Electronic case report forms (eCRFs) instead of the traditional paper case report forms (pCRFs) are increasingly used by investigators and sponsors of clinical research. We include a total of 14 phase III studies (8 pCRF, 6 eCRF) to compare paper and electronic data documentation both quantitatively and qualitatively in clinical studies. The result suggests that adaptions of electronic data capture (EDC) in clinical trials have the advantages in optimization of data capture process, improvement of data quality and earlier clinical decision compared to paper-based methods. Furthermore, the successful implementation of EDC requires accouplements with corresponding data management processes and reallocation of resources.
Clinical Trials, Phase III as Topic ; Data Collection ; methods ; Information Storage and Retrieval ; methods ; Medical Informatics

Objective: To study and design a software system of filling out and submitting on line for the utilization rate of medical equipment so as to realize automatic analysis for the utilization rate of medical equipment in accordance with the time slot. Methods: SQL Server2000 was used as backend database, and Visual Studi2005 that was object-oriented language was adopted as procedure software to research this system. The filled data of client-side were saved in internal storage array of client, and the array of internal storage could be visited through Socket C of client, and then all of these data were disposably send to server. The Socket of server saved these received data in array of internal storage through the link of Socket C at client-side. And server was used as bridge between client and database through to link active data object of Sql serve2000 database, and it saved these received data of client and visited these data of database, and then returned to client and displayed them at client. Results: The software system realized submission on line for the service situation of medical equipment and saved the times of department that used medical equipment and statistic staff who count utilization rate. Through statistic analysis of computer, the system tremendously reduced the error rate and enhanced the accuracy and work efficiency of statistic work for the utilization rate of medical equipment. Conclusion: The software system can effectively replace the manual filling and calculate the utilization situation of medical equipment, and it can enhance timeliness and accuracy of statistic analysis for the utilization of medical equipment.

China ; Disaster Medicine ; Disasters ; statistics & numerical data ; Earthquakes ; statistics & numerical data ; First Aid ; statistics & numerical data ; Humans ; Mass Casualty Incidents ; statistics & numerical data ; Rescue Work

The bioinformatics software was used to predict the B cell and T cell epitopes of Toxoplasma gondii microneme 16 (TgMIC16) followed by epitopes display on the yeast of Saccharomyces cerevisiae.B and T cell epitopes of TgMIC16 were predicted by DNAStar and IEDB,and software of SYFPEITHI and BIMAS,respectively.According to the predicted results,the antigenic epitope region was expressed with pCTCON2/EBY100 display system.The expression protein was detected by indirect immunofluorescence (IFA) and flow cytometry.Results showed that there were potential B/T cell epitopes in TgMIC16 and concentrated in the aa343-625 region.The epitope region was successfully displayed on the surface of yeast cells,and the optimal induction time was 24 hours.The study would lay the foundation for the development and efficacy evaluation of the yeast carrier vaccine in the further research.

Objective To learn the current situation of Quality of Life (QoL)among patients with various Chronic Diseases (CDs)and the effects of CDs on QoL.Methods Data was from the fifth health service survey in Ningbo City with self -reported CDs cases and QoL was measured by EQ -5D scale.Semi -parameter Additive Models and Semi -parameter Generalized Additive Models (GAMs)were used to analyze influencing factor of QoL.Results Different CDs had different effects on EQ -5D index,with the most severe impairments for stroke which was followed by tumor,COPD,diabetes and hypertension successively.Stroke,tumor and diabetes could improve the probability of self -reporting "problems"in all five dimensions (including mobility,self -care,usual activities,pain/discomfort and anxiety/depression dimension)and COPD could only increase the probability of self -reporting "problems"in dimension of usual activities.Hypertension could affect the other four dimensions except for the dimension of anxiety/depression.The relationship between Body Mass Index (BMI)and EQ -5D index was appeared inversed U -shaped with the maximum EQ -5D index located around the BMI of 20.90.Conclusion Different CDs had different effects on QoL and reaching optimal BMI was beneficial to improve the QoL.

