In recent decades,control performance monitoring(CPM)has experienced remarkable progress in research and industrial applications.While CPM research has been investigated using various benchmarks,the historical data be...In recent decades,control performance monitoring(CPM)has experienced remarkable progress in research and industrial applications.While CPM research has been investigated using various benchmarks,the historical data benchmark(HIS)has garnered the most attention due to its practicality and effectiveness.However,existing CPM reviews usually focus on the theoretical benchmark,and there is a lack of an in-depth review that thoroughly explores HIS-based methods.In this article,a comprehensive overview of HIS-based CPM is provided.First,we provide a novel static-dynamic perspective on data-level manifestations of control performance underlying typical controller capacities including regulation and servo:static and dynamic properties.The static property portrays time-independent variability in system output,and the dynamic property describes temporal behavior driven by closed-loop feedback.Accordingly,existing HIS-based CPM approaches and their intrinsic motivations are classified and analyzed from these two perspectives.Specifically,two mainstream solutions for CPM methods are summarized,including static analysis and dynamic analysis,which match data-driven techniques with actual controlling behavior.Furthermore,this paper also points out various opportunities and challenges faced in CPM for modern industry and provides promising directions in the context of artificial intelligence for inspiring future research.展开更多
Objective:To evaluate the efficacy and safety of acupoint application for post-stroke depression(PSD)by regulating gastrointestinal function.A secondary objective is to explore the potential mechanism underlying this ...Objective:To evaluate the efficacy and safety of acupoint application for post-stroke depression(PSD)by regulating gastrointestinal function.A secondary objective is to explore the potential mechanism underlying this approach from the perspective of gut microbiota.Methods:This multicenter,randomized,double-blind(patients and assessors),placebo-controlled trial will enroll 80 patients with PSD,and include a 1-week run-in period,a 4-week treatment phase,and a 12-week follow-up.Eligible participants will randomly be assigned in a 1:1 ratio to either the acupoint application or placebo(non-acupoint)groups.Treatments will be administered thrice weekly for 4 weeks.The primary outcome is change in the Hamilton Rating Scale for Depression(HAMD)score.Secondary outcomes include the Beck Depression Inventory(BDI),36-Item Short-Form Health Survey(SF-36),Barthel Index of Activities of Daily Living,Social Adaptation Self-Evaluation Scale(SASS),and gut microbiota profiling.All outcomes will be assessed at baseline(prior to treatment),during treatment(weeks 2 and 4),and during follow-up(weeks 8,12,and 16).The Treatment Emergent Symptom Scale(TESS)will be used for evaluation throughout the 4-week treatment phase.Discussion:The results of this study will provide important evidence supporting a novel treatment strategy for PSD that targets gastrointestinal regulation,potentially informing future clinical practice.展开更多
Dear Editor,The attacker is always going to intrude covertly networked control systems(NCSs)by dynamically changing false data injection attacks(FDIAs)strategy,while the defender try their best to resist attacks by de...Dear Editor,The attacker is always going to intrude covertly networked control systems(NCSs)by dynamically changing false data injection attacks(FDIAs)strategy,while the defender try their best to resist attacks by designing defense strategy on the basis of identifying attack strategy,maintaining stable operation of NCSs.To solve this attack-defense game problem,this letter investigates optimal secure control of NCSs under FDIAs.First,for the alterations of energy caused by false data,a novel attack-defense game model is constructed,which considers the changes of energy caused by the actions of the defender and attacker in the forward and feedback channels.展开更多
Dear Editor,This letter is concerned with a coordinated path following control method for multiple unmanned underwater vehicles(UUVs)to carry out maritime search and rescue(MSR)missions.The kinetic model parameters of...Dear Editor,This letter is concerned with a coordinated path following control method for multiple unmanned underwater vehicles(UUVs)to carry out maritime search and rescue(MSR)missions.The kinetic model parameters of each UUV is totally unknown.Firstly,a kinematic control law is constructed by designing a vertical line-of-sight(LOS)guidance scheme.展开更多
[Objective]In response to the issue of insufficient integrity in hourly routine meteorological element data files,this paper aims to improve the availability and reliability of data files,and provide high-quality data...[Objective]In response to the issue of insufficient integrity in hourly routine meteorological element data files,this paper aims to improve the availability and reliability of data files,and provide high-quality data file support for meteorological forecasting and services.[Method]In this paper,an efficient and accurate method for data file quality control and fusion processing is developed.By locating the missing measurement time,data are extracted from the"AWZ.db"database and the minute routine meteorological element data file,and merged into the hourly routine meteorological element data file.[Result]Data processing efficiency and accuracy are significantly improved,and the problem of incomplete hourly routine meteorological element data files is solved.At the same time,it emphasizes the importance of ensuring the accuracy of the files used and carefully checking and verifying the fusion results,and proposes strategies to improve data quality.[Conclusion]This method provides convenience for observation personnel and effectively improves the integrity and accuracy of data files.In the future,it is expected to provide more reliable data support for meteorological forecasting and services.展开更多
In order to further enhance the numerical application of weather radar radial velocity,this paper proposes a quality control scheme for weather radar radial velocity from the perspective of data assimilation.The propo...In order to further enhance the numerical application of weather radar radial velocity,this paper proposes a quality control scheme for weather radar radial velocity from the perspective of data assimilation.The proposed scheme is based on the WRFDA(Weather Research and Forecasting Data Assimilation)system and utilizes the biweight algorithm to perform quality control on weather radar radial velocity data.A series of quality control tests conducted over the course of one month demonstrate that the scheme can be seamlessly integrated into the data assimilation process.The scheme is characterized by its simplicity,fast implementation,and ease of maintenance.By determining an appropri-ate threshold for quality control,the percentage of outliers identified by the scheme remains highly stable over time.Moreover,the mean errors and standard deviations of the O-B(observation-minus-background)values are significantly reduced,improving the overall data quality.The main information and spatial distribution features of the data are pre-served effectively.After quality control,the distribution of the O-B Probability Density Function is adjusted in a manner that brings it closer to a Gaussian distribution.This adjustment is beneficial for the subsequent data assimilation process,contributing to more accurate numerical weather predictions.Thus,the proposed quality control scheme provides a valuable tool for improving weather radar data quality and enhancing numerical forecasting performance.展开更多
This article focuses on the current computer monitoring and control as the research direction,studying the application strategies of artificial intelligence and big data technology in this field.It includes an introdu...This article focuses on the current computer monitoring and control as the research direction,studying the application strategies of artificial intelligence and big data technology in this field.It includes an introduction to artificial intelligence and big data technology,the application strategies of artificial intelligence and big data technology in computer hardware,software,and network monitoring,as well as the application strategies of artificial intelligence and big data technology in computer process,access,and network control.This analysis aims to serve as a reference for the application of artificial intelligence and big data technology in computer monitoring and control,ultimately enhancing the security of computer systems.展开更多
