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:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT02405533
Eligibility Criteria:
Inclusion Criteria:
* • Women over 30 years of age who have a HPV positive test and normal/negative cytology, atypical cells, ASCUS, or CIN1 or CIN2 cervical dysplasia within three months of study entry.
* Women must have had 2 other HPV positive tests with normal/negative cytology, atypical cells, ASCUS, or CIN1 or CIN2 cervical dysplasia
* 1 greater than 6 months and no more than 18 months prior to study entry
* 1 greater than 24 months prior to study entry.
* Women of child bearing potential must have a negative urine pregnancy test within 7 days of therapy start.
* Patients must have adequate hematologic, renal, and hepatic function as noted from labs within the previous 12 months: ANC \>/= 1,500 cells/mm3, platelets 100,000 \>/= cells/mm3; Creatinine clearance\>/= 60 mL/min (estimated by Cockcroft Gault equation), total bilirubin, SGPT, SGOT, and alkaline phosphatase \</= 1.5 times normal.
* Patients of child-bearing age must agree to use effective methods of contraception (oral contraceptives, condoms, etc.) while on study.
Exclusion Criteria:
* • History of myocardial infarction within past 6 months, unstable angina, CHF, or uncontrolled hypertension (\> 140/90).
* Women with a current or prior diagnosis of cancer
* Women with a current diagnosis of CIN3 cervical dysplasia
* Women that are pregnant or breast feeding.
* Women with a history of Hepatitis (autoimmune, A, B, or C) or antigen positive
* Patients with history of significant psychiatric disorders (schizophrenia, bipolar, psychosis) or uncontrolled seizures.
* Patients with significant medical co-morbidities at the discretion of the primary Gynecologist. Including immunosuppressive conditions (i.e. HIV+, rheumatoid arthritis, etc) or taking immune modulation mediations (i.e. immunosuppressants)
* Women that have taken AHCC within the past six months.
* Women currently taking other immune modulating nutritional supplements.
* Patients who have undergone a hysterectomy (supracervical hysterectomy allowed)
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
30 Years
Study:
NCT02405533
Study Brief:
Protocol Section:
NCT02405533