ID

43056

Description

ODM derived from http://clinicaltrials.gov/show/NCT00296361

Link

http://clinicaltrials.gov/show/NCT00296361

Keywords

  1. 3/7/12 3/7/12 -
  2. 4/13/14 4/13/14 - Julian Varghese
  3. 9/17/21 9/17/21 -
Uploaded on

September 17, 2021

DOI

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License

Creative Commons BY 4.0

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Eligibility NCT00296361 Kidney Transplantation

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Age 18 Years to 60 Years
Description

Age

Data type

boolean

Patients having end stage kidney disease who will undergo primary renal transplantation or retransplantation are eligible for the study. Patients receiving a kidney transplant, from a cadaveric or living donor (not HLA identical) with compatible AB0 blood type can be included.
Description

Patients with end stage kidney disease who will undergo renal transplantation. Patients receiving a kidney transplant with compatible ABO blood type.

Data type

boolean

Exclusion Criteria
Description

Exclusion Criteria

Patient has a high immunological risk
Description

high immunological risk

Data type

boolean

Cold ischemia time greater than 30 hours
Description

Cold ischemia time >30 hours

Data type

boolean

Patient has significant liver disease
Description

liver disease

Data type

boolean

Patient has severe hyper-cholesterolaemia
Description

severe hyper-cholesterolaemia

Data type

boolean

Patient is allergic or intolerant to study medication
Description

allergy or intolerance to study medication

Data type

boolean

Patient requires ongoing dosing with corticosteroids.
Description

corticosteroids

Data type

boolean

Patient or donor is known to be HIV positive
Description

Patient or donor is HIV positive

Data type

boolean

Patient with malignancy or history of malignancy
Description

malignancy or history of malignancy

Data type

boolean

Medical Concepts
Description

Medical Concepts

Age
Description

Age

Data type

string

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
397669002
Diagnosis
Description

Diagnosis

Data type

string

Alias
UMLS CUI
C0011900
SNOMED CT 2010_0731
439401001
LOINC Version 232
MTHU008876
Renal Disease, End-Stage
Description

End stage kidney disease

Data type

string

Alias
UMLS CUI
C1261469
SNOMED CT 2010_0731
46177005
ICD-9-CM Version 2011
585.6
Renal transplant
Description

Kidney Transplantation

Data type

string

Alias
UMLS CUI
C0022671
SNOMED CT 2010_0731
70536003
MedDRA 13.1
10038533
ICD-9-CM Version 2011
55.6
retransplantation
Description

retransplantation

Data type

string

Alias
UMLS CUI
C0597409
Structure of transplanted kidney
Description

Transplanted kidney

Data type

string

Alias
UMLS CUI
C1261317
SNOMED CT 2010_0731
70948008
LOINC Version 232
MTHU017667
Live donor
Description

Living Donors

Data type

string

Alias
UMLS CUI
C0348050
SNOMED CT 2010_0731
105456007
Donor person
Description

Donor

Data type

string

Alias
UMLS CUI
C0013018
Human leukocyte antigen
Description

HLA Antigens

Data type

string

Alias
UMLS CUI
C0019721
SNOMED CT 2010_0731
47038001
LOINC Version 232
MTHU018438
ABO blood group antigen system
Description

ABO blood group system

Data type

string

Alias
UMLS CUI
C0000778
SNOMED CT 2010_0731
63915006
LOINC Version 232
MTHU004899
Immunological Risk Factors
Description

Immunological Risk Factors

Data type

string

Alias
UMLS CUI
CL365957
Cold Ischemic Time
Description

Cold Ischemia Time

Data type

string

Alias
UMLS CUI
C1563922
LOINC Version 232
MTHU020173
Liver diseases
Description

Liver disorder

Data type

string

Alias
UMLS CUI
C0023895
SNOMED CT 2010_0731
235856003
MedDRA 13.1
10024670
ICD-10-CM Version 2010
K76.9
ICD-9-CM Version 2011
573.9
Hypercholesterolaemia
Description

Hypercholesterolemia

Data type

string

Alias
UMLS CUI
C0020443
SNOMED CT 2010_0731
13644009
MedDRA 13.1
10020603
CTCAE Version 4.03
E12127
Drug intolerance
Description

Drug intolerance

Data type

string

Alias
UMLS CUI
C0277585
SNOMED CT 2010_0731
59037007
MedDRA 13.1
10061822
HL7 V3 02-34
DINT
Therapeutic Corticosteroid
Description

Corticosteroids

Data type

string

Alias
UMLS CUI
C0001617
SNOMED CT 2010_0731
79440004
continuous, ongoing
Description

continue

Data type

string

Alias
UMLS CUI
C0549178
HIV Seropositivity
Description

HIV positive

Data type

string

Alias
UMLS CUI
C0019699
SNOMED CT 2010_0731
165816005
MedDRA 13.1
10020188
ICD-10-CM Version 2010
Z21
Malignant Neoplasms
Description

