ID

41784

Description

PKD Clinical and Translational Core Study; ODM derived from: https://clinicaltrials.gov/show/NCT01873235

Link

https://clinicaltrials.gov/show/NCT01873235

Keywords

  1. 1/20/21 1/20/21 - Ahmed Rafee, MD
  2. 1/21/21 1/21/21 - Ahmed Rafee, MD
Copyright Holder

UUniversity of Maryland, Baltimore

Uploaded on

January 20, 2021

DOI

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License

Creative Commons BY 4.0

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Eligibility Polycystic Kidney Disease NCT01873235

Eligibility Polycystic Kidney Disease NCT01873235

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 18 and older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
adpkd confirmed by genetic testing or ultrasound criteria using modified ravine criteria: with family history:several cysts per kidney (3 by sonography, 5 if by computerized tomography or mri)without family history: 10 cysts (by any radiologic method) per kidney and exclusion of other cystic kidney diseases
Description

ADPKD Diagnosis confirmed by genetic testing | ADPKD Diagnosis confirmed by ultrasound using modified Ravine criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0085413
UMLS CUI [1,2]
C0679560
UMLS CUI [2,1]
C0085413
UMLS CUI [2,2]
C4736886
UMLS CUI [2,3]
C0679228
ability to provide written informed consent prior to initiation of any study procedures and the ability in the opinion of the investigator to comply with all requirements of the study
Description

Informed Consent | Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
glomerular filtration rate (gfr) less than 20ml/min/1.73m2
Description

GFR

Data type

boolean

Alias
UMLS CUI [1]
C0017654
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
end stage renal disease or presently on dialysis or a prior kidney transplant
Description

End stage renal disease | Currently on renal dialysis | History of kidney transplantation

Data type

boolean

Alias
UMLS CUI [1]
C0022661
UMLS CUI [2,1]
C0011946
UMLS CUI [2,2]
C0521116
UMLS CUI [3]
C0022671
inability to undergo MRI due to any reason including presence of pacemaker and defibrillator
Description

Contraindication to MRI | Presence of a Pacemaker | Presence of an implantable Defibrillator

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
UMLS CUI [2]
C0030163
UMLS CUI [3]
C0162589
allergy to contrast or iodine
Description

Allergy to Contrast Media | Iodine Allergy

Data type

boolean

Alias
UMLS CUI [1]
C0570562
UMLS CUI [2]
C0571818
pregnant, lactating, or intention to get pregnant in next 6 weeks
Description

Pregnancy | Breast Feeding | Pregnancy Intention

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0032961
UMLS CUI [3,2]
C0162425
another systemic disease such as diabetes or lupus
Description

Systemic Disease | Diabetes Mellitus | Lupus Erhythematosus, Systemic

Data type

boolean

Alias
UMLS CUI [1]
C0442893
UMLS CUI [2]
C0011849
UMLS CUI [3]
C0024141
life expectancy less than 2 years
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
current participation in a drug treatment trial
Description

Current participation in a drug treatment trial

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0521116
non english speaking
Description

Non english speaking

Data type

boolean

Alias
UMLS CUI [1]
C1546417

Similar models

Eligibility Polycystic Kidney Disease NCT01873235

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 18 and older
boolean
C0001779 (UMLS CUI [1])
ADPKD Diagnosis confirmed by genetic testing | ADPKD Diagnosis confirmed by ultrasound using modified Ravine criteria
Item
adpkd confirmed by genetic testing or ultrasound criteria using modified ravine criteria: with family history:several cysts per kidney (3 by sonography, 5 if by computerized tomography or mri)without family history: 10 cysts (by any radiologic method) per kidney and exclusion of other cystic kidney diseases
boolean
C0085413 (UMLS CUI [1,1])
C0679560 (UMLS CUI [1,2])
C0085413 (UMLS CUI [2,1])
C4736886 (UMLS CUI [2,2])
C0679228 (UMLS CUI [2,3])
Informed Consent | Protocol Compliance
Item
ability to provide written informed consent prior to initiation of any study procedures and the ability in the opinion of the investigator to comply with all requirements of the study
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
GFR
Item
glomerular filtration rate (gfr) less than 20ml/min/1.73m2
boolean
C0017654 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
End stage renal disease | Currently on renal dialysis | History of kidney transplantation
Item
end stage renal disease or presently on dialysis or a prior kidney transplant
boolean
C0022661 (UMLS CUI [1])
C0011946 (UMLS CUI [2,1])
C0521116 (UMLS CUI [2,2])
C0022671 (UMLS CUI [3])
Contraindication to MRI | Presence of a Pacemaker | Presence of an implantable Defibrillator
Item
inability to undergo MRI due to any reason including presence of pacemaker and defibrillator
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C0030163 (UMLS CUI [2])
C0162589 (UMLS CUI [3])
Allergy to Contrast Media | Iodine Allergy
Item
allergy to contrast or iodine
boolean
C0570562 (UMLS CUI [1])
C0571818 (UMLS CUI [2])
Pregnancy | Breast Feeding | Pregnancy Intention
Item
pregnant, lactating, or intention to get pregnant in next 6 weeks
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C0162425 (UMLS CUI [3,2])
Systemic Disease | Diabetes Mellitus | Lupus Erhythematosus, Systemic
Item
another systemic disease such as diabetes or lupus
boolean
C0442893 (UMLS CUI [1])
C0011849 (UMLS CUI [2])
C0024141 (UMLS CUI [3])
Life Expectancy
Item
life expectancy less than 2 years
boolean
C0023671 (UMLS CUI [1])
Current participation in a drug treatment trial
Item
current participation in a drug treatment trial
boolean
C2348568 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
Non english speaking
Item
non english speaking
boolean
C1546417 (UMLS CUI [1])

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