bluuebunny/crossref_metadata_2025_split huggingface dataset:
Outcomes in patients with lung cancer treated with crizotinib and erlotinib in routine clinical practice: A post‐authorization safety cohort study conducted in Europe and in the United States
Authors: Ehrenstein Vera , Huang Kui , Kahlert Johnny , Bahmanyar Shahram , Karlsson Pär , Löfling Lukas , Nunes Anthony P. , Enger Cheryl , Bezemer Irene D. , Kuiper Josephina G. , Hoti Fabian , Juuti Rosa , Korhonen Pasi , Mo Jingping , Schachterle Stephen E. , Wilner Keith D. , Rørth Mikael , Sørensen Henrik T. 
Published: January 2021

AbstractPurposeWe examined safety outcomes of interest (SOI) and overall survival (OS) among lung cancer patients initiating crizotinib and erlotinib in routine clinical practice.MethodsThis descriptive cohort study used routinely collected health data in Denmark, Finland, Sweden, the Netherlands, and the United States (US) during 2011–2017, following crizotinib commercial availability in each country. Among crizotinib or erlotinib initiators, we reported baseline characteristics and incidence rates and cumulative incidences of the SOI – hepatotoxicity, pneumonitis/interstitial lung disease, QT interval prolongation‐related events, bradycardia, vision disorders, renal cysts, edema, leukopenia, neuropathy, photosensitivity, malignant melanoma, gastrointestinal perforation, cardiac failure and OS. Results from the European Union (EU) countries were combined using meta‐analysis; results from the US were reported separately.ResultsThere were 456 patients in the crizotinib cohort and 2957 patients in the erlotinib cohort. Rates of the SOI per 1000 person‐years in the crizotinib cohort ranged from 0 to 65 in the EU and from 0 to 374 in the US. Rates of the SOI per 1000 person‐years in the erlotinib cohort ranged from 0 to 91 in the EU and from 3 to 394 in the US. In the crizotinib cohort, 2‐year OS was ~50% in both EU and US. In the erlotinib cohort, 2‐year OS was 21% in the EU and 35% in the US.ConclusionsThis study describes clinical outcomes among lung cancer patients initiating crizotinib or erlotinib in routine clinical practice. Differences between SOI rates in EU and US may be partially attributable to differences in the underlying databases.
Bacteriophage therapy for infections in CF
Authors: Chan Benjamin K. , Stanley Gail , Modak Mrinalini , Koff Jon L. , Turner Paul E. 
Published: January 2021

AbstractPseudomonas aeruginosa and Staphylococcus aureus are bacterial pathogens frequently associated with pulmonary complications and disease progression in cystic fibrosis (CF). However, these bacteria increasingly show resistance to antibiotics, necessitating novel management strategies. One possibility is bacteriophage (phages; bacteria‐specific viruses) therapy, where lytic phages are administered to kill target bacterial pathogens. Recent publications of case reports of phage therapy to treat antibiotic‐resistant lung infections in CF have garnered significant attention. These cases exemplify the renewed interest in phage therapy, an older concept that is being newly updated to include rigorous collection and analysis of patient data to assess clinical benefit, which will inform the development of clinical trials. As outcomes of these trials become public, the results will valuable gauge the potential usefulness of phage therapy to address the rise in antibiotic‐resistant bacterial infections. In addition, we highlight the further need for basic research to accurately predict the different responses of target bacterial pathogens when phages are administered alone, sequentially, or as mixtures (cocktails), and whether within‐cocktail interactions among phages hold consequences for the efficacy of phage therapy in patient treatment.
Epidemiologic Study of Cystic Fibrosis: 25 years of observational research
Authors: Konstan Michael W. , Pasta David J. , VanDevanter Donald R. , Wagener Jeffrey S. , Morgan Wayne J. ,   Scientific Advisory Group and the Investigators and Coordinators of ESCF
Published: January 2021

AbstractThe Epidemiologic Study of Cystic Fibrosis (ESCF) was a prospective observational study of over 32,000 people with cystic fibrosis (CF) from 250 clinical care sites in North America from 1994 to 2005. Begun as a pharmacovigilance study in connection with the approval of dornase alfa in 1993, ESCF was open to all people with CF treated at any participating site in the United States or Canada. In addition to obtaining safety and effectiveness data on dornase alfa, ESCF collected encounter‐based data to characterize the natural history and management of CF with a special focus on lung disease. During the study, 32,178 patients reported at least one encounter, contributing 869,136 encounters, 622,592 pulmonary function tests, 432,896 cultures, and 118,563 pulmonary exacerbations treated with intravenous antibiotics. Although ESCF data collection concluded in 2005, through a collaboration with the U.S. Cystic Fibrosis Foundation Patient Registry, additional follow‐up data through 2017 was available for two‐thirds of patients. This allowed for updating of CF genotype and survival information. Fifty‐six peer‐reviewed publications (cited over 3600 times) resulted from this study. In this manuscript we summarize the published ESCF manuscripts in thematic groups with key study findings and brief comments, and speculate on how ESCF findings will inform future data registries and patient care practices.
Reduction of pulmonary exacerbations in young children with cystic fibrosis during the COVID‐19 pandemic
Authors: Patel Shreya , Thompson Misty D. , Slaven James E. , Sanders Don B. , Ren Clement L. 
Published: January 2021

AbstractTo assess the impact of COVID‐19 restrictions on cystic fibrosis (CF) pulmonary exacerbations (PEx) we performed a retrospective review of PEx events at our CF Center and compared the rate of PEx in 2019 versus 2020. Restrictions on social interaction due to the COVID‐19 pandemic were associated with a lower number of PEx events at our pediatric CF Center, suggesting that these restrictions also reduced exposure to other respiratory viral infection in children with CF.
Novel metabolites from the Cercis chinensis derived endophytic fungus Alternaria alternataZHJG5 and their antibacterial activities
Authors: Zhao Shuangshuang , Wang Biao , Tian Kailin , Ji Wenxia , Zhang Tianyi , Ping Chuan , Yan Wei , Ye Yonghao 
Published: January 2021

AbstractBACKGROUNDPhytopathogenic bacteria, such as Xanthomonas oryzae pv. oryzae (Xoo) and Ralstonia solanacearum (Rs), seriously threaten crop production and are the cause of enormous yield losses. Endophytic fungi are abundant sources of bioactive metabolites that may be potential candidates in the development of new agrochemicals. This work emphasizes the discovery of bioactive polyketides from endophytic Alternaria alternata ZHJG5 and reports their structural elucidation and antibacterial activities in detail.RESULTSFive novel polyketide derivatives, isotalaroflavone (2), (+/−)‐5′‐dehydroxytalaroflavone (3a/3b), (+)‐talaroflavone (4b), and bialternacin G (7), along with five known compounds (1, 4a, 5, 6, and 8), were obtained from the Cercis chinensis‐derived fungus A. alternata ZHJG5. The compounds' structures were characterized using spectroscopic methods and X‐ray diffraction. Chiral high‐performance liquid chromatography was used to separate the racemates 3 and 4, whose absolute configurations were unambiguously confirmed by comparing their experimental and calculated electron circular dichroism data. All isolated compounds were tested for antibacterial activity against the phytopathogenic bacteria Xoo, Xanthomonas oryzae pv. oryzicola (Xoc) and Rs. Compounds 1, 2 and 8 showed pronounced antibacterial activity against all tested bacteria, with minimal inhibitory concentrations ranging from 0.5 to 64 μg/ml. In addition, compound 1 showed a potent protective effect against rice bacterial leaf blight caused by Xoo with a protective efficacy of 75.1% at a concentration of 200 μg/ml.CONCLUSIONThese findings highlight the practical potential of antibacterial compounds as candidates for the discovery of novel bactericides. © 2021 Society of Chemical Industry
Insecticide resistance management and industry: the origins and evolution of the Insecticide Resistance Action Committee (IRAC) and the mode of action classification scheme
Authors: Sparks Thomas C , Storer Nicholas , Porter Alan , Slater Russell , Nauen Ralf 
Published: January 2021

