Looking closely into how the differences among populations are debated at the ICH, this paper aims to provide a comprehensive account on what actually occurs when states with different cultural backgrounds encounter one another at the frontier of pharmaceutical regulation, where neither West nor East shall exist.

Reflecting on the tension of which he was aware between the imperial West and the still-mysterious East, Victorian writer Rudyard Kipling penned the above phrase to express the incommensurable situation wherein the Westerner never understands the Asian, as the latter’s culture differs too greatly from his own. However, aware that East and West nevertheless cannot remain separated forever, the author ends the poem with an eventual encounter between the two.Over 100 years have passed since this poem was written, yet the (...) ambivalent encounter between East and West that it depicts still exists and is currently playing out within the field of pharmaceuticals. On one side of the divide are the many people in the industry who want to standardize global acceptance of drugs; on the other are the local authorities who want to maintain the overruling legal need not to compromise on health care at a national level. In this sense, the divergence and unity that Kipling captures is what this paper aims to discuss as it addresses how race is debated at the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. (shrink)

BackgroundBreast cancer patients are at elevated risk of depression during treatment, thus provoking the chance of poor clinical outcomes. This retrospective cohort study aimed to investigate whether integrating Chinese herbal medicines citation into conventional cancer therapy could decrease the risk of depression in the long-term breast cancer survivors.MethodsA cohort of patients aged 20–70 years and with newly diagnosed breast cancer during 2000–2008 was identified from a nationwide claims database. In this study, we focused solely on survivors of breast cancer at (...) least1 year after diagnosis. After one-to-one matching for age, sex, and baseline comorbidities, breast cancer patients who received and did not receive CHM treatment were enrolled. The incidence rate and hazard ratio citation for depression between the two groups was estimated at the end of 2012. A Cox proportional hazard model was constructed to examine the impact of the CHM use on the risk of depression.ResultsDuring the study period, the incidence rate of depression was significantly lower in the treated cohort than in the untreated cohort [8.57 compared with 11.01 per 1,000 person-years citation], and the adjusted HR remained significant at 0.74 in a Cox proportional hazards regression model. The corresponding risk further decreasing to 43% among those using CHM for more than 1 year.ConclusionFinding from this investigation indicated that the lower risk of depression observed in breast cancer patients treated with CHM, suggesting that CHM treatment should be considered for disease management toward breast cancer. Yet, the optimal administered dose should be determined in further clinical trials. (shrink)

论述了春秋时期法家思想的萌芽和先驱人物,战国前期和中期和法家学派的形成与勃兴,战国末期法家学派思想的总结与秦王朝法家政治的终结及法家思想对后世的影响。.

BackgroundThe rating of perceived exertion scales with respiratory and muscular illustrations are recognized as simple and practical methods to understand individual psychometric characteristics in breathing and muscle exertion during exercise. However, the implementation of respiratory and muscular RPE to quantify training load in futsal training camps has not been examined. This study investigates respiratory and muscular RPE relationships during domestic training camps and overseas training camps in an under 20 futsal national team.MethodsData collected from eleven field players were used for (...) comparison in this study. All players reported Borg CR10 RPE and 7-scales respiratory RPE and muscular RPE after training sessions and matches. Additionally, total distance covered and training impulse were used to quantify external and internal loads via the Polar Team Pro system. Paired-sample t-tests were used to compare the RPECR10, RPErespiration, RPEmuscle, TD, and TRIMP between DTC and OTC. Furthermore, linear regression was performed to determine the relationships among all RPE scales, TD, and TRIMP.ResultsThe RPECR10, TD, and TRIMP showed significant difference between DTC and OTC. Furthermore, linear regression analyses showed significant correlation between RPErespiration and RPEmuscle, RPECR10 and RPErespiration, and RPECR10 and RPEmuscle.ConclusionPictorial RPErespiration or RPEmuscle can be used as an alternative to quantify perceived measures of internal loads during DTC and OTC in futsal players. Interpretation of perceived measures of training load and cardiac-related responses in association with external training loads during short-term training camps would be useful in further understanding the demands of futsal players’ experience in these circumstances. (shrink)

