bluuebunny/crossref_metadata_2025_split huggingface dataset:
Dermatologic Device Clearance Within the Food and Drug Administration's 510(k) Pathway
Authors: Ezaldein Harib H. , Hill Sheena T. , Merati Miesha , Suggs Amanda , Reichert Barbara , Scott Jeffrey F. 
Published: March 2020

Background and ObjectivesDevice innovation in dermatology is increasing. Medical devices identified as “substantially equivalent” to predicate ones by the United States Food and Drug Administration (FDA) may be exempt from premarket approval through the 510(k) pathway. The 510(k) pathway has been criticized for having less stringent clinical data requirements, and implications of dermatologic device clearance via this pathway are incompletely described. The objective of this study is to characterize dermatologic device clearance via the 510(k) pathway.Study Design/Materials and MethodsWe performed a retrospective review of the FDA's 510(k) database between January 1, 1996 and December 31, 2018. Dermatologic devices were included based on product code and classified by the application. Approval pathways and decision characteristics were compared among dermatologic device categories.ResultsOf the 76,607 records screened, 4,637 met inclusion criteria. Laser/thermal devices comprised the largest category (64.2%), followed by wound (24.0%) and light‐based devices (5.8%). The majority of 510(k) pathway submissions were traditional (89.2%) compared with alternative (10.8%) submission types (P = 0.003). Devices that were deemed substantially equivalent without limitations (98.5%) were the most common among all device categories. Rates of device clearance over the study period increased for all categories except laser/thermal devices.ConclusionsDermatologic devices are increasingly cleared via the FDA's 510(k) pathway through “substantial equivalence” with minimal requirements for premarket clinical data. Lasers Surg. Med. © 2020 Wiley Periodicals, Inc.
Sleep patterns and problems among children with 22q11 deletion syndrome
Authors: Arganbright Jill M. , Tracy Meghan , Hughes Susan Starling , Ingram David G. 
Published: March 2020

AbstractBackgroundTo delineate sleep habits and problems in children with 22q11.2 deletion syndrome (22q11DS).MethodsThirty children, age 1–15 (mean 6.8) years, participated in the study, which was an internet‐based anonymous survey of parents of children with 22q11DS administered via the 22q11.2 Foundation. The main outcome was the Childhood Sleep Habits Questionnaire (CSHQ).ResultsScores on the CSHQ demonstrated clinically significant sleep problems in 29 of the 30 children. When compared with previously reported normative values for typically developing children of the same age, children with 22q11DS had significantly greater sleep problems. Only 30% of children had previously undergone sleep study. While about half of children had tried a medication for sleep, it usually was not felt to be helpful. In contrast, parents reported that behavioral interventions, such as consistent bedtime routine and appropriate sleep environment, were helpful. This is one of the first studies to specifically address sleep problems other than obstructive sleep apnea in children with 22q11DS.ConclusionsThe findings suggest children with 22q11DS may have a higher risk of experiencing clinical sleep problems, compared to typically developing children. Consideration of additional screening and treatment of sleep disorders in children with 22q11DS is warranted.
Secrecy rate optimization for intelligent reflecting surface aided multi‐input‐single‐output terahertz communication
Authors: Chen Wenjie , Chen Zhi , Ma Xinying , Chi Yaojia , Li Zhuoxun 
Published: March 2020

AbstractIntelligent reflecting surface (IRS) is an emerging paradigm to enhance terahertz (THz) communications with low hardware costs and reduced power consumptions. In this work, we study an IRS‐aided THz multi‐input‐single‐output secure communication system, where a base station (BS) transmits confidential signals to a single‐antenna user with the presence of a single‐antenna eavesdropper. We seek to maximize the secrecy rate by designing the discrete phase‐shifts at the IRS and the precoder at the BS, which is an intractable nonconvex optimization problem. To solve it, we propose to iteratively design the above two matrix variables. Specifically, with a given phase‐shift matrix, we can obtain the optimal precoder by the Rayleigh‐Ritz theorem. And with a given precoder matrix, we propose a cross‐entropy‐based algorithm to obtain the optimal phase‐shift matrix. Numerical results demonstrate that our proposed solution is able to improve the secrecy rate than that of the case without IRS.
Could the glycosylation analysis of seminal plasma clusterin become a novel male infertility biomarker?
Authors: Janiszewska Ewa , Kratz Ewa Maria 
Published: March 2020

