ID

21154

Description

A Study Comparing Outcomes of Kidney Transplants in Patients on Steroids Versus Those Who Discontinue Steroids; ODM derived from: https://clinicaltrials.gov/show/NCT00273559

Link

https://clinicaltrials.gov/show/NCT00273559

Keywords

Versions (1)
  1. 4/12/17 4/12/17 -
Uploaded on

April 12, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Kidney Diseases NCT00273559

English

Eligibility Kidney Diseases NCT00273559

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients undergoing a single renal transplant from deceased or living donor
Description

Kidney Transplant Single Cadaver donor | Kidney Transplant Single Living Donor

Data type

boolean

Alias
UMLS CUI [1,1]
C0022671
UMLS CUI [1,2]
C0205171
UMLS CUI [1,3]
C0524354
UMLS CUI [2,1]
C0022671
UMLS CUI [2,2]
C0205171
UMLS CUI [2,3]
C0348050
adults 18 years and older
Description

Adult | Age

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
first or second renal transplant
Description

Kidney Transplant First | Kidney Transplant second

Data type

boolean

Alias
UMLS CUI [1,1]
C0022671
UMLS CUI [1,2]
C0205435
UMLS CUI [2,1]
C0022671
UMLS CUI [2,2]
C0205436
capable of understanding the purposes of the study, has given written informed consent, and agrees to comply with the study requirements
Description

Study Protocol Comprehension | Informed Consent | Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0162340
UMLS CUI [2]
C0021430
UMLS CUI [3]
C0525058
women of child bearing age should have a negative serum pregnancy test
Description

Childbearing Potential Serum pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
greater than 2 renal transplants
Description

Kidney Transplant Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0022671
UMLS CUI [1,2]
C1265611
age < 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients receiving immunosuppressive therapy within the preceding 28 days for first transplant and 3 months for the second transplant
Description

Therapeutic immunosuppression | Kidney Transplant First | Kidney Transplant second

Data type

boolean

Alias
UMLS CUI [1]
C0021079
UMLS CUI [2,1]
C0022671
UMLS CUI [2,2]
C0205435
UMLS CUI [3,1]
C0022671
UMLS CUI [3,2]
C0205436
cold ischemia time > 30 hours
Description

Cold Ischemia Time

Data type

boolean

Alias
UMLS CUI [1]
C1563922
history of malignancy in the last 5 years except successfully treated localized non-melanoma skin cancer
Description

Malignant Neoplasms | Skin carcinoma Localized Treated Successful

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0699893
UMLS CUI [2,2]
C0392752
UMLS CUI [2,3]
C1522326
UMLS CUI [2,4]
C1272703
hiv, hepatitis b virus (hbv), or hepatitis c virus (hcv) positive serology
Description

HIV Seropositivity | Hepatitis B Virus Seropositive | Hepatitis C virus Seropositive

Data type

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2,1]
C0019169
UMLS CUI [2,2]
C0521143
UMLS CUI [3,1]
C0220847
UMLS CUI [3,2]
C0521143
loss of previous transplant in < 1 year
Description

Transplant Loss

Data type

boolean

Alias
UMLS CUI [1,1]
C0332835
UMLS CUI [1,2]
C1517945
history of non-compliance
Description

Non-compliance

Data type

boolean

Alias
UMLS CUI [1]
C0457432
any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may impair communication with the investigator or compliance with study procedures
Description

Substance Use Disorders | Mental disorders | Condition Protocol Compliance Limited

Data type

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0004936
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C0525058
UMLS CUI [3,3]
C0439801
multiple organ transplant
Description

Organ Transplant multiple

Data type

boolean

Alias
UMLS CUI [1,1]
C0029216
UMLS CUI [1,2]
C0439064
history of chronic steroid use except for inhaled steroids for asthma
Description

steroid use chronic | Inhaled steroids use Asthma

Data type

boolean

Alias
UMLS CUI [1,1]
C0281991
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0586793
UMLS CUI [2,2]
C0004096
pregnant or lactating females
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
women of childbearing potential not willing to use a reliable form of contraception.
Description

Childbearing Potential Contraceptive methods Inadequate

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0205412
patients with severe medical condition(s) that, in the view of the investigator, prohibits participation in the study
Description

Medical condition Severe | Study Subject Participation Status Exclusion

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C2348568
UMLS CUI [2,2]
C2828389
known sensitivity to study drugs or class of study drugs
Description

