ID

17068

Beskrivning

Sedating Antidepressant Improves Driving Safety in Patients With Major Depressive Disorder; ODM derived from: https://clinicaltrials.gov/show/NCT00385437

Länk

https://clinicaltrials.gov/show/NCT00385437

Nyckelord

Versioner (1)
  1. 2016-08-23 2016-08-23 -
Uppladdad den

23 augusti 2016

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Depression NCT00385437

Engelsk

Eligibility Depression NCT00385437

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00385437
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
fulfilling dsm-iv criteria for major depressive disorder
Beskrivning

Major Depressive Disorder

Datatyp

boolean

Alias
UMLS CUI [1]
C1269683
score of hamilton rating scale for depression (hdrs-17) > 17
Beskrivning

Hamilton rating scale for depression

Datatyp

boolean

Alias
UMLS CUI [1]
C0451203
patient to be prescribed mirtazapine (remeron) as determined by physician
Beskrivning

Mirtazapine prescribed | Remeron prescribed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0049506
UMLS CUI [1,2]
C0278329
UMLS CUI [2,1]
C0525726
UMLS CUI [2,2]
C0278329
subject has no known clinically significant abnormal vital signs or other clinical findings at screening.
Beskrivning

Abnormal vital signs Clinical Significance | Clinical findings

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0277804
UMLS CUI [1,2]
C2826293
UMLS CUI [2]
C0037088
patients should have a driving license for more than 3 years and drive over 15,000 km year.
Beskrivning

Has driving license | driving performance

Datatyp

boolean

Alias
UMLS CUI [1]
C2960399
UMLS CUI [2]
C0681592
females of childbearing potential must willingly use effective birth control.
Beskrivning

Childbearing Potential Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
night shift workers.
Beskrivning

Night shift worker

Datatyp

boolean

Alias
UMLS CUI [1]
C0555008
a history or present condition of: bipolar disorder or depressive disorder not otherwise specified,schizophrenia or other psychotic disorders (according to dsm-iv), schizotypal or borderline personality disorder, organic mental disorders
Beskrivning

Bipolar Disorder | Depressive disorder | Schizophrenia | Psychotic Disorders | Schizotypal Personality Disorder | Borderline Personality Disorder | Organic mental disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0005586
UMLS CUI [2]
C0011581
UMLS CUI [3]
C0036341
UMLS CUI [4]
C0033975
UMLS CUI [5]
C0036363
UMLS CUI [6]
C0006012
UMLS CUI [7]
C0029227
a present condition of: anxiety disorders (according to dsm-iv), eating disorders, postpartum depression
Beskrivning

Anxiety Disorders | Eating Disorders | Depression, Postpartum

Datatyp

boolean

Alias
UMLS CUI [1]
C0003469
UMLS CUI [2]
C0013473
UMLS CUI [3]
C0221074
epilepsy or a history of seizure disorder or ever received treatment with anticonvulsant medication for epilepsy or seizures
Beskrivning

Epilepsy | Anticonvulsants Epilepsy | Anticonvulsants Seizures

Datatyp

boolean

Alias
UMLS CUI [1]
C0014544
UMLS CUI [2,1]
C0003286
UMLS CUI [2,2]
C0014544
UMLS CUI [3,1]
C0003286
UMLS CUI [3,2]
C0036572
psg recording of an extremely abnormal sleep eeg (other than that which would be expected with depression)
Beskrivning

Polysomnography | Abnormal EEG activity during sleep Extreme | Sleep electroencephalogram | Depressive disorder

Datatyp

boolean

Alias
UMLS CUI [1]
C0162701
UMLS CUI [2,1]
C3279431
UMLS CUI [2,2]
C0205403
UMLS CUI [3]
C0200101
UMLS CUI [4]
C0011581
alcohol or substance abuse (according to dsm-iv) during the last 6months prior to baseline.
Beskrivning

Substance Use Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
any physical disease, which may explain the symptoms of depression.
Beskrivning

Disease Physical Explanation Depressive Symptoms

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205485
UMLS CUI [1,3]
C0681841
UMLS CUI [1,4]
C0086132
any chronic physical disease, which is not stabilized.
Beskrivning

