ID

38970

Beskrivning

Avoiding Diabetes After Pregnancy Trial in Moms; ODM derived from: https://clinicaltrials.gov/show/NCT01918345

Länk

https://clinicaltrials.gov/show/NCT01918345

Nyckelord

Versioner (1)
  1. 2019-11-16 2019-11-16 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

16 november 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Diabetes NCT01918345

Engelsk

Eligibility Diabetes NCT01918345

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01918345
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
18 years of age or older
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
physician-diagnosed gestational diabetes mellitus (gdm) during most recent pregnancy based on canadian diabetes association (cda) diagnostic criteria
Beskrivning

Gestational Diabetes | Pregnancy Most Recent

Datatyp

boolean

Alias
UMLS CUI [1]
C0085207
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C1513491
3-6 months postpartum after a gdm pregnancy
Beskrivning

Postpartum Period | Status post Gestational Diabetes Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0086839
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0085207
UMLS CUI [2,3]
C0032961
during gdm pregnancy, followed by a diabetes in pregnancy clinic at one of study sites (i.e. sunnybrook health sciences centre, mount sinai hospital, st. michael's hospital, toronto east general hospital)
Beskrivning

Gestational Diabetes Pregnancy | Followed by Diabetes in pregnancy clinic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0085207
UMLS CUI [1,2]
C0032961
UMLS CUI [2,1]
C0332283
UMLS CUI [2,2]
C3839840
english-speaking
Beskrivning

Able to speak English Language

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0564215
UMLS CUI [1,2]
C0376245
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
current diabetes (type i or type ii) and/or treatment with any anti-diabetic therapy
Beskrivning

Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent | Diabetes Therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0011860
UMLS CUI [3]
C3274787
any major illness that may interfere with participation
Beskrivning

Illness Major Interferes with Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205164
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C2348568
any obstetrical or fetal complication that may interfere with participation
Beskrivning

Obstetrical complication Interferes with Study Subject Participation Status | Complication Fetal Interferes with Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0178292
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C0009566
UMLS CUI [2,2]
C0521457
UMLS CUI [2,3]
C0521102
UMLS CUI [2,4]
C2348568
involvement in any other clinical trial requiring drug therapy
Beskrivning

Study Subject Participation Status | Pharmacotherapy Required

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0013216
UMLS CUI [2,2]
C1514873
history of cardiovascular disease or ecg abnormalities on graded exercise treadmill test
Beskrivning

Cardiovascular Disease | Progressive exercise test on treadmill ECG abnormal

Datatyp

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2,1]
C0430507
UMLS CUI [2,2]
C0522055
new pregnancy within postpartum period
Beskrivning

Pregnancy New | Postpartum Period

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0205314
UMLS CUI [2]
C0086839
any illness affecting carbohydrate digestion and/or metabolism including kidney disease, hepatitis, hiv/aids, celiac disease
Beskrivning

Illness Affecting Carbohydrate Digestion | Illness Affecting Metabolism | Kidney Disease | Hepatitis | HIV Infection | AIDS | Celiac Disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0007004
UMLS CUI [1,4]
C0012238
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0025519
UMLS CUI [3]
C0022658
UMLS CUI [4]
C0019158
UMLS CUI [5]
C0019693
UMLS CUI [6]
C0001175
UMLS CUI [7]
C0007570
any other factor likely to limit study adherence, in the opinion of the principal investigator
Beskrivning

Factor Limiting Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1521761
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0525058
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Similar models

Eligibility Diabetes NCT01918345

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01918345
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Gestational Diabetes | Pregnancy Most Recent
Item
physician-diagnosed gestational diabetes mellitus (gdm) during most recent pregnancy based on canadian diabetes association (cda) diagnostic criteria
boolean
C0085207 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C1513491 (UMLS CUI [2,2])
Postpartum Period | Status post Gestational Diabetes Pregnancy
Item
3-6 months postpartum after a gdm pregnancy
boolean
C0086839 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C0085207 (UMLS CUI [2,2])
C0032961 (UMLS CUI [2,3])
Gestational Diabetes Pregnancy | Followed by Diabetes in pregnancy clinic
Item
during gdm pregnancy, followed by a diabetes in pregnancy clinic at one of study sites (i.e. sunnybrook health sciences centre, mount sinai hospital, st. michael's hospital, toronto east general hospital)
boolean
C0085207 (UMLS CUI [1,1])
C0032961 (UMLS CUI [1,2])
C0332283 (UMLS CUI [2,1])
C3839840 (UMLS CUI [2,2])
Able to speak English Language
Item
english-speaking
boolean
C0564215 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent | Diabetes Therapy
Item
current diabetes (type i or type ii) and/or treatment with any anti-diabetic therapy
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
C3274787 (UMLS CUI [3])
Illness Major Interferes with Study Subject Participation Status
Item
any major illness that may interfere with participation
boolean
C0221423 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
Obstetrical complication Interferes with Study Subject Participation Status | Complication Fetal Interferes with Study Subject Participation Status
Item
any obstetrical or fetal complication that may interfere with participation
boolean
C0178292 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0009566 (UMLS CUI [2,1])
C0521457 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C2348568 (UMLS CUI [2,4])
Study Subject Participation Status | Pharmacotherapy Required
Item
involvement in any other clinical trial requiring drug therapy
boolean
C2348568 (UMLS CUI [1])
C0013216 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
Cardiovascular Disease | Progressive exercise test on treadmill ECG abnormal
Item
history of cardiovascular disease or ecg abnormalities on graded exercise treadmill test
boolean
C0007222 (UMLS CUI [1])
C0430507 (UMLS CUI [2,1])
C0522055 (UMLS CUI [2,2])
Pregnancy New | Postpartum Period
Item
new pregnancy within postpartum period
boolean
C0032961 (UMLS CUI [1,1])
C0205314 (UMLS CUI [1,2])
C0086839 (UMLS CUI [2])
Illness Affecting Carbohydrate Digestion | Illness Affecting Metabolism | Kidney Disease | Hepatitis | HIV Infection | AIDS | Celiac Disease
Item
any illness affecting carbohydrate digestion and/or metabolism including kidney disease, hepatitis, hiv/aids, celiac disease
boolean
C0221423 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0007004 (UMLS CUI [1,3])
C0012238 (UMLS CUI [1,4])
C0221423 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0025519 (UMLS CUI [2,3])
C0022658 (UMLS CUI [3])
C0019158 (UMLS CUI [4])
C0019693 (UMLS CUI [5])
C0001175 (UMLS CUI [6])
C0007570 (UMLS CUI [7])
Factor Limiting Protocol Compliance
Item
any other factor likely to limit study adherence, in the opinion of the principal investigator
boolean
C1521761 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
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