AbstractMale infertility is becoming a rapidly growing problem around the world, mainly in the highly developed countries. Seminal proteome composition seems to be one of the crucial factors of the proper course of fertilization ‐ clusterin (CLU) is among the most important ones. CLU, as one of the crucial seminal plasma glycoproteins, plays a very important role in sperm capacitation and immune tolerance in the female reproductive tract. CLU is also known as a sensitive marker of oxidative stress. It has six n‐glycosylation sites and also exhibits chaperone activity. An analysis of changes in the profile and degree of CLU glycosylation may shed some new light on the molecular mechanisms of the fertilization process and may be used as an additional diagnostic marker of male fertility. This study constitutes a review of the recently available literature concerning human seminal CLU, including changes in its glycosylation, analyzed in the context of human reproduction.
The value, impact and role of nurses in rheumatology outpatient care: Critical review of the literature
Authors: Lempp Heidi , Baggott Rhiannon , Scott David L. , Parker Louise , Bosworth Ailsa , Georgopoulou Sofia , Firth Jill 
Published: March 2020

AbstractBackgroundAs rheumatology nurses make substantial contributions to intensive management programmes following ‘treat to target’ principles of people with rheumatoid arthritis (RA), there is a need to understand the impacts of their involvement. A structured literature review was undertaken of qualitative studies, clinical trials and observational studies to assess the impacts of rheumatology nurses on clinical outcomes and the experiences of patients with RA and to examine the skills and training of the nurses involved.MethodA structured literature review was conducted to examine the value, impact and professional role of nurses in RA management.ResultsThe literature search identified 657 publications, and 20 of them were included comprising: seven qualitative studies (242 patients), nine trials (a total of 2,440 patients) and four observational studies (1,234 patients). In clinical trials, nurses achieved similar patient clinical outcomes to doctors, and nurses also enhanced patients' satisfaction of received care and self‐efficacy. In the qualitative studies reviewed, the nurses increased patients' knowledge and promoted their self‐management. The observational studies studied examined found that nursing care led to improved patients' global functioning. The nurses in the various studies had a wide range of titles, experiences and training.DiscussionOur structured literature review provides strong evidence that rheumatology nurses are effective in delivering care for RA patients. However, their titles, experience and training were highly variable.ConclusionThere is a convincing case to maintain and extend the role of nurses in managing RA, but further work is needed on standardisation of their titles and training.
Simulation of mixed‐mode fracture using SPH particles with an embedded fracture process zone
Authors: Wang Yingnan , Tran Hieu T. , Nguyen Giang D. , Ranjith Pathegama G. , Bui Ha H. 
Published: March 2020

SummaryThis paper focuses on the modelling of mixed‐mode fracture using the conventional smoothed particle hydrodynamics (SPH) method and a mixed‐mode cohesive fracture law embedded in the particles. The combination of conventional SPH and a mixed‐mode cohesive model allows capturing fracture and separation under various loading conditions efficiently. The key advantage of this framework is its capability to represent complex fracture geometries by a set of cracked SPH particles, each of which can possess its own mixed‐mode cohesive fracture with arbitrary orientations. Therefore, this can naturally capture complex fracture patterns without any predefined fracture topologies. Because a characteristic length scale related to the size of the fracture process zone is incorporated in the constitutive formulation, the proposed approach is independent from the spatial discretisation of the computational domain (or mesh independent). Furthermore, the anisotropic fracture responses of materials can be naturally captured thanks to the orientation of the fracture process zone embedded at the particle level. The performance of the proposed approach demonstrates its potentials in modelling mixed‐mode fracture of rocks and similar quasi‐brittle materials.
The prediction of cervical cancer screening beliefs based on big five personality traits
Authors: Rashidi Fakari Farzaneh , Mohammadzadeh Farnaz , Rashidi Fakari Fahimeh , Saei Ghare Naz Marzieh , Ozgoli Giti 
Published: March 2020

