ID

16861

Beskrivning

Erythropoietin in Radiocontrast Induced Nephropathy (ERIN) Trial; ODM derived from: https://clinicaltrials.gov/show/NCT00476619

Länk

https://clinicaltrials.gov/show/NCT00476619

Nyckelord

Versioner (1)
  1. 2016-08-11 2016-08-11 -
Uppladdad den

11 augusti 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Contrast Induced Nephropathy NCT00476619

Engelsk

Eligibility Contrast Induced Nephropathy NCT00476619

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. subjects age 18 and over and of either gender.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
2. scheduled to receive ct scan with intravenous contrast dye.
Beskrivning

X-Ray Computed Tomography Planned | CONTRAST DYE INTRAVENOUS

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0040405
UMLS CUI [1,2]
C1301732
UMLS CUI [2]
C0742799
3. non diabetics or subjects with type 1 or 2 diabetes mellitus
Beskrivning

Diabetic | Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent

Datatyp

boolean

Alias
UMLS CUI [1]
C0241863
UMLS CUI [2]
C0011854
UMLS CUI [3]
C0011860
4. written informed consent.
Beskrivning

Informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
5. subjects who are on diuretics and non-steroidal inflammatory agents will not be excluded.
Beskrivning

Diuretics | Anti-Inflammatory Agents, Non-Steroidal

Datatyp

boolean

Alias
UMLS CUI [1]
C0012798
UMLS CUI [2]
C0003211
6. subjects who have received n-acetylcysteine or sodium bicarbonate pre ct scan will not be excluded
Beskrivning

n-Acetylcysteine Before X-Ray Computed Tomography | Sodium Bicarbonate Before X-Ray Computed Tomography

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0001047
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0040405
UMLS CUI [2,1]
C0074722
UMLS CUI [2,2]
C0332152
UMLS CUI [2,3]
C0040405
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. pregnant or lactating women.
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
2. end-stage renal disease (on hemodialysis or peritoneal dialysis)
Beskrivning

Kidney Failure, Chronic | Hemodialysis | Peritoneal Dialysis

Datatyp

boolean

Alias
UMLS CUI [1]
C0022661
UMLS CUI [2]
C0019004
UMLS CUI [3]
C0031139
3. a known history of acute renal failure
Beskrivning

Kidney Failure, Acute

Datatyp

boolean

Alias
UMLS CUI [1]
C0022660
4. subjects receiving glucophage/metformin or glucovance
Beskrivning

Glucophage | Metformin | Glucovance

Datatyp

boolean

Alias
UMLS CUI [1]
C0591573
UMLS CUI [2]
C0025598
UMLS CUI [3]
C0939344
5. subjects who cannot give written informed consent.
Beskrivning

Informed Consent Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
6. subjects receiving peritoneal dialysis or hemodialysis.
Beskrivning

Peritoneal Dialysis | Hemodialysis

Datatyp

boolean

Alias
UMLS CUI [1]
C0031139
UMLS CUI [2]
C0019004
7. subjects enrolled in another investigational drug study ≤ 30 days of enrollment into the present study.
Beskrivning

Study Subject Participation Status | Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
8. subjects with a known hypersensitivity or anaphylaxis to contrast dye or iodine.
Beskrivning

contrast dye allergy | Iodine allergy | anaphylaxis contrast dye | anaphylaxis Iodine

Datatyp

boolean

Alias
UMLS CUI [1]
C0742797
UMLS CUI [2]
C0571818
UMLS CUI [3,1]
C0002792
UMLS CUI [3,2]
C0742795
UMLS CUI [4,1]
C0002792
UMLS CUI [4,2]
C0021968
9. subjects with known hypersensitivity or anaphylaxis to erythropoietin, mammalian-cell derived products, or human albumin.
Beskrivning

Hypersensitivity Erythropoietin | anaphylaxis Erythropoietin | Hypersensitivity product Mammalian Cell Derived | anaphylaxis product Mammalian Cell Derived | Hypersensitivity Albumin Human | anaphylaxis Albumin Human

