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.

ObjectiveTo discuss the effect of neonatal behavioral neurological assessment (NBNA) and developmental screening test (DST) on newborns with hypoxic ischemic encephalopathy (HIE). MethodsNBNA was performed for 60 newborns with HIE within 12-14 days and DST was also performed at 6th month after birth.ResultsMild and severe degree HIE newborns with low NBNA scores had unfavorable prognosis. Conclusions NBNA and DST can provide evidence for early interference for newborn's HIE.

ObjectiveTo analyze and compare the difference and prognosis between vascular embolization and craniotomy occlusion in patients suffering from aneurysmal subarachnoid hemorrhage (aSAH) with Hunt-Hess levelⅢ-Ⅳ, and acute postoperative hydrocephalus.Methods A retrospective study was conducted on 767 patients who had undergone vascular embolization (vascular embolization group,n = 403) or craniotomy occlusion operation (craniotomy occlusion operation group,n = 364), and the patients with postoperative acute hydrocephalus were screened. The clinical data of patients of both groups was analyzed. By judging short-term prognosis in patients with hydrocephalus with Glasgow outcome scale (GOS) score estimated at discharge, the advantages and disadvantages of two surgical procedures were compared.Results The number of cases with postoperative hydrocephalus in vascular embolization group was 56 (13.90%), while that in craniotomy occlusion group was 33 (9.07%). The difference between the two groups of incidence of hydrocephalus was statistically significant (χ2= 4.350,P = 0.037 ). In 767 patients with aSAH, the incidence of hydrocephalus among the patients after the hematoma removal operation was significantly lower than that of patients without hematoma removal [3.07% (11/358) vs. 19.07% (78/409),χ2 = 47.635,P = 0.000]. The incidence of hydrocephalus among the patients after ventricular drainage was significantly lower than that of patients without the drainage [2.77% (19/685) vs. 85.37% (70/82),χ2 = 487.032,P = 0.000]. In 403 cases of vascular embolization group, the incidence of hydrocephalus in the patients after the hematoma removal operation was lower than that of patients without it [8.06% (5/62) vs. 14.96% (51/341),χ2 = 2.082,P = 0.168]. The incidence of hydrocephalus in the patients after the ventricular drainage was lower than that of patients without drainage [2.59% (9/347) vs. 83.93% (47/56),χ2 = 266.599,P = 0.000]. In 364 cases of craniotomy occlusion operation group, the incidence of hydrocephalus in the patients after hematoma removal operation was significantly lower than that of patients did not receive [2.03% (6/296) vs. 39.71% (27/68),χ2 = 95.226,P = 0.000]. The incidence of hydrocephalus among the patients after the ventricular drainage was significantly lower than that of patients without drainage [2.96% (10/338) vs. 88.46% (23/26),χ2 = 203.852,P = 0.000]. The difference in incidence of hydrocephalus between the patients who had hematoma removal surgery between vascular embolization group and craniotomy occlusion operation group was statistically significant [8.06% (5/62) vs. 2.03% (6/296),χ2 = 4.411,P = 0.027], while no statistically difference was present in ventricular drainage patients [2.59% (9/347) vs. 2.96% (10/338),χ2 = 0.085,P = 0.819]. There were 23 patients (41.07%) with good outcome (GOS score 4-5), while 33 (58.93%) with poor outcome (GOS score 1-3) in 56 patients undergone vascular embolization operation. Good result (GOS score 4-5) was shown in 21 (63.64%) and 12 (36.36%) with poor outcome (GOS score 1-3) among 33 patients with hydrocephalus after craniotomy occlusion operation, and the difference was statistically significant (χ2 = 4.230,P = 0.039).Conclusions Hematoma is one of the main factor contributing to the differences in the incidence of postoperative hydrocephalus of Hunt-Hess gradeⅢ-Ⅳ patients either receiving vascular embolization or craniotomy occlusion operation. Lateral ventricle drainage may not be the factor that contributes to the difference in incidence of hydrocephalus formation between the vascular embolization and craniotomy occlusion operation groups in Hunt-Hess levelⅢ-Ⅳ patients. The short term prognosis in the craniotomy occlusion operation group is superior to that of endovascular intervention embolization group.

OBJECTIVETo screen efficient siRNA for inhibiting hepatitis B virus using the technique of PCR-based tRNA(val) Pol III-shRNA expression cassettes (SECs).