AbstractAimThe present study was designed with the aim to predict Pap smear screening beliefs based on Big Five personality traits.DesignThe present cross‐sectional study was conducted with 235 women over 18 years of age in Tehran (Iran) in 2018.MethodsThe data collection tools included the demographic information questionnaire, Pap Smear Belief Questionnaire (PSBQ) and the 10‐item measure of the Big Five personality traits.ResultsPeople with Agreeableness personality trait were more faced with risks and Barriers and factors associated with Pap smear screening beliefs; and those with Conscientiousness personality trait were more faced with risks and Barriers. Results of the present study can help to understand how the personality affects decision‐making and interactions. Therefore, consequences of counselling about screening beliefs and behavioural changes can be improved by personality‐based education.
T‐cell exhaustion interrelates with immune cytolytic activity to shape the inflamed tumor microenvironment
Authors: Cai Mei‐Chun , Zhao Xiaojing , Cao Min , Ma Pengfei , Chen Minjiang , Wu Jie , Jia Chenqiang , He Chunming , Fu Yujie , Tan Li , Xue Xinying , Yu Zhuang , Zhuang Guanglei 
Published: March 2020

AbstractDirect quantification of exhausted T cells in human cancer is lacking, and its predictive value for checkpoint‐based treatment remains poorly investigated. We sought to systematically characterize the pan‐cancer landscape and molecular hallmarks of T‐cell dysfunction for the purpose of precision immunotherapy. Here, we defined a transcriptional signature for T‐cell exhaustion through analyzing differential gene expression between PD‐1‐high and PD‐1‐negative CD8+ T lymphocytes from primary non‐small cell lung cancer (NSCLC), followed by positive correlation tests with PDCD1 in TCGA lung carcinomas. A 78‐gene signature for exhausted CD8+ T cells (GET) was identified and validated to reflect dysfunctional immune state spanning different species and disease models. We discovered that GET estimation significantly correlated with intratumoral immune cytolytic activity (CYT) and T‐cell‐inflamed gene expression profile (GEP) across 30 solid tumor types. Miscellaneous tumor‐intrinsic and ‐extrinsic properties, in particular leukocyte proportions, genomic abnormalities, specific mutational signatures, and signaling pathways, were notably associated with GET levels. Furthermore, higher GET expression predicted an increased likelihood of clinical response to immune checkpoint inhibitors. These findings highlight the interrelation between T‐cell exhaustion and immune cytolytic activity at the pan‐cancer scale. The resulting inflamed tumor microenvironment may further crosstalk with other molecular and clinicopathological factors, which should be properly considered during immunotherapy biomarker development. © 2020 Pathological Society of Great Britain and Ireland. Published by John Wiley & Sons, Ltd.
Self‐assembled nanostructures of diblock copolymer films under homopolymer topcoats
Authors: Ji Siyu , Zhang Runrong , Zhang Liangshun , Yuan Yuan , Lin Jiaping 
Published: March 2020

AbstractTo mitigate the interface energies of block copolymers with high interaction parameters, a topcoat strategy has been experimentally proposed to produce perpendicular oriented domains on a length scale of sub‐10 nm. However, the origin of perpendicular oriented domains and the effect of topcoats on the self‐assembled nanostructures remain to be uncovered. Herein, we use the dynamic self‐consistent field theory to explore the self‐assembly behaviors of symmetric block copolymer films under homopolymer topcoats. It is clearly demonstrated that the introduction of homopolymer topcoats enables a wide formation range of perpendicular oriented lamellae, originating from the fluctuating diblock copolymer/homopolymer interfaces in the process of in‐plane microphase separation of block copolymer films. Our simulation results also demonstrate that the formation range of perpendicular oriented lamellae can be tuned by changing the wetting properties of homopolymer topcoats and the thickness of block copolymer films, but is weakly dependent upon the chain length of homopolymers. Our theoretical findings have wide implications for understanding the formation of perpendicular oriented domains of block copolymer films, which are important for the rational design of self‐assembled nanostructures with new horizons for block copolymer lithography. © 2020 Society of Chemical Industry
Supporting the information gathering practices of academically advanced college‐bound students
Authors: Meyer Melanie S. , Cranmore Jeff 
Published: March 2020

