0 Ratings

ID

18597

Description

A Randomized, Open-Label Study to Compare the Efficacy and Safety of AT1001 and Enzyme Replacement Therapy (ERT) in Patients With Fabry Disease and AT1001-Responsive GLA Mutations, Who Were Previously Treated With ERT Unscheduled Visit

Keywords

  1. 11/2/16 11/2/16 -
  2. 11/11/16 11/11/16 -
Uploaded on

November 11, 2016

DOI

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License

Creative Commons BY-NC 3.0

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    Unscheduled Visit Galafold (migalastat) AT1001-012 NCT01218659

    Unscheduled Visit Galafold (migalastat) AT1001-012 NCT01218659

    Date of visit
    Description

    Date of visit

    Alias
    UMLS CUI-1
    C1320303
    Date of visit
    Description

    Date of visit

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    12 Lead ECG
    Description

    12 Lead ECG

    Alias
    UMLS CUI-1
    C1623258
    Date ECG was performed
    Description

    ECG Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0013798
    UMLS CUI [1,2]
    C0011008
    ECG results
    Description

    ECG results

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1623258
    Hematology/Coagulation
    Description

    Hematology/Coagulation

    Alias
    UMLS CUI-1
    C0474523
    Hematology Sample Collection Date
    Description

    Hematology Sample Collection Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0474523
    UMLS CUI [1,2]
    C0011008
    Are there any laboratory abnormalities, deemed clinically significant by the PI, noted for Hematology?
    Description

    Hematology finding; Laboratory test finding

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0474523
    UMLS CUI [1,2]
    C0587081
    Hematology: clinically significant abnormal laboratory values, please sepcify
    Description

    Hematology: clinically significant abnormal laboratory values, please sepcify

    Alias
    UMLS CUI-1
    C0474523
    UMLS CUI-2
    C1853129
    UMLS CUI-3
    C2826293
    Hematology: clinically significant abnormal laboratory values, please sepcify
    Description

    If lab abnormalities=Yes

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0474523
    UMLS CUI [1,2]
    C1853129
    UMLS CUI [1,3]
    C2826293
    Chemistry, Laboratory findings
    Description

    Chemistry, Laboratory findings

    Alias
    UMLS CUI-1
    C0005774
    Chemistry Sample Collection Date
    Description

    Chemistry Sample Collection Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0005774
    Are there any laboratory abnormalities, deemed clinically significant by the PI, noted for Chemistry?
    Description

    Science of Chemistry; Laboratory test finding

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0005774
    UMLS CUI [1,2]
    C0587081
    Chemistry: clinically significant abnormal laboratory values, please specify
    Description

    Chemistry: clinically significant abnormal laboratory values, please specify

    Alias
    UMLS CUI-1
    C0005774
    UMLS CUI-2
    C2826293
    Chemistry: clinically significant abnormal laboratory values, please specify
    Description

    If lab abnormalities=Yes

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0005774
    UMLS CUI [1,2]
    C2826293
    Urinanalysis
    Description

    Urinanalysis

    Alias
    UMLS CUI-1
    C0042014
    Urinalysis Sample Collection Date
    Description

    Urinalysis Sample Collection Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C0022877
    UMLS CUI [1,3]
    C0011008
    Are there any laboratory abnormalities, deemed clinically significant by the PI, noted for Urinalysis?
    Description

    Urinalysis; Laboratory test finding

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C0587081
    Urinalysis: clinically significant abnormal laboratory values
    Description

    Urinalysis: clinically significant abnormal laboratory values

    Alias
    UMLS CUI-1
    C0042014
    UMLS CUI-2
    C1853129
    UMLS CUI-3
    C2826293
    Urinalysis: clinically significant abnormal laboratory values, please specify
    Description

    If lab abnormalities=Yes

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C1853129
    UMLS CUI [1,3]
    C2826293
    24-Hr Urine Collection
    Description

    24-Hr Urine Collection

    Alias
    UMLS CUI-1
    C0455060
    24-Hr Urine Collection Start Date
    Description

    24-Hr Urine Collection Start Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0455060
    UMLS CUI [1,2]
    C0808070
    24-Hr Urine Collection Start Time
    Description

    24-Hr Urine Collection Start Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0455060
    UMLS CUI [1,2]
    C1301880
    24-Hr Urine Collection Stop Date
    Description

    24-Hr Urine Collection Stop Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0455060
    UMLS CUI [1,2]
    C0806020
    24-Hr Urine Collection Stop Time
    Description

