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ID

36358

Beschreibung

Study of Ibuprofen Effects on Brain Function; ODM derived from: https://clinicaltrials.gov/show/NCT02507219

Link

https://clinicaltrials.gov/show/NCT02507219

Stichworte

  1. 07.05.19 07.05.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

7. Mai 2019

DOI

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Lizenz

Creative Commons BY 4.0

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    Eligibility Major Depressive Disorder NCT02507219

    Eligibility Major Depressive Disorder NCT02507219

    Inclusion Criteria
    Beschreibung

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. male, or female
    Beschreibung

    Gender

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0079399
    2. between the ages of 18-50.
    Beschreibung

    Age

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    3. in good general health
    Beschreibung

    General health good

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1277245
    Exclusion Criteria
    Beschreibung

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. subjects who report a history of any mental health disorder such as dysthymia, simple phobia, major depression, obsessive compulsive disorder or panic disorder as a primary diagnosis currently or within 6 months prior to the screening visit.
    Beschreibung

    Mental disorders | Dysthymic Disorder | Phobia Simple | Major Depressive Disorder | Obsessive-Compulsive Disorder | Panic Disorder

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0004936
    UMLS CUI [2]
    C0013415
    UMLS CUI [3]
    C0236801
    UMLS CUI [4]
    C1269683
    UMLS CUI [5]
    C0028768
    UMLS CUI [6]
    C0030319
    2. subjects with a history of schizophrenia, schizoaffective disorder, or a bipolar disorder.
    Beschreibung

    Schizophrenia | Schizoaffective Disorder | Bipolar Disorder

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0036341
    UMLS CUI [2]
    C0036337
    UMLS CUI [3]
    C0005586
    3. subjects who report dsm-v criteria for substance use disorder (alcohol or drugs) currently or within 6 months prior to screening
    Beschreibung

    Substance Use Disorders

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0038586
    4. subjects who have a positive urine illicit drug screen.
    Beschreibung

    Urine drug screen positive Illicit Drug

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0743300
    UMLS CUI [1,2]
    C0086190
    5. subjects that regularly (more than 15 days for past 30 days) use nsaids and have not used nsaids in the previous 5 days.
    Beschreibung

    NSAIDs Regular

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0003211
    UMLS CUI [1,2]
    C0205272
    6. subjects with a history of clinically significant hepatic cardiac, renal, neurologic, cerebrovascular, metabolic or pulmonary disease, gastric disease.
    Beschreibung

    Liver diseases | Heart Diseases | Kidney Diseases | Nervous system disorder | Cerebrovascular Disorders | Metabolic Diseases | Lung diseases | Stomach Diseases

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0023895
    UMLS CUI [2]
    C0018799
    UMLS CUI [3]
    C0022658
    UMLS CUI [4]
    C0027765
    UMLS CUI [5]
    C0007820
    UMLS CUI [6]
    C0025517
    UMLS CUI [7]
    C0024115
    UMLS CUI [8]
    C0038354
    7. subjects who have taken psychotropic drugs or antidepressants (including monoamine oxidase inhibitors, maoi's) within the last year
    Beschreibung

    Psychotropic Drugs | Antidepressive Agents | Monoamine Oxidase Inhibitors

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0033978
    UMLS CUI [2]
    C0003289
    UMLS CUI [3]
    C0026457
    8. subjects with a history of seizure disorders (except for febrile seizures in childhood).
    Beschreibung

    Seizure disorders | Exception Febrile seizures in early childhood

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0014544
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C0009952
    9. subjects who, in the investigator's judgment pose a current, serious suicidal or homicidal risk or have made a suicide attempt within the past 6 months.
    Beschreibung

    At risk for suicide serious | Risk homicidal serious | Suicide attempt

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0563664
    UMLS CUI [1,2]
    C0205404
    UMLS CUI [2,1]
    C0035647
    UMLS CUI [2,2]
    C0745031
    UMLS CUI [2,3]
    C0205404
    UMLS CUI [3]
    C0038663
    10. women who have a positive serum hcg pregnancy test at screen visit or who are lactating or planning to become pregnant within the next 18 weeks following the screen visit.
    Beschreibung

