Case report form (CRF) is a key document for data collection in clinical trials. A well-designed CRF is required for database construction, data accuracy, data query/cleaning, CRF completion and statistical analysis. A well-defined process or SOP should be in place for CRF design. Data collection should fully meet the demand of study protocol. The layout of CRF should be clear with well-structured fields and standard coding for fields.
Clinical Trials as Topic ; standards ; Data Collection ; standards ; Documentation ; standards ; Research Design ; standards

0.05).Conclusion Serum leptin play an important role in puberty of girls and closely is correlated with BMI and BF% regardless of age and sex in 6-14 years old children in poor rural areas.

Objective To examine the expression of toll-like receptor 2(TLR2)in peripheral blood monocytes and explore its association with disease stages and clinical manifestations and to explore the patho- genesis of rheumatoid arthritis(RA).Methods The expression of toll-like receptor 2 in peripheral blood monocytes from 47 RA patientis(27 in active stage and 20 in stable stage)and 18 normal individuals were de- tected by flowcytometry and RT-PCR.Results The expression of toll-like receptor 2 in peripheral blood monocytes in patients with active disease was significantly increased compared to non-active patients and nor- mal individuals,The expression was found to correlate with the Disease Active Score(DAS),serum C-reactive protein(CRP)level and the erythrocyte sedimentation rate(ESR),but not correlate with rheumatoid factor (RF)and the anti-cyclic citrullinated peptide(CCP)antibody.Conclusion The expression of toll-like recep- tor 2 in peripheral blood monocytes of patients with active RA is significantly increased.And the expression is correlated with disease activity index.The innate immune system is activated in patients with active disease. And the increased expression may promote the activities of monocytes.

Objective To determine the effects of~(99)Tc-MDP on joint inflammation and bone destruc- tion in collagen-induced arthritis(CIA)rats model and its effect on tumor necrosis factor alpha(TNF-?). Methods CIA was induced by immunization of male SD rats with an emulsion of collagen.~(99)Tc-MDP or placebo was intravenous infused to rats for 20 days.Joint inflammation was assessed by arthritis index.Lesions of bone were assessed based on the histological changes in ankle joints,radiographic analysis in hind paw with Larsen score.Systemic TNF-?level was measured by radioimmune assay.Results~(99)Tc-MDP suppressed joint swelling(P

The objective of this study is to combine troponin and indicators of cardiac acoustics for synthetically evaluating cardiac fatigue of rabbits, analyzing exercise-induced cardiac fatigue (EICF) and exercise-induced cardiac damage (EICD). New Zealand white rabbits were used to conduct a multi-step swimming experiments with load, reaching an exhaustive state for evaluating if the amplitude ratio of the first to second heart sound (S1/S2) and heart rate (HR) during the exhaustive exercise would decrease or not and if they would be recovered 24-48 h after exhaustive exercise. The experimental end point was to complete 3 times of exhaustions or death from exhaustion. Circulating troponin I (cTnI) were detected from all of the experimental rabbits at rest [(0. 02±0. 01) ng/mL], which, in general, indicated that there existed a physiological release of troponin. After the first exhaustive swim, cTnI of the rabbits increased. However, with 24-hour rest, S1/S2, HR, and cTnI of the tested rabbits all returned toward baseline levels, which meant that the experimental rabbits experienced a cardiac fatigue process. After repeated exhaustion, overloading phenomena were observed, which led to death in 3 out of 11 rabbits, indicating their cardiac damage; the troponin elevation under this condition could be interpreted by pathological release. Evaluation of myocardial damage can not be based on the troponin levels alone, but can only be based on a comprehensive analysis.
Animals ; Fatigue ; Heart ; physiopathology ; Heart Rate ; Myocardium ; pathology ; Rabbits ; Swimming ; Troponin I ; blood

Objective:It is demostrated that the porous protein-mineral mechanics model could provide more accurate prediction for biomaterial properties of dentine compared with the other established models.This paper would use the model to reevaluate the mechanical properties and its interacting mechanism of human dentine.Method:By using a porous proteinmineral mechanics model,the effect from the interactions between tubules,pedtubular and intertubular matrix on dentine microstructure was discussed.Results:The dentinal micromechanical properties were dependent on the tubular direction,and the absolute values of the stresses derived from the hydraulic and gas tubular pressures increased parabolically with theincreasing diameter of the tubules.It was also found that the effective elastic constants of the dentine microstructure would vary with the aging and the distribution of mineral and collagen within peritubular and intertubular matrix of detine.Conclusions:The theoretical analyses provided in this paper demonstrated that the microstructural characteristics of tubules,peritubular and intertubular dentinal matdx could have different influences on the micromechanical properties of human dentine,which showed the validity of porous protein-mineral mechanics model,and the limitation of some models that neglected the interacting mechanism.

