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Redefinition of Fatty Liver Disease from NAFLD to MAFLD through the Lens of Drug Development and Regulatory Science

Journal of Clinical and Translational Hepatology 2022年第2期10卷 374-382页

作者： Yasser Fouad Melissa Palmer Minjun Chen Arie Regev Rajarshi Banerjee Rob Myers Robert Riccio Richard Torstenson Ramy Younes Puneet SArora Henrik Landgren Morten A.Karsdal Martin Blake david a.shapiro Hans-Juergen Gruss Muhammad Y.Sheikh Dina Attia Steven Bollipo Alastair D.Smith Bradley Freilich Robert G.Gish Detlef Schuppan Department of Gastroenterology Hepatologyand Endemic MedicineFaculty of MedicineMinia UniversityMiniaEgypt Gan-nex/Ascletis Pharma Co Ltd BeijingChina Liver Consulting LLC New YorkNYUSA Division of Bioinformatics and Biostatis-tics National Center for Toxicological ResearchUS Food and Drug AdministrationJeffersonARUSA Eli Lilly and Company IndianapolisINUSA Perspectum Diagnostics Ltd OxfordUK Gilead Sciences Inc Foster CityCAUSA Syneos Health LLC MorrisvilleNCUSA Allergan Marlow International BuckinghamshireUKAstraZenecaCambridgeUK Boehringer Ingel-heim International GmbHIngelheimGermany Genentech IncSouth San FranciscoCAUSA AbbVie MarlowBuck-inghamshireUK Nordic Bioscience A/S HerlevDenmark Resonance Health BurswoodWAAustralia Intercept Phar-maceuticals Inc San DiegoCAUSA Fresno Clinical Research Center FresnoCAUSA Gastroenterology and Hepatology Department Beni-Suef UniversityBeni SuefEgypt Department of Gastroenterology and Endoscopy John Hunter HospitalNewcastleNSWAustralia School of Medicine and Public Health University of NewcastleNewcastleNSWAustralia Kan-sas City Research Institute Kansas CityMOUSA Division of Gastroenterology and Hepatology Loma Linda UniversityLoma LindaCAUSA Institute of Translational Immunology and Research Center for Immune Therapy University Medical CenterMainzGermany Division of Gastroenterology Beth Israel Deaconess Medical CenterHarvard Medical SchoolBostonMAUSA

Metabolic(dysfunction)-associated fatty liver disease(MAFLD)affects a third of the population and is a leading cause of liver-related *** no effective treatments exist,novel approaches to drug development are ***,outdated terminology and definitions of the disease are hampering efforts to develop new drugs and *** international consensus panel has put forth an influential proposal for the disease to be renamed from nonalcoholic fatty liver disease(NAFLD)to MAFLD,includ-ing a proposal for how the disease should be *** allies with the many stakeholders in MAFLD care―including patients,patients’advocates,clinicians,researchers,nurse and allied health groups,regional societies,and others―we are aware of the negative consequences of the NAFLD term and *** share the sense of urgency for change and will act in new ways to achieve our *** there is much work to be done to overcome clinical inertia and reverse worrisome recent trends,the MAFLD initiative provides a firm foundation to build *** provides a roadmap for moving for-ward toward more efficient care and affordable,sustainable drug and device innovation in MAFLD *** hope it will bring promising new opportunities for a brighter future for MAFLD care and improve care and outcomes for patients of one of the globe’s largest and costliest public health *** this viewpoint,we have revisited this initiative through the perspectives of drug development and regulatory science.

关键词： NAFLD MAFLD NASH Fatty liver disease Liver Fibrosis

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完美的工作

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领导文萃 2000年第1期 139-141页

作者： Aichardi Leider david a.shapiro

每个人都知道什么是“完美的工作”:一个人拥有一间可爱的办公室,收入可观,有大量可以自由支配的时间,能无拘无束地游览美景胜地,而且没有人对你指手划脚。遗憾的是,这种工作根本不存在。每种工作都有它好的一面和坏的一面。

关键词：表达能力听力听觉

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Routine utilization of machine perfusion in liver transplantation:Ready for prime time?

