Informações:
Falhas:
ID
43056
Descrição
ODM derived from http://clinicaltrials.gov/show/NCT00296361
Link
http://clinicaltrials.gov/show/NCT00296361
Palavras-chave
Versões (3)
- 07/03/2012 07/03/2012 -
- 13/04/2014 13/04/2014 - Julian Varghese
- 17/09/2021 17/09/2021 -
Transferido a
17 de setembro de 2021
DOI
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Licença
Creative Commons BY 4.0
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Eligibility NCT00296361 Kidney Transplantation
Similar models
Eligibility
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
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
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
Age
Item
Age
string
C0001779 (UMLS CUI)
397669002 (SNOMED CT 2010_0731)
397669002 (SNOMED CT 2010_0731)
Diagnosis
Item
Diagnosis
string
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)
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)
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
Living Donors
Item
Live donor
string
C0348050 (UMLS CUI)
105456007 (SNOMED CT 2010_0731)
105456007 (SNOMED CT 2010_0731)
Donor
Item
Donor person
string
C0013018 (UMLS CUI)
HLA Antigens
Item
Human leukocyte antigen
string
ABO blood group system
Item
ABO blood group antigen system
string
Immunological Risk Factors
Item
Immunological Risk Factors
string
CL365957 (UMLS CUI)
Cold Ischemia Time
Item
Cold Ischemic Time
string
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)
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)
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)
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)
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)
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)
363346000 (SNOMED CT 2010_0731)
10028997 (MedDRA 13.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)