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

This paper introduces the principles of an Environmental Temperature Supervising Network System, explain its hardware and software structure and the function of network system. The whole system is proved stable and reliable by experiment. It may have some profit in the market and great future in the application.

Objective To investigate effects of different doses of recombinant human bone morphogenetic protein-2 (rhBMP-2) on vascular endothelial growth factor (VEGF) expression in fetal mouse osteoblasts.Methods Calvaria osteoblasts of fetal mice of 19 days were cultured.The effects of rhBMP-2 at different doses and different action times on VEGF expression patterns in fetal mouse osteoblasts were observed with reverse transcrip- tion-polymerase chain reaction (RT-PCR) and Western blot staining.Results In the present study,RT-PCR detected a steady expression of VEGF mRNA in the control fetal mouse osteoblasts.The levels of VEGF mRNA increased in an apparent biphasic manner with a maximum stimulation (about 2-fold above the control,P＜0.05 ) in both VEGF mRNA species observed at 300 ng/mL of rbBMP-2.After 48 h of rhBMP-2 treatment,the VEGF mRNA levels approached those in the control.The VEGF mRNA levels appeared to be biphasic in rhBMP-2-treated cultures,showing peak induction at 3 and 24 h and remaining elevated at 48 b.Compared with the individual control value at each time point,an apparent maximum increase (about 2.5-fold above the control,P＜0.05) occurred at 6 h.The second peak induction,about 2-fold above that in the control,occurred at about 36 h.Conclusions The expression of VEGF mRNA is steady in the control fetal mouse osteoblasts.RhBMP-2 can promote the expression of VEGF in dose-dependent and time-dependent manners.

Objective To explore the potential of breast cancer stem cells in differentiating into vascular endothelial cells and participating in the angiogenesis of breast tumor.Methods The expressions of mutant P53, CD31 ,VEGF and Her-2 amplification in tumor blood vessels were detected and the single cell suspension of breast cancer was prepared.CD44+/CD24-/low cells were selected and cultured in culture system.The expressions of CD31 and CD105 on endothelial cell surface were detected by EGM-2 endothelial cell culture medium.The ability of uptake of acetylated low-density lipoprotein was measured.The endothelial cells were cultured in vitro to observe their vascular structure.Results The expressions of CD31,VEGF and mutant P53 were found in paraffin sections of breast cancer tissue samples, and they were arranged along the vessel lumen or blood vessel sphere. Immunofluorescence showed that CD31 and DAPI signals were expressed intravascularly in breast cancer tissues. Four samples of Her-2 positive amplification and 9 cases of non-amplification were detected in the samples.The successful separation of breast cancer stem cells was carried out by immunomagnetic sorting.The percentage of CD44+ cells in the pre-sorting cells was (7.5±2.6)% and that of CD44+ cells was about (94.3±4.7)% after magnetic sorting (P<0.05).The ratio of CD24+ cells was (48.2±9.4)% before sorting,and that of CD24+ cells was (4.3±1.6)% after immunomagnetic bead sorting.The proportion of CD105+ cells in mammary gland cells was (4.5±0.9)% and the proportion of CD31+ cells was (6.2±1.3)%.After cultured for three generations,the percentages of CD105+ cells and CD31+ cells were (79.6±9.3)% and (84.1±10.7)%,respectively (P<0.05). DiL-Ac-LDL could be phagocytized by endothelial cells cultured in endothelial cell culture system.Vessel-like structure was found in the endothelial cell group while the control group did not have the tendency of vascular changes.Conclusion Breast cancer stem cell-derived endothelial cells differentiate into endothelial cells in vitro and have the ability of vascular formation,suggesting that breast cancer stem cells may be involved in the formation of tumor blood vessels.

Objective To explore the effect of different indexes on evaluating insulin resistance in obese children. Methods Oral glucose tolerance test (OGTT) was performed in obese children (n= 61) and age - matched normal volunteers( n= 23) Serum glucose and insulin levels were determined at 0,30,60,120,180 min after OGTT, insulin resistance was estimated by homeostasis model assessment of insulin resistance (HOMA-IR). Indexes such as the ratio of area under the curve of glucose(AUCG)/area under the curve of insulin(AUCI), the ratio of fasting blood sugar(FBG) and fasting blood insulin (FINS) were meanwhile calculated. Results The level of serum FINS was significantly higher in obese children(P

AIM: To investigate the role of retinal pigment epithelium (RPE) in the growth of Müller cells using a co-culture system in vitro . METHODS: Müller cells were cocultured with RPE cells under both normoxic and hypoxic conditions in Transwell chamber culture system. Müller cell proliferation was evaluated by MTT assay. The number of cells which migrate through micropores and stay on the outer bottom side of insert systems were observed and counted. RESULTS: The activities of proliferation and migration of Müller cells when cocultured with RPE cells were significantly higher than those of the Müller cells when cultured alone at all time points under both normoxic and hypoxic conditions. However, for both the coculture and control groups, there is no significant difference between the measurements at 3 and 6 hours. CONCLUSION: Evidence suggests that RPE, when co-cultured with Müller cells, can stimulate migration and proliferation of Müller cells under both hypoxic and normoxic conditions in a time-dependent manner; how-ever, there is no evidence to support the synergetic interaction of RPE and Müller cells co-cultured under hypoxic conditions.