Cancer

Data type

string

Alias
UMLS CUI
C0006826
SNOMED CT 2010_0731
363346000
MedDRA 13.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96

Similar models

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
Age
Item
Age 18 Years to 60 Years
boolean
Patients with end stage kidney disease who will undergo renal transplantation. Patients receiving a kidney transplant with compatible ABO blood type.
Item
Patients having end stage kidney disease who will undergo primary renal transplantation or retransplantation are eligible for the study. Patients receiving a kidney transplant, from a cadaveric or living donor (not HLA identical) with compatible AB0 blood type can be included.
boolean
Item Group
Exclusion Criteria
high immunological risk
Item
Patient has a high immunological risk
boolean
Cold ischemia time >30 hours
Item
Cold ischemia time greater than 30 hours
boolean
liver disease
Item
Patient has significant liver disease
boolean
severe hyper-cholesterolaemia
Item
Patient has severe hyper-cholesterolaemia
boolean
allergy or intolerance to study medication
Item
Patient is allergic or intolerant to study medication
boolean
corticosteroids
Item
Patient requires ongoing dosing with corticosteroids.
boolean
Patient or donor is HIV positive
Item
Patient or donor is known to be HIV positive
boolean
malignancy or history of malignancy
Item
Patient with malignancy or history of malignancy
boolean
Item Group
Medical Concepts
Age
Item
Age
string
C0001779 (UMLS CUI)
397669002 (SNOMED CT 2010_0731)
Diagnosis
Item
Diagnosis
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
MTHU008876 (LOINC Version 232)
End stage kidney disease
Item
Renal Disease, End-Stage
string
C1261469 (UMLS CUI)
46177005 (SNOMED CT 2010_0731)
585.6 (ICD-9-CM Version 2011)
Kidney Transplantation
Item
Renal transplant
string
C0022671 (UMLS CUI)
70536003 (SNOMED CT 2010_0731)
10038533 (MedDRA 13.1)
55.6 (ICD-9-CM Version 2011)
retransplantation
Item
retransplantation
string
C0597409 (UMLS CUI)
Transplanted kidney
Item
Structure of transplanted kidney
string
C1261317 (UMLS CUI)
70948008 (SNOMED CT 2010_0731)
MTHU017667 (LOINC Version 232)
Living Donors
Item
Live donor
string
C0348050 (UMLS CUI)
105456007 (SNOMED CT 2010_0731)
Donor
Item
Donor person
string
C0013018 (UMLS CUI)
HLA Antigens
Item
Human leukocyte antigen
string
C0019721 (UMLS CUI)
47038001 (SNOMED CT 2010_0731)
MTHU018438 (LOINC Version 232)
ABO blood group system
Item
ABO blood group antigen system
string
C0000778 (UMLS CUI)
63915006 (SNOMED CT 2010_0731)
MTHU004899 (LOINC Version 232)
Immunological Risk Factors
Item
Immunological Risk Factors
string
CL365957 (UMLS CUI)
Cold Ischemia Time
Item
Cold Ischemic Time
string
C1563922 (UMLS CUI)
MTHU020173 (LOINC Version 232)
Liver disorder
Item
Liver diseases
string
C0023895 (UMLS CUI)
235856003 (SNOMED CT 2010_0731)
10024670 (MedDRA 13.1)
K76.9 (ICD-10-CM Version 2010)
573.9 (ICD-9-CM Version 2011)
Hypercholesterolemia
Item
Hypercholesterolaemia
string
C0020443 (UMLS CUI)
13644009 (SNOMED CT 2010_0731)
10020603 (MedDRA 13.1)
E12127 (CTCAE Version 4.03)
Drug intolerance
Item
Drug intolerance
string
C0277585 (UMLS CUI)
59037007 (SNOMED CT 2010_0731)
10061822 (MedDRA 13.1)
DINT (HL7 V3 02-34)
Corticosteroids
Item
Therapeutic Corticosteroid
string
C0001617 (UMLS CUI)
79440004 (SNOMED CT 2010_0731)
continue
Item
continuous, ongoing
string
C0549178 (UMLS CUI)
HIV positive
Item
HIV Seropositivity
string
C0019699 (UMLS CUI)
165816005 (SNOMED CT 2010_0731)
10020188 (MedDRA 13.1)
Z21 (ICD-10-CM Version 2010)
Cancer
Item
Malignant Neoplasms
string
C0006826 (UMLS CUI)
363346000 (SNOMED CT 2010_0731)
10028997 (MedDRA 13.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)

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