bluuebunny/crossref_metadata_2025_split huggingface dataset:
Safety and efficacy of Razumab™ (world’s first biosimilar ranibizumab) in wet age-related macular degeneration: a post-marketing, prospective ASSET study
Authors: Sharma Shashikant , Gupta Vishali , Maiti Aniruddha , Natesh Sribhargava , Saxena Sandeep , Dave Vivek , Parmar Vimal , Sampangi Raju , Murthy Hemanth , Dharwadkar Sandhya , Yadav Naresh Kumar , Joshi Shrinivas , Mayor Rahul , Ratra Dhanashree , Basu Soumyava , Goel Neha , Chaturvedi Alok , Patel Ronak , Jose Vinu 
Published: March 2021

Abstract
Background
Razumab™ (world’s first biosimilar ranibizumab) is approved for several macular disorders including wet age-related macular degeneration (AMD). We evaluated the safety and efficacy of biosimilar ranibizumab in wet AMD.

Methods
This prospective, multicentre, rAnibizumab bioSimilar Safety Efficacy postmarkeTing (ASSET) study enrolled patients aged ≥ 50 years with wet AMD having best-corrected visual acuity (BCVA) between 20/40 and 20/320. The patients received intravitreal biosimilar ranibizumab 0.5 mg every 4 weeks for 24 weeks. Safety endpoints included the incidence of adverse events (AEs), serious AEs (SAEs), and immunoreactivity after 6 months. The efficacy endpoints were the proportion of patients who lose fewer than 15 letters, increase in BCVA, change in central retinal thickness (CRT), and change in Visual Function Questionnaire-25 (VFQ-25) score, from baseline to 24 weeks.

Results
Of the 126 enrolled patients, majority (95.24%) of the patients received all 6 doses of biosimilar ranibizumab (total 3 mg). Nineteen AEs were reported (n = 16; 12.7%); majority (78.9%) were mild. There were no serious AEs reported, except one AE of death which was unrelated to the study drug. None of the patients discontinued the study due to an AE. The most common ocular AE was increase in intraocular pressure (4 events) and non-ocular AE was pyrexia (5 events). A total of 7.9% (10/126) patients prior to dosing and 7.1% (9/126) patients post-treatment were positive for anti-ranibizumab antibodies. No AEs suggestive of immunogenicity were noted. At 24-weeks, 97.60% patients in the intent-to-treat (ITT) population (N = 125) and 97.41% patients in the per-protocol (PP) population (N = 116) lost < 15 letters from baseline visual acuity. In the ITT and PP populations, 31.20% and 32.76% patients, respectively, showed improved visual acuity by ≥ 15 letters. Significant improvements in BCVA (mean difference: 8.8, 9.2, p < 0.001 for ITT, PP) and VFQ-25 (8.5, 9.2, p < 0.001 for ITT, PP) were seen; CRT reduced significantly (125 µm, 119.3 µm, p < 0.001 for ITT, PP).

Conclusion
Razumab™ (world’s first biosimilar ranibizumab) was well-tolerated without new safety concerns and significantly improved visual acuity in wet AMD patients.
Trial registration CTRI/2016/03/006739. Registered 18 March 2016—Prospectively registered, http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=13141&EncHid=&userName=2016/03/006739
Reliability sensitivity of wind power system considering correlation of forecast errors based on multivariate NSTPNT method
Authors: Dong Wangchao , Li Shenghu 
Published: March 2021

AbstractThe impact of wind power forecast errors (WPFEs) on power system reliability can be quantified by a sensitivity model, which helps to determine the importance of different wind farms. However, the unknown distribution and correlation of WPFEs make it difficult to calculate the reliability sensitivity. The existing univariate non-standard third-order polynomial normal transformation (NSTPNT) expresses the reliability sensitivity of WPFEs by a normal random variable with explicit distribution, and is not suitable for multiple wind farms with correlated forecast errors. In this paper, the univariate NSTPNT method is extended to the multivariate by deriving the analytical expression of the correlation coefficients before and after the transformation, to establish the transformation between the WPFEs and a normal random vector (RV) with the specific correlation. A reliability sensitivity model to the WPFEs expressed to the normal RV is then proposed. The numerical results validate the accuracy of the proposed multivariate NSTPNT and the sensitivity model. The maximum relative error for using the sensitivity to approximate the change of reliability with distribution parameters of the WPFEs is less than 2.42%. The necessity of considering the correlation of WPFEs is analyzed. The maximum relative error of the sensitivity reaches 83% when the correlation is ignored.
On L-fuzzy closure operators and L-fuzzy pre-proximities
Authors: Ramadan A. A. , Elkordy E. H. , Usama M. A. 
Published: March 2021

