Chen YM, Chen HH, Hsieh CW, Hsieh TY, Lan JL, Chen DY A close association of body cell mass loss with disease activity and disability in Chinese patients with rheumatoid arthritis. Clinics (Sao Paulo). 2011;66(7):1217-22. doi: 10.1590/s1807-5932201100070
De Luca F, Shoenfeld Y The microbiome in autoimmune diseases. Clin Exp Immunol. 2019 Jan;195(1):74-85. doi: 10.1111/cei.13158.
Fransen J, van Riel PL The Disease Activity Score and the EULAR response criteria. Rheum Dis Clin North Am. 2009 Nov;35(4):745-57, vii-viii. doi: 10.1016/j.rdc.2009.10.001.
Sciences NCIDoCCP DHQIII Diet History Questionnaire Secondary DHQIII Diet History Questionnaire https://epi.grants.cancer.gov/dhq3/.
Services USDoHaH Progress in Autoimmune Diseases and Research. National Institutes of Health: The autoimmune Diseases Coordinating Committee, 2005:1-126.
Vieira SM, Pagovich OE, Kriegel MA Diet, microbiota and autoimmune diseases. Lupus. 2014 May;23(6):518-26. doi: 10.1177/0961203313501401.
Wang L, Wang FS, Gershwin ME Human autoimmune diseases: a comprehensive update. J Intern Med. 2015 Oct;278(4):369-95. doi: 10.1111/joim.12395. Epub 2015 Jul 25.
Xu J, Yang Y Gut microbiome and its meta-omics perspectives: profound implications for cardiovascular diseases. Gut Microbes. 2021 Jan-Dec;13(1):1936379. doi: 10.1080/19490976.2021.1936379.
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.