ID

12956

Description

Effectiveness of the Investigational Drug Campath-1H in Preventing Rejection of Transplanted Kidneys; ODM derived from: https://clinicaltrials.gov/show/NCT00001984

Link

https://clinicaltrials.gov/show/NCT00001984

Keywords

Versions (1)
  1. 1/7/16 1/7/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

January 7, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Graft Rejection NCT00001984

English

Eligibility Graft Rejection NCT00001984

1 forms  
Criteria
Description

Criteria

candidates for a kidney transplant performed at the warren g. magnuson clinical center.
Description

candidates for a kidney transplant performed at the warren g. magnuson clinical center.

Data type

boolean

Alias
UMLS CUI [1]
C0022671
willingness and legal ability to give informed consent, or permission from a legal guardian.
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
willingness to travel to the clinical center for protocol specific samples to be taken, or in some cases, the ability to send samples via overnight mail.
Description

willingness to travel to the clinical center for protocol specific samples to be taken, or in some cases, the ability to send samples via overnight mail.

Data type

boolean

Alias
UMLS CUI [1]
C1321605
availability of donor tissue for testing. this could include splenic or peripheral blood lymphocytes from a cadaveric donor or a willing living donor enrolled on the clinic center living donor protocol who consents to periodic phlebotomy for peripheral blood lymphocyte isolation.
Description

availability of donor tissue

Data type

boolean

Alias
UMLS CUI [1]
C0040300
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
immunosuppressive drug therapy at the time of or 2 months prior to enrollment. specifically, candidates must not be taking prednisone, cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil, antilymphocyte agents, cyclophosphamide, methotrexate, or other agents whose therapeutic effect is immunosuppressive.
Description

immunosuppressive drug therapy

Data type

boolean

Alias
UMLS CUI [1]
C0021081
any condition that precludes serial follow-up.
Description

any condition that precludes serial follow-up.

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
any active malignancy or any history of a hematogenous malignancy or lymphoma. patients with primary, cutaneous basal cell or squamous cell cancers may be enrolled providing the lesions are appropriately treated prior to transplant.
Description

malignancy

Data type

boolean

Alias
UMLS CUI [1]
C0006826
significant coagulopathy or requirement for anticoagulation therapy that would contraindicate protocol allograft biopsies.
Description

coagulopathy or requirement for anticoagulation therapy

Data type

boolean

Alias
UMLS CUI [1]
C0005779
UMLS CUI [2]
C0449867
platelet count less than 100,000/mm(3).
Description

platelet count

Data type

boolean

Alias
UMLS CUI [1]
C0005821
hemoglobin less than 9.0 mg/dl. patients may be on erythropoietin therapy, but will not be placed on therapy solely to facilitate research sample acquisition.
Description

hemoglobin

Data type

boolean

Alias
UMLS CUI [1]
C0019046
any known immunodeficiency syndrome.
Description

immunodeficiency syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0021051
hla identical status with a living donor.
Description

hla status

Data type

boolean

Alias
UMLS CUI [1]
C0019721
any history of uncompensated cardiac insufficiency, major vascular disease, or symptomatic coronary artery disease.
Description

cardiovascular disease

Data type

boolean

Alias
UMLS CUI [1]
C0007222
systemic or pulmonary edema.
Description

systemic or pulmonary edema

Data type

boolean

Alias
UMLS CUI [1]
C0013604
inability to be effectively dialyzed.
Description

inability to be effectively dialyzed.

Data type

boolean

Alias
UMLS CUI [1]
C0011946
chronic hypotension (sbp less than 100 mmhg).
Description

hypotension

Data type

boolean

Alias
UMLS CUI [1]
C0020649
any condition that would likely increase the risk of protocol participation or confound the interpretation of the data.
Description

any condition that would likely increase the risk of protocol participation or confound the interpretation of the data.