The authors aim to explore a better fitting leadership style that is designed for the sustainable era in believing and committing to work for cherishing resources and developing the organization toward a new sustainable direction. This study developed the questionnaire items of the Resource-Dilemma-Handling-Leadership scale, representing a new sustainable era's new leadership style, and then to compare it with the transformational leadership style in order to highlight the importance of RHDL for sustainable development. This study took companies, which have more (...) than 100 employees in Taiwan as research samples. Those companies were selected because they were socially tagged as being operating continuously for more than 20 years and identifying themselves with the operational orientation of social responsibility as their business philosophy and core values for management. A total of 532 valid questionnaires were collected, with a 90.6% valid return rate, and tested with the SEM method. Consistent with the authors' inferences from the literature, the test results suggest that CSR plays the role of full mediator between RDHL and OC. CSR itself is like a sense of responsibility, giving employees a sense of mission, to complete meaningful sustainability-relevant tasks in the organization. RDHL, compared with TL, has a better prediction power on CSR and OC. Theoretically, this study implies that the impact of leadership of the organization on OC in the aspects of sustainable development should be going through the influence of the ELB system in the form of CSR to promote the organization's internal and external organizational CSR performance, with added internal strengthening power from OC. Practically, the new RDHL concepts brought up by this study include the training and enhancement of leadership skills based on the content of the scale items being explored. The new RDHL scale contains a comprehensive description of the spirit of the new sustainable era's leadership style. Also, the future applications of RDHL ideas in the form of human resource development should help the realization of the ideally sustainability behavioral patterns of leaders and employees in the organizations. (shrink)

Based on 24 hours of videotaped data, this study investigates, both qualitatively and quantitatively, gender differences in the use of person pronouns in televised sports in Taiwan. This analysis has found that, regardless of their speaker role, male sports reporters use the second-person singular pronoun nimuch more frequently than their female counterparts. In addition, there is a significant difference in the distribution ofpragmatic functions of nibetween men’s and women’s reporting. While male sports reporters use niin a more varied way, i.e. (...) to refer to the TV audience, a specific athlete or team, an indefinite or non-specific athlete, or to include this pronoun in direct speech to dramatize their reporting, female reporters use this pronoun predominately to referto a non-specific athlete. In other words, male sports reporters tend to employ impersonal niand dramatic nito signal their strong self-involvement, their interpersonal involvement with the athlete and the TV audience, and their involvement with the reported sports event. Finally, malesports reporters’ more frequent use of the second-person pronoun niin the data also marks their informal and conversational speech style.This result contradicts those previous studies which claim that formality and detachment characterize men’s information-oriented public discourse. (shrink)

Based on video-taped data from five televised 1998 Taipei mayoral debates, this article examines the use of reported speech in Chinese political discourse, with a particular focus on direct quotation. The findings are that direct quotation or constructed dialogue not only creates the rhetorical effect of vividness and immediacy but also establishes interpersonal involvement. More importantly, the three debaters in this study use direct quotation as an indirect strategy for self-promotion and for denigration. Citing someone else's words objectifies debaters' praise (...) of themselves and vilification of their opponents, thereby heightening the reliability of their claims: these claims are presented as shared knowledge and reference is made to an external source. However, direct quotation is also a strategy of evasion: the speakers disclaim responsibility and distance themselves from the source of knowledge. Finally, the different use of citations made by the three debaters also marks their different communicative styles. While the two politicians who speak more formally generally tend to cite figures from newspapers or magazines, the one who speaks most casually frequently employs direct quotations. (shrink)

Adopting Fairclough's multidimensional approach, this corpus-based study explores discursive changes in current Taiwanese society, with a particular focus on conversationalization in printed media. Data were collected from three major newspapers catering to different readerships during three time periods. The analyzed linguistic features include noun phrases, Chinese four-character set expressions, mixing of local dialect, and slang. My analysis shows that over the past two decades there has been an increase of conversational features in all three newspapers. In addition, a cross-sectional comparison (...) has revealed that soft news texts include more conversational features than hard news texts. It is also found that the newspaper which stresses local values and advocates an independent Taiwan identity tends to adopt more conversational features, particularly the mixing of Taiwanese in Mandarin news texts. Finally, I suggest that this trend of conversationalization in the Taiwanese press can be linked to substantive democratization and marketization of the Taiwanese society as well as the change and development of modern written Chinese. (shrink)

Ben shu bi jiao yan jiu liang shu ming he hu kuo de wen hua qu xiang, zheng zhi qu xiang, xue shu zhi qu, zhong xi wen hua guan, ke xue yu min zhu guan dui chuan tong wen hua de tai du he dui zhong guo wen hua chu lu de xuan ze deng wen ti.