In the production processes of modern industry,accurate assessment of the system’s health state and traceability non-optimal factors are key to ensuring“safe,stable,long-term,full load and optimal”operation of the ...In the production processes of modern industry,accurate assessment of the system’s health state and traceability non-optimal factors are key to ensuring“safe,stable,long-term,full load and optimal”operation of the production process.The benzene-to-ethylene ratio control system is a complex system based on anMPC-PID doublelayer architecture.Taking into consideration the interaction between levels,coupling between loops and conditions of incomplete operation data,this paper proposes a health assessment method for the dual-layer control system by comprehensively utilizing deep learning technology.Firstly,according to the results of the pre-assessment of the system layers and loops bymultivariate statisticalmethods,seven characteristic parameters that have a significant impact on the health state of the system are identified.Next,aiming at the problem of incomplete assessment data set due to the uneven distribution of actual system operating health state,the original unbalanced dataset is augmented using aWasserstein generative adversarial network with gradient penalty term,and a complete dataset is obtained to characterise all the health states of the system.On this basis,a new deep learning-based health assessment framework for the benzeneto-ethylene ratio control system is constructed based on traditionalmultivariate statistical assessment.This framework can overcome the shortcomings of the linear weighted fusion related to the coupling and nonlinearity of the subsystem health state at different layers,and reduce the dependence of the prior knowledge.Furthermore,by introducing a dynamic attention mechanism(AM)into the convolutional neural network(CNN),the assessment model integrating both assessment and traceability is constructed,which can achieve the health assessment and trace the non-optimal factors of the complex control systems with the double-layer architecture.Finally,the effectiveness and superiority of the proposed method have been verified by the benzene-ethylene ratio control system of the alkylation process unit in a styrene plant.展开更多
Background: Insomnia is a common complaint that is closely related to gastrointestinal symptoms, which is consistent with the traditional Chinese medicine classical theory of ‘‘stomach disharmony leading to restless...Background: Insomnia is a common complaint that is closely related to gastrointestinal symptoms, which is consistent with the traditional Chinese medicine classical theory of ‘‘stomach disharmony leading to restless sleep." Acupuncture is an effective complementary and alternative medicine therapy to improve gastrointestinal function and restore the normal sleep-wake cycle. However, studies on the effectiveness of acupuncture for insomnia due to spleen-stomach disharmony syndrome are limited to case reports and few randomized controlled trials; deeper research on its mechanism is still lacking. This randomized controlled trial aims to assess the treatment efficacy of ‘‘harmonizing stomach to tranquilize mind"acupuncture for insomnia and its influence on the intestinal microbiome.Methods/design: This is a randomized, single-blind, parallel-group study. Sixty eligible patients with insomnia due to spleen-stomach disharmony syndrome will be randomly divided into two groups(1:1 allocation ratio). The intervention group will use ‘‘harmonizing stomach to tranquilize mind"acupuncture, and the control group will receive sham acupuncture. Participants will receive 5 acupuncture treatment sessions per week for 4 consecutive weeks. The Pittsburgh Sleep Quality Index will be used to evaluate the clinical efficacy of acupuncture treatment by making assessments at baseline, the end of treatment and the end of the follow-up. High-throughput 16 S ribosomal ribonucleic acid gene sequencing will be performed to detect changes in the intestinal microbial composition before and after treatment.Discussion: The results of this trial are expected to confirm that ‘‘harmonizing stomach to tranquilize mind" acupuncture can effectively relieve insomnia and alter the intestinal microbiome.展开更多
Background: Fire-needle acupuncture, an important kind of acupuncture therapy, has been clinically used to treat upper limb spastic paralysis(ULSP) after stroke. Clinical experience has indicated that fire-needle acup...Background: Fire-needle acupuncture, an important kind of acupuncture therapy, has been clinically used to treat upper limb spastic paralysis(ULSP) after stroke. Clinical experience has indicated that fire-needle acupuncture treatment takes less time, requires fewer visits, and has more rapid results and fewer side effects compared to chemical medicine alternatives. This study will evaluate the effects of fire-needle acupuncture for ULSP in the context of standardized clinical research and provide high-quality data to inform clinical procedures and future study design.Methods/Design: A randomized controlled trial will be carried out to evaluate the effects of fire-needle acupuncture therapy in patients with ULSP from stroke. ULSP patients(n = 120) will be recruited at Changhai Hospital in Shanghai, China. Patients will be randomly divided into three groups, including fire-needle acupuncture group(FAG), filiform-needle acupuncture group(FFAG) and rehabilitation treatment group(RTG). During the 3-week treatment, the FAG will be treated every two days, while FFAG and RTG will be treated 5 d in a row and then rest for 2 d. The Simplified Fugl-Meyer Motor Function Scale and Modified Ashworth Scale will be used as the primary outcome measures. Statistical analysis will be conducted by an independent statistician.Discussion: Through this study, the utility of fire-needle acupuncture in treating ULSP after stroke will be tested, and some specific claims of fire-needle acupuncture therapy will be evaluated, such as relieving spasm and muscular tension, improving activities of daily living, rapidity of response and less frequency of treatment compared with other treatments.展开更多
BACKGROUND： Chronic obstructive pulmonary disease （COPD） is a major public health problem worldwide. Pulmonary rehabilitation （PR） is an established intervention for the management of patients with COPD. Exercise...BACKGROUND： Chronic obstructive pulmonary disease （COPD） is a major public health problem worldwide. Pulmonary rehabilitation （PR） is an established intervention for the management of patients with COPD. Exercise training is an important part of PR, and its effectiveness in patients with COPD is well established. However, alternative methods of PR training such as Daoyin have not been appropriately studied. Hence, alternative forms of exercise training that require less exercise equipment and no specific training place should be evaluated. This paper describes the study protocol of a clinical trial that aims to determine if pulmonary Daoyin training will improve the exercise capacity and psychosocial function of patients with COPD in China. METHODS AND DESIGN： A multicenter, randomized, controlled trial will be conducted. A total of 464 patients meeting the inclusion criteria will be enrolled into this study with 232 patients in each of the trial group and the control group. Based on patient education, patients in the trial group will receive pulmonary Daoyin and continue with their usual therapy for three months. In the control group, patients will continue with their usual therapy. The primary outcome measures are exercise capacity assessed by the six-minute walking distance test and lung function. Secondary outcomes include dyspnea and quality of life. Measurements will be taken at baseline （month 0） and after the study period （month 3）. DISCUSSION： It is hypothesized that pulmonary Daoyin will have beneficial effects in improving exercise capacity and psychosocial function of patients with stable COPD, and will provide an alternative form of exercise training that is accessible for the large number of people with COPD. TRIAL REGISTRATION： This trial has been registered in ClinicalTrials.gov. The identifier is NCT01482000.展开更多
