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16 Hyperbaric Oxygenation Therapy KCE Reports 74 Table 5. RCTs in NIH clinical trials database Name End date Sponsor Enrolment Pilot Study of the Effect of Hyperbaric Oxygen Treatment on Behavioral and Biomarker Measures in Children With Autism sep/08 University of California, Davis Enrolling by invitation Effects of Hyperbaric Oxygen Therapy in Autistic Children: A Pilot Study not stated International Hyperbarics Association Completed Hyperbaric Oxygen, Oxidative Stress, NO Bioavailability and Tissue Oxygenation sep/05 Assaf-Harofeh Medical Center Completed Study to Determine if Hyperbaric Oxygen Therapy is Helpful for Treating Radiation Tissue Injuries aug/10 Baromedical Research Foundation Wright State University; Recruiting An Evaluation of Hyperbaric Treatments for Children With Cerebral Palsy feb/09 Department of Defense; Children's Medical Center of Dayton; Kettering Medical Center Network Baromedical Research Recruiting Dose Escalation Study of Hyperbaric Oxygen Foundation; Palmetto Health With Radiation and Chemotherapy to Treat Squamous Cell Carcinoma of the Head and jul/08 Richland; Mayo Clinic; Dartmouth-Hitchcock Medical Recruiting Neck Center; Eastern Virginia Medical School One vs. Three Hyperbaric Oxygen Treatments for Acute Carbon Monoxide Poisoning may/09 Intermountain Health Care, Inc.; Deseret Foundation Recruiting A Controlled Trial of the Clinical Effects of Hyperbaric Therapy in Autistic Children mar/07 International Hyperbarics Association Completed Is it Possible to Treat Cyanide Poisoning With HBO? nov/06 Rigshospitalet, Denmark Recruiting Effects of Hyperbaric Oxygen Therapy on Children With Autism sep/07 Thoughtful House Recruiting Efficacy of Hyperbaric Oxygen Therapy in Laryngectomy Patients aug/05 National Center for Complementary and Alternative Medicine (NCCAM) Completed Hyperbaric Oxygen Therapy and Angiogenesis in Diabetic Patients With Foot Ulcers not stated Assaf-Harofeh Medical Center Recruiting Hyperbaric Oxygen Treatment in Patients With White Matter Hyperintensities jul/09 St. Luke's Hospital, Chesterfield, Missouri; Washington University School of Medicine Recruiting Effects of Hyperbaric Oxygenation Therapy on Adaptive, Aberrant and Stereotyped Behaviors in Children With Autism dec/07 The Center for Autism and Related Disorders; The International Child Development Resource Center Recruiting Hyperbaric Therapy and Deep Chemical Peeling jul/07 Assaf-Harofeh Medical Center Recruiting Hyperbaric Oxygen in Lower Leg Trauma jun/10 Bayside Health Recruiting Effect of Hyperbaric Therapy on Markers of Oxidative Stress in Children With Autism Hyperbaric Oxygen Therapy Compared With feb/06 The International Child Development Resource Center Recruiting Standard Therapy in Treating Chronic Arm Lymphedema in Patients Who Have Undergone Radiation Therapy for Cancer Randomized Controlled Trial of Hyperbaric not stated Institute of Cancer Research, United Kingdom Active, not recruiting Oxygen in Patients Who Have Taken Bisphosphonates dec/10 Duke University Recruiting Comparison Between Different Types of Oxygen Treatment Following Traumatic Brain Injury nov/08 Minneapolis Medical Research Foundation Recruiting Hyperbaric Oxygen Therapy in Treating Patients With Radiation Necrosis of the Brain Jun/05 Barrett Cancer Center; National Cancer Institute (NCI) Active, not recruiting Radiation Therapy Plus Hyperbaric Oxygen in Treating Patients With Newly Diagnosed not stated Barrett Cancer Center Active, not recruiting
KCE Reports 74 Hyperbaric Oxygenation Therapy 17 Glioblastoma Multiforme Slowing the Degenerative Process, Long Lasting Effect of Hyperbaric Oxygen Therapy in Retinitis Pigmentosa Effect of Body Mass Index on the Dose of Intrathecal Hyperbaric Bupivacaine for Elective Cesarean Section Effect of Repeated Exposures to Compressed Air on Patients With AIDS Can Erythopoietin Protect the Cerebral Blood Flow and Oxygenation During Simulated Dive? Effects of Mild Hypobaric Hypoxia on Sleep and Post-Sleep Performance The Evaluation of OrCel for the Treatment of Venous Ulcers The Use of Pentoxifylline and Vitamin E in the Treatment of Late Radiation Related Injuries not stated Azienda Policlinico Umberto I Completed dec/07 not stated Samuel Lunenfeld Research Institute, Mount Sinai Hospital Designed Altobaric Non- Atmospheric Environmental Technology Recruiting Suspended jan/07 Rigshospitalet, Denmark Recruiting aug/07 Oklahoma State University Center for Health Sciences; The Boeing Company not stated Ortec International not stated University Health Network, Toronto; Princess Margaret Hospital, Canada Active, not recruiting Active, not recruiting Recruiting A Study of the Safety and Efficacy of a New Treatment for Diabetic Macular Edema jun/14 Allergan National Center for Complementary and Alternative Recruiting Trial to Assess Chelation Therapy (TACT) jul/09 Medicine (NCCAM); National Heart, Lung, and Blood Institute (NHLBI) Recruiting Source: NIH Clinical Trials database (www.clinicaltrials.gov) For the evaluation of the effectiveness of HBOT for different indications we have chosen to use the most recent systematic reviews and HTAs available. Where available, we also include results from the more recent RCTs not yet included in those systematic reviews. 3.4 EVIDENCE FOR SPECIFIC INDICATIONS The specific data sources used are listed in more detail and by indication in the appendix. 3.4.1 Carbon Monoxide (CO) intoxication 3.4.1.1 Short description of the condition Carbon monoxide (CO) is a gas generated during incomplete combustion of carbonbased (fossil) fuels such as coal. It is a colourless and odourless gas and CO intoxication is an important source of accidental or intentional intoxication worldwide and has a high mortality rate. The affinity of CO to bind to haemoglobin (but also to intra- and extracellular haeme-containing proteins), is much greater than that of oxygen, forming carboxy-haemoglobin (COHb) thereby decreasing the ability of the oxygen-carrying capacity of blood in addition to other important pathophysiological mechanisms. Injuries caused by CO have been viewed as mainly due to hypoxic stress mediated through an elevated carboxy-haemoglobin level, but recent investigations have established that systemic oxidative stress can arise from exposure to CO and cause perivascular and neuronal reperfusion injury. 8 The two most vulnerable organs are the brain and the heart.
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KCE reports 33 Effects and costs of
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