ID

11262

Descripción

AMC Clinical Trials - Eligibility Form for Protocol #038 - PR3801 NCT00075777 Valproic Acid in Treating Patients With Kaposi's Sarcoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=DB418191-47FB-4C91-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=DB418191-47FB-4C91-E034-0003BA12F5E7

Palabras clave

Versiones (3)
  1. 19/9/12 19/9/12 -
  2. 9/1/15 9/1/15 - Martin Dugas
  3. 27/6/15 27/6/15 -
Subido en

27 de junio de 2015

DOI

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Licencia

Creative Commons BY-NC 3.0 Legacy
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AMC Clinical Trials - Eligibility Form for Protocol #038 - PR3801 NCT00075777

Inglés

No Instruction available.

1 formularios  
  1. StudyEvent: AMC Clinical Trials - Eligibility Form for Protocol #038 - PR3801
    1. No Instruction available.
Eligibility Assessment
Descripción

Eligibility Assessment

Patient Initials
Descripción

Patient Initials

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Patient Study ID
Descripción

Patient Study ID

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25462
NCI Thesaurus Property-2
C25364
Date of Assessment
Descripción

Dateofassessment

Tipo de datos

text

Does the patient have serologic documentation of HIV infection any time prior to study entry, as evidenced by positive ELISA, positive Western Blot, or viral load determination?
Descripción

TransplantPatientHumanImmunodeficiencyVirusAntibodyInd-3

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass-2
C12981
UMLS 2011AA ObjectClass-2
C0332835
NCI Thesaurus Property
C14219
UMLS 2011AA Property
C0019682
NCI Thesaurus Property-2
C16295
UMLS 2011AA Property-2
C0003241
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
the patient's life expectancy >= 3 months?
Descripción

PatientLifeExpectancyEligibilityDeterminationInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C37987
UMLS 2011AA Property
C0376558
NCI Thesaurus Property-2
C25171
UMLS 2011AA Property-2
C0013893
NCI Thesaurus Property-3
C25359
UMLS 2011AA Property-3
C0679138
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Is the patient age 18 or older?
Descripción

PatientAge18YearsIndicator

Tipo de datos

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Does the patient have biopsy proven KS involving the skin and /or lymph nodes, HIV related, not requiring systemic treatment (radiation or chemotherapy) less than 2 weeks before enrollment?
Descripción

DoesthepatienthavebiopsyprovenKSinvolvingtheskinand/orlymphnodes,HIVrelated,notrequiringsystemictreatment(radiationorchemotherapy)lessthan2weeksbeforeenrollment?

Tipo de datos

boolean

Is the patient's baseline Karnofsky performance status >= 60%?
Descripción

Isthepatient'sbaselineKarnofskyperformancestatus>=60%?

Tipo de datos

boolean

Is the patient's hemoglobin >= 8 g/dl within 14 days of study entry?
Descripción

Isthepatient'shemoglobin>=8g/dlwithin14daysofstudyentry?

Tipo de datos

boolean

Is the patient's absolute neutrophil count >= 750 cells/ mm and platelets >=5,000 cells/mm within 14 days of study entry?
Descripción

Isthepatient'sabsoluteneutrophilcount>=750cells/mmandplatelets >=5,000cells/mmwithin14daysofstudyentry?

Tipo de datos

boolean

Is the patient's serum creatinine < 1.5 times the upper limit of normal within 14 days of study entry?
Descripción

Isthepatient'sserumcreatinine<1.5timestheupperlimitofnormalwithin14daysofstudyentry?

Tipo de datos

boolean

Is the patient's total bilirubin <=1.5x ULN within 14 days of study entry? If not, is the patient's total bilirubin <= 3.5 mg/dl with a normal direct bilirubin, and is the elevated bilirubin thought to be secondary to Indinavir therapy?
Descripción

Isthepatient'stotalbilirubin<=1.5xULNwithin14daysofstudyentry? Ifnot,isthepatient'stotalbilirubin<=3.5mg/dlwithanormaldirect bilirubin,andistheelevatedbilirubinthoughttobesecondarytoIndinavirtherapy?

