa , Ogami Akira ,   CORoNaWork Project
Published: May 2021

AbstractBackgroundTo prevent the spread of coronavirus disease (COVID-19), it is important to avoid 3Cs (closed spaces, crowded places, and close-contact settings). However, the risk of contact with an unspecified number of people is inevitable while commuting to and from work. In this study, we investigated the relationship between commuting, and the risk of COVID-19 and COVID-19-induced anxiety.MethodsAn internet-based questionnaire survey was conducted to obtain a dataset from 27036 respondents. One-way commuting time was evaluated using a five-case method. The commuting distance was estimated using zip codes of the home and workplace. Logistic regression analysis was performed with the following outcomes: COVID-19 risk, close contact, infection anxiety, and infection anxiety due to commuting. Commuting distance and commuting time were analyzed separately in the model. We excluded participants with incalculable commuting distance, commuting distance exceeding 300 km, commuting distance of 0 km, or who telecommuted at least once a week.ResultsThe total number of participants included in the analysis was 14038. The adjusted odds ratios (aORs) of using public transportation for severe acute respiratory syndrome coronavirus 2 infection were 4.17 (95% confidence interval [CI]: 2.51-6.93) (commuting time) and 5.18 (95% CI: 3.06-8.78) (commuting distance). The aOR of COVID-19 diagnosis decreased significantly with increasing commuting distance. The aORs of using public transportation to infection anxiety were 1.44 (95% CI: 1.31-1.59) (commuting time) and 1.45 (95% CI: 1.32-1.60) (commuting distance). The longer the commuting time, the more the aOR increased..ConclusionsCOVID-19 risk, close contact, and infection anxiety were all associated with the use of public transportation during commuting. Both commuting distance and time were associated with infection anxiety due to commuting, and the strength of the association increased with increase in commuting time distance. Since transportation by commuting is associated with COVID-19 risk and anxiety, we recommend the use of telecommuting and other means of work.
Methodological quality of recommendations on vitamin D and calcium – a systematic review of bone health guidelines
Authors: Dai Zhaoli , McKenzie Joanne E , McDonald Sally , Baram Liora , Page Matthew J , Allman-Farinelli Margaret , Raubenheimer David , Bero Lisa A. 
Published: May 2021

AbstractThere are numerous guidelines developed for bone health. Yet it is unclear the differences in guideline development methods explain the variability in recommendations for vitamin D and calcium intakes. The objective of this systematic review was to collate and compare recommendations for vitamin D and calcium across bone health guidelines, assess methods used to form the recommendations, and explore which methodological factors were associated with these guideline recommendations. We searched MEDLINE, EMBASE, CINAHL and other databases indexing guidelines to identify records in English between 2009 and 2019. Guidelines or policy statements on bone health or osteoporosis prevention for generally healthy adults aged ≥40 years were eligible for inclusion. Two reviewers independently extracted recommendations on daily vitamin D and calcium intake, supplement use, serum 25 hydroxy vitamin D [25(OH)D] level, and sunlight exposure; assessed guideline development methods against 25 recommended criteria in the World Health Organization (WHO) Handbook for Guideline Development; and, identified types of evidence underpinning the recommendations. We included 47 eligible guidelines from 733 records: 74% of the guidelines provided vitamin D (200∼600-4000 IU/day) and 70% provided calcium (600-1200 mg/day) recommendations; 96% and 88% recommended vitamin D and calcium supplements, respectively; and 70% recommended a specific 25(OH)D concentration. The mean of meeting 25 WHO methodological criteria per guideline was 10 (95% CI: 9-12; interquartile range: 6-15). There was uncertainty in the associations between the methodological criteria and the proportion of guidelines that provided recommendations on daily vitamin D or calcium. Various types of evidence, ranging from previous bone guidelines, nutrient reference reports, systematic reviews, observational studies, to perspectives/editorials were used to underpin the recommendations. In conclusion, there is considerable variability in vitamin D and calcium recommendation and in guideline development methods in bone health guidelines. Effort is required to strengthen methodological rigor of guideline development and utilize the best available evidence to underpin public health nutrition.HighlightsThis systematic review provides evidence on the variabilities in vitamin D and calcium recommendations as well as guideline development methods in 47 bone health guidelines globally.Our findings point to continued effort to utilize the best available evidence to underpin nutrition recommendations and strengthen methodological rigor of guideline development in bone health guidelines.Registration of protocolPROSPERO: CRD42019126452
Tool to assess risk of bias due to missing evidence in network meta-analysis (ROB-MEN): elaboration and examples
Authors: Chiocchia Virginia , Nikolakopoulou Adriani , Higgins Julian PT , Page Matthew J , Papakonstantinou Theodoros , Cipriani Andrea , Furukawa Toshi A , Siontis George CM , Salanti Georgia 
Published: May 2021

