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.

ObjectiveAssess the efficacy of repetitive transcranial magnetic stimulation (rTMS) in the treatment of schizophrenia and its social function .Methods 156 patients with schizophrenia were randomly assigned to a real rTMS treatment group (n=78) or a sham rTMS treatment group(n=78) ,each patient in the real rTMS group received 20 rTMS sessions over 4 weeks .Efficacy was evaluated using the Positive and Negative Syndrome Scale (PANSS) at baseline and at 4 weeks .Social function was evaluated u-sing the Personal and Social Performance Scale(PSP) at baseline and at 4 weeks .Results The study group is better than the control group in PANSS total and negative symptoms and PSP total after treatment (P<0 .05) .There is not serious adverse reactions in the treatment .Conclusion rTMS can reduce the negative symptoms and improve social function in schizophrenia with high safety .

Objective To establish a method of TRFIA with high sensitivity and broad detecting range for serum HBV large surface protein (HBV-LP).Methods The monoclonal antibody of HBV-LP was covered on the microwell plate and incubated with HBV-LP in blood sample,then Eu3+ labeled antibody of HBs was added.HBV-LP in standard substance,blood samples of 66 chronic hepatitis B patients and 30 healthy controls was detected by the TRFIA and ELISA.x2 test and linear correlation analysis were used for data analysis.Results The dose-response curve of standard substance with TRFIA had good linear correlation (r=0.999).Normal reference range was established at 0-1.36 mg/L based on the ELISA results of 30 healthy controls.The sensitivity was 0.10 mg/L.The specificity was 100％ (30/30).Correlation coefficient between the TRFIA and the ELISA was 0.800 9 (P＜0.001).The positive detecting rates of the 2 methods were significantly different (89.4％(59/66) vs 77.3％(51/66),x2 =6.13,P＜0.01).The recovery rate for HBV-LP was between 95.93％-107.62％.The effective detecting range(CV＜10％) of TRFIA was 1.35-2 764.00 mg/L,and that of ELISA was 10.8-691.0 mg/L.Conclusion The TRFIA was established for HBV-LP detection with higher sensitivity and wider detecting range compared to ELISA.It has potential value for HBV screening and monitoring of antiviral therapy.

Objective To compare the clinical effect of the peripheral balloon closure with surgical intervention for developed retroperitoneal hematoma(RPH) caused by femoral artery perforation .Methods A retrospecive analysis was performed on 2 492 consecutive patients underwent PCI from January 2005 to December 2013 in Guangdong people′s hospital .Twenty -four cases of developed RPH caused by femoral artery puncture operation for PCI were retrospectively analyzed ,13 cases of patients who took peripheral balloon closure were divided into balloon block group and the other 11 patients adopted surgery vascular repair process‐ing ,were enrolled in the surgical treatment group .Comparison was done among the hemostatic effect and the time ,and postoperative adverse events ,including lower limb blood supply obstacles for puncture side postoperative ,major adverse cardiovascular events (MACE) during hospitalization ,all‐cause mortality ;Multivariate logistic regression was used to assesse the RPH risk factors .Re‐sults The incidence of RPH caused by femoral artery perforation was about 0 .96% .During coronary intervention ,the following variables were found to be independent predictors of RPH caused by femoral artery perforation:female gender(OR=8 .94 ,95% CI:3 .75-21 .98 ,P< 0 .01) ,femoral artery ulcer(OR= 6 .43 ,P<0 .05) and multiple puncture (> 3 times) (OR= 7 .39 ,95% CI:2 .74-13 .76 ,P<0 .01) .Hemostatic success rates of the two groups were all 100% ;the average times of processing perforation were (76 .8 ± 34 .6) min and ((88 .5 ± 37 .3) min ,P<0 .05 ,the difference was statistically significant ;3 cases (23 .1% ) and 2 cases (18 .2% ) developed into postoperative severe anemia (Hgb<60 g/L) in each group ,P>0 .05;Each group had 1 case for in‐hospital MACE (7 .7% vs .9 .1 % ,P>0 .05);In the two groups ,there was no lower limb blood supply obstacles and death case .Conclusion For progress RPH caused by femoral artery perforation ,peripheral balloon closure can be a faster ,better sealing hemostatic ,and shorten the rescue time ,and the success rate is high ,and there is less postoperative adverse events .The safety and effectiveness be‐have good .