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World Journal of Gastroenterology 2024年第11期30卷 1488-1493页

作者： Alessandro Parente Keyue Sun Philipp Dutkowski AM James shapiro Andrea Schlegel Department of Surgery Division of TransplantationUniversity of Alberta HospitalEdmonton T6G 2B7Canada Immunity and Inflammation Lerner Research InstituteClevelandOH 44195United States Swiss Hepato-Pancreato-Biliary Center Department of Visceral and Transplantation SurgeryUniversity Hospital ZurichZurich 8091Switzerland Immunity and Inflammation Digestive Disease and Surgery InstituteClevelandOH 44195United States

The last decade has been notable for increasing high-quality research and dramatic improvement in outcomes with dynamic liver *** evidence from numerous randomized controlled trials has been pooled by meta-analyses,providing the highest available evidence on the protective effect of machine perfusion(MP)over static cold storage in liver transplantation(LT).Based on a protective effect with less complications and improved graft survival,the field has seen a paradigm shift in organ *** editorial focuses on the role of MP in LT and how it could become the new“gold standard”.Strong collaborative efforts are needed to explore its effects on long-term outcomes.

关键词： Liver transplantation Machine perfusion Viability assessment Hypothermic oxygenated perfusion Normothermic machine perfusion

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Protective effects of cyclosporine and its analog NIM-811 in a murine model of hepatic ischemia-reperfusion injury

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Liver Research 2024年第1期8卷 46-53页

作者： Joshua Hefler Rena Pawlick Braulio A.Marfil-Garza Aducio Thiesen Nerea Cuesta-Gomez Sanaz Hatami Darren H.Freed Constantine Karvellas david L.Bigam A.M.James shapiro Department of Surgery Faculty of Medicine&DentistryUniversity of AlbertaEdmontonABCanada Department of Medicine Faculty of Medicine&DentistryUniversity of AlbertaEdmontonABCanada CHRISTUS-LatAm Hub Excellence&Innovation Center MonterreyMexico Alberta Diabetes Institute University of AlbertaEdmontonABCanada Clinical Islet Transplant Program University of AlbertaEdmontonABCanada Department of Laboratory Medicine&Pathology Faculty of Medicine&DentistryUniversity of AlbertaEdmontonABCanada

Background and aim:The liver is susceptible to ischemia-reperfusion injury(IRI)during hepatic surgery,when the vessels are compressed to control bleeding,or liver transplantation,when there is an obligate period of *** hallmark of IRI comprises mitochondrial dysfunction,which generates reactive oxygen species,and cell death through necrosis or ***(CsA),which is a well-known immunosuppressive agent that inhibits calcineurin,has the additional effect of inhibiting the mito-chondrial permeability transition pore(mPTP),thereby,preventing mitochondrial swelling and ***-811,which is the nonimmunosuppressive analog of CsA,has a similar effect on the *** this study,we tested the effect of both agents on mitigating warm hepatic IRI in a murine *** and methods:Before ischemic insult,the mice were administered with intraperitoneal normal saline(control);CsA at 2.5,10,or 25 mg/kg;or NIM-811 at 10 mg/***,the mice were subjected to partial warm hepatic ischemia by selective pedicle clamping for 60 min,followed by 6 h of recovery after *** alanine transaminase(ALT)was measured,and the liver tissue was examined histologically for the presence of apoptosis and the levels of inflammatory ***:Compared with the control mice,the mice treated with 10 and 25 mg/kg of CsA and NIM-811 had significantly lower ALT levels(P<0.001,0.007,and 0.031,respectively).Moreover,the liver tissue showed reduced histological injury scores after treatment with CsA at 2.5,10,and 25 mg/kg and NIM-811(P=0.041,<0.001,0.003,and 0.043,respectively)and significant decrease in apoptosis after treatment with CsA at all doses(P=0.012,0.007,and<0.001,respectively).Levels of the pro-inflammatory cyto-kines,particularly interleukin(IL)-1β,IL-2,IL-4,IL-10,and keratinocyte chemoattractant/human growth-regulated oncogene significantly decreased in the mice treated with the highest dose of CsA(25 mg/kg)than those in the control ***

关键词： Cyclosporine(CsA) Cyclosporine analogue Liver surgery Ischemia-reperfusion injury(IRI) Animal model NIM-811

