EUCTR2017-003705-17-NL进行中（未招募）1 期
Prevention of neuropsychiatric adverse effects caused by dexamethasone: translational insights from a placebo-controlled trial with hydrocortisone. - DEXA-CORT
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- MC
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Cranial glioma, meningioma or brain metastasis scheduled to undergo surgery (resection)
- •Minimal dose of peri-operative cumulative dexamethasone exposure of 24mg or more in 6 days
- •Good clinical condition; KPS = 70 (see attachments 1)
- •Life expectancy = 6 months
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 130
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •Non-native speakers of Dutch or insufficient command of the Dutch language
- •Patients that are unable to overview consequences of trial participation
- •Patients with aphasia
- •Patients that are not able to fill in the questionnaires because of cognitive impairments at the discretion of the physician
- •Patients with psychiatric diseases or neurological deficits that interfere with the study to the judgement of treating physician
研究者
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