Offshore waters provide resources for human beings,while on the other hand,threaten them because of marine disasters.Ocean stations are part of offshore observation networks,and the quality of their data is of great s...Offshore waters provide resources for human beings,while on the other hand,threaten them because of marine disasters.Ocean stations are part of offshore observation networks,and the quality of their data is of great significance for exploiting and protecting the ocean.We used hourly mean wave height,temperature,and pressure real-time observation data taken in the Xiaomaidao station(in Qingdao,China)from June 1,2017,to May 31,2018,to explore the data quality using eight quality control methods,and to discriminate the most effective method for Xiaomaidao station.After using the eight quality control methods,the percentages of the mean wave height,temperature,and pressure data that passed the tests were 89.6%,88.3%,and 98.6%,respectively.With the marine disaster(wave alarm report)data,the values failed in the test mainly due to the influence of aging observation equipment and missing data transmissions.The mean wave height is often affected by dynamic marine disasters,so the continuity test method is not effective.The correlation test with other related parameters would be more useful for the mean wave height.展开更多
In this paper, the stability of iterative learning control with data dropouts is discussed. By the super vector formulation, an iterative learning control （ILC） system with data dropouts can be modeled as an asynchr...In this paper, the stability of iterative learning control with data dropouts is discussed. By the super vector formulation, an iterative learning control （ILC） system with data dropouts can be modeled as an asynchronous dynamical system with rate constraints on events in the iteration domain. The stability condition is provided in the form of linear matrix inequalities （LMIS） depending on the stability of asynchronous dynamical systems. The analysis is supported by simulations.展开更多
BACKGROUND： Rheumatoid arthritis （RA）, as a common systemic inflammatory autoimmune disease, affects approximately 1 in 100 individuals. Effective treatment for RA is not yet available because current research does...BACKGROUND： Rheumatoid arthritis （RA）, as a common systemic inflammatory autoimmune disease, affects approximately 1 in 100 individuals. Effective treatment for RA is not yet available because current research does not have a clear understanding of the etiology and pathogenesis of RA. Xinfeng Capsule, a patent Chinese herbal medicine, has been used in the treatment of RA in recent years. Despite its reported clinical efficacy, there are no large-sample, multicenter, randomized trials that support the use of Xinfeng Capsule for RA. Therefore, we designed a randomized, double-blind, multicenter, placebo-controlled trial to assess the efficacy and safety of Xinfeng Capsule in the treatment of RA. METHODS AND DESIGN： This is a 12-week, randomized, placebo-controlled, double-blind, multicenter trial on the treatment of RA. The participants will be randomly assigned to the experimental group and the control group at a ratio of 1：1. Participants in the experimental group will receive Xinfeng Capsule and a pharmaceutical placebo （imitation leflunomide）. The control group will receive leflunomide and an herbal placebo （imitation Xinfeng Capsule）. The American College of Rheumatology （ACR） Criteria for RA will be used to measure the efficacy of the Xinfeng Capsule. The primary outcome measure will be the percentage of study participants who achieve an ACR 20% response rate （ACR20）, which will be measured every 4 weeks after randomization. Secondary outcomes will include the ACR50 and ACR70 responses, the side effects of the medications, the Disease Activity Score 28, RA biomarkers, quality of life, and X-rays of the hands and wrists. The first four of the secondary outcomes will be measured every 4 weeks and the others will be measured at baseline and after 12 weeks of treatment. DISCUSSION： The result of this trial will help to evaluate whether Xinfeng Capsule is effective and safe in the treatment of RA. TRIAL REGISTRATION： This trial has been registered in ClinicalTrials.gov. The identifier is N CT01774877.展开更多
Owing to wide applications of automatic control systems in the process industries, the impacts of controller performance on industrial processes are becoming increasingly significant. Consequently, controller maintena...Owing to wide applications of automatic control systems in the process industries, the impacts of controller performance on industrial processes are becoming increasingly significant. Consequently, controller maintenance is critical to guarantee routine operations of industrial processes. The workflow of controller maintenance generally involves the following steps: monitor operating controller performance and detect performance degradation, diagnose probable root causes of control system malfunctions, and take specific actions to resolve associated problems. In this article, a comprehensive overview of the mainstream of control loop monitoring and diagnosis is provided, and some existing problems are also analyzed and discussed. From the viewpoint of synthesizing abundant information in the context of big data, some prospective ideas and promising methods are outlined to potentially solve problems in industrial applications.展开更多
BACKGROUND： Parkinson＇s disease （PD） is a complicated disease, commonly diagnosed among the elderly, which leads to degeneration of the central nervous system. It presently lacks an effective therapy for its compl...BACKGROUND： Parkinson＇s disease （PD） is a complicated disease, commonly diagnosed among the elderly, which leads to degeneration of the central nervous system. It presently lacks an effective therapy for its complex pathogenesis. Adverse effects from Western drug-based medical intervention prevent long-term adherence to these therapies in many patients. Traditional Chinese medicine （TCM） has long been used to improve the treatment of PD by alleviating the toxic and adverse effects of Western drug-based intervention. Therefore, the aim of this study is to evaluate the efficacy and safety of Xifeng Dingchan Pill （XFDCP）, a compound traditional Chinese herbal medicine, taken in conjunction with Western medicine in the treatment of PD patients at different stages in the progression of the disease. METHODS AND DESIGN： This is a multicenter, randomized controlled trial. In total, 320 patients with early- （n = 160） and middle-stage PD （n = 160） will be enrolled and divided evenly into control and trial groups. Of the 160 patients with early-stage PD, the trial group （n = 80） will be given XFDCP, and the control group （n = 80） will be given Madopar. Of the 160 patients with middle-stage PD, the trial group （n = 80） will be given XFDCP combined with Madopar and Piribedil, and the control group （n = 80） will be given Madopar and Piribedil. The Unified Parkinson＇s Disease Rating Scale scores, TCM symptoms scores, quality of life, change of Madopar＇s dosage and the toxic and adverse effects of Madopar will be observed during a 3-month treatment period and through a further 6-month follow-up period. DISCUSSION： It is hypothesized that XFDCP, combined with Madopar and Piribedil, will have beneficial effects on patients with PD. The results of this study will provide evidence for developing a comprehensive therapy regimen, which can delay the progress of the disease and improve the quality of life for PD patients in different stages. TRIAL REGISTRATION： This trial has been registered in the Chinese Clinical Trial Registry with the identifer ChiCTR-TRC-12002150.展开更多
Different choices of control variables in variational assimilation can bring about different influences on the analyzed atmospheric state. Based on the WRF model＇s three-dimensional variational assimilation system, t...Different choices of control variables in variational assimilation can bring about different influences on the analyzed atmospheric state. Based on the WRF model＇s three-dimensional variational assimilation system, this study compares the be- havior of two momentum control variable options-streamfunction velocity potential （ψ-χ） and horizontal wind components （U-V）-in radar wind data assimilation for a squall line case that occurred in Jiangsu Province on 24 August 2014. The wind increment from the single observation test shows that the ψ-χ control variable scheme produces negative increments in the neighborhood around the observation point because streamfunction and velocity potential preserve integrals of velocity. On the contrary, the U-V control variable scheme objectively reflects the information of the observation itself. Furthermore, radial velocity data from 17 Doppler radars in eastern China are assimilated. As compared to the impact of conventional observation, the assimilation of radar radial velocity based on the U-V control variable scheme significantly improves the mesoscale dynamic field in the initial condition. The enhanced low-level jet stream, water vapor convergence and low-level wind shear result in better squall line forecasting. However, the ψ-χ control variable scheme generates a discontinuous wind field and unrealistic convergence/divergence in the analyzed field, which lead to a degraded precipitation forecast.展开更多