Data type

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
cmv negative status receiving an organ from a known cmv positive donor.
Description

cmv status

Data type

boolean

Alias
UMLS CUI [1]
C0010825
ebv negative status receiving an organ from a known ebv positive donor.
Description

ebv status

Data type

boolean

Alias
UMLS CUI [1]
C0014644
panel reactive antibody greater than 20% due to hla antibodies.
Description

panel reactive antibody

Data type

boolean

Alias
UMLS CUI [1]
C1141951
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Similar models

Eligibility Graft Rejection NCT00001984

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
candidates for a kidney transplant performed at the warren g. magnuson clinical center.
Item
candidates for a kidney transplant performed at the warren g. magnuson clinical center.
boolean
C0022671 (UMLS CUI [1])
informed consent
Item
willingness and legal ability to give informed consent, or permission from a legal guardian.
boolean
C0021430 (UMLS CUI [1])
willingness to travel to the clinical center for protocol specific samples to be taken, or in some cases, the ability to send samples via overnight mail.
Item
willingness to travel to the clinical center for protocol specific samples to be taken, or in some cases, the ability to send samples via overnight mail.
boolean
C1321605 (UMLS CUI [1])
availability of donor tissue
Item
availability of donor tissue for testing. this could include splenic or peripheral blood lymphocytes from a cadaveric donor or a willing living donor enrolled on the clinic center living donor protocol who consents to periodic phlebotomy for peripheral blood lymphocyte isolation.
boolean
C0040300 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
immunosuppressive drug therapy
Item
immunosuppressive drug therapy at the time of or 2 months prior to enrollment. specifically, candidates must not be taking prednisone, cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil, antilymphocyte agents, cyclophosphamide, methotrexate, or other agents whose therapeutic effect is immunosuppressive.
boolean
C0021081 (UMLS CUI [1])
any condition that precludes serial follow-up.
Item
any condition that precludes serial follow-up.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
malignancy
Item
any active malignancy or any history of a hematogenous malignancy or lymphoma. patients with primary, cutaneous basal cell or squamous cell cancers may be enrolled providing the lesions are appropriately treated prior to transplant.
boolean
C0006826 (UMLS CUI [1])
coagulopathy or requirement for anticoagulation therapy
Item
significant coagulopathy or requirement for anticoagulation therapy that would contraindicate protocol allograft biopsies.
boolean
C0005779 (UMLS CUI [1])
C0449867 (UMLS CUI [2])
platelet count
Item
platelet count less than 100,000/mm(3).
boolean
C0005821 (UMLS CUI [1])
hemoglobin
Item
hemoglobin less than 9.0 mg/dl. patients may be on erythropoietin therapy, but will not be placed on therapy solely to facilitate research sample acquisition.
boolean
C0019046 (UMLS CUI [1])
immunodeficiency syndrome
Item
any known immunodeficiency syndrome.
boolean
C0021051 (UMLS CUI [1])
hla status
Item
hla identical status with a living donor.
boolean
C0019721 (UMLS CUI [1])
cardiovascular disease
Item
any history of uncompensated cardiac insufficiency, major vascular disease, or symptomatic coronary artery disease.
boolean
C0007222 (UMLS CUI [1])
systemic or pulmonary edema
Item
systemic or pulmonary edema.
boolean
C0013604 (UMLS CUI [1])
inability to be effectively dialyzed.
Item
inability to be effectively dialyzed.
boolean
C0011946 (UMLS CUI [1])
hypotension
Item
chronic hypotension (sbp less than 100 mmhg).
boolean
C0020649 (UMLS CUI [1])
any condition that would likely increase the risk of protocol participation or confound the interpretation of the data.
Item
any condition that would likely increase the risk of protocol participation or confound the interpretation of the data.
boolean
C2348563 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
cmv status
Item
cmv negative status receiving an organ from a known cmv positive donor.
boolean
C0010825 (UMLS CUI [1])
ebv status
Item
ebv negative status receiving an organ from a known ebv positive donor.
boolean
C0014644 (UMLS CUI [1])
panel reactive antibody
Item
panel reactive antibody greater than 20% due to hla antibodies.
boolean
C1141951 (UMLS CUI [1])
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