Case report form (CRF) is a key document for data collection in clinical trials. A well-designed CRF is required for database construction, data accuracy, data query/cleaning, CRF completion and statistical analysis. A well-defined process or SOP should be in place for CRF design. Data collection should fully meet the demand of study protocol. The layout of CRF should be clear with well-structured fields and standard coding for fields.
Clinical Trials as Topic ; standards ; Data Collection ; standards ; Documentation ; standards ; Research Design ; standards

BACKGROUND:Bone marrow mesenchymal stem cel transplantation is a hot spot in the treatment of ischemic cerebrovascular diseases, and CT brain perfusion scan is mostly used to observe the improvement in the blood flow in the ischemic region. However, X-ray irradiation during CT brain perfusion may affect the viability of transplanted bone marrow mesenchymal stem cel s, and then influence the therapeutic efficacy. OBJECTIVE:To investigate the effect of CT brain perfusion dose on the viability of bone marrow mesenchymal stem cel s. METHODS:Passage 5 bone marrow mesenchymal stem cel s from Sprague-Dawley rats were selected and randomized into three groups, with 6 tubes in each group. One of the six tubes in each group was randomly selected with no irradiation, and the remaining five tubes in each group were subjected to CT brain perfusion scans 1-5 times, respectively. After scanning, the cel number was counted after 10-day continuous culture and cel growth curve of each tube was drawn. Cel cycle was detected by flow cytometry, and cel viability was measured by MTT method. RESULTS AND CONCLUSION:After 10 days of continuous counting, the number of cel s per tube showed no difference (P>0.05), and cel growth curves were basical y coincided. Moreover, there was no significant difference in the cel cycle and cel viability (P>0.05). Experimental findings show that the CT brain perfusion scan has no effect on the viability of bone marrow mesenchymal stem cel s.

AlM: To observe the influence on the incidence of diffuse lamellar keratitis ( DLK ) after laser in situ keratomileusis ( LASlK ) whether or not wearing sterile gloves with talc during operation, and to confirm the role of residual talc in the occurrence of DLK.
METHODS: Totally 563 patients ( 1 126 eyes ) accepted operation with the method of surgical hand antisepsis only were set as the experimental group, while 592 patients ( 1 184 eyes ) with the method of surgical hand antisepsis and sterile gloves as the control group. Each patient was rechecked to observe the occurrence of DLK on the first day and the seventh day after the operation. Then the data of DLK were statistically analyzed byχ2 test and rank sum test.
RESULTS:On the first postoperative day, the incidence of DLK was 7. 4% (83 eyes) in experimental group and 12. 2% (144 eyes) in control group. ln the former group, stage Ⅰ of DLK accounted for 4. 6% (52 eyes) and stageⅡ for 2. 8% (31 eyes);while in the latter, stage l did for 7. 7% (91 eyes) and stageⅡfor 4. 5% (53 eyes). On the seventh day, all DLK were cured. The other 2 cases ( 3 eyes) occurred in stage Ⅳ DLK ( the first time recheck was on the eighth day after operation and fluorometholone ophthalmic solution was not used on time ) . The incidence and the severity were both significant lower in the experimental group than in the control (both P<0. 01).
CONCLUSlON: Talc is one of the most important factors resulting in DLK after LASlK. The method of surgical hand antisepsis without wearing gloves could avoid the stimulation of talc and reduce the incidence of DLK obviously.

There is no a systemic performance metrics for clinical data management. While the CDMC in China starts to develop the quality metrics for clinical data management, it is essential to think over the performance and pursue metrics implementation of clinical data management in China. This article provides the basic concept, development and implementation of the performance metric in clinical data management.
China ; Clinical Trials as Topic ; standards ; Data Collection ; standards ; Information Storage and Retrieval ; standards

Microarray has become a popular biotechnology in biological and medical research.However, systematic and stochastic variabilities in microarray data are expected and unavoidable, resulting in the problem that the raw measurements have inherent "noise" within microarray experiments. Currently, logarithmic ratios are usually analyzed by various clustering methods directly, which may introduce bias interpretation in identifying groups of genes or samples. In this paper, a statistical method based on mixed model approaches was proposed for microarray data cluster analysis. The underlying rationale of this method is to partition the observed total gene expression level into various variations caused by different factors using an ANOVA model, and to predict the differential effects of G V (gene by variety)interaction using the adjusted unbiased prediction (AUP) method. The predicted G V interaction effects can then be used as the inputs of cluster analysis. We illustrated the application of our method with a gene expression dataset and elucidated the utility of our approach using an external validation.

Acute Disease ; Adult ; Animals ; Brucellosis ; transmission ; Cattle ; blood ; Female ; Food Handling ; Humans ; Male ; Middle Aged ; Occupational Diseases ; etiology ; Sheep ; blood

Objective To find out severity and types of syphilis infection in blood donors, attendants and persons to have their premrital medical examination in Zhoushan City and offer a new measure for prevention and treatment of syphilis. Methods Totally, 174 589 blood donors, attendants and persons to have their premarital medical examinations were screened preliminarily for inapparent syphilis with non-TPHA, and then TPHA was applied to confirm the diagnosis, according to the National Standard No. GB 15974-1995, combining with clinical symptoms and physical check-up. Results A total of 1 327 cases of syphilis from 174 589 samples tested, including blood donors, attendants and persons to have their premarital medical examinations, were diagnosed, with an inapparent infection rate of 7. 60‰ in average, 6. 42‰in males and 8. 74‰ in females, with a sex ratio of 0.71 (X2 = 29. 92, P

The optimization on liquid fermentation and purification of the fibrinolytic enzyme from Stenotrophomonas maltophilia(DR-929) was investigated.The results showed the best fermentation are amidulin 2.0%,soya flour 1.0%,yeast extract 0.5%,NaCl 1.0%,CaCl2 0.02%,MgSO4 0.05%,inoculum of 36 hours,fermental time 4d,initial pH 8.0 or 9.0,temperature 25℃,volume of media 30ml,volume of inoculum 5% or 6%.The purification process includes the following steps: removing cells by the centrifugation,25%~70% saturation ammonium sulfate precipitation,HIC with Phenyl FF(high sub),IEC with Q-Sepharose FF,gel filtration chromatography with Superdex 75.SDS-PAGE electrophoresis was used to examine the purification effect,and the results indicated that homogeneous strap in SDS-PAGE and has a molecular weight around 28.3kDa.The purification factor and activity recovery of the fibrinolytic enzyme are 271.5 and 24.5%,respectively.

Objective To study the biological activities of Synechococcus sp.PCC7942 with trans-mutated hCu,Zn-SOD-gene.Methods Synechococcus sp.PCC7942 with trans-mutated hCu,Zn-SOD were administered orally for 20d to mice,then the activities of glutathione peroxidase(GSH-Px),catalase(CAT),superoxide dismutase(SOD) and the content of malondialdehyde(MDA) were determined.Results The activities of GSHPx in serum and the activities of CAT in blood increased obviously;the activity of SOD in serum and liver increased markedly;the content of MDA in serum and liver decreased obviously.Conclusion Synechococcus sp.PCC7942 with trans-mutated hCu,Zn-SOD-gene had obvious antioxidant effect in vivo.