ID

12955

Description

Monitoring for Tolerance to Kidney or Combined Kidney-Pancreas Transplants; ODM derived from: https://clinicaltrials.gov/show/NCT00001858

Link

https://clinicaltrials.gov/show/NCT00001858

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 NCT00001858

English

Eligibility Graft Rejection NCT00001858

1 forms  
Criteria
Description

Criteria

candidates for a kidney or combined kidney-pancreas transplant performed at the national institutes of health, or non-uremic healthy volunteers who are not on immunosuppressive medications.
Description

candidates for a kidney or combined kidney-pancreas transplant performed at the national institutes of health, or non-uremic healthy volunteers who are not on immunosuppressive medications.

Data type

boolean

Alias
UMLS CUI [1]
C0022671
UMLS CUI [2]
C0994103
UMLS CUI [3]
C0021081
previous recipients of kidney or combined kidney-pancreas transplants.
Description

previous recipients of kidney or combined kidney-pancreas transplants.

Data type

boolean

Alias
UMLS CUI [1]
C0994103
recipients of kidney or combined kidney-pancreas transplants interested in participation in the recurrent disease allograft registry.
Description

recipients of kidney or combined kidney-pancreas transplants interested in participation in the recurrent disease allograft registry.

Data type

boolean

Alias
UMLS CUI [1]
C0022671
UMLS CUI [2]
C0994103
willingness and legal ability to give informed consent or permission from a legal guardian.
Description

willingness and legal ability to give informed consent or permission from a legal guardian.

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
for transplant patients, 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 clinical center living donor protocol who consents to periodic phlebotomy for peripheral blood lymphocyte isolation.
Description

for transplant patients, 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 clinical center living donor protocol who consents to periodic phlebotomy for peripheral blood lymphocyte isolation.

Data type

boolean

Alias
UMLS CUI [1]
C0040300
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
inability or unwillingness to comply with protocol monitoring and therapy, including, among others, a history of noncompliance, circumstances where compliance with protocol requirements is not feasible due to living conditions, travel restrictions, access to urgent medical services, or access to anti-rejection drugs after the research protocol is completed.
Description

inability or unwillingness to comply with protocol

Data type

boolean

Alias
UMLS CUI [1]
C1321605
any active malignancy. patients with primary, cutaneous basal cell or squamous cell cancers may be enrolled providing these are appropriately eliminated 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

significant coagulopathy or requirement for anticoagulation therapy that would contraindicate protocol allograft biopsies.

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
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Similar models

Eligibility Graft Rejection NCT00001858

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
candidates for a kidney or combined kidney-pancreas transplant performed at the national institutes of health, or non-uremic healthy volunteers who are not on immunosuppressive medications.
Item
candidates for a kidney or combined kidney-pancreas transplant performed at the national institutes of health, or non-uremic healthy volunteers who are not on immunosuppressive medications.
boolean
C0022671 (UMLS CUI [1])
C0994103 (UMLS CUI [2])
C0021081 (UMLS CUI [3])
previous recipients of kidney or combined kidney-pancreas transplants.
Item
previous recipients of kidney or combined kidney-pancreas transplants.
boolean
C0994103 (UMLS CUI [1])
recipients of kidney or combined kidney-pancreas transplants interested in participation in the recurrent disease allograft registry.
Item
recipients of kidney or combined kidney-pancreas transplants interested in participation in the recurrent disease allograft registry.
boolean
C0022671 (UMLS CUI [1])
C0994103 (UMLS CUI [2])
willingness and legal ability to give informed consent or permission from a legal guardian.
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])
for transplant patients, 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 clinical center living donor protocol who consents to periodic phlebotomy for peripheral blood lymphocyte isolation.
Item
for transplant patients, 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 clinical center living donor protocol who consents to periodic phlebotomy for peripheral blood lymphocyte isolation.
boolean
C0040300 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
inability or unwillingness to comply with protocol
Item
inability or unwillingness to comply with protocol monitoring and therapy, including, among others, a history of noncompliance, circumstances where compliance with protocol requirements is not feasible due to living conditions, travel restrictions, access to urgent medical services, or access to anti-rejection drugs after the research protocol is completed.
boolean
C1321605 (UMLS CUI [1])
malignancy
Item
any active malignancy. patients with primary, cutaneous basal cell or squamous cell cancers may be enrolled providing these are appropriately eliminated prior to transplant.
boolean
C0006826 (UMLS CUI [1])
significant coagulopathy or requirement for anticoagulation therapy that would contraindicate protocol allograft biopsies.
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])
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