AbstractInsecticide resistance is a long‐standing problem affecting the efficacy and utility of crop protection compounds. Insecticide resistance also impacts the ability and willingness of companies around the world to invest in new crop protection compounds and traits. The Insecticide Resistance Action Committee (IRAC) was formed in 1984 to provide a coordinated response by the crop protection industry to the problem of insecticide resistance. Since its inception, participation in IRAC has grown from a few agrochemical companies in Europe and the US to a much larger group of companies with global representation and an active presence (IRAC Country Groups) involving an even wider array of companies in more than 20 countries. The focus of IRAC has also evolved from that of defining and documenting cases of insecticide resistance to a pro‐active role in addressing insecticide resistance management (IRM) providing an array of informational and educational tools (videos, posters, pamphlets) on insect pests, bioassay methods, insecticide mode of action and resistance management, all publicly available through its website (https://irac-online.org/). A key tool developed by IRAC is the Insecticide Mode of Action (MoA) Classification Scheme, which has evolved from a relatively simple acaricide classification started in 1998 to the far broader scheme that now includes biologics as well as insecticides and acaricides. A separate MoA Classification Scheme has also been recently developed for nematicides. The IRAC MoA Classification Scheme coupled with expanding use of MoA labeling on insecticide and acaricide product labels provides a straightforward means to implement IRM. An overview of the history of IRAC along with some of its notable accomplishments and future directions are reviewed. © 2021 The Authors. Pest Management Science published by John Wiley & Sons Ltd on behalf of Society of Chemical Industry.
The role of Desmodium intortum, Brachiaria sp. and Phaseolus vulgaris in the management of fall armyworm Spodoptera frugiperda (J. E. Smith) in maize cropping systems in Africa
Authors: Scheidegger Laetitia , Niassy Saliou , Midega Charles , Chiriboga Xavier , Delabays Nicolas , Lefort François , Zürcher Roger , Hailu Girma , Khan Zeyaur , Subramanian Sevgan 
Published: January 2021

AbstractBACKGROUNDThe fall armyworm (FAW), Spodoptera frugiperda (J.E. Smith) is a serious pest of maize. Farming systems such as push‐pull or maize‐legume intercropping have been reported to reduce FAW infestations significantly. However, the exact mechanisms involved in FAW management have not been practically elucidated. We therefore assessed larval host preference, feeding and survival rate when exposed to four host plants commonly used in push‐pull and legume intercropping. We also compared adult moths' oviposition preference between maize and other grasses used as trap crops in push‐pull.RESULTSThe larval orientation and settlement study showed that maize was the most preferred host plant followed by bean, desmodium and Brachiaria brizantha cv Mulato II. The larval arrest and dispersal experiment showed that mean number of larvae was significantly higher on maize than on Desmodium or B. brizantha cv Mulato II. However, no significant differences were found between maize and bean after 24 h. Maize was the most consumed plant, followed by bean, desmodium and finally brachiaria. The mean percentage of survival to the pupation stage was significantly higher on maize. The study on FAW oviposition preference showed no significant differences in egg deposited between maize and other grasses. However, B. brizantha cv Xaraes, which received more eggs than maize, could be a promising alternative to B. brizantha cv Mulato II for the control of FAW.CONCLUSIONThe study provides a better understanding of the mechanisms involved in the control of fall armyworm under the push‐pull and maize legume intercropping. © 2021 The Authors. Pest Management Science published by John Wiley & Sons Ltd on behalf of Society of Chemical Industry.
Population pharmacokinetic model with time‐varying clearance for lorlatinib using pooled data from patients with non‐small cell lung cancer and healthy participants
Authors: Chen Joseph , Houk Brett , Pithavala Yazdi K. , Ruiz‐Garcia Ana 
Published: January 2021

AbstractLorlatinib, a selective inhibitor of anaplastic lymphoma kinase (ALK) and c‐ROS oncogene 1 (ROS1) tyrosine kinase, is indicated for the treatment of ALK‐positive metastatic non‐small cell lung cancer (NSCLC) following progression on crizotinib and at least one other ALK inhibitor, or alectinib/ceritinib as the first ALK inhibitor therapy for metastatic disease. The population pharmacokinetics (PopPK) of lorlatinib was conducted by nonlinear mixed effects modeling of data from 330 patients with ALK‐positive or ROS1‐positive NSCLC and 95 healthy participants from six phase I studies in healthy volunteers; demographic, metabolizer phenotype, and patient prognostic factors were evaluated as covariates. Lorlatinib plasma PK was well‐characterized by a two‐compartment model with sequential zero‐order and first‐order absorption and a time‐varying induction of clearance. Single dose clearance was estimated to be 9.04 L/h. Assuming that the metabolic auto‐induction of lorlatinib reaches saturation in ~ 5 half‐lives, clearance was estimated to approach a maximum of 14.5 L/h at steady‐state after a period of ~ 7.25 days. The volume of distribution of the central compartment was estimated to be 121 L and the first‐order absorption rate constant was estimated to be 3.1 h−1. Baseline albumin and lorlatinib total daily dose were significant covariates on lorlatinib clearance. Use of proton pump inhibitors was found to be a significant covariate on the lorlatinib absorption rate constant. These factors were assessed to have no clinically meaningful impact on lorlatinib plasma exposure, and no dose adjustments are considered necessary based on the examined covariates.
Determining sample size for specification limits verification with tolerance intervals
Authors: Vasta Alessandro 
Published: January 2021