Thermo-therapeutic has been proved to be an effective approach for cancer therapy.This paper introduces a kind of new equipment suitable for liver oncology based on this theory,which uses the RF field as the thermal energy and adopts sequential-delivering technology.Its principle and advantages are introduced in detail.

OBJECTIVETo observe the clinical effect of low-dose once-daily tadalafil combined with Shuganyiyang Capsules in the treatment of mild-to-moderate erectile dysfunction (ED).

METHODSNinety patients with mild-to-moderate ED were equally randomized to groups A, B and C to receive Shuganyiyang Capsules, tadalafil, and tadalafil + Shuganyiyang Capsules, respectively. The scores of the patients on IIEF-5 and SF-PAIRS (15-Item Short Form of Psychological Interpersonal Relationship Scales) were recorded before and at 1 and 3 months after treatment.

RESULTSThe IIEF-5 scores of groups A, B and C were 10.13 +/- 1.55, 11.00 + 1.60 and 10.73 +/- 1.91 before treatment, and 13.77 +/- 2.11, 17.77 +/- 2.13 and 17.17 +/- 3.84 at 1 month after treatment, significantly higher in B and C than in A (P <0. 001) , but with no remarkable difference between B and C (P =0. 411). At 3 months after treatment, the IIEF-5 scores were 15.77 +/- 2.05, 18.07 +/- 2.24 and 19.37 +/- 3.76 in the three groups, dramatically higher in B and C than in A (P <0.001) as well as in C than in B (P<0.05). The scores on sexual self-confidence, sexual spontaneity and time concerns in SF-PAIRS were 3.90 +/-0.80, 8.67 +/- 1.94 and 14.43 +/- 1.92 before medication, 5.83 +/- 1.02, 9.90 +/- 1.75 and 11.17 +/- 1.68 at 1 month and 6.73 +/- 0.98, 11.07 +/- 2.08 and 10.67 +/-1.60 at 3 months after medication in group A; 4.17 +/- 0.87, 9.37 +/-1.43 and 14.47 +/-1.57 before medication, 6.47 +/-0.78, 10.83 +/- 2.18 and 10.20 +/-1.56 at 1 month and 6.83 +/-0.91, 11.30 +/- 1.88 and 9.47 +/- 1.57 at 3 months in group B; and 4.23 +/-0. 94, 9.50 +/- 1.89 and 14.67 +/- 2.91 before medication, 8.03 +/- 1.67, 13.43 +/-1.10 and 9.70 +/-1.21 at 1 month and 8.93 +/- 1.78, 14.70 +/- 1.26 and 8. 87 +/- 0. 97 at 3 months in group C. Compared with the baseline, the SF-PAIRS scores of the three groups were all significantly improved after treatment (P <0. 05) , and markedly higher in C than in the other two groups (P <0.05).

CONCLUSIONLow-dose once-daily tadalafil combined with Shuganyiyang Capsules is obviously effective in the treatment of mild-to-moderate ED, which not only improves the patients'erectile function, sexual self-confidence and sexual spontaneity, but also reduces their time concerns.

Adult ; Carbolines ; administration & dosage ; therapeutic use ; Drugs, Chinese Herbal ; therapeutic use ; Erectile Dysfunction ; drug therapy ; Humans ; Male ; Tadalafil ; Treatment Outcome

Objective To evaluate the therapeutic effects of liver transplantation (LT) for cholangiocarcinoma(CC)and analyze the prognostic factors.Methods From December 2001 to December 2006,234 patients receiving LT for hepatic carcinoma in our institute were enrolled as a basis of comparative study for 6 CC patients undergoing LT during the same period.Results These 6 patients were followed-up from 1 to 56 months.Five patients died and one recurred.The 0.5-,1-and 2-year patient cumulative survival rates were 4/6,3/6 and 1/6,respectively.The 0.5-,1-and 2-year tumor-free survival rates were 3/6,2/6 and 1/6,respectively.The average patient or tumor-free survival time were both(14±4) months.Conclusion The prognosis of cholangioearcinoma patients after LT iS poor.