ID

31555

Description

Ketoconazole, Dexamethasone, and Hydrocortisone in Treating Patients With Prostate Cancer That Did Not Respond to Androgen-Deprivation Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT00559481

Lien

https://clinicaltrials.gov/show/NCT00559481

Mots-clés

Versions (1)
  1. 03/09/2018 03/09/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

3 septembre 2018

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.

Retour au modèle Commentaires
Groupe Item commentaires pour :

Item commentaires pour :

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

Eligibility Prostate Cancer NCT00559481

Anglais

Eligibility Prostate Cancer NCT00559481

1 Formulaires  
Criteria
Description

Criteria

confirmed diagnosis of prostate cancer
Description

Prostate carcinoma

Type de données

boolean

Alias
UMLS CUI [1]
C0600139
must have failed standard androgen-deprivation therapy
Description

Antiandrogen therapy failed

Type de données

boolean

Alias
UMLS CUI [1,1]
C0279492
UMLS CUI [1,2]
C0231175
evidence of rising psa
Description

Raised prostate specific antigen

Type de données

boolean

Alias
UMLS CUI [1]
C0178415
patient characteristics:
Description

Client Characteristics

Type de données

boolean

Alias
UMLS CUI [1]
C0815172
ecog performance status 0-2
Description

ECOG performance status

Type de données

boolean

Alias
UMLS CUI [1]
C1520224
creatinine ≤ 2.0 mg/dl
Description

Creatinine measurement, serum

Type de données

boolean

Alias
UMLS CUI [1]
C0201976
ast and alt < 4 times upper limit of normal
Description

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
bilirubin < 2.0 mg/dl
Description

Serum total bilirubin measurement

Type de données

boolean

Alias
UMLS CUI [1]
C1278039
no active congestive heart failure
Description

Exclusion | Congestive heart failure

Type de données

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2]
C0018802
no allergy to ketoconazole, dexamethasone, hydrocortisone, or to one of the components of dexamethasone, hydrocortisone, or ketoconazole
Description

Exclusion Criteria | Ketoconazole allergy | Dexamethasone allergy | Hydrocortisone allergy | Hypersensitivity Dexamethasone Component | Hypersensitivity Hydrocortisone Component | Hypersensitivity Ketoconazole Component

Type de données

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C0571275
UMLS CUI [3]
C0571611
UMLS CUI [4]
C0571588
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0011777
UMLS CUI [5,3]
C1705248
UMLS CUI [6,1]
C0020517
UMLS CUI [6,2]
C0020268
UMLS CUI [6,3]
C1705248
UMLS CUI [7,1]
C0020517
UMLS CUI [7,2]
C0022625
UMLS CUI [7,3]
C1705248
no active infection
Description

Exclusion | Communicable Disease

Type de données

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2]
C0009450
no uncontrolled glaucoma
Description

Exclusion | Glaucoma Uncontrolled

Type de données

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2,1]
C0017601
UMLS CUI [2,2]
C0205318
no active peptic ulcer disease
Description

Exclusion | Peptic Ulcer

Type de données

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2]
C0030920
no uncontrolled diabetes mellitus
Description

Exclusion | Diabetic - poor control

Type de données

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2]
C0421258
fertile patients must use effective contraception during and for 3 months after completion of study therapy
Description

Fertility Contraceptive methods

Type de données

boolean

Alias
UMLS CUI [1,1]
C0015895
UMLS CUI [1,2]
C0700589
prior concurrent therapy:
Description

Therapeutic procedure

Type de données

boolean

Alias
UMLS CUI [1]
C0087111
more than 2 weeks since prior and no concurrent drugs known to interact with study treatment
Description

Exclusion | Pharmaceutical Preparations Interaction Investigational Therapy

Type de données

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0687133
UMLS CUI [2,3]
C0949266
Retour au début de la page

Similar models

Eligibility Prostate Cancer NCT00559481

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Prostate carcinoma
Item
confirmed diagnosis of prostate cancer
boolean
C0600139 (UMLS CUI [1])
Antiandrogen therapy failed
Item
must have failed standard androgen-deprivation therapy
boolean
C0279492 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Raised prostate specific antigen
Item
evidence of rising psa
boolean
C0178415 (UMLS CUI [1])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Creatinine measurement, serum
Item
creatinine ≤ 2.0 mg/dl
boolean
C0201976 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
ast and alt < 4 times upper limit of normal
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Serum total bilirubin measurement
Item
bilirubin < 2.0 mg/dl
boolean
C1278039 (UMLS CUI [1])
Exclusion | Congestive heart failure
Item
no active congestive heart failure
boolean
C2828389 (UMLS CUI [1])
C0018802 (UMLS CUI [2])
Exclusion Criteria | Ketoconazole allergy | Dexamethasone allergy | Hydrocortisone allergy | Hypersensitivity Dexamethasone Component | Hypersensitivity Hydrocortisone Component | Hypersensitivity Ketoconazole Component
Item
no allergy to ketoconazole, dexamethasone, hydrocortisone, or to one of the components of dexamethasone, hydrocortisone, or ketoconazole
boolean
C0680251 (UMLS CUI [1])
C0571275 (UMLS CUI [2])
C0571611 (UMLS CUI [3])
C0571588 (UMLS CUI [4])
C0020517 (UMLS CUI [5,1])
C0011777 (UMLS CUI [5,2])
C1705248 (UMLS CUI [5,3])
C0020517 (UMLS CUI [6,1])
C0020268 (UMLS CUI [6,2])
C1705248 (UMLS CUI [6,3])
C0020517 (UMLS CUI [7,1])
C0022625 (UMLS CUI [7,2])
C1705248 (UMLS CUI [7,3])
Exclusion | Communicable Disease
Item
no active infection
boolean
C2828389 (UMLS CUI [1])
C0009450 (UMLS CUI [2])
Exclusion | Glaucoma Uncontrolled
Item
no uncontrolled glaucoma
boolean
C2828389 (UMLS CUI [1])
C0017601 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Exclusion | Peptic Ulcer
Item
no active peptic ulcer disease
boolean
C2828389 (UMLS CUI [1])
C0030920 (UMLS CUI [2])
Exclusion | Diabetic - poor control
Item
no uncontrolled diabetes mellitus
boolean
C2828389 (UMLS CUI [1])
C0421258 (UMLS CUI [2])
Fertility Contraceptive methods
Item
fertile patients must use effective contraception during and for 3 months after completion of study therapy
boolean
C0015895 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
Exclusion | Pharmaceutical Preparations Interaction Investigational Therapy
Item
more than 2 weeks since prior and no concurrent drugs known to interact with study treatment
boolean
C2828389 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0687133 (UMLS CUI [2,2])
C0949266 (UMLS CUI [2,3])
Retour au début de la page 

Contact

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

Les champs marqués d’un * sont obligatoires.

Aide

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