With worldwide improvements in the regulations of international and domestic clinical trial conductions, the quality of clinical trials and trial data management are receiving a great deal of attention. To ensure the quality of clinical trials, maintain business flexibilities and effectively utilize internal and external resources, the outsourcing model is used in the management of clinical data in operation of pharmaceutical companies. The essential criteria of a successful outsourcing mode in clinical trial are selection of qualified contract research organizations (CRO); establishment of appropriate outsourcing model, and generation of effective quality control systems to ensure the authenticity, integrity and accuracy of the clinical trial data.
Clinical Trials as Topic ; Data Collection ; methods ; Information Storage and Retrieval ; methods ; Outsourced Services ; Quality Control

Objective To investigate the clinical values of loop electrosurgical excision procedure (LEEP) in diagnosis and treatment of cervical intraepithelial neoplasia(CIN). Methods Fifty-two patients with cervical intraepithelial neoplasia underwent LEEP following cytology, colposcopy and multiple biopsies, were treated by LEEP. The cure rate, the operative time, bleeding volume and patients reaction of LEEP to the cervical intraepithelial neoplasia were investigated during the follow-up. Results The effective rate was 98.07 % in the patients treated by LEEP. The effective rate was 100 % in the patients in grade CIN Ⅰ or CIN Ⅱ by LEEP. No patients in grade CIN Ⅰ and Ⅱ had recurrence during the follow-up 1 year. The mean operative time was 7.8 minutes. The mean bleeding volume was 10 ml. No secondary bleeding and post-operative infection occurred. All these surgical specimens were checked successfully for pathology diagnosis. Conclusion The advantages to use the LEEP to manage cervical intraepithelial neoplasia include its simpleness to handle, short operative time,less bleeding, less vaginal discharge, safety, and high cure rate. LEEP can offer intact sample for pathological diagnosis. LEEP electrotome is a very ideal therapy for the cervical intraepithelial neoplasia, and can block the development of precancerosis to infiltrating carcinoma effectively.

With worldwide improvements in the regulations of international and domestic clinical trial conductions, the quality of clinical trials and trial data management are receiving a great deal of attention. To ensure the quality of clinical trials, maintain business flexibilities and effectively utilize internal and external resources, the outsourcing model is used in the management of clinical data in operation of pharmaceutical companies. The essential criteria of a successful outsourcing mode in clinical trial are selection of qualified contract research organizations (CRO); establishment of appropriate outsourcing model, and generation of effective quality control systems to ensure the authenticity, integrity and accuracy of the clinical trial data.

Triple-negative breast cancer (TNBC) is a special type of breast cancer, accounting for 15%-20% of all diagnosed breast cancer cases. Its estrogen receptor (ER), progesterone receptor (PR), human epidermal growth factor receptor-2 (HER-2) expression is negative, with unique biological characteristics, clinicopathological features and tumor heterogeneity. Its clinical features include high incidence of relapse, early metastasis and poor prognosis. Currently, it lacks effective treatment. This review described the clinicopathological features of TNBC, its molecular subtypes, several important pathways and targets, as well as presented the progress in clinical studies of targeted drugs in the hope of generating new ideas for the treatment of TNBC in the future.

Human cytomegalovirus (HCMV) has a higher prevalence in the population, and most normal individuals after primary infection can establish latent infections. Recent reports have suggested that cytomegalovirus infection associated with lipid metabolism, and play an important role in the pathogenesis of many diseases, such as hepatitis, atherosclerosis, isolated syndrome, metabolic syndrome, etc. This article summarized the relationship between cytomegalovirus infection and lipid metabolism, as well as its role in a variety of diseases progression.

Despite a combination of all available treatment, the mortality of liver failure is very high,especially in children patients. Artificial liver support methods have been tested for over 50 years. Standard techniques of blood purification like hemodialysis, adsorption, hemo or plasma filtration as well as bioreactorbased approaches using liver cells or tissues have been used. It' s believed that the damaged liver has the ability to return to normal. Artificial liver support systems are expected to be useful for temporary support of liver function. If the liver does not regenerate to normal functions, an artificial liver support system may be useful as a bridge to liver transplantation. In conclusion, artificial liver support method appears to be a reliable therapy for advanced liver diseases and has significantly decreased the mortality of liver failure. Artificial liver support system has been used in children patients as well, but it still needs more researches.

Objective To evaluate the immunoprotective effect of Schistosoma japonicum (Chinese strain) recombinant signaling protein 14-3-3(rSj14-3-3), and to observe the synergism of rSj14-3-3 and rSjGST proteins as candidate vaccine and the effect of ??-T cells activated by Mtb against Schistosoma japonicum. Methods BALB/c mice immunized with rSj14-3-3 and rSjGST purified through SDS-PAGE, electroelution and dialysis were challenged by cercaria infection. Six weeks after challenging infection, the mice were killed and the worm and egg reduction rates were calculated. Results Worm reduction rate was found to be 32.20% in rSj14-3-3+Freund adjuvant group, 31.10% in rSj14-3-3+rSjGST+Freund adjuvant group, 27.96% in rSj14-3-3+Mtb group, 26.00% in rSj14-3-3+rSjGST+Mtb group, and 27.10 % in rSjGST+Mtb group, respectively, number of eggs in liver tissue was reduced by 50.40%, 53.30%, 51.10%, 58.60% and 51.30%, respectively. Conclusion rSj14-3-3 could induce partial immunity against Schistosoma japonicum in BALB/c mice, and might serve as a candidate vaccine; ??-T cell activated by Mtb played a role in anti-Schistosoma japonicum similar to the immune reactions induced by Freund adjuvant, but no synergistic effect combined with rSjGST was observed.

Objective To study the localization of the signaling protein 14-3-3 of Schistosoma japonicum (Sj14-3-3)in the parasite. Methods Cercariae were collected from the infected Oncomelania hupensis for the infection of rabbits. Fifteen-day-old schistosomula and adult worms obtained from infected rabbits 15 and 42 days post-infection were used for frozen sections and indirect immunofluorescence staining with monoclonal antibody to rSj14-3-3. Results The results showed that the Sj14-3-3 distributed mainly in the tegument, subtegument, muscle, and parenchyma of both adult worms and 15-day-old schistosomula. Conclusion The wide distribution and large sites of Sj14-3-3 in the parasite were clearly demonstrated, which established a significant clue for further studies of biologic actions and application of 14-3-3 protein.

OBJECTIVE To evaluate the effect of air disinfection methods to improve air quality in dental clinic.METHODS Electrostatic attraction method was used to disinfect air in dental clinic.Air samples here collected before,during and after daily and treatments compared.Bacterial colonies were counted. The air effect of disinfection was compared with undisinfected control group in terms of total number of germs.RESULTS Bacterial count of disinfected group was lower than that of undisinfected group(P