METHODSBased on core gene sequence of HBV, five target sites of siRNA were designed. tRNAval Pol III-shRNA expression cassettes produced by one-step overlapping extension PCR strategy were co-transfected with HBV C gene and pC-EGFP plasmid into AD293 cells respectively. Forty-eight hours after transfection, fluorescence of HBVC-GFP protein was detected by fluorescence-activated cell sorting (FACS); HBV C mRNA was detected by semi-quantitative RT-PCR. HBV-producing HepG2. 2. 15 cells were transfected with selected SECs for 72 h, HBsAg and HBeAg in the cell culture medium were detected by radioimmunoassay assay (RIA). HBV pgRNA from cell total RNA was detected by semi-quantitative PCR.

RESULTCo-transfection with pC-GFP plasmid and SECs into AD293 cells resulted in inhibition expression of HBV C gene and decrease of EGFP fluorescence intensity. SEC-492i showed most significant inhibition effect on HBV C-EGFP expression compared with other SECs. Selected SEC-492i or SEC-282i targeting core gene could efficiently decrease expression of HBeAg and the level of HBV pgRNA in a dose-dependent manner. SEC-492i inhibited HBV replication and antigen expression in a more efficient way than SEC-282i at the same final concentration.

CONCLUSIONThe expressed shRNA, which targets sites on HBV C mRNA in 492i, is to have having most efficient RNAi effect. tRNAval Pol III-shRNA expression cassettes produced by one-step overlapping extension PCR strategy should be useful for identification of optimal siRNA.

Base Sequence ; Carcinoma, Hepatocellular ; pathology ; Cell Line, Tumor ; Cells, Cultured ; Embryo, Mammalian ; Green Fluorescent Proteins ; genetics ; Hepatitis B Core Antigens ; biosynthesis ; genetics ; Hepatitis B e Antigens ; biosynthesis ; genetics ; Hepatitis B virus ; genetics ; Humans ; Kidney ; cytology ; Liver Neoplasms ; pathology ; Molecular Sequence Data ; Polymerase Chain Reaction ; RNA, Messenger ; genetics ; RNA, Small Interfering ; RNA, Transfer, Val ; genetics ; RNA, Viral ; genetics ; Transfection

OBJECTIVETo investigate and evaluate the quality of life and its influencing factors in Miao and Gelao Minority groups in Guizhou province with the aim of providing evidence for valid health promotion measures.

METHODSBased on a self-designed questionnaire to evaluate the quality of life on 582 subjects. Kruskal-wallis test and stepwise regression analysis were used to test the quality of life and its influencing factors.

RESULTSThere were significant differences among the groups of quality of life and its influencing factors. The quality of life of Miao Minority was the highest and Gelao the lowest. Sex, age, acute disease prevalence of the past two-weeks, prevalence of chronic diseases, drinking unboiled water, tobacco-smoking habit, educational level and the family expenditure on life were correlated with all or most of the domains of quality of life.

CONCLUSIONThe key steps on quality of life promotion should include: strengthening the basis medical health service, pushing cooperative medical service, enhancing prevention and care of chronic diseases, speeding the development of economics etc.

Acute Disease ; epidemiology ; Asian Continental Ancestry Group ; China ; Chronic Disease ; epidemiology ; Health Status ; Humans ; Minority Groups ; Prevalence ; Quality of Life

OBJECTIVETo analyze the clinical risk factors for deep vein thrombosis (DVT) after total hip and knee arthroplasty in Chinese patients who received prophylactic treatment for DVT.

METHODSWe evaluated 128 total hip arthroplasty (THA) and total knee arthroplasty (TKA) in 95 patients performed at our center from April 2004 to August 2004, which included 48 THAs in 43 patients and 80 TKAs in 52 patients. There were 27 men and 68 women with a mean age of 59.77 years (range, 23-78 years). All patients had been given low-molecular-weight heparin before operation and for 7-10 days post-operation to prevent DVT. Color Doppler ultrasonography was used to detect DVT of bilateral lower extremities in all patients before operation and at 7-10 days after operation. Nineteen clinical factors were examined preoperation and 7-10 days post-operation in order to analyze their influences on DVT formation after surgery.

