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11.
OBJECTIVE: A Japanese version of the Rosenberg Self-Esteem Scale (RSES) was developed through the forward-backward translation procedure. METHODS: Married couples consisting of a native English speaker and a native Japanese speaker acted as translators to enhance the representativeness of language in the target population. Multiple translations were produced, and a panel of reviewers identified problems in conceptual and semantic equivalence between the original scale and the translated version. The Japanese version was altered accordingly with reference to alternate Japanese forms from the original English to Japanese translations. The altered translation was again retranslated into English, and problematic differences were checked. This forward-backward process was repeated until satisfactory agreement had been attained. The RSES was administered to 222 native English speakers, and the developed Japanese version (RSES-J) was administered to 1320 native Japanese speakers. RESULTS: Factor analysis revealed nearly identical factor structure and structural coefficients of the items between two sets of data. Target rotation confirmed the factorial agreement of the two scales in different cultural groups. High Cronbach's alpha coefficients supported the reliability of test scores on both versions. CONCLUSION: The equivalence between the RSES and the RSES-J was supported in this study. It is suggested that the RSES and the RSES-J are potential tools for comparative cross-cultural studies. 相似文献
12.
Two control schemes are devised to minimize a quadratic cost functional associated with a time varying linear system, when the linear system forms part of a plant that may contain delays in both control and measurement. Control scheme (1) makes use of prior knowledge of the initial state of the linear system, whereas control scheme (2) does not. Both control schemes contain models of the plant and any difference between plant and model is referred to as mismatch. Matched control scheme (1) is optimal, whereas matched control scheme (2) is optimal if and only if the plant does not contain measurement delay. As matched control scheme (2) is suboptimal for plant with delay in measurement, in this instance mismatch may improve performance. The type of mismatch which may produce this improvement is obtained using a concept referred to as equivalence. 相似文献
13.
Two experiments were conducted employing derived relational responding and conditioned motivating operations to establish untaught mands with 11 children with autism spectrum disorder (ASD) who lacked a vocal repertoire. Following formal language assessments and preference assessments, a multi-stage automated protocol was implemented on touchscreen tablet computers. Children were first taught to mand by picture exchange for missing items necessary to play with a toy and then learned to conditionally relate the dictated names of the items to the corresponding pictures of the items (A-B training) and to relate the dictated names to the corresponding printed words (A-C training). Test probes, in the absence of reinforcement, were presented to determine whether or not participants would mand for the missing items using text exchange (hence demonstrating derived manding/requesting). Probes for spontaneous matching (B-C and C-B) and labeling (B-A and C-A) were also presented in both experiments, one of which employed a pretest/posttest design and the other a multiple probe across participants design. Across both experiments, all but one of the participants showed evidence of derived requesting and derived stimulus relations. Implications for research on high-tech devices for facilitating independent communication skills of children with ASD and for derived relational responding approaches to verbal operants are discussed. 相似文献
14.
Currently, methods for evaluation of equivalence under a matched-pair design use either difference in proportions or relative risk as measures of risk association. However, these measures of association are only for cross-sectional studies or prospective investigations, such as clinical trials and they cannot be applied to retrospective research such as case-control studies. As a result, under a matched-pair design, we propose the use of the conditional odds ratio for assessment of equivalence in both prospective and retrospective research. We suggest the use of the asymptotic confidence interval of the conditional odds ratio for evaluation of equivalence. In addition, a score test based on the restricted maximum likelihood estimator (RMLE) is derived to test the hypothesis of equivalence under a matched-pair design. On the other hand, a sample size formula is also provided. A simulation study was conducted to empirically investigate the size and power of the proposed procedures. Simulation results show that the score test not only adequately controls the Type I error but it can also provide sufficient power. A numerical example illustrates the proposed methods. 相似文献
15.
The current method for pooling the data from different batches or factors, suggested by ICH Q1E guidance, is to use analysis of covariance (ANCOVA) for test interaction between slopes and intercepts and factors. Failure to reject the null hypothesis of equality of slopes and equality of intercepts, however, does not prove that slopes and intercepts from different levels of factors are the same, and the data can be pooled for estimation of shelf life. In addition, the ANCOVA approach uses indirect parameters of intercepts and slopes in the regression model for assessment of poolability. The hypothesis for poolability is then formulated on the basis of the concept of equivalence for the means among the distributions of the quantitative attributes at a particular time point. Methods based on the intersection-union procedure are proposed to test the hypothesis of equivalence. A large simulation study was conducted to empirically investigate the size and power of the proposed method for the bracketing and matrixing designs given in the ICH QID guidance. Simulation results show that the proposed method can adequately control the size and provides sufficient power when the number of factors considered is fewer than three. A numerical example using the published data illustrates the proposed method. 相似文献
16.
