bluuebunny/crossref_metadata_2025_split huggingface dataset:
Biosimilar SB11 versus reference ranibizumab in neovascular age-related macular degeneration: 1-year phase III randomised clinical trial outcomes
Authors: Bressler Neil M , Veith Miroslav , Hamouz Jan , Ernest Jan , Zalewski Dominik , Studnička Jan , Vajas Attila , Papp András , Vogt Gabor , Luu James , Matuskova Veronika , Yoon Young Hee , Pregun Tamás , Kim Taehyung , Shin Donghoon , Oh Inkyung , Jeong Hansol , Kim Mercy Yeeun , Woo Se Joon 
Published: October 2021

Background/AimsTo provide longer-term data on efficacy, safety, immunogenicity and pharmacokinetics (PK) of ranibizumab biosimilar SB11 compared with the reference ranibizumab (RBZ) in patients with neovascular age-related macular degeneration (nAMD).MethodsSetting: Multicentre.Design: Randomised, double-masked, parallel-group, phase III equivalence study.Patient population: ≥50 years old participants with nAMD (n=705), one ‘study eye’. Intervention: 1:1 randomisation to monthly intravitreal injection of 0.5 mg SB11 or RBZ.Main outcome measures: Visual efficacy endpoints, safety, immunogenicity and PK up to 52 weeks.ResultsBaseline and disease characteristics were comparable between treatment groups. Of 705 randomised participants (SB11: n=351; RBZ: n=354), 634 participants (89.9%; SB11: n=307; RBZ: n=327) completed the study until week 52. Previously reported equivalence in primary efficacy remained stable up to week 52 and were comparable between SB11 and RBZ. The adjusted treatment difference between SB11 and RBZ in full analysis set at week 52 of change from baseline in best-corrected visual acuity was −0.6 letters (90% CI −2.1 to 0.9) and of change from baseline in central subfield thickness was −14.9 µm (95% CI –25.3 to –4.5). The incidence of ocular treatment-emergent adverse events (TEAEs) (SB11: 32.0% vs RBZ: 29.7%) and serious ocular TEAE (SB11: 2.9% vs RBZ: 2.3%) appeared comparable between treatment groups, and no new safety concerns were observed. The PK and immunogenicity profiles were comparable, with a 4.2% and 5.5% cumulative incidence of antidrug antibodies up to week 52 for SB11 and RBZ, respectively.ConclusionsLonger-term results of this study further support the biosimilarity established between SB11 and RBZ.
Relationship between vision impairment and employment
Authors: Chai Yi Xuen , Gan Alfred Tau Liang , Fenwick Eva K , Sui Abraham Y , Tan Benjamin Kye Jyn , Quek Debra Q Y , Qian Chaoxu , Wong Tien Yin , Cheng Ching-Yu , Lamoureux Ecosse Luc , Man Ryan Eyn Kidd 
Published: October 2021

AimsTo examine the relationship between vision impairment (VI) and employment outcomes in a multiethnic Asian population.MethodsWe included 7608 Asian individuals aged ≥40 years (mean (SD) age: 58.4 (10.3) years; 64.8% male) from the Singapore Epidemiology Eye Disease Study (response rate: 78.8%), a population-based cohort study (mean follow-up period: 6.2 years). Presenting visual acuity (VA) was assessed using a logarithm of the minimum angle of resolution (logMAR) chart, with VI defined as mild (VA >0.3 to <0.6 logMAR) and moderate to severe (VA ≥0.6 logMAR). Self-reported employment statuses at both baseline and follow-up were used as outcomes. Underemployment was defined as a decline in occupational skill level, categorised by International Standard Classification of Occupations, at follow-up compared with baseline. Multinomial logistic regression models were used to determine independent associations between VI and various employment outcomes, adjusted for variables that were found to significantly differ across employment statuses.ResultsPresenting VI was prevalent in 20.2% (N=1536) of participants. Compared with those without VI, participants with mild and moderate to severe VI were more likely to be unemployed at baseline (OR 1.47, 95% CI 1.15 to 1.87, p=0.002 and 2.74, 95% CI 1.94 to 3.89, p<0.001, respectively). At follow-up, participants with any VI at baseline were more likely to be underemployed (OR 1.46, 95% CI 1.03 to 2.05, p=0.033).ConclusionVI, even when mild, is associated with unemployment and underemployment. Future studies should investigate whether visual interventions could be used as part of a multipronged strategy to improve employment outcomes for the population.
Cost-effectiveness of rapid laboratory-based mass-spectrometry diagnosis of bloodstream infection: evidence from the RAPIDO randomised controlled trial
Authors: Dixon Padraig , Hollingworth William , Pike Katie , Reynolds Rosy , Stoddart Margaret , MacGowan Alasdair 
Published: October 2021

