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.

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.

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

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

OBJECTIVETo compare the effects of dust exposure and smoking on mortality.

METHODSBased on the Guangzhou Occupational Health Surveillance Record System established in 1989-1992, 80 987 factory workers, aged > or = 30, occupationally exposed to dust and non-exposure to dust, were included in a prospective cohort study.

RESULTS(1) The mean age of the cohort was 43.5. Most subjects were workers, with secondary education, and married. Out of them 16.3% having ever exposed to dust, 43.7% ever smoked and 33.5% drank alcohol. (2) The cohort were traced for 8 years on average, but 35 were lost for follow-up. Malignant neoplasm was most commonly seen among 1539 deaths. (3) The adjusted relative risk (RRs) of death of all causes, malignant neoplasm and cerebro-cardiovascular diseases for dust exposed workers were close to those for smokers. However, the adjusted RRs of death of nasopharynx cancer and respiratory system diseases for dust exposed workers were higher than those for smokers. The adjusted RRs of death of lung cancer and stomach cancer for smokers were 2.2 times and 1.5 times of that for dust exposed workers respectively. Dust exposure combined with smoking caused significantly higher death RR. (4) In males, the adjusted RRs of death of all causes, malignant neoplasm and respiratory system diseases for silica dust exposed workers and the adjusted RR of death of cerebro-cardiovascular diseases for wood dust exposed workers were higher those in smokers. (5) The population attributable risk percentage (PARP) of all causes of death for smokers was 2.5 times of that for dust exposed workers. (6) In males, the risks of death for all causes, malignant neoplasm, lung cancer and stomach cancer increased with the amount of smoking per day and the duration of smoking. The risks of death caused by coronary heart disease and respiratory system diseases were increasing with the amount of smoking per day and the duration of smoking respectively.

CONCLUSIONSThe adjusted RRs for dust exposed workers were close to those for smokers with dust exposure and smoking having synergistic effects. Some of the adjusted RRs for smokers were higher than those for dust exposed workers PARP for smokers was higher than that for dust exposed workers. Our findings suggested that there was a significant dose-effect between smoking and risk of deaths.

Adult ; Cause of Death ; China ; epidemiology ; Coal ; Cohort Studies ; Dust ; Female ; Humans ; Male ; Occupational Exposure ; adverse effects ; Prospective Studies ; Risk Factors ; Silicon Dioxide ; Smoking ; adverse effects

OBJECTIVETo assess the associations between schizophrenia and six functional genes: dopamine D2 receptor gene (DRD2), dopamine D4 receptor gene (DRD4), 5-hydroxytryptamine 2A receptor gene (5-HT2A), 5-HT6 receptor gene (5-HT6), catechol-O-methyltransferase gene (COMT) and dopamine transporter gene (DAT1).

METHODSWith the techniques of Amp-RFLP and Amp-FLP, association analysis was made between schizophrenia and the six genes in 67 schizophrenic patients from Chinese Han population.

RESULTS(1) Neither genotypes nor alleles of DRD2, 5-HT2A, 5-HT6 and COMT gene showed significant differences between patients and controls (P>0.05). (2) Six repeats (6R) in DRD4 gene, the allele of 480 bp and the genotype of 480/520 in DAT1 gene were found to be of significant differences between the two groups (P<0.05). (3) Only one negative association was observed between the 480 bp allele of DAT1 gene and schizophrenia (OR=0.441, 95% CI:0.202-0.963, Z=2.05, P<0.05).

CONCLUSIONThe 480 bp allele of DAT1 gene is negatively associated with schizophrenia in Chinese Han population, which stands for the dopamine hypothesis of schizophrenia.

Adult ; Alleles ; Catechol O-Methyltransferase ; genetics ; DNA ; genetics ; Dopamine Plasma Membrane Transport Proteins ; Female ; Gene Frequency ; Genetic Predisposition to Disease ; genetics ; Genotype ; Humans ; Male ; Membrane Glycoproteins ; Membrane Transport Proteins ; genetics ; Middle Aged ; Nerve Tissue Proteins ; Polymorphism, Restriction Fragment Length ; Receptor, Serotonin, 5-HT2A ; Receptors, Dopamine D2 ; genetics ; Receptors, Dopamine D4 ; Receptors, Serotonin ; genetics ; Schizophrenia ; genetics