AbstractFor academically advanced college‐bound students, decisions about where to apply, and ultimately, where to enroll are influenced by a wide range of factors. One key factor in the decision‐making process is access to quality information about universities. This qualitative descriptive study used semistructured interviews with 10 high school seniors to explore the research practices academically advanced high school students used as they formed initial choice sets and subsequently eliminated options in the college decision‐making process. Participants in this study primarily researched the availability of academic support, career development opportunities, and peer support. These students used online sources, word of mouth, campus visits, and university contacts to find answers to specific questions about school culture. These findings suggest a need for counselors and school psychologists to help students access credible college information sources and to provide support for students as they evaluate that information in light of academic, social, and career development goals.
Super‐kdr mutation M918L and multiple cytochrome P450s associated with the resistance of Rhopalosiphum padi to pyrethroid
Authors: Wang Kang , Bai Jiaoyang , Zhao Junning , Su Sha , Liu Lang , Han Zhaojun , Chen Maohua 
Published: March 2020

AbstractBACKGROUNDRhopalosiphum padi is an important pest affecting cereal crops worldwide. Pyrethroid, including lambda‐cyhalothrin, has been widely used to control R. padi in the field. This work investigated the resistance levels of R. padi field populations to lambda‐cyhalothrin, and analysed biochemical and molecular mechanisms of aphid resistance to the insecticide pyrethroid.RESULTSA lambda‐cyhalothrin‐resistant field population (JY) was sampled, and a super‐kdr mutation, M918L, in the voltage‐gated sodium channel (VGSC) was identified in the population. The lambda‐cyhalothrin‐resistant strain (LC‐R) was subsequently established by selecting the field population with lambda‐cyhalothrin. All individuals of the R. padi LC‐R strain showed the M918L heterozygous mutation in the VGSC IIS4–IIS6 region. Cross‐resistance profiles of the LC‐R strain to nine insecticides were detected. Both synergistic and enzyme activity studies indicated that cytochrome P450 monooxygenase played an important role in this resistance. Further gene expression analysis showed that seven P450 genes were significantly upregulated in the LC‐R strain compared with the susceptible strain.CONCLUSIONField‐evolved resistance to pyrethroid insecticides has been found in R. padi. The M918L (super‐kdr) mutation in the VGSC was documented for the first time in field samples obtained from an important wheat‐growing area. The super‐kdr mutation, as well as metabolic resistance mediated by P450 genes, was determined to contribute to the lambda‐cyhalothrin resistance in R. padi. © 2020 Society of Chemical Industry
Binding energies and isomer distribution of neutral acetonitrile clusters
Authors: Malloum Alhadji , Fifen Jean J. , Conradie Jeanet 
Published: March 2020

AbstractStructures and relative stabilities of neutral acetonitrile clusters up to decamer have been investigated. We used the ABCluster code to thoroughly explore the potential energy surfaces (PESs) of the acetonitrile clusters and to generate initial geometries, which are further fully optimized at the MN15/6‐31++G(d,p) level of theory. Our exploration yielded several new local and global minima structures of the acetonitrile clusters. We located new global minimum structures of the acetonitrile pentamer to decamer. The results show that the PESs of the acetonitrile clusters are very flat, yielding several isoenergetic structures. Our investigations also revealed that the stability of the acetonitrile clusters is due both to CH⋯N and dipole–dipole interactions. Structures stabilized by the latter are found to be more stable than those stabilized by the former at low temperatures. Furthermore, we examined the effect of temperature on the stability of the structures of the acetonitrile clusters for temperatures in the range 20 to 400 K. We found that several structures contribute to the population of the clusters at high temperatures, and also that a significant contribution to the population comes from isomers that lie within 2.0 kcal/mol from the most stable one. In addition, we used the most stable structures to compute the binding energies of the acetonitrile clusters and to assess the performance of some DFT functionals (MN15, ωB97XD, PW6B95D3, and B2PLYP) in comparison with the MP2 method associated to the aug‐cc‐pVTZ basis set in calculating the binding energies. We found that the MN15 functional performs better than ωB97XD and PW6B95D3, and that MN15 is less sensitive to the basis set change. We also used an extrapolation scheme to calculate the binding energies of the acetonitrile clusters at the highly accurate W1BD, CBS‐QB3, and G4MP2 levels of theory. The resulting binding energies are recommended for future benchmarking of the acetonitrile clusters.
Soil hydraulic model parameters and methodology as affected by sodium salt solutions
Authors: Klopp H.W. , Daigh A.L.M. 
Published: March 2020