    24-Hr Urine Collection Stop Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0455060
    UMLS CUI [1,2]
    C1522314
    24-Hr Urine Collection Total Volume
    Description

    24-Hr Urine Collection Total Volume

    Data type

    float

    Measurement units
    • ml
    Alias
    UMLS CUI [1,1]
    C0455060
    UMLS CUI [1,2]
    C2700258
    ml
    24-Hr Urine Collection Date Sent to Laboratory
    Description

    24-Hr Urine Collection Date Sent to Laboratory

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0455060
    UMLS CUI [1,2]
    C1515023
    UMLS CUI [1,3]
    C0011008
    Additional Observations
    Description

    Additional Observations

    Alias
    UMLS CUI-1
    C0700325
    Reference date
    Description

    reference date

    Data type

    date

    Alias
    UMLS CUI [1]
    C1719096
    Visit Type
    Description

    Visit

    Data type

    text

    Alias
    UMLS CUI [1]
    C0545082
    electronic case report form
    Description

    eCRF

    Data type

    text

    Alias
    UMLS CUI [1]
    C1516308
    Comment
    Description

    Comment

    Data type

    text

    Alias
    UMLS CUI [1]
    C0947611
    Vital Signs
    Description

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    Date of Assessment
    Description

    Assessment Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2985720
    Body weight
    Description

    Weight

    Data type

    float

    Measurement units
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Blood pressure measurement systolic
    Description

    Blood pressure

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0005823
    mmHg
    Blood pressure measurement diastolic
    Description

    Blood pressure

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0005823
    mmHg
    Heart rate
    Description

    Heart rate

    Data type

    integer

    Measurement units
    • bpm
    Alias
    UMLS CUI [1]
    C0018810
    bpm
    Respiration rate, Breathing rate (BR)
    Description

    Respiration Rate

    Data type

    integer

    Measurement units
    • /min
    Alias
    UMLS CUI [1]
    C0231832
    /min
    GFR of Iohexol
    Description

    GFR of Iohexol

    Alias
    UMLS CUI-1
    C0017654
    GFR of Iohexol
    Description

    GFR of Iohexol

    Data type

    float

    Alias
    UMLS CUI [1]
    C0017654
    Echocardiography
    Description

    Echocardiography

    Alias
    UMLS CUI-1
    C0013516
    Date of echocardiography
    Description

    Date echocardiography

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0013516
    Brain MRI
    Description

    Brain MRI

    Alias
    UMLS CUI-1
    C0412675
    MRI: Date
    Description

    MRI date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0024485
    UMLS CUI [1,2]
    C0011008
    MRI: Results
    Description

    MRI Results

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0024485
    UMLS CUI [1,2]
    C1274040
    MRI Abnormalities
    Description

    If clinically significant: please specify any abnormal interpretation

    Data type

    text

    Alias
    UMLS CUI [1]
    C0024485
    Physical Examination
    Description

    Physical Examination

    Alias
    UMLS CUI-1
    C0031809
    Date Physical Examination performed:
    Description

    Date of Examination

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826643
    Physical Exam Status
    Description

    Physical Exam Status

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0031809
    Physical Exam Findings, Body Systems
    Description

    Body Systems Physical Exam Findings

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0031809
    UMLS CUI [2]
    C0460002
    Physical Exam Findings
    Description

    If Clinically significant findings, please specify

    Data type

    text

    Alias
    UMLS CUI [1]
    C0031809
    Unscheduled Visit
    Description

    Unscheduled Visit

    Alias
    UMLS CUI-1
    C0545082
    UMLS CUI-2
    C3854240
    Which forms do you need to complete at this unscheduled visit?
    Description

    Which forms do you need to complete at this unscheduled visit?

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1516308
    UMLS CUI [1,2]
    C0205197