Python language has become the most popular computer language. Python is widely adopted in computer courses. However, Python language’s effects on the college and university students’ learning performance, motivations, computer programming self-efficacy, and maladaptive cognition have still not been widely examined. The main objective of this study is to explore the effects of learning Python on students’ programming learning. The junior students of two classes in a college are the research participants. One class was taught Java language and the other (...) class was taught Python language. The learning performance, motivations, and maladaptive cognition in the two classes were compared to evaluate the differences. The results showed that the motivations, computer programming self-efficacy, and maladaptive cognition on the learning performance were significant in the Python class. The results and findings of this study can be used in Python course arrangement and development. (shrink)

本书简要介绍了从明中叶至辛亥革命这一历史时期中国文化史上的主流思潮。全书按历史顺序分别评介了晚明人文主义思潮、明清之际启蒙主义思潮、嘉道之际实学思潮和19世纪末—20世纪初的新民思潮。.

Understanding the neural basis of schizophrenia (SZ) is important for shedding light on the neurobiological mechanisms underlying this mental disorder. Structural and functional alterations in the anterior cingulate cortex (ACC), dorsolateral prefrontal cortex (DLPFC), hippocampus, and medial prefrontal cortex (MPFC) have been implicated in the neurobiology of SZ. However, the effective connectivity among them in SZ remains unclear. The current study investigated how neuronal pathways involving these regions were affected in first-episode SZ using functional magnetic resonance imaging (fMRI). Forty-nine patients (...) with a first-episode of psychosis and diagnosis of SZ—according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision—were studied. Fifty healthy controls (HCs) were included for comparison. All subjects underwent resting state fMRI. We used spectral dynamic causal modeling (DCM) to estimate directed connections among the bilateral ACC, DLPFC, hippocampus, and MPFC. We characterized the differences using Bayesian parameter averaging (BPA) in addition to classical inference (t-test). In addition to common effective connectivity in these two groups, HCs displayed widespread significant connections predominantly involved in ACC not detected in SZ patients, but SZ showed few connections. Based on BPA results, SZ patients exhibited anterior cingulate cortico-prefrontal-hippocampal hyperconnectivity, as well as ACC-related and hippocampal-dorsolateral prefrontal-medial prefrontal hypoconnectivity. In summary, spectral DCM revealed the pattern of effective connectivity involving ACC in patients with first-episode SZ. This study provides a potential link between SZ and dysfunction of ACC, creating an ideal situation to associate mechanisms behind SZ with aberrant connectivity among these cognition and emotion-related regions. (shrink)

Ben shu gong fen san bu: di yi bu hui gui zhen wo, di er bu hui gui tian di, di san bu hui gui tai ji. Nei rong bao kuo: lun sheng ming; sheng ming yu shi ge; sheng ming yu yin yue; xian dai ren sheng ming de yan bian; wo shi shui, tian di yu wo deng.

The objective of this study is to investigate the effects of emotional labor on job performance and satisfaction, as well as to examine the mediating effect of sleep problems and the moderating effects of personality traits. A time-lagged study was conducted on 864 health professionals. Scales for emotional labor, sleep, personality traits, and job satisfaction were used and job performance data was obtained from records maintained by human resources. Structural equation modeling was performed to investigate the relations. Sleep problems only (...) partially mediated the relationship between surface acting and job satisfaction but completely mediated the relationship between surface acting and job performance. Several personality traits were shown to moderate the relationship between surface acting and sleep problems. The effects were stronger for people with low agreeableness and high neuroticism. The relationship between high levels of deep acting and low levels of sleep problems was more pronounced in individuals with low extraversion. Supervisors should be conscious of emotional labor in the work context and provide necessary deep acting training to facilitate emotional regulation. (shrink)

Ben shu shi yi ben yan jiu ke xue li shi de shu ji. zhu yao nei rong bao kuo: Xi fang wen hua chuan tong he jin dai ke xue de dan sheng, Wen yi fu xing he Yidali ke xue zhong xin de xing qi, Xin jiao jing shen he Yingguo ke xue zhong xin shi dai de dao lai deng.

