ICH GCP requires that all information of clinical trial should be recorded, processed, and stored in a way that allows the accurate reporting, interpretation and verification. A trial master file (TMF) contains all paper or electronic records/documentations related to a clinical trial. As a tool of the retrospective analysis, the TMF profile should be able to reproduce the full procedure of the trial completely. As a part of TMF profiles, both the accuracy and completeness of clinical data management documentation are important in data integrity. It is helpful to learn the workflow of clinical data management in different stage of a clinical trial, to understand which documents are essential, and why the documentation of clinical data management is important for data integrity. This paper elaborates how to perform the good documentation practice of clinical data management, and suggests that both the precise and efficient document management and regular quality control may ensure the high quality of clinical data documentation management on the basis of an intensive awareness of the overall process of clinical data management.
Clinical Trials as Topic ; Data Curation ; standards ; Information Storage and Retrieval ; methods ; standards

AIM: To investigate effect of autogenous conjunctival flap transplantation in the treatment of severe fungal corneal ulcer.
METHODS: A total of 83 cases ( 83 eyes ) with severe fungal corneal ulcer treated in our hospital from Jan. 2013 to Jan. 2016 were selected. Among them, 36 cases ( 36 eyes) were treated with drug therapy, and 47 patients(47 eyes ) were treated with autogenous conjunctival flap transplantation, two group did fungal culture and identification, observed the two groups treatment effect.RESULTS:The effective rate of surgical treatment group was 89%, significantly higher than that of drug treatment group, the difference was statistically significant ( P <0.05 ); The effective rate of surgical treatment of filamentous bacteria was 92%, which was significantly higher than that of drug treatment, the difference was statistically significant(P<0. 05). The effective rates of surgical treatment and drug treatment of yeast were 80%and 78%, the difference was not statistically significant( P<0. 05).
CONCLUSION: Autologous conjunctival flap transplantation in the treatment of severe fungal corneal ulcer has good curative effect. The operation is simple, worthy of recommendation method. Filamentous bacterial corneal ulcer without good drug therapy effect, surgical treatment should be performed in a timely manner to improve the curative effect.

Adult ; Bronchi ; Diagnostic Errors ; Foreign Bodies ; diagnosis ; Humans ; Male

Objective To observe the effect of ethanol extract and ethyl acetate extract of Capparis Spinosa on the thickness of dermis,synthesis of collagen type Ⅰ,type Ⅲ,and expression of transforming growth factor-β1 in mouse models of scleroderma.Methods Mouse models of scleroderma were established through local injection of bleomycin on the back once a day for 4 weeks.After confirmation of model establishment,72 mouse models were equally and randomly divided into three groups.Two groups received topical treatment with ethanol extract of Capparis Spinosa and ethyl acetate extract of Capparis Spinosa,respectively,no treatment was given to the rest of the control group.After 2-,4-,6-week treatment,8 mice were sacrificed and tissue samples were obtained from the back,and subiected to the measurement of dermal thickness by HE staining,as well as to the analysis of expression of collagen type Ⅰ,collagen type Ⅲ and transforming growth factor-β1 by immunohistochemical staining.Results On week 2,4,6,the thickness of dermis was 23.22,24.94,19.97 μm respectively in mice treated with ethanol extract of Capparis Spinosa,27.66.26.15,22.13 μm respectively in those treated with ethyl acetate extract of Capparis Spinosa.Compared with the mouse models without treatment,the thickness of dermis significantly decreased(F=12.99,P＜0.01),the expression of collagen type Ⅰ(F=7.47,P＜0.01)and transforming growth factor-β1(F=11.76,P＜0.01)were also inhibited in those receiving treatment.However,the expression of collagen type Ⅲ was not affected obviously by the treatment.Conclusion The ethanol extract and ethyl acetate extract of Capparis Spinosa have the effect against skin fibrosis.

BACKGROUND: Delirium is an acute organic brain syndrome caused by various reasons, and it is common in elderly patients. Antipsychotics treatment is an important method to control delirium.OBJECTIVE: To observe the efficacy of new antipsychotic agent of olanzapine and the traditional antipsychotic agent of haloperidol in treating senile delirium.DESIGN: A randomized controlled observation. SETTING: Mental Health Center, the First Affiliated Hospital of Chongqing University of Medical Sciences.PARTICIPANTS: Totally 175 inpatients with senile delirium were selected from the First Affiliated Hospital of Chongqing University of Medical Sciences from September 2001 to September 2003, they were randomly divided into olanzapine treatment group (n=74), haloperidol treatment group (n=72) and a control group(n=29). There were 111 males (63.4%) and 64 females (36.6%). Delirium had occurred for a duration of 30 minutes to 17 days, with an average of (3.02±2.71) days. The enrolled patients were classified according to the etiological factors of delirium: metabolic (n=68), toxic (n=47), structural (n=25) and infectious (n=35).METHODS: Different treatments were used in different groups. Control group (n=29): The patients were only given somatic treatment aiming at delirium, and not any drug for central nervous system was used. Olanzapine group (n=74): Besides the somatic treatment aiming at delirium, the patients were given olanzapine (Zyprexa, produced by Eli Lilly and Company,5 mg/tablet) taken orally or sublingually (fasted patients), the initial dosage was 1.25-2.5 mg per day, and then adjusted to 1.25-20 mg per day. Haloperidol group (n=72): Besides the somatic treatment aiming at delirium, they were treated with intramuscular injection of haloperidol (2.5-10 mg per day). The effects were prospectively observed for 1 week.The scores were observed before enrollment and at 1-7 days respectively,the severity of mental disorder and amelioration were evaluated by the clinical global impression scale-severity of illness (CGI-SI) and global improvement item of clinical global impression scale (CGI-GI). The dosage and time of administration was taken as the dosage and time to take effect when the CGI-SI baseline scores decreased by more than 1 point.MAIN OUTCOME MEASURES: The severity of mental disorder and amelioration were observed.RESULTS: ① The scores of CGI-SI after treatment were significantly decreased in the olanzapine group, haloperidol group and control group, and there were significant differences (P ＜ 0.01). ② The rates of marked effect in the three groups were 82.4%, 87.5% and 31.0%, respectively, and those in the two treatment groups were significantly different from that in the control group (P ＜ 0.01). ③ Both olanzapine and haloperidol began to take effect at small dosages, and it was the fasted in the olanzapine group, followed by the haloperidol group, and slowest in the control group.CONCLUSION: Olanzapine and haloperidol have similar effects in treating senile delirium. However, olanzapine is faster to take effect than haloperidol.

