CDISC standard has become a set of global data standards that can be used in clinical study, covering the full life cycle of clinical researches. After nearly 20 years of development and continuous version upgrades, CDISC standard can improve the quality and efficiency of clinical research and drug review, and to facilitate all stakeholders involved in researches to exchange the study data and communicate the outcomes. CDISC standard has been or is to be adopted as standard format in data submission by multiple regulatory authorities, and more widely implemented by the global pharmaceutical community. CDISC standard is gradually adopted in China. The feasibility and roadmap of CDISC standard as the Chinese data submission format requirements are undergoing exploration and piloting further.
Biomedical Research ; standards ; China ; Clinical Trials as Topic ; standards ; Data Collection ; standards

BACKGROUND: At present, finite element analysis can be used to judge intertrochanteric fractures, but mostly limited in the distribution of stress. Finite element model of various intertrochanteric fractures has not been reported in detail.OBJECTIVE: To build various types of intertrochanteric fracture models with Hypermesh 14.0 and LS-DYNA software to simulate the falling-induced external force on proximal femur, and to evaluate the effect of models, and to analyze the biomechanical mechanism of intertrochanteric fractures. METHODS: Normal side CT image data of one case of elderly intertrochanteric fracture were collected and imported into Mimics software to establish the proximal femur geometric models, were then analyzed and operated by LZ-DYNA solver after imported into Geomagic studio 2013 and Hypermesh 14.0 for smoothing and meshing. Before analysis, the material parameters were set, the boundary conditions were confirmed, and given the loading parameters. The operating results were checked in Hyper View. RESULTS AND CONCLUSION: (1) The distribution of stress of proximal femur exactly matched to the previous study. EvansⅠtype intertrochanteric fracture model was obtained under continuous shear stresses, and six types of fractures were obtained by adjusting the load. (2) These results manifest that based on the Hypermesh 14.0 and LS-DYNA software, the finite element can well simulate the intertrochanteric fractures, and shear stress plays an important role in intertrochanteric fractures, which can provide experimental basis for the prevention and treatment of intertrochanteric fractures.

OBJECTIVETo observe the changes in Aβ40, Aβ42 and ADDLs in brains of 3 month-old APPswe/PS1dE9 double transgenic mice after six-month intervention with curcumin, in order to discuss the neuroprotective effect of curcumin.

METHODAPPswe/PS1dE9dtg mice were randomly divided into the model group, the Rosiglitazone group (10 mg x kg(-1) x d(-1)) and curcumin high (400 mg x kg9-1) x d(-1)), medium (200 mg x kg(-1) x d(-1)) and low (100 mg x kg(-1) x d(-1)) dosage groups, with C57/BL6J mice of the same age and the same background in the normal control group. After 6 months, the immunohistochemical staining (IHC) and the Western blot method were used to observe the changes in positive cell of Aβ40, Aβ42 and ADDLs in hippocampal CA1 area, their distribution and protein expressions.

RESULTBoth of the immunohistochemical staining and the Western blot method showed more positive cell of Aβ40, Aβ42 and ADDLs in hippocampal CA1 area and higher protein expressions in the model group than the normal group (P < 0.01). IHC showed a lower result in the Rosiglitazone group than the model group (P < 0.05), while Western blot showed a much lower result (P < 0.01). The number of Aβ40, Aβ42 and ADDLs positive cells and the protein expressions decreased in the curcumin high group, the medium group showed a significant decrease (P < 0.01), and the low dose group also showed reductions in the protein expressions of Aβ40 and Aβ42.

CONCLUSIONThe six-month intervention with curcumin can significantly reduce the expressions of hippocampal Aβ40, Aβ42 and ADDLs in brains of APPswe/PS1dE9 double transgenic mice. Whether curcumin can impact Aβ cascade reaction by down-regulating expressions of Aβ40, Aβ42 and ADDLs and show the neuroprotective effect needs further studies.

