ID

4888

Description

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

Lien

http://clinicaltrials.gov/show/NCT00296361

Mots-clés

  1. 07/03/2012 07/03/2012 -
  2. 13/04/2014 13/04/2014 - Julian Varghese
  3. 17/09/2021 17/09/2021 -
Téléchargé le

13 avril 2014

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

Modèle Commentaires :

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Eligibility NCT00296361 Kidney Transplantation

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Einschlusskriterien
Description

Einschlusskriterien

Alter 18 bis 60 Jahre
Description

Age

Type de données

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.

Type de données

boolean

Ausschlusskriterien
Description

Ausschlusskriterien

Patient has a high immunological risk
Description

high immunological risk

Type de données

boolean

Cold ischemia time greater than 30 hours
Description

Cold ischemia time >30 hours

Type de données

boolean

Patient has significant liver disease
Description

liver disease

Type de données

boolean

Patient has severe hyper-cholesterolaemia
Description

severe hyper-cholesterolaemia

Type de données

boolean

Patient is allergic or intolerant to study medication
Description

allergy or intolerance to study medication

Type de données

boolean

Patient requires ongoing dosing with corticosteroids.
Description

corticosteroids

Type de données

boolean

Patient or donor is known to be HIV positive
Description

Patient or donor is HIV positive

Type de données

boolean

Patient with malignancy or history of malignancy
Description

malignancy or history of malignancy

Type de données

boolean

Medizinische Konzepte
Description

Medizinische Konzepte

Alter
Description

Age

Type de données

string

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
397669002
Diagnose
Description

Diagnosis

Type de données

string

Alias
UMLS CUI
C0011900
SNOMED CT 2010_0731
439401001
LOINC Version 232
MTHU008876
terminale Niereninsuffizienz
Description

End stage kidney disease

Type de données

string

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

Kidney Transplantation

Type de données

string

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

retransplantation

Type de données

string

Alias
UMLS CUI
C0597409
Nierentransplantat
Description

Transplanted kidney

Type de données

string

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

Living Donors

Type de données

string

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

Donor

Type de données

string

Alias
UMLS CUI
C0013018
humanes Leukozytenantigen, HLA
Description

HLA Antigens

Type de données

string

Alias
UMLS CUI
C0019721
SNOMED CT 2010_0731
47038001
LOINC Version 232
MTHU018438
ABO Blutgruppensystem
Description

ABO blood group system

Type de données

string

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

Immunological Risk Factors

Type de données

string

Alias
UMLS CUI
CL365957
Cold Ischemic Time
Description

Cold Ischemia Time

Type de données

string

Alias
UMLS CUI
C1563922
LOINC Version 232
MTHU020173
Lebererkrankung
Description

Liver disorder

Type de données

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
Hypercholesterinämie
Description

Hypercholesterolemia

Type de données

string

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

Drug intolerance

Type de données

string

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

Corticosteroids

Type de données

string

Alias
UMLS CUI
C0001617
SNOMED CT 2010_0731
79440004
fortlaufend
Description

continue

Type de données

string

Alias
UMLS CUI
C0750536
HIV-positiv
Description

HIV positive

Type de données

string

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

Cancer

Type de données

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)
Type de données
Alias
Item Group
Einschlusskriterien
Age
Item
Alter 18 bis 60 Jahre
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
Ausschlusskriterien
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
Medizinische Konzepte
Age
Item
Alter
string
C0001779 (UMLS CUI)
397669002 (SNOMED CT 2010_0731)
Diagnosis
Item
Diagnose
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
MTHU008876 (LOINC Version 232)
End stage kidney disease
Item
terminale Niereninsuffizienz
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
Nierentransplantat
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
humanes Leukozytenantigen, HLA
string
C0019721 (UMLS CUI)
47038001 (SNOMED CT 2010_0731)
MTHU018438 (LOINC Version 232)
ABO blood group system
Item
ABO Blutgruppensystem
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
Lebererkrankung
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
Hypercholesterinämie
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
Corticosteroide
string
C0001617 (UMLS CUI)
79440004 (SNOMED CT 2010_0731)
continue
Item
fortlaufend
string
C0750536 (UMLS CUI)
HIV positive
Item
HIV-positiv
string
C0019699 (UMLS CUI)
165816005 (SNOMED CT 2010_0731)
10020188 (MedDRA 13.1)
Z21 (ICD-10-CM Version 2010)
Cancer
Item
Krebs
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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