ID

21194

Beschrijving

Immunosuppression Impact on the Metabolic Control of First Kidney Transplant Recipients With Pre-Existing Type 2 Diabetes (DM); ODM derived from: https://clinicaltrials.gov/show/NCT00296296

Link

https://clinicaltrials.gov/show/NCT00296296

Trefwoorden

  1. 12-04-17 12-04-17 -
Geüploaded op

12 april 2017

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Kidney Transplant NCT00296296

Eligibility Kidney Transplant NCT00296296

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patient is a recipient of a first cadaveric kidney, or a kidney living donor mismatched (at least one mismatch.)
Beschrijving

Recipient Kidney First Cadaver donor | Kidney Living Donor Mismatch Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C1709854
UMLS CUI [1,2]
C0022646
UMLS CUI [1,3]
C0205435
UMLS CUI [1,4]
C0524354
UMLS CUI [2,1]
C0022646
UMLS CUI [2,2]
C0348050
UMLS CUI [2,3]
C1881865
UMLS CUI [2,4]
C1265611
2. patient is a minimum of 18 years of age at the time of transplant.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
3. patient has type 2 non-insulin dependent diabetes.
Beschrijving

Diabetes Mellitus, Non-Insulin-Dependent

Datatype

boolean

Alias
UMLS CUI [1]
C0011860
4. patient or legal guardian has signed and dated an ethics committee-approved informed consent document and is willing and able to follow study procedures.
Beschrijving

Informed Consent | Informed Consent Legal Guardians | Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0023226
UMLS CUI [3]
C0525058
5. if female and is childbearing potential, patient has a negative pregnancy test and utilizes adequate contraceptive methods.
Beschrijving

Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. recipients of a transplant graft from a donor age 65 and older.
Beschrijving

Recipient Tissue Graft Age of kidney donor

Datatype

boolean

Alias
UMLS CUI [1,1]
C1709854
UMLS CUI [1,2]
C0348047
UMLS CUI [1,3]
C2170306
2. recipient of a multi-organ transplant.
Beschrijving

Recipient Organ Transplant multiple

Datatype

boolean

Alias
UMLS CUI [1,1]
C1709854
UMLS CUI [1,2]
C0029216
UMLS CUI [1,3]
C0439064
3. patients who are being re-transplanted will not be eligible for study.
Beschrijving

retransplantation

Datatype

boolean

Alias
UMLS CUI [1]
C0597409
4. patients who have lost a previous graft to rejection less than one year from transplant.
Beschrijving

Graft loss Rejection

Datatype

boolean

Alias
UMLS CUI [1,1]
C0877042
UMLS CUI [1,2]
C0018129
5. patient has any form of substance abuse, psychiatric disorder, or a condition in the opinion of the investigator, may invalidate communication with the investigator.
Beschrijving

Substance Use Disorders | Mental disorder | Condition Limiting Communication Investigator

Datatype

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0004936
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C0439801
UMLS CUI [3,3]
C0009452
UMLS CUI [3,4]
C0035173
6. pra > 30%
Beschrijving

Panel-reactive antibody

Datatype

boolean

Alias
UMLS CUI [1]
C1141951

Similar models

Eligibility Kidney Transplant NCT00296296

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Item Group
C1512693 (UMLS CUI)
Recipient Kidney First Cadaver donor | Kidney Living Donor Mismatch Quantity
Item
1. patient is a recipient of a first cadaveric kidney, or a kidney living donor mismatched (at least one mismatch.)
boolean
C1709854 (UMLS CUI [1,1])
C0022646 (UMLS CUI [1,2])
C0205435 (UMLS CUI [1,3])
C0524354 (UMLS CUI [1,4])
C0022646 (UMLS CUI [2,1])
C0348050 (UMLS CUI [2,2])
C1881865 (UMLS CUI [2,3])
C1265611 (UMLS CUI [2,4])
Age
Item
2. patient is a minimum of 18 years of age at the time of transplant.
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent
Item
3. patient has type 2 non-insulin dependent diabetes.
boolean
C0011860 (UMLS CUI [1])
Informed Consent | Informed Consent Legal Guardians | Protocol Compliance
Item
4. patient or legal guardian has signed and dated an ethics committee-approved informed consent document and is willing and able to follow study procedures.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0023226 (UMLS CUI [2,2])
C0525058 (UMLS CUI [3])
Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods
Item
5. if female and is childbearing potential, patient has a negative pregnancy test and utilizes adequate contraceptive methods.
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Recipient Tissue Graft Age of kidney donor
Item
1. recipients of a transplant graft from a donor age 65 and older.
boolean
C1709854 (UMLS CUI [1,1])
C0348047 (UMLS CUI [1,2])
C2170306 (UMLS CUI [1,3])
Recipient Organ Transplant multiple
Item
2. recipient of a multi-organ transplant.
boolean
C1709854 (UMLS CUI [1,1])
C0029216 (UMLS CUI [1,2])
C0439064 (UMLS CUI [1,3])
retransplantation
Item
3. patients who are being re-transplanted will not be eligible for study.
boolean
C0597409 (UMLS CUI [1])
Graft loss Rejection
Item
4. patients who have lost a previous graft to rejection less than one year from transplant.
boolean
C0877042 (UMLS CUI [1,1])
C0018129 (UMLS CUI [1,2])
Substance Use Disorders | Mental disorder | Condition Limiting Communication Investigator
Item
5. patient has any form of substance abuse, psychiatric disorder, or a condition in the opinion of the investigator, may invalidate communication with the investigator.
boolean
C0038586 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
C0348080 (UMLS CUI [3,1])
C0439801 (UMLS CUI [3,2])
C0009452 (UMLS CUI [3,3])
C0035173 (UMLS CUI [3,4])
Panel-reactive antibody
Item
6. pra > 30%
boolean
C1141951 (UMLS CUI [1])

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