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 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT01306994
Eligibility Criteria:
Syndrome Group Inclusion Criteria:
* Freeman-Sheldon syndrome,
* Sheldon-Hall syndrome,
* Distal arthrogryposis type 1, or
* Distal arthrogryposis type 3
* Deceased patients with enough clinical information available to satisfy study requirements
Syndrome Group Exclusion Criteria:
* Individuals not confirmed to have a condition under study
* Deceased patients without enough clinical information available to satisfy study requirements
* Patients with other anomalies, not having one of the above syndromes
* Patients or parents of minor children not willing to give consent
* Mature female patients who are pregnant or breast-feeding will be reassessed for consideration for enrolment.
* Mature female patients who are currently experiencing menses will be reassessed for consideration for enrolment.
* Patients with active, acute comorbid illness will be reassessed for consideration for enrolment.
Control Group Inclusion Criteria:
* Subjects must be healthy and free of active disease.
* Subject or parent of minor child must be willing to give consent.
* Subjects must fall within the age-bracket to be matched with a Syndrome Group patient already screened and enroled in the study
* Subjects must be non-tobacco users and non-drinkers.
Control Group Exclusion Criteria:
* Subjects exceptional for their age in body weight, stature, or habitus according to commonly accepted guidelines
* Subjects with active psychiatric illness, as manifested by abnormal mental status examination
* Subjects with active physical illness, especially respiratory or cardiac problem, as manifested by abnormal findings on physical examination
* Subjects with significant diagnosis of a constitutional disease or genetic disorder
* Subjects with a history of severe trauma resulting in either an anatomical of physiological deformity that impairs function
* Non-living subjects
* Candidates who fail the stress test
* Mature female subjects who are pregnant or breast-feeding will be reassessed for consideration for enrolment.
* Mature female subjects who are currently experiencing menses will be reassessed for consideration for enrolment.
* Subjects with active, acute illness will be reassessed for consideration for enrolment.
* Any other condition or anomaly expected to affect current physiology listed in AFI-48-123.
Healthy Volunteers:
True
Sex:
ALL
Study:
NCT01306994
Study Brief:
Protocol Section:
NCT01306994