NL-OMON50327已完成不适用
Double blind placebo controlled randomized intervention study to validate the beneficial effect of hydrocortisone on dexamethasone-induced neurobehavioral side effects in pediatric acute lymphoblastic leukemia - DexaDays-2 study
niversitair Medisch Centrum Utrecht0 个研究点目标入组 106 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 106
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 17(—)
入选标准
- •- Written informed consent
- •- Age 3-18
- •- Histologically or cytologically confirmed acute lymphoblastic leukemia (ALL)
- •- Inclusion in DCOG ALL medium risk group protocol
- •- Able to comply with scheduled follow-up
排除标准
- •- Patient or parent refusal
- •- Anticipated compliance problems
- •- Underlying conditions which affect the absorption of oral medication
- •- Pregnant or lactating patients
- •- Current uncontrolled infection or any other complication which may interfere
- •dexamethasone treatment
- •- Language barrier
- •- Pre-existing mental retardation
- •- Current oral hydrocortisone treatment
- •- Current risperidone treatment
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