AbstractSelective outcome reporting and publication bias threaten the validity of systematic reviews and meta-analysis and ultimately can affect clinical decision-making. A rigorous methodology to evaluate the impact of this bias on the meta-analysis results of a network of interventions is still lacking. We present a tool to assess the Risk Of Bias due to Missing Evidence in Network meta-analysis (ROB-MEN) by expanding the methods previously developed for pairwise meta-analysis (ROB-ME, http://www.riskofbias.info).ROB-MEN first evaluates the risk of bias due to missing evidence for each pairwise comparison separately. This step considers possible bias due to the presence of studies with unavailable results (known unknowns) and the potential for unpublished studies (unknown unknowns). The second step combines the overall judgements about the risk of bias due to missing evidence in pairwise comparisons with the percentage contribution of direct comparisons on the NMA estimates, the presence or absence of small-study effects, as evaluated by network meta-regression, and any bias from unobserved comparisons. Then, a level of “low risk”, “some concerns” or “high risk” for the bias due to missing evidence is assigned to each NMA estimate, which is our tool’s final output.We describe the methodology of ROB-MEN step-by-step using an illustrative example from a published NMA of non-diagnostic modalities for the detection of coronary artery disease in patients with low risk acute coronary syndrome. We also report a full application of the tool on a larger and more complex published network of 18 drugs from head-to-head studies for the acute treatment of adults with major depressive disorder. The ROB-MEN tool is the first tool for evaluating the risk of bias due to missing evidence in NMA and it is applicable to networks of all sizes and geometry.
Infants are more susceptible to COVID-19 than children
Authors: Leung Char 
Published: May 2021

AbstractAngiotensin-converting enzyme 2 (ACE2) has been found to mediate the host cell entry of SARS-CoV-2 that causes COVID-19. However, the link between ACE2 and the observed susceptibility of SARS-CoV-2 infection remains elusive. In contrast, observational studies can help identify the susceptibility biomarker of SARS-CoV-2 infection, those associated with age for example. Data of all PCR tests performed in the state of São Paulo of Brazil were gathered from the government database and were analyzed using multivariate logistic regression. Adjusted odds ratios for positive test results were calculated with the adjustment of age, gender, and comorbidities. Over 1.7 million test results were included in the study of which 38% were positive. Elderly was most vulnerable to SARS-CoV-2 infection. While underages were less susceptible than adults aged below 60 years, susceptibility was not equal among different pediatric groups. It is found that age and susceptibility to SARS-CoV-2 infection are not inversely related, but U-shaped, with infants more susceptible than children. Biomarkers that are linearly associated with age cannot explain the reduced susceptibility in children. These include lymphocyte count and cross-reactive antibodies against other coronaviruses that offers cross-protection. The expression level of ACE2 may still be able to explain but further investigations are needed.
Lipid-Modulating Agents for Prevention or Treatment of COVID-19 in Randomized Trials
Authors: Talasaz Azita H. , Sadeghipour Parham , Aghakouchakzadeh Maryam , Dreyfus Isaac , Kakavand Hessam , Ariannejad Hamid , Gupta Aakriti , Madhavan Mahesh V. , Van Tassell Benjamin W. , Jimenez David , Monreal Manuel , Vaduganathan Muthiah , Fanikos John , Dixon Dave L , Piazza Gregory , Parikh Sahil A. , Bhatt Deepak L. , Lip Gregory YH , Stone Gregg W. , Krumholz Harlan M. , Libby Peter , Goldhaber Samuel Z. , Bikdeli Behnood 
Published: May 2021

ABSTRACTCoronavirus disease 2019 (COVID-19) is associated with systemic inflammation, endothelial activation, and multi-organ manifestations. Lipid modulating agents may be useful in treating patients with COVID-19. They may inhibit viral entry by lipid raft disruption or ameliorate the inflammatory response and endothelial activation. In addition, dyslipidemia with lower high-density lipoprotein cholesterol and higher triglycerides portends worse outcome in patients with COVID-19. Upon a systematic search, 40 RCTs with lipid modulating agents were identified, including 17 statin trials, 14 omega-3 fatty acids RCTs, 3 fibrates RCTs, 5 niacin RCTs, and 1 dalcetrapib RCT for management or prevention of COVID-19. This manuscript summarizes the ongoing or completed randomized controlled trials (RCTs) of lipid modulating agents in COVID-19 and the implications of these trials for patient management.
Protocol of the COVID-19 Health Adherence Research in Scotland Vaccination (CHARIS-V) study: Understanding the influence of vaccination decisions on adherence to transmission-reducing behaviours in a prospective longitudinal study of the Scottish Population
Authors: Maciver Marina , Den Daas Chantal , Johnston Marie , Dixon Diane , Hubbard Gill 
Published: May 2021

ABSTRACTIntroductionThe global population has been asked to live under tight restrictions to slow the spread of SARS-CoV-2. Transmission-reducing behaviours (TRBs), (physical distancing, hand washing, wearing a face covering) were introduced by governments in 2020 prior to vaccine availability. People should maintain TRBs throughout the vaccination programme, because there is much uncertainty about the vaccine efficacy, immunity duration, whether there will be the requirement for booster vaccines, and whether vaccinated individuals can be carriers of the virus. This study will explore the effect of the vaccination programme in Scotland on adherence to TRBs.Methods and analysisTelephone interviews will be conducted with participants from the nationally representative CHARIS project that agreed to be contacted for further research. Approximately 200, ten-minute telephone interviews will be conducted. Data will be collected on vaccine uptake or intention and adherence to TRBs. Univariate and multivariate logistic regression analyses and moderation analyses will be used to analyse the data collected. Ethical approval was granted by the Life Sciences and Medicine School Ethics Review Board (SERB) at the University of Aberdeen.DiscussionCHARIS-V will provide an understanding of the effect of the vaccination programme on adherence to TRBs in Scotland. Findings should be useful to governments and public health agencies for the current COVID-19 pandemic and vaccination programme and assist in the management of any future outbreaks.