Establishing Normal Values for Neuropsychological Testing in HIV-negative Thais
研究概览
地位
条件
详细说明
The Southeast Asia Research Collaboration with Hawaii (SEARCH) operates or collaborates on several neuroAIDS research protocols. To allow accurate interpretation of neuropsychological data, normative data that are obtained in a similar population are needed. Currently, there are limited such data available for this purpose.
The SEARCH 001 study evaluated the neurocognitive changes before and after highly active antiretroviral therapy in 30 HIV positive subjects and has also enrolled 230/300 proposed HIV-negative controls for this purpose. Normative data tables typically require many more individuals so that age and education strata can be established. We now propose to enroll up to 1000 HIV-seronegative individuals for this purpose.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Bangkok、泰国、10330
- SEARCH Thailand
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Age 20-69
- Male or female
- Negative HIV antibody at screening
- Have the ability to understand the study and signed the informed consent form
Exclusion Criteria:
- Head injury with loss of consciousness greater than 1 hour
- Current or past illicit drug use or positive drug screen for amphetamine, methamphetamines, cocaine, marijuana, or narcotics
- Severe illness within 30 days prior to entry
- Current or recent fevers or meningeal signs.
- History of pre-existing neurologic disease to include stroke, multiple sclerosis or autoimmune disease.
- active major depression will be excluded as well - patients with past depression that is controlled and patients with or minor depressive symptoms will be allowed to enroll.
- Known learning disability including dyslexia
- Confusion or other signs and symptoms of metabolic encephalopathy or delirium
- Focal neurological deficit on examination
- Examining physician's concern that participant may not be able to complete visit requirements.
学习计划
研究是如何设计的?
设计细节
- 观测模型:队列
- 时间观点:预期
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
To establish normal values for neuropsychological testing in HIV negative Thais stratified by age (1 decade) and education
大体时间:July 31, 2014
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July 31, 2014
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次要结果测量
结果测量 |
大体时间 |
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To estimate the learning effect on these test at 6 months and 12 months.
大体时间:July 31, 2014
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July 31, 2014
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合作者和调查者
调查人员
- 首席研究员:Victor - Valcour, M.D.、University of Hawaii
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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