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0014822
UMLS CUI [2,1]
C0002792
UMLS CUI [2,2]
C0014822
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C1514468
UMLS CUI [3,3]
C1512977
UMLS CUI [3,4]
C1441547
UMLS CUI [4,1]
C0002792
UMLS CUI [4,2]
C1514468
UMLS CUI [4,3]
C1512977
UMLS CUI [4,4]
C1441547
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0304925
UMLS CUI [6,1]
C0002792
UMLS CUI [6,2]
C0304925
10. age < 18 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
11. use of any erythropoietin replacement or transfusion within the prior 3 days
Beskrivning

Erythropoietin Replacement | Erythropoietin Transfusion

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0014822
UMLS CUI [1,2]
C0559956
UMLS CUI [2,1]
C0014822
UMLS CUI [2,2]
C1879316
12. baseline hemoglobin > 12.0 g/dl
Beskrivning

Hemoglobin

Datatyp

boolean

Alias
UMLS CUI [1]
C0019046
13. uncontrolled hypertension, systolic bp > 180 mmhg or diastolic bp > 110 mmhg in any recording in the past 24 hours.
Beskrivning

Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure

Datatyp

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
14. evidence of hemodynamic instability
Beskrivning

Hemodynamic instability Evidence of

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0948268
UMLS CUI [1,2]
C0332120
15. subject unable to follow protocol due to mental incompetence or other reason
Beskrivning

Mental Incompetency Protocol Compliance Limited | Other Reason Protocol Compliance Limited

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0086455
UMLS CUI [1,2]
C0525058
UMLS CUI [1,3]
C0439801
UMLS CUI [2,1]
C3840932
UMLS CUI [2,2]
C0525058
UMLS CUI [2,3]
C0439801
16. inaccessibility of medical record
Beskrivning

Medical Record accessibility

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0025102
UMLS CUI [1,2]
C0814423
17. subjects with a history of mi, cva, active angina or unstable angina within the past three months
Beskrivning

Myocardial Infarction | Cerebrovascular accident | Angina Pectoris | Angina, Unstable

Datatyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0002962
UMLS CUI [4]
C0002965
18. subjects with a history of current malignancy, where current malignancy is defined as subjects undergoing treatment with chemotherapy or radiation therapy, subjects with known metastatic disease, and those with terminal malignant disease.
Beskrivning

Malignant Neoplasms | Chemotherapy Regimen | Therapeutic radiology procedure | Neoplasm Metastasis | End stage cancer

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0392920
UMLS CUI [3]
C1522449
UMLS CUI [4]
C0027627
UMLS CUI [5]
C0741884
19. subject with any known history of seizure disorders
Beskrivning

Epilepsy

Datatyp

boolean

Alias
UMLS CUI [1]
C0014544
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Similar models