AbstractThe aim of this paper is to investigate the relations among the L-fuzzy pre-proximities, L-fuzzy closure operators and L-fuzzy co-topologies in complete residuated lattices. We show that there is a Galois correspondence between the category of separated L-fuzzy closure spaces and that of separated L-fuzzy pre-proximity spaces and we give their examples.
Resistance of bacteria isolated from leachate to heavy metals and the removal of Hg by Pseudomonas aeruginosa strain FZ-2 at different salinity levels in a batch biosorption system
Authors: Imron Muhammad Fauzul , Kurniawan Setyo Budi , Abdullah Siti Rozaimah Sheikh 
Published: March 2021

AbstractLeachate is produced from sanitary landfills containing various pollutants, including heavy metals. This study aimed to determine the resistance of bacteria isolated from non-active sanitary landfill leachate to various heavy metals and the effect of salinity levels on the removal of Hg by the isolated bacterium. Four dominant bacteria from approximately 33 × 1017 colony-forming units per mL identified as Vibrio damsela, Pseudomonas aeruginosa, Pseudomonas stutzeri, and Pseudomonas fluorescens were isolated from non-active sanitary landfill leachate. Heavy metal resistance test was conducted for Hg, Cd, Pb, Mg, Zn, Fe, Mn, and Cu (0–20 mg L− 1). The removal of the most toxic heavy metals by the most resistant bacteria was also determined at different salinity levels, i.e., fresh water (0‰), marginal water (10‰), brackish water (20‰), and saline water (30‰). Results showed that the growth of these bacteria is promoted by Fe, Mn, and Cu, but inhibited by Hg, Cd, Pb, Mg, and Zn. The minimum inhibitory concentration (MIC) of all the bacteria in Fe, Mn, and Cu was > 20 mg L− 1. The MIC of V. damsela was 5 mg L− 1 for Hg and >  20 mg L− 1 for Cd, Pb, Mg, and Zn. For P. aeruginosa, MIC was > 20 mg L− 1 for Cd, Pb, Mg, and Zn and 10 mg L− 1 for Hg. Meanwhile, the MIC of P. stutzeri was > 20 mg L− 1 for Pb, Mg, and Zn and 5 mg L− 1 for Hg and Cd. The MIC of P. fluorescens for Hg, Pb, Mg, and Zn was 5, 5, 15, and 20 mg L− 1, respectively, and that for Cd was > 20 mg L− 1. From the MIC results, Hg is the most toxic heavy metal. In marginal water (10‰), P. aeruginosa FZ-2 removed up to 99.7% Hg compared with that in fresh water (0‰), where it removed only 54% for 72 h. Hence, P. aeruginosa FZ-2 is the most resistant to heavy metals, and saline condition exerts a positive effect on bacteria in removing Hg.
Evaluation of in vitro antioxidant, anticancer activities and molecular docking studies of Capparis zeylanica Linn. leaves
Authors: Warake Ruturaj A. , Jarag Ravindra J. , Dhavale Rakesh P. , Jarag Rekha R. , Lohar Nikhil S. 
Published: March 2021

Abstract
Background
Capparis zeylanica Linn. leaf extract was subjected to phytochemical screening for the determination of antioxidant and anticancer activity on (MCF-7) human breast cancer cells. The phytoconstituents previously determined were subjected to molecular docking studies against human epidermal growth factor receptor 2 (HER2) protein as a target receptor to support antioxidant and anticancer activities.