Objectives and interventionBloodstream infection, the presence of viable micro-organisms in the blood, is a prevalent clinical event associated with substantial mortality. Patient outcomes may be improved when the causative micro-organism is identified quickly. We assessed the cost-effectiveness of rapid microbial identification by matrix-assisted laser desorption/ionisation time-of-flight (MALDI-TOF) mass spectrometry.DesignEconomic evaluation alongside a randomised multicentre trial (RAPIDO: RAPId Diagnosis on Outcome) assessing the impact of rapid identification by MALDI-TOF spectrometry.SettingAdult inpatients with bloodstream infections at seven National Health Service hospital trusts in England and Wales.Primary outcomeNet monetary benefit, estimated as incremental costs compared with incremental 28-day survival, of rapid identification by MALDI-TOF spectrometry compared with conventional identification.MethodsPatients were randomised (1:1) to receive diagnosis by conventional methods of microbial identification (conventional arm) only or by MALDI-TOF spectrometry in addition to conventional identification (RAPIDO arm).ResultsData from 5550 patients were included in primary analysis. Mean imputed costs in 2018/2019 prices per patient were lower by £126 in the RAPIDO arm (95% CI −£784 to £532) but the proportion of patients alive at day 28 was lower (81.4% vs 82.3%). The probability of cost-effectiveness of MALDI-TOF was <0.5 at cost-effectiveness thresholds between £20 000 and £50 000.ConclusionsAdjunctive MALDI-TOF diagnosis was unlikely to be cost-effective when measured as cost per death avoided at 28 days. However, the differences between arms in cost and effect were modest, associated with uncertainty and may not accurately reflect ‘real-world’ routine use of MALDI-TOF technology in this patient group.Trial registration numbersISRCTN97107018/UKCRN 11978.
Prevalence and correlates of pre-diabetes in adults of mixed ethnicities in the South African population: a systematic review and meta-analysis protocol
Authors: Sosibo Aubrey Mbulelo , Mzimela Nomusa Christina , Ngubane Phikelelani Siphosethu , Khathi Andile 
Published: October 2021

IntroductionPre-diabetes is a metabolic condition characterised by moderate glycaemic dysregulation and is a front-line risk factor to multiple metabolic complications such as overt diabetes. To the best of our knowledge, this will be the first systematic review and meta-analysis that focuses on generating a comprehensive pooling of studies that report on the pre-diabetes prevalence in South Africa. Therefore, the review’s purpose will be to screen and elect reports that can be used to synthesise and provide the best estimate prevalence and correlate of pre-diabetes in the South African population.Methods and analysisTo determine the prevalence and correlates of pre-diabetes in South African, we will search PubMed, Embase and African Journal online for published or unpublished studies reporting the prevalence of pre-diabetes in South Africa starting from the year 2000 to 2020. Studies will be assessed for eligibility by checking if they meet the inclusion criteria. Eligible studies will undergo data extraction and risk of bias assessment. We will perform a subgroup analysis to detect probable causes of heterogeneity.Ethics and disseminationThe review will not require ethics clearance because non-identifiable data will be used. The review outcomes will give more insight into the current burden that pre-diabetes has in South Africa.PROSPERO registration numberCRD42020182430.
Systematic review of occupational hazards at postharvest grain operations
Authors: Bellochio Sabrina Dalla Corte , Coradi Paulo Carteri 
Published: October 2021

IntroductionAgriculture stands out in relation to the high number of occupational incidents and diseases. In this sense, grains postharvest operations, such as receiving, precleaning, drying, storage and shipping the grains, are highlighted in the number of injuries and fatalities.AimTo identify and extract qualitative and quantitative data related to the main occupational hazards present in grains postharvest operations at preprocessing and storage facilities.MethodsA systematic review was carried out in the databases of Science Direct, Scopus and Web of Science for papers published between 1980 and 2019. The abstract should have described a study related to any occupational hazard (physical, chemical, biological, ergonomic and mechanical) and at least one of the occupational hazards should be related to any postharvest operations.Results and discussionsIn total, 42% of 38 analysed papers were published between 2015 and 2019. Three journals were responsible for 45% of publications related to occupational hazards present in grains postharvest operations. The most part of analysed publications related to confined spaces, grain entrapment, machine entanglement and falls hazards are related to Purdue University’s Agricultural Safety and Health Program which applied research in occupational safety at grains postharvest.ConclusionsThe creation of standardised internationals can collaborate to reduce occupational risks in grain storage units. It is suggested the development of monitoring technologies to obtain real-time information on noise, dust, gases and heat in postharvest operations and equipment. The use of intelligent algorithms can create prevention mechanisms for possible occupational risks and avoid injuries to employees.
Missing cases of injury death: use of quantitative methods and case reviews to inform future improvements in case definition
Authors: Cryer Colin , Gulliver Pauline , Davie Gabrielle , Samaranayaka Ari , Fowler Christine 
Published: October 2021

