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Trial Equation Method to Nonlinear Evolution Equations with Rank Inhomogeneous: Mathematical Discussions and Its Applications 被引量:8
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作者 LIU Cheng-Shi 《Communications in Theoretical Physics》 SCIE CAS CSCD 2006年第2期219-223,共5页
A trial equation method to nonlinear evolution equation with rank inhomogeneous is given. As appncations, the exact traveling wave solutions to some higher-order nonlinear equations such as generalized Boussinesq equa... A trial equation method to nonlinear evolution equation with rank inhomogeneous is given. As appncations, the exact traveling wave solutions to some higher-order nonlinear equations such as generalized Boussinesq equation, generalized Pochhammer-Chree equation, KdV-Burgers equation, and KS equation and so on, are obtained. Among these, some results are new. The proposed method is based on the idea of reduction of the order of ODE. Some mathematical details of the proposed method are discussed. 展开更多
关键词 trial equation method solvable equation nonlinear evolution equation exact solution
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Trial function method and exact solutions to the generalized nonlinear Schrdinger equation with time-dependent coefficient 被引量:2
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作者 曹瑞 张健 《Chinese Physics B》 SCIE EI CAS CSCD 2013年第10期182-185,共4页
In this paper, the trial function method is extended to study the generalized nonlinear Schrodinger equation with time- dependent coefficients. On the basis of a generalized traveling wave transformation and a trial f... In this paper, the trial function method is extended to study the generalized nonlinear Schrodinger equation with time- dependent coefficients. On the basis of a generalized traveling wave transformation and a trial function, we investigate the exact envelope traveling wave solutions of the generalized nonlinear Schrodinger equation with time-dependent coefficients. Taking advantage of solutions to trial function, we successfully obtain exact solutions for the generalized nonlinear Schrodinger equation with time-dependent coefficients under constraint conditions. 展开更多
关键词 generalized nonlinear SchriSdinger equation exact solution trial function method
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A New Trial Equation Method and Its Applications 被引量:2
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作者 LIU Cheng-Shi 《Communications in Theoretical Physics》 SCIE CAS CSCD 2006年第3期395-397,共3页
As an improved version of trial equation method, a new trial equation method is proposed. Using this method, abundant new exact traveling wave solutions to a high-order KdV-type equation are obtained.
关键词 trial equation method traveling wave solution high-order KdV equation
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Trial Equation Method for Solving the Improved Boussinesq Equation 被引量:1
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作者 Yang Li 《Advances in Pure Mathematics》 2014年第2期47-52,共6页
Trial equation method is a powerful tool for obtaining exact solutions of nonlinear differential equations. In this paper, the improved Boussinesq is reduced to an ordinary differential equation under the travelling w... Trial equation method is a powerful tool for obtaining exact solutions of nonlinear differential equations. In this paper, the improved Boussinesq is reduced to an ordinary differential equation under the travelling wave transformation. Trial equation method and the theory of complete discrimination system for polynomial are used to establish exact solutions of the improved Boussinesq equation. 展开更多
关键词 The Nonlinear Partial Differential EQUATION Complete Discrimination System for Polynomial trial EQUATION method Traveling Wave Transform The IMPROVED BOUSSINESQ EQUATION
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Yield Stability of Maize Hybrids Evaluated in Maize Regional Trials in Southwestern China Using Nonparametric Methods
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作者 LIU Yong-jian DUAN Chuan +2 位作者 TIAN Meng-liang HU Er-liang HUANG Yu-bi 《Agricultural Sciences in China》 CAS CSCD 2010年第10期1413-1422,共10页
