EUCTR2005-005226-31-GB进行中（未招募）1 期
TIME 1 The First Therapeutic Intervention in Malignant Pleural Effusion Trial (TIME1) A 2 x 2 randomised factorial trial to assess whether non-steroidal anti-inflammatory analgesics and small bore chest tubes are less painful than opiate analgesics and large bore chest tubes in pleurodesis for malignant pleural effusion. - TIME 1
niversity of Oxford, Nuffield Department of Medicine0 个研究点目标入组 320 人开始时间: 2005年12月12日最近更新:
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相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 320
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
入选标准
- •Inclusion Criteria:
- •1. Clinically confident diagnosis of malignant pleural effusion requiring pleurodesis. The diagnosis may be established by:
- •a) Histologically proven pleural malignancy
- •b) Typical features of pleural malignancy seen on direct vision during thoracoscopy
- •c) Pleural effusion in the context of histologically proven cancer elsewhere
- •2. Written informed consent
- •3. Expected survival more than 1 month
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Age < 18 years
- •2. Primary lymphoma or small cell lung carcinoma
- •3. Patients who are pregnant or lactating
- •4. Inability to give informed consent
- •5. History of gastrointestinal bleeding or of untreated peptic ulceration
- •6. Known sensitivity to Non-steroidal anti-inflammatory drugs (NSAIDs) / opiates
- •7. Hypercapnic respiratory failure
- •8. Known intravenous drug abuse
- •9. Severe renal or liver disease
- •10. Known bleeding diathesis
- •11. Warfarin therapy
研究者
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