BackgroundKnowledge of fatal injuries is required to inform prevention activities. Where hospital patients with an injury principal diagnosis (PDx) died and were certified to a medical underlying cause of death (UCoD), there is the potential to underestimate injury mortality. We sought to characterise injury/non-injury (NI) mismatches between PDx and UCoD by identifying which subgroups had small/large mismatches, and to understand why mismatches had occurred using informative examples.MethodHospital records (n=10 234) with a PDx of injury were linked to the mortality collection using a unique personal identifier. Percentages UCoD coded to a NI were tabulated, for three follow-up periods and by selected variables. Additionally, we reviewed a sample of 70 records for which there was a mismatch.Results%NIs were 39%, 66% and 77% for time from injury to death of <1 week, <90 days and <1 year, respectively. Variations in %NI were found for all variables. Illustrative examples of 70 medical UCoD deaths showed that for 12 cases the injury event was unequivocally judged to have resulted in premature death. A further 16 were judged as injury deaths using balance of probability arguments.ConclusionThere is variation in rates of mismatch between PDx of injury and UCoD of NI. While legitimate reasons exist for mismatches in certain groups, a material number of injury deaths are not captured using UCoD alone; a new operational definition of injury death is needed. Early solutions are proposed. Further work is needed to investigate operational definitions with acceptable false positive and negative detection rates.
Automatic oxygen titration versus constant oxygen flow rates during walking in COPD: a randomised controlled, double-blind, crossover trial
Authors: Schneeberger Tessa , Jarosch Inga , Leitl Daniela , Gloeckl Rainer , Hitzl Wolfgang , Dennis Clancy John , Geyer Tatjana , Criée Carl-Peter , Koczulla Andreas Rembert , Kenn Klaus 
Published: October 2021

RationaleIn patients with COPD, oxygen (O2)-supplementation via a constant flow oxygen system (CFOS) can result in insufficient oxygen saturation (SpO2<90%) during exercise. An automatically titrating O2-system (ATOS) has been shown to be beneficial compared with an untitrated CFOS, however, it is unknown if ATOS is superior to CFOS, titrated during exercise as stipulated by guidelines. The aim was to investigate the effects of ATOS compared with titrated CFOS on walking capacity in people with hypoxaemic COPD.MethodsFifty participants completed this prospective randomised controlled, double-blind, crossover trial. Participants performed two endurance shuttle walk tests (ESWTs) with: (1) exercise titrated CFOS (ESWTCFOS) and (2) ATOS targeting an SpO2of 92% (ESWTATOS). Primary outcome measure was walking time. Secondary measures were SpO2, transcutaneous-PCO2(TcPCO2), respiratory rate (RR), heart rate (HR) at isotime (end of shortest ESWT) with blood gases and dyspnoea at rest and end exercise.ResultsParticipants (median (IQR): age 66 (59, 70) years, FEV128.8 (24.8, 35.1) % predicted, PO254.7 (51.0, 57.7) mm Hg, PCO244.2 (38.2, 47.8) mm Hg) walked significantly longer with ESWTATOSin comparison to ESWTCFOS(median effect (95% CI) +144.5 (54 to 241.5) s, p<0.001). At isotime, SpO2was significantly higher (+3 (95% CI 1 to 4) %, p<0.001) with ATOS while TcPCO2, RR and HR were comparable. End exercise, PO2(+8.85 (95% CI 6.35 to 11.9) mm Hg) and dyspnoea (−0.5 (95% CI −1.0 to −0.5) points) differed significantly in favour of ATOS (each p<0.001) while PCO2was comparable.ConclusionIn patients with hypoxaemia with severe COPD the use of ATOS leads to significant, clinically relevant improvements in walking endurance time, SpO2, PO2and dyspnoea with no impact on PCO2.Trial registration numberNCT03803384.
Qubit-based momentum measurement of a particle
Authors: Konrad Bernd , Di Pumpo Fabio , Freyberger Matthias 
Published: October 2021