Eligibility Contrast Induced Nephropathy NCT00476619

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. subjects age 18 and over and of either gender.
boolean
C0001779 (UMLS CUI [1])
X-Ray Computed Tomography Planned | CONTRAST DYE INTRAVENOUS
Item
2. scheduled to receive ct scan with intravenous contrast dye.
boolean
C0040405 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0742799 (UMLS CUI [2])
Diabetic | Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent
Item
3. non diabetics or subjects with type 1 or 2 diabetes mellitus
boolean
C0241863 (UMLS CUI [1])
C0011854 (UMLS CUI [2])
C0011860 (UMLS CUI [3])
Informed consent
Item
4. written informed consent.
boolean
C0021430 (UMLS CUI [1])
Diuretics | Anti-Inflammatory Agents, Non-Steroidal
Item
5. subjects who are on diuretics and non-steroidal inflammatory agents will not be excluded.
boolean
C0012798 (UMLS CUI [1])
C0003211 (UMLS CUI [2])
n-Acetylcysteine Before X-Ray Computed Tomography | Sodium Bicarbonate Before X-Ray Computed Tomography
Item
6. subjects who have received n-acetylcysteine or sodium bicarbonate pre ct scan will not be excluded
boolean
C0001047 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0040405 (UMLS CUI [1,3])
C0074722 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
C0040405 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
1. pregnant or lactating women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Kidney Failure, Chronic | Hemodialysis | Peritoneal Dialysis
Item
2. end-stage renal disease (on hemodialysis or peritoneal dialysis)
boolean
C0022661 (UMLS CUI [1])
C0019004 (UMLS CUI [2])
C0031139 (UMLS CUI [3])
Kidney Failure, Acute
Item
3. a known history of acute renal failure
boolean
C0022660 (UMLS CUI [1])
Glucophage | Metformin | Glucovance
Item
4. subjects receiving glucophage/metformin or glucovance
boolean
C0591573 (UMLS CUI [1])
C0025598 (UMLS CUI [2])
C0939344 (UMLS CUI [3])
Informed Consent Unable
Item
5. subjects who cannot give written informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Peritoneal Dialysis | Hemodialysis
Item
6. subjects receiving peritoneal dialysis or hemodialysis.
boolean
C0031139 (UMLS CUI [1])
C0019004 (UMLS CUI [2])
Study Subject Participation Status | Investigational New Drugs
Item
7. subjects enrolled in another investigational drug study ≤ 30 days of enrollment into the present study.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
contrast dye allergy | Iodine allergy | anaphylaxis contrast dye | anaphylaxis Iodine
Item
8. subjects with a known hypersensitivity or anaphylaxis to contrast dye or iodine.
boolean
C0742797 (UMLS CUI [1])
C0571818 (UMLS CUI [2])
C0002792 (UMLS CUI [3,1])
C0742795 (UMLS CUI [3,2])
C0002792 (UMLS CUI [4,1])
C0021968 (UMLS CUI [4,2])
Hypersensitivity Erythropoietin | anaphylaxis Erythropoietin | Hypersensitivity product Mammalian Cell Derived | anaphylaxis product Mammalian Cell Derived | Hypersensitivity Albumin Human | anaphylaxis Albumin Human
Item
9. subjects with known hypersensitivity or anaphylaxis to erythropoietin, mammalian-cell derived products, or human albumin.
boolean
C0020517 (UMLS CUI [1,1])
C0014822 (UMLS CUI [1,2])
C0002792 (UMLS CUI [2,1])
C0014822 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C1514468 (UMLS CUI [3,2])
C1512977 (UMLS CUI [3,3])
C1441547 (UMLS CUI [3,4])
C0002792 (UMLS CUI [4,1])
C1514468 (UMLS CUI [4,2])
C1512977 (UMLS CUI [4,3])
C1441547 (UMLS CUI [4,4])
C0020517 (UMLS CUI [5,1])
C0304925 (UMLS CUI [5,2])
C0002792 (UMLS CUI [6,1])
C0304925 (UMLS CUI [6,2])
Age
Item
10. age < 18 years
boolean
C0001779 (UMLS CUI [1])
Erythropoietin Replacement | Erythropoietin Transfusion
Item
11. use of any erythropoietin replacement or transfusion within the prior 3 days
boolean
C0014822 (UMLS CUI [1,1])
C0559956 (UMLS CUI [1,2])
C0014822 (UMLS CUI [2,1])
C1879316 (UMLS CUI [2,2])
Hemoglobin
Item
12. baseline hemoglobin > 12.0 g/dl
boolean
C0019046 (UMLS CUI [1])
Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure
Item
13. uncontrolled hypertension, systolic bp > 180 mmhg or diastolic bp > 110 mmhg in any recording in the past 24 hours.
boolean
C1868885 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Hemodynamic instability Evidence of
Item
14. evidence of hemodynamic instability
boolean
C0948268 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
Mental Incompetency Protocol Compliance Limited | Other Reason Protocol Compliance Limited
Item
15. subject unable to follow protocol due to mental incompetence or other reason
boolean
C0086455 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C3840932 (UMLS CUI [2,1])
C0525058 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
Medical Record accessibility
Item
16. inaccessibility of medical record
boolean
C0025102 (UMLS CUI [1,1])
C0814423 (UMLS CUI [1,2])
Myocardial Infarction | Cerebrovascular accident | Angina Pectoris | Angina, Unstable
Item
17. subjects with a history of mi, cva, active angina or unstable angina within the past three months
boolean
C0027051 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0002962 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
Malignant Neoplasms | Chemotherapy Regimen | Therapeutic radiology procedure | Neoplasm Metastasis | End stage cancer
Item
18. subjects with a history of current malignancy, where current malignancy is defined as subjects undergoing treatment with chemotherapy or radiation therapy, subjects with known metastatic disease, and those with terminal malignant disease.
boolean
C0006826 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0027627 (UMLS CUI [4])
C0741884 (UMLS CUI [5])
Epilepsy
Item
19. subject with any known history of seizure disorders
boolean
C0014544 (UMLS CUI [1])
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