Results
Powdered plant leaves were extracted by maceration method using ethyl acetate, chloroform, methanol, ethanol and distilled water. Preliminary phytochemical evaluation and total phenolic and flavonoid content of the extract were evaluated using biochemical tests. Total antioxidant capacity of the extract was evaluated using different assays. Anticancer potential of methanolic and ethanolic extracts was studied on human breast cancer cells. Molecular docking studies were performed to evaluate the binding interactions of phytoconstituents on HER2 protein using AutoDock Vina.
Phytochemical evaluation confirmed the presence of saponins, flavonoids, tannins, phenols, carbohydrates and proteins. Ethanolic extract showed a maximum total phenolic and flavonoid content in support with antioxidant and anticancer activities. The ethanolic leaf extract showed 66.63% cell growth inhibition against MCF-7 cells. Molecular docking studies revealed the highest binding affinity (− 8.4 Kcal/mol) of α-amyrin followed by quercetin and β-carotene. Glucocapparin, syringic acid, vanillic acid and p-coumaric acid showed almost a similar binding affinity to the amino acid residues of HER2 protein as compared to 5-FU.

Conclusion
C. zeylanica leaf extract showed the presence of phenolic and flavonoid constituents responsible for antioxidant and in vitro anticancer activities. Molecular docking studies showed the binding affinity of phytoconstituents on targeted HER2 protein.
Risk of SARS-CoV-2 infection and COVID-19 prognosis with the use of renin–angiotensin–aldosterone system (RAAS) inhibitors: a systematic review
Authors: Iheanacho Chinonyerem O. , Odili Valentine U. , Eze Uchenna I. H. 
Published: March 2021

Abstract
Background
Angiotensin-converting-enzyme-2, being the receptor for SARS-CoV-2, is increased in the use of RAAS inhibitors. Therefore, concerns have been raised over risks of SARS-CoV-2 infection and poor prognosis of COVID-19 in persons with prior exposure to these drugs. This study aimed to systematically review available evidence for associations between exposure to RAAS inhibitors with susceptibility to SARS-CoV-2 infection and clinical outcomes in infected persons. It hopes to address the question on the effects of RAAS inhibitors on the risk of COVID-19 and its prognosis.

Main body
Search was conducted in the databases of PubMed, Scopus, Cochrane, Embase and MedRxiv.org from December 2019 to May 31, 2020, using relevant keywords. Additional articles were identified through hand-searching of reference lists. Studies that reported associations between positive tests to COVID-19 and use of RAAS inhibitors, and treatment outcomes of COVID-19 patients who had exposure to RAAS inhibitors were considered eligible. The Newcastle–Ottawa scale was used to assess risk of bias in individual studies. The review was conducted in line with Preferred Regulatory Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines 2009. From the 952 studies screened and 2 studies from reference hand-searching, 18 were reviewed. Four studies evaluated the risks for SARS-CoV-2 infection among RAAS inhibitors users, and 16 (including 2 of the 4 studies) evaluated the clinical outcomes associated with previous exposure to RAAS inhibitors.

Conclusion
Evidence does not suggest higher risks for SARS-CoV-2 infection or poor disease prognosis in the use of RAAS inhibitors. This suggests the continued use of RAAS inhibitors by patients with existing needs, which supports the position statements of American Heart Association and European societies for Cardiology.
Identification of Patient-Reported Outcome Phenotypes Among Oncology Patients With Palliative Care Needs
Authors: Kaufmann Tara L. , Getz Kelly D. , Hsu Jesse Y. , Bennett Antonia V. , Takvorian Samuel U. , Kamal Arif H. , DeMichele Angela 
Published: March 2021

