Key trial activities include: development of the trial protocol;development of standard operating procedures;development of support systems and tools;generation and approval of trial information documents;selection of trial sites and the selection of properly qualified,trained,and experienced investigators and study personnel;ethics committee review and approval of the protocol;review and approval by applicable regulatory authorities;enrollment of subjects into the study: recruitment,eligibility,and informed consent;the investigational product(s): quality,handling,and accounting;trial data acquisition: conducting the trial;trial data acquisition: conducting the trial; safety management and reporting;monitoring the trial;managing trial data;quality assurance of the trial performance and data;reporting the trial.

Cochlear Implantation ; Cochlear Implants ; Humans ; Tinnitus

Adult ; Coal Mining ; Cognition Disorders ; etiology ; Explosions ; Follow-Up Studies ; Humans ; Surveys and Questionnaires ; Survivors ; Young Adult

Objective To analyse the antibiotics susceptibility result of Neisseria gonorrhoeae(N.g) isolates.Method 95 strains of N.g were performed the in-vitro susceptibility test.MICs of penicillin, tetracycline, ciprofloxacin, levofloxacin, ceftriaxone, cefotaxime, cefepime, and spectinomycin were determined by agar dilution.Results Almost all of the N.g strains were susceptible to the first-line antibiotics used for treating the infection. The resistance rate to ciprofloxacin, tetracycline and penicillin were 100%, 78.9% and 68.4% respectively.Conclusion Although N.g is susceptible to first-line antibiotics used for treating the infections at the clinics, the situation of resistance to penicillin, tetracycline and ciprofloxacin is very serious.

Objective:To evaluate the diagnostic values of single and combined detection of serum CA199, complement 3 (C3),complement 4 (C4),total cholesterol (TC),triglyceride (TG),and lipid metabolism levels in the patients with pancreatic cancer, and to explore their correlations with TNM stage and pathological stage of pancreatic cancer.Methods:Total 185 subjects were enrolled into the study by three groups:pancreatic cancer patients group (Pc group,n=77),non-digestive system cancer patients group (Ndc group,n=58)and healthy control group (Hc group,n=50).The levels of serum CA199,C3,C4,and high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), apolipoprotein A (ApoA), apolipoprotein B (ApoB), apolipoprotein E (ApoE),and lipoprotein a (Lpa)levels were detected.Results:① The serum level of CA199, C3,C4,and ApoE of the patients in Pc group were higher than those in Ndc and Hc groups (P<0.01).No statistical difference was observed in the serum CA199 between Ndc and Hc groups (P>0.05).The levels of C3, C4,and ApoE in Pc group and Ndc group was higher than those in Hc group (P<0.01),and the levels of the biomarkers in Pc group were also higher than those in Ndc group (P<0.01).The levels of HDL-C,ApoA and Lp (a)of the patients in Pc group were significantly lower than those in Ndc and Hc groups (P<0.05).② The area under ROC curve (AUC)of serum CA199,C3,C4,ApoE,HDL-C,and ApoA were 0.916,0.841, 0.788,0.785,0.834,and 0.810,respectively.Furthermore,multiple factor analysis showed that the combined detection of CA199,C3,and HDL-C (AUC=0.968)improved the diagnosis compared with detecting CA199 alone (P<0.05).③ The CA199 level of the patients inⅢ-Ⅳ stage of TNM stage was higher than that in the patients inⅠ-Ⅱ stage (P<0.01).For the pathological stage,the ApoA level in low differentiation group was higher than that in moderate and high differentiation group (P<0.05).There was no statistical difference in other biomarkers between the different TNM stages and pathological stages.Conclusion:The levels of CA199,C3,C4 and ApoE of pancreatic cancer patients are significantly increased, while the levels of HDL-C, ApoA, and Lp (a ) are significantly reduced.Combined detection of CA199,C3,and HDL-C can improve the early diagnosis of pancreatic cancer compared with the single assessment of each biomarker.

AIM:To investigate the effect of ERK1/2/c-Fos signal pathway during angiotensin-(1-7)inhibiting proliferation of rat glomerular mesangial cell strain(GMCS)induced by angiotensin Ⅱ.METHODS:Rat glomerular mesangial cells(GMC)were co-cultured with angiotensin Ⅱ and different doses of angiotensin-(1-7).The numbers of GMC were evaluated by crystal violet staining.The amounts of p-ERK1/2 and c-Fos expressions were detected by Western blotting.RESULTS:Angiotensin-(1-7)showed its inhibitory effects on GMC number increasing induced by angiotensin Ⅱ as well as the amounts of p-ERK1/2 and c-Fos expressions in a concentration dependent manner.CONCLUSION:ERK/c-Fos signal pathway is involved in the inhibitory effects of angiotensin-(1-7)on angiotensin Ⅱ-induced GMC proliferation.