Objective The change of thyroid hormones affects male sexual function, but the underlying physiological mechanism is not yet clear.The aim of this study was to explore the association of thyroid hormones with abnormal penile neuro-electrophysiology in patients with premature ejaculation (PE).Methods This retrospective study included 52 acquired PE (APE) patients aged 35.36 ± 8.39 years and 24 healthy males aged 32.87±7.45 years.We measured the levels of thyroid hormones in all the subjects and, based on the latency time of penile sympathetic skin responses (PSSR), classified the APE patients into a normal (n=31) and an abnormal PSSR type (n=31).Results The concentration of total tetraiodothyronine (TT4) in the serum was significantly higher in the APE patients than in the normal control ([102.81±18.37] vs [92.68±11.56] nmol/L, P=0.018).The levels of serum TT4 and free tetraiodothyronine (FT4) were both markedly increased in the APE patients of the abnormal PSSR type as compared with those of the normal PSSR type ([113.28±20.89] vs [95.72±12.42] nmol/L, P<0.001 and [12.02±0.88] vs [10.81±1.63] nmol/L, P=0.003).The FT4 concentration was correlated negatively with the latency time of PSSR (r=-0.363, P=0.008) and positively with the Premature Ejaculation Diagnostic Tool (PEDT) scores (r=0.455, P=0.001).Conclusion Abnormal PSSR may be associated with elevated levels of thyroid hormones in APE patients, and regulation of thyroid hormone levels may help improve the symptoms of PE with abnormal PSSR.

refer to the cases with pression caused by both posterior and anterior matters, the posterior-anterior surgery is better.

BACKGROUND:In recent years, tissue engineering technology as a new model for tissue regeneration has provided new ideas and methods for the repair of periodontal tissue defects. OBJECTIVE:To investigate the effect of human periodontal ligament cels-polyglycolic acid scaffold complex for repair of periodontal tissue defects. METHODS:Passage 4 human periodontal ligament cels at a density of 1.5×109/L were seeded onto the polyglycolic acid scaffold to prepare cel-scaffold complex. Then mongrel dogs were selected to make animal models of periodontal tissue defects and then randomly assigned into experimental group subjected to cel-scaffold complex implantation or control group subjected to direct coronal reset and suture of the gingival flap. Colagen content, new blood capilaries, new cementum, new alveolar bone and new periodontal ligament were detected within 4 weeks after operation; hematoxylin-eosin staining of periodontal tissue defects was done at 8 weeks after operation. RESULTS AND CONCLUSION:In the experimental group, the colagen content, number of newborn capilaries, amount of new cementum, new alveolar bone and new periodontal ligament tissues were significantly higher than those in the control group at postoperative 1, 2, 3, 4 weeks (P< 0.05). At 8 weeks after operation, in the experimental group, there were more vessels arranging on the connective tissue surface of new alveolar bone, the alveolar bone showed a sawtooth-like interlinking with the periodontal tissues in the presence of a thin layer of cementum; in the control group, only new alveolar bone and cementum formed below the incisure. These findings indicate that human periodontal ligament cels-polyglycolic acid scaffold complex can promote periodontal tissue regeneration.