    Serum pregnancy test (B-HCG) Positive | Breast Feeding | Pregnancy, Planned

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0430060
    UMLS CUI [1,2]
    C1446409
    UMLS CUI [2]
    C0006147
    UMLS CUI [3]
    C0032992
    11. women who are currently menstruating.
    Beschreibung

    Gender Menstruation

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0079399
    UMLS CUI [1,2]
    C0025344
    12. the subject suffers from claustrophobia, or phobia for injections or blood.
    Beschreibung

    Claustrophobia | Phobia Injection | Fear of blood

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0008909
    UMLS CUI [2,1]
    C0349231
    UMLS CUI [2,2]
    C1533685
    UMLS CUI [3]
    C0522183
    13. magnetic resonance imaging related exclusion criteria: cardiac pacemaker, metal fragments in eyes/skin/body (shrapnel), subjects who have ever been a metal worker/welder; history of eye surgery/eyes washed out because of metal, aortic/aneurysm clips, prosthesis, by-pass surgery/coronary artery clips, hearing aid, heart valve replacement, subjects who are in the first trimester of pregnancy, subjects with an i.u.d. (birth control device), a shunt (ventricular or spinal), electrodes, metal plates/pins/screws/wires, or neuro/bio-stimulators (tens unit).
    Beschreibung

    Magnetic Resonance Imaging Exclusion Criteria | Artificial cardiac pacemaker | Metal foreign body in eye region | Metal splinters in skin | Metallic foreign body Human body | Shrapnel Human body | Metal worker | Welder | Ophthalmologic Surgical Procedures | Eye Washout Due to Metal | Clip Aortic | Aneurysm clip | Prosthesis | Bypass surgery Clip | Coronary artery clip | Hearing Aid | Prosthetic replacement of heart valve | Pregnancy Trimester, First | Intrauterine Device | Shunt Ventricular | Shunt spinal | Electrode | Metal plates | Pins metallic | Screw | Wire | Neurostimulator | Tens unit electrodes

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0024485
    UMLS CUI [1,2]
    C0680251
    UMLS CUI [2]
    C0030163
    UMLS CUI [3]
    C0562528
    UMLS CUI [4]
    C2229035
    UMLS CUI [5,1]
    C1720389
    UMLS CUI [5,2]
    C1318419
    UMLS CUI [6,1]
    C0522670
    UMLS CUI [6,2]
    C1318419
    UMLS CUI [7]
    C0402937
    UMLS CUI [8]
    C0336106
    UMLS CUI [9]
    C0038901
    UMLS CUI [10,1]
    C0015392
    UMLS CUI [10,2]
    C1710661
    UMLS CUI [10,3]
    C0678226
    UMLS CUI [10,4]
    C0025552
    UMLS CUI [11,1]
    C0175722
    UMLS CUI [11,2]
    C0003483
    UMLS CUI [12]
    C0179977
    UMLS CUI [13]
    C0175649
    UMLS CUI [14,1]
    C1536078
    UMLS CUI [14,2]
    C0175722
    UMLS CUI [15]
    C4510021
    UMLS CUI [16]
    C0018768
    UMLS CUI [17]
    C0190163
    UMLS CUI [18]
    C0032979
    UMLS CUI [19]
    C0021900
    UMLS CUI [20,1]
    C0542331
    UMLS CUI [20,2]
    C0018827
    UMLS CUI [21,1]
    C0542331
    UMLS CUI [21,2]
    C0521329
    UMLS CUI [22]
    C0013812
    UMLS CUI [23]
    C0013866
    UMLS CUI [24,1]
    C0175718
    UMLS CUI [24,2]
    C2986473
    UMLS CUI [25]
    C0301559
    UMLS CUI [26]
    C4522306
    UMLS CUI [27]
    C0582124
    UMLS CUI [28]
    C1967354

