For pharmaceutical industries, clinical data is one of the most valuable deliverables. It is also the basis of analysis, submission, approval, labeling and marketing of a drug product. To ensure the integrity and reliability of clinical data, a scientific standardized quality control (QC) has to be established at each step of a clinical trial. Data validation is conducted to ensure the reasonability and compliance of clinical data by checking data quality before the data is statistically analyzed. This paper focuses on purpose of data validation, creation of data validation plan, rationale of data validation, types of data validation and performance of user acceptance testing on clinical database.
Clinical Trials as Topic ; standards ; Data Accuracy ; Data Collection ; standards ; Databases, Factual ; Quality Control ; Reproducibility of Results

OBJECTIVETo compare the clinical efficacy differences between medicinal vesiculation combined with quick cupping at Shenque (CV 8) and regular medication for allergic rhinitis with syndrome of yang deficiency.

METHODSEighty-two cases were randomly divided into an observation group (42 cases) and a control group (40 cases). The observation group was treated with medicinal vesiculation combined with quick cupping at Shenque (CV 8). The medicinal vesiculation was applied at Feishu (BL 13), Gaohuang (BL 43), Fengmen (BL 12), Mingmen (GV 4) on the dog days in the summer, one treatment on the 1st dog-day, 2nd dog-day and last dog-day respectively with an interval of 10 days between two treatments. Three treatments were taken as one course, and totally one course was given. The quick cupping was applied at Shenque (CV 8), once a day, ten treatments were taken as one course, and totally three courses was given. The control group was treated with oral administration of loratadine and nasal spray of budesonide. The loratadine was given 10 mg per time, once a day for continuous 14 days; budesonide was given once a day, ten treatments were taken as one course, and totally three courses was given. The clinical efficacy in two groups after treatment was observed, and the contents of immune globulin E (IgE), interleukin-4 (IL-4), interleukin-5 (IL-5) and tumor necrosis factor-α (TNF-α) in peripheral serum were measured before and after the treatments.

RESULTSOf all the 82 patients, 79 cases completed the treatment, and 1 patient in the observation group and 2 patients in the control group dropped out. The effective rate was 87.8% (36/41) in the observation group, which was superior to 78.9% (30/38) in the control group (P<0.05). After treatment, both groups effectively reduced the contents of IgE, IL-4, IL-5 and TNF-α, and the observation group had superior effect on reducing IgE and IL-4 to the control group (P<0.05).

CONCLUSIONThe medicinal vesiculation combined with quick cupping at Shenque (CV 8) have better effect for allergic rhinitis with syndrome of yang deficiency than oral administration of loratadine and nasal spray of budesonide.

Acupuncture Points ; Acupuncture Therapy ; Adolescent ; Adult ; Budesonide ; administration & dosage ; Combined Modality Therapy ; Drugs, Chinese Herbal ; administration & dosage ; Female ; Humans ; Male ; Middle Aged ; Rhinitis, Allergic ; drug therapy ; therapy ; Yang Deficiency ; drug therapy ; therapy ; Young Adult

[Objective]To investigate the effect of transforming growth factor ?1(TGF-?1) genes transfection on the proliferation and differentiation of chondrocyte by adenovirus vector,and to observe the quality in repair cartilage defect through constructing tissue-engineered cartilage.[Method]Using replicat ion defective adenovirus Adeno-X~(TM) as a carrier,Articular chondrocytes were transferred by high titers level recombinant adenovirus taking TGF-?1 genes.Ultromicrostructure,prolife ration anddifferentiation were observed by light and electron microscope,flow cytometry and so on.Induce expression of exogenous genes coding protein and cartilage cell phenotype were detected by Immunocytochemistry and Northern blot.Gross observation,histology and effect classification were used to evaluate results in repair cartilage defect by combi nation of infected chondrocytes and bone matrix gelatin(BMG).[Result]Immunocytochemistric staining showedthe expression of exogenous gene coding proteins after infection,and procollagen Ⅱ mRNA in cells was detected increasingly by Northern blot.TGF-?1 stimulated proliferation of chondrocytes in primary cultured,and resulted in recruitment of articular chondrocytes into S-G2/M phase.Chondrocytes seeded onto BMG showed high level of proliferation.Transplantation in vivo showed: cartilage defect was repaired satisfactorily by Combination of BMG and infected chondrocytes,and the structure of repair tissue got close to normal articular cartilage.[Conclusion] Articular chondrocytes prolifera tion could be stimulated by adenovirus vector taking TGF-?1 genes,which could be used to constructed tissue-engineered cartilage,and applied in repairing joint cartilage defect.

