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 @ 5:41 PM
Ignite Modification Date:
2025-12-24 @ 5:41 PM
NCT ID:
NCT02734368
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent was obtained and documented (after the investigator has given oral and written information about the study to the subject).
* The subject was conscious, co-operative, and agreed to return for the scheduled visits and tests and any visits required to obtain additional safety information.
* The subject's medical history, physical examination (including vital signs, pulse oximetry, PFT's, and 12-lead electrocardiogram \[ECG\]), and clinical laboratory tests (hematology, serum chemistry) obtained at the screening visit were within acceptable limits for entry into the study, as judged by the investigator.
Exclusion Criteria:
* Subject is \<40 or \>70 years old
* Subject known to be pregnant
* Subject with a baseline oxygen requirement \> 2 l/min via nasal cannula
* Any known contraindication to MRI examination
* Inability to provide informed consent
* A language, communication, cognitive or behavioral impairment that might interfere with fully informed consent
* Active drug or alcohol dependence
* Homelessness or other unstable living situation
* Active drug or alcohol dependence
* Significant co-morbidities such as heart disease, kidney disease, liver disease, hematologic or neurological disease that require continuing treatment.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
70 Years
Study:
NCT02734368
Study Brief:
Protocol Section:
NCT02734368