    Ähnliche Modelle

    Eligibility Major Depressive Disorder NCT02507219

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Gender
    Item
    1. male, or female
    boolean
    C0079399 (UMLS CUI [1])
    Age
    Item
    2. between the ages of 18-50.
    boolean
    C0001779 (UMLS CUI [1])
    General health good
    Item
    3. in good general health
    boolean
    C1277245 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Mental disorders | Dysthymic Disorder | Phobia Simple | Major Depressive Disorder | Obsessive-Compulsive Disorder | Panic Disorder
    Item
    1. subjects who report a history of any mental health disorder such as dysthymia, simple phobia, major depression, obsessive compulsive disorder or panic disorder as a primary diagnosis currently or within 6 months prior to the screening visit.
    boolean
    C0004936 (UMLS CUI [1])
    C0013415 (UMLS CUI [2])
    C0236801 (UMLS CUI [3])
    C1269683 (UMLS CUI [4])
    C0028768 (UMLS CUI [5])
    C0030319 (UMLS CUI [6])
    Schizophrenia | Schizoaffective Disorder | Bipolar Disorder
    Item
    2. subjects with a history of schizophrenia, schizoaffective disorder, or a bipolar disorder.
    boolean
    C0036341 (UMLS CUI [1])
    C0036337 (UMLS CUI [2])
    C0005586 (UMLS CUI [3])
    Substance Use Disorders
    Item
    3. subjects who report dsm-v criteria for substance use disorder (alcohol or drugs) currently or within 6 months prior to screening
    boolean
    C0038586 (UMLS CUI [1])
    Urine drug screen positive Illicit Drug
    Item
    4. subjects who have a positive urine illicit drug screen.
    boolean
    C0743300 (UMLS CUI [1,1])
    C0086190 (UMLS CUI [1,2])
    NSAIDs Regular
    Item
    5. subjects that regularly (more than 15 days for past 30 days) use nsaids and have not used nsaids in the previous 5 days.
    boolean
    C0003211 (UMLS CUI [1,1])
    C0205272 (UMLS CUI [1,2])
    Liver diseases | Heart Diseases | Kidney Diseases | Nervous system disorder | Cerebrovascular Disorders | Metabolic Diseases | Lung diseases | Stomach Diseases
    Item
    6. subjects with a history of clinically significant hepatic cardiac, renal, neurologic, cerebrovascular, metabolic or pulmonary disease, gastric disease.
    boolean
    C0023895 (UMLS CUI [1])
    C0018799 (UMLS CUI [2])
    C0022658 (UMLS CUI [3])
    C0027765 (UMLS CUI [4])
    C0007820 (UMLS CUI [5])
    C0025517 (UMLS CUI [6])
    C0024115 (UMLS CUI [7])
    C0038354 (UMLS CUI [8])
    Psychotropic Drugs | Antidepressive Agents | Monoamine Oxidase Inhibitors
    Item
    7. subjects who have taken psychotropic drugs or antidepressants (including monoamine oxidase inhibitors, maoi's) within the last year
    boolean
    C0033978 (UMLS CUI [1])
    C0003289 (UMLS CUI [2])
    C0026457 (UMLS CUI [3])
    Seizure disorders | Exception Febrile seizures in early childhood
    Item
    8. subjects with a history of seizure disorders (except for febrile seizures in childhood).
    boolean
    C0014544 (UMLS CUI [1])
    C1705847 (UMLS CUI [2,1])
    C0009952 (UMLS CUI [2,2])
    At risk for suicide serious | Risk homicidal serious | Suicide attempt
    Item
    9. subjects who, in the investigator's judgment pose a current, serious suicidal or homicidal risk or have made a suicide attempt within the past 6 months.
    boolean
    C0563664 (UMLS CUI [1,1])
    C0205404 (UMLS CUI [1,2])
    C0035647 (UMLS CUI [2,1])
    C0745031 (UMLS CUI [2,2])
    C0205404 (UMLS CUI [2,3])
    C0038663 (UMLS CUI [3])
    Serum pregnancy test (B-HCG) Positive | Breast Feeding | Pregnancy, Planned
    Item
    10. women who have a positive serum hcg pregnancy test at screen visit or who are lactating or planning to become pregnant within the next 18 weeks following the screen visit.
    boolean
    C0430060 (UMLS CUI [1,1])
    C1446409 (UMLS CUI [1,2])
    C0006147 (UMLS CUI [2])
    C0032992 (UMLS CUI [3])
    Gender Menstruation
    Item
    11. women who are currently menstruating.
    boolean
    C0079399 (UMLS CUI [1,1])
    C0025344 (UMLS CUI [1,2])
    Claustrophobia | Phobia Injection | Fear of blood
    Item
    12. the subject suffers from claustrophobia, or phobia for injections or blood.
    boolean
    C0008909 (UMLS CUI [1])
    C0349231 (UMLS CUI [2,1])
    C1533685 (UMLS CUI [2,2])
    C0522183 (UMLS CUI [3])
    Magnetic Resonance Imaging Exclusion Criteria | Artificial cardiac pacemaker | Metal foreign body in eye region | Metal splinters in skin | Metallic foreign body Human body | Shrapnel Human body | Metal worker | Welder | Ophthalmologic Surgical Procedures | Eye Washout Due to Metal | Clip Aortic | Aneurysm clip | Prosthesis | Bypass surgery Clip | Coronary artery clip | Hearing Aid | Prosthetic replacement of heart valve | Pregnancy Trimester, First | Intrauterine Device | Shunt Ventricular | Shunt spinal | Electrode | Metal plates | Pins metallic | Screw | Wire | Neurostimulator | Tens unit electrodes
    Item
    13. magnetic resonance imaging related exclusion criteria: cardiac pacemaker, metal fragments in eyes/skin/body (shrapnel), subjects who have ever been a metal worker/welder; history of eye surgery/eyes washed out because of metal, aortic/aneurysm clips, prosthesis, by-pass surgery/coronary artery clips, hearing aid, heart valve replacement, subjects who are in the first trimester of pregnancy, subjects with an i.u.d. (birth control device), a shunt (ventricular or spinal), electrodes, metal plates/pins/screws/wires, or neuro/bio-stimulators (tens unit).
    boolean
    C0024485 (UMLS CUI [1,1])
    C0680251 (UMLS CUI [1,2])
    C0030163 (UMLS CUI [2])
    C0562528 (UMLS CUI [3])
    C2229035 (UMLS CUI [4])
    C1720389 (UMLS CUI [5,1])
    C1318419 (UMLS CUI [5,2])
    C0522670 (UMLS CUI [6,1])
    C1318419 (UMLS CUI [6,2])
    C0402937 (UMLS CUI [7])
    C0336106 (UMLS CUI [8])
    C0038901 (UMLS CUI [9])
    C0015392 (UMLS CUI [10,1])
    C1710661 (UMLS CUI [10,2])
    C0678226 (UMLS CUI [10,3])
    C0025552 (UMLS CUI [10,4])
    C0175722 (UMLS CUI [11,1])
    C0003483 (UMLS CUI [11,2])
    C0179977 (UMLS CUI [12])
    C0175649 (UMLS CUI [13])
    C1536078 (UMLS CUI [14,1])
    C0175722 (UMLS CUI [14,2])
    C4510021 (UMLS CUI [15])
    C0018768 (UMLS CUI [16])
    C0190163 (UMLS CUI [17])
    C0032979 (UMLS CUI [18])
    C0021900 (UMLS CUI [19])
    C0542331 (UMLS CUI [20,1])
    C0018827 (UMLS CUI [20,2])
    C0542331 (UMLS CUI [21,1])
    C0521329 (UMLS CUI [21,2])
    C0013812 (UMLS CUI [22])
    C0013866 (UMLS CUI [23])
    C0175718 (UMLS CUI [24,1])
    C2986473 (UMLS CUI [24,2])
    C0301559 (UMLS CUI [25])
    C4522306 (UMLS CUI [26])
    C0582124 (UMLS CUI [27])
    C1967354 (UMLS CUI [28])

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