Objective To evaluate the prognostic values of common definition compared to traditional definition of contrast-induced nephropathy (CIN) in patients with normal serum creatinine (SCr). Methods Patients undergoing percutaneous coronary angiology or intervention with normal baseline SCr were enrolled prospectively. Those who were diagnosed as CIN according to common definition were divided into two groups based on the peak increase from baseline in the SCr concentration within 48 ~ 72 hours after the procedure: ≥ 44.2 μmol/L (CIN44.2 group, in common with traditional definition), ≥25% of baseline to < 44.2 μmol/L (CIN25%-44.2 group, interval between the two definitions). Hospital stay and long-term outcomes were compared among CIN44.2, CIN25%-44.2, and non-CIN groups. Results Of all 3,044 patients enrolled, 302 (9.9%) patients developed CIN according to common definition including CIN44.2 occurred in 56 (1.8%) patients and CIN25%-44.2 in 246 (8.1%) patients. Patients in CIN44.2 group indicated significant longer hospital stay and long-term outcomes compared with non-CIN group (P < 0.05). However, patients in CIN25%-44.2 group had similar in-hospital mortality and long-term cumulative risk of major clinical adverse events (MACE) and death with non-CIN group (all, P = 1.00). Multivariate Cox proportional hazard analyses also demonstrated that CIN25%-44.2 did not associate with long-term MACE (HR 1.16, P = 0.645) and death (HR 0.98, P = 0.964) after adjusting for potential confounding factors. Conclusions For patients with normal baseline SCr, common definition based on traditional definition of CIN is unreasonable and overestimates the incidence of CIN, whose extension of traditional denifition proves no significant clinical value.

Objective To make a comparison between the plain radiograph, CT, and MR findings of gouty arthritis and to analyse the relationship between clinical data and imaging findings. Methods Fifty-four joints of 33 patients with a confirmed diagnosis of gouty arthritis were included in this study. In the morning, the blood uric acid level of patients was tested before meal. In the afternoon, their clinical data were recorded and joints were examinated by plain radiography, CT, and MRI. The imaging findings were evaluated by tophi, bone erosion, soft tissue swelling, hydrarthrosis, synovial thickness, and bone oedema. The data was analyzed by Chi-square test, indepentdent-samples t test, and logistic regression. Results The Chi-square test was utilized to evaluate number of joints with tophi(CT>plain radiography, MR>plain radiography, P<0. 01), soft tissue swelling (MR>CT>plain radiography, P<0. 01), hydrarthrosis(MR>CT, P<0. 01). In addition, 35 joints had bone oedema and 50 joints had synovial thickness. The course of disease(tophi positive group vs tophi negative group, P<0. 01) was analyzed by indepentdent-samples t test. The tophi's causative agents including bone erosion and course of disease were analysed by logistic regression(P<0. 01). Conclusions MRI is superior to CT and plain radiography on the early diagnosis of gout. Tophi and bone erosion may not affect the blood uric acid level. With the progression of disease, the probability of tophi formation increases. The relationship between the formation of tophi and bone erosion may be interpromotied.

Recent research based on various animal models has shown the neuroprotective effects of erythropoietin (EPO). However, few studies have examined such effects of EPO in the clinic. In this study we enrolled patients with spinal cord ischemia-reperfusion (I-R) injury to investigate the clinical application of EPO and methylprednisolone (MP) for the neuroprotection against spinal cord I-R injury. Retrospective analysis of 63 cases of spinal cord I-R injury was performed. The Frankel neurological performance scale was used to evaluate the neurological function after spinal cord injury (SCI), including 12 cases of scale B, 30 cases of scale C, and 21 cases of scale D. These cases were divided into 2 groups: group A (27 cases) got treatment with both EPO and MP; group B (36 cases) got treatment with MP only. The neurological function of patients after treatment was evaluated by American Spinal Cord Injury Association (ASIA) index score, and activity of daily living (ADL) of the patients was also recorded. All patients got follow-up and the follow-up period ranged from 24 to 39 months (mean 26 months). There was no significance difference in neurological function between groups A and B before the treatment (P>0.05). However, the neurological function and ADL scores were significantly improved 1 week, 1 year or 2 years after the treatment compared to those before the treatment (P<0.05), and the improvement was more significant in group A than in group B (P<0.05). It is suggested that the clinical application of EPO and MP provides the neuroprotection against spinal cord I-R injury.