AbstractSoil salinization from shallow ground waters is problematic in numerous regions of the world. These ground waters can degrade soil physical properties and require special land management to maintain soil salinity levels ideal for crop and rangeland production. The objectives of this study were to evaluate how saline and sodic solutions changed soil hydrologic properties and how hydrologic parameters change with solution composition. Four soils ranging in texture from sandy loam to silty clay, were saturated with solutions ranging in electrical conductivities (EC) of 0.5 to 8 dS m−1 and sodium adsorption ratios (SAR) of 0 to 20. The hydraulic conductivity and water retention were measured using pressure plates, HYPROP evaporation method, and a dewpoint potentiometer. Data was fit with the van Genuchten and dual porosity models and the model parameters were evaluated. There was an increase in water retention and decrease in hydraulic conductivity when soils were near saturation as solution SAR increased and EC decreased at potentials near saturation. Water retention method combinations agreed well for low salinity treatments, but fitting parameters did not agree well for the higher salinity treatments. The coarser textured soil had a stronger disagreement in fitting parameters for the different water retention method combinations and greater salt build up near soil surface. Capillary rise of salt bearing waters of low EC and high SAR increases soil water retention and decreases hydraulic conductivity near saturation which will slow rates of downward water movement and salt leaching.
Improving patient outcomes with regenerative medicine: How the Regenerative Medicine Manufacturing Society plans to move the needle forward in cell manufacturing, standards, 3D bioprinting, artificial intelligence-enabled automation, education, and training
Authors: Hunsberger Joshua , Simon Carl , Zylberberg Claudia , Ramamoorthy Preveen , Tubon Thomas , Bedi Ram , Gielen Kurt , Hansen Caitlin , Fischer Lynn , Johnson Jed , Baraniak Priya , Mahdavi Behzad , Pereira Taciana , Hadjisavas Michael , Eaker Shannon , Miller Cameron 
Published: March 2020

Abstract
The Regenerative Medicine Manufacturing Society (RMMS) is the first and only professional society dedicated toward advancing manufacturing solutions for the field of regenerative medicine. RMMS's vision is to provide greater patient access to regenerative medicine therapies through innovative manufacturing solutions. Our mission is to identify unmet needs and gaps in regenerative medicine manufacturing and catalyze the generation of new ideas and solutions by working with private and public stakeholders. We aim to accomplish our mission through outreach and education programs and securing grants for public-private collaborations in regenerative medicine manufacturing. This perspective will cover four impact areas that the society's leadership team has identified as critical: (a) cell manufacturing and scale-up/out, respectively, for allogeneic and autologous cell therapies, (b) standards for regenerative medicine, (c) 3D bioprinting, and (d) artificial intelligence-enabled automation. In addition to covering these areas and ways in which the society intends to advance the field in a collaborative nature, we will also discuss education and training. Education and training is an area that is critical for communicating the current challenges, developing solutions to accelerate the commercialization of the latest technological advances, and growing the workforce in the rapidly expanding sector of regenerative medicine.

Significance statement The Regenerative Medicine Manufacturing Society highlights focus areas to advance the field in a collaborative nature through working groups. These focus areas include cell manufacturing, standards for regenerative medicine, 3D bioprinting, and artificial intelligence-enabled automation. These working groups will help disseminate this knowledge through future publications, as well as by identifying and developing education and training programs. Education and training programs can disseminate knowledge on current challenges and new technology innovations, as well as train the next generation workforce that will assist in making therapies the next standard of care.