Analysis of multi-environment trials (METs) of crops for the evaluation and recommendation of varieties is an important issue in plant breeding research. Evaluating on the both stability of performance and high yiel... Analysis of multi-environment trials (METs) of crops for the evaluation and recommendation of varieties is an important issue in plant breeding research. Evaluating on the both stability of performance and high yield is essential in MET analyses. The objective of the present investigation was to compare 11 nonparametric stability statistics and apply nonparametric tests for genotype-by-environment interaction (GEI) to 14 maize (Zea mays L.) genotypes grown at 25 locations in southwestern China during 2005. Results of nonparametric tests of GEl and a combined ANOVA across locations showed that both crossover and noncrossover GEI, and genotypes varied highly significantly for yield. The results of principal component analysis, correlation analysis of nonparametric statistics, and yield indicated the nonparametric statistics grouped as four distinct classes that corresponded to different agronomic and biological concepts of stability. Furthermore, high values of TOP and low values of rank-sum were associated with high mean yield, but the other nonparametric statistics were not positively correlated with mean yield. Therefore, only rank-sum and TOP methods would be useful for simultaneously selection for high yield and stability. These two statistics recommended JY686 and HX168 as desirable and ND108, CM12, CN36, and NK6661 as undesirable genotypes. 展开更多
关键词 Zea mays L. genotype environment multi-environment trials nonparametric methods
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Constructing exact solutions to discrete systems with the trial function method
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作者 Taogetusang Sirendaoerji 《Applied Mathematics(A Journal of Chinese Universities)》 SCIE CSCD 2008年第3期286-294,共9页
Based on the homogenous balance method and the trial function method, several trial function methods composed of exponential functions are proposed and applied to nonlinear discrete systems. With the.help of symbolic ... Based on the homogenous balance method and the trial function method, several trial function methods composed of exponential functions are proposed and applied to nonlinear discrete systems. With the.help of symbolic computation system, the new exact solitary wave solutions to discrete nonlinear mKdV lattice equation, discrete nonlinear (2 + 1) dimensional Toda lattice equation, Ablowitz-Ladik-lattice system are constructed.The method is of significance to seek exact solitary wave solutions to other nonlinear discrete systems. 展开更多
关键词 the trial function method discrete system (2+1)-dimensional Hybrid-lattice system exact solitary wave solution
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The Substantive Reform of Court Trials: A Transformation of Logic in the Methods of Evidence Investigation——Summary of the Reform Pilot Project in Chengdu
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作者 Ma Jinghua Wang Jian 《Contemporary Social Sciences》 2019年第4期59-74,共16页
In the pilot project of the substantive reform of court trials,“unexpected” judgments appeared constantly because the traditional documentary investigation mode has been replaced by an investigation mode under the p... In the pilot project of the substantive reform of court trials,“unexpected” judgments appeared constantly because the traditional documentary investigation mode has been replaced by an investigation mode under the principle of directness and verbalism. This change in the logic of factual judgments has caused a change in the methods of evidence examination. In traditional evidence examination, evidence obtained from investigations is supposed to be genuine and reliable. In the substantive reform of court trials, it is presumed that evidence obtained from investigations cannot be fully trusted and it is easier to ascertain the facts of the case by investigating using the principles