Objective:It is demostrated that the porous protein-mineral mechanics model could provide more accurate prediction for biomaterial properties of dentine compared with the other established models.This paper would use the model to reevaluate the mechanical properties and its interacting mechanism of human dentine.Method:By using a porous proteinmineral mechanics model,the effect from the interactions between tubules,pedtubular and intertubular matrix on dentine microstructure was discussed.Results:The dentinal micromechanical properties were dependent on the tubular direction,and the absolute values of the stresses derived from the hydraulic and gas tubular pressures increased parabolically with theincreasing diameter of the tubules.It was also found that the effective elastic constants of the dentine microstructure would vary with the aging and the distribution of mineral and collagen within peritubular and intertubular matrix of detine.Conclusions:The theoretical analyses provided in this paper demonstrated that the microstructural characteristics of tubules,peritubular and intertubular dentinal matdx could have different influences on the micromechanical properties of human dentine,which showed the validity of porous protein-mineral mechanics model,and the limitation of some models that neglected the interacting mechanism.

Objective To study the association between body mass index (BMI) and the health-related quality of life (HRQOL) in the middle-aged and older Chinese people. Methods Data of 9539 middle-aged and older adults was collected from a cross-sectional survey performed in 9 provinces of China (Jiangsu, Anhui, Gansu, Qinghai, Fujian, Beijing, Jilin, Jiangxi and Henan province). MO SSF-36 was used to measure HRQOL. BMI classification was in accordance with the criteria recommended by the Ministry of Health of China. Rank sum test was used to compare HRQOL between subjects with normal weight and those with different BMI classification. Multiple logistic regression analysis was used to assess the association of HRQOL with BMI after adjusted for sex, age, marital, education, physical activity status and chronic diseases. Results When compared with middle-aged and older adults at normal weight range (18.5≤BMI<24) , data on physical domain (P<0.001) , mental domain (P< 0.01) and 8 dimensions of HRQOL (physical functioning, mental health, P<0.05; role-physical, bodily pain, general health, vitality, social functioning, role-emotional, P<0.01)among subjects with underweight (BMI<18.5) were significantly lower while mental component summary (P<0.05) of overweight subjects (24≤BMI<28) was significantly higher. Obese subjects (BMI≥28) had worse physical function (physical functioning, P<0.01) but better mental health (mental health, P<0.01; mental component summary, P<0.05). After adjusting for other factors, and compared to middle aged and older adults with normal weight, data on odds ratios (ORs) of impaired HRQOL in physical domain (OR=1.67, 95% CI: 1.35-2.06), mental domain (OR=1.39, 95%CI: 1.13-1.70) and 8 dimensions increased among underweight subjects while ORs of impaired HRQOL in mental domain (0R=0.86,95% CI: 0.78-0.95) and role-physical, vitality, social functioning, role-emotional and mental health dimensions decreased among overweight subjects. ORs increased (OR=1.51,95% CI: 1.27-1.80) in impaired HRQOL in physical functioning dimension but decreased in mental domain (OR=0.71,95%CI: 0.60-0.85) as well as vitality, role-emotional and mental health dimensions among obese subjects. Conclusion HRQOL of each domain were different among middle aged and older adults with different BM1 classification. Underweight people had poor HRQOL in both physical domain and psychological domain, and obese people had poor physical function but good mental health condition.

Objective To evaluate the effect of team-based rehabilitation education on daily life ability of old patients having undergone operations on hip fractures.Methods Sixty elderly reconvalescents from operations on hip fractures were equally assigned into the intervention and control groups according to admission sequence:The intervention group received rehabilitation education by community nurses at months 1,3 and 6 and the control group were managed with convalesce at home.The two groups were compared in terms of daily life ability at the three time points. Result The daily life ability of the intervention group was better than that of the control group at all the three time points(P<0.05). Conclusion The team-based rehabilitation education is effective for the enhancement of daily life ability of old patients having undergone operations on hip fractures.

Objective To improve the usage of foam dressing at the sacrococcygeal region and observe its application effect. Methods A total of 80 hospitalized patients with high risk of pressure ulcer were chosen during May to December 2015 as study objects. Patients were drawn into the observation group and the control group, each group contained 40 members. Proper-cutting foam dressings and normal foam dressing were applied in patients by the observation group and the control group individually. Researchers made records by comparing and analyzing the usage time of dressing and the skin intact of two groups. Results The observation group used foam dressing (1.88±0.12) blocks per person, foam dressing use time was (3.87±0.34) d per block, and in the control group, they were (2.60±0.38) blocks per person, (2.13±0.89) d per block, there was significant difference between two groups (t=11.427, 11.551, P<0.05). The skin integrity rate of the observation group and the control group were 95.0%(38/40) and 75.0%(30/40), the difference was statistically significant (χ2=6.275, P<0.05). Conclusions This study shows that the foam dressing need to be cut appropriately before pasting so that the clinical nurses can observe patient's skin conveniently. Once the skin has pressure red, the nurse can take timely measures to deal with it, which can decrease the incidence of pressure sores. The cutting dressing prolongs the period of using without removing the viscose part, which also can reduce the medical expenses.