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重新打包从现在起，清点你的生活

重新打包从现在起，清点你的生活

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2004年

作者：（美）理查德·莱德（Richard J.Leider）（美）戴维·夏皮罗（david a.shapiro）丁海生译

本书为人生提供基本的行为模式，书中说明重新打包，意味着为人生做出选择，这种选择，来自于内心的需求，来自于崭新的人生视角。

关键词：人生观人生观

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Critical role of mitochondrial aldehyde dehydrogenase 2 in acrolein sequestering in rat spinal cord injury

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Neural Regeneration Research 2022年第7期17卷 1505-1511页

作者： Seth A.Herr Liangqin Shi Thomas Gianaris Yucheng Jiao Siyuan Sun Nick Race Scott shapiro Riyi Shi Center for Paralysis Research&Department of Basic Medical Sciences College of Veterinary MedicinePurdue UniversityWest LafayetteINUSA Department of Orthopedics Ruijin HospitalSchool of MedicineShanghai Jiaotong UniversityInstitute of Trauma and OrthopedicsShanghaiChina Department of Neurological Surgery Indiana University School of MedicineIndianapolisINUSA

Lipid peroxidation-derived aldehydes,such as acrolein,the most reactive aldehyde,have emerged as key culprits in sustaining post-spinal cord injury(SCI)secondary pathologies leading to functional *** evidence suggests that mitochondrial aldehyde dehydrogenase-2(ALDH2),a key oxidoreductase and powerful endogenous anti-aldehyde machinery,is likely important for protecting neurons from aldehydesmediated *** a rat model of spinal cord contusion injury and recently discovered ALDH2 activator(Alda-1),we planned to validate the aldehyde-clearing and neuroprotective role of *** an acute 2 day period post injury,we found that ALDH2 expression was significantly lowered post-SCI,but not so in rats given *** lower enzymatic expression may be linked to heightened acrolein-ALDH2 adduction,which was revealed in co-immunoprecipitation *** have also found that administration of Alda-1 to SCI rats significantly lowered acrolein in the spinal cord,and reduced cyst *** addition,Alda-1 treatment also resulted in significant improvement of motor function and attenuated post-SCI mechanical hypersensitivity up to 28 days ***,ALDH2 was found to play a critical role in in vitro protection of PC12 cells from acrolein *** is expected that the outcome of this study will broaden and enhance anti-aldehyde strategies in combating post-SCI neurodegeneration and potentially bring treatment to millions of SCI *** animal work was approved by Purdue Animal Care and Use Committee(approval No.1111000095)on January 1,2021.

关键词： acrolein acrolein-lysine adduct alda-1 enzymatic catalyst lipid peroxidation mitochondrial aldehyde dehydrogenase-2 neurotrauma oxidative stress reactive aldehydes spinal cord contusion

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Chiral universality class of normal-superconducting and exciton condensation transitions on surface of topological insulator

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Frontiers of physics 2015年第3期10卷 65-82页

作者： Dingping Li Baruch Rosenstein B. Ya. shapiro I. shapiro School of Physics Peking University Beijing 100871 China Collaborative Innovation Center of Quantum Matter Beijing 100084 China Electrophysics Department National Chiao Tung University Hsinchu 30050 Taiwan China physics Department Ariel University Ariel 40700 Israel Physics Department Bar-Ilan University 52900 Ramat-Gan Israel

New two-dimensional systems such as the surfaces of topological insulators （TIs） and graphene offer the possibility of experimentally investigating situations considered exotic just a decade ago. These situations include the quantum phase transition of the chiral type in electronic systems with a relativistic spectrum. Phonon-mediated （conventional） pairing in the Dirac semimetal appearing on the surface of a TI causes a transition into a chiral superconducting state, and exciton condensation in these gapless systems has long been envisioned in the physics of narrow-band semiconductors. Starting from the microscopic Dirac Hamiltonian with local attraction or repulsion, the Bardeen- Cooper-Schrieffer type of Gaussian approximation is developed in the framework of functional integrals. It is shown that owing to an ultrarelativistic dispersion relation, there is a quantum critical point governing the zero-temperature transition to a superconducting state or the exciton condensed state. Quantum transitions having critical exponents differ greatly from conventional ones and belong to the chiral universality class. We discuss the application of these results to recent experiments in which surface superconductivity was found in TIs and estimate the feasibility of phonon pairing.