Objective: This study aims to investigate the correlation between the expression of FoxP3, TGF-β1, and epitheli-al-mesenchymal transition (EMT) in breast cancer and to determine the clinical significance of FoxP3. Methods: The expression of FoxP3, TGF-β1, E-Cadherin, N-Cadherin, Vimentin, and Fibronectin protein were detected in the cancer cells of 74 cases with breast carcinoma via immunohistochemistry. The correlation of FoxP3 protein with clinico-pathologic features of breast carcinoma and the re-lationships among the expressions of FoxP3, TGF-β1, and epithelial-mesenchymal transition (EMT) were analyzed. Results:The ex-pression rates of FoxP3, TGF-β1, and EMT are 36.5%(27/74), 39.2%(29/74), and 40.5%(30/74), respectively. The FoxP3 protein ex-pression in breast cancer is correlated with lymph node metastasis (P<0.05) but not with other clinico-pathological features (P>0.05). The expression of FoxP3 is also correlated with the expression of TGF-β1. Furthermore, TGF-β1 can induce EMT (P<0.05). Conclu-sion:The expression of FoxP3 is correlated with lymph node metastasis and EMT in breast cancer. Therefore, FoxP3 may be a marker for predicting metastasis.

Antimony ; blood ; Humans ; Spectrophotometry, Atomic ; methods

Objective To develop the clinical application and the method for functional repair in fa- cial nerve defect in parotideetomy of parotid carainoma.Methods Defect of facial nerve in parotidectomy was repaired by transplantation of sternocleidomastoid muscle-great auricular nerve flap with anastomosis of great auricular nerve-facial nerve under microscope.Results Eight eases of facial nerve defect in parotid carcinoma were repaired by this method.The facial nerve function almost recovered and access to normal dur- ing 3 to 6 month after operation in this series.6 of 8 patients achieved a gradeⅡ,2 of 8 patients achieved a gradeⅢ.Conclusion Reconstruction of facial nerve defect using sternocleidomastoid muscle-great auricu- lar nerve flap can provide better blood supply for the plerosis and regeneration of nerve.The nerve flap also ac- celerate the functional recovery after nerve grafting.

Actins ; metabolism ; Antigens, CD34 ; metabolism ; Diagnosis, Differential ; Female ; Hemangioma ; metabolism ; pathology ; surgery ; Hemangiosarcoma ; pathology ; Humans ; Middle Aged ; Platelet Endothelial Cell Adhesion Molecule-1 ; metabolism ; Sarcoma, Kaposi ; pathology ; Skin Neoplasms ; metabolism ; pathology ; surgery ; Vimentin ; metabolism

Through scale-up cultivation of Eriobotrya japonica suspension cells using WAVE bioreactor, the cell growth and ursolic acid (UA) accumulation were studied. The comparison test was carried out in the flask and the reactor with cell dry weight (DW) and UA content as evaluation indexes. The culture medium, DW and UA content were compared in 1 L and 5 L working volumes of bioreactor. The orthogonal test with main actors of inoculation amount, speed and angle of rotation was developed to find the optimal combination, in 1 L working volume of bioreactor. DW of the cell growth and the UA content in bioreactor were higher than those of the shaker by 105.5% and 27.65% respectively. In bioreactor, the dynamic changes of elements in the fluid culture, the dry weight of the cell growth and the UA content in 1 L and 5 L working volumes were similar. Inoculation of 80 g, rotational speed of 26 r · min(-1), and angle of 6 ° was the optimal combination, and the cell biomass of 19.01 g · L(-1) and the UA content of 27.750 mg · g(-1) were achieved after 100 h cultivation in 1 L working volume of bioreactor. WAVE Bioreactor is more suitable than flasks for the E. japonica cell suspension culture, and culture parameters can be achieved from 1 L to 5 L amplification.
Biomass ; Bioreactors ; Cell Culture Techniques ; instrumentation ; methods ; Culture Media ; chemistry ; metabolism ; Eriobotrya ; chemistry ; growth & development ; metabolism ; Triterpenes ; analysis ; metabolism