Consensus tracking control problems for single-integrator dynamics of multi-agent systems with switching topology are investigated. In order to design effective consensus tracking protocols for a more general class of...Consensus tracking control problems for single-integrator dynamics of multi-agent systems with switching topology are investigated. In order to design effective consensus tracking protocols for a more general class of networks, which are aimed at ensuring that the concerned states of agents converge to a constant or time-varying reference state, new consensus tracking protocols with a constant and time-varying reference state are proposed, respectively. Particularly, by contrast with spanning tree, an improved condition of switching interaction topology is presented. And then, convergence analysis of two consensus tracking protocols is provided by Lyapunov stability theory. Moreover, consensus tracking protocol with a time-varying reference state is extended to achieve the fbrmation control. By introducing formation structure set, each agent can gain its individual desired trajectory. Finally, several simulations are worked out to illustrate the effectiveness of theoretical results. The test results show that the states of agents can converge to a desired constant or time-varying reference state. In addition, by selecting appropriate structure set, agents can maintain the expected formation under random switching interaction topologies.展开更多
BACKGROUND： Traditional Chinese medicine （TCM） is considered an important complementary therapy with beneficial effects for cancer patients. Elderly patients with non-small-cell lung cancer （NSCLC） are a complex ...BACKGROUND： Traditional Chinese medicine （TCM） is considered an important complementary therapy with beneficial effects for cancer patients. Elderly patients with non-small-cell lung cancer （NSCLC） are a complex patient group with increasing co-morbidity and shrinking physiological reserve, and may derive substantial benefit from the supportive aspects of TCM Researchers from Shanghai Longhua Hospital found that qi and yin deficiency is a common syndrome in patients with stage III or IV lung cancer. This project was designed to study the combination of single-agent chemotherapy with TCM methods of benefiting qi and yin in elderly patients with advanced NSCLC. METHODS AND DESIGN： This is a double-blind controlled, multi-center, and prospective study with randomly selected participants from elderly NSCLC patients in China. Seventy-six patients who meet the inclusion criteria will be allocated into two groups, which will receive treatments of 3-week single-agent chemotherapy with TCM or placebo for four cycles Progression-free survival （PFS） is the primary end point, and the secondary end points are overall survival, objective response rate, time-to-progression, and quality of life （EORTC QLQ-LC43, and TCM syndrome score） Meanwhile, other end points such as toxicity, side effects and safety of the treatments will be assessed. DISCUSSION： Results from this study may provide evidence on the effectiveness, and parameters for the usage of single-agent chemotherapy combined with or without TCM on PFS of elderly patients with NSCLC.展开更多
Human umbilical cord mesenchymal stem cells(hUC-MSCs)support revascularization,inhibition of inflammation,regulation of apoptosis,and promotion of the release of beneficial factors.Thus,they are regarded as a promisin...Human umbilical cord mesenchymal stem cells(hUC-MSCs)support revascularization,inhibition of inflammation,regulation of apoptosis,and promotion of the release of beneficial factors.Thus,they are regarded as a promising candidate for the treatment of intractable spinal cord injury(SCI).Clinical studies on patients with early chronic SCI(from 2 months to 1 year post-injury),which is clinically common,are rare;therefore,we will conduct a prospective,multicenter,randomized,placebo-controlled,single-blinded clinical trial at the Third Affiliated Hospital of Sun Yat-sen University,West China Hospital of Sichuan University,and Shanghai East Hospital,Tongji University School of Medicine,China.The trial plans to recruit 66 early chronic SCI patients.Eligible patients will undergo randomization at a 2:1 ratio to two arms:the observation group and the control group.Subjects in the observation group will receive four intrathecal transplantations of stem cells,with a dosage of 1×106/kg,at one calendar month intervals.Subjects in the control group will receive intrathecal administrations of 10 mL sterile normal saline in place of the stem cell transplantations.Clinical safety will be assessed by the analysis of adverse events and laboratory tests.The American Spinal Injury Association(ASIA)total score will be the primary efficacy endpoint,and the secondary efficacy outcomes will be the following:ASIA impairment scale,International Association of Neural Restoration-Spinal Cord Injury Functional Rating Scale,muscle tension,electromyogram,cortical motor and cortical sensory evoked potentials,residual urine volume,magnetic resonance imaging–diffusion tensor imaging,T cell subtypes in serum,neurotrophic factors and inflammatory factors in both serum and cerebrospinal fluid.All evaluations will be performed at 1,3,6,and 12 months following the final intrathecal administration.During the entire study procedure,all adverse events will be reported as soon as they are noted.This trial is designed to evaluate the clinical safety and efficacy of subarachnoid transplantation of hUC-MSCs to treat early chronic SCI.Moreover,it will establish whether cytotherapy can ameliorate local hostile microenvironments,promote tracking fiber regeneration,and strengthen spinal conduction ability,thus improving overall motor,sensory,and micturition/defecation function in patients with early chronic SCI.This study was approved by the Stem Cell Research Ethics Committee of the Third Affiliated Hospital of Sun Yat-sen University,China(approval No.[2018]-02)on March 30,2018,and was registered with ClinicalTrials.gov(registration No.NCT03521323)on April 12,2018.The revised trial protocol(protocol version 4.0)was approved by the Stem Cell Research Ethics Committee of the Third Affiliated Hospital of Sun Yat-sen University,China(approval No.[2019]-10)on February 25,2019,and released on ClinicalTrials.gov on April 29,2019.展开更多
基金supported in part by the National Natural Science Foundation of China(62125306)Zhejiang Key Research and Development Project(2024C01163)the State Key Laboratory of Industrial Control Technology,China(ICT2024A06)
文摘In recent decades,control performance monitoring(CPM)has experienced remarkable progress in research and industrial applications.While CPM research has been investigated using various benchmarks,the historical data benchmark(HIS)has garnered the most attention due to its practicality and effectiveness.However,existing CPM reviews usually focus on the theoretical benchmark,and there is a lack of an in-depth review that thoroughly explores HIS-based methods.In this article,a comprehensive overview of HIS-based CPM is provided.First,we provide a novel static-dynamic perspective on data-level manifestations of control performance underlying typical controller capacities including regulation and servo:static and dynamic properties.The static property portrays time-independent variability in system output,and the dynamic property describes temporal behavior driven by closed-loop feedback.Accordingly,existing HIS-based CPM approaches and their intrinsic motivations are classified and analyzed from these two perspectives.Specifically,two mainstream solutions for CPM methods are summarized,including static analysis and dynamic analysis,which match data-driven techniques with actual controlling behavior.Furthermore,this paper also points out various opportunities and challenges faced in CPM for modern industry and provides promising directions in the context of artificial intelligence for inspiring future research.