AbstractIn the traditional industrial verification process, when the aim is the compliance to assigned specifications, it is difficult to find an affordable statistical method for the purpose. Most data tables in industrial procedures and standards deal with tolerance limits neglecting the potential needs to verify assigned specification limits. A two‐sided tolerance interval, combined with a bivariate statistical hypothesis test can be used to address this problem. The proposed risk‐based approach leads to the determination of the minimum sample size with preestablished probabilities of Type I and Type II errors, that are essential elements for estimating the safety and reliability risk. A novel method is proposed for determination of the tolerance interval testing factors. This approach calculates the testing factors based on the deviation of the mean and the variance from the null hypothesis when a specified value of Type II error is found. The deviations of the mean and variance are determined in such a way that an assigned proportion of the population falls within the specification limits. Additional studies are provided to assess the robustness of the method for nonnormal environments and to compare it with other methods.
A novel solution of using mixed reality in bowel and oral and maxillofacial surgical telepresence: 3D mean value cloning algorithm
Authors: Maharjan Arjina , Alsadoon Abeer , Prasad P.W.C. , AlSallami Nada , Rashid Tarik A. , Alrubaie Ahmad , Haddad Sami 
Published: January 2021

AbstractBackground and AimMost of the mixed reality models used in the surgical telepresence are suffering from the discrepancies in the boundary area and spatial–temporal inconsistency due to the illumination variation in the video frames. The aim behind this work is to propose a new solution that helps produce the composite video by merging the augmented video of the surgery site and virtual hand of the remote expertise surgeon. The purpose of the proposed solution is to decrease the processing time and enhance the accuracy of merged video by decreasing the overlay and visualization error and removing occlusion and artefacts.MethodologyThe proposed system enhanced mean‐value cloning algorithm that helps to maintain the spatial–temporal consistency of the final composite video. The enhanced algorithm includes the three‐dimensional mean‐value coordinates and improvised mean‐value interpolant in the image cloning process, which helps to reduce the sawtooth, smudging and discolouration artefacts around the blending region.ResultsThe accuracy in terms of overlay error of the proposed solution is improved from 1.01 to 0.80 mm, whereas the accuracy in terms of visualization error is improved from 98.8% to 99.4%. The processing time is reduced to 0.173 s from 0.211 s. The processing time and the accuracy of the proposed solution are enhanced as compared to the state‐of‐art solution.ConclusionOur solution helps make the object of interest consistent with the light intensity of the target image by adding the space distance that helps maintain the spatial consistency in the final merged video.
Design, implementation, and verification of a low‐cost terminal guidance system for small fixed‐wing UAVs
Authors: Yang Yachao , Liu Chang , Li Jie , Yang Yu , Li Juan , Zhang Zhidong , Ye Bobo 
Published: January 2021

AbstractA terminal guidance control system for small fixed‐wing unmanned aerial vehicles (SUAV, with a wingspan of around 1.5 m) is proposed in this paper based on a visible light strap‐down seeker. The system is implemented using low‐cost, open‐source components with a cost less than $2000 and proved to be feasible, transplantable and effective for different types of SUAVs, achieving a good terminal guidance accuracy (circular error probable = 1.5 m) against a nonmaneuvering target on the ground. Impacts of low‐cost and low‐precision electrical modules mainly include influence on terminal guidance information, measurement of SUAV state values and the presented system's time‐delay. We examine the practical median flow algorithm for target tracking, the attitude pursuit guidance law for terminal guidance control and the pursuit image frame method for large delay interception to eliminate adverse effects. Furthermore, the performance and robustness are evaluated by laboratory tests as well as field flight trials on two different SUAV platforms. This paper provides a robust, effective and proven reference for the development of the aggressive SUAV for SUAV swarms.
Retracted: Multi‐model penalized regression
Authors: Wendelberger Laura J. , Reich Brian J. , Wilson Alyson G. 
Published: January 2021