of directness, verbalism and individualized judging methods for evidence examinations. In practice, there are three main factors affecting the genuineness of evidence: the cognitive rules of testifiers, the motivation of the subjects who provide evidence, and the methods used by investigators to obtain evidence. Based on any one of these three factors, it cannot be concluded that evidence obtained from investigations is superior to evidence presented in court. The substantive court investigation is more advantageous to establishing the facts of a case than the traditional court investigation. The essential characteristics of the substantive reform of court trials are pursuing reality in essence instead of in form, and using the files of the court trials instead of the files of the investigation to avoid the evidence obtained through investigations from playing a decisive role in the adjudication thus making criminal procedures trial-centered rather than investigation-centered. 展开更多
关键词 the SUBSTANTIVE REFORM of court trials the methodS of EVIDENCE INVESTIGATION trialcentered REALITY in essence REALITY in form
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Application of Trial Equation Method for Solving the Benjamin Ono Equation
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作者 Yang Li 《Journal of Applied Mathematics and Physics》 2014年第3期45-49,共5页
In the article, the nonlinear equation is reduced to an ordinary differential equation under the travelling wave transformation. Using trial equation method, the ODE is reduced to the elementary integral form. In the ... In the article, the nonlinear equation is reduced to an ordinary differential equation under the travelling wave transformation. Using trial equation method, the ODE is reduced to the elementary integral form. In the end, complete discrimination system for polynomial is used to solve the corresponding integrals and obtain the classification of all single travelling wave solutions to the equation. 展开更多
关键词 The Nonlinear Partial Differential EQUATION Complete Discrimination System for POLYNOMIAL trial EQUATION method TRAVELING Wave Transform The BENJAMIN Ono EQUATION
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Usefulness of the clip-flap method of endoscopic submucosal dissection: A randomized controlled trial 被引量:5
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作者 Hiromitsu Ban Mitsushige Sugimoto +6 位作者 Taketo Otsuka Masaki Murata Toshiro Nakata Hiroshi Hasegawa Osamu Inatomi Shigeki Bamba Akira Andoh 《World Journal of Gastroenterology》 SCIE CAS 2018年第35期4077-4085,共9页
AIM To prospectively investigate the efficacy and safety of clipflap assisted endoscopic submucosal dissection(ESD) for gastric tumors.METHODS From May 2015 to October 2016, we enrolled 104 patients with gastric cance... AIM To prospectively investigate the efficacy and safety of clipflap assisted endoscopic submucosal dissection(ESD) for gastric tumors.METHODS From May 2015 to October 2016, we enrolled 104 patients with gastric cancer or adenoma scheduled for ESD at Shiga University of Medical Science Hospital. We randomized patients into two subgroups using the minimization method based on location of the tumor(upper, middle or lower third of the stomach), tumor size(< 20 mm or > 20 mm) and ulcer status: ESD using an endoclip(the clip-flap group) and ESD without an endoclip(the conventional group). Therapeutic efficacy(procedure time) and safety(complication: Gastrointestinal bleeding and perforation) were assessed. RESULTS En bloc resection was performed in all patients. Four patients had delayed bleeding(3.8%) and two had perforation(1.9%). No significant differences in en bloc resection rate(conventional group: 100%, clip flap group: 100%), curative endoscopic resection rate(conventional group: 90.9%, clip flap group: 89.8%, P = 0.85), procedure time(conventional group: 70.8 ± 46.2 min, clip flap group: 74.7 ± 53.3 min, P = 0.69), area of resected specimen(conventional group: 884.6 ± 792.1 mm^2, clip flap group: 1006.4 ± 1004.8 mm^2, P = 0.49), delayed bleeding rate(conventional group: 5.5%, clip flap group: 2.0%, P = 0.49), or perforation rate(conventional group: 1.8%, clip flap group: 2.0%, P = 0.93) were found between the two groups. Lessexperienced endoscopists did not show any differences in procedure time between the two groups.CONCLUSION For patients with early-stage gastric tumors, the clipflap method has no advantage in efficacy or safety compared with the conventional method. 展开更多