Tipo de datos

boolean

Are the patient's AST (SGOT) and ALT (SGPT) <= 3 x the upper limit of normal within 14 days of study entry ?
Descripción

Arethepatient'sAST(SGOT)andALT(SGPT)<=3xtheupperlimitofnormalwithin14daysofstudyentry?

Tipo de datos

boolean

Is the patient's albumin > 2.5?
Descripción

Isthepatient'salbumin>2.5?

Tipo de datos

boolean

Does the patient have the ability and willingness to give informed consent ?
Descripción

Doesthepatienthavetheabilityandwillingnesstogiveinformed consent?

Tipo de datos

boolean

If the patient is a female capable of childbearing, has she had a negative serum beta-HCG within 72 hours prior to study entry?
Descripción

Ifthepatientisafemalecapableofchildbearing,hasshehada negativeserumbeta-HCGwithin72hourspriortostudyentry?

Tipo de datos

text

If the patient is a female capable of childbearing , does she agree to practice adequate birth control to prevent pregnancy while receiving treatment and for three months after treatment is discontinued?
Descripción

Ifthepatientisafemalecapableofchildbearing,doessheagree topracticeadequatebirthcontroltopreventpregnancywhile receivingtreatmentandforthreemonthsaftertreatmentis discontinued?

Tipo de datos

text

If the patient is a male of child fathering potential, does he agree to practice adequate birth control?
Descripción

Ifthepatientisamaleofchildfatheringpotential,doesheagreetopracticeadequatebirthcontrol?

Tipo de datos

text

Is the patient capable of complying with the protocol?
Descripción

Isthepatientcapableofcomplyingwiththeprotocol?

Tipo de datos

boolean

If the patient is receiving antiretroviral therapy, has the patient been on a stable regimen for at least 4 weeks prior to study entry? Patients may receive any FDA approved antiretroviral therapy or agents available through a treatment IND, except regime
Descripción

Ifthepatientisreceivingantiretroviraltherapy,hasthepatientbeenonastableregimenforatleast4weekspriortostudyentry?PatientsmayreceiveanyFDAapprovedantiretroviraltherapyoragentsavailablethroughatreatmentIND,exceptregime

Tipo de datos

boolean

Has the patient had a concurrent, acute, active opportunistic infection other than oral thrush or genital herpes within 14 days of enrollment?
Descripción

Hasthepatienthadaconcurrent,acute,activeopportunisticinfection otherthanoralthrushorgenitalherpeswithin14daysofenrollment?

Tipo de datos

boolean

Does the patient have visceral Kaposi's Sarcoma?
Descripción

DoesthepatienthavevisceralKaposi'sSarcoma?

Tipo de datos

boolean

Does the patient have oral Kaposi's sarcoma as the only site of disease?
Descripción

DoesthepatienthaveoralKaposi'ssarcomaastheonlysiteofdisease?

Tipo de datos

boolean

Does the patient have a concurrent neoplasm requiring cytotoxic therapy?
Descripción

Doesthepatienthaveaconcurrentneoplasmrequiringcytotoxictherapy?

Tipo de datos

boolean

Has the patient had anti-neoplastic treatment for Kaposi's Sarcoma (including chemotherapy, radiation therapy, local therapy, biological therapy, or investigational therapy) within two weeks of study entry?
Descripción

Hasthepatienthadanti-neoplastictreatmentforKaposi'sSarcoma (includingchemotherapy,radiationtherapy,localtherapy,biological therapy,orinvestigationaltherapy)withintwoweeksofstudyentry?

Tipo de datos

boolean

Has the patient had previous local therapy of any KS-marker lesion within 60 days (Exception: the lesion has clearly progressed since treatment)?
Descripción

HasthepatienthadpreviouslocaltherapyofanyKS-markerlesion within60days(Exception:thelesionhasclearlyprogressedsince treatment)?

Tipo de datos

boolean

Has the patient used investigational agents other than antiretroviral drugs available under expanded access or compassionate use protocols?
Descripción

Hasthepatientusedinvestigationalagentsotherthanantiretroviral drugsavailableunderexpandedaccessorcompassionateuseprotocols?

Tipo de datos

boolean

Does the patient have a history of valproic acid or valproate use in the previous year?
Descripción

Doesthepatienthaveahistoryofvalproicacidorvalproateuseinthe previousyear?

