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 @ 12:04 PM
Ignite Modification Date:
2025-12-24 @ 12:04 PM
NCT ID:
NCT01501461
Eligibility Criteria:
Inclusion Criteria:
* Males and Females Age \>55.
* Frailty syndrome defined by:
BMD\< T-1 (Based on QCT results) Body Mass: males \<8% or \>17% fat, females\<10% or\>24% fat (Lean Body Mass=Total Body Mass- %Body Fat)
* Ability to participate in the short physical performance battery
* Up to date on all age and gender appropriate cancer screening per American Cancer Society
Exclusion Criteria:
* Life expectancy \< 6 months due to concomitant illnesses.
* Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study.
* Active infectious disease patients known to have tested positive for HIV, HTLV, HBV, HCV, CMV (IgM \> IgG) and/or syphilis. will have an expert consulted as to patient eligibility based on the patient's infectious status
* Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
* Patients on chronic immunosuppressive transplant therapy
* Active clinical infection being treated by antibiotics within one week of enrollment.
* Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate.
* History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years.
* Unwilling and/or not able to give written informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Maximum Age:
90 Years
Study:
NCT01501461
Study Brief:
Protocol Section:
NCT01501461