基金supported by the Chinese Medicine Development Fund,Hong Kong SAR,China(23B2/027A_R1)the National Natural Science Foundation of China(81704198).
文摘Objective:To evaluate the efficacy and safety of acupoint application for post-stroke depression(PSD)by regulating gastrointestinal function.A secondary objective is to explore the potential mechanism underlying this approach from the perspective of gut microbiota.Methods:This multicenter,randomized,double-blind(patients and assessors),placebo-controlled trial will enroll 80 patients with PSD,and include a 1-week run-in period,a 4-week treatment phase,and a 12-week follow-up.Eligible participants will randomly be assigned in a 1:1 ratio to either the acupoint application or placebo(non-acupoint)groups.Treatments will be administered thrice weekly for 4 weeks.The primary outcome is change in the Hamilton Rating Scale for Depression(HAMD)score.Secondary outcomes include the Beck Depression Inventory(BDI),36-Item Short-Form Health Survey(SF-36),Barthel Index of Activities of Daily Living,Social Adaptation Self-Evaluation Scale(SASS),and gut microbiota profiling.All outcomes will be assessed at baseline(prior to treatment),during treatment(weeks 2 and 4),and during follow-up(weeks 8,12,and 16).The Treatment Emergent Symptom Scale(TESS)will be used for evaluation throughout the 4-week treatment phase.Discussion:The results of this study will provide important evidence supporting a novel treatment strategy for PSD that targets gastrointestinal regulation,potentially informing future clinical practice.
基金supported in part by the National Science Foundation of China(62373240,62273224,U24A20259).
文摘Dear Editor,The attacker is always going to intrude covertly networked control systems(NCSs)by dynamically changing false data injection attacks(FDIAs)strategy,while the defender try their best to resist attacks by designing defense strategy on the basis of identifying attack strategy,maintaining stable operation of NCSs.To solve this attack-defense game problem,this letter investigates optimal secure control of NCSs under FDIAs.First,for the alterations of energy caused by false data,a novel attack-defense game model is constructed,which considers the changes of energy caused by the actions of the defender and attacker in the forward and feedback channels.
基金supported by the National Science and Technology Major Project(2022ZD0119902)the Doctoral Scientific Research Foundation of Liaoning Province(2023-BS-077)+2 种基金the Postdoctoral Research Foundation of China(2024M751980)the Open Project of State Key Laboratory of Maritime Technology and Safety(SKLMTA-DMU2024Y3)Bolian Research Funds of Dalian Maritime University/Fundamental Research Funds for the Central Universities(3132023616).
文摘Dear Editor,This letter is concerned with a coordinated path following control method for multiple unmanned underwater vehicles(UUVs)to carry out maritime search and rescue(MSR)missions.The kinetic model parameters of each UUV is totally unknown.Firstly,a kinematic control law is constructed by designing a vertical line-of-sight(LOS)guidance scheme.
基金the Fifth Batch of Innovation Teams of Wuzhou Meteorological Bureau"Wuzhou Innovation Team for Enhancing the Comprehensive Meteorological Observation Ability through Digitization and Intelligence"Wuzhou Science and Technology Planning Project(202402122,202402119).
文摘[Objective]In response to the issue of insufficient integrity in hourly routine meteorological element data files,this paper aims to improve the availability and reliability of data files,and provide high-quality data file support for meteorological forecasting and services.[Method]In this paper,an efficient and accurate method for data file quality control and fusion processing is developed.By locating the missing measurement time,data are extracted from the"AWZ.db"database and the minute routine meteorological element data file,and merged into the hourly routine meteorological element data file.[Result]Data processing efficiency and accuracy are significantly improved,and the problem of incomplete hourly routine meteorological element data files is solved.At the same time,it emphasizes the importance of ensuring the accuracy of the files used and carefully checking and verifying the fusion results,and proposes strategies to improve data quality.[Conclusion]This method provides convenience for observation personnel and effectively improves the integrity and accuracy of data files.In the future,it is expected to provide more reliable data support for meteorological forecasting and services.
基金funded by Beijige Fund of Nanjing Joint Institute for Atmospheric Sciences(BJG202501)the Joint Research Project for Meteorological Capacity Improvement(22NLTSY009)+2 种基金Key Scientific Research Projects of Jiangsu Provincial Meteorological Bureau(KZ202203)China Meteorological Administration projects(CMAJBGS202316)the Guiding Research Projects of Jiangsu Provincial Meteorological Bureau(ZD202404,ZD202419).
文摘In order to further enhance the numerical application of weather radar radial velocity,this paper proposes a quality control scheme for weather radar radial velocity from the perspective of data assimilation.The proposed scheme is based on the WRFDA(Weather Research and Forecasting Data Assimilation)system and utilizes the biweight algorithm to perform quality control on weather radar radial velocity data.A series of quality control tests conducted over the course of one month demonstrate that the scheme can be seamlessly integrated into the data assimilation process.The scheme is characterized by its simplicity,fast implementation,and ease of maintenance.By determining an appropri-ate threshold for quality control,the percentage of outliers identified by the scheme remains highly stable over time.Moreover,the mean errors and standard deviations of the O-B(observation-minus-background)values are significantly reduced,improving the overall data quality.The main information and spatial distribution features of the data are pre-served effectively.After quality control,the distribution of the O-B Probability Density Function is adjusted in a manner that brings it closer to a Gaussian distribution.This adjustment is beneficial for the subsequent data assimilation process,contributing to more accurate numerical weather predictions.Thus,the proposed quality control scheme provides a valuable tool for improving weather radar data quality and enhancing numerical forecasting performance.
文摘This article focuses on the current computer monitoring and control as the research direction,studying the application strategies of artificial intelligence and big data technology in this field.It includes an introduction to artificial intelligence and big data technology,the application strategies of artificial intelligence and big data technology in computer hardware,software,and network monitoring,as well as the application strategies of artificial intelligence and big data technology in computer process,access,and network control.This analysis aims to serve as a reference for the application of artificial intelligence and big data technology in computer monitoring and control,ultimately enhancing the security of computer systems.