    Similar models

    Unscheduled Visit Galafold (migalastat) AT1001-012 NCT01218659

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Date of visit
    C1320303 (UMLS CUI-1)
    Date of visit
    Item
    Date of visit
    date
    C1320303 (UMLS CUI [1])
    Item Group
    12 Lead ECG
    C1623258 (UMLS CUI-1)
    ECG Date
    Item
    Date ECG was performed
    date
    C0013798 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    ECG results
    integer
    C1623258 (UMLS CUI [1])
    Code List
    ECG results
    CL Item
    Normal (1)
    CL Item
    Abnormal, not clinically significant (2)
    CL Item
    Abnormal, clinically significant (3)
    Item Group
    C0474523 (UMLS CUI-1)
    Hematology Sample Collection Date
    Item
    Hematology Sample Collection Date
    date
    C0474523 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Are there any laboratory abnormalities, deemed clinically significant by the PI, noted for Hematology?
    integer
    C0474523 (UMLS CUI [1,1])
    C0587081 (UMLS CUI [1,2])
    Code List
    Are there any laboratory abnormalities, deemed clinically significant by the PI, noted for Hematology?
    CL Item
    Yes (1)
    CL Item
    No (2)
    Item Group
    Hematology: clinically significant abnormal laboratory values, please sepcify
    C0474523 (UMLS CUI-1)
    C1853129 (UMLS CUI-2)
    C2826293 (UMLS CUI-3)
    Item
    Hematology: clinically significant abnormal laboratory values, please sepcify
    integer
    C0474523 (UMLS CUI [1,1])
    C1853129 (UMLS CUI [1,2])
    C2826293 (UMLS CUI [1,3])
    Code List
    Hematology: clinically significant abnormal laboratory values, please sepcify
    CL Item
    Total Hemoglobin (1)
    CL Item
    Hematocrit (2)
    CL Item
    Erythrocyte (3)
    CL Item
    Platelet Count (4)
    CL Item
    Leukocyte (5)
    CL Item
    MCV (6)
    CL Item
    MCH (7)
    CL Item
    MCHC (8)
    CL Item
    RDW (9)
    CL Item
    Neutrophils (10)
    CL Item
    Lymphocytes (11)
    CL Item
    Monocytes (12)
    CL Item
    Eosinophils (13)
    CL Item
    Basophils (14)
    CL Item
    Neutrophils, ABS (15)
    CL Item
    Lymphocytes, ABS (16)
    CL Item
    Monocytes, ABS (17)
    CL Item
    Eosinophils, ABS (18)
    CL Item
    Basophils, ABS (19)
    CL Item
    Morphology (20)
    CL Item
    Co-Ag, INR (Screening only) (21)
    CL Item
    Co-Ag, aPTT (Screening only) (22)
    Item Group
    Chemistry, Laboratory findings
    C0005774 (UMLS CUI-1)
    Chemistry Sample Collection Date
    Item
    Chemistry Sample Collection Date
    date
    C0005774 (UMLS CUI [1])
    Item
    Are there any laboratory abnormalities, deemed clinically significant by the PI, noted for Chemistry?
    integer
    C0005774 (UMLS CUI [1,1])
    C0587081 (UMLS CUI [1,2])
    Code List
    Are there any laboratory abnormalities, deemed clinically significant by the PI, noted for Chemistry?
    CL Item
    Yes (1)
    CL Item
    No (2)
    Item Group
    Chemistry: clinically significant abnormal laboratory values, please specify
    C0005774 (UMLS CUI-1)
    C2826293 (UMLS CUI-2)
    Item
    Chemistry: clinically significant abnormal laboratory values, please specify
    integer
    C0005774 (UMLS CUI [1,1])
    C2826293 (UMLS CUI [1,2])
    Code List
    Chemistry: clinically significant abnormal laboratory values, please specify
    CL Item
    AST (1)
    CL Item
    ALT (2)
    CL Item
    Alkaline Phosphate (3)
    CL Item
    Total Bilirubin (4)
    CL Item
    Creatinine (5)
    CL Item
    Urea (6)
    CL Item
    Non-Fasting Glucose (7)
    CL Item
    Calcium (8)
    CL Item
    Calcium (Albumin Corrected) (9)
    CL Item
    Sodium (10)
    CL Item
    Potassium (11)
    CL Item
    Magnesium (12)
    CL Item
    Total Protein (13)
    CL Item
    Albumin (14)
    CL Item
    Bicarbonate (15)
    CL Item
    LDH (16)
    CL Item
    Blood Urea Nitrogen (BUN) (17)
    CL Item
    Chloride (18)
    CL Item
    Phosphorus (19)
    CL Item
    eGFR MDRD, ID MS Traceable (20)
