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:
2025-12-26 @ 5:19 PM
Ignite Modification Date:
2025-12-26 @ 5:19 PM
NCT ID:
NCT00005906
Eligibility Criteria:
* INCLUSION CRITERIA:
Patients enrolled in the lymphangioleiomyomatosis natural history protocol who have symptoms associated with one of the following:
1. lymphangioleiomyomas
2. chylous pleural effusions
3. peripheral lymph-edema
4. chyloptysis
5. protein-losing enteropathy
6. chyluria
Patients will be included in this protocol if symptoms are attributed to the above processes. Patients with malabsorption disorders, diabetes, hypo/hyperthyroidism, or other endocrine-related disorders will be included if justified clinically based on severity of symptoms.
EXCLUSION CRITERIA:
1. Hypersensitivity to somatostatin, octreotide or its analogues
2. Patients with hepatitis B, hepatitis C, or other clinically significant liver diseases
3. Transplant patients
4. Pregnant women or women who are beast-feeding
5. Patient or another responsible party is unable to give the subcutaneous injection
6. Patient unwilling to be followed per the guidelines set forth
7. Patients with decreased renal function (creatinine greater than 1.5)
8. Patients with HIV infection
9. Immunosuppressed patients
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00005906
Study Brief:
Protocol Section:
NCT00005906