ID

31807

Beskrivning

Evaluation of the Risk of NSF Following ProHance Injection in Patients With Chronic Kidney Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00600834

Länk

https://clinicaltrials.gov/show/NCT00600834

Nyckelord

Versioner (1)
  1. 2018-09-29 2018-09-29 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

29 september 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Renal Insufficiency NCT00600834

Engelsk

Eligibility Renal Insufficiency NCT00600834

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
cohort 1
Beskrivning

Cohort Number

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0599755
UMLS CUI [1,2]
C0237753
is going to receive or has received prohance injection during an mri examination;
Beskrivning

Prohance Injection During MRI

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0245925
UMLS CUI [1,2]
C1828121
UMLS CUI [1,3]
C0347984
UMLS CUI [1,4]
C0024485
has ckd with egfr stably comprised between 30 and 59 ml/min/1.73m2, as calculated from a scr value obtained from the local laboratory within 24 hours prior to the prohance injection.
Beskrivning

Chronic Kidney Diseases | Estimated Glomerular Filtration Rate Stable | Creatinine measurement, serum

Datatyp

boolean

Alias
UMLS CUI [1]
C1561643
UMLS CUI [2,1]
C3811844
UMLS CUI [2,2]
C0205360
UMLS CUI [3]
C0201976
provides written informed consent and is willing to comply with protocol requirements.
Beskrivning

Informed Consent | Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
cohort 2
Beskrivning

Cohort Number

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0599755
UMLS CUI [1,2]
C0237753
is going to receive or has received prohance injection during an mri examination;
Beskrivning

Prohance Injection During MRI

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0245925
UMLS CUI [1,2]
C1828121
UMLS CUI [1,3]
C0347984
UMLS CUI [1,4]
C0024485
has ckd with egfr below 30 ml/min/1.73m2, as calculated from a scr value obtained from the local laboratory within 24 hours prior to the prohance injection.
Beskrivning

Chronic Kidney Diseases | Estimated Glomerular Filtration Rate | Creatinine measurement, serum

Datatyp

boolean

Alias
UMLS CUI [1]
C1561643
UMLS CUI [2]
C3811844
UMLS CUI [3]
C0201976
provides written informed consent and is willing to comply with protocol requirements.
Beskrivning

Informed Consent | Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
cohort 1
Beskrivning

Cohort Number

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0599755
UMLS CUI [1,2]
C0237753
has received a gbca within the past 12 months prior to inclusion in this study;
Beskrivning

Gadolinium-based Contrast Agent

Datatyp

boolean

Alias
UMLS CUI [1]
C3249258
has unstable kidney function;
Beskrivning

Renal function Unstable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0232804
UMLS CUI [1,2]
C0443343
has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data and achieving study objectives;
Beskrivning

Medical condition Limiting Research data | Circumstances Limiting Research data | Medical condition Limiting Study Objective | Circumstances Limiting Study Objective

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0681873
UMLS CUI [2,1]
C0680082
UMLS CUI [2,2]
C0439801
UMLS CUI [2,3]
C0681873
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0439801
UMLS CUI [3,3]
C2985627
UMLS CUI [4,1]
C0680082
UMLS CUI [4,2]
C0439801
UMLS CUI [4,3]
C2985627
has ever been suspected of, or diagnosed with, nsf prior to the study-specific mri;
Beskrivning

Nephrogenic Systemic Fibrosis Suspected | Nephrogenic Systemic Fibrosis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3888044
UMLS CUI [1,2]
C0750491
UMLS CUI [2]
C3888044
is unable or unwilling to return for necessary office visits, to be examined by dermatologists or to undergo deep skin biopsy should development of nsf be suspected.
Beskrivning

Office Visits Unable | Office Visits Unwilling | Examination Dermatologist Unable | Examination Dermatologist Unwilling | Deep biopsy Skin Unable | Deep biopsy Skin Unwilling | Relationship Nephrogenic Systemic Fibrosis Suspected

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0028900
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0028900
UMLS CUI [2,2]
C0558080
UMLS CUI [3,1]
C0031809
UMLS CUI [3,2]
C0259831
UMLS CUI [3,3]
C1299582
UMLS CUI [4,1]
C0031809
UMLS CUI [4,2]
C0259831
UMLS CUI [4,3]
C0558080
UMLS CUI [5,1]
C4038483
UMLS CUI [5,2]
C1123023
UMLS CUI [5,3]
C1299582
UMLS CUI [6,1]
C4038483
UMLS CUI [6,2]
C1123023
UMLS CUI [6,3]
C0558080
UMLS CUI [7,1]
C0439849
UMLS CUI [7,2]
C3888044
UMLS CUI [7,3]
C0750491
cohort 2
Beskrivning