RESULTSThere were 45 patients who developed DVT after operation. The incidence of DVT in all patients was 47.4% (45/95) and the incidence of proximal DVT was 3.2%. There were more asymptomatic DVT (57.8%, 26/45) than symptomatic ones, and some patients without DVT (14%, 7/50) presented some of the DVT symptoms. Logistic regression analysis demonstrated a definite association of female, obesity (representative by BMI), cement usage and diagnosed RA with DVT with odds ratio of 10.008, 3.094, 8.887, and 0.194 respectively. Other clinical factors had no statistically significant association with DVT.

CONCLUSIONSFemale, obesity, and cement usage were the risk factors for DVT after THA and TKA, and diagnosed RA was the protecting factors for DVT after THA and TKA. Other clinical factors such as age, OA, type of implant, monolateral or bilateral operation, duration of anesthesia, surgery and bandage usage for blood control, time for immobilization et al were not the risk factors for DVT.

Adult ; Aged ; Arthritis, Rheumatoid ; Arthroplasty, Replacement, Hip ; adverse effects ; Arthroplasty, Replacement, Knee ; adverse effects ; Bone Cements ; adverse effects ; Female ; Humans ; Male ; Middle Aged ; Obesity ; Postoperative Complications ; prevention & control ; Retrospective Studies ; Risk Factors ; Sex Factors ; Thrombophlebitis ; etiology ; prevention & control

The use of radioisotope tracer technique in human new drug trials has some ethical issues , such as the risk of radiation damage to the subject and to the staff , the concern of environmental contamination by the radiolabeled drugs.This article describes the process of the ethical review of a radiolabelled drug clinical trial and our ethical considerations , for the purpose of peer discussion and reference to promote the improve-ment of ethical review of clinical trials for such technology .

Objective To investigate the effects of transcranial direct current stimulation (tDCS) on motor function of upper limbs of stroke patients. Methods 80 stroke patients were randomly divided into experimental group and control group. Both groups accepted routine rehabilitation, while the experimental group accepted anodal stimulation, and the control group received sham stimulation. They were assessed with Brunnstrom stages of arms and hands, Fugl-Meyer Assessment (FMA) of upper extremities, Action Research Arm Test (ARAT), Motor Assessment Scale (MAS) and modified Barthel Index (MBI) before and 1 month after treatment. Results All the scores improved in both groups after treatment (P<0.05), and improved more in the Brunnstrom stages of arms and hands, FMA, ARAT in the experimental group than in the control group (P<0.05). Conclusion tDCS may promote the recovery of arms and hands function of stroke patients.

Background/Aims: Functional dyspepsia (FD) overlapping with other gastrointestinal disorders are quite common. The characteristics of FD overlap in Chinese population with latest Rome IV criteria were unclear. This large-scale outpatient-based study assessed the characteristics of FD overlap in South China. Methods: Consecutive FD patients visited the Gastroenterology Clinic at 2 tertiary medical centers in Hangzhou, China who fulfilled the Rome IV criteria were enrolled. Complete questionnaires related to the gastrointestinal symptoms (Rome IV criteria), Reflux Disease Questionnaire, anxiety and depression, quality of sleep and life, and demographic information were collected. Results: Among the total of 3281 FD patients, 50.69% overlapped with gastroesophageal reflux disease, 21.46% overlapped with irritable bowel syndrome, 6.03% overlapped with functional constipation. FD overlap had higher proportion of single/divorced/widowed rate, high education level, being employed, drinking, night shift, unhealthy dietary habit than FD only (P < 0.05). They had higher frequency of consultation and economic burden, as well as lower scores in quality of life (P < 0.001). Multivariate logistic regression showed that increasing age, female, low body mass index, history of gastroenteritis, anxiety, depression, and poor sleep quality were independent risk factors for FD overlap. Conclusions FD overlap was quite common in China with high economic burden and poor quality of life, FD patients with history of gastroenteritis, anxiety, depression, and poor sleep quality were more likely to have overlap disorders. Awareness of the physical and psychosocial stressors in overlapping condition would help optimize the management of FD overlap in clinical practice.

Adolescent ; Adult ; Antiviral Agents ; therapeutic use ; DNA, Viral ; blood ; Female ; Hepatitis B virus ; genetics ; Hepatitis B, Chronic ; drug therapy ; virology ; Humans ; Male ; Middle Aged ; Nucleosides ; therapeutic use ; Pyrimidinones ; therapeutic use ; Thymidine ; analogs & derivatives ; Young Adult