Consumer ethics is the moral principles and standards that guide consumers to determine the certain consumption behaviors are ethically right or wrong. Whereas cultural and personal dimensions are crucial constructs affecting individual ethical attitudes and behaviors, few studies consider Confucian dynamism and the role of money in consumer ethics. Confucian dynamism, a cultural dimension based on Confucianism, has played a central role in guiding moral obligations and ethics in human relations in several East Asian countries. Thus, this study tested its (...) hypotheses using a sample of 521 respondents obtained via a systematic random sampling technique. The authors find that individuals with a higher tendency to Confucian dynamism are less tolerant of unethical practices. These findings also show that the role of money partially influences consumer ethical beliefs. Finally, we examine the impact of demographic variables and find age and education affect consideration of ethical values. (shrink)

We investigated whether, in the emergency department, educational video-assisted informed consent is superior to the conventional consent process, to inform trauma patients undergoing surgery about the procedure, benefits, risks, alternatives, and postoperative care. We conducted a prospective randomized controlled trial, with superiority study design. All trauma patients scheduled to receive trauma-related debridement surgery in the ED of Kaohsiung Medical University Hospital were included. Patients were assigned to one of two education protocols. Participants in the intervention group watched an educational video (...) illustrating informed consent information, whereas those in the control group read an informed consent document. The primary outcome was knowledge scores and the secondary outcome was assessment of patient satisfaction. A multivariable regression model, with predefined covariates, was used to analyze differences in knowledge scores and patient satisfaction levels between the groups. A total of 142 patients were enrolled, with 70 and 72 assigned to the intervention and control groups, respectively. Mean knowledge scores were higher in the intervention ) than in the control group. By multivariate analysis, the intervention group had significantly greater differences in knowledge scores. Age, injury severity score, and baseline knowledge score significantly affected the differences in knowledge scores. Significant improvements were observed in patients’ perception of statements addressing comprehension of the information provided, helpfulness of the supplied information for decision making, and satisfaction with the informed consent process. Multivariate analysis showed significant correlations between video education and patient satisfaction. Both the educational approach and severity of injury may have an impact on patient understanding during the informed consent process in an emergency environment. Video-assisted informed consent may improve the understanding of surgery and satisfaction with the informed consent process for trauma patients in the ED. Institutions should develop structured methods and other strategies to better inform trauma patients, facilitate treatment decisions, and improve patient satisfaction. The ClinicalTrials.gov Identifier is NCT01338480. The date of registration was April 18, 2011. (shrink)

Ben shu shi zuo zhe cong du shu bi ji zhong xie qu de yi zu san wen sui bi, fan ying le zuo zhe zai yi shu he zhe xue shang de tan suo yu zhui qiu.

While univariate functional magnetic resonance imaging data analysis methods have been utilized successfully to map brain areas associated with cognitive and emotional functions during viewing of naturalistic stimuli such as movies, multivariate methods might provide the means to study how brain structures act in concert as networks during free viewing of movie clips. Here, to achieve this, we generalized the partial least squares analysis, based on correlations between voxels, experimental conditions, and behavioral measures, to identify large-scale neuronal networks activated during (...) the first time and repeated watching of three ∼5-min comedy clips. We identified networks that were similarly activated across subjects during free viewing of the movies, including the ones associated with self-rated experienced humorousness that were composed of the frontal, parietal, and temporal areas acting in concert. In conclusion, the PLS method seems to be well suited for the joint analysis of multi-subject neuroimaging and behavioral data to quantify a functionally relevant brain network activity without the need for explicit temporal models. (shrink)

