This paper is prepared to discuss the common issues in data management, such as building and training of data management team, standard operation procedure, document management, execution and communication, strategies to correct and prevent mistakes, and measures to improve the quality and efficiency of clinical trials and data management.
Clinical Trials as Topic ; Data Collection ; standards ; Information Storage and Retrieval ; standards

Abscess ; etiology ; Adult ; Humans ; Male ; Nasal Septum ; pathology ; Tooth, Impacted ; complications

Objective To explore a new pathogenic gene mutationin in COL4A3 and COL4A4 genes of a family with thin-basement-membrane nephropathy (TBMN), and explain its mechanism.Methods Genomic DNA was extracted from blood samples.Mutation screening for all the exons in COL4A3 and COL4A4 of the proband was carried out by direct PCR sequencing.The sequences of the proband were compared with standard sequences in GenBank.After identifying the mutation in COL4A4, screening for the mutation site in 200 healthy controls and the rest of family members were conducted.RNA sequence of the proband was analyzed by reverse transcription PCR and TA cloning.The positive clones were sequenced for RNA screening.Results There was a G to A mutation in the 1459 site of COL4A4 (c.1459+G ＞ A) in the proband, her mother, and the elder sister, whereas the mutation was not found in other family members and healthy people.RNA screening showed that the COL4A4 (c.1459+G ＞ A) mutation was a heterozygous substitution in position + 1 of exon 21, in the splicing region.This mutation leaded to eliminating of exon 21 from the COL4A4 mRNA, causing the exon 21 deletion and frameshift mutation following the exon 20 in its amino acids sequence.Conclusions It is described that COL4A4 (c.1459+G ＞ A) is a new pathogenic mutation in TBMN, which further help understanding the pathogenesis and clinical diagnosis of TBMN.

The antibacterial peptide CM4 having potent antifungal activity on inhibitiong the cell wall regeneration of Saccharomyces cerevisiae protoplasts.When the peptide increased,the ratio of the regenerated colonies drop obviously.To study the antifungal mechanism of the antibacterial peptide,fluorescence\|labeled peptide mixted with the protoplast of yeast,then confocal laser scanning microscopy were performed.The results indicated that the peptides interactted with the protoplast membrane and damaged the structure of the membrane,then the permeation of protoplast changed.Finally the protoplasts with the peptide failed to regenerate the cell walls leading to killing the cell.

Talents constitute core resource in the development of healthcare sector. Based on the situation of the talent team in the Affiliated Hospital of Qingdao University, the authors systematically constructed the hierarchical and classified system for talent cultivation, centering on three key areas of talent cultivation, evaluation and assessment. The authors analyzed the achievements since the implementation in 2016, namely the innovation of talent evaluation, the construction of discipline echelon, and the communication and inter-departmental cooperation. At the same time, the authors further put forward targeted suggestions to promote the development of talent teams in terms of transforming the human resource management model, increasing policy support and funding, implementing refined management, and improving talent evaluation indicators by the levels and types.

Objective To investigate the clinical effects of liver transplantation including living related liver transplantation for Caroli's disease (CD). Methods Seven consecutive patients with diffused type of Caroli's disease had undergone liver transplantation (LT) from September 1999 to February 2007 in our single center. The clinical characteristics and survival of these patients were retrospectively reviewed. Results All 7 patients were diagnosed as Caroli's disease with diffused type which manifested recurrent cholangitis in clinical symptoms. Among them, 4 were female and 3 male.The mean age was 16 years old (ranging from 10 to 31 years old). Six patients were subjected to conservative therapy and only one patient had previously undergone cholecystectomy and T tube drainage before transplantation. In types of surgery, 4 patients accepted split liver transplantation with right liver lobe, two got whole liver transplantation and only one underwent living related liver transplantation. In two patients venovenous bypass was done during the operation. The mean duration of surgery was 9. 1 h. Post-transplant complications included pulmonary infection (3 cases), acute rejection (2 cases), pleural effusion (2 cases) and biliary leakage in the split section of donor liver (1 case). One patient died within 19 days caused by acute renal failure and multiple organs dysfunction.The rest six patients are alive without any signs of recurrence of protopathy and the longest survival time is 7 years. Conclusion Liver transplantation is a valuable treatment to Caroli's disease with diffused type. Due to the organ shortage, living related liver transplantation may own identical effects on LT.

