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41.
Maria Stella Aniello Davide Martino Gianluca Masi Paolo Livrea Giovanni Defazio 《Movement disorders》2006,21(4):571-575
We developed a self-administered questionnaire for screening the most common adult-onset dystonias. It was tested in 90 first-degree relatives of 22 adult-onset dystonia patients, yielding 79% sensitivity and 94% specificity. Simulation of a case-finding procedure based on serial application of the questionnaire and clinical examination of both subjects screening positive and subjects screening negative who had < 8 years of schooling increased sensitivity to 95% and specificity to 100%. This questionnaire may be an important screening resource for familial aggregation studies to be used in the context of a complex case-finding procedure. 相似文献
42.
S. V. Terent’eva E. N. Komarova T. N. Sapozhnikova A. T. Teplyakov E. A. Ivanovskaya T. I. Andreeva 《Pharmaceutical Chemistry Journal》2006,40(12):694-696
A rapid procedure for determining angiotensin II in the blood by inverse voltammetry using a TA-2 device (Tekhnoanalit Company,
Tomsk) with a graphite electrode has been developed. The results of analyses using the proposed technique agree with the clinical
data. The rapid analytical procedure favors optimization of cardiotropic drug therapy.
__________
Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 40, No. 12, pp. 54–56, December, 2006. 相似文献
43.
Six patients who injured their wrists had radiographs documenting a dorsal, 5- to 10-mm oblong fragment of bone immediately proximal to the base of the fourth and/or fifth metacarpal bones. The fragment was seen on the pronation oblique and/or lateral projections, but not on the posteroanterior projection. The radiographic appearance of the fragment was remarkably similar in all cases. In the one patient in which it was performed, pluridirectional tomography demonstrated that the fragment originated from the dorsal surface of the hamate. Five of the six patients also had associated posterior dislocation of the fourth and/or fifth metacarpals. We conclude that this fragment represents a coronal fracture through the body of the hamate resulting from posterior dislocation or subluxation of the fourth and/or fifth metacarpal. 相似文献
44.
45.
Tiziano Curti MD Gianandrea Pasquinelli MD Paola Preda BS Antonio Freyrie MD Renzo Laschi MD Massimo D’Addato MD 《Annals of vascular surgery》1989,3(4):351-363
Human adult endothelial cells were enzymatically harvested from adipose tissue. Cell viability was established by Trypan blue exclusion and transmission and scanning electron microscopy. Endothelial cells were identified by immunocytochemical investigation at light microscopy, transmission electron microscopy, and scanning electron microscopy. Isolated cells were positive for actin and vimentin, negative for desmin. Factor VIII RA was mainly expressed at cell surface and occasionally disclosed in the cytoplasm. Reactivity for UEA I and J15 was weak or undetectable. Human endothelial cells were seeded and left to adhere for one hour onto different nonvascular substrates (glass, poly-l-lysine, formvar-carbon, fibronectin, Teflon). Scanning electron microscopy defined surface features, suggesting tenacious cell adhesion on the substrate. Different vascular substrates were tested (preclotted Dacron, albumin Dacron, Hemashield Dacron, Gelseal Dacron, ePTFE, fibronectin-ePTFE). Commercially available coated grafts showed qualitative and quantitative differences in cell adhesion. In particular, Gelseal Dacron provided the best quantitative results, even though a wide variability was observed. In contrast, fibronectin-coated ePTFE gave more reliable results and high spreading efficiency. In the short term, coated grafts do not seem to offer greater advantages than fibronectin-coated ePTFE. However, specific incubation times for each coated graft should be selected and the long-term approach (graft culture) should also be attempted. 相似文献
46.
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48.
