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 @ 11:42 PM
Ignite Modification Date:
2025-12-24 @ 11:42 PM
NCT ID:
NCT05587751
Eligibility Criteria:
Inclusion Criteria:
* Subjects speaking any language will be offered participation.
* Subjects capable of providing informed consent to the study. For those subjects younger than 18 years old who agree to participate in the study, informed consent will be obtained from patient's parents/guardian.
* Subjects capable of performing pulmonary function test (PFT) maneuvers, as per pulmonary function test laboratory protocol.
* Patients will be enrolled through the Mayo Clinic Rochester Transgender and Intersex
* Specialty Care Clinic (TISCC), once patient has decided to undergo hormonal gender-affirming therapies (pubertal blockers, and masculinizing or feminizing hormone therapies).
Exclusion Criteria:
* Subjects unable to provide consent, or subjects who do not agree to discuss the study with their parents/guardians.
* The presence of contraindications for pulmonary function testing including (these will be reviewed at the time of recruitment and prior to each spirometry associated with the study):
* Recent surgical procedures (\<3 months) that could be affected by lung function testing, including the following categories: Abdominal surgery, Eye surgery, Thoracic surgery, Ear surgery, Brain surgery, Vascular surgery.
* The presence of previously known respiratory disorders including pulmonary embolism (\<6 months), pleural effusion, pneumothorax, hemoptysis.
* Recent myocardial infarction (\<1 month), new cardiac arrythmia (\<3 months), recent cardiac pacemaker implantation (\<3 months).
* Heart failure symptoms, significant shortness of breath, tachycardia, or angina
* The presence of chronic pulmonary diseases that maybe associated with changes in pulmonary function overtime such as asthma, chronic obstructive pulmonary disease, or interstitial lung diseases.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Study:
NCT05587751
Study Brief:
Protocol Section:
NCT05587751