Objective To discuss the influence of anatomical variations of the cystic duct on preoperative diagnosis and operational scheme for cholecystectomy. Methods A 47-year-old woman was admitted to our hospital with diagnosis of cholecystolithiasis. Ultrasonography suggested minimal intra- and extrahepatic ductal dilatation. Laboratory tests showed that serum levels of alanine aminotransferase, aspartate aminotransferase and alkaline phosphatase were 189 IU/L, 366 IU/L and 144 IU/L, respectively. In order to make a certain diagnosis, the patient received both magnetic resonance cholangiopancreatography (MRCP) and endoscopic retrograde cholangiopancreatography (ERCP). Results MRCP showed the bile duct slightly dilated with a shuttle shape figure and a lower signal with a strip form in it. MRCP could not confirm the quality of this signal and was doubtful of choledochus diaphragma. Subsequently, ERCP was applied to demonstrate that the cystic duct was collateral with the common hepatic duct when arriving into its left side and converged into the bile duct with a lower position, which was the reason for why MRCP misjudged the formation of choledochus diaphragma in the bile duct. Finally, the patient underwent open cholecystectomy. Conclusion There are some kinds of variations in the cystic duct including course, appearance and location of confluence. Combing MRCP with ERCP can significantly elevate the diagnostic accuracy of the cystic duct before operation, especially in those patients with doubtful diagnosis upon admission. To avoid biliary injury as much as possible, open cholecystectomy is superior to the laparoscopic cholecystectomy (LC)with regard to the patients suffering from cholecystolithiasis complicated with variation of the cystic duct.

Adult ; Female ; Humans ; Nasal Polyps ; Sphenoid Sinus

Objective To study the influence of total flavonoids of hemerocallis fulva(TFHF) on hepatocyte apoptosis and related protein expression in mice with alcoholic hepatic injury.Methods A total of 40 mice were randomly divided into four groups:blank control,model control andsmall and high dose TFHF groups,10 cases in each group.The mice were given the continuous gavage administration for 7 d.Then the model group was given once gavage by 50％ ethanol 12.0 mL/kg after 1 h of the last administration.The blank control group was given the equal volume of distilled water.The activity levels of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) in serum as well as the superoxide dismutase(SOD) activity and malondialdehyde (MDA) content in liver tissue hemogenate were detected.Hematoxylin and Eosin(HE) staining was performed for observing the pathological changes of the liver tissue.The flow cytometer was used to test the apoptosis ratio in hepatocyte suspension.The expressions of caspase-3,Bcl-2 and Bax protein were detected by Western blot.Results The various TFHF groups could decrease the activities of ALT and AST in serum (P＜0.05),while could decrease the MDA content in liver tissue hemogenate (P＜0.01) and increased the SOD activity;the liver tissue pathological examination showed that the high dose TFHF group could make the liver cell degeneration,alleviated the necrosis degree and relieved the pathological change of hepatic tissue;compared with the model group,the hepatocyte apoptosis rate in each TFHF group was decreased significantly;Western blotting results showed that the caspase-3 protein level in each TFHF group was decreased,expression of Bcl-2 protein was increased,whereas which of Bax protein was decreased and Bax/Bcl-2 ratio was reduced.Conclnsion TFHF has obvious protective effect on mice acute hepatic injury induced by ethanol,and can inhibit the hepatocyte apptosis,its action mechanism may be related to its antioxidation and regulation of caspase-3,Bcl-2 and Bax expression.

Objective To investigate the prevalence of BRCA1/2 mutations in breast cancer patients of Han ethnic group in southcrn China,and to provide the genetic basis for early diagnosis and treatment of breast cancer.Methods 70 samples of breast cancer patients of Han ethnic group in southern China and 70 normal control samples were tested.The whole coding exons of BRCA1 and BRCA2 genes were analyzed using hybridization based enrichment and next-generation sequencing (NGS).According to the results of NGS,we detected pathogenic mutations of BRCA genes.Results In 70 breast cancer patients,a total of 5 deleterious mutations were identified,4 of these were novel mutations,and no pathogenic variation was found in normal control group.Furthermore,we detected 3 low frequency mutations which are likely to relate to cancer susceptibility.Conclusions 4 novel deleterious mutations were reported,as well as some variants of unknown clinical significance for the prevalence of BRCA1/2 mutations of 70 breast cancer patients of Han ethnic group in southern China.