Crohn Disease — Non-invasive Approaches to Identify the Cause of Fatigue in Inflammatory Bowel Disease Patients.
Citation(s)
Artom M, Czuber-Dochan W, Sturt J, Norton C Targets for Health Interventions for Inflammatory Bowel Disease-fatigue. J Crohns Colitis. 2016 Jul;10(7):860-9. doi: 10.1093/ecco-jcc/jjw029. Epub 2016 Jan 22. Erratum In: J Crohns Colitis. 2018 Nov 15;12(11):1382.
Gandevia SC Spinal and supraspinal factors in human muscle fatigue. Physiol Rev. 2001 Oct;81(4):1725-89. doi: 10.1152/physrev.2001.81.4.1725.
Glover GH, Li TQ, Ress D Image-based method for retrospective correction of physiological motion effects in fMRI: RETROICOR. Magn Reson Med. 2000 Jul;44(1):162-7. doi: 10.1002/1522-2594(200007)44:13.0.co;2-e.
Jelsness-Jorgensen LP, Bernklev T, Henriksen M, Torp R, Moum BA Chronic fatigue is associated with impaired health-related quality of life in inflammatory bowel disease. Aliment Pharmacol Ther. 2011 Jan;33(1):106-14. doi: 10.1111/j.1365-2036.2010.04498.x. Epub 2010 Oct 25.
Marimuthu K, Murton AJ, Greenhaff PL Mechanisms regulating muscle mass during disuse atrophy and rehabilitation in humans. J Appl Physiol (1985). 2011 Feb;110(2):555-60. doi: 10.1152/japplphysiol.00962.2010. Epub 2010 Oct 28.
Murton AJ, Marimuthu K, Mallinson JE, Selby AL, Smith K, Rennie MJ, Greenhaff PL Obesity Appears to Be Associated With Altered Muscle Protein Synthetic and Breakdown Responses to Increased Nutrient Delivery in Older Men, but Not Reduced Muscle Mass or Contractile Function. Diabetes. 2015 Sep;64(9):3160-71. doi: 10.2337/db15-0021. Epub 2015 May 26.
Werkstetter KJ, Ullrich J, Schatz SB, Prell C, Koletzko B, Koletzko S Lean body mass, physical activity and quality of life in paediatric patients with inflammatory bowel disease and in healthy controls. J Crohns Colitis. 2012 Jul;6(6):665-73. doi: 10.1016/j.crohns.2011.11.017. Epub 2012 Jan 9.
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.