    CL Item
    Cholesterol  (21)
    CL Item
    Creatinine Phosphokinase (CPK) (22)
    CL Item
    Glutamyltransferase (23)
    CL Item
    Triglyceride (24)
    CL Item
    Uric Acid (25)
    Item Group
    C0042014 (UMLS CUI-1)
    Urinalysis Sample Collection Date
    Item
    Urinalysis Sample Collection Date
    date
    C0042014 (UMLS CUI [1,1])
    C0022877 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Item
    Are there any laboratory abnormalities, deemed clinically significant by the PI, noted for Urinalysis?
    integer
    C0042014 (UMLS CUI [1,1])
    C0587081 (UMLS CUI [1,2])
    Code List
    Are there any laboratory abnormalities, deemed clinically significant by the PI, noted for Urinalysis?
    CL Item
    Yes (1)
    CL Item
    No (2)
    Item Group
    Urinalysis: clinically significant abnormal laboratory values
    C0042014 (UMLS CUI-1)
    C1853129 (UMLS CUI-2)
    C2826293 (UMLS CUI-3)
    Item
    Urinalysis: clinically significant abnormal laboratory values, please specify
    integer
    C0042014 (UMLS CUI [1,1])
    C1853129 (UMLS CUI [1,2])
    C2826293 (UMLS CUI [1,3])
    Code List
    Urinalysis: clinically significant abnormal laboratory values, please specify
    CL Item
    Specific Gravity (1)
    CL Item
    pH (2)
    CL Item
    Protein (3)
    CL Item
    Glucose (4)
    CL Item
    Ketones (5)
    CL Item
    Blood (6)
    CL Item
    Leukocyte Esterase (7)
    CL Item
    Nitrite (8)
    CL Item
    Bilirubin (9)
    CL Item
    Urobilinogen (10)
    CL Item
    WBC (11)
    CL Item
    RBC (12)
    CL Item
    Color (13)
    CL Item
    Apperance (14)
    CL Item
    Microalbumin, 24-HR Urine (mg/day) (15)
    CL Item
    Protein, 24-HR Urine (mg/day) (16)
    CL Item
    Microscopic (17)
    CL Item
    WBC Casts (18)
    CL Item
    Epithelial Cells (19)
    CL Item
    Renal Tubular Cells (20)
    CL Item
    Transitional Epithelial Cells (21)
    CL Item
    Bacterial Casts (22)
    CL Item
    Epithelial Casts (23)
    CL Item
    Fatty Casts (24)
    CL Item
    Granular Casts (25)
    CL Item
    Hyaline Casts (26)
    CL Item
    Mixed Casts (27)
    CL Item
    RBC Casts (28)
    CL Item
    Waxy Casts (29)
    CL Item
    Amorphous Urate Crystals (30)
    CL Item
    Acid Urate Crystals (31)
    CL Item
    Ammonium Biurate Crystals (32)
    CL Item
    Amorphous Crystals (33)
    CL Item
    Ammonium Oxalate Crystals (34)
    CL Item
    Ammonium Phosphate Crystals (35)
    CL Item
    Bilirubin Crystals (36)
    CL Item
    Calcium Oxalate Crystals (37)
    CL Item
    Calcium Phospate Crystals (38)
    CL Item
    Calcium Carbonate Crystals (39)
    CL Item
    Cystine Crystals (40)
    CL Item
    Cholesterol Crystals (41)
    CL Item
    Hippuric Acid Crystals (42)
    CL Item
    Leucine Crystals (43)
    CL Item
    Monosodium Urate Crystals (44)
    CL Item
    Sulfa Crystals (45)
    CL Item
    Triple Phosphate Crystals (46)
    CL Item
    Tyrosine Crystals (47)
    CL Item
    Uric Acid Crystals (48)
    CL Item
    Bacteria (49)
    CL Item
    Fat Bodies (50)
    CL Item
    Starch Granules (51)
    CL Item
    Trichomonas (52)
    CL Item
    Yeast (53)
    CL Item
    Microalbumin, Urine Conc (54)
    CL Item
    Creatinine, Urine 24-Hr (55)
    CL Item
    Creatinine, Urine Conc (56)
    CL Item
    Protein, Urine 24-Hr (57)
    CL Item
    Urine total protein, random (58)
    Item Group
    24-Hr Urine Collection
    C0455060 (UMLS CUI-1)
    24-Hr Urine Collection Start Date
    Item
    24-Hr Urine Collection Start Date
    date
    C0455060 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    24-Hr Urine Collection Start Time
    Item
    24-Hr Urine Collection Start Time
    time
    C0455060 (UMLS CUI [1,1])
    C1301880 (UMLS CUI [1,2])
    24-Hr Urine Collection Stop Date
    Item
    24-Hr Urine Collection Stop Date
    date
    C0455060 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    24-Hr Urine Collection Stop Time
    Item
    24-Hr Urine Collection Stop Time
