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.

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

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.

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

OBJECTIVETo compare differences of clinical therapeutic effect of heat-sensitive moxibustion with different doses for irritable bowel syndrome (IBS).

METHODSSixty cases of IBS were randomly divided into a saturated-dose group (30 cases) and a traditional-dose group (30 cases). Heat-sensitive moxibustion was applied in both groups. The acupoints that had the strongest heat-sensitive feeling were selected and treated by warm and suspended moxibustion with moxa stick. Disappearance of heat-sensitive feeling was taken as the sign of treatment time in the saturated-dose group, while the traditional-dose group was treated for 15 min each time. The treatment in both groups was given twice a day for first 5 days, and from the sixth day it was given once a day for continuous 25 times, totally 30 days. Clinical symptom scores and therapeutic effect before and after treatment in two groups were observed.

RESULTSAfter the treatment, the cured and markedly effective rate was 75.0% (21/28) in the saturated-dose group, which was inferior to 44.4% (12/27) in the traditional-dose group (P < 0.05). The clinical symptom scores, including diarrhea, abdominal distension and pain, were obviously reduced in two groups compared with those before the treatment (all P < 0.05). Compared with the traditional-dose group, the symptom scores of diarrhea and abdominal distension in the saturated-dose group were obviously decreased (0.87 +/- 0.13 vs 1.27 +/- 0.21, P < 0.01; 1.12 +/- 0.41 vs 1.32 +/- 0.26, P < 0.05).

CONCLUSIONThe moxibustion featured with disappearance of heat-sensitive feeling and saturated dose has better therapeutic effect than that with traditional-dose for treatment of IBS. As individual dynamic amount of moxibustion, disappearance of heat-sensitive and quantitation varies from person to person, which is one of the key factors to obtain the best curative effect.

Acupuncture Points ; Adult ; Female ; Humans ; Irritable Bowel Syndrome ; therapy ; Male ; Middle Aged ; Moxibustion ; Treatment Outcome ; Young Adult

Traditional mineral Chinese medicine is a characteristic part of Chinese medicine, in the development of traditional Chinese medicine has its unique role. With the development of science and technology and the increase of the medical level, traditional mineral medicine research is gradually thorough and wide-ranging. In recent years, traditional mineral Chinese medicine research mainly includes the physical properties of mineral medicine, structure, chemical composition, pharmacology and treatment mechanism research. The above several aspects of research in the mineral medicine has important practical and theoretical significance. The above several aspects of research status and the problems existing in the research were briefly summarized and reviewed in this paper, and its development were discussed, to provide reference for further studies in the future.
Animals ; Humans ; Medicine, Chinese Traditional ; methods ; Minerals ; chemistry ; pharmacology ; toxicity ; Physical Phenomena