Emory University PD Neuroprotecion Clinical Trail Center

描述（由申请人提供）：在Emory网站，我们招募了52名受试者，没有发生重大不良事件（ae）。请参阅本文件末尾的细目，以了解细目的详情。在专注于招聘之后，我们一直在努力留住员工和遵守规定。为此，我们整合了研究访问和患者护理访问，以更好地监测安全性，制定结果措施，并提高患者的便利性，从而将其保留到一个很长的研究中。大多数受试者都在埃默里大学接受临床随访这有助于记忆。对于这20%的转诊患者，或者是除了Juncos和Freeman医生之外的Emory医生，与转诊医生的持续沟通是提高转诊率和留用率的关键。当检测到实验室异常，或认为需要改变PD药物或其他药物时，将简短的笔记转发给持久性有机污染物或转介神经科医生。这一努力以优异的留存率继续发挥作用。在上述52名受试者中，1名未通过筛查，1名死于非相关和慢性心脏原因，2名失去随访，2名因非相关医学问题和健康状况不佳退出研究。这些是研究期间的总数还有46人在这个地点进行研究。所有的SAEs都与参与研究无关。今年的两个突出的是：1)一个年轻的PD受试者有一个不明原因的晕厥发作，随后的阴性工作。他继续做得很好，并由外部心脏病专家跟进；2)停止使用肌酸后，第二名受试者计划研究住院。虽然他已经不在研究中，但我们会按照协议的规定定期对他进行随访。其他患者继续参与，无重大主诉。

DESCRIPTION (provided by applicant): At the Emory site we have enrolled 52 subjects and have had no major adverse events (AEs). Please refer to the breakdown at the end of this document for details of this breakdown. After focusing on recruitment, our efforts have been on retention and compliance. For this we have integrated research visits and patient care visits to better monitor safety, make outcome measures and to enhance patient convenience and thus retention into a very long study. Most of the subjects are followed clinically at Emory which has helped retention. For that 20% that are followed elsewhere, or by physicians at Emory other than Dr. Juncos and Freeman, consistent communication with referring physicians has been key to promoting referrals and retention. Brief notes were forwarded to POPs or referring neurologist as laboratory abnormalities were detected, or there was a perceived need to make changes in PD medications or in other medications. This effort continues to work with excellent retention. Of the 52 subjects above, 1 failed screening, 1 died of unrelated and chronic cardiac causes, 2 were lost to follow-up, 2 withdrew from the study due to unrelated medical problems and failing health. These are the totals for the duration of the study with 46 remaining in the study at this site. All are SAEs have been unrelated to participation in the study. The two salient ones this year are: 1) A young onset PD subject had an unexplained syncopal episode followed by a negative work up. He continues to do well and is followed by an outside cardiologists; 2) After stopping use of creatine, a second subject had a planned research hospitalization. Although no longer in the study, he is followed periodically by us as stipulated in the protocol. Other patient continue to participate without major complaints.