ID

36358

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT02507219

Trefwoorden

Versies (1)
  1. 07-05-19 07-05-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

7 mei 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT02507219

Engels

Eligibility Major Depressive Disorder NCT02507219

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male, or female
Beschrijving

Gender

Datatype

boolean

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

Age

Datatype

boolean

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

General health good

Datatype

boolean

Alias
UMLS CUI [1]
C1277245
Exclusion Criteria
Beschrijving

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.
Beschrijving

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

Datatype

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.
Beschrijving

Schizophrenia | Schizoaffective Disorder | Bipolar Disorder

Datatype

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
Beschrijving

Substance Use Disorders

Datatype

boolean

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

Urine drug screen positive Illicit Drug

Datatype

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.
Beschrijving

NSAIDs Regular

Datatype

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.
Beschrijving

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

Datatype

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
Beschrijving

Psychotropic Drugs | Antidepressive Agents | Monoamine Oxidase Inhibitors

Datatype

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).
Beschrijving

Seizure disorders | Exception Febrile seizures in early childhood

Datatype

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.
Beschrijving

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

Datatype

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.
Beschrijving

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

Datatype

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.
Beschrijving

Gender Menstruation

Datatype

boolean

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

Claustrophobia | Phobia Injection | Fear of blood

Datatype

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).
Beschrijving

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

Datatype

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
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Similar models

Eligibility Major Depressive Disorder NCT02507219

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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