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71.
Surrogate endpoints are important for validation of mechanism, early proof of concept, and the rational design of clinical trials for regulatory approval of drugs. The recent failure of several drugs in peripheral arterial disease (PAD) and in atherosclerosis highlights the importance of understanding drug effect and is a clarion call for better endpoints. This review focuses on aspects relating to the current state of surrogate endpoints in PAD and reviews emerging endpoints using imaging approaches that may have the potential of improving study design in PAD. 相似文献
72.
Herédia V Ramalho M de Campos RO Lee CH Dale B Vaidean GD Semelka RC 《Journal of magnetic resonance imaging : JMRI》2011,33(6):1482-1490
Purpose:
To compare in‐phase (IP) /out‐of‐phase (OP) single shot magnetization‐prepared gradient‐recalled‐echo (MP‐GRE) with a standard two‐dimensional gradient‐recalled‐echo (2D‐GRE), and to compare image quality of MP‐GRE in cooperative and noncooperative subjects.Materials and Methods:
Ninety‐six consecutive subjects (52 males, 44 females; mean age, 53.2 ± 16.7 years), both cooperative (n = 73) and noncooperative (n = 23) subjects who had MRI examinations including precontrast T1‐weighted IP/OP MP‐GRE with or without IP/OP 2D‐GRE were included in the study. The sequences were independently qualitatively evaluated by two radiologists. Quantitative analysis of liver fat index, signal‐to‐noise ratio (SNR) and liver‐lesion contrast‐to‐noise ratio (CNR) was also performed. Data were subjected to statistical analysis.Results:
The visual detection of the presence or absence of liver steatosis showed no differences between 2D‐GRE and MP‐GRE imaging (k = 1). Minor differences were observed on image quality between MP‐GRE and 2D‐GRE in cooperative subjects, and between MP‐GRE sequences performed in cooperative and noncooperative subjects. Liver fat index results were strongly positively correlated (r = .98; 95% confidence interval [CI] 0.97 to 0.98; P < .0001). Intercept (.14; 95% CI .13 to .15; P < .0001) and slope (.83; 95% CI .79 to .86; P < .0001) were statistically significant.Conclusion:
IP/OP MP‐GRE and 2D‐GRE comparably demonstrate the presence or absence of hepatic steatosis. Image quality of MP‐GRE was also comparable to 2D‐GRE, and was not substantially adversely affected if subjects were unable to cooperate with breathholding instructions. J. Magn. Reson. Imaging 2011;33:1482–1490. © 2011 Wiley‐Liss, Inc. 相似文献73.
74.
Bajgar J Hajek P Kassa J Slizova D Krs O Karasova JZ Fusek J Capek L Voicu VA 《Toxicology mechanisms and methods》2012,22(1):60-66
Reactivation effects of K203 and currently available oximes (obidoxime, HI-6) in combination with atropine on acetylcholinesterase activities in the brain parts of rats poisoned with tabun were studied. The activity was determined by quantitative histochemical and biochemical methods correlating between them very well. The tabun-induced changes in acetylcholinsterase activity as well as in reactivation potency of reactivators used were different in various parts of the brain. Pontomedullar area seems to be important for observed changes following tabun intoxication and its treatment. From the oximes studied, the reactivation effect of K203 was comparable with obidoxime; HI-6 was ineffective. Combination of bio- and histochemical methods allow fine differentiation among the action of different oximes following tabun poisoning. 相似文献
75.
