ID

12955

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00001858

Nyckelord

  1. 2016-01-07 2016-01-07 -
Rättsinnehavare

CC BY-NC 3.0

Uppladdad den

7 januari 2016

DOI

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Licens

Creative Commons BY-NC 3.0

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Eligibility Graft Rejection NCT00001858

Eligibility Graft Rejection NCT00001858

Criteria
Beskrivning

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.
Beskrivning

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.

Datatyp

boolean

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

previous recipients of kidney or combined kidney-pancreas transplants.

Datatyp

boolean

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

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

Datatyp

boolean

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

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

Datatyp

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.
Beskrivning

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.

Datatyp

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.
Beskrivning

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.

Datatyp

boolean

Alias
UMLS CUI [1]
C0040300
Exclusion Criteria
Beskrivning

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.
Beskrivning

inability or unwillingness to comply with protocol

Datatyp

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.
Beskrivning

malignancy

Datatyp

boolean

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

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

Datatyp

boolean

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

platelet count

Datatyp

boolean

Alias
UMLS CUI [1]
C0005821

Similar models

Eligibility Graft Rejection NCT00001858

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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