Hypersensitivity Investigational New Drugs | Hypersensitivity Class of Trial Agent

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C2983595
use of any investigational agent in the last 30 days
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
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Similar models

Eligibility Kidney Diseases NCT00273559

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Kidney Transplant Single Cadaver donor | Kidney Transplant Single Living Donor
Item
patients undergoing a single renal transplant from deceased or living donor
boolean
C0022671 (UMLS CUI [1,1])
C0205171 (UMLS CUI [1,2])
C0524354 (UMLS CUI [1,3])
C0022671 (UMLS CUI [2,1])
C0205171 (UMLS CUI [2,2])
C0348050 (UMLS CUI [2,3])
Adult | Age
Item
adults 18 years and older
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Kidney Transplant First | Kidney Transplant second
Item
first or second renal transplant
boolean
C0022671 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
C0022671 (UMLS CUI [2,1])
C0205436 (UMLS CUI [2,2])
Study Protocol Comprehension | Informed Consent | Protocol Compliance
Item
capable of understanding the purposes of the study, has given written informed consent, and agrees to comply with the study requirements
boolean
C2348563 (UMLS CUI [1,1])
C0162340 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
C0525058 (UMLS CUI [3])
Childbearing Potential Serum pregnancy test negative
Item
women of child bearing age should have a negative serum pregnancy test
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Kidney Transplant Quantity
Item
greater than 2 renal transplants
boolean
C0022671 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Age
Item
age < 18 years
boolean
C0001779 (UMLS CUI [1])
Therapeutic immunosuppression | Kidney Transplant First | Kidney Transplant second
Item
patients receiving immunosuppressive therapy within the preceding 28 days for first transplant and 3 months for the second transplant
boolean
C0021079 (UMLS CUI [1])
C0022671 (UMLS CUI [2,1])
C0205435 (UMLS CUI [2,2])
C0022671 (UMLS CUI [3,1])
C0205436 (UMLS CUI [3,2])
Cold Ischemia Time
Item
cold ischemia time > 30 hours
boolean
C1563922 (UMLS CUI [1])
Malignant Neoplasms | Skin carcinoma Localized Treated Successful
Item
history of malignancy in the last 5 years except successfully treated localized non-melanoma skin cancer
boolean
C0006826 (UMLS CUI [1])
C0699893 (UMLS CUI [2,1])
C0392752 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1272703 (UMLS CUI [2,4])
HIV Seropositivity | Hepatitis B Virus Seropositive | Hepatitis C virus Seropositive
Item
hiv, hepatitis b virus (hbv), or hepatitis c virus (hcv) positive serology
boolean
C0019699 (UMLS CUI [1])
C0019169 (UMLS CUI [2,1])
C0521143 (UMLS CUI [2,2])
C0220847 (UMLS CUI [3,1])
C0521143 (UMLS CUI [3,2])
Transplant Loss
Item
loss of previous transplant in < 1 year
boolean
C0332835 (UMLS CUI [1,1])
C1517945 (UMLS CUI [1,2])
Non-compliance
Item
history of non-compliance
boolean
C0457432 (UMLS CUI [1])
Substance Use Disorders | Mental disorders | Condition Protocol Compliance Limited
Item
any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may impair communication with the investigator or compliance with study procedures
boolean
C0038586 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
C0348080 (UMLS CUI [3,1])
C0525058 (UMLS CUI [3,2])
C0439801 (UMLS CUI [3,3])
Organ Transplant multiple
Item
multiple organ transplant
boolean
C0029216 (UMLS CUI [1,1])
C0439064 (UMLS CUI [1,2])
steroid use chronic | Inhaled steroids use Asthma
Item
history of chronic steroid use except for inhaled steroids for asthma
boolean
C0281991 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0586793 (UMLS CUI [2,1])
C0004096 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
pregnant or lactating females
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Inadequate
Item
women of childbearing potential not willing to use a reliable form of contraception.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0205412 (UMLS CUI [1,3])
Medical condition Severe | Study Subject Participation Status Exclusion
Item
patients with severe medical condition(s) that, in the view of the investigator, prohibits participation in the study
boolean
C3843040 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2348568 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
Hypersensitivity Investigational New Drugs | Hypersensitivity Class of Trial Agent
Item
known sensitivity to study drugs or class of study drugs
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C2983595 (UMLS CUI [2,2])
Investigational New Drugs
Item
use of any investigational agent in the last 30 days
boolean
C0013230 (UMLS CUI [1])
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