    time
    C0455060 (UMLS CUI [1,1])
    C1522314 (UMLS CUI [1,2])
    24-Hr Urine Collection Total Volume
    Item
    24-Hr Urine Collection Total Volume
    float
    C0455060 (UMLS CUI [1,1])
    C2700258 (UMLS CUI [1,2])
    24-Hr Urine Collection Date Sent to Laboratory
    Item
    24-Hr Urine Collection Date Sent to Laboratory
    date
    C0455060 (UMLS CUI [1,1])
    C1515023 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Item Group
    C0700325 (UMLS CUI-1)
    reference date
    Item
    Reference date
    date
    C1719096 (UMLS CUI [1])
    Visit
    Item
    Visit Type
    text
    C0545082 (UMLS CUI [1])
    eCRF
    Item
    electronic case report form
    text
    C1516308 (UMLS CUI [1])
    Comment
    Item
    Comment
    text
    C0947611 (UMLS CUI [1])
    Item Group
    Vital Signs
    C0518766 (UMLS CUI-1)
    Assessment Date
    Item
    Date of Assessment
    date
    C2985720 (UMLS CUI [1])
    Weight
    Item
    Body weight
    float
    C0005910 (UMLS CUI [1])
    Blood pressure
    Item
    Blood pressure measurement systolic
    integer
    C0005823 (UMLS CUI [1])
    Blood pressure
    Item
    Blood pressure measurement diastolic
    integer
    C0005823 (UMLS CUI [1])
    Heart rate
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1])
    Respiration Rate
    Item
    Respiration rate, Breathing rate (BR)
    integer
    C0231832 (UMLS CUI [1])
    Item Group
    C0017654 (UMLS CUI-1)
    GFR of Iohexol
    Item
    GFR of Iohexol
    float
    C0017654 (UMLS CUI [1])
    Item Group
    C0013516 (UMLS CUI-1)
    Date echocardiography
    Item
    Date of echocardiography
    date
    C0011008 (UMLS CUI [1,1])
    C0013516 (UMLS CUI [1,2])
    Item Group
    Brain MRI
    C0412675 (UMLS CUI-1)
    MRI date
    Item
    MRI: Date
    date
    C0024485 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    MRI: Results
    integer
    C0024485 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    Code List
    MRI: Results
    CL Item
    Normal  (1)
    CL Item
    Abnormal, not clinically significant  (2)
    CL Item
    Abnormal, clinically significant (3)
    MRI Abnormalities
    Item
    MRI Abnormalities
    text
    C0024485 (UMLS CUI [1])
    Item Group
    Physical Examination
    C0031809 (UMLS CUI-1)
    Date of Examination
    Item
    Date Physical Examination performed:
    date
    C2826643 (UMLS CUI [1])
    Item
    Physical Exam Status
    integer
    C0031809 (UMLS CUI [1])
    Code List
    Physical Exam Status
    CL Item
    No clinically significant findings since previous Physical Examination  (1)
    CL Item
    Clinically significant findings  (2)
    CL Item
    Not done (3)
    Item
    Physical Exam Findings, Body Systems
    integer
    C0031809 (UMLS CUI [1])
    C0460002 (UMLS CUI [2])
    Code List
    Physical Exam Findings, Body Systems
    CL Item
    Head/Eyes/Ears/Nose/Throat  (1)
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    Respiratory  (2)
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    General (10)
    Physical Exam Findings
    Item
    Physical Exam Findings
    text
    C0031809 (UMLS CUI [1])
    Item Group
    Unscheduled Visit
    C0545082 (UMLS CUI-1)
    C3854240 (UMLS CUI-2)
    Item
    Which forms do you need to complete at this unscheduled visit?
    integer
    C1516308 (UMLS CUI [1,1])
    C0205197 (UMLS CUI [1,2])
    Code List
    Which forms do you need to complete at this unscheduled visit?
    CL Item
    Vitals (1)
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    PE (2)
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    ECK (3)
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    Hematology (4)
    CL Item
    Chemistry (5)
    CL Item
    Urinalysis (6)
    CL Item
    GFR of Iohexol (7)
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    24-Hr Urine Collection (8)
    CL Item
    Echocardiography (9)
    CL Item
    Brain MRI (10)

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