ID

39374

Beschrijving

Pharmacokinetics - Pharmacodynamic Study of HT-2157 in Healthy Subjects and in Patients With Major Depressive Disorder; ODM derived from: https://clinicaltrials.gov/show/NCT01413932

Link

https://clinicaltrials.gov/show/NCT01413932

Trefwoorden

Versies (1)
  1. 03-01-20 03-01-20 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

3 januari 2020

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Healthy Volunteers (Part 1) NCT01413932

Engels

Eligibility Healthy Volunteers (Part 1) NCT01413932

1 Formulieren  
Criteria
Beschrijving

Criteria

no clinically relevant abnormalities
Beschrijving

Abnormality Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0332197
age 18 to 55 years, inclusive
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
body mass index (bmi) of 18.5 to 32 kg/m2
Beschrijving

Body mass index

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
main inclusion criteria (part 2)
Beschrijving

Inclusion criteria Main

Datatype

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1542147
no clinically relevant abnormalities
Beschrijving

Abnormality Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0332197
age 18 to 55 years, inclusive
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
body mass index (bmi) of 18.5 to 32 kg/m2
Beschrijving

Body mass index

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
mild-to-moderate major depressive disorder
Beschrijving

Major depressive disorder, mild | Major depressive disorder, moderate

Datatype

boolean

Alias
UMLS CUI [1]
C1740001
UMLS CUI [2]
C1741422
main exclusion criteria (part 1)
Beschrijving

Exclusion Criteria Main

Datatype

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
any disorder that would interfere with the absorption, distribution, metabolism, or excretion of drugs
Beschrijving

Disease Interferes with Drug absorption | Disease Interferes with Drug distribution | Disease Interferes with Drug metabolism | Disease Interferes with Drug elimination

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0678745
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0699903
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0683140
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0683141
main exclusion criteria (part 2)
Beschrijving

Exclusion Criteria Main

Datatype

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
any disorder that would interfere with the absorption, distribution, metabolism, or excretion of drugs
Beschrijving

Disease Interferes with Drug absorption | Disease Interferes with Drug distribution | Disease Interferes with Drug metabolism | Disease Interferes with Drug elimination

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0678745
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0699903
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0683140
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0683141
current and primary axis i disorder other than mdd
Beschrijving

Axis I diagnosis | Exception Major Depressive Disorder

Datatype

boolean

Alias
UMLS CUI [1]
C0270287
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1269683
Terug naar het begin van de pagina

Similar models

Eligibility Healthy Volunteers (Part 1) NCT01413932

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Abnormality Absent
Item
no clinically relevant abnormalities
boolean
C1704258 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Age
Item
age 18 to 55 years, inclusive
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) of 18.5 to 32 kg/m2
boolean
C1305855 (UMLS CUI [1])
Inclusion criteria Main
Item
main inclusion criteria (part 2)
boolean
C1512693 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Abnormality Absent
Item
no clinically relevant abnormalities
boolean
C1704258 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Age
Item
age 18 to 55 years, inclusive
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) of 18.5 to 32 kg/m2
boolean
C1305855 (UMLS CUI [1])
Major depressive disorder, mild | Major depressive disorder, moderate
Item
mild-to-moderate major depressive disorder
boolean
C1740001 (UMLS CUI [1])
C1741422 (UMLS CUI [2])
Exclusion Criteria Main
Item
main exclusion criteria (part 1)
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Disease Interferes with Drug absorption | Disease Interferes with Drug distribution | Disease Interferes with Drug metabolism | Disease Interferes with Drug elimination
Item
any disorder that would interfere with the absorption, distribution, metabolism, or excretion of drugs
boolean
C0012634 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0678745 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0699903 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0683140 (UMLS CUI [3,3])
C0012634 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0683141 (UMLS CUI [4,3])
Exclusion Criteria Main
Item
main exclusion criteria (part 2)
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Disease Interferes with Drug absorption | Disease Interferes with Drug distribution | Disease Interferes with Drug metabolism | Disease Interferes with Drug elimination
Item
any disorder that would interfere with the absorption, distribution, metabolism, or excretion of drugs
boolean
C0012634 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0678745 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0699903 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0683140 (UMLS CUI [3,3])
C0012634 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0683141 (UMLS CUI [4,3])
Axis I diagnosis | Exception Major Depressive Disorder
Item
current and primary axis i disorder other than mdd
boolean
C0270287 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1269683 (UMLS CUI [2,2])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

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