Abstract
An early approach to include pointers representing measurement devices into quantum mechanics was given by von Neumann. Based on this idea, we model such pointers by qubits and couple them to a free particle, in analogy to a classical time-of-flight arrangement. The corresponding Heisenberg dynamics leads to pointer observables whose expectation values allow us to reconstruct the particle’s momentum distribution via the characteristic function. We investigate different initial qubit states and find that such a reconstruction can be considerably simplified by initially entangled pointers.

Graphical abstract
Risk Factors of Enterostomy Infection Caused by Bacterial Infection through Mathematical Modelling-Based Information Data Analysis
Authors: Li Jing , Liu Xiaoyu , Chen Jun 
Published: October 2021

Objective. The study aimed to explore the risk factors of infections after enterostomy through the information data analysis method based on a mathematical model. Methods. 156 cases of enterostomy patients admitted to the hospital were retrospectively selected as the study subjects and were divided into the infection group (17 cases) and normal group (139 cases) according to whether they were complicated with infections. Then, the factors of infection and related indexes before and after surgery were analyzed, and the data of the whole hospital were estimated by mathematical modelling. Results. The length of hospital stay in the infection group was 21 ± 11.2 days, which is longer than 10.1 ± 7.1 days in the normal group (

P

< 0.05). The incidence of anastomotic fistula in the infection group was 14%, which is higher than 2% in the normal group. The mortality rate of infection group (44%) was higher than that of normal group (5%). In the infection group, the incidence of single-cavity stoma (69%) was higher than that of double-cavity stoma (31%), the nosocomial infection rate (11%) was significantly higher compared with out of hospital (2%), and there were significant differences (

P

< 0.05). Conclusions. Patients with malnutrition and hypoproteinemia before enterostomy, the use of gastric tube and ventilator in the treatment, single lumen stomy in the operation, and the occurrence of anastomotic fistula were more likely to have concurrent infections.
A Novel Developed Bioactive Composite Resin Containing Silver/Zinc Oxide (Ag/ZnO) Nanoparticles as an Antimicrobial Material against Streptococcus mutans, Lactobacillus, and Candida albicans
Authors: Kachoei Mojgan , Divband Baharak , Rahbar Mahdi , Esmaeilzadeh Mahdiyeh , Ghanizadeh Milad , Alam Mostafa 
Published: October 2021

Aim. The objectives of this study were to develop a new bioactive composite resin containing silver/zinc oxide (Ag/ZnO) nanoparticles and investigate the effects on mechanical, cytotoxic, biocompatibility, and antimicrobial properties. Materials and Methods. Disc-shaped specimens were prepared from composite with and without nanoparticles in separate culture media containing Streptococcus mutans, Lactobacillus, and Candida albicans. Bracket bonding evaluation was performed on composite without nanoparticles (O), composite containing ZnO (Z) nanoparticles, composite containing ZnO nanoparticles and silver ions (A&Z), and composite containing Ag/ZnO nanoparticles (AZ) synthesized using optical precipitation. Results. Composite resin with nanoparticles (AZ, A&Z, and Z) showed significant antimicrobial properties (

P

< 0.05). The mean shear bond strength of A&Z composite resin (13.61 ± 0.73 MPa) was significantly less than that of conventional composite resin (19.03 ± 4.12 MPa) (

P

< 0.05). In addition, the mean shear bond strength of AZ composite resin (20.49 ± 1.03 MPa) was significantly higher than that of Z (16.35 ± 1.03 MPa) and A&Z composite resins. Conclusions. Incorporation of ZnO nanoparticles and their compounds into orthodontic composite resins induced antibacterial properties against oral pathogens, and of all these nanoparticles, the AZ group exhibited the best antimicrobial activity and highest shear bond strength.
E-customer loyalty in gamified trusted store platforms: a case study analysis in Iran
Authors: Hosseini Ehsan , Rezvani Mohammad Hossein 
Published: October 2021