Objective To investigate the relationship between bus drivers' personality characteristics with driving experience and to provide reference for safe driving. Methods A total of 158 bus drivers who work for one year and above were extracted by random sampling from a bus company in Ningbo during March 2016 to May 2016. The survey was carried out by 16 personality factor questionnaire (16PF), and compared with the national norm. Results The subjects were male, and average age was 39.24±6.78. The average bus driving year was 15.54±6.66 and mainly with high school education (62.66%) . The scores of agreeableness (9.21±3.18), intelligence (8.12±1.81), excitability (9.60± 3.26), excitement (10.84±4.59), suspicion (8.94±2.87), introversion (9.01±2.60), experiment (10.18±2.52) and independence (10.51±3.13) of the subjects were significantly lower than the national norm (P<0.05) . The scores of sensitivity (10.67±2.72), anxiety (9.60±3.78) and the self-discipline (13.30±2.42) were significantly higher than the national norm (P<0.05) . And 54.43% of bus drivers have high score in eight sub-personality analysis of mental health factors and 67.09% of them have low score in professional achievement factor. The analysis of personality characteristics of bus drivers with different bus driving experiences showed that the highest stability score was in 16 bus driving years and above, and the highest anxiety score was in 6~ <11 bus driving years and the highest tension and anxiety score were in 11 ~ <16 bus driving years (P <0.05) . Conclusion Bus drivers show special professional personality traits, and some characteristics will be strengthened and weakened with the growth of bus driving experience. It is necessary to carry out special training for the bus drivers with different bus driving experience, especially about dealing with various types of accident risk for new bus driver timely and psychological counseling for old bus driver regularly.

To investigate the cell-killing effect and its possible mechanism of rClone30-hDR5 in combination with TRAIL on human hepatic carcinoma (HCC) cell line, first of all, recombinant plasmid pee12.4-hDR5 was introduced into HepG2 cells by liposome transfection. After five rounds of screening by flow cytometry, HepG2 cells expressing high levels of DR5 on cell surface were isolated. The cytotoxicity of TRAIL to selected cells was higher than that of TRAIL to HepG2 cells by MTT method (P < 0.01). The result suggested that the cloned hDR5 gene had biological activity. MTT assay showed that, rClone30- hDR5 in combination with TRAIL more efficiently inhibited the tumor growth of HepG2 cells compared to rClone30-hDR5 or TRAIL in vitro. The results of Annexin V-FITC/PI staining and Quantitative Real-time PCR indicated that rClone30-hDR5 in combination with TRAIL significantly increased the mRNA levels of caspase 3 and caspase 8, and induced the apoptosis of tumor cells. HepG2 cells were infected with rClone30-hDR5 or rClone30 at MOI of 1. The expression of hDR5 on tumor surface increased significantly by rClone30-hDR5 compared to that by rClone30, which contributed to the sensitivity to TRAIL. In conclusion, rClone30-hDR5 in combination with TRAIL has potential application value in cancer treatment.
Apoptosis ; Carcinoma, Hepatocellular ; pathology ; Caspase 3 ; metabolism ; Caspase 8 ; metabolism ; Drug Synergism ; Hep G2 Cells ; Humans ; Liver Neoplasms ; pathology ; Real-Time Polymerase Chain Reaction ; Receptors, TNF-Related Apoptosis-Inducing Ligand ; pharmacology ; TNF-Related Apoptosis-Inducing Ligand ; pharmacology ; Transfection

Heishui county, located in northwest Sichuan province, southwestern China, is an endemic area of zoonotic visceral leishmaniasis (VL) and is the most intractable area. VL is never destroyed in it. Asymptomatic dogs (Leishmania parasites have been diagnosed but clinically healthy) are considered to be a potential reservoir host in zoonotic VL area, and most can lead to infection of individuals, that is a new challenge for controlling VL in humans. The present study aimed to assess the Leishmania infection rate of asymptomatic dogs in Heishui county. Total 105 asymptomatic domestic dogs were gathered from 4 districts in Heishui county to investigate the infection rate with serological and molecular methods based on ELISA and kinetoplast minicircle DNA(kDNA) PCR, respectively. Out of 105 dogs, 44 (41.9%) were positive by more than 1 method; 21 (20.0%) were positive by ELISA, and 30 (28.6%) were positive by kDNA-PCR. Our study showed that Leishmania infection of domestic dogs which is clinically healthy is prevalent in the studied district, and the asymptomatic dogs infected by Leishmania may be the primary reason for the prevalence of visceral leishmaniasis in the area.
Animals ; China* ; Dogs* ; Enzyme-Linked Immunosorbent Assay ; Epidemiology ; Humans ; Leishmania* ; Leishmaniasis, Visceral* ; Methods ; Parasites ; Polymerase Chain Reaction ; Prevalence

