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.

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.

Objective To examine the association of arteriovenous fistula (AVF) blood flow (Qa) dynamics with inflammation state and its effect on cardiovascular diseases (CVD) in maintenance hemodialysis (MHD) patients.Methods Thirty MHD patients with AVF and twelve healthy people were enrolled in the study.Qa and cardiac output (CO) were measured by Transonic Hemodialysis Monitor HD 02.In MHD patients,pre-dialysis blood samples were taken before Qa monitoring.High-sensitivity C-reactive protein (hsCRP) was measured by immunoturbidimetry (Kyoma,Japan).Inflammatory factors IL-2,IL-6,IL-10,TNF were measured by Cytometric Bead Array (BDTM).Cardiovascular diseases morbidity was monitored prospectively within nineteen months follow-up period.Results There were no significant differences in age and sex between MHD patients and healthy people.The serum IL-6,IL-10,TNF and hsCRP were significantly higher in MHD patients than those in healthy controls [2.38 (1.86-4.69) vs 1.14 (0.27-1.18) ng/L,P＜0.01; 1.47 (1.19-2.10) vs 1.04 (0.00-1.23) ng/L,P＜0.01; 1.33 (1.05-1.56) vs 0.54 (0.00-1.24) ng/L,P＜0.05; 4.90 (1.58-7.45) vs 1.50 (0.63-1.90) mg/L,P=0.01].During the follow-up period,6 patients (20.0％) developed at least one episode of cardiovascular event.Qa,serum IL-6 and hsCRP levels were significantly higher in patients with CVD as compared to those without CVD [(1120±192) vs (893±189) ml/min,P＜0.05; 4.86 (2.96-7.85) vs 2.20 (1.80-3.10) ng/L,P＜ 0.01;11.75 (3.83-31.53) vs 4.45 (1.05-6.68) mg/L,P＜0.05].Binary Logistic regression analysis demonstrated that serum IL-6 was an independent and stronger risk factor for CVD morbidity [HR=1.943,95％CI (1.110-3.402),P=0.02].Spearman rank correlation analysis and liner regression analysis showed that Qa was positively correlated with serum IL-6 (β=0.492,P＜0.01).Path analysis suggested that Qa contributed to CVD mortality via the increase of serum IL-6.Conclusions AVF blood flow monitoring is important for MHD patients.IL-6 is an independent risk factor of CVD in MHD patients.AVF blood flow increases cardiovascular diseases morbidity in MHD patients via its promotion of IL-6 production.

Objective To determine the risk factors for post-operative delirium(POD)and post-operative cognitive dysfunction(POCD)in patients undergoing spine surgery.Methods One hundred and twenty ASA Ⅰ-Ⅲ of both sexes aged 50-76 yr undergoing elective spine surgery under general anesthesia were studied.POD was assessed by Delirium Rating Scale revised 98 at 2 days after operation and the patients were assigned into POD and nonPOD group.Cognitive function was assessed by Mini-Mental State Examination(MMSE)at 1 day before and 3 days after operation.The patients were diagnosed as having POCD if MMSEpre-MMSEpost ≥ 3.The palients were assigned into POCD and nonPOCD group.Executive function and depression were assessed by stroop interference test and Beck Depression Inventory(BDI)at 1 day before operation.Age,sex,education,alcohol consumption per week,a history of psychiatric disease,ASA physical status,Charlson comorbidity score,type of anesthesia,anticholinergic drug administration and VAS score at 1 day after operation were recorded.If there was signifirant difference between the 2 groups,the factor was analyzed using multi-factor logistic regression to select risk factor for incidence of POD and POC).Results Eleven patients developed POD(9.2％)and 30 patients developed POCD(25.0％).Logistic regression model showed that lower Stroop-CW,higher BDI score,higher Charlson comorbidity score and a history of psychiatric disease were risk factors for POD,while lower Stroop-CW,higher BDI score,higher Charlson comorbidity score and higher alcohol consumption per week were risk factors for POCD.Conclusion Preoperative executive dysfunction,depression and greater preoperative comorbidity are risk factors for both POD and POCD.A history of psychiatric disease is a risk factor for POD and higher alcohol consumption is a risk factor for POCD in patients undergoing spine surgery.