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New clinical trial design in precision medicine:discovery,development and direction

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Signal Transduction and Targeted Therapy 2024年第4期9卷 1293-1321页

作者： Xiao-Peng Duan bao-dong Qin Xiao-dong Jiao Ke Liu Zhan Wang Yuan-Sheng Zang Department of Medical Oncology Changzheng HospitalNaval Medical UniversityShanghaiChina

In the era of precision medicine,it has been increasingly recognized that individuals with a certain disease are complex and different from each *** to the underestimation of the significant heterogeneity across participants in traditional"one-sizefits-all"trials,patient-centered trials that could provide optimal therapy customization to individuals with specific biomarkers were developed including the basket,umbrella,and platform trial designs under the master protocol *** recent years,the successive FDA approval of indications based on biomarker-guided master protocol designs has demonstrated that these new clinical trials are ushering in tremendous *** the rapid increase in the number of basket,umbrella,and platform trials,the current clinical and research understanding of these new trial designs,as compared with traditional trial designs,remains *** majority of the research focuses on methodologies,and there is a lack of in-depth insight concerning the underlying biological logic of these new clinical trial ***,we provide this comprehensive review of the discovery and development of basket,umbrella,and platform trials and their underlying logic from the perspective of precision ***,we discuss future directions on the potential development of these new clinical design in view of the"Precision Pro","Dynamic Precision",and"Intelligent Precision".This review would assist trial-related researche.s to enhance the innovation and feasibility of clinical trial designs by expounding the underlying logic,which be essential to accelerate the progression of precision medicine.

关键词： clinical approval successive

A 10-yr Rainfall and Cloud-to-Ground Lightning Climatology over Coastal and Inland Regions of Guangdong,China during the Pre-Summer Rainy Season

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Journal of Meteorological Research 2024年第3期38卷 469-488页

作者： Yuqing RUAN Rudi XIA Xinghua bao dong ZHENG Yan SHEN Jinfang YIN State Key Laboratory of Severe Weather Chinese Academy of Meteorological SciencesChina Meteorological AdministrationBeijing100081China Collaborative Innovation Center on Forecast and Evaluation of Meteorological Disasters Nanjing University of Information Science&TechnologyNanjing210044China National Meteorological Information Centre China Meteorological AdministrationBeijing100081China

A comparative analysis of the spatiotemporal distribution characteristics of rainfall and lightning in coastal and inland areas of Guangdong Province of China during the pre-summer rainy season(PSRS)from 2008 to 2017 reveals distinct *** the inland target region(ITR),rainfall is concentrated in the central and eastern mountainous *** exhibits a bimodal diurnal variation,with peaks in the afternoon and *** afternoon peak becomes more pronounced during the post-monsoon-onset period because of the increased rainfall ***,in the coastal target region(CTR),rainfall concentrates around mountainous ***,CTR’s rainfall is weaker than ITR’s during the pre-monsoon-onset period,primarily associated with the lower-level moisture outflow in CTR,but it strengthens significantly during the post-monsoon-onset period owing to enhanced moisture ***’s diurnal rainfall variation transitions from bimodal to a single broad peak during the post-monsoon-onset period,influenced by changes in both rainfall frequency and *** contrast to rainfall,the spatiotemporal distribution of lightning centers remains relatively stable during the *** strongest center is located over ITR’s plains west of the rainfall center,with a secondary center in the western plains of *** activity significantly increases during the post-monsoon-onset period,particularly in ITR,primarily because of the increased lightning *** diurnal lightning flash density and lightning hours show a single afternoon peak in the two target regions,and the timing of the peak in ITR is approximately two hours later than in *** circulation analysis indicates that during early morning,the lower atmosphere is nearly neutral in *** advected warm,moist,unstable airflow,combined with topography,favors convection *** the afternoon,solar radiation increases thermal instability,further enhancing the convection frequency and in

关键词： rainfall lightning spatiotemporal distribution diurnal variation pre-summer rainy season

Improving fatigue properties of normal direction ultrasonic vibration assisted face grinding Inconel 718 by regulating machined surface integrity

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International Journal of Extreme Manufacturing 2024年第3期6卷 458-475页

