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 @ 6:45 PM
Ignite Modification Date:
2025-12-24 @ 6:45 PM
NCT ID:
NCT01182857
Eligibility Criteria:
* INCLUSION CRITERIA:
Patients:
* Patients must be enrolled on protocol 01-HG-0189 in order to be eligible for enrollment on this protocol.
* Written informed consent from adult patients, or from the parents or guardians of minor patients must be obtained. Assent must be obtained from minor children when applicable.
* Patients must be English-speaking. Not all of the study instruments have been validated in other languages, and personnel are not available with training to administer the instruments in other languages.
Parents or Guardians
* Parents must have a child enrolled on protocol 01-HG-0189 in order to be eligible for enrollment on this protocol. Guardians must have a ward enrolled on protocol 01-HG-0189 in order to be eligible for enrollment on this protocol.
* Written informed consent must be obtained from parents or guardians.
EXCLUSION CRITERIA:
* Inability to complete the study instruments. This includes inability to speak English. Not all of the study instruments have been validated in other languages, and personnel are not available to administer the test instruments in other languages.
* Judgment of the clinical investigators that participation would be detrimental to the patient, parent or guardian.
* Judgment of the clinical investigators that participation would be detrimental to the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Months
Maximum Age:
50 Years
Study:
NCT01182857
Study Brief:
Protocol Section:
NCT01182857