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Eval of Efficacy and Mechs of Anti-inflammatory Intervention for Mucosal Injury

Eval of Efficacy and Mechs of Anti-inflammatory Intervention for Mucosal Injury
粘膜损伤抗炎干预的疗效及机制评价
批准号:
7594631
负责人:
jane fall-dickson
金额:
$16.0万
依托单位国家:
美国
项目类别:
财政年份:
--
资助国家:
美国
项目状态:
未结题
起止时间:
至

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中文摘要
翻译
CCOP现场启动访问于2006年7月顺利完成,评价员间可靠性培训于2006年11月2日完成。CCOP于2007年被批准进行科目招聘。一名患者已被招募到位于南加州格林维尔的CCOP进行这项研究。从这位参与者那里获得了书面知情同意。患者随机接受依那西普含漱液或安慰剂,按方案给药。测量口腔炎和口咽部疼痛,并按方案采集生物样本。受试者选择在BMT+4天停止治疗。所有数据和生物样本都由NINR研究协调中心适当地收到。
英文摘要
The CCOP site initiation visit was successfully completed in July 2006, and the interrater reliability training was completed November 2, 2006. The CCOP was approved for subject recruitment in 2007. One patient has been recruited to the study at the Greenville, SC, CCOP. Written informed consent was obtained from this participant. Patient was randomized to receive either etanercept mouthwash or placebo, which was administered by protocol schedule. Stomatitis and oropharyngeal pain were measured and biological samples were collected per protocol. The subject chose to take himself off protocol on BMT day +4. All data and biological samples were received appropriately by the NINR Study Coordinating Center.
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