作者： Nianwei Xu Renke Kang Bi Zhang Yuan Zhang che.xu Wang Yan bao Zhigang dong State Key Laboratory of High-Performance Precision Manufacturing Dalian University of TechnologyDalian 116024People’s Republic of China Department of Mechanical and Energy Engineering Southern University of Science and TechnologyShenzhen 518055People’s Republic of China

Fatigue properties are crucial for critical aero-engine components in extreme serviceenvironments,which are significantly affected by surface integrity(SI)indexes(especially surface topography,residual stressσ_(res),and microhardness)after machining ***-direction ultrasonic vibration-assisted face grinding(ND-UVAFG)has advantages in improving the machinability of Inconel 718,but there is a competitive relationship between higher compressiveσ_(res)and higher surface roughness R_(a)in affecting fatigue *** lack of a quantitative relationship between multiple SI indexes and fatigue strength makes theindeterminacy of a regulatory strategy for improving fatigue *** this work,a model of fatigue strength(σ_f)_(sur)considering multiple SI indexes was ***,high-cycle fatigue tests were carried out on Inconel 718 samples with different SI characteristics,and the influence of ND-UVAFG process parameters on SI was *** on SI indexes data,the(σ_f)_(sur)distribution in the grinding surface layer for ND-UVAFG Inconel 718 samples was determined using the developed model,and then the fatigue crack initiation(FCI)sites were *** predicted FCI sites corresponded well with the experimental results,therebyverifying this model.A strategy for improving the fatigue life was proposed in this work,which was to transfer the fatigue source from the machined surface to the bulk material by controlling the SI ***,a critical condition of SI indexes that FCI sites appeared on the surface or in bulk material was given by fitting the predicted *** to the critical condition,an SI field where FCI sites appeared in the bulk material could be *** this field,thefatigue life of Inconel 718 samples could be improved by approximately 140%.

关键词： surface integrity fatigue strength Inconel 718 ultrasonic assisted grinding

Precise Planar-Twisted Molecular Engineering to Construct Semiconducting Polymers with Balanced Absorption and Quantum Yield for Efficient Phototheranostics

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Research 2024年第2期2023卷 227-238页

作者： Xiang Su Zhirong bao Wei Xie Deliang Wang Ting Han dong Wang Ben Zhong Tang Center for AIE Research Shenzhen Key Laboratory of Polymer Science and TechnologyGuangdong Research Center for Interfacial Engineering of Functional MaterialsCollege of Materials Science and EngineeringShenzhen UniversityShenzhen 518060China School of Biomedical and Pharmaceutical Sciences Guangdong University of TechnologyGuangzhou 510006China Department of Radiation and Medical Oncology Hubei Key Laboratory of Tumor Biological BehaviorsHubei Cancer Clinical Study CenterZhongnan Hospital of Wuhan UniversityWuhan 430071China Department of Materials che.istry Huzhou UniversityHuzhou 313000China School of Science and Engineering Shenzhen Institute of Aggregate Science and TechnologyThe Chinese University of Hong KongShenzhenGuangdong 518172China

Semiconducting polymers(SPs)have shown great feasibility as candidates for near-infrared-II(NIR-Ⅱ)fluorescence imaging-navigated photothermal therapy due to their strong light-harvesting ability and flexible ***,the fluorescence signal of traditional SPs tends to quench in their aggregate states owing to the strongπ-πstacking,which can lead to the radiative decay pathway shutting *** address this issue,aggregation-induced emission effect has been used as a rational tactic to boost the aggregate-state fluorescence of NIR-Ⅱ*** this contribution,we developed a precise molecular engineering tactic based on the block copolymerizations that integrate planar and twisted segments into one conjugated polymer backbone,providing great flexibility in tuning the photophysical properties and photothermal conversion capacity of *** monomers featured with twisted and planar architectures,respectively,were tactfully incorporated via a ternary copolymerization approach to produce a series of new *** optimal copolymer(SP2)synchronously shows desirable absorption ability and good NIR-Ⅱquantum yield on the premise of maintaining typical aggregation-induced emission characteristics,resulting in balanced NIR-Ⅱfluorescence brightness and photothermal ***-dispersible nanoparticles fabricated from the optimal SP2 show efficient photothermal therapeutic effects both in vitro and in *** in vivo investigation reveals the distinguished NIR-Ⅱfluorescence imaging performance of SP2 nanoparticles and their photothermal ablation toward tumor with prominent tumor accumulation ability and excellent biocompatibility.

