0 Evaluaciones
ID

16861

Descripción

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

Link

https://clinicaltrials.gov/show/NCT00476619

Palabras clave

Versiones (1)
  1. 11/8/16 11/8/16 -
Subido en

11 de agosto de 2016

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

  • El más nuevo
  • Más antiguo
  • Popular
  • El más nuevo
    • El más nuevo
    • Más antiguo
    • Popular

    Sin comentarios

    Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

    Eligibility Contrast Induced Nephropathy NCT00476619

    Inglés

    Eligibility Contrast Induced Nephropathy NCT00476619

    1 formularios  
    Inclusion Criteria
    Descripción

    Inclusion Criteria

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

    Age

    Tipo de datos

    boolean

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

    X-Ray Computed Tomography Planned | CONTRAST DYE INTRAVENOUS

    Tipo de datos

    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
    Descripción

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

    Tipo de datos

    boolean

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

    Informed consent

    Tipo de datos

    boolean

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

    Diuretics | Anti-Inflammatory Agents, Non-Steroidal

    Tipo de datos

    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
    Descripción

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

    Tipo de datos

    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
    Descripción

    Exclusion Criteria

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

    Pregnancy | Breast Feeding

    Tipo de datos

    boolean

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

    Kidney Failure, Chronic | Hemodialysis | Peritoneal Dialysis

    Tipo de datos

    boolean

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

    Kidney Failure, Acute

    Tipo de datos

    boolean

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

    Glucophage | Metformin | Glucovance

    Tipo de datos

    boolean

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

    Informed Consent Unable

    Tipo de datos

    boolean

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

    Peritoneal Dialysis | Hemodialysis

    Tipo de datos

    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.
    Descripción

    Study Subject Participation Status | Investigational New Drugs

    Tipo de datos

    boolean

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

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

    Tipo de datos

    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.
    Descripción

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

    Tipo de datos

    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
    Descripción

    Age

    Tipo de datos

    boolean

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

    Erythropoietin Replacement | Erythropoietin Transfusion

    Tipo de datos

    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
    Descripción

    Hemoglobin

    Tipo de datos

    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.
    Descripción

    Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure

    Tipo de datos

    boolean

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

    Hemodynamic instability Evidence of

    Tipo de datos

    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
    Descripción

    Mental Incompetency Protocol Compliance Limited | Other Reason Protocol Compliance Limited

    Tipo de datos

    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
    Descripción

    Medical Record accessibility

    Tipo de datos

    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
    Descripción

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

    Tipo de datos

    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.
    Descripción

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

    Tipo de datos

    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
    Descripción

    Epilepsy

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0014544
    Volver a la parte superior de la página

    Similar models

    Eligibility Contrast Induced Nephropathy NCT00476619

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    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])
    Volver a la parte superior de la página 

    Ayuda

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial