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ID
10584
Description
AMC-052 Eligibility Checklist Segment B NCT00513526 Human Papillomavirus Vaccine Therapy in Treating Men With HIV-1 Infection Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=3BAEF387-E2CE-2E35-E044-0003BA3F9857
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Keywords
Versions (3)
- 9/19/12 9/19/12 -
- 5/28/15 5/28/15 -
- 6/3/15 6/3/15 -
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June 3, 2015
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License
Creative Commons BY-NC 3.0 Legacy
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AMC-052 Eligibility Checklist Segment B NCT00513526
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- StudyEvent: AMC-052 Eligibility Checklist Segment B
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- StudyEvent: AMC-052 Eligibility Checklist Segment B
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item
Inclusion Criteria
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C19707 (NCI Thesaurus ObjectClass-2)
C1515830 (UMLS 2011AA ObjectClass-2)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C25532 (NCI Thesaurus Property-2)
C1512693 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C0030705 (UMLS 2011AA ObjectClass)
C19707 (NCI Thesaurus ObjectClass-2)
C1515830 (UMLS 2011AA ObjectClass-2)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C25532 (NCI Thesaurus Property-2)
C1512693 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL Item
Anal Hpv Dna Pcr Result: Type 16; Positive, Negative Type 18; Positive, Negative (Anal HPV DNA PCR result: Type 16; positive, negative Type 18; positive, negative)
CL Item
Did The Participant Have A Normal Anal Cytological Results, Or Ascus/lsil Result, Within 45 Days Prior To Entry (Did the participant have a normal anal cytological results, or ASCUS/LSIL result, within 45 days prior to entry)
CL Item
Is The Participant Receiving Antiretroviral Therapy (Is the participant receiving antiretroviral therapy)
CL Item
Karnofsky Performance Status (must Be >=70 And Assessed Within 45 Or Fewer Days Prior To Entry) (Karnofsky performance status (must be >=70 and assessed within 45 or fewer days prior to entry))
CL Item
Were The Following Hematologic Parameters Met And Performed Within 45 Days Prior To Study Entry: Absolute Neutrophil Count (>750 Cells/mm^3); Hemoglobin (>=9.0 G/dl); Platelet Count (>=100,000/ Mm^3) (Were the following hematologic parameters met and performed within 45 days prior to study entry: Absolute neutrophil count (>750 cells/mm^3); Hemoglobin (>=9.0 g/dL); Platelet count (>=100,000/ mm^3))
CL Item
Were The Following Laboratory Parameters Met And Performed Within 45 Days Prior To Study Entry: Creatinine (<=3 X Uln); Ast (<=3 X Uln); Alt (<=3 X Uln); Bilirubin (total Or Direct) (<=2.5 X Uln) (Were the following laboratory parameters met and performed within 45 days prior to study entry: Creatinine (<=3 x ULN); AST (<=3 x ULN); ALT (<=3 x ULN); Bilirubin (total or direct) (<=2.5 x ULN))
CL Item
Is The Participant's Screening Cd4+ Cell Count >200 Cells/mm^3 (Is the participant's screening CD4+ cell count >200 cells/mm^3)
CL Item
Is The Participant's Screening Plasma Hiv-1 Rna Result (i.e. Viral Load) Below The Limit Of Detection (with The Lower Limit Of Detection 200 Copies Or Less) Or Detectable But < 200 Copies/ml (Is the participant's screening plasma HIV-1 RNA result (i.e. viral load) below the limit of detection (with the lower limit of detection 200 copies or less) or detectable but < 200 copies/ml)
CL Item
Has The Participant Received Antiretroviral Therapy Continuously (i.e. No Interruptions Of Antiretroviral Therapy Lasting Longer Then 7 Days) For At Least 6 Months Prior To Entry (Has the participant received antiretroviral therapy continuously (i.e. no interruptions of antiretroviral therapy lasting longer then 7 days) for at least 6 months prior to entry)
CL Item
Has The Participant's Antiretroviral Therapy Remained Unchanged In The 30 Days Prior To Entry (Has the participant's antiretroviral therapy remained unchanged in the 30 days prior to entry)
CL Item
Is The Participant's Screening Cd4+ Cell Count >=350 Cells/mm^3 (within 90 Days Prior To Entry) (Is the participant's screening CD4+ cell count >=350 cells/mm^3 (within 90 days prior to entry))
CL Item
Is The Participant Planning To Remain Off Antiretroviral Therapy Within 28 Weeks After Entry (Is the participant planning to remain off antiretroviral therapy within 28 weeks after entry)
Item
Exclusion Criteria
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C19707 (NCI Thesaurus ObjectClass-2)
C1515830 (UMLS 2011AA ObjectClass-2)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C25370 (NCI Thesaurus Property-2)
C0680251 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C0030705 (UMLS 2011AA ObjectClass)
C19707 (NCI Thesaurus ObjectClass-2)
C1515830 (UMLS 2011AA ObjectClass-2)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C25370 (NCI Thesaurus Property-2)
C0680251 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL Item
Did The Participant Have Serious Illness Requiring Systemic Treatment And/or Hospitalization Within 45 Days Prior To Entry (Did the participant have serious illness requiring systemic treatment and/or hospitalization within 45 days prior to entry)
CL Item
Does The Participant Have A History Of Anal Cytological Result With Hsil, Atypical Squamous Cells Suggestive Of Hsil, Or Suggestive Of Carcinoma (Does the participant have a history of anal cytological result with HSIL, atypical squamous cells suggestive of HSIL, or suggestive of carcinoma)
CL Item
Does The Participant Have A History Of Anal Or Perianal Carcinoma (Does the participant have a history of anal or perianal carcinoma)
CL Item
Does The Participant Have A History Of High Grade Ain (i.e. Ain 2 Or 3) Or High Grade Perianal Intraepithelial Neoplasia (Does the participant have a history of high grade AIN (i.e. AIN 2 or 3) or high grade perianal intraepithelial neoplasia)
CL Item
Does The Participant Have Active Drug Or Alcohol Use Or Dependence That, In The Opinion Of The Site Investigator, Would Interfere With Adherence To Study Requirements (Does the participant have active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements)
CL Item
Has The Participant Received Any Systemic Antineoplastic Or Immunomodulatory Treatment, Systemic Corticosteroids, Investigational Vaccines, Interleukins, Interferons, Growth Factors, Or Ivig, <=45 Days Prior To Entry (Has the participant received any systemic antineoplastic or immunomodulatory treatment, systemic corticosteroids, investigational vaccines, interleukins, interferons, growth factors, or IVIG, <=45 days prior to entry)
CL Item
Is The Participant Receiving Anticoagulation Therapy Other Than Acetylsalicylic Acid At The Time Of Entry (Is the participant receiving anticoagulation therapy other than acetylsalicylic acid at the time of entry)
KarnofskyPerformanceStatusScore
Item
Karnofsky Performance Status
text
C25367 (NCI Thesaurus Property)
C20641 (NCI Thesaurus ObjectClass)
C1518965 (UMLS 2011AA ObjectClass)
C25338 (NCI Thesaurus ValueDomain)
C0449820 (UMLS 2011AA ValueDomain)
C20641 (NCI Thesaurus ObjectClass)
C1518965 (UMLS 2011AA ObjectClass)
C25338 (NCI Thesaurus ValueDomain)
C0449820 (UMLS 2011AA ValueDomain)