With worldwide improvements in the regulations of international and domestic clinical trial conductions, the quality of clinical trials and trial data management are receiving a great deal of attention. To ensure the quality of clinical trials, maintain business flexibilities and effectively utilize internal and external resources, the outsourcing model is used in the management of clinical data in operation of pharmaceutical companies. The essential criteria of a successful outsourcing mode in clinical trial are selection of qualified contract research organizations (CRO); establishment of appropriate outsourcing model, and generation of effective quality control systems to ensure the authenticity, integrity and accuracy of the clinical trial data.
Clinical Trials as Topic ; Data Collection ; methods ; Information Storage and Retrieval ; methods ; Outsourced Services ; Quality Control

Objective The application of modern information technology to manage critical values of clinical examination,in order to improve the management level of patients safety and reduce the medical risk.Methods The critical values reminder in medical security alert system is developed and applied,the core module of the system are warning monitor of equipment record and SMS warning monitor of alerting in testing critical value.Results Through the application of system,the information of testing critical values are obtained duly,comprehensively and accurately,the notification time of clinical testing critical values are abbreviated,the notification scopes are spread and achieved the management of critical value at different levels.Conclusion The application of the system can be perfected the management of critical values,ensured patients safety,improved the medical quality and enhanced the management level of hospital,and then the system has become another example of informationization creating value.

With worldwide improvements in the regulations of international and domestic clinical trial conductions, the quality of clinical trials and trial data management are receiving a great deal of attention. To ensure the quality of clinical trials, maintain business flexibilities and effectively utilize internal and external resources, the outsourcing model is used in the management of clinical data in operation of pharmaceutical companies. The essential criteria of a successful outsourcing mode in clinical trial are selection of qualified contract research organizations (CRO); establishment of appropriate outsourcing model, and generation of effective quality control systems to ensure the authenticity, integrity and accuracy of the clinical trial data.

Objects:To investigate the current situation of interpersonal communication inpreparatory students in one Xinjiang medical college from the exchanges between students.Methods:Using self-developed questionnaire,a survey was conducted among 200 preparatory students and depth interviews were conducted for typical cases.Results:Preppies showed a strong willing of interpersonal communication.In the process of students' interaction,some features were presented as followings:pure motives but dissimilarity,narrow range of interactions,lack of interaction ability and the single form of social activities.Conclusion:Based on the above current situation of interpersonal communication in preparatory students,it should enhance the language application ability of preparatory stage,change the idea and attach importance to the education of humanistic quality in preparatory education and train preppy's expression and listening art.

Candidiasis, Oral ; diagnosis ; drug therapy ; microbiology ; Humans

Objective To study the assiociation of-866G/A polymorphism in the promoter of uncoupling protein 2(UCP2)gene in patients with type 2 diabetes and B-cell function in Han population in Nanjing.Methods For the case-control study,PCR-RFLP method was used to determine the distributions of allele and genotype frequencies of-866G/A polymorphism in the human UCP2 gene in 229 type 2 diabetic patients and 196 normal control subjects.All of the testees accepted oral glucose tolerance test and insulin releasing test to detect B-cell secretion function and insulin sensitivity.Results The distribution of genotype and allele frequencies of-866G/A polymorphism in the promoter of the human UCP2 gene were significantly different between type 2 diabetic patients and normal control subjects(?2=6.555,P=0.038;?2=6.363,P=0.012 respectively).The frequency of A/A genotype and A allele in type 2 diabetic were significantly higher than that in contrast(OR=1.99,OR=1.42 respectively,both P

Objective To investigate the accuracy of 64-detector helical CT in assessing stenoses of coronary arteries. Methods 64-detector helical CT angiography was performed in 128 patients with suspected coronary artery disease,and the results were compared with that of invasive coronary angiography. Results Among 128 patients, 1 724 of 1 920 coronary artery segments were assessable (90%). Overall sensitivity for classifying stenoses was 92%, specificity was 94%, positive predictive value was 82%, and negative predictive value was 96%.Conclusion 64-detector helical CT provides a high diagnostic accuracy in assessing coronary artery stenoses.

Objective　To study the relationship between the stress-related psychosocial factors and the psychosomatic symptoms of sterilized women. Methods　120 sterilized women were assessed with Symptom Check List 90(SCL-90),Social Supports Questionnaire(SSQ),Eysenck Personality Questionnaire(EPQ),Psychosocial Stress Scale for Group(PSSG)and a self-developed preoperative cognition scale.Data were analysed with SPSS. Results　There was a significant correlation between scores of psychosomatic symptoms and stress-related psychosocial factors such as EPQ-N,subjective social support(SSS),negative emotion(NE),positive emotion(PE),negative coping style(NC) and some negative characteristics of pre-operative cognition.Multiple stepwise regression analysis showed that EPQ-N,PE and religion belief were in the equation. Conclusion　The results indicated that neurotic syndrome of sterilized women may be mediated or influenced by negative characteristics of cognition,emotion,coping style and personality.

To investigate the kinetic expression of cytokine in allografts in rats and the effect of hydrocamptothecin on such expression, syngenic and allogenic heart transplantation models were developed. Recipient rats were divided into 3 groups: group A, SD-SD; group B, Wistar-SD group C,Wistar-SD plus treatment with HPCT 2. Omg/(kg ?d). The grafts and spleens were harvested on days 1, 3, 5, 7, and 14 post-transplantation for morphology and RT-PCR detecting the expressions of IL-2, IFN-?, IL-4, IL-10 mRNA. The results showed that the cytokine generally increased commensurately with the infiltration of this leukocyte population. The cytokine mRNA transcript could be detected on days 1 and 3 after transplantation in group A. The IL-2 and IFN-? mRNA transcript could be detected on days 1, 3, 5, 7 and 14 with a peak on day 7 in group B, but on day 3 in group C. The IL-4 and IL-10 mRNA transcript could be detected on days 1,3,5,7 and 14 with a peak on day 5 in group B, while on day 7 in group C. The levels of IL-2 IFN-? mRNA expression were significantly lower in grafts of group C than those in grafts of group B, whereas the levels of IL-4 and IL-10 mRNA were significantly higer in grafts of group C than those in grafts of group B. The level of cytokine mRNA expression in the grafts was similar to that of spleen of recipients. Our conculssion is the expression of cytokine mRNA in allografts can be detected on day 1 after transplantation ,with peaking of IL-2 and IFN-? on day 7, IL-4 and IL-10 on day 5. The survival time of allograft can be prolonged by HCPT. The levels of IL-2 and IFN-? mRNA expression can be reduced, while the levels of IL-4 and IL-10 mRNA expression be enhanced by HCPT.