关键词 Gastric cancer CLIP FLAP method Endoscopic SUBMUCOSAL dissection Procedure time Complication Randomized clinical trial
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A SIMPLE FAST METHOD IN FINDING PARTICULAR SOLUTIONS OF SOME NONLINEAR PDE 被引量:2
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作者 刘式适 付遵涛 +1 位作者 刘式达 赵强 《Applied Mathematics and Mechanics(English Edition)》 SCIE EI 2001年第3期326-331,共6页
The 'trial function method' ( TFM for short) and a routine way in finding traveling,wave solutions to some nonlinear partial differential equations( PDE for short), wer explained. Two types of evolution equati... The 'trial function method' ( TFM for short) and a routine way in finding traveling,wave solutions to some nonlinear partial differential equations( PDE for short), wer explained. Two types of evolution equations are studied, one is a generalized Burgers or KdV equation, the other is the Fisher equation with special nonlinear forms of its reaction rate term. One can see that this method is simple, fast and allowing further extension. 展开更多
关键词 trial function method nonlinear PDE shock wave solution solitary wave solution
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BLOCK PIVOT METHODS FOR SOLVING FRICTIONAL CONTACT PROBLEMS
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作者 陈万吉 陈国庆 冯恩民 《Acta Mechanica Sinica》 SCIE EI CAS CSCD 1995年第1期51-58,共8页
Based on elementary group theory, the block pivot methods for solving two-dimensional elastic frictional contact problems are presented in this paper. It is proved that the algorithms converge within a finite number o... Based on elementary group theory, the block pivot methods for solving two-dimensional elastic frictional contact problems are presented in this paper. It is proved that the algorithms converge within a finite number of steps when the friction coefficient is ''relative small''. Unlike most mathematical programming methods for contact problems, the block pivot methods permit multiple exchanges of basic and nonbasic variables. 展开更多
关键词 ELASTIC FRICTIONAL CONTACT trial AND ERROR method MATHEMATICAL PROGRAMMING method BLOCK PIVOT method CONVERGENCE
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SEMI-INVERSE METHOD AND GENERALIZED VARIATIONAL PRINCIPLES WITH MULTI-VARIABLES IN ELASTICITY 被引量:2
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作者 何吉欢 《Applied Mathematics and Mechanics(English Edition)》 SCIE EI 2000年第7期797-808,共12页
Semi-inverse method, which is an integration and an extension of Hu's try-and-error method, Chien's veighted residual method and Liu's systematic method, is proposed to establish generalized variational pr... Semi-inverse method, which is an integration and an extension of Hu's try-and-error method, Chien's veighted residual method and Liu's systematic method, is proposed to establish generalized variational principles with multi-variables without arty variational crisis phenomenon. The method is to construct an energy trial-functional with an unknown function F, which can be readily identified by making the trial-functional stationary and using known constraint equations. As a result generalized variational principles with two kinds of independent variables (such as well-known Hellinger-Reissner variational principle and Hu-Washizu principle) and generalized variational principles with three kinds of independent variables (such as Chien's generalized variational principles) in elasticity have been deduced without using Lagrange multiplier method. By semi-inverse method, the author has also proved that Hu-Washizu principle is actually a variational principle with only two kinds of independent variables, stress-strain relations are still its constraints. 展开更多
