ID

14610

Beschrijving

A Study of the Efficacy and Safety of Topiramate in the Treatment fo Obese, Type 2 Diabetic Patients Treated With Metformin; ODM derived from: https://clinicaltrials.gov/show/NCT00231660

Link

https://clinicaltrials.gov/show/NCT00231660

Trefwoorden

  1. 24-04-16 24-04-16 -
Geüploaded op

24 april 2016

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.

Itemgroep Commentaren voor :

Item Commentaren voor :

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

Eligibility Obesity NCT00231660

Eligibility Obesity NCT00231660

  1. StudyEvent: Eligibility
    1. Eligibility Obesity NCT00231660
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of type 2 diabetes and receiving metformin monotherapy for at least the previous 4 months and on a stable daily dose for at least 2 months prior to enrollment
Beschrijving

Type 2 diabetes and metformin monotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0025598
metformin total daily dose not to exceed 2.1 grams/day
Beschrijving

Metformin total daily dose

Datatype

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C2348070
body mass index >= 27 and < 50
Beschrijving

BMI

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
hba1c < 11%
Beschrijving

HbA1C

Datatype

boolean

Alias
UMLS CUI [1]
C0019018
fasting plasma glucose >= 126 and < 240
Beschrijving

Fasting plasma glucose

Datatype

boolean

Alias
UMLS CUI [1]
C0583513
stable weight
Beschrijving

Stable weight

Datatype

boolean

Alias
UMLS CUI [1]
C0517386
female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, or practicing an acceptable method of contraception (requires negative pregnancy test)
Beschrijving

Gynaecological status

Datatype

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0015787
UMLS CUI [3]
C0700589
UMLS CUI [4]
C0032976
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
known contraindication, or hypersensitivity to topiramate
Beschrijving

Contraindication or hypersensitivity to topiramate

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0076829
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0076829
use of other antidiabetic medications within the last 4 months
Beschrijving

Antidiabetic medications

Datatype

boolean

Alias
UMLS CUI [1]
C0935929
excessive weight loss
Beschrijving

Weight loss

Datatype

boolean

Alias
UMLS CUI [1]
C1262477
diagnosis of type 1 diabetes
Beschrijving

Type 1 diabetes

Datatype

boolean

Alias
UMLS CUI [1]
C0011854
history of severe or recurrent hypoglycemic episodes
Beschrijving

Hypoglycemia

Datatype

boolean

Alias
UMLS CUI [1]
C0020615
severe pulmonary disease
Beschrijving

Pulmonary disease

Datatype

boolean

Alias
UMLS CUI [1]
C0024115

Similar models

Eligibility Obesity NCT00231660

  1. StudyEvent: Eligibility
    1. Eligibility Obesity NCT00231660
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Type 2 diabetes and metformin monotherapy
Item
diagnosis of type 2 diabetes and receiving metformin monotherapy for at least the previous 4 months and on a stable daily dose for at least 2 months prior to enrollment
boolean
C0011860 (UMLS CUI [1])
C0025598 (UMLS CUI [2])
Metformin total daily dose
Item
metformin total daily dose not to exceed 2.1 grams/day
boolean
C0025598 (UMLS CUI [1,1])
C2348070 (UMLS CUI [1,2])
BMI
Item
body mass index >= 27 and < 50
boolean
C1305855 (UMLS CUI [1])
HbA1C
Item
hba1c < 11%
boolean
C0019018 (UMLS CUI [1])
Fasting plasma glucose
Item
fasting plasma glucose >= 126 and < 240
boolean
C0583513 (UMLS CUI [1])
Stable weight
Item
stable weight
boolean
C0517386 (UMLS CUI [1])
Gynaecological status
Item
female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, or practicing an acceptable method of contraception (requires negative pregnancy test)
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
C0032976 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Contraindication or hypersensitivity to topiramate
Item
known contraindication, or hypersensitivity to topiramate
boolean
C1301624 (UMLS CUI [1,1])
C0076829 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0076829 (UMLS CUI [2,2])
Antidiabetic medications
Item
use of other antidiabetic medications within the last 4 months
boolean
C0935929 (UMLS CUI [1])
Weight loss
Item
excessive weight loss
boolean
C1262477 (UMLS CUI [1])
Type 1 diabetes
Item
diagnosis of type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
Hypoglycemia
Item
history of severe or recurrent hypoglycemic episodes
boolean
C0020615 (UMLS CUI [1])
Pulmonary disease
Item
severe pulmonary disease
boolean
C0024115 (UMLS CUI [1])

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

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