Traumatic Brain Injury — Test of Chamber Pressure to Divers and Chamber Attendants
Citation(s)
Clarke D Effective patient blinding during hyperbaric trials. Undersea Hyperb Med. 2009 Jan-Feb;36(1):13-7.
Jansen T, Mortensen CR, Tvede MF It is possible to perform a double-blind hyperbaric session: a double-blinded randomized trial performed on healthy volunteers. Undersea Hyperb Med. 2009 Sep-Oct;36(5):347-51.
Weaver LK, Churchill SK, Bell J, Deru K, Snow GL A blinded trial to investigate whether 'pressure-familiar' individuals can determine chamber pressure. Undersea Hyperb Med. 2012 Jul-Aug;39(4):801-5.
Weaver LK, Hopkins RO, Churchill S, Haberstock D Double-Blinding is Possible in Hyperbaric Oxygen (HBO2) Randomized Clinical Trials (RCT) Using a Minimal Chamber Pressurization as Control. Undersea Hyperb Med 1997;24(Suppl):36.
Test of Chamber Pressure to Divers and Chamber Attendants: A Blinded Trial to Investigate if "Pressure-familiar" Individuals Can Determine Pressure
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
