Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:59 PM
Ignite Modification Date:
2025-12-24 @ 3:59 PM
NCT ID:
NCT02506192
Eligibility Criteria:
Inclusion Criteria:
* Scores moderate-severe on at least 3 out of 6 domains from the Kansas GWI Case Definition
* Deployed, (and honorably discharged), from the Kuwaiti Theater of Operation (August 2, 1990-July 31, 1991)
Exclusion Criteria:
* Hospitalization anytime since 1990 for Alcohol or Drug Dependence, Depression, or PTSD
* Known hypersensitivity to Prednisone
* Liver, (active or recent Hepatitis B or C treatment with a completion date within the past 6 months, or alcohol liver disease), or Kidney Disease (Hep B and C ok if after 6 months of treatment)
* Treated Diabetes
* Females who are Pregnant or Nursing
* Female who refuses to use an accepted method of birth control
* Exclusionary Labs: C-Reactive Protein \>25, Creatinine Clearance \<30, EFGR ≥ 30, Hgb A1-C \>7, Glucose \>120, WBC \>12, RBC \>6.2, Hematocrit \>60, Hemoglobin \<11, Platelets \<100, Liver Function Tests (2 x the upper limit of AST and ALT, 2 x the upper limit of Total Bilirubin, and Alkaline Phosphatase)
* Has Inflammatory Arthritis (RA, or Psoriatic Arthritis, Spondylitis, Polyarthritis)
* Reactive Arthritis, or IBD associated Arthritis
* Has any major inflammatory disease (acute Chronic Infections, Ulcerative Colitis, Crohn's Disease, Inflammatory lung diseases- COPD or Asthma requiring steroid treatment, Pericarditis, Vasculitis)
* Has an chronic/active infection
* Chronic use of Prednisone or Corticosteroids (occasional inhaled use of steroids acceptable)
* Active Gum Disease or Dental Infection
* Has been diagnosed with Lupus, Stroke, or Multiple Sclerosis. or any other diagnosis that produces symptoms of fatigue, cognitive impairment, or pain will be excluded based on the Kansas GWI Case definition
* Has a condition that may interfere with the ability to accurately report symptoms, (Severe Psychiatric Problems, Schizophrenia, Bipolar Disorder, Alcohol or Drug Dependence requiring hospitalization, or regular illegal drug use)
* Heart Disease (other than Hypertension), Heart Failure or Coronary Heart Disease requiring hospitalization within the past 12 months
* Cancer (other than basal cell skin cancer), requiring treatment within the past 12 months, or life expectancy of less than 1 year.
* Hospitalization within the past 3 months
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT02506192
Study Brief:
Protocol Section:
NCT02506192