Cohort Number

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0599755
UMLS CUI [1,2]
C0237753
has received a gbca within the past 12 months prior to inclusion in this study;
Beskrivning

Gadolinium-based Contrast Agent

Datatyp

boolean

Alias
UMLS CUI [1]
C3249258
has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data and achieving study objectives;
Beskrivning

Medical condition Limiting Research data | Circumstances Limiting Research data | Medical condition Limiting Study Objective | Circumstances Limiting Study Objective

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0681873
UMLS CUI [2,1]
C0680082
UMLS CUI [2,2]
C0439801
UMLS CUI [2,3]
C0681873
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0439801
UMLS CUI [3,3]
C2985627
UMLS CUI [4,1]
C0680082
UMLS CUI [4,2]
C0439801
UMLS CUI [4,3]
C2985627
has ever been suspected of, or diagnosed with, nsf prior to the study-specific mri;
Beskrivning

Nephrogenic Systemic Fibrosis Suspected | Nephrogenic Systemic Fibrosis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3888044
UMLS CUI [1,2]
C0750491
UMLS CUI [2]
C3888044
is unable or unwilling to return for necessary office visits, to be examined by dermatologists or to undergo deep skin biopsy should development of nsf be suspected.
Beskrivning

Office Visits Unable | Office Visits Unwilling | Examination Dermatologist Unable | Examination Dermatologist Unwilling | Deep biopsy Skin Unable | Deep biopsy Skin Unwilling | Relationship Nephrogenic Systemic Fibrosis Suspected

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0028900
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0028900
UMLS CUI [2,2]
C0558080
UMLS CUI [3,1]
C0031809
UMLS CUI [3,2]
C0259831
UMLS CUI [3,3]
C1299582
UMLS CUI [4,1]
C0031809
UMLS CUI [4,2]
C0259831
UMLS CUI [4,3]
C0558080
UMLS CUI [5,1]
C4038483
UMLS CUI [5,2]
C1123023
UMLS CUI [5,3]
C1299582
UMLS CUI [6,1]
C4038483
UMLS CUI [6,2]
C1123023
UMLS CUI [6,3]
C0558080
UMLS CUI [7,1]
C0439849
UMLS CUI [7,2]
C3888044
UMLS CUI [7,3]
C0750491
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Similar models