关键词： topological insulator Weyl semimetal superconductivity quantum criticality

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Upper cluster algebras and choice of ground ring

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Science China Mathematics 2019年第7期62卷 1257-1266页

作者： Eric Bucher John Machacek Michael shapiro Department of Mathematics Xavier University Cincinnati OH 45207 USA Department of Mathematics and Statistics York University Toronto Ontario A13J 1P3 Canada Department of Mathematics Michigan State University East Lansing MI 48824 USA

We initiate a study of the dependence of the choice of ground ring on the problem on whether a cluster algebra is equal to its upper cluster algebra. A condition for when there is equality of the cluster algebra and upper cluster algebra is given by using a variation of Muller's theory of cluster localization. An explicit example exhibiting dependence on the ground ring is provided. We also present a maximal green sequence for this example.

关键词： cluster algebras upper cluster algebras locally acyclic cluster algebras

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Viscoelastic analysis of single-component and composite PEG and alginate hydrogels

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Acta Mechanica Sinica 2014年第1期30卷 7-14页

作者： Jenna M.shapiro Michelle L.Oyen Cambridge University Engineering Department CambridgeUK Eunice Kennedy Shriver National Institute of Child Health and Human Development National Institutes of Health

Hydrogels, three-dimensional hydrophilic polymer networks, are appealing candidate materials for study- ing the cellular microenvironment as their substantial water content helps to better mimic soft tissue. However, hydrogels can lack mechanical stiffness, strength, and tough- ness. Composite hydrogel systems have been shown to improve upon mechanical properties compared to their single- component counterparts. Poly （ethylene glycol） dimethacrylate （PEGDMA） and alginate are polymers that have been used to form hydrogels for biological applications. Single- component and composite PEGDMA and alginate systems were fabricated with a range of total polymer concentrations. Bulk gels were mechanically characterized using spherical indentation testing and a viscoelastic analysis framework. An increase in shear modulus with increasing polymer con- centration was demonstrated for all systems. Alginate hydro- gels were shown to have a smaller viscoelastic ratio than the PEGDMA gels, indicating more extensive relaxation over time. Composite alginate and PEGDMA hydrogels exhib- ited a combination of the mechanical properties of the con- stituents, as well as a qualitative increase in toughness. Additionally, multiple hydrogel systems were produced that had similar shear moduli, but different viscoelastic behaviors. Accurate measurement of the mechanical properties of hydrogels is necessary in order to determine what parameters are key in modeling the cellular microenvironment.

关键词： Hydrogel Viscoelastic Indentation Nanoin-dentation Composite

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An Efficient Multi-Scale Modelling Approach for ssDNA Motion in Fluid Flow

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Journal of Bionic Engineering 2008年第4期5卷 299-307页

作者： M. Benke E. shapiro D. Drikakis Fluid Mechanics and Computational Science Group Department of Aerospace Sciences Cranfield University

The paper presents a multi-scale modelling approach for simulating macromolecules in fluid flows. Macromolecule transport at low number densities is frequently encountered in biomedical devices, such as separators, detection and analysis systems. Accurate modelling of this process is challenging due to the wide range of physical scales involved. The continuum approach is not valid for low solute concentrations, but the large timescales of the fluid flow make purely molecular simulations prohibitively expensive. A promising multi-scale modelling strategy is provided by the meta-modelling approach considered in this paper. Meta-models are based on the coupled solution of fluid flow equations and equations of motion for a simplified mechanical model of macromolecules. The approach enables simulation of individual macromolecules at macroscopic time scales. Meta-models often rely on particle-corrector algorithms, which impose length constraints on the mechanical model. Lack of robustness of the particle-corrector algorithm employed can lead to slow convergence and numerical instability. A new FAst Linear COrrector （FALCO） algorithm is introduced in this paper, which significantly improves computational efficiency in comparison with the widely used SHAKE algorithm. Validation of the new particle corrector against a simple analytic solution is performed and improved convergence is demonstrated for ssDNA motion in a lid-driven micro-cavity.

关键词： multi-scale modelling DNA macromolecule transport meta-modelling particle corrector

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