关键词： property. conducting twisted

Silicone oil as a corneal lubricant to reduce corneal edema and improve visualization during

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International Journal of Ophthalmology(English edition) 2024年第1期17卷 92-96页

作者： Dan-Yang che.Zhu-Lin Chan Ji-Bo Zhou dong-Qing Zhu Department of Ophthalmology Ninth People’s HospitalShanghai Jiao Tong University School of MedicineShanghai 200011China College of Health Science and Technology Shanghai Jiao Tong University School of MedicineShanghai 200011China The PLA Navy Anqing Hospital Anqing 246004Anhui ProvinceChina

AIM:To evaluate the efficacy and safety of silicone oil(SO)as a corneal lubricant to improve visualization during ***:Patients who underwent vitreoretinal surgery were divided into two *** 1 was operated on with initial SO(Oxane 5700)as a corneal *** 2 was operated on with initial lactated ringer’s solution(LRS)and then replaced with SO as *** clarity was scored during the *** staining was performed to determine the damage to corneal ***:Totally 114 eyes of 114 patients were *** SO use maintained a clear cornea and provided excellent visualization of surgical *** group 1,the fundus clarity was grade 3 in 41/45 eyes and grade 2 in 4/45 *** group 2,corneal edema frequently occurred after initial LRS *** fundus clarity was grade 3 in 19/69 eyes,2 in 37/69 eyes and 1 in 13/69 eyes(P0.05).CONCLUSION:The use of SO as a corneal lubricant is effective and safe for preserving and improving corneal clarity and providing clear surgical field during vitrectomy.

关键词： silicone oil corneal lubricant corneal edema vitrectomy

Data-driven casting defect prediction model for sand casting based on random forest classification algorithm

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China Foundry 2024年第2期21卷 137-146页

作者： Bang Guan dong-hong Wang Da Shu Shou-qin Zhu Xiao-yuan Ji bao-de Sun Shanghai Key Lab of Advanced High-Temperature Materials and Precision Forming School of Materials Science and EngineeringShanghai Jiao Tong UniversityShanghai 200240China State Key Lab of Metal Matrix Composites Shanghai Jiao Tong UniversityShanghai 200240China Hefei Casting and Forging Factory of Anhui Heli Co. LtdHefei 230000China State Key Laboratory of Materials Processing and Die&Mould Technology Huazhong University of Science and TechnologyWuhan 430074China

The complex sand-casting process combined with the interactions between process parameters makes it difficult to control the casting quality,resulting in a high scrap rate.A strategy based on a data-driven model was proposed to reduce casting defects and improve production efficiency,which includes the random forest(RF)classification model,the feature importance analysis,and the process parameters optimization with Monte Carlo *** collected data includes four types of defects and corresponding process parameters were used to construct the RF *** results show a recall rate above 90% for all *** Gini Index was used to assess the importance of the process parameters in the formation of various defects in the RF ***,the classification model was applied to different production conditions for quality *** the case of process parameters optimization for gas porosity defects,this model serves as an experimental process in the Monte Carlo method to estimate a better temperature *** prediction model,when applied to the factory,greatly improved the efficiency of defect *** show that the scrap rate decreased from 10.16% to 6.68%.

关键词： sand casting process data-driven method classification model quality prediction feature importance

Multi-physical fields distribution in billet during helical electromagnetic stirring:A numerical simulation research

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China Foundry 2024年第1期21卷 51-59页

作者： dong Pan Qing-tao Guo Kai-lun Zhang Fu-zhi Yu Yu-ying Li Yu-bao Xiao State Key Laboratory of Metal Materials for Marine Equipment and Application Anshan 114009LiaoningChina Ansteel Beijing Research Institute Co. Ltd.Beijing 102200China