PURPOSE: Despite evidence-based guidelines recommending early palliative care, it remains unclear how to identify and refer oncology patients, particularly in settings with constrained access to palliative care. We hypothesize that patient-reported outcome (PRO) data can be used to characterize patients with palliative care needs. To determine if PRO data can identify latent phenotypes that characterize indications for specialty palliative care referral. METHODS: We conducted a retrospective study of self-reported symptoms on the Edmonton Symptom Assessment System collected from solid tumor oncology patients (n = 745) referred to outpatient palliative care. Data were collected as part of routine clinical care from October 2012 to March 2018 at eight community and academic sites. We applied latent profile analysis to identify PRO phenotypes and examined the association of phenotypes with clinical and demographic characteristics using multinomial logistic regression. RESULTS: We identified four PRO phenotypes: (1) Low Symptoms (n = 295, 39.6%), (2) Moderate Pain/Fatigue + Mood (n = 180, 24.2%), (3) Moderate Pain/Fatigue + Appetite + Dyspnea (n = 201, 27.0%), and (4) High Symptoms (n = 69, 9.3%). In a secondary analysis of 421 patients, we found that two brief items assessing social and existential needs aligned with higher severity symptom and psychological distress phenotypes. CONCLUSION: Oncology patients referred to outpatient palliative care in a real-world setting can be differentiated into clinically meaningful phenotypes using brief, routinely collected PRO measures. Latent modeling provides a mechanism to use patient-reported data on a population level to identify distinct subgroups of patients with unmet palliative needs.
Compositional Stasis and Flexibility in American Indian Tribes
Authors: Orr Raymond I. , Orr Yancey A. 
Published: March 2021

AbstractAmerican Indian tribal power has typically expanded since the 1960s. During this period, often referred to as the Self-Determination Era, tribes have regained much of their earlier political centrality. One rarely addressed limitation during this period is the inability of tribal polities to break into smaller units while maintaining recognition as legitimate. This essay identifies the inability of tribes to exercise what the authors call compositional flexibility and fracture to form new polities discrete of the previous tribe. The authors argue the absence of compositional flexibility shapes tribal politics and is at odds with many forms of traditional governance systems.
A simple and cheap aerosol penetrometer for filter testing using an electronic cigarette.
Authors: Lifka Sebastian , Ponomarev Ivan , Weth Agnes , Baumgartner David , Lamprecht Bernd , Baumgartner Werner 
Published: March 2021

Background: During the coronavirus disease 2019 (COVID-19) pandemic face masks grew in importance as their use by the general population was recommended by health officials in order to minimize the risk of infection and prevent further spread of the virus. To ensure health protection of medical personal and other system relevant staff, it is of considerable interest to quickly test if a certain lot of filtering facepiece masks meets the requirements or if the permeability changes under different conditions. As certified penetrometers are rather expensive and were difficult to obtain during the COVID-19 pandemic, we describe two quite simple and cheap methods to quickly test the filter permeability based on an electronic cigarette. Methods: The first method uses a precision scale, the second method uses a light scattering detector to measure the filter penetration. To make sure these two methods yield reliable results, both were tested with freshly cut filter samples covering the range of approx. 2 % to 60 % permeability and compared to the results of a certified penetrometer. Results: The comparison of the two methods with the certified penetrometer showed a good correlation and therefore allow a quick and rather reliable estimation of the permeability. Conclusions: Several examples about the use of faulty masks and the resulting health risks show that simple, fast, cheap and broadly available methods for filter characterization might be useful in these days.
‘Baltic catacombs.’ Translating corpisanti catacomb relic-sculptures between Rome, Polish Livonia, and the Lithuanian Grand Duchy circa 1750-1800
Authors: Budzyński Radosław , Filipchyk Dzianis , Jakubowski Melchior , Marozau Dzmitry , Noyes Ruth Sargent , Veličkaitė Vika 
Published: March 2021

This article offers a first study of the traffic of corpisanti catacomb relic-sculptures between Rome and sites in the Grand Duchy of Lithuania and Polish Livonia in the decades just before and during the Age of Partition (c. 1750-1800). The article firstly frames an overview of current knowledge on corpisanti more broadly against cases in Livonia and the Grand Duchy. It secondly provides a clearinghouse of secondary and primary source evidence on this topic, with particular attention to providing previously largely unpublished or under-studied texts pertaining to corpisanti cults in the north in translation, included as appendices. This article also presents a study in methods of collaborative scholarship in the pandemic era, investigating across distinct genres of source materials and material and artistic cultural heritage objects accessed via scholarly networks both in the field and online, representing historic sites and institutions in present-day Italy, Ukraine, Belarus, Poland, Latvia, and Lithuania.
Generation of pure longitudinal magnetization focal spot with a triplex metalens
Authors: Zhao Kun , Zhang Zhiyu , Zang Haofeng , Du Jing , Lu Yonghua , Wang Pei 
Published: March 2021