基金supported by the National Science Foundation of China(62263020)the Key Project of Natural Science Foundation of Gansu Province(25JRRA061)+1 种基金the Key R&D Program of Gansu Province(23YFGA0061)the Scientific Research Initiation Fund of Lanzhou University of Technology(061602).
文摘In the production processes of modern industry,accurate assessment of the system’s health state and traceability non-optimal factors are key to ensuring“safe,stable,long-term,full load and optimal”operation of the production process.The benzene-to-ethylene ratio control system is a complex system based on anMPC-PID doublelayer architecture.Taking into consideration the interaction between levels,coupling between loops and conditions of incomplete operation data,this paper proposes a health assessment method for the dual-layer control system by comprehensively utilizing deep learning technology.Firstly,according to the results of the pre-assessment of the system layers and loops bymultivariate statisticalmethods,seven characteristic parameters that have a significant impact on the health state of the system are identified.Next,aiming at the problem of incomplete assessment data set due to the uneven distribution of actual system operating health state,the original unbalanced dataset is augmented using aWasserstein generative adversarial network with gradient penalty term,and a complete dataset is obtained to characterise all the health states of the system.On this basis,a new deep learning-based health assessment framework for the benzeneto-ethylene ratio control system is constructed based on traditionalmultivariate statistical assessment.This framework can overcome the shortcomings of the linear weighted fusion related to the coupling and nonlinearity of the subsystem health state at different layers,and reduce the dependence of the prior knowledge.Furthermore,by introducing a dynamic attention mechanism(AM)into the convolutional neural network(CNN),the assessment model integrating both assessment and traceability is constructed,which can achieve the health assessment and trace the non-optimal factors of the complex control systems with the double-layer architecture.Finally,the effectiveness and superiority of the proposed method have been verified by the benzene-ethylene ratio control system of the alkylation process unit in a styrene plant.
基金supported by a grant from the Science and Technology Planned Project of Sichuan Province,China (No.18YYJC0949)
文摘Background: Insomnia is a common complaint that is closely related to gastrointestinal symptoms, which is consistent with the traditional Chinese medicine classical theory of ‘‘stomach disharmony leading to restless sleep." Acupuncture is an effective complementary and alternative medicine therapy to improve gastrointestinal function and restore the normal sleep-wake cycle. However, studies on the effectiveness of acupuncture for insomnia due to spleen-stomach disharmony syndrome are limited to case reports and few randomized controlled trials; deeper research on its mechanism is still lacking. This randomized controlled trial aims to assess the treatment efficacy of ‘‘harmonizing stomach to tranquilize mind"acupuncture for insomnia and its influence on the intestinal microbiome.Methods/design: This is a randomized, single-blind, parallel-group study. Sixty eligible patients with insomnia due to spleen-stomach disharmony syndrome will be randomly divided into two groups(1:1 allocation ratio). The intervention group will use ‘‘harmonizing stomach to tranquilize mind"acupuncture, and the control group will receive sham acupuncture. Participants will receive 5 acupuncture treatment sessions per week for 4 consecutive weeks. The Pittsburgh Sleep Quality Index will be used to evaluate the clinical efficacy of acupuncture treatment by making assessments at baseline, the end of treatment and the end of the follow-up. High-throughput 16 S ribosomal ribonucleic acid gene sequencing will be performed to detect changes in the intestinal microbial composition before and after treatment.Discussion: The results of this trial are expected to confirm that ‘‘harmonizing stomach to tranquilize mind" acupuncture can effectively relieve insomnia and alter the intestinal microbiome.
基金funded by Science and Technology Commission of Shanghai Municipality(No.17401933900)
文摘Background: Fire-needle acupuncture, an important kind of acupuncture therapy, has been clinically used to treat upper limb spastic paralysis(ULSP) after stroke. Clinical experience has indicated that fire-needle acupuncture treatment takes less time, requires fewer visits, and has more rapid results and fewer side effects compared to chemical medicine alternatives. This study will evaluate the effects of fire-needle acupuncture for ULSP in the context of standardized clinical research and provide high-quality data to inform clinical procedures and future study design.Methods/Design: A randomized controlled trial will be carried out to evaluate the effects of fire-needle acupuncture therapy in patients with ULSP from stroke. ULSP patients(n = 120) will be recruited at Changhai Hospital in Shanghai, China. Patients will be randomly divided into three groups, including fire-needle acupuncture group(FAG), filiform-needle acupuncture group(FFAG) and rehabilitation treatment group(RTG). During the 3-week treatment, the FAG will be treated every two days, while FFAG and RTG will be treated 5 d in a row and then rest for 2 d. The Simplified Fugl-Meyer Motor Function Scale and Modified Ashworth Scale will be used as the primary outcome measures. Statistical analysis will be conducted by an independent statistician.Discussion: Through this study, the utility of fire-needle acupuncture in treating ULSP after stroke will be tested, and some specific claims of fire-needle acupuncture therapy will be evaluated, such as relieving spasm and muscular tension, improving activities of daily living, rapidity of response and less frequency of treatment compared with other treatments.
基金supported by 2011 Special Fund for TCM-scientific Research in the Public Interest of Ministry of Finance, People’s Republic of ChinaState Administration of Traditional Chinese Medicine (No. 201107002)
文摘BACKGROUND： Chronic obstructive pulmonary disease （COPD） is a major public health problem worldwide. Pulmonary rehabilitation （PR） is an established intervention for the management of patients with COPD. Exercise training is an important part of PR, and its effectiveness in patients with COPD is well established. However, alternative methods of PR training such as Daoyin have not been appropriately studied. Hence, alternative forms of exercise training that require less exercise equipment and no specific training place should be evaluated. This paper describes the study protocol of a clinical trial that aims to determine if pulmonary Daoyin training will improve the exercise capacity and psychosocial function of patients with COPD in China. METHODS AND DESIGN： A multicenter, randomized, controlled trial will be conducted. A total of 464 patients meeting the inclusion criteria will be enrolled into this study with 232 patients in each of the trial group and the control group. Based on patient education, patients in the trial group will receive pulmonary Daoyin and continue with their usual therapy for three months. In the control group, patients will continue with their usual therapy. The primary outcome measures are exercise capacity assessed by the six-minute walking distance test and lung function. Secondary outcomes include dyspnea and quality of life. Measurements will be taken at baseline （month 0） and after the study period （month 3）. DISCUSSION： It is hypothesized that pulmonary Daoyin will have beneficial effects in improving exercise capacity and psychosocial function of patients with stable COPD, and will provide an alternative form of exercise training that is accessible for the large number of people with COPD. TRIAL REGISTRATION： This trial has been registered in ClinicalTrials.gov. The identifier is NCT01482000.
