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31.
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
32.
Eric Y. T. Chan Daniel K. Ng Chung-hong Chan Ka-li Kwok Pok-yu Chow Josephine M. Cheung Suk-yu Leung 《Sleep & breathing》2009,13(1):59-63
Background and objective The purpose of this study is to assess whether Chinese children with high apnea–hypopnea index (AHI) are sleepier by a modified Epworth Sleepiness Scale (ESS).
Materials and methods Records were retrospectively reviewed. We included children who were between 3 and 12 years old, admitted for overnight polysomnogram
because of suspected obstructive sleep apnea syndrome (OSAS). A modified ESS was used to assess excessive daytime sleepiness
(EDS) of the children.
Results One hundred ninety-two Chinese children were included. Children with high AHI, defined as AHI > 5.0, were sleepier than children with AHI less than or equal
to 5. After adjustment by age, gender, and obesity, children with high AHI remained significantly sleepier. Modified ESS was
significantly correlated with AHI (rho = 0.124, 95% CI = 0.004–0.281). Modified ESS score of >8 was the best cutoff point
with the sensitivity and specificity of 0.29 and 0.91, respectively. The odds ratio of children with modified ESS > 10 having
high AHI was 4.231 (95%CI = 1.248 to 14.338) and children with modified ESS > 8 had the highest odds ratio, 4.295(95%CI = 1.66
to 11.1), of having high AHI.
Conclusion
Chinese children with high AHI appear to be sleepier than children with low AHI. Children with suspected OSAS and high modified ESS,
i.e., ESS > 8, had significantly higher odds ratio of having high AHI. Increased sleepiness is a specific but not a sensitive
symptom in snoring children with high AHI. Screening for EDS in snoring children may help us identify those with high AHI
and prioritize the management of those children.
All authors worked and the study was carried out in Kwong Wah Hospital in Hong Kong. There was no conflict of interest and
no specific source of funding for the study. 相似文献
33.
Jing‐Ping Zhang Limin Zheng Jiang‐Hai Wang Karl‐Eric Magnusson Xin Liu 《Phytotherapy research : PTR》2009,23(6):844-850
Ganoderma sinensis has been used widely in Oriental countries for the prevention and treatment of various diseases including cancer. Previous studies have shown that the lipid extract from Ganoderma exhibits direct cytotoxicity against tumor cells. Here, it is reported that the lipid extract from germinating G. sinensis spores, at lower concentrations that have no direct tumoricidal activity, induce potent antitumor immune responses in human monocytes/macrophages. Upon stimulation with the lipid extract, monocytes/macrophages exhibited markedly increased production of proinflammatory cytokines and surface expression of costimulatory molecules. Conditioned medium from stimulated cells effectively suppressed the growth of tumor cells. Apparently, the lipid extract triggered macrophage activation via a mechanism different from that associated with LPS. Moreover, it was observed that the lipid extract could partially re‐establish the antitumor activity of the immunosuppressive tumor‐associated macrophages. These results indicated that in addition to its direct tumoricidal activity, the lipid extract from G. sinensis spores could exert antitumor activity by stimulating the activation of human monocytes/macrophages. Copyright © 2008 John Wiley & Sons, Ltd. 相似文献
34.
35.
A serotonin (5-HT)-mediated phosphoinositide hydrolysis response was characterized in fibroblasts cultured from rabbit choroid plexus. 5-HT elicited a maximum 8-fold increase in [3H]inositol-phosphate ([3H]IP) formation, while the partial agonists, (+)-lysergic acid diethylamide and (−)-1-(4-bromo-2,5-dimethyoxyphenyl)-2-aminopropane caused 2- and 5-fold increases, respectively. Mianserin, ketanserin, and spiperone were equipotent at blocking the 5-HT-mediated response. Thus, agonist and antagonist profiles indicate interactions with 5-HT2 receptors. 相似文献
36.
Edbert B Hsu Tamara L Thomas Eric B Bass Dianne Whyne Gabor D Kelen Gary B Green 《BMC medical education》2006,6(1):19-9
Background
Although training and education have long been accepted as integral to disaster preparedness, many currently taught practices are neither evidence-based nor standardized. The need for effective evidence-based disaster training of healthcare staff at all levels, including the development of standards and guidelines for training in the multi-disciplinary health response to major events, has been designated by the disaster response community as a high priority. We describe the application of systematic evidence-based consensus building methods to derive educational competencies and objectives in criteria-based preparedness and response relevant to all hospital healthcare workers. 相似文献37.
38.
39.
Brigitte Belmont Eric Plaisance Aliette Vérillon 《ALTER. European Journal of Disability research, Journal europeen de recherche sur le handicap》2009,3(4):320-339
Coinciding with the present period of unemployment, a corps of school assistants – assistants de vie scolaire (AVS) – has been created in order to meet the demand for in-school assistance raised by the development of schooling for children with special needs. This paper reports on a questionnaire-based survey carried out among 151 AVS working in the Seine Saint-Denis department. It aims at describing their working conditions considering the precariousness of their status (temporary jobs, poor pay) and the nature of their assignment. The main question bears on whether these conditions enable the assistants to develop the capabilities necessary for dealing with their tasks. Results could contribute to the present issue of reorienting government action in order to improve these jobs in terms of professional development. Notably, they reveal that AVS's training is usually brief and that their opportunities for developing workplace professional relationships are scant even though these are needed for them to collaborate with the other workers concerned by schooling children with special needs. 相似文献
40.
Mao-Sheng Ran Meng-Ze Xiang Jie Li Jian Huang Eric Yu-Hai Chen Cecilia Lai-Wan Chan Yeates Conwell 《Archives of Suicide Research》2007,11(1):119-127
The aim of this study was to compare the demographic and clinical characteristics of individuals with affective disorders who had attempted suicide at some time in their lives and those who had not made a suicide attempt. In a Chinese rural community, individuals with suicide attempt (N = 30) and those without suicide attempt (N = 166) were assessed with Present State Examination (PSE). Attempters had a significantly higher level of family economic status, higher rate of lifetime depressed mood and hopelessness, and delusions than nonattempters. The logistic regression models also indicated that depressed mood and hopelessness were the most important predictors of suicide attempts. No significant difference in treatment condition was found between attempters and non-attempters. Early identification and interventions focusing on reducing depressed mood, hopelessness, and controlling psychotic symptoms may be helpful in reducing the risk of suicide attempts among individuals with affective disorders residing in the community. 相似文献