ID

29431

Beskrivning

Impact of Conversion From Tacrolimus to Sirolimus in African American Renal Transplant Recipients; ODM derived from: https://clinicaltrials.gov/show/NCT00999258

Länk

https://clinicaltrials.gov/show/NCT00999258

Nyckelord

Versioner (1)
  1. 2018-03-23 2018-03-23 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

23 mars 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Glomerular Filtration Rate NCT00999258

Engelsk

Eligibility Glomerular Filtration Rate NCT00999258

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
african american (self-identified) renal transplant recipients.
Beskrivning

African American | Kidney Transplant Recipient

Datatyp

boolean

Alias
UMLS CUI [1]
C0085756
UMLS CUI [2,1]
C0022671
UMLS CUI [2,2]
C1709854
primary or re-transplant kidney-only recipients.
Beskrivning

Kidney Transplant Primary Recipient | Renal retransplantation Recipient

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0022671
UMLS CUI [1,2]
C0205225
UMLS CUI [1,3]
C1709854
UMLS CUI [2,1]
C4087495
UMLS CUI [2,2]
C1709854
recipients on tacrolimus-based immunosuppression regimen.
Beskrivning

Recipient Therapeutic immunosuppression | Tacrolimus

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1709854
UMLS CUI [1,2]
C0021079
UMLS CUI [2]
C0085149
time interval after transplant: at least 3 months but not greater than 5 years.
Beskrivning

Time Interval Post Transplantation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0872291
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C0040732
renal transplant recipients with 10% decrease in gfr from baseline.
Beskrivning

Kidney Transplant Recipient | Decreased glomerular filtration rate Percentage

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0022671
UMLS CUI [1,2]
C1709854
UMLS CUI [2,1]
C0853068
UMLS CUI [2,2]
C0439165
women of childbearing potential must have a negative pregnancy test upon enrollment, and must consent to receive contraceptive counseling and to use effective contraception while enrolled in the study. two reliable forms of contraception must be used simultaneously unless abstinence is the chosen method.
Beskrivning

Childbearing Potential Pregnancy test negative | Childbearing Potential Contraception counseling | Childbearing Potential Contraceptive methods | Contraceptive methods Quantity | Exception Sexual Abstinence

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C1443484
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [4,1]
C0700589
UMLS CUI [4,2]
C1265611
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0036899
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
gfr <40ml/min.
Beskrivning

Glomerular Filtration Rate

Datatyp

boolean

Alias
UMLS CUI [1]
C0017654
urine protein-to-creatinine ratio >0.5.
Beskrivning

Urine protein/creatinine ratio measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C1096054
significant chronic allograft nephropathy grade 3 banff score.
Beskrivning

Chronic rejection of renal transplant Grade Other Coding

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0403592
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C3846158
evidence of acute rejection episodes within the past 3 months.
Beskrivning

Graft rejection episode

Datatyp

boolean

Alias
UMLS CUI [1]
C0877542
evidence of active infection within the past month.
Beskrivning

Communicable Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0009450
any malignancy except treated non-melanoma skin cancer within the past 3 years.
Beskrivning

Malignant Neoplasms | Exception Skin carcinoma Treated

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [2,3]
C1522326
leucopenia <2,000/mm3 within the past month.
Beskrivning

Leukopenia

Datatyp

boolean

Alias
UMLS CUI [1]
C0023530
thrombocytopenia <100,000/mm3 within the past month.
Beskrivning

Thrombocytopenia

Datatyp

boolean

Alias
UMLS CUI [1]
C0040034
total cholesterol >300mg/dl, despite adequate treatment.
Beskrivning

Serum total cholesterol measurement | Therapeutic procedure Adequate

Datatyp

boolean

Alias
UMLS CUI [1]
C1445957
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0205411
triglycerides >500mg/dl, despite adequate treatment.
Beskrivning

Triglycerides measurement | Therapeutic procedure Adequate

Datatyp

boolean

Alias
UMLS CUI [1]
C0202236
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0205411
non-healed post-surgical or non-surgical wound.
Beskrivning

