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Informações:
Falhas:
ID
231
Descrição
ODM derived from http://clinicaltrials.gov/show/NCT00275379
Link
http://clinicaltrials.gov/show/NCT00275379
Palavras-chave
Versões (2)
- 06/03/2012 06/03/2012 -
- 07/06/2017 07/06/2017 - Martin Dugas
Transferido a
6 de março de 2012
DOI
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Licença
Creative Commons BY-NC 3.0
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Eligibility NCT00275379 Cystitis, Interstitial
Similar models
Eligibility
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Age
Item
Alter 18 Jahre und älter
boolean
medical treatment for IC
Item
Subjects seeking medical treatment for symptoms consistent with IC that have been ongoing for > 9 months or seeking medical treatment for a previous documented diagnosis of IC
boolean
agreement to birth control
Item
Subjects who are not surgically sterile or postmenopausal (amenorrheic > 12 months) must agree and commit to the use of a medically acceptable, highly-effective (i.e. double-barrier or IUD), non-hormonal form of birth control during the study and for 30 days after the last dose of test
boolean
Use of herbal supplements
Item
Use of herbal supplements (except for a daily multivitamin/mineral supplement not containing herbal components)
boolean
History of cancer
Item
History of cancer (other than resected cutaneous basal or squamous cell carcinoma or in situ cervical cancer) with less than 5 years documentation of a disease-free state
boolean
Vaginitis or vaginal infection
Item
Vaginitis or vaginal infection within 1 month before randomization
boolean
Age
Item
Alter
integer
C0001779 (UMLS CUI)
397669002 (SNOMED CT 2010_0731)
397669002 (SNOMED CT 2010_0731)
Diagnosis
Item
Diagnose
string
medical treatment method
Item
medical treatment approach
string
C0679624 (UMLS CUI)
IC
Item
Interstitial Cystitis
string
C0282488 (UMLS CUI)
197834003 (SNOMED CT 2010_0731)
10011796 (MedDRA 13.1)
197834003 (SNOMED CT 2010_0731)
10011796 (MedDRA 13.1)
Female Sterilizations
Item
Contraceptive method: female sterilization
string
C0015787 (UMLS CUI)
169549004 (SNOMED CT 2010_0731)
10056199 (MedDRA 13.1)
169549004 (SNOMED CT 2010_0731)
10056199 (MedDRA 13.1)
Postmenopause
Item
Postmenopause
string
C0206159 (UMLS CUI)
10051775 (MedDRA 13.1)
10051775 (MedDRA 13.1)
Amenorrhea
Item
Absence of menstruation
string
C0002453 (UMLS CUI)
14302001 (SNOMED CT 2010_0731)
10001928 (MedDRA 13.1)
N91.2 (ICD-10-CM Version 2010)
626.0 (ICD-9-CM Version 2011)
14302001 (SNOMED CT 2010_0731)
10001928 (MedDRA 13.1)
N91.2 (ICD-10-CM Version 2010)
626.0 (ICD-9-CM Version 2011)
Informed Consent
Item
Einverständniserklärung
string
C0021430 (UMLS CUI)
Contraception
Item
Kontrazeption
string
C0700589 (UMLS CUI)
146680009 (SNOMED CT 2010_0731)
10010808 (MedDRA 13.1)
146680009 (SNOMED CT 2010_0731)
10010808 (MedDRA 13.1)
Contraception, Barrier
Item
Barrier contraception method
string
C0004764 (UMLS CUI)
225370004 (SNOMED CT 2010_0731)
225370004 (SNOMED CT 2010_0731)
IUD
Item
Intrauterine contraceptive device
string
C0021900 (UMLS CUI)
268460000 (SNOMED CT 2010_0731)
10022745 (MedDRA 13.1)
268460000 (SNOMED CT 2010_0731)
10022745 (MedDRA 13.1)
Herbal supplement
Item
Herbal supplement
string
C1504473 (UMLS CUI)
10063340 (MedDRA 13.1)
10063340 (MedDRA 13.1)
Cancer
Item
Krebs
string
C0006826 (UMLS CUI)
363346000 (SNOMED CT 2010_0731)
10028997 (MedDRA 13.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
363346000 (SNOMED CT 2010_0731)
10028997 (MedDRA 13.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
Basal cell carcinoma
Item
Basalzellenkarzinom
string
C0007117 (UMLS CUI)
1338007 (SNOMED CT 2010_0731)
10004146 (MedDRA 13.1)
1338007 (SNOMED CT 2010_0731)
10004146 (MedDRA 13.1)
Squamous cell carcinoma
Item
Squamous cell carcinoma
string
C0007137 (UMLS CUI)
28899001 (SNOMED CT 2010_0731)
10041823 (MedDRA 13.1)
28899001 (SNOMED CT 2010_0731)
10041823 (MedDRA 13.1)
Cervix carcinoma
Item
Carcinoma of cervix
string
C0302592 (UMLS CUI)
285432005 (SNOMED CT 2010_0731)
10008342 (MedDRA 13.1)
285432005 (SNOMED CT 2010_0731)
10008342 (MedDRA 13.1)
Vaginitis
Item
Inflammation of vagina
string
C0042267 (UMLS CUI)
30800001 (SNOMED CT 2010_0731)
10046950 (MedDRA 13.1)
E13270 (CTCAE Version 4.03)
30800001 (SNOMED CT 2010_0731)
10046950 (MedDRA 13.1)
E13270 (CTCAE Version 4.03)
Infective vaginitis
Item
Vaginal infection
string
C0404521 (UMLS CUI)
237091009 (SNOMED CT 2010_0731)
10046914 (MedDRA 13.1)
N76.0 (ICD-10-CM Version 2010)
E11624 (CTCAE Version 4.03)
237091009 (SNOMED CT 2010_0731)
10046914 (MedDRA 13.1)
N76.0 (ICD-10-CM Version 2010)
E11624 (CTCAE Version 4.03)
Randomization
Item
Random Allocation
string
C0034656 (UMLS CUI)