Eligibility Renal Insufficiency NCT00600834

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Cohort Number
Item
cohort 1
boolean
C0599755 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Prohance Injection During MRI
Item
is going to receive or has received prohance injection during an mri examination;
boolean
C0245925 (UMLS CUI [1,1])
C1828121 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0024485 (UMLS CUI [1,4])
Chronic Kidney Diseases | Estimated Glomerular Filtration Rate Stable | Creatinine measurement, serum
Item
has ckd with egfr stably comprised between 30 and 59 ml/min/1.73m2, as calculated from a scr value obtained from the local laboratory within 24 hours prior to the prohance injection.
boolean
C1561643 (UMLS CUI [1])
C3811844 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
C0201976 (UMLS CUI [3])
Informed Consent | Protocol Compliance
Item
provides written informed consent and is willing to comply with protocol requirements.
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Cohort Number
Item
cohort 2
boolean
C0599755 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Prohance Injection During MRI
Item
is going to receive or has received prohance injection during an mri examination;
boolean
C0245925 (UMLS CUI [1,1])
C1828121 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0024485 (UMLS CUI [1,4])
Chronic Kidney Diseases | Estimated Glomerular Filtration Rate | Creatinine measurement, serum
Item
has ckd with egfr below 30 ml/min/1.73m2, as calculated from a scr value obtained from the local laboratory within 24 hours prior to the prohance injection.
boolean
C1561643 (UMLS CUI [1])
C3811844 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
Informed Consent | Protocol Compliance
Item
provides written informed consent and is willing to comply with protocol requirements.
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Cohort Number
Item
cohort 1
boolean
C0599755 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Gadolinium-based Contrast Agent
Item
has received a gbca within the past 12 months prior to inclusion in this study;
boolean
C3249258 (UMLS CUI [1])
Renal function Unstable
Item
has unstable kidney function;
boolean
C0232804 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
Medical condition Limiting Research data | Circumstances Limiting Research data | Medical condition Limiting Study Objective | Circumstances Limiting Study Objective
Item
has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data and achieving study objectives;
boolean
C3843040 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0681873 (UMLS CUI [1,3])
C0680082 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0681873 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C0439801 (UMLS CUI [3,2])
C2985627 (UMLS CUI [3,3])
C0680082 (UMLS CUI [4,1])
C0439801 (UMLS CUI [4,2])
C2985627 (UMLS CUI [4,3])
Nephrogenic Systemic Fibrosis Suspected | Nephrogenic Systemic Fibrosis
Item
has ever been suspected of, or diagnosed with, nsf prior to the study-specific mri;
boolean
C3888044 (UMLS CUI [1,1])
C0750491 (UMLS CUI [1,2])
C3888044 (UMLS CUI [2])
Office Visits Unable | Office Visits Unwilling | Examination Dermatologist Unable | Examination Dermatologist Unwilling | Deep biopsy Skin Unable | Deep biopsy Skin Unwilling | Relationship Nephrogenic Systemic Fibrosis Suspected
Item
is unable or unwilling to return for necessary office visits, to be examined by dermatologists or to undergo deep skin biopsy should development of nsf be suspected.
boolean
C0028900 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0028900 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
C0031809 (UMLS CUI [3,1])
C0259831 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
C0031809 (UMLS CUI [4,1])
C0259831 (UMLS CUI [4,2])
C0558080 (UMLS CUI [4,3])
C4038483 (UMLS CUI [5,1])
C1123023 (UMLS CUI [5,2])
C1299582 (UMLS CUI [5,3])
C4038483 (UMLS CUI [6,1])
C1123023 (UMLS CUI [6,2])
C0558080 (UMLS CUI [6,3])
C0439849 (UMLS CUI [7,1])
C3888044 (UMLS CUI [7,2])
C0750491 (UMLS CUI [7,3])
Cohort Number
Item
cohort 2
boolean
C0599755 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Gadolinium-based Contrast Agent
Item
has received a gbca within the past 12 months prior to inclusion in this study;
boolean
C3249258 (UMLS CUI [1])
Medical condition Limiting Research data | Circumstances Limiting Research data | Medical condition Limiting Study Objective | Circumstances Limiting Study Objective
Item
has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data and achieving study objectives;
boolean
C3843040 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0681873 (UMLS CUI [1,3])
C0680082 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0681873 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C0439801 (UMLS CUI [3,2])
C2985627 (UMLS CUI [3,3])
C0680082 (UMLS CUI [4,1])
C0439801 (UMLS CUI [4,2])
C2985627 (UMLS CUI [4,3])
Nephrogenic Systemic Fibrosis Suspected | Nephrogenic Systemic Fibrosis
Item
has ever been suspected of, or diagnosed with, nsf prior to the study-specific mri;
boolean
C3888044 (UMLS CUI [1,1])
C0750491 (UMLS CUI [1,2])
C3888044 (UMLS CUI [2])
Office Visits Unable | Office Visits Unwilling | Examination Dermatologist Unable | Examination Dermatologist Unwilling | Deep biopsy Skin Unable | Deep biopsy Skin Unwilling | Relationship Nephrogenic Systemic Fibrosis Suspected
Item
is unable or unwilling to return for necessary office visits, to be examined by dermatologists or to undergo deep skin biopsy should development of nsf be suspected.
boolean
C0028900 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0028900 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
C0031809 (UMLS CUI [3,1])
C0259831 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
C0031809 (UMLS CUI [4,1])
C0259831 (UMLS CUI [4,2])
C0558080 (UMLS CUI [4,3])
C4038483 (UMLS CUI [5,1])
C1123023 (UMLS CUI [5,2])
C1299582 (UMLS CUI [5,3])
C4038483 (UMLS CUI [6,1])
C1123023 (UMLS CUI [6,2])
C0558080 (UMLS CUI [6,3])
C0439849 (UMLS CUI [7,1])
C3888044 (UMLS CUI [7,2])
C0750491 (UMLS CUI [7,3])
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