Objective To study the effect of rehabil it ation training on the expression of S-100, GFAP and Nestin in the cortex of cer ebrally infarcted rats. Methods Sixty Sprague-Dawle y rats were used. Experimental cerebral infarction was caused in all the rat s. 24 hours after the infarction, all the rats were randomly divided into 3 grou ps: a rehabilitation group, an immobiliaztion group and a control group. The rat s in the rehabilitation group were given balancing, grasping, rotating and walki ng exercises everyday, while those in the immobilization group were immobilized in cages. The rats in the control group was without any treatment. Immunohistoc hemical technique was used to detect the S-100, GFAP and Nestin expression at t he time points of 24 hours, 1, 2, 3 and 4 weeks after infarction, respectively. Results S-100, GFAP and Nestin expression were foun d around the infarcted cortex. The response increased as the extension of the su rviving time. The immunohistochemical reaction in rats in the rehabilitation gro up was stronger than that in the immobilization group. Conclusi on Rehabilitation training can activate astrocytes, which could impr ove the internal environment, protect the neurons and promote repairing of neuro n.

Objective To explore the clinical value of 18F-FDG PET/CT in the diagnosis of cardiac neoplasm.Methods Between January 2007 and December 2011,18F-FDG PET/CT was performed in 8649 patients in our hospital,and 14 (0.16％ ; 11 males,3 females,average age 46.9 (35-68) years) patients were diagnosed with cardiac neoplasm.18F-FDG PET/CT data of those 14 patients were retrospectively analyzed.Final diagnoses were confirmed by either histopathology (n =5) or follow-up (n =9).Results Accurate tumor localization and diagnoses were made by 18 F-FDG PET/CT in all 14 patients.Among them,13 were malignant (2(14.3％,2/14) primary and 11(78.6％,11/14) metastatic tumors (8 HCC,2 lung cancer,1 esophageal cancer) ; SUVmax 3.2-10.7) and 1 (7.1％,1/14) was benign (myxoma).Conclusion 18F-FDG PET/CT is useful for the detection and staging of primary malignant and metastatic cardiac neoplasms.

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

Basal ganglion lesions often result in language impairment. Its patterns of manifestation are complicated. Patients may either have oral language disorders or written language disorders, which almost includes all types of aphasia, The article reviews the anatomy, definition, feature and mechanisms of basal ganglia aphasia as well as the effect of lesion sites on language.

Objective To detect the difference of intensity of A ,B ,H antigen on erythrocytes between neonates and adult .Meth-ods Anti-A ,anti-B and anti-H serum were diluted in multiple proportions ,then add the sample erythrocytes into the test tube to react with the serum above .Observe the agglutination between the erythrocytes and the serum ,and score for every agglutination re-action .The total of the score in different dilution of every sample were brought into statistics analysis by SPSS software .Results The A ,B ,H antigen intensity on the surface of erythrocyte of neonates were less than that of adult (P<0 .05) .And no matter neo-nates or adult ,the A antigen intensity on the surface of type A erythrocytes were higher than that of B antigen on the surface of type B erythrocyte(P<0 .05) .The A ,B ,H antigen intensity have no significant difference between adult male and female (P>0 .05) .Conclusion There is a significant difference of A ,B ,H antigen intensity on erythrocytes between neonates and adult .It also can be concluded that the varity of the antigen has effect on intensity of A ,B ,H antigen in erythrocytes ,except sex .

Objective In order to protect the natural resources of Swertia bimaculata which has been destroyed seriously,the method of artificial propagation by way of tissue culture have been systematically studied.Methods The stems,leaves,and stems with buds which were from the seedlings germinated from the seeds on the initial medium were taken as explants.These explants were cultured on MS culture media by adding different portions of hormones at various cultural conditions.Results The stems were the best material in speeding propagation among the three explants.The proper initial medium for the stems was MS+ BA 0.5 mg/L+saccharose 3.0%,the optimum medium for proliferation was MS+BA 0.5 mg/L+IBA 0.1 mg/L+saccharose 3.0%,and the best medium for rooting was 1/2MS+NAA 0.5 mg/L+saccharose 1.5%.Conclusion Tissue culture of S.bimaculata could make its propagation rapid,its resources preserved,and its utilization last.

Objective To explore the correlated risk factors of bile duct injury induced by laparoscopic cholecystectomy ,and to reduce the rate of bile duct injury companied with LC and improved patients condition after LC .Methods One thousand two hun‐dred and forty four patients who had been done the laparoscopic cholecystectomy in our hospital were searched from December 2003 to December 2013 for their case notes .The relationship between rate of bile duct injury induced by laparoscopic cholecystectomy and gender ,age ,time of LC surgery ,pathology ,gallbladder wall thickness ,liver function levels ,the existence of the gallbladder triangle anatomical anomalies and physician experience were analyzed by logistic regression method .Results Logistic regression analysis showed that patients did LC surgery at early time ,with acute cholecystitis ,with gallstones combined effusion ,with gallbladder wall thicker than 4 mm and with gallbladder triangle anatomical anomalies were likely to have bile duct injury induced by LC (P<0 .05) .And doctor′s experience on LC is another important factor as well (P<0 .05) .Conclusion According to the correlated risk factors of bile duct injury caused by laparoscopic cholecystectomy ,methods should be employed to reduce the bile duct injury .And sharing experience between doctors and learning new techniques could be helpful ,too .