Alzheimer Disease ; drug therapy ; genetics ; metabolism ; Amyloid beta-Peptides ; genetics ; metabolism ; Animals ; Brain ; drug effects ; metabolism ; Curcumin ; administration & dosage ; Disease Models, Animal ; Hippocampus ; drug effects ; metabolism ; Humans ; Mice ; Mice, Inbred C57BL ; Mice, Transgenic ; Neuroprotective Agents ; administration & dosage ; Plant Extracts ; administration & dosage

Objective To investigate the value and dynamic characteristics of diffusion-weighted imaging(DWI)in rabbit liver VX_2 tumor model,with correlation of pathology.Methods Forty New Zealand rabbits were included in the study and VX_2 tumor piece was implanted directly into the liver after laporotomy.Fiffteen had two intrahepatic implants while twenty-five had one implant.DWI was performed on the seventh,fourteenth and twenty-first day after implantation,while routine T_1WI and T_2WI sequences were done on the seventh and fourteenth day.Ten VX_2 tumor samples were studied by pathology.Results The lump detection rates on the seventh day after implantation of DWI,T_1WI and T_2WI were 78.7%(37/47), 10.7%(3/28)and 53.6%(15/28)respectively with statistical significance(x~2=32.61,P

Purpose: Gastric cancer (GC) has high morbidity and mortality and is a serious threat to public health. The flavonoid compound vitexin is known to exhibit anti-tumor activity. In this study, we explored the therapeutic potential of vitexin in GC and its underlying mechanism. Materials and Methods: The viability, migration, and invasion of GC cells were determined using MTT, scratch wound healing, and transwell assays, respectively. Target molecule expression was determined by western blotting. Tumor growth and liver metastasis were evaluated in vivo using nude mice. Protein expression in the tumor tissues was examined by immunohistochemistry. Results: Vitexin inhibited GC cell viability, migration, invasion, and epithelial-mesenchymal transition (EMT) in a dose-dependent manner. Vitexin treatment led to the inactivation of phosphatidylinositol-3-kinase (PI3K)/AKT/hypoxia-inducible factor-1α (HIF-1α) pathway by repressing HMGB1 expression. Vitexin-mediated inhibition in proliferation, migration, invasion and EMT of GC cells were counteracted by hyper-activation of PI3K/AKT/HIF-1α pathway or HMGB1 overexpression. Finally, vitexin inhibited the xenograft tumor growth and liver metastasis in vivo by suppressing HMGB1 expression. Conclusions Vitexin inhibited the malignant progression of GC in vitro and in vivo by suppressing HMGB1-mediated activation of PI3K/Akt/HIF-1α signaling pathway. Thus, vitexin may serve as a promising therapeutic agent for the treatment of GC.

OBJECTIVE: To study the morphological changes of the rat claw inner skeletal muscle after ulnar nerve injury at different sections and different recovery times. METHODS: Forty-two adult male Sprague-Dawley rats were selected and placed randomly in seven groups. After establishing model of injury and repair of claw inner skeletal muscle by cutting off the ulnar nerve, the muscle wet weight, cross section area of myocytes, and collagen fibers were measured. RESULTS: Claw inner skeletal muscle atrophy was significantly less in experiment groups compared with the control groups after ulnar nerve injuries. The functional recovery was better in the early repair groups than the late repair group. Collagen fibers increased slowly in earlier stage, but more significantly in late stage. The muscle atrophy was similar in wrist and elbow after ulnar nerve injury during the same recovery period. CONCLUSION The function can recover completely or partly in early repair groups, but not quite effective in late stage. The increase of collagen fiber is one of the reasons to undermine the recovery effect of damaged ulnar nerve. There is no obvious difference of effect on the morphological changes of the rat claw inner skeletal muscle no matter the ulnar nerve is injured at wrist or elbow.
Animals ; Male ; Muscle, Skeletal/pathology* ; Muscular Atrophy/prevention & control* ; Nerve Regeneration/physiology* ; Random Allocation ; Rats ; Rats, Sprague-Dawley ; Plastic Surgery Procedures ; Ulnar Nerve/surgery*

OBJECTIVETo evaluate the correlation of 64-multidetector-row CT (64MDCT) perfusion imaging with microvessel density(MVD) and vascular endothelial growth factor(VEGF) in colorectal carcinoma.

