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 @ 10:58 PM
Ignite Modification Date:
2025-12-24 @ 10:58 PM
NCT ID:
NCT02154269
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of Chagas' disease confirmed by two serological tests with different methodologies;
* Diagnosis of Chagas' cardiomyopathy in NYHA functional classes II, III and IV of heart failure;
* Availability and willingness to participate, given the schedule of the study;
* Agreement and signing the written form.
Exclusion Criteria:
* Acute systemic infections
* Solid neoplasms, myelodysplastic syndrome, acute or chronic myeloid leukemia, confirmed by imaging studies or past medical history;
* Valvulopathies with hemodynamic consequences;
* Autoimmune, pulmonary, or degenerative diseases, confirmed by imaging studies or past medical history;
* Severe renal, hepatic or thyroid dysfunction, confirmed by imaging studies or past medical history;
* Pregnancy (confirmed by examination of β HCG) or lactation;
* Known hypersensitivity to G-CSF or to other components of the formula and / or hypersensitivity to proteins derived from E. coli.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
70 Years
Study:
NCT02154269
Study Brief:
Protocol Section:
NCT02154269