ID

43873

Beskrivning

Lilly's Emotional and Physical Symptoms of Depression Study; ODM derived from: https://clinicaltrials.gov/show/NCT00479414

Länk

https://clinicaltrials.gov/show/NCT00479414

Nyckelord

Versioner (3)
  1. 2016-10-18 2016-10-18 -
  2. 2016-10-19 2016-10-19 -
  3. 2021-09-20 2021-09-20 -
Uppladdad den

20 september 2021

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 Major Depressive Disorder NCT00479414

Engelsk

Eligibility Major Depressive Disorder NCT00479414

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
meet criteria for major depressive disorder according to the dsm-iv diagnostic criteria
Beskrivning

Major Depressive Disorder

Datatyp

boolean

Alias
UMLS CUI [1]
C1269683
outpatients at least 18 years of age
Beskrivning

Outpatients | Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0029921
UMLS CUI [2]
C0001779
sign the informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
all females must test negative for a urine pregnancy test at visit 1. females of child bearing potential must agree to utilize medically acceptable and reliable means of birth control
Beskrivning

Gender Urine pregnancy test negative | Childbearing Potential Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0430057
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
have a level of understanding sufficient to communicate with the investigator and are able to complete all patient self-rated scales in the study
Beskrivning

Able to communicate Investigator | Depression self rating scale Completion Ability

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2364293
UMLS CUI [1,2]
C0035173
UMLS CUI [2,1]
C0451108
UMLS CUI [2,2]
C0205197
UMLS CUI [2,3]
C0085732
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
are investigator site personnel directly affiliated with the study or immediate family.
Beskrivning

Research Personnel Affiliated Clinical Trial Family | Research Personnel Affiliated Immediate family

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0035173
UMLS CUI [1,2]
C1510826
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C0015576
UMLS CUI [2,1]
C0035173
UMLS CUI [2,2]
C1510826
UMLS CUI [2,3]
C2371717
are employed by eli lilly and company
Beskrivning

Employee Eli Lilly & Co Ltd

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0599987
UMLS CUI [1,2]
C0470942
have received treatment within the last 30 days or are currently enrolled in a study with a drug that has not received regulatory approval for any indication at time of study entry
Beskrivning

Study Subject Participation Status | Therapeutic procedure Drug Approval Lacking

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0162696
UMLS CUI [2,3]
C0332268
current substance dependence, excluding nicotine and caffeine
Beskrivning

Substance Dependence | Nicotine Dependence | Caffeine dependence

Datatyp

boolean

Alias
UMLS CUI [1]
C0038580
UMLS CUI [2]
C0028043
UMLS CUI [3]
C1386553
treatment with a monoamine oxidase inhibitor within 14 days prior to visit 1 or potential need to use an maoi within 5 days after discontinuation of study drug
Beskrivning

Monoamine Oxidase Inhibitors

Datatyp

boolean

Alias
UMLS CUI [1]
C0026457
acute live injury or severe (child-pugh class c) cirrhosis
Beskrivning

Injury of liver | Liver Cirrhosis Severe | Child-Pugh Classification

Datatyp

boolean

Alias
UMLS CUI [1]
C0160390
UMLS CUI [2,1]
C0023890
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C4050412
Tillbaka till toppen

Similar models

Eligibility Major Depressive Disorder NCT00479414

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Major Depressive Disorder
Item
meet criteria for major depressive disorder according to the dsm-iv diagnostic criteria
boolean
C1269683 (UMLS CUI [1])
Outpatients | Age
Item
outpatients at least 18 years of age
boolean
C0029921 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Informed Consent
Item
sign the informed consent
boolean
C0021430 (UMLS CUI [1])
Gender Urine pregnancy test negative | Childbearing Potential Contraceptive methods
Item
all females must test negative for a urine pregnancy test at visit 1. females of child bearing potential must agree to utilize medically acceptable and reliable means of birth control
boolean
C0079399 (UMLS CUI [1,1])
C0430057 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Able to communicate Investigator | Depression self rating scale Completion Ability
Item
have a level of understanding sufficient to communicate with the investigator and are able to complete all patient self-rated scales in the study
boolean
C2364293 (UMLS CUI [1,1])
C0035173 (UMLS CUI [1,2])
C0451108 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C0085732 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Research Personnel Affiliated Clinical Trial Family | Research Personnel Affiliated Immediate family
Item
are investigator site personnel directly affiliated with the study or immediate family.
boolean
C0035173 (UMLS CUI [1,1])
C1510826 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0015576 (UMLS CUI [1,4])
C0035173 (UMLS CUI [2,1])
C1510826 (UMLS CUI [2,2])
C2371717 (UMLS CUI [2,3])
Employee Eli Lilly & Co Ltd
Item
are employed by eli lilly and company
boolean
C0599987 (UMLS CUI [1,1])
C0470942 (UMLS CUI [1,2])
Study Subject Participation Status | Therapeutic procedure Drug Approval Lacking
Item
have received treatment within the last 30 days or are currently enrolled in a study with a drug that has not received regulatory approval for any indication at time of study entry
boolean
C2348568 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0162696 (UMLS CUI [2,2])
C0332268 (UMLS CUI [2,3])
Substance Dependence | Nicotine Dependence | Caffeine dependence
Item
current substance dependence, excluding nicotine and caffeine
boolean
C0038580 (UMLS CUI [1])
C0028043 (UMLS CUI [2])
C1386553 (UMLS CUI [3])
Monoamine Oxidase Inhibitors
Item
treatment with a monoamine oxidase inhibitor within 14 days prior to visit 1 or potential need to use an maoi within 5 days after discontinuation of study drug
boolean
C0026457 (UMLS CUI [1])
Injury of liver | Liver Cirrhosis Severe | Child-Pugh Classification
Item
acute live injury or severe (child-pugh class c) cirrhosis
boolean
C0160390 (UMLS CUI [1])
C0023890 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C4050412 (UMLS CUI [3])
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