关键词 variational principle in elasticy Chien's generalized variational principles Hu-Washizu principle semi-inverse method trial-functional variational crisis
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Digital blinding of radiographs to mask allocation in a randomized control trial 被引量:1
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作者 Gerard P Slobogean Lukasz Soswa +2 位作者 Giuliana Rotunno Peter J O'Brien Kelly A Lefaivre 《World Journal of Orthopedics》 2017年第10期785-789,共5页
AIM To demonstrate the effectiveness of a digital radiographic altering technique in concealing treatment allocation to blind outcome assessment of distal femur fracture fixation.METHODS Digital postoperative anteropo... AIM To demonstrate the effectiveness of a digital radiographic altering technique in concealing treatment allocation to blind outcome assessment of distal femur fracture fixation.METHODS Digital postoperative anteroposterior and lateral radiographs from a sample of 33 randomly-selected patients with extra-articular distal femur fractures treated by surgical fixation at a Level 1 trauma center were included. Using commercially available digital altering software, we devised a technique to blind the radiographs by overlaying black boxes over the implant hardware while preserving an exposed fracture site for assessment of fracture healing. Three fellowship-trained surgeons evaluated a set of blinded radiographs twice and a control set of unblinded radiographs once. Each set of radiographs were reviewed independently and in a randomly-assigned order. The degrees of agreement and disagreement among evaluators in identifying implant type while reviewing both blinded and unblinded radiographs were assessed using the Bang Blinding Index and James Blinding Index. The degree of agreement in fracture union was assessed using kappa statistics.RESULTS The assessment of blinded radiographs with both the Bang Blinding Index(BBI) and James Blinding Index(JBI) demonstrated a low degree of evaluator success at identifying implant type(Mean BBI, far cortical locking:-0.03, SD: 0.04; Mean BBI, standard screw: 0, SD: 0; JBI: 0.98, SD: 0), suggesting near perfect blinding. The assessment of unblinded radiographs with both blinding indices demonstrated a high degree of evaluator success at identifying implant type(Mean BBI, far cortical locking: 0.89, SD: 0.19; Mean BBI, standard screw: 0.87, SD: 0.04; JBI: 0.26, SD: 0.12), as expected. There was moderate agreement with regard to assessment of fracture union among the evaluators in both the blinded(Kappa: 0.38, 95%CI: 0.25-0.52) and unblinded(Kappa: 0.35, 95%CI: 0.25-0.45) arms of the study. There was no statistically significant difference in fracture union agreement between the blinded and unblinded groups.CONCLUSION The digital blinding technique successfully masked the surgeons to the type of implant used for surgical treatment of distal femur fractures but did not interfere with the surgeons' ability to reliably evaluate radiographic healing at the fracture site. 展开更多
关键词 methods RANDOMIZED controlled trials Patient outcome assessment Fracture HEALING FEMORAL FRACTURES
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合作尝试法联合仿真模拟人在妇产科见习中的应用研究 被引量:2
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作者 李瑞珍 李月燃 +3 位作者 程春霞 冯晴 王楠 刘心利 《中国继续医学教育》 2024年第4期34-38,共5页
目的分析合作尝试教学法联合仿真模拟人在妇产科主动融通见习中的应用效果。方法2022年10月,选择在中南大学湘雅三医院妇产科见习的五年制学生,共131名,随机分2组:研究组66名学生采用合作尝试教学法联合仿真模拟人进行教学,对照组65名... 目的分析合作尝试教学法联合仿真模拟人在妇产科主动融通见习中的应用效果。方法2022年10月,选择在中南大学湘雅三医院妇产科见习的五年制学生,共131名,随机分2组:研究组66名学生采用合作尝试教学法联合仿真模拟人进行教学,对照组65名学生采用以案例为导向的教学法(case-based learning,CBL),教学评估内容为产后出血的模拟训练,通过理论测试、迷你临床演练评估(mini-clinical evaluation exercise,Mini-CEX)、学生评教表、课后调查问卷表等多方面评估教学效果。结果研究组的理论测试成绩、Mini-CEX评分表中的各项成绩、课后问卷调查的满意度均高于对照组,差异有统计学意义(P<0.001)。学生评教表中研究组学生对带教老师的教学基本功、教学内容、教学方法、教学效果的评分远高于对照组,差异有统计学意义(P<0.001)。在师德、教学管理方面的评分一致,差异无统计学意义(P>0.05)。结论在妇产科主动融通见习教学中,应用合作尝试教学法联合仿真模拟人的教学形式,可以有效促进理论知识的学习、提高体格检查及操作技能水平、调动学生学习的主动性、积极性,能够真正做到“主动、融通”,并能够使学生更准确地做出临床判断、更好地做到人文关怀、改善其在临床工作中的整体表现,显著提高临床见习教学效果,并能够改善学生对教师的主观评价,更好的体现教师的教学能力及价值,值得在医学生本科教学中应用。 展开更多
关键词 合作尝试教学法 仿真模拟人 见习 妇产科学 主动融通 产后出血 教学效果
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Stepwise Method Based on Confidence Bound and Information Incorporation for Identifying the Maximum Tolerable Dose