Tipo de datos

boolean

Does the patient have evidence of a prior MI or cardiac ischemia?
Descripción

DoesthepatienthaveevidenceofapriorMIorcardiacischemia?

Tipo de datos

boolean

Is the patient using AZT ?
Descripción

IsthepatientusingAZT?

Tipo de datos

boolean

Does the patient have a history of lactic acidosis greater than 2 mmoles / liter?
Descripción

Doesthepatienthaveahistoryoflacticacidosisgreaterthan 2mmoles/liter?

Tipo de datos

boolean

Does the patient have a history of lipoatrophy or hypercholesterolemia secondary to retroviral treatment?
Descripción

Doesthepatienthaveahistoryoflipoatrophyorhypercholesterolemia secondarytoretroviraltreatment?

Tipo de datos

boolean

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Similar models

No Instruction available.

1 formularios
  1. StudyEvent: AMC Clinical Trials - Eligibility Form for Protocol #038 - PR3801
    1. No Instruction available.
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Eligibility Assessment
Patient Initials
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Patient Study ID
Item
Patient Study ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25462 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Dateofassessment
Item
Date of Assessment
text
TransplantPatientHumanImmunodeficiencyVirusAntibodyInd-3
Item
Does the patient have serologic documentation of HIV infection any time prior to study entry, as evidenced by positive ELISA, positive Western Blot, or viral load determination?
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C12981 (NCI Thesaurus ObjectClass-2)
C0332835 (UMLS 2011AA ObjectClass-2)
C14219 (NCI Thesaurus Property)
C0019682 (UMLS 2011AA Property)
C16295 (NCI Thesaurus Property-2)
C0003241 (UMLS 2011AA Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
PatientLifeExpectancyEligibilityDeterminationInd-2
Item
the patient's life expectancy >= 3 months?
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C37987 (NCI Thesaurus Property)
C0376558 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
C25359 (NCI Thesaurus Property-3)
C0679138 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientAge18YearsIndicator
Item
Is the patient age 18 or older?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
DoesthepatienthavebiopsyprovenKSinvolvingtheskinand/orlymphnodes,HIVrelated,notrequiringsystemictreatment(radiationorchemotherapy)lessthan2weeksbeforeenrollment?
Item
Does the patient have biopsy proven KS involving the skin and /or lymph nodes, HIV related, not requiring systemic treatment (radiation or chemotherapy) less than 2 weeks before enrollment?
boolean
Isthepatient'sbaselineKarnofskyperformancestatus>=60%?
Item
Is the patient's baseline Karnofsky performance status >= 60%?
boolean
Isthepatient'shemoglobin>=8g/dlwithin14daysofstudyentry?
Item
Is the patient's hemoglobin >= 8 g/dl within 14 days of study entry?
boolean
Isthepatient'sabsoluteneutrophilcount>=750cells/mmandplatelets >=5,000cells/mmwithin14daysofstudyentry?
Item
Is the patient's absolute neutrophil count >= 750 cells/ mm and platelets >=5,000 cells/mm within 14 days of study entry?
boolean
Isthepatient'sserumcreatinine<1.5timestheupperlimitofnormalwithin14daysofstudyentry?
Item
Is the patient's serum creatinine < 1.5 times the upper limit of normal within 14 days of study entry?
boolean
Isthepatient'stotalbilirubin<=1.5xULNwithin14daysofstudyentry? Ifnot,isthepatient'stotalbilirubin<=3.5mg/dlwithanormaldirect bilirubin,andistheelevatedbilirubinthoughttobesecondarytoIndinavirtherapy?
Item
Is the patient's total bilirubin <=1.5x ULN within 14 days of study entry? If not, is the patient's total bilirubin <= 3.5 mg/dl with a normal direct bilirubin, and is the elevated bilirubin thought to be secondary to Indinavir therapy?
boolean
Arethepatient'sAST(SGOT)andALT(SGPT)<=3xtheupperlimitofnormalwithin14daysofstudyentry?
Item
Are the patient's AST (SGOT) and ALT (SGPT) <= 3 x the upper limit of normal within 14 days of study entry ?
boolean
Isthepatient'salbumin>2.5?
Item
Is the patient's albumin > 2.5?
boolean
Doesthepatienthavetheabilityandwillingnesstogiveinformed consent?
Item
Does the patient have the ability and willingness to give informed consent ?