Customer satisfaction, trust, and loyalty are the three most fundamental elements of e-marketing. Previous researchers have noted that satisfaction is a key factor in commanding loyalty. However, the relationship between satisfaction, trust, and loyalty is strongly dependent on the type of platform provided by digital stores. On the other hand, gamification in E-businesses has grown rapidly in recent years. In this context, it is necessary to explore the effects of gamification on e-customer satisfaction and loyalty. In this paper, it is argued that customer satisfaction alone cannot inspire loyalty. Simply speaking, customers’ satisfaction with gamified services can lead to developing trust and, in turn, loyalty. This research also presents a thorough review of the effect of store-related motivational factors, such as gamification, on trust. These factors include moderator and mediator variables. The hypotheses of this study are considered in the context of one of the largest online retail stores in Iran which enjoys a large market share in the Middle East. To this end, Lawshe content validity ratio is utilized and expert opinions are applied to the proposed model. Evaluation results, obtained through the smartPLS, established the robustness of our modeling in terms of reliability analysis, significance level analysis, discriminant validity analysis, coefficient of determination, model fitting, and cross-validation.
Advanced Baseline Imager Cloud-Top Trajectories and Properties of Electrified Snowfall Flash Initiation
Authors: Harkema Sebastian S. , Berndt Emily B. , Mecikalski John R. , Cordak Alana 
Published: October 2021

AbstractUsing gridded and interpolated Derived Motion Winds from the Advanced Baseline Imager (ABI), a Lagrangian cloud-feature tracking technique was developed to create, and document trajectories associated with electrified snowfall and changes in cloud characteristics leading up to the initiation of lightning, respectively. This study implemented the thundersnow detection algorithm and defined thundersnow initiation (TSI) as the first group in a flash detected by the Geostationary Lightning Mapper when snow was occurring. Ten ABI channels and four multispectral (e.g., red-green-blue–RGB) composites were analyzed to investigate characteristics that lead up to TSI for 16,644 thundersnow (TSSN) flashes. From the 10.3 μm channel, TSI trajectories were associated with a median decrease of 12.2 K in brightness temperature (TB) one hour prior to TSI. Decreases in the reflectance component of the 3.9 μm channel indicated that TSI trajectories were associated with ice crystal collisions and/or particle settling at cloud top. The Nighttime Microphysics, Day Cloud Phase Distinction, Differential Water Vapor, and Airmass RGBs were examined to evaluate the microphysical and environmental changes prior to TSI. For daytime TSI trajectories, the predominant colors associated with the Day Cloud Phase Distinction RGB transitioned from cyan to yellow/green, physically representing cloud growth and glaciation at cloud top. Gold/orange hues in the Differential Water Vapor RGB indicated that some trajectories were associated with dry upper-level air masses prior to TSI. The analysis of ABI characteristics prior to TSI, and subsequently relating those characteristics to physical processes, inherently increases the fundamental understanding and ability to forecast TSI; thus, providing additional lead-time into changes in surface conditions (i.e., snowfall rates).
Antipsychotic utilisation and persistence in Australia: A nationwide 5-year study
Authors: Taylor Mark , Dangelo-Kemp Dante , Liu Dennis , Kisely Steve , Graham Simon , Hartmann Jodie , Colman Sam 
Published: October 2021

Objectives: To evaluate the utilisation and persistence of antipsychotics for the treatment of schizophrenia in Australia. Methods: A retrospective study using the Australian Pharmaceutical Benefits Scheme database of a representative 10% sample. All adults with schizophrenia who were dispensed three or more supplies of oral (including clozapine) or long-acting injectable antipsychotics between 1 June 2015 and 31 May 2020 were included. Persistence time in treatment was evaluated using survival analysis and Cox hazard ratios. Results: In all, 26,847 adults with schizophrenia were studied. Oral second-generation antipsychotics were more frequently dispensed than the other antipsychotic groups studied. Median treatment persistence times were 18.3 months for second-generation antipsychotic long-acting injectables, 10.7 months for oral second-generation antipsychotics and were significantly lower for both formulations of first-generation antipsychotics at 5.2 months (long-acting injectables) and 3.7 months (oral). The median persistence time for clozapine was significantly longer than all other antipsychotics groups. Conclusions: Oral second-generation antipsychotics and second-generation antipsychotic long-acting injectables accounted for over 75% and 13% of all antipsychotics in Australia, respectively. Concerns over medication adherence and subsequent relapse have not translated into increased long-acting injectable usage despite their significantly longer persistence. Clozapine, the single most ‘persistent’ antipsychotic, was only used in 9% of people, although up to a third of all cases are likely to be treatment-resistant. Our data suggest clinicians should give consideration to the earlier use of second-generation antipsychotic long-acting injectables and clozapine, to ameliorate prognosis in schizophrenia.