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作者 王雪丽 陶剑 史宁中 《Northeastern Mathematical Journal》 CSCD 2005年第1期117-126,共10页
The primary goal of a phase I clinical trial is to find the maximum tolerable dose of a treatment. In this paper, we propose a new stepwise method based on confidence bound and information incorporation to determine t... The primary goal of a phase I clinical trial is to find the maximum tolerable dose of a treatment. In this paper, we propose a new stepwise method based on confidence bound and information incorporation to determine the maximum tolerable dose among given dose levels. On the one hand, in order to avoid severe even fatal toxicity to occur and reduce the experimental subjects, the new method is executed from the lowest dose level, and then goes on in a stepwise fashion. On the other hand, in order to improve the accuracy of the recommendation, the final recommendation of the maximum tolerable dose is accomplished through the information incorporation of an additional experimental cohort at the same dose level. Furthermore, empirical simulation results show that the new method has some real advantages in comparison with the modified continual reassessment method. 展开更多
关键词 confidence bound continual reassessment method information incorporation maximum tolerable dose phase I clinical trials stepwise method
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Implementation of an open-source customizable minimization program for allocation of patients to parallel groups in clinical trials
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作者 Mahmoud Saghaei Sara Saghaei 《Journal of Biomedical Science and Engineering》 2011年第11期734-739,共6页
Current minimization programs do not permit full control over different aspects of minimization algorithm such as distance or probability measures and may not allow for unequal allocation ratios. This article describe... Current minimization programs do not permit full control over different aspects of minimization algorithm such as distance or probability measures and may not allow for unequal allocation ratios. This article describes the implementation of “MinimPy” an open-source minimization program in Python programming language, which provides full customizetion of minimization features. MinimPy supports naive and biased coin minimization together with various new and classic distance measures. Data syncing is provided to facilitate minimization of multicenter trial over the network. MinimPy can easily be modified to fit special needs of clinical trials and in particular change it to a pure web application, though it currently supports network syncing of data in multi-center trials using network repositories. 展开更多
关键词 Clinical trial ALLOCATION methods RANDOMIZATION MINIMIZATION Unequal Group ALLOCATION Biased COIN MINIMIZATION Network Synchronization of Data
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Evaluation of Trial Tests
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作者 Alfred M.Kracht K. H.Nicolaysen H. J.Stitterich(The Berlin Model Basin,D 10623 Berlin,Germany) 《武汉理工大学学报(交通科学与工程版)》 1999年第S1期53-63,共11页
An evaluation method of trial tests will be presented which is based on propeller characteristic functions provided by open water tests.Main reference quantity is the rate of revolutions which is constant during one t... An evaluation method of trial tests will be presented which is based on propeller characteristic functions provided by open water tests.Main reference quantity is the rate of revolutions which is constant during one trial double run and reliably to measure and,furthermore,the basic quantity of the mathematical adjustment of the hydrodynamically coupled test quantities by means of regression analysis.Using this physical plausible analysis of the trial test data and the propeller open water diagram an evaluation of current speed and ship’s speed through the water is possible.Assumed that thrust deduction fraction and relative rotative efficiency are scale independent,speed and power under contract conditions may be calculated at constant propeller speed where the results are corrected with respect to wind and waves using the linear dependance of speed and power at moderate differences of propeller load. 展开更多