Disease physical chronic unstable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205485
UMLS CUI [1,3]
C0205191
UMLS CUI [1,4]
C0443343
Tillbaka till toppen

Similar models

Eligibility Depression NCT00385437

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00385437
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Major Depressive Disorder
Item
fulfilling dsm-iv criteria for major depressive disorder
boolean
C1269683 (UMLS CUI [1])
Hamilton rating scale for depression
Item
score of hamilton rating scale for depression (hdrs-17) > 17
boolean
C0451203 (UMLS CUI [1])
Mirtazapine prescribed | Remeron prescribed
Item
patient to be prescribed mirtazapine (remeron) as determined by physician
boolean
C0049506 (UMLS CUI [1,1])
C0278329 (UMLS CUI [1,2])
C0525726 (UMLS CUI [2,1])
C0278329 (UMLS CUI [2,2])
Abnormal vital signs Clinical Significance | Clinical findings
Item
subject has no known clinically significant abnormal vital signs or other clinical findings at screening.
boolean
C0277804 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0037088 (UMLS CUI [2])
Has driving license | driving performance
Item
patients should have a driving license for more than 3 years and drive over 15,000 km year.
boolean
C2960399 (UMLS CUI [1])
C0681592 (UMLS CUI [2])
Childbearing Potential Contraceptive methods
Item
females of childbearing potential must willingly use effective birth control.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Night shift worker
Item
night shift workers.
boolean
C0555008 (UMLS CUI [1])
Bipolar Disorder | Depressive disorder | Schizophrenia | Psychotic Disorders | Schizotypal Personality Disorder | Borderline Personality Disorder | Organic mental disorders
Item
a history or present condition of: bipolar disorder or depressive disorder not otherwise specified,schizophrenia or other psychotic disorders (according to dsm-iv), schizotypal or borderline personality disorder, organic mental disorders
boolean
C0005586 (UMLS CUI [1])
C0011581 (UMLS CUI [2])
C0036341 (UMLS CUI [3])
C0033975 (UMLS CUI [4])
C0036363 (UMLS CUI [5])
C0006012 (UMLS CUI [6])
C0029227 (UMLS CUI [7])
Anxiety Disorders | Eating Disorders | Depression, Postpartum
Item
a present condition of: anxiety disorders (according to dsm-iv), eating disorders, postpartum depression
boolean
C0003469 (UMLS CUI [1])
C0013473 (UMLS CUI [2])
C0221074 (UMLS CUI [3])
Epilepsy | Anticonvulsants Epilepsy | Anticonvulsants Seizures
Item
epilepsy or a history of seizure disorder or ever received treatment with anticonvulsant medication for epilepsy or seizures
boolean
C0014544 (UMLS CUI [1])
C0003286 (UMLS CUI [2,1])
C0014544 (UMLS CUI [2,2])
C0003286 (UMLS CUI [3,1])
C0036572 (UMLS CUI [3,2])
Polysomnography | Abnormal EEG activity during sleep Extreme | Sleep electroencephalogram | Depressive disorder
Item
psg recording of an extremely abnormal sleep eeg (other than that which would be expected with depression)
boolean
C0162701 (UMLS CUI [1])
C3279431 (UMLS CUI [2,1])
C0205403 (UMLS CUI [2,2])
C0200101 (UMLS CUI [3])
C0011581 (UMLS CUI [4])
Substance Use Disorders
Item
alcohol or substance abuse (according to dsm-iv) during the last 6months prior to baseline.
boolean
C0038586 (UMLS CUI [1])
Disease Physical Explanation Depressive Symptoms
Item
any physical disease, which may explain the symptoms of depression.
boolean
C0012634 (UMLS CUI [1,1])
C0205485 (UMLS CUI [1,2])
C0681841 (UMLS CUI [1,3])
C0086132 (UMLS CUI [1,4])
Disease physical chronic unstable
Item
any chronic physical disease, which is not stabilized.
boolean
C0012634 (UMLS CUI [1,1])
C0205485 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
C0443343 (UMLS CUI [1,4])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

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