Electromagnetic stirring is one of the widely applied techniques to modify the quality of casting *** from conventional rotate stirring,the helical stirring is more professional in assisting multi-dimensional flow of molten metal and eliminating solidification *** this study,the single-winding helical stirring(SWHS)was introduced,offering advantages such as smaller volume and lower electromagnetic shielding compared to traditional helical stirring *** a comprehensive numerical simulation,the stirring parameters of SWHS were adjusted to yoke inclination angle of 43°and frequency of 12 *** higher electromagnetic force and flow velocity in drawing direction,as well as the lower temperature gradient induced by the SWHS,are positive factors for homogeneous solidification of *** experimental results on Al-8%Si alloy and 0.4%C-1.1%Mn steel demonstrate that compared to rotate stirring,the SWHS process can induce better billet quality and is more effective in accelerating the equiaxed expansion and reducing element *** SWHS process can enhance the equiaxed ratio of the billet by 58.3%and reduce segregation degree of carbon element by 10.97%.Consequently,SWHS holds great promise as a potential approach for improving the quality of continuous casting billets.

关键词： billet electromagnetic stirring helical solidification element segregation numerical simulation

Sensitivity impacts owing to the variations in the type of zero-range pairing forces on the fission properties using the density functional theory

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Nuclear Science and Techniques 2024年第3期35卷 198-207页

作者： Yang Su Ze-Yu Li Li-Le Liu Guo-Xiang dong Xiao-bao Wang Yong-Jing che. China Nuclear Data Center China Institute of Atomic EnergyBeijing 102413China School of Science Huzhou UniversityHuzhou 313000China

Using the Skyrme density functional theory,potential energy surfaces of^(240)Pu with constraints on the axial quadrupole and octupole deformations(q_(20)and q_(30))were *** volume-like and surface-like pairing forces,as well as a combination of these two forces,were used for the Hartree–Fock–Bogoliubov *** in the least-energy fission path,fission barrier,pairing energy,total kinetic energy,scission line,and mass distribution of the fission fragments based on the different forms of the pairing forces were analyzed and *** fission dynamics were studied based on the timedependent generator coordinate method plus the Gaussian overlap *** results demonstrated a sensitivity of the mass and charge distributions of the fission fragments on the form of the pairing *** on the investigation of the neutron-induced fission of^(239)Pu,among the volume,mixed,and surface pairing forces,the mixed pairing force presented a good reproduction of the experimental data.

关键词： Nuclear fission Density functional theory Pairing force Potential energy surfaces Fission fragment distribution

Dynamic shielding of bacterial outer membrane vesicles for safe and efficient che.o-immunotherapy against tumors

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Nano Research 2024年第2期17卷 836-847页

作者： Shuping Li Xin Li Jiaqi Meng Weier bao Shuang Wang Peng Ye Xiao-dong Gao Wei Wei Key Laboratory of Carbohydrate che.istry and Biotechnology Ministry of Education School of BiotechnologyJiangnan UniversityWuxi 214122China State Key Laboratory of Bioche.ical Engineering Institute of Process EngineeringChinese Academy of SciencesBeijing 100190China School of che.ical Engineering University of Chinese Academy of SciencesBeijing 100049China

Bacterial outer membrane vesicles(OMVs)are potent immunostimulants of regulating the tumor microenvironment(TME)for immunotherapy,and can be used to deliver ***,the severe systemic inflammatory response triggered by OMVs upon intravenous(i.v.)injection has limited their ***,we developed a safe and effective strategy by conjugating doxorubicin-loaded serum albumin(SA-DOX,AD)onto the surface of OMVs using a matrix metalloproteinase(MMP)-cleavable peptide linker(cL).This approach enabled the dynamic shielding of OMVs to reduce the systemic side effects while simultaneously enhancing the anti-tumor effects through ***,the resulting OMV-cL-AD formulation exhibited significantly enhanced accumulation at the tumor site after ***,facilitated by the SA decoration on the OMVs ***,the shield on the OMV-cL-AD was cleaved by the over-expressed MMP in the TME,leading to the release of both OMVs and *** process provided OMV-induced immunotherapy and DOX-induced che.otherapy,resulting in synergistic tumor *** conclusion,our work demonstrated the potential of OMV-cL-AD as an effective immunoche.otherapy strategy that can prolong the survival time of mice without inducing side effects.

关键词： outer membrane vesicles doxorubicin tumor microenvironment immunotherapy che.otherapy