A pure longitudinal magnetization focal spot is greatly desired by all-optical magnetic recording. In this Letter, a triplex metalens is proposed and demonstrated to possess triple functions of an azimuthal polarization converter, a helical phase plate, and a focusing lens. The three-in-one combination enables conversion of linearly polarized incident light to the first-order azimuthally polarized vortex beam and focusing into a diffraction-limited spot. The state of polarization of the focal spot is measured to be pure circular polarization implying that a pure longitudinal magnetization field can be induced by the inverse Faraday effect. The lateral full width at half-maximum of the focal spot is 1.9 µm, and the experimental conversion efficiency of the metasurface is about 19.3%.
Activity data from wearables as an indicator of functional capacity in patients with cardiovascular disease
Authors: Rens Neil , Gandhi Neil , Mak Jonathan , Paul Jeddeo , Bent Drew , Liu Stephanie , Savage Dasha , Nielsen-Bowles Helle , Triggs Doran , Ata Ghausia , Talgo Julia , Gutierrez Santiago , Aalami Oliver 
Published: March 2021

Background
Smartphone and wearable-based activity data provide an opportunity to remotely monitor functional capacity in patients. In this study, we assessed the ability of a home-based 6-minute walk test (6MWT) as well as passively collected activity data to supplement or even replace the in-clinic 6MWTs in patients with cardiovascular disease.

Methods
We enrolled 110 participants who were scheduled for vascular or cardiac procedures. Each participant was supplied with an iPhone and an Apple Watch running the VascTrac research app and was followed for 6 months. Supervised 6MWTs were performed during clinic visits at scheduled intervals. Weekly at-home 6MWTs were performed via the VascTrac app. The app passively collected activity data such as daily step counts. Logistic regression with forward feature selection was used to assess at-home 6MWT and passive data as predictors for “frailty” as measured by the gold-standard supervised 6MWT. Frailty was defined as walking <300m on an in-clinic 6MWT.

Results
Under a supervised in-clinic setting, the smartphone and Apple Watch with the VascTrac app were able to accurately assess ‘frailty’ with sensitivity of 90% and specificity of 85%. Outside the clinic in an unsupervised setting, the home-based 6MWT is 83% sensitive and 60% specific in assessing “frailty.” Passive data collected at home were nearly as accurate at predicting frailty on a clinic-based 6MWT as was a home-based 6MWT, with area under curve (AUC) of 0.643 and 0.704, respectively.

Conclusions
In this longitudinal observational study, passive activity data acquired by an iPhone and Apple Watch were an accurate predictor of in-clinic 6MWT performance. This finding suggests that frailty and functional capacity could be monitored and evaluated remotely in patients with cardiovascular disease, enabling safer and higher resolution monitoring of patients.
Small RNAs as biomarkers to differentiate benign and malign prostate diseases: An alternative for transrectal punch biopsy of the prostate?
Authors: Markert Lukas , Holdmann Jonas , Klinger Claudia , Kaufmann Michael , Schork Karin , Turewicz Michael , Eisenacher Martin , Savelsbergh Andreas 
Published: March 2021

Prostate cancer (PCa) is the most common cancer and the third most frequent cause of male cancer death in Germany. MicroRNAs (miRNA) appear to be involved in the development and progression of PCa. A diagnostic differentiation from benign prostate hyperplasia (BPH) is often only possible through transrectal punch biopsy. This procedure is described as painful and carries risks. It was investigated whether urinary miRNAs can be used as biomarkers to differentiate the prostate diseases above. Therefore urine samples from urological patients with BPH (25) or PCa (28) were analysed using Next-Generation Sequencing to detect the expression profile of total and exosomal miRNA/piRNA.
79 miRNAs and 5 piwi-interacting RNAs (piRNAs) were significantly differentially expressed (adjusted p-value < 0.05 and log2-Fc > 1 or < -1). Of these, 6 miRNAs and 2 piRNAs could be statistically validated (AUC on test cohort > = 0.7). In addition, machine-learning algorithms were used to identify a panel of 22 additional miRNAs, whose interaction makes it possible to differentiate the groups as well. There are promising individual candidates for potential use as biomarkers in prostate cancer. The innovative approach of applying machine learning methods to this kind of data could lead to further small RNAs coming into scientific focus, which have so far been neglected.