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临床试验/ISRCTN01022468
ISRCTN01022468已完成未知

Hyperbaric Oxygen Radiation Tissue Injury Study - VII (Laryngeal radionecrosis)

Baromedical Research Foundation (USA)0 个研究点目标入组 42 人开始时间: 2008年10月17日最近更新:

试验速览

阶段
未知
状态
已完成
发起方
入组人数
42

研究概览

简要总结

2008 results in: https://www.ncbi.nlm.nih.gov/pubmed/18342453 [added 17/01/2019]

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • 1. Both males and females between the ages of 18 and 70 years
  • 2. Patients whose cancer treatment included radiotherapy and who have developed late radiation tissue injury, manifesting as one or more of the diagnostic criteria listed below:
  • 2.1. Endarteritis
  • 2.2. Hypocellularity
  • 2.3. Hypovascularity
  • 2.4. Vascular congestion
  • 2.3. Telangiectasis
  • 2.4. Oedema
  • 2.5. Pain
  • 2.6. Fistula
  • 2.7. Hoarseness
  • 2.8. Odyrophagia
  • 2.9. Persistent cough
  • 2.10. Airway obstruction
  • 2.11. Airway compromise
  • 2.12. Erythema
  • 2.13. Necrosis
  • 2.14. Cord motility impairment
  • 2.15. Cord fixation
  • 2.16. Tissue hypoxia

排除标准

  • 1. Pregnancy
  • 2. Reactive airway disease
  • 3. Radiographic evidence of pulmonary blebs or bullae
  • 4. Untreated pneumothorax
  • 5. Previously documented ejection fraction less than 35%
  • 6. History of seizures (except childhood febrile seizures)
  • 7. Cardiovascular instability
  • 8. Mechanical ventilator support
  • 9. Unable to follow simple commands
  • 10. Not orientated to person, place, time
  • 11. Participating as a subject in any other medical or biomedical research project (if previously involved as a subject, sufficient time must have elapsed to permit wash out of any investigational agent)

研究者

发起方
Baromedical Research Foundation (USA)

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