关键词 trial TEST regression analysis VWS method THRUST DEDUCTION FRACTION
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Chinese herbal medicine Xinfeng Capsule in treatment of rheumatoid arthritis:study protocol of a multicenter randomized controlled trial 被引量:9
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作者 Jian Liu Chuan-bing Huang +5 位作者 Yuan Wang Gui-qin Xu Yuan-yuan Cheng Yun-xia Feng Lei Liu Ya-jun Qi 《Journal of Integrative Medicine》 SCIE CAS CSCD 2013年第6期428-434,共7页
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
关键词 Xinfeng Capsule rheumatoid arthritis double-blind method PLACEBOS ACRcriteria quality of life randomized controlled trials clinical protocols
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Formulation, stability testing, and analytical characterization of melatonin-based preparation for clinical trial 被引量:1
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作者 Samira Filali Charlotte Bergamelli +6 位作者 Mamadou Lamine Tall Damien Salmon Diane Laleye Carole Dhelens Elhadji Diouf Christine Pivot Fabrice Pirot 《Journal of Pharmaceutical Analysis》 SCIE CAS CSCD 2017年第4期237-243,共7页
A new institutional clinical trial assessed the improvement of sleep disorders in 40 children with autism treated by immediate-release melatonin formulation in different regimens(0.5 mg, 2 mg, and 6 mg daily) for one ... A new institutional clinical trial assessed the improvement of sleep disorders in 40 children with autism treated by immediate-release melatonin formulation in different regimens(0.5 mg, 2 mg, and 6 mg daily) for one month. The objectives of present study were to(i) prepare low-dose melatonin hard capsules for pediatric use controlled by two complementary methods and(ii) carry out a stability study in order to determine a use-bydate. Validation of preparation process was claimed as ascertained by mass uniformity of hard capsules.Multicomponent analysis by attenuated total reflectance Fourier transformed infrared(ATR-FTIR) of melatonin/microcrystalline cellulose mixture allowed to identify and quantify relative content of active pharmaceutical ingredients and excipients. Absolute melatonin content analysis by high performance liquid chromatography in 0.5 mg and 6 mg melatonin capsules was 93.6% ± 4.1% and 98.7% ± 6.9% of theoretical value, respectively. Forced degradation study showed a good separation of melatonin and its degradation products. The capability of the method was 15, confirming a risk of false negative < 0.01%. Stability test and dissolution test were compliant over 18 months of storage with European Pharmacopoeia. Preparation of melatonin hard capsules was completed manually and melatonin in hard capsules was stable for 18 months, in spite of low doses of active ingredient. ATR-FTIR offers a real alternative to HPLC for quality control of highdose melatonin hard capsules before the release of clinical batches. 展开更多
关键词 MELATONIN STABILITY-INDICATING method High-performance liquid CHROMATOGRAPHY MULTICOMPONENT infrared analysis Clinical trial AUTISM
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基于德尔菲法的中医药临床试验监查指标体系构建研究 被引量:1
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作者 唐欢 霍岩 +4 位作者 吕文文 渠田田 谭红胜 张剑宁 黄平 《上海中医药杂志》 CSCD 2024年第1期71-76,共6页
目的基于德尔菲法构建中医药临床试验监查指标体系。方法通过文献研究法和临床监查实践经验,形成中医药临床试验基于风险的监查指标池;通过德尔菲法进行两轮的专家咨询,对于结果进行统计分析,并运用Yaahp软件中层次分析法(AHP)为指标体... 目的基于德尔菲法构建中医药临床试验监查指标体系。方法通过文献研究法和临床监查实践经验,形成中医药临床试验基于风险的监查指标池;通过德尔菲法进行两轮的专家咨询,对于结果进行统计分析,并运用Yaahp软件中层次分析法(AHP)为指标体系的各项指标进行权重赋值。结果①初步形成了包含9个一级指标、22个二级指标和47个三级指标的中医药临床试验风险监查指标体系。②最终共邀请到15位从事临床监查、西医/中西医结合临床、中医临床、医院/行政管理、卫生统计相关领域的专家。③两轮专家咨询问卷有效回收率分别为93.75%和100%。④两轮专家咨询的权威系数(Cr)分别为0.760和0.775。⑤两轮专家咨询的协调系数分别为0.192(P<0.05)和0.194(P<0.05),两轮专家咨询的一级、二级、三级指标的变异系数(CV)均<0.25。⑥最终构建了包含4个一级指标、11个二级指标和45个三级指标的中医药临床试验风险监查指标体系。结论参与该研究的专家权威程度和积极性高,协调程度好;最终构建的指标体系中一级指标“研究设计管理”以及其二级指标和三级指标的权重相对较高,提示中医药临床试验的设计是决定临床试验结果的关键因素。 展开更多
关键词 中医药疗法 临床试验 德尔菲法 质量控制 循证医学
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