ID

15247

Description

A Study To Evaluate The Effect Of Topiramate On Clinical And Electrophysiological Parameters In Subjects With Diabetic Peripheral Polyneuropathy; ODM derived from: https://clinicaltrials.gov/show/NCT00231673

Lien

https://clinicaltrials.gov/show/NCT00231673

Mots-clés

  1. 23/05/2016 23/05/2016 -
Téléchargé le

23 mai 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

Eligibility Diabetic Neuropathies NCT00231673

Eligibility Diabetic Neuropathies NCT00231673

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of type 2 diabetes mellitus
Description

diabetes mellitus

Type de données

boolean

Alias
UMLS CUI [1]
C0011860
pain for at least 6 months prior to randomization that the investigator attributes to diabetic peripheral polyneuropathy
Description

pain due to diabetic peripheral polyneuropathy

Type de données

boolean

Alias
UMLS CUI [1,1]
C2673754
UMLS CUI [1,2]
C2673754
UMLS CUI [1,3]
C0011849
two sets of baseline nerve conduction studies and quantitative sensory testing
Description

nerve conduction studies and quantitative sensory testing

Type de données

boolean

Alias
UMLS CUI [1]
C0200125
UMLS CUI [2]
C0430838
hba1c =< 9%
Description

HbA1c

Type de données

boolean

Alias
UMLS CUI [1]
C0019018
diabetes controlled on stable regimen
Description

diabetes controlled

Type de données

boolean

Alias
UMLS CUI [1]
C3274787
female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, practicing abstinence, or practicing an acceptable method of contraception (requires negative pregnancy test)
Description

postmenopausal or contraceptive use

Type de données

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C1999124
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
diagnosis of type 1 diabetes mellitus
Description

diabetes mellitus type I

Type de données

boolean

Alias
UMLS CUI [1]
C0011854
polyneuropathy due to other underlying causes
Description

polyneuropathy

Type de données

boolean

Alias
UMLS CUI [1]
C0152025
hospitalization within the past 3 months due to episodes of hyper/hypoglycemia
Description

hospitalization due to episodes of hyper/hypoglycemia

Type de données

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0020456
UMLS CUI [2,1]
C0019993
UMLS CUI [2,2]
C0020615
other unstable medical conditions
Description

other unstable medical conditions

Type de données

boolean

Alias
UMLS CUI [1]
C3843040
history of suicidal attempts
Description

history of suicidal attempts

Type de données

boolean

Alias
UMLS CUI [1]
C0038663
exposure to any other experimental drugs or device within the past 30 days
Description

exposure to any other experimental drugs

Type de données

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0013230

Similar models

Eligibility Diabetic Neuropathies NCT00231673

Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
diabetes mellitus
Item
diagnosis of type 2 diabetes mellitus
boolean
C0011860 (UMLS CUI [1])
pain due to diabetic peripheral polyneuropathy
Item
pain for at least 6 months prior to randomization that the investigator attributes to diabetic peripheral polyneuropathy
boolean
C2673754 (UMLS CUI [1,1])
C2673754 (UMLS CUI [1,2])
C0011849 (UMLS CUI [1,3])
nerve conduction studies and quantitative sensory testing
Item
two sets of baseline nerve conduction studies and quantitative sensory testing
boolean
C0200125 (UMLS CUI [1])
C0430838 (UMLS CUI [2])
HbA1c
Item
hba1c =< 9%
boolean
C0019018 (UMLS CUI [1])
diabetes controlled
Item
diabetes controlled on stable regimen
boolean
C3274787 (UMLS CUI [1])
postmenopausal or contraceptive use
Item
female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, practicing abstinence, or practicing an acceptable method of contraception (requires negative pregnancy test)
boolean
C0232970 (UMLS CUI [1])
C1999124 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
diabetes mellitus type I
Item
diagnosis of type 1 diabetes mellitus
boolean
C0011854 (UMLS CUI [1])
polyneuropathy
Item
polyneuropathy due to other underlying causes
boolean
C0152025 (UMLS CUI [1])
hospitalization due to episodes of hyper/hypoglycemia
Item
hospitalization within the past 3 months due to episodes of hyper/hypoglycemia
boolean
C0019993 (UMLS CUI [1,1])
C0020456 (UMLS CUI [1,2])
C0019993 (UMLS CUI [2,1])
C0020615 (UMLS CUI [2,2])
other unstable medical conditions
Item
other unstable medical conditions
boolean
C3843040 (UMLS CUI [1])
history of suicidal attempts
Item
history of suicidal attempts
boolean
C0038663 (UMLS CUI [1])
exposure to any other experimental drugs
Item
exposure to any other experimental drugs or device within the past 30 days
boolean
C2348568 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

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