基金Supported by the National Key Research and Development Program of China(Nos.2016YFC1402000,2018YFC1407003,2017YFC1405300)
文摘Offshore waters provide resources for human beings,while on the other hand,threaten them because of marine disasters.Ocean stations are part of offshore observation networks,and the quality of their data is of great significance for exploiting and protecting the ocean.We used hourly mean wave height,temperature,and pressure real-time observation data taken in the Xiaomaidao station(in Qingdao,China)from June 1,2017,to May 31,2018,to explore the data quality using eight quality control methods,and to discriminate the most effective method for Xiaomaidao station.After using the eight quality control methods,the percentages of the mean wave height,temperature,and pressure data that passed the tests were 89.6%,88.3%,and 98.6%,respectively.With the marine disaster(wave alarm report)data,the values failed in the test mainly due to the influence of aging observation equipment and missing data transmissions.The mean wave height is often affected by dynamic marine disasters,so the continuity test method is not effective.The correlation test with other related parameters would be more useful for the mean wave height.
基金supported by General Program (No. 60774022)State Key Program (No. 60834001) of National Natural Science Foundation of China
文摘In this paper, the stability of iterative learning control with data dropouts is discussed. By the super vector formulation, an iterative learning control （ILC） system with data dropouts can be modeled as an asynchronous dynamical system with rate constraints on events in the iteration domain. The stability condition is provided in the form of linear matrix inequalities （LMIS） depending on the stability of asynchronous dynamical systems. The analysis is supported by simulations.
基金supported by the Twelfth Five-Year Support Project of the Ministry of Science and Technology for clinical studies investigating Xin'an medicine in the treatment of complicated ascites diseases(No.2012BAI26B02)
文摘BACKGROUND： Rheumatoid arthritis （RA）, as a common systemic inflammatory autoimmune disease, affects approximately 1 in 100 individuals. Effective treatment for RA is not yet available because current research does not have a clear understanding of the etiology and pathogenesis of RA. Xinfeng Capsule, a patent Chinese herbal medicine, has been used in the treatment of RA in recent years. Despite its reported clinical efficacy, there are no large-sample, multicenter, randomized trials that support the use of Xinfeng Capsule for RA. Therefore, we designed a randomized, double-blind, multicenter, placebo-controlled trial to assess the efficacy and safety of Xinfeng Capsule in the treatment of RA. METHODS AND DESIGN： This is a 12-week, randomized, placebo-controlled, double-blind, multicenter trial on the treatment of RA. The participants will be randomly assigned to the experimental group and the control group at a ratio of 1：1. Participants in the experimental group will receive Xinfeng Capsule and a pharmaceutical placebo （imitation leflunomide）. The control group will receive leflunomide and an herbal placebo （imitation Xinfeng Capsule）. The American College of Rheumatology （ACR） Criteria for RA will be used to measure the efficacy of the Xinfeng Capsule. The primary outcome measure will be the percentage of study participants who achieve an ACR 20% response rate （ACR20）, which will be measured every 4 weeks after randomization. Secondary outcomes will include the ACR50 and ACR70 responses, the side effects of the medications, the Disease Activity Score 28, RA biomarkers, quality of life, and X-rays of the hands and wrists. The first four of the secondary outcomes will be measured every 4 weeks and the others will be measured at baseline and after 12 weeks of treatment. DISCUSSION： The result of this trial will help to evaluate whether Xinfeng Capsule is effective and safe in the treatment of RA. TRIAL REGISTRATION： This trial has been registered in ClinicalTrials.gov. The identifier is N CT01774877.
基金Supported by the National Basic Research Program of China(2012CB720505)the National Natural Science Foundation of China(21276137,61433001)+1 种基金Tsinghua University Initiative Scientific Research Programthe seventh framework programme(FP7-PEOPLE-2013-IRSES-612230)of European Union
文摘Owing to wide applications of automatic control systems in the process industries, the impacts of controller performance on industrial processes are becoming increasingly significant. Consequently, controller maintenance is critical to guarantee routine operations of industrial processes. The workflow of controller maintenance generally involves the following steps: monitor operating controller performance and detect performance degradation, diagnose probable root causes of control system malfunctions, and take specific actions to resolve associated problems. In this article, a comprehensive overview of the mainstream of control loop monitoring and diagnosis is provided, and some existing problems are also analyzed and discussed. From the viewpoint of synthesizing abundant information in the context of big data, some prospective ideas and promising methods are outlined to potentially solve problems in industrial applications.
基金Specific Research Funding for the Traditional Chinese Medicine Industry of State Administration of Traditional Chinese Medicine (No.200807052)
文摘BACKGROUND： Parkinson＇s disease （PD） is a complicated disease, commonly diagnosed among the elderly, which leads to degeneration of the central nervous system. It presently lacks an effective therapy for its complex pathogenesis. Adverse effects from Western drug-based medical intervention prevent long-term adherence to these therapies in many patients. Traditional Chinese medicine （TCM） has long been used to improve the treatment of PD by alleviating the toxic and adverse effects of Western drug-based intervention. Therefore, the aim of this study is to evaluate the efficacy and safety of Xifeng Dingchan Pill （XFDCP）, a compound traditional Chinese herbal medicine, taken in conjunction with Western medicine in the treatment of PD patients at different stages in the progression of the disease. METHODS AND DESIGN： This is a multicenter, randomized controlled trial. In total, 320 patients with early- （n = 160） and middle-stage PD （n = 160） will be enrolled and divided evenly into control and trial groups. Of the 160 patients with early-stage PD, the trial group （n = 80） will be given XFDCP, and the control group （n = 80） will be given Madopar. Of the 160 patients with middle-stage PD, the trial group （n = 80） will be given XFDCP combined with Madopar and Piribedil, and the control group （n = 80） will be given Madopar and Piribedil. The Unified Parkinson＇s Disease Rating Scale scores, TCM symptoms scores, quality of life, change of Madopar＇s dosage and the toxic and adverse effects of Madopar will be observed during a 3-month treatment period and through a further 6-month follow-up period. DISCUSSION： It is hypothesized that XFDCP, combined with Madopar and Piribedil, will have beneficial effects on patients with PD. The results of this study will provide evidence for developing a comprehensive therapy regimen, which can delay the progress of the disease and improve the quality of life for PD patients in different stages. TRIAL REGISTRATION： This trial has been registered in the Chinese Clinical Trial Registry with the identifer ChiCTR-TRC-12002150.