AbstractWendelberger, LJ, Reich, BJ, Wilson, AG. Multi‐model penalized regression. Stat Anal Data Min: The ASA Data Sci Journal. 2021; 1 ‐ 25. https://doi.org/10.1002/sam.11496The above article from Statistical Analysis and Data Mining, published online on 13 January 2021 in Wiley Online Library (wileyonlinelibrary.com), has been retracted by agreement between the authors, the journal Editor‐in‐Chief and Wiley Periodicals, LLC. The retraction has been agreed due to inadvertent but substantial overlap with a previously published article in the journal Technometrics.
Mixed Magnetic Dispersive Micro‐Solid Phase–Cloud Point Extraction of Sunset Yellow in Food and Pharmaceutical Samples
Authors: Khani Rouhollah , Irani Majid 
Published: January 2021

AbstractThe simple and green separation/pre‐concentration technique combining magnetic dispersive micro‐solid phase extraction (MD‐μ‐SPE) with cloud point extraction (CPE) was applied for the trace determination of sunset yellow FCF (SY). Reduced graphene oxide‐cobalt oxide nanocomposite (RGO‐Co3O4) with high extraction ability as a suitable adsorbent was synthesized and characterized. In the proposed method, rapid and reproducible extraction is accomplished, lending reduced analysis time and relative inertness to surfactant concentration and equilibration temperature compared to conventional CPE. The influences of solution pH, concentration of sunset yellow, amount of RGO‐Co3O4, and triton X‐35 surfactant (10 % w/v) volume on the extraction performance of SY were investigated and optimized by multivariate optimization strategy. The proposed method, combining two different and effective techniques, offers satisfactory analytical features in terms of the limit of detection (9 ng mL−1), repeatability (1.8 %), and accuracy (89–102 %). Furthermore, the MD‐μ‐SPE/CPE method showed a good ability to analyze SY in food and pharmaceutical samples.
Gemini Surfactants with Different Function Groups as High Efficiency Corrosion Inhibitors for Low Carbon Steel
Authors: Guo Jixiang , Han Tong , Zhao Qing , Zhang HaiPeng 
Published: January 2021

AbstractThis study pioneered in applying two Gemini surfactants with different spacers to corrosion protection. Bis‐N, N, N,‐hexadecyldimethyl‐p‐biphenylenediammonium dichloride (BHBP) and 1,3‐bis (hexadecyldimethylammonio)‐2‐hydroxypropane dichloride (BHHP) were successfully prepared. In order to study the impact of various spacer functional groups on the performance of corrosion inhibitors, a number of different tests were conducted, including electrochemical experiments, weight loss test, surface analysis and so on. According to the experimental results, BHHP with hydroxyl group has better corrosion protection capacity on P110 steel in HCl than BHBP with biphenyl group, with the maximum efficiency reaching 95.67 % for BHBP, and 76.32 % for BHHP. Meanwhile, the results from quantum chemistry demonstrated that theoretically the hydroxyl spacer is superior to biphenyl spacer, which inspires the development of Gemini inhibitors.
Resourcefulness revisited: Further psychometric evaluation of resourcefulness scale
Authors: Rossetti Kristina G. , Zlomke Kimberly R. 
Published: January 2021

AbstractResourcefulness, a collection of problem‐solving, coping, self‐control and emotion regulation skills, has been shown to moderate health outcomes in various caregiver populations. Caregivers of children with neurodevelopmental disorders, such as autism spectrum disorder (ASD), report higher levels of stress, anxiety and depressive symptoms with poorer health‐related quality of life. The current study replicated and extended psychometric research on the Resourcefulness Scale (RS) among caregivers of children with ASD (n = 287) and a comparison group of caregivers of non‐affected children (n = 207). Results suggest acceptable internal consistency and construct validity when using the RS among caregivers of children with and without ASD. The RS demonstrated poor temporal stability over an average of 4 weeks (r = 0.087, p = 0.434). Caregivers of children with ASD report higher levels of general, social, and personal resourcefulness than non‐affected caregivers. Findings validate the use of the RS within caregiving populations with implications for clinical use and future research in the development of interventions to enhance caregiver QoL.