AIM:To investigate the expression of CUE domain-containing 2 (CUEDC2) in hepatocellular car-cinoma ( HCC) and to analyze its clinical prognostic significance .METHODS:Total 186 formalin-fixed paraffin-embed-ded tissues obtained from surgical HCC with detailed clinicopathological and follow -up data were used .The expression of CUEDC2 was detected by immunohistochemistry .The relationships between the expression of CUEDC 2 and clinicopatholog-ical characteristics and prognosis were analyzed .RESULTS: The positive rate of CUEDC 2 in HCC was 85.5% ( 159/186), among which, the low expression was 52.2%(97/186) and the high expression was 47.8%(89/186).CUEDC2 expression was correlated with serum alpha-fetal protein (AFP) level, tumor size, tumor number, tumor differentiation and TNM stage (P<0.05).Kaplan-Meier survival curves showed that the patients with high expression of CUEDC 2 were asso-ciated with significantly shorter overall survival and recurrence-free survival than those with low CUEDC 2 expression ( P<0.05).Multivariate Cox regression analysis revealed 3 independent prognostic factors including CUEDC 2 expression, ser-um AFP and tumor number .CONCLUSION:CUEDC2 was expressed in most HCC tissues , which was relevant to tumor growth, tumor differentiation and prognosis .CUEDC2 could be a novel valuable molecular marker to predict the HCC prog-nosis.

BACKGROUNDBlood coagulation factor VII (FVII) is physiologically synthesized in the liver and released into the blood. Binding of FVII to tissue factor (TF) is related to the metastatic potential of tumor cells, also a significant risk factor in the development of hepatic metastasis in patients with colorectal cancer (CRC). It has been found that some cancer cells can produce FVII extrahepatically. However, little is known about FVII and CRC. We therefore hypothesized that CRC cells may synthese FVII, leading to tumor invasion and metastasis.

METHODSWe detected the expression of FVII protein in 55 CRC specimens by immunohistochemical staining. The FVII mRNA in 45 of 55 CRC cases, 6 colon cancer cell lines and one hepatoma cell line was measured by real-time reverse transcription-PCR (RT-PCR). Transwell invasion assays were performed to evaluate the changes of cell migration and invasion of LoVo cancer cells in vitro. We further observed the likely effectors regulated by the TF/FVIIa complex Western blotting assay.

RESULTSExtrahepatic synthesis of FVII was detected in the cytoplasm of 32 (58.2%) CRC specimens by immunohistochemistry, but not in normal mucosa. Liver metastasis (P = 0.003) and TNM staging (P = 0.005) were significantly correlated with FVII antigen expression. The positive ratios in stages I, II, III and IV were 33.3%, 40.0%, 52.4% and 87.5%, respectively. The expression of FVII mRNA in CRC with hepatic metastasis was significantly higher than CRC without hepatic metastasis (5.33 ± 2.88 vs. 1.47 ± 0.51, P = 0.03). Ectopic FVIIa induced a slight increase (1.34-fold) in the number of migrating cells, which was inhibited by the specific TF antibody. The formation of TF/FVIIa complex resulted in a marked increase in the expression of matrix metalloproteinases (MMP)-2 (3.5-fold) and MMP-9 (4.7-fold) in a time-dependent and dose-dependent manner.

CONCLUSIONSExtrahepatic synthesis of FVII by CRC cells may promote tumor invasion and metastasis. MMPs, as downstream effectors of TF/FVIIa signaling, facilitate the development of metastasis in colon cancer.

Adult ; Aged ; Aged, 80 and over ; Cell Line, Tumor ; Cell Movement ; Colorectal Neoplasms ; metabolism ; pathology ; Factor VII ; analysis ; biosynthesis ; genetics ; Female ; Humans ; Immunohistochemistry ; Liver Neoplasms ; secondary ; Male ; Matrix Metalloproteinase 2 ; analysis ; Matrix Metalloproteinase 9 ; analysis ; Middle Aged ; Neoplasm Invasiveness ; Neoplasm Staging ; RNA, Messenger ; analysis ; Thromboplastin ; physiology