Jorge Quiroz 《Journal of biopharmaceutical statistics》2013,23(3):433-443
In medical device clinical studies, including therapeutic device and in vitro test assay method studies, the investigator is frequently interested in demonstrating the equivalence of clinical response, generally in continuous measurements, between a standard assay method and a new assay method over various occasions or times. The new assay method may be less invasive or more convenient or cheaper to use than the standard assay method. In this paper, several statistical approaches are discussed, including various repeated-measure regression models, the simultaneous 95% confidence interval for paired mean differences derived from Hotelling's multivariate T 2 analysis for repeated-measure, paired data, repeatability and reproducibility studies, and concordance correlation coefficient. 相似文献
17.
In this article, the use of statistical equivalence testing for providing evidence of process comparability in an accelerated stability study is advocated over the use of a test of differences. The objective of such a study is to demonstrate comparability by showing that the stability profiles under nonrecommended storage conditions of two processes are equivalent. Because it is difficult at accelerated conditions to find a direct link to product specifications, and hence product safety and efficacy, an equivalence acceptance criterion is proposed that is based on the statistical concept of effect size. As with all statistical tests of equivalence, it is important to collect input from appropriate subject-matter experts when defining the acceptance criterion. 相似文献
18.
《Statistics In Biopharmaceutical Research》2013,5(3):264-272
The opportunities for biosimilar medicines have stimulated much legal and regulatory debates and actions around the world, most notably the passing of the Biologics Price Competition and Innovation Act in the United States in 2009. A key difference between the development of a biosimilar product versus a generic chemical entity is the requirement for well-controlled clinical studies to demonstrate similarity in efficacy and safety. The main objective of this article is to extend the clinical study design methods commonly used in noninferiority trials to equivalence trials within the context of biosimilar product development. We extend the synthesis method to the equivalence setting and provide sample size considerations. We show that while an equivalence trial in general requires a larger sample size than a noninferiority trial, the difference may not be substantial depending on the significance level required for the equivalence trial. 相似文献
19.
Strength training and aerobic exercise have beneficial effects on pain in adults with fibromyalgia. However, the equivalence of strengthening and aerobic exercise has not been reported. The primary aim of this randomized equivalence trial involving patients with fibromyalgia admitted to an interdisciplinary pain treatment program was to test the hypothesis that strengthening (n=36) and aerobic (n=36) exercise have equivalent effects (95% confidence interval within an equivalence margin ± 8) on pain, as measured by the pain severity subscale of the Multidimensional Pain Inventory. Secondary aims included determining the effects of strengthening and aerobic exercise on peak Vo(2) uptake, leg strength, and pressure pain thresholds. In an intent-to-treat analysis, the mean (± standard deviation) pain severity scores for the strength and aerobic groups at study completion were 34.4 ± 11.5 and 37.6 ± 11.9, respectively. The group difference was -3.2 (95% confidence interval, -8.7 to 2.3), which was within the equivalence margin of Δ8. Significant improvements in pain severity (P<.001), peak Vo(2) (P<.001), strength (P<.001), and pain thresholds (P<.001) were observed from baseline to week 3 in the intent-to-treat analysis; however, patients in the aerobic group (mean change 2.0 ± 2.6 mL/kg/min) experienced greater gains (P<.013) in peak Vo(2) compared to the strength group (mean change 0.4 ± 2.6 mL/kg/min). Knowledge of the equivalence and physiological effects of exercise have important clinical implications that could allow practitioners to target exercise recommendations on the basis of comorbid medical conditions or patient preference for a particular type of exercise. This study found that strength and aerobic exercise had equivalent effects on reducing pain severity among patients with fibromyalgia. 相似文献
20.
A comparison of the pharmacodynamic effects of two source plants of Murrayae Folium et Cacumen (MFC), Murraya exotica L. and Murraya paniculata (L.) Jack, was performed in order to supply reference for its multi-source rationality and interchangeability in clinical practice. According to the traditional efficacy of MFC, the effects of promoting Qi, relieving pain, promoting blood circulation and removing blood stasis were systematically evaluated by the models of writhing response in mice, foot swelling in rats, gastric emptying and small intestine propulsion in mice, and acute blood stasis in rats, respectively. The results showed that both M. exotica and M. paniculata could significantly inhibit the writhing reaction induced by acetic acid in mice and the paw swelling induced by carrageenan in rats, reduce IL-6, TNF-α and PGE2 levels in plasma of paw-swelling rats and increase gastric empty rate and intestinal propulsive rate. The above-mentioned effects were dose-dependent, and there was no significant difference between M. exotica and M. paniculata at the same doses. Therefore, M. exotica and M. paniculata had the similar anti-inflammatory, analgesic and gastrointestinal motility promotion effects, which provided a support for the pharmacodynamic equivalence of the multi-source plants of MFC. 相似文献