boolean
Item
If the patient is a female capable of childbearing, has she had a negative serum beta-HCG within 72 hours prior to study entry?
text
CL.13
Code List
If the patient is a female capable of childbearing, has she had a negative serum beta-HCG within 72 hours prior to study entry?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
N/A (N/A)
Item
If the patient is a female capable of childbearing , does she agree to practice adequate birth control to prevent pregnancy while receiving treatment and for three months after treatment is discontinued?
text
CL.14
Code List
If the patient is a female capable of childbearing , does she agree to practice adequate birth control to prevent pregnancy while receiving treatment and for three months after treatment is discontinued?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
N/A (N/A)
Item
If the patient is a male of child fathering potential, does he agree to practice adequate birth control?
text
CL.15
Code List
If the patient is a male of child fathering potential, does he agree to practice adequate birth control?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
N/A (N/A)
Isthepatientcapableofcomplyingwiththeprotocol?
Item
Is the patient capable of complying with the protocol?
boolean
Ifthepatientisreceivingantiretroviraltherapy,hasthepatientbeenonastableregimenforatleast4weekspriortostudyentry?PatientsmayreceiveanyFDAapprovedantiretroviraltherapyoragentsavailablethroughatreatmentIND,exceptregime
Item
If the patient is receiving antiretroviral therapy, has the patient been on a stable regimen for at least 4 weeks prior to study entry? Patients may receive any FDA approved antiretroviral therapy or agents available through a treatment IND, except regime
boolean
Hasthepatienthadaconcurrent,acute,activeopportunisticinfection otherthanoralthrushorgenitalherpeswithin14daysofenrollment?
Item
Has the patient had a concurrent, acute, active opportunistic infection other than oral thrush or genital herpes within 14 days of enrollment?
boolean
DoesthepatienthavevisceralKaposi'sSarcoma?
Item
Does the patient have visceral Kaposi's Sarcoma?
boolean
DoesthepatienthaveoralKaposi'ssarcomaastheonlysiteofdisease?
Item
Does the patient have oral Kaposi's sarcoma as the only site of disease?
boolean
Doesthepatienthaveaconcurrentneoplasmrequiringcytotoxictherapy?
Item
Does the patient have a concurrent neoplasm requiring cytotoxic therapy?
boolean
Hasthepatienthadanti-neoplastictreatmentforKaposi'sSarcoma (includingchemotherapy,radiationtherapy,localtherapy,biological therapy,orinvestigationaltherapy)withintwoweeksofstudyentry?
Item
Has the patient had anti-neoplastic treatment for Kaposi's Sarcoma (including chemotherapy, radiation therapy, local therapy, biological therapy, or investigational therapy) within two weeks of study entry?
boolean
HasthepatienthadpreviouslocaltherapyofanyKS-markerlesion within60days(Exception:thelesionhasclearlyprogressedsince treatment)?
Item
Has the patient had previous local therapy of any KS-marker lesion within 60 days (Exception: the lesion has clearly progressed since treatment)?
boolean
Hasthepatientusedinvestigationalagentsotherthanantiretroviral drugsavailableunderexpandedaccessorcompassionateuseprotocols?
Item
Has the patient used investigational agents other than antiretroviral drugs available under expanded access or compassionate use protocols?
boolean
Doesthepatienthaveahistoryofvalproicacidorvalproateuseinthe previousyear?
Item
Does the patient have a history of valproic acid or valproate use in the previous year?
boolean
DoesthepatienthaveevidenceofapriorMIorcardiacischemia?
Item
Does the patient have evidence of a prior MI or cardiac ischemia?
boolean
IsthepatientusingAZT?
Item
Is the patient using AZT ?
boolean
Doesthepatienthaveahistoryoflacticacidosisgreaterthan 2mmoles/liter?
Item
Does the patient have a history of lactic acidosis greater than 2 mmoles / liter?
boolean
Doesthepatienthaveahistoryoflipoatrophyorhypercholesterolemia secondarytoretroviraltreatment?
Item
Does the patient have a history of lipoatrophy or hypercholesterolemia secondary to retroviral treatment?
boolean
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