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 @ 1:19 PM
Ignite Modification Date:
2025-12-24 @ 1:19 PM
NCT ID:
NCT01730495
Eligibility Criteria:
Inclusion Criteria:
* chronic fatigue syndrome/ myalgic encephalomyelitis (CFS/ME)
* moderate and serious CFS/ME severity
* age 18-66 years
* informed consent
Exclusion Criteria:
* patients with fatigue, not fulfilling criteria for CFS
* pregnancy or lactation
* previous malignant disease, except basal cell carcinoma of skin and cervical carcinoma in situ
* previous long-term systemic treatment with immunosuppressive drugs such as cyclosporine, azathioprin, mycophenolate mofetil, except steroids e.g. in obstructive lunge disease.
* demyelinating disease, such as multiple sclerosis.
* heart failure.
* endogenous depression.
* lack of ability to comply to the protocol.
* multi-allergy with risk of serious drug reaction
* reduced renal function (creatinine \> 1.5 x UNL)
* reduced liver function (bilirubin or transaminases \> 1.5 x UNL)
* HIV positivity. Evidence of clinically significant infection. Previous viral hepatitis with risk of reactivation. High risk of opportunistic infections. Latent tuberculosis must be treated before inclusion.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
66 Years
Study:
NCT01730495
Study Brief:
Protocol Section:
NCT01730495