Objective To explore the possibility of using 131I as a targeted therapy method for malignant glioma by infecting U87 and U251 cells with conditionally replicative adenovirus Ad-Tp-E1a-Gp-NIS.Methods Human telomerase reverse transcriptase (hTERT) promoter and glial fibrillary acidic protein (GFAP) promoter were cloned and their transcriptional activities were detected by luciferase assay.The conditionally replicative adenovirus Ad-Tp-E1 a-Gp-NIS was constructed,purified,and transfected into U87 and U251 glioma cells.For these transfected cells,the selective replication ability was evaluated by plaque forming assay,and protein expression was detected by Western blot assay.125I-iodide uptake and exflux,the clonoy formation of 131I-iodide treated cells were also measured.Results Transcriptions activity of the GFAP and hTERT promoters was 59.75％-62.10％ (F =11.89,P ＜ 0.01) in U87 cells and 37.31％-49.00％ (F =5.87,P ＜ 0.05) in U251 cells.The Ad-Tp-E1a-Gp-NIS could be selectively replicated and the hNIS gene was successfully expressed in the hTERT-positive and GFAP-positive glioma cells which showed two protein bands with relative molecular mass of 120 × 103 and 49 × 103 in Western blot assay.After infection with Ad-Tp-E1a-Gp-NIS,the cell ability of 125I uptake was increased by 78.80 (F =2 914.58,P ＜0.01) and 92.48 (F =2 275.91,P ＜0.01) times in U87 and U251 cells,respectively.The GFAP-negative MRC-5 cells could not take in 125I.The in vitro clonogenic assay indicated that,after 131I treatment,more than 90％ of the transfected cells were killed,while only about 65％ (t =11.73-78.33,P ＜ 0.01) of control cells were killed.Conclusions The Ad-Tp-E1a-Gp-NIS has a good ability in selective replication and the enhancement of antitumor therapy effect by increasing tumor-specific iodide uptake in malignant glioma cells.

OBJECTIVETo investigate clinical outcomes of Kirschner wire as blocking screws combined with interlocking intramedullary nail internal fixation in treating tibial metaphyseal fractures (AO 43A).

METHODSFrom March 2011 to June 2012, 9 patients with tibial metaphyseal fractures were treated with blocking screws Kirschner wire combined with interlocking intramedullary nail, including 7 males and 2 females aged from 23 to 54 years old with an average of 37.4. Postoperative complications, X-ray were observed, AOFAS scoring were used to evaluate function after operation at 12 weeks.

RESULTSAll patients were followed up from 6 to 40 weeks (mean 20.1), and healed at stage I. No serious swelling, infection and skin necrosis occurred. No fracture instability and displacement appeaered at 4 and 8 week after operation. AOFAS score was (95.2±4.6) at 12 weeks after operation and 7 patients gained excellent result and 2 patients good.

CONCLUSIONKirschner wire as blocking screws with interlocking intramedullary nail for treatment of tibial metaphyseal fractures can fix well and perform simply.

Adult ; Bone Screws ; Bone Wires ; Female ; Fracture Fixation, Intramedullary ; methods ; Humans ; Male ; Middle Aged ; Tibial Fractures ; surgery

Objective: To compare the similarities and differences of teeth movement at different time points after distraction osteogenesis, and to explore the best time point of teeth movement after distraction osteogenesis. Methods: The experiment was carried out on 8 beagle dogs. Group I: started teeth movement at the second week after distraction osteogenesis. Group Ⅱ: started teeth movement at the sixth week after distraction osteogenesis. Analyzed the root, periodontal ligament and alveolar bone by physical measurement, X-rays and HE staining methods. Results: In the second and sixth week after distraction osteogenesis, the distance between the third and fourth premolar teeth reduced significantly(P<0.05), there was a remarkable difference between group I and group Ⅱ(P<0.05). Conclusion: Under the same force, the speed of tooth movement in the second week is faster than that in the sixth week, but periodontal absorption in the second week is more serious than that in the sixth week.

Objective To investigate the effect of angiotensin-(1-7) on the expression of cellular c-fos in angiotensin II -induced proliferative glomerular mesangial cells (GMC). Methods GMC were treated with angiotensin II and different dose of angiotensin-(1-7). GMC number were evaluated by crystal violet staining and the expression of c-foe were detected by western blot. Results Angiotensin-(1-7) inhibit angiotensin II -induced GMC proliferation as well as the expression c-foe in a concentration dependent manner. Conclusion c-fos is involved in the inhibiting effects of angiotensin-(1-7) on angiotensin II -induced GMC proliferation.