基金jointly supported by the National Fundamental Research(973)Program of China(Grant Nos.2015CB452801 and 2013CB430100)the Jiangsu Meteorological Bureau Research Fund Project for the Youth(Grant Nos.Q201514 and Q201407)+3 种基金the Shandong Institute of Meteorological Sciences Research Fund Project(Grant No.SDQXKF2015M10)the Jiangsu Provincial Key Technology R&D Program(Grant No.BE2013730)the Jiangsu Meteorological Bureau Key Research Fund Project(Grant No.KZ201502)the National Key Technology R&D Program(Grant No.2014BAG01B01)
文摘Different choices of control variables in variational assimilation can bring about different influences on the analyzed atmospheric state. Based on the WRF model＇s three-dimensional variational assimilation system, this study compares the be- havior of two momentum control variable options-streamfunction velocity potential （ψ-χ） and horizontal wind components （U-V）-in radar wind data assimilation for a squall line case that occurred in Jiangsu Province on 24 August 2014. The wind increment from the single observation test shows that the ψ-χ control variable scheme produces negative increments in the neighborhood around the observation point because streamfunction and velocity potential preserve integrals of velocity. On the contrary, the U-V control variable scheme objectively reflects the information of the observation itself. Furthermore, radial velocity data from 17 Doppler radars in eastern China are assimilated. As compared to the impact of conventional observation, the assimilation of radar radial velocity based on the U-V control variable scheme significantly improves the mesoscale dynamic field in the initial condition. The enhanced low-level jet stream, water vapor convergence and low-level wind shear result in better squall line forecasting. However, the ψ-χ control variable scheme generates a discontinuous wind field and unrealistic convergence/divergence in the analyzed field, which lead to a degraded precipitation forecast.
基金Projects(61075065,60774045) supported by the National Natural Science Foundation of ChinaProject supported by the Graduate Degree Thesis Innovation Foundation of Central South University,China
文摘Consensus tracking control problems for single-integrator dynamics of multi-agent systems with switching topology are investigated. In order to design effective consensus tracking protocols for a more general class of networks, which are aimed at ensuring that the concerned states of agents converge to a constant or time-varying reference state, new consensus tracking protocols with a constant and time-varying reference state are proposed, respectively. Particularly, by contrast with spanning tree, an improved condition of switching interaction topology is presented. And then, convergence analysis of two consensus tracking protocols is provided by Lyapunov stability theory. Moreover, consensus tracking protocol with a time-varying reference state is extended to achieve the fbrmation control. By introducing formation structure set, each agent can gain its individual desired trajectory. Finally, several simulations are worked out to illustrate the effectiveness of theoretical results. The test results show that the states of agents can converge to a desired constant or time-varying reference state. In addition, by selecting appropriate structure set, agents can maintain the expected formation under random switching interaction topologies.
基金supported by the Longhua Medicial Project (D-11)The Science and Technology Commission of Shanghai Municipality (No.12401905700)
文摘BACKGROUND： Traditional Chinese medicine （TCM） is considered an important complementary therapy with beneficial effects for cancer patients. Elderly patients with non-small-cell lung cancer （NSCLC） are a complex patient group with increasing co-morbidity and shrinking physiological reserve, and may derive substantial benefit from the supportive aspects of TCM Researchers from Shanghai Longhua Hospital found that qi and yin deficiency is a common syndrome in patients with stage III or IV lung cancer. This project was designed to study the combination of single-agent chemotherapy with TCM methods of benefiting qi and yin in elderly patients with advanced NSCLC. METHODS AND DESIGN： This is a double-blind controlled, multi-center, and prospective study with randomly selected participants from elderly NSCLC patients in China. Seventy-six patients who meet the inclusion criteria will be allocated into two groups, which will receive treatments of 3-week single-agent chemotherapy with TCM or placebo for four cycles Progression-free survival （PFS） is the primary end point, and the secondary end points are overall survival, objective response rate, time-to-progression, and quality of life （EORTC QLQ-LC43, and TCM syndrome score） Meanwhile, other end points such as toxicity, side effects and safety of the treatments will be assessed. DISCUSSION： Results from this study may provide evidence on the effectiveness, and parameters for the usage of single-agent chemotherapy combined with or without TCM on PFS of elderly patients with NSCLC.
基金supported by the National Key Research and Development Program of China,No.2017YFA0105403(to LMR)the Key Research and Development Program of Guangdong Province of China,No.2019B020236002(to LMR)+4 种基金The Clinical Innovation Research Program of Guangzhou Regenerative Medicine and Health Guangdong Laboratory of China,No.2018GZR0201006(to LMR)the National Natural Science Foundation of China,Nos.81772349(to BL),31470949(to BL)the Guangzhou Science and Technology Project of China,Nos.201704020221(to LMR),201707010115(to BL)the Natural Science Foundation of Guangdong Province of China,No.2017A030313594(to BL)the Medical Scientific Research Foundation of Guangdong Province of China,No.A2018547(to MP)
文摘Human umbilical cord mesenchymal stem cells(hUC-MSCs)support revascularization,inhibition of inflammation,regulation of apoptosis,and promotion of the release of beneficial factors.Thus,they are regarded as a promising candidate for the treatment of intractable spinal cord injury(SCI).Clinical studies on patients with early chronic SCI(from 2 months to 1 year post-injury),which is clinically common,are rare;therefore,we will conduct a prospective,multicenter,randomized,placebo-controlled,single-blinded clinical trial at the Third Affiliated Hospital of Sun Yat-sen University,West China Hospital of Sichuan University,and Shanghai East Hospital,Tongji University School of Medicine,China.The trial plans to recruit 66 early chronic SCI patients.Eligible patients will undergo randomization at a 2:1 ratio to two arms:the observation group and the control group.Subjects in the observation group will receive four intrathecal transplantations of stem cells,with a dosage of 1×106/kg,at one calendar month intervals.Subjects in the control group will receive intrathecal administrations of 10 mL sterile normal saline in place of the stem cell transplantations.Clinical safety will be assessed by the analysis of adverse events and laboratory tests.The American Spinal Injury Association(ASIA)total score will be the primary efficacy endpoint,and the secondary efficacy outcomes will be the following:ASIA impairment scale,International Association of Neural Restoration-Spinal Cord Injury Functional Rating Scale,muscle tension,electromyogram,cortical motor and cortical sensory evoked potentials,residual urine volume,magnetic resonance imaging–diffusion tensor imaging,T cell subtypes in serum,neurotrophic factors and inflammatory factors in both serum and cerebrospinal fluid.All evaluations will be performed at 1,3,6,and 12 months following the final intrathecal administration.During the entire study procedure,all adverse events will be reported as soon as they are noted.This trial is designed to evaluate the clinical safety and efficacy of subarachnoid transplantation of hUC-MSCs to treat early chronic SCI.Moreover,it will establish whether cytotherapy can ameliorate local hostile microenvironments,promote tracking fiber regeneration,and strengthen spinal conduction ability,thus improving overall motor,sensory,and micturition/defecation function in patients with early chronic SCI.This study was approved by the Stem Cell Research Ethics Committee of the Third Affiliated Hospital of Sun Yat-sen University,China(approval No.[2018]-02)on March 30,2018,and was registered with ClinicalTrials.gov(registration No.NCT03521323)on April 12,2018.The revised trial protocol(protocol version 4.0)was approved by the Stem Cell Research Ethics Committee of the Third Affiliated Hospital of Sun Yat-sen University,China(approval No.[2019]-10)on February 25,2019,and released on ClinicalTrials.gov on April 29,2019.
