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

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.

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.

Objective To investigate the cognitive impairment of middle-aged patients with type 2 diabetes mellitus(T2DM). Methods Wechsler adult intelligence scale-Chinese revised edition (WATS-RC) was used as the tool to examine the cognitive function of middle-aged patients with T2DM and the healthy controls in 51 cases. The t-test was used to compare the differences in score between patients and the control group. The patients were divided into two groups with or without cognitive dysfunction. The logistic regression analysis was made for all the variables to confirm risk factors for the cognitive dysfunction in diabetes. Results The WAITS-RC scores of digit-symbol coding test and block design test were much lower(P<0.05) in diabetes versus control group. The other tests showed no significant difference. The cognitive function was negatively correlated with HbA_1>c and HOMA-IR by logistic regression analysis. Conclusions For middle-aged patients with type 2 diabetes, their cognitive functions such as learning ability, analysis and comprehensive capabilities are impaired. The cognitive function is closely related with HbA_1c and HOMA-IR.

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

Objective To study the mechanism of diabetic nephropathy(DN) in type 2 diabetes mellitus of blood glucose fluctuation and oxidative stress.Methods 90 patients with type 2 DN were selected,included 30 cases of the normal albuminuria (DM group),30 cases of microalbuminuria (NA group),30 cases of the mass albuminuria (MA group),and during the same period,30 healthy persons in our hospital for medical examination were selected as the control group(NC group).The blood glucose,blood lipid,blood glucose fluctuation and oxidative stress were compared among the 4 groups.Results The blood glucose(FBG),postprandial 2h blood glucose(2hPG),glycosylated hemoglobin(HbA1c) levels had statistically significantly differences among the 4 groups(F=23.088,24.356,43.553,all P<0.05),which in the NC group[(4.03±1.12)mmol/L,(7.11±1.41)mmol/L,(4.11±0.83)%]were lower than the other 3 groups[DM group:(6.34±1.48)mmol/L,(9.13±1.52)mmol/L,(6.67±1.24)%;NA group:(6.58±1.53)mmol/L,(9.78±1.79)mmol/L,(7.53±1.51)%;MA group:(6.84±1.71)mmol/L,(10.23±1.36)mmol/L,(8.11±2.02)%](F=23.088,24.356,43.553,all P<0.05).There were no statistically significant differences in total cholesterol(TC),three acyl glycerin(TG),high density lipoprotein cholesterol(HDL-C) and low density lipoprotein cholesterol(LDL-C) among the 4 groups(F=1.079,1.732,0.358,1.428,all P>0.05).The mean amplitude of glycemic excursions(MAGE),mean absolute value of blood glucose(MODD),superoxide dismutase(SOD) and malondialdehyde(MDA) levels in the 4 groups had statistically significant differences(F=37.350,216.899,21.003,93.211,all P<0.05).Correlation analysis showed that in patients with type 2 DN,negative correlation was observed between SOD and MAGE and MODD(r=-0.430,-0.523,all P<0.05),MDA and MAGE,MODD was positively correlated(r=0.534,0.624,all P<0.05).Conclusion Blood glucose fluctuation is involved in the occurrence and development of DN,the mechanism may be correlated with oxidative stress.

Objective To investigate the genetic polymorphism of the transmembrane region of the MICA locus in Guangdong Han population,and to protract the genetic distance in different populations.Methods DNA samples from 106 unrelated Han individuals were genotyped by PCR to analyze the frequencies of MICA alleles.The genetic distance was estimated and the phylogenetic tree was protracted by DISPAN Software.Results In total,5 alleles of MICA-TM were observed,they were A4,A5,A5.1,A6 and A9.MICA-TM A5 was the dominant allele(0.2877),whereas A4 was the least popular one(0.1321).From genetic distance and phylogenetic tree we made,the preliminary finding is that Chinese Hans may have migrated from southwest China to northern and southern China.Conclusion MICA-TM locus has high genetic polymorphism and obvious variance in different populations.Since the genetic distance could be estimated effectively through MICA-TM locus,it could serve as the genetic marker in human migration and evolution research.

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 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