Ensuring adequate informed consent for surgery in a trauma setting is challenging. We developed and pilot tested an educational video containing information regarding the informed consent process for surgery in trauma patients and a knowledge measure instrument and evaluated whether the audiovisual presentation improved the patients’ knowledge regarding their procedure and aftercare and their satisfaction with the informed consent process. A modified Delphi technique in which a panel of experts participated in successive rounds of shared scoring of items to forecast (...) outcomes was applied to reach a consensus among the experts. The resulting consensus was used to develop the video content and questions for measuring the understanding of the informed consent for debridement surgery in limb trauma patients. The expert panel included experienced patients. The participants in this pilot study were enrolled as a convenience sample of adult trauma patients scheduled to receive surgery. The modified Delphi technique comprised three rounds over a 4-month period. The items given higher scores by the experts in several categories were chosen for the subsequent rounds until consensus was reached. The experts reached a consensus on each item after the three-round process. The final knowledge measure comprising 10 questions was developed and validated. Thirty eligible trauma patients presenting to the Emergency Department were approached and completed the questionnaires in this pilot study. The participants exhibited significantly higher mean knowledge and satisfaction scores after watching the educational video than before watching the video. Our process is promising for developing procedure-specific informed consent and audiovisual aids in medical and surgical specialties. The educational video was developed using a scientific method that integrated the opinions of different stakeholders, particularly patients. This video is a useful tool for improving the knowledge and satisfaction of trauma patients in the ED. The modified Delphi technique is an effective method for collecting experts’ opinions and reaching a consensus on the content of educational materials for informed consent. Institutions should prioritize patient-centered health care and develop a structured informed consent process to improve the quality of care. The ClinicalTrials.gov Identifier is NCT01338480. The date of registration was April 18, 2011. (shrink)

Background Ensuring adequate informed consent for surgery in a trauma setting is challenging. We developed and pilot tested an educational video containing information regarding the informed consent process for surgery in trauma patients and a knowledge measure instrument and evaluated whether the audiovisual presentation improved the patients’ knowledge regarding their procedure and aftercare and their satisfaction with the informed consent process. Methods A modified Delphi technique in which a panel of experts participated in successive rounds of shared scoring of items (...) to forecast outcomes was applied to reach a consensus among the experts. The resulting consensus was used to develop the video content and questions for measuring the understanding of the informed consent for debridement surgery in limb trauma patients. The expert panel included experienced patients. The participants in this pilot study were enrolled as a convenience sample of adult trauma patients scheduled to receive surgery. Results The modified Delphi technique comprised three rounds over a 4-month period. The items given higher scores by the experts in several categories were chosen for the subsequent rounds until consensus was reached. The experts reached a consensus on each item after the three-round process. The final knowledge measure comprising 10 questions was developed and validated. Thirty eligible trauma patients presenting to the Emergency Department were approached and completed the questionnaires in this pilot study. The participants exhibited significantly higher mean knowledge and satisfaction scores after watching the educational video than before watching the video. Conclusions Our process is promising for developing procedure-specific informed consent and audiovisual aids in medical and surgical specialties. The educational video was developed using a scientific method that integrated the opinions of different stakeholders, particularly patients. This video is a useful tool for improving the knowledge and satisfaction of trauma patients in the ED. The modified Delphi technique is an effective method for collecting experts’ opinions and reaching a consensus on the content of educational materials for informed consent. Institutions should prioritize patient-centered health care and develop a structured informed consent process to improve the quality of care. Trial registration The ClinicalTrials.gov Identifier is NCT01338480. The date of registration was April 18, 2011. (shrink)

Background: To evaluate the effectiveness of a multifaceted intervention in improving emergency department (ED) patient privacy and satisfaction in the crowded ED setting. Methods: A pre- and post-intervention study was conducted. A multifaceted intervention was implemented in a university-affiliated hospital ED. The intervention developed strategies to improve ED patient privacy and satisfaction, including redesigning the ED environment, process management, access control, and staff education and training, and encouraging ethics consultation. The effectiveness of the intervention was evaluated using patient surveys. Eligibility (...) data were collected after the intervention and compared to data collected before the intervention. Differences in patient satisfaction and patient perception of privacy were adjusted for predefined covariates using multivariable ordinal logistic regression. Results: Structured questionnaires were collected with 313 ED patients before the intervention and 341 ED patients after the intervention. There were no important covariate differences, except for treatment area, between the two groups. Significant improvements were observed in patient perception of "personal information overheard by others", being "seen by irrelevant persons", having "unintentionally heard inappropriate conversations from healthcare providers", and experiencing "providers' respect for my privacy". There was significant improvement in patient overall perception of privacy and satisfaction. There were statistically significant correlations between the intervention and patient overall perception of privacy and satisfaction on multivariable analysis. Conclusions: Significant improvements were achieved with an intervention. Patients perceived significantly more privacy and satisfaction in ED care after the intervention. We believe that these improvements were the result of major philosophical, administrative, and operational changes aimed at respecting both patient privacy and satisfaction. (shrink)

Ben shu chan shu de nei rong shi zhi shi zhong ya fang wen hua de shen tou yu jiao liu.