Brugada Syndrome ; etiology ; physiopathology ; Coronary Artery Disease ; physiopathology ; Coronary Vasospasm ; physiopathology ; Electrocardiography ; Humans ; Male ; Middle Aged

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

Angioplasty, Balloon, Coronary ; instrumentation ; Female ; Humans ; Middle Aged ; Prosthesis Failure ; Stents

Aged ; Coronary Disease ; Coronary Sinus ; pathology ; Female ; Heart Atria ; pathology ; Humans ; Middle Aged

OBJECTIVE To investigate the spectrum of organisms causing purulent endophthalmitis and to identify the variance of bacterial spectra and their sensitivities to commonly used antibiotics.METHODS The medical records of patients with purulent endophthalmitis receiving pathogen examination in Zhongshan Ophthalmic Center from Jan 2000 to Dec 2006 were analyzed retrospectively.RESULTS Of the 416 cases,82.0% purulent endophthalmistis were caused by ocular trauma and the organisms were isolated in 181(43.5%)of them.Among the pathogens isolated,14.9%,47.5%,9.9% and 27.6% were fungi,Gram-positive cocci,Gram-positive bacilli and Gram-negative bacilli,respectively.The fungal endophthalmistis was sporadic per annum.The most common bacterial pathogen was staphylococcus epidermidis(33.1%) which increased year by year.The most common Gram-negative bacterium was Escherichia coli(10.5%).Among the common pathogens,the Gram-positive cocci were sensitive to fluoroquinolones and cefoperazone,and the Gram-positive bacilli were sensitive to aminoglycosides and cefoperazone while the Gram-negative bacilli were resistant to various kinds of antibiotics in different degree.CONCLUSIONS The purulent endophthalmistis should be monitored in patients with open ocular injury.Fluoroquinolones with cefoperazone to treat the ocular inflammation are a preferred therapeutic regimen for patients with bacterial endophthalmitis with unknown etiopathogenesis.

Objective To investigate the effect of aspirin on the incidence of thromboembolism in hypertensive patients associated with paroxysmal atrial fibrillation.MethodsFour hundred hypertensive patients with paroxysmal atrial fibrillation (mean age 59 years) free of thromboembolic events were randomized assigned to receive aspirin (0.3 g/d) or placebo. Cerebral thromboembolism,including transient ischemic attack and embolism of peripheral arteries were defined as primary outcomes. Event-free survival curves were estimated by Kaplan-Meier curve. Results During 3.6 years follow-up,primary outcomes occurred in 61 patients (4.3% per year). Aspirin significantly reduced the incidence of primary outcome as compared with placebo group( 9.0% vs 21.5%,P

SARS coronavims is an emerging virus. A lot of animals could be infected by SARS-CoV and Himalayan palm civets, as one of important hosts, is an ideal animal model. Viral genetic factors have been implicated in the emergence of SARS-CoV, with the suggestion that this virus is a recombinant between mammalian and avian coronaviruses. However, the recombination is unlikely to explain the appearance of SARS in humans.

Objective To investigate the value of 18F-FDG PET/CT in the phasing and grading of renal cell carcinoma (RCC) complicated with vena cava tumor thrombus (VCTT).Methods From December 2011 to September 2015,a total of 72 patients (52 males,20 females,age:36-74 years) were enrolled in this retrospectively study.All patients underwent 18F-FDG PET/CT and contrast-enhanced CT studies,and were diagnosed as RCC.The RCC patients combined with VCTT were classified by Mayo-level.Wilcoxon rank sum test was used to compare the grading of VCTT by PET/CT and contrast-enhanced CT.NM staging on abdominal area level was performed and the results were compared with x2 test.Results VCTT was identified in 18 RCC patients and the grading results by PET/CT were as follows:9 cases in Level 0,4 cases in Level Ⅰ,2 cases in Level Ⅱ,1 case in Level Ⅲ,and 2 cases in Level Ⅳ.When evaluated by PET/CT,20 cases were in N0M0,21 were in N1M0,9 were in N0M1,and 22 were in N1M1.NM staging results by contrast-enhanced CT were as follows:50 cases in N0M0,10 in N1M0,10 in N0M1,and 2 in N1M1.In addition,2 N1 and 2 M1 were found by the whole body PET/CT.The classification results of VCTT and staging of abdominal level by PET/CT were significantly better than those by contrast-enhanced CT (z=-2.462,P＜0.05;x2=32.806,P＜0.01).Conclusion 18F-FDG PET/CT is not only valuable for detecting primary RCC and local metastasis,but also useful for finding where the VCTT extends,which is conducive to therapeutic planning and further clinical treatment.

ObjectiveTo explore the relationship of marriage quality with individual characteristics and copy style among the epilepsy patients.MethodsThe Chinese Marriage Quality Questionnaire,and Eysenck Personality Questionnaire Short Form Scale-Chinese edition (EPQ-RSC),and the Questionnaire of Simple Way to Coping were assessed used to assess 97 cases of the aduh married epilepsy patients and 93 cases of the control group 1 (epilepsy patients spouses) and 91 cases of the control group 2 (healthy crowds ).ResultsThe total scores of the marriage quality of epilepsy patients ( 295.78 ± 40.37 ) was lower than ones in the control group 2 ( ( 354.85 ± 28.11 ),P =0.000) and higher than that of the control group 1 ( (278.55 ± 42.23 ),P =0.014),the difference was all statistically significant(P＜ 0.05).The total scores of marriage quality of the epilepsy patients was negative correlated with the sex,and the age,and the marriage age and the severity,and the duration,and psychoticism( the Pearson correlation was respectively:-0.204,-0.436,-0.243,-0.691,-0.568,-0.635 ),and was positive correlated with which the formal schooling,and the attack types (symptoms epilepsy),and the introversion or extroversion,and the hidness,and the positive( the Pearson correlation was respectively 0.317,0.750,0.267,0.386,0.188) the difference was all statistically significant (P ＜ 0.05).Those seven variables that the attack type,and the hidness,and the severity,and the sex,and the education,and the psychoticism,and the positive could be predict to marriage quality of epilepsy patients,Adjusted R square was 0.903,After adjustment was 0.021 (P ＜ 0.05 ).ConclusionThe lever of marriage quality of the epilepsy patients is lower,and correlate with severity of epilepsy disease,and personality,copy style,and can be do comprehensive intervention from those.

This list of clincal data management documentation is to ensure standardized and adequate archival of trial documents and records in clinical data management, which is applicable to all of phase I-IV clinical trials.
Clinical Trials as Topic ; Data Collection ; standards ; Documentation ; standards