Leslee J. Shaw Romalisa Miranda-Peats Piotr Slomka John Friedman Sean W. Hayes Daniel S. Berman Gary V. Heller Marcin Dada William E. Boden Paul Casperson Robert A. O’Rourke Ronald Schwartz William S. Weintraub David J. Maron Spencer King Koon Teo Pamela Hartigan 《Journal of nuclear cardiology》2006,13(5):685-698
Background Stress gated myocardial perfusion single photon emission computed tomography (gSPECT) is increasingly used before and after
intercurrent therapeutic intervention and is the basis for ongoing evaluation in the Department of Veterans Affairs clinical
outcomes utilizing revascularization and aggressive drug evaluation (COURAGE) trial.
Methods and Results The COURAGE trial is a North American multicenter randomized clinical trial that enrolled 2287 patients to aggressive medical
therapy vs percutaneous coronary intervention plus aggressive medical therapy. Three COURAGE nuclear substudies have been
designed. The goals of substudy 0 are to examine the diagnostic accuracy of the extent and severity of inducible ischemia
at baseline in COURAGE patients compared with patient symptoms and quantitative coronary angiography and to explore the relationship
between inducible ischemia and the benefit from revascularization when added to medical therapy. Substudy 1 will correlate
the extent and severity of provocative ischemia with the frequency, quality, and instability of recurrent symptoms in postcatheterization
patients. Substudy 2 (n _ 300) will examine the usefulness of sequential gSPECT monitoring 6 to 18 months after therapeutic
intervention. Together, these nuclear substudies will evaluate the role of gSPECT to determine the effectiveness of aggressive
risk-factor modifications, lifestyle interventions, and anti-ischemic medical therapies with or without revascularization
in reducing patients’ ischemic burdens.
Conclusions The unfolding of evidence on the application of gSPECT in trials such as COURAGE defines a new era for nuclear cardiology.
We hope the evidence that emerges from the COURAGE trial will further establish the role of nuclear imaging in the evidence-based
management of patients with stable coronary disease.
The COURAGE trial was supported by the Cooperative Studies Program of the Department of Veterans Affairs Office of Research
and Development in collaboration with the Canadian Institutes of Health Research. Unrestricted research grants were obtained
from Merck & Co; Pfizer Pharmaceuticals; Bristol-Myers Squibb Medical Imaging; Astellas Pharma; Kos Pharmaceuticals; Data
Scope; Astra Zeneca Pharmaceuticals; Astra-Zeneca-Canada; Schering-Plough Coorporation, Ltd; Sanofi-Aventis, Inc; First Horizon;
and GE Healthcare. All industrial funding for this trial was directed through the Department of Veterans Affairs. Additional
funding for this substudy was provided by grants to the Department of Veterans Affairs and Canadian Institutes of Health Research
from Astellas Pharma and Bristol-Myers-Squibb Medical Imaging. 相似文献
49.
50.
FDA’S Perspectives on Cardiovascular Devices 总被引:1,自引:0,他引:1
Eric A. Chen Sonna M. Patel-Raman Kathryn O’Callaghan Matthew G. Hillebrenner 《Journal of cardiovascular translational research》2009,2(2):143-146
The Food and Drug Administration (FDA) decision process for approving or clearing medical devices is often determined by a
review of robust clinical data and extensive preclinical testing of the device. The mission statement for the Center for Devices
and Radiological Health (CDRH) is to review the information provided by manufacturers so that it can promote and protect the
health of the public by ensuring the safety and effectiveness of medical devices deemed appropriate for human use (Food, Drug
& Cosmetic Act, §903(b)(1, 2(C)), December 31, 2004; accessed December 17, 2008 ). For high-risk devices, such as ventricular assist devices (VADs), mechanical heart valves, stents, cardiac resynchronization
therapy (CRT) devices, pacemakers, and defibrillators, the determination is based on FDA’s review of extensive preclinical
bench and animal testing followed by use of the device in a clinical trial in humans. These clinical trials allow the manufacturer
to evaluate a device in the intended use population. FDA reviews the data from the clinical trial to determine if the device
performed as predicted and the clinical benefits outweigh the risks. This article reviews the regulatory framework for different
marketing applications related to cardiovascular devices and describes the process of obtaining approval to study a cardiovascular
device in a U.S. clinical trial. 相似文献