Non-healed wound Postoperative | Wound Free of Operative Surgical Procedures

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0750433
UMLS CUI [1,2]
C0032790
UMLS CUI [2,1]
C0043250
UMLS CUI [2,2]
C0332296
UMLS CUI [2,3]
C0543467
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Similar models

Eligibility Glomerular Filtration Rate NCT00999258

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
African American | Kidney Transplant Recipient
Item
african american (self-identified) renal transplant recipients.
boolean
C0085756 (UMLS CUI [1])
C0022671 (UMLS CUI [2,1])
C1709854 (UMLS CUI [2,2])
Kidney Transplant Primary Recipient | Renal retransplantation Recipient
Item
primary or re-transplant kidney-only recipients.
boolean
C0022671 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C1709854 (UMLS CUI [1,3])
C4087495 (UMLS CUI [2,1])
C1709854 (UMLS CUI [2,2])
Recipient Therapeutic immunosuppression | Tacrolimus
Item
recipients on tacrolimus-based immunosuppression regimen.
boolean
C1709854 (UMLS CUI [1,1])
C0021079 (UMLS CUI [1,2])
C0085149 (UMLS CUI [2])
Time Interval Post Transplantation
Item
time interval after transplant: at least 3 months but not greater than 5 years.
boolean
C0872291 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0040732 (UMLS CUI [1,3])
Kidney Transplant Recipient | Decreased glomerular filtration rate Percentage
Item
renal transplant recipients with 10% decrease in gfr from baseline.
boolean
C0022671 (UMLS CUI [1,1])
C1709854 (UMLS CUI [1,2])
C0853068 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
Childbearing Potential Pregnancy test negative | Childbearing Potential Contraception counseling | Childbearing Potential Contraceptive methods | Contraceptive methods Quantity | Exception Sexual Abstinence
Item
women of childbearing potential must have a negative pregnancy test upon enrollment, and must consent to receive contraceptive counseling and to use effective contraception while enrolled in the study. two reliable forms of contraception must be used simultaneously unless abstinence is the chosen method.
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C1443484 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0700589 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0036899 (UMLS CUI [5,2])
Item Group
C0680251 (UMLS CUI)
Glomerular Filtration Rate
Item
gfr <40ml/min.
boolean
C0017654 (UMLS CUI [1])
Urine protein/creatinine ratio measurement
Item
urine protein-to-creatinine ratio >0.5.
boolean
C1096054 (UMLS CUI [1])
Chronic rejection of renal transplant Grade Other Coding
Item
significant chronic allograft nephropathy grade 3 banff score.
boolean
C0403592 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C3846158 (UMLS CUI [1,3])
Graft rejection episode
Item
evidence of acute rejection episodes within the past 3 months.
boolean
C0877542 (UMLS CUI [1])
Communicable Disease
Item
evidence of active infection within the past month.
boolean
C0009450 (UMLS CUI [1])
Malignant Neoplasms | Exception Skin carcinoma Treated
Item
any malignancy except treated non-melanoma skin cancer within the past 3 years.
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
Leukopenia
Item
leucopenia <2,000/mm3 within the past month.
boolean
C0023530 (UMLS CUI [1])
Thrombocytopenia
Item
thrombocytopenia <100,000/mm3 within the past month.
boolean
C0040034 (UMLS CUI [1])
Serum total cholesterol measurement | Therapeutic procedure Adequate
Item
total cholesterol >300mg/dl, despite adequate treatment.
boolean
C1445957 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0205411 (UMLS CUI [2,2])
Triglycerides measurement | Therapeutic procedure Adequate
Item
triglycerides >500mg/dl, despite adequate treatment.
boolean
C0202236 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0205411 (UMLS CUI [2,2])
Non-healed wound Postoperative | Wound Free of Operative Surgical Procedures
Item
non-healed post-surgical or non-surgical wound.
boolean
C0750433 (UMLS CUI [1,1])
C0032790 (UMLS CUI [1,2])
C0043250 (UMLS CUI [2,1])
C0332296 (UMLS CUI [2,2])
C0543467 (UMLS CUI [2,3])
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