METHODS64MDCT perfusion imaging was performed in 33 patients with pathologically verified colorectal carcinoma. Time-density curves (TDC) were created from the region of interest (ROI) drawn over the tumor, target artery and vein by 64MDCT with perfusion functional software. The individual perfusion maps generated were for blood flow (BF), blood volume (BV), mean transit time (MTT) and permeability-surface area product (PS). MVD and VEGF expression of surgical specimens were examined by immunohistochemical staining with anti-CD34, anti-VEGF monoclonal antibody. MVD and VEGF were compared among the different types of TDC in colorectal carcinoma. The correlation of CT perfusion parameters with MVD and VEGF was also examined.

RESULTSTDC of colorectal carcinoma was divided into five types according to their shapes. MVD in the colorectal carcinoma was 22.61+/-9.01. VEGF staining was found in 25 of 29 tumors (86.2%). The score of VEGF expression was 4.15+/-1.09. No significant differences of MVD and VEGF expression among TDC types were found (F=2.59, 1.11, P>0.05). There were also no correlations of MVD and VEGF expression with any dynamic CT parameters (P>0.05).

CONCLUSION64MDCT perfusion imaging, MVD and VEGF may reflect angiogenic activity, but no significant correlations are found among them.

Adult ; Aged ; Colorectal Neoplasms ; blood supply ; diagnostic imaging ; Female ; Humans ; Male ; Microvessels ; Middle Aged ; Neovascularization, Pathologic ; Tomography, Spiral Computed ; methods ; Vascular Endothelial Growth Factor A ; metabolism ; Young Adult

OBJECTIVETo investigate the relationship between the changes of amino acids contents in hippocampus of rats and electromagnetic pulse (EMP) exposure.

METHODSRats were decapitated and hippocampus were removed after EMP (6 x 10(4) V/m, rise time 20 ns, pulse width 30 micro s, 5 pulses in 2 minutes) irradiation, and contents of amino acids were detected with high performance liquid chromatograpy (HPLC).

RESULTSThe contents of aspartic acid (Asp) and glutamic acid (Glu) increased significantly 0, 3, 6 h after irradiation. The peak values of Asp [(17.25 +/- 1.63) pmol/ micro l] and Glu [(13.67 +/- 0.95) pmol/ micro l] were higher than those of control [(10.56 +/- 1.50), (6.94 +/- 1.10) pmol/ micro l respectively, P < 0.05]. Then both decreased gradually and reached the normal level 24 - 48 h after irradiation. The contents of glycine (Gly), taurine (Tau) and gamma-aminobutyric acid (GABA) also rose after exposure, the peak value of them [(4.51 +/- 0.60), (29.85 +/- 2.70), (5.14 +/- 0.73) pmol/ micro l respectively] were higher than those of control group [(2.18 +/- 0.31), (9.88 +/- 1.47), (2.84 +/- 0.67) pmol/ micro l, P < 0.05], then recovered 48 h after irradiation. The value of Glu/GABA increased immediately after exposure (3.45 +/- 0.25, P < 0.05), then decreased 24 h (1.62 +/- 0.23, P < 0.05) and recovered 48 h after exposure.

CONCLUSIONThe toxic effect of excess excitatory amino acids may be partly responsible for the early retardation (within 24 h) of learning of rats.

Amino Acids ; analysis ; Animals ; Chromatography, High Pressure Liquid ; methods ; Glutamic Acid ; analysis ; Hippocampus ; metabolism ; radiation effects ; Male ; Radiation ; Random Allocation ; Rats ; Rats, Wistar ; Time Factors

We reported a technical report of traumatic lower cervical spondylolisthesisca used by bilateral pedicle fracture, without neurological compression. The patient was treated with the minimally invasive technique of percutaneous pedicle screw fixation. Fracture healing and normal cervical motion were confirmed by plain films and physical examinations on the 18-monthpostoperatively. The technique of percutaneous pedicle screw fixation might be an alternative strategy for the treatment of traumatic lower cervical spondylolisthesis with pedicle fracture.
Cervical Vertebrae ; Female ; Fracture Healing ; Humans ; Physical Examination ; Spondylolisthesis*