Litian Yu Patricia A. Baxter Horatiu Voicu Sivashankarappa Gurusiddappa Yijue Zhao Adekunle Adesina Tsz-Kwong Man Qin Shu Yu-Jing Zhang Xiu-Mei Zhao Jack M. Su Lazlo Perlaky Robert Dauser Murali Chintagumpala Ching C. Lau Susan M. Blaney Pulivarthi H. Rao Hon-chiu Eastwood Leung Xiao-Nan Li 《Neuro-oncology》2010,12(6):580-594
Limited availability of in vitro and in vivo model systems has hampered efforts to understand tumor biology and test novel therapies for ependymoma, the third most common malignant brain tumor that occurs in children. To develop clinically relevant animal models of ependymoma, we directly injected a fresh surgical specimen from a 9-year-old patient into the right cerebrum of RAG2/severe complex immune deficiency (SCID) mice. All five mice receiving the initial transplantation of the patient tumor developed intracerebral xenografts, which have since been serially subtransplanted in vivo in mouse brains for 4 generations and can be cryopreserved for long-term maintenance of tumorigenicity. The xenograft tumors shared nearly identical histopathological features with the original tumors, harbored 8 structural chromosomal abnormalities as detected with spectral karyotyping, maintained gene expression profiles resembling that of the original patient tumor with the preservation of multiple key genetic abnormalities commonly found in human ependymomas, and contained a small population (<2.2%) of CD133+ stem cells that can form neurospheres and display multipotent capabilities in vitro. The permanent cell line (BXD-1425EPN), which was derived from a passage II xenograft tumor and has been passaged in vitro more than 70 times, expressed similar differentiation markers of the xenograft tumors, maintained identical chromosomal abnormalities, and formed tumors in the brains of SCID mice. In conclusion, direct injection of primary ependymoma tumor cells played an important role in the generation of a clinically relevant mouse model IC-1425EPN and a novel cell line, BXD-1425EPN. This cell line and model will facilitate the biological studies and preclinical drug screenings for pediatric ependymomas. 相似文献
76.
Schuller E Jilma B Voicu V Golor G Kollaritsch H Kaltenböck A Klade C Tauber E 《Vaccine》2008,26(34):4382-4386
Japanese encephalitis (JE) is the most common viral encephalitis in Asia. IC51 is a new Vero cell-derived, inactivated JE virus vaccine with non-inferior immunogenicity (after 2 months) compared to the US-licensed vaccine JE-VAX (mouse brain-derived, inactivated) and with a more convenient (two injections instead of three) intramuscular dose schedule. Adult subjects from two studies were followed-up for comparative immunogenicity (JE-VAX) at 6 months and long-term immunogenicity of IC51 alone at 12 months. At 6 months, immunogenicity was higher with IC51 (seroconversion rate [SCR] 95%; geometric mean titer [GMT] 84) than with JE-VAX (SCR 74%; GMT 34). At 12 months, the SCR was 83% and the GMT (41) remained above the protective titer of 1:10. Most people immunized with IC51 will have protective neutralizing antibody levels for at least a year. 相似文献
77.
78.
Starting from natural raw materials, cements based calcium sulphoaluminate (CSA) clinkers have been successfully obtained as an eco-friendly alternative to ordinary Portland cement. CSA-based cements with ye’elimite as the main phase have been produced over the years and are widely used today. In this regard, the present paper considers the study of hydration processes for CSA pastes prepared with a water/cement ratio of 0.5 according to the EN-197 standard and their characterization by thermal analysis (DTA-TG), X-ray diffraction analysis (XRD), and scanning electron microscopy coupled with energy dispersive X-ray spectroscopy (SEM-EDX). A mechanical strength of 60.9 MPa was the greatest achieved for mortars hardened for 28 days. 相似文献
79.
The aim of this study is to assess the possibility to solidify/stabilize a liquid waste from a municipal waste landfill using binders based on coal ash (fly ash and bottom ash) and specially designed cements for waste treatment (INERCEM). The leaching test proved that all cementitious systems are efficient for the solidification/stabilization of the studied wastes and can reduce the leaching potential of heavy metals present in both liquid waste and coal ash. Therefore, these wastes cease to be a source of environmental pollution. X-ray diffraction (XRD) and thermal complex analysis (DTA-TG) were used to assess the nature and amount of compounds formed in these cementitious systems during the hydration and hardening processes; ettringite, calcium silicate hydrates and CaCO3 were the main compounds formed in these systems assessed by these methods. The microstructure of hardened specimens was assessed by scanning electronic microscopy (SEM); the presence of hydrate phases, at the surface of cenospheres present in fly ash, proved the high pozzolanic reactivity of this phase. 相似文献