ID

37341

Beskrivning

Exenatide Once Weekly, Cardiovascular Risk and Type-2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT02380521

Länk

https://clinicaltrials.gov/show/NCT02380521

Nyckelord

Versioner (1)
  1. 2019-07-18 2019-07-18 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

18 juli 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT02380521

Engelsk

Eligibility Type 2 Diabetes Mellitus NCT02380521

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. provision of informed consent prior to any study specific procedures;
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
2. men and women with t2dm aged >18 years;
Beskrivning

Diabetes Mellitus, Non-Insulin-Dependent | Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0001779
3. bmi >25 kg/m2;
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
4. hba1c 7.5-8.5 %;
Beskrivning

Hemoglobin A1c measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0474680
5. receiving metformin therapy (doses ranging from 1500 to 3000 mg daily) for at least 8 weeks.
Beskrivning

Metformin Dose U/day

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0456683
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. pregnancy or willingness to become pregnant;
Beskrivning

Pregnancy | Pregnancy, Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
2. moderate and severe liver dysfunction;
Beskrivning

Liver Dysfunction Moderate | Liver Dysfunction Severe

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0086565
UMLS CUI [1,2]
C0205081
UMLS CUI [2,1]
C0086565
UMLS CUI [2,2]
C0205082
3. moderate and severe renal failure;
Beskrivning

RENAL FAILURE MODERATE | Kidney Failure Severe

Datatyp

boolean

Alias
UMLS CUI [1]
C0748307
UMLS CUI [2,1]
C0035078
UMLS CUI [2,2]
C0205082
4. previous major cardiovascular event;
Beskrivning

Cardiovascular event Major

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1320716
UMLS CUI [1,2]
C0205164
5. severe infections at the discretion of the investigator (such as human immunodeficiency virus [hiv], hepatitis b virus [hbv] and hepatitis c virus [hcv]);
Beskrivning

Communicable Diseases Severe | HIV Infection | Hepatitis B | Hepatitis C

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0019693
UMLS CUI [3]
C0019163
UMLS CUI [4]
C0019196
6. any malignancy;
Beskrivning

Malignant Neoplasms

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
7. plasma triglycerides >400 mg/dl, plasma ldl-cholesterol > 250 mg/dl.
Beskrivning

Plasma triglyceride measurement | Plasma LDL cholesterol measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0583329
UMLS CUI [2]
C1278149
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT02380521

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. provision of informed consent prior to any study specific procedures;
boolean
C0021430 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent | Age
Item
2. men and women with t2dm aged >18 years;
boolean
C0011860 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Body mass index
Item
3. bmi >25 kg/m2;
boolean
C1305855 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
4. hba1c 7.5-8.5 %;
boolean
C0474680 (UMLS CUI [1])
Metformin Dose U/day
Item
5. receiving metformin therapy (doses ranging from 1500 to 3000 mg daily) for at least 8 weeks.
boolean
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Pregnancy, Planned
Item
1. pregnancy or willingness to become pregnant;
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Liver Dysfunction Moderate | Liver Dysfunction Severe
Item
2. moderate and severe liver dysfunction;
boolean
C0086565 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0086565 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
RENAL FAILURE MODERATE | Kidney Failure Severe
Item
3. moderate and severe renal failure;
boolean
C0748307 (UMLS CUI [1])
C0035078 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Cardiovascular event Major
Item
4. previous major cardiovascular event;
boolean
C1320716 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
Communicable Diseases Severe | HIV Infection | Hepatitis B | Hepatitis C
Item
5. severe infections at the discretion of the investigator (such as human immunodeficiency virus [hiv], hepatitis b virus [hbv] and hepatitis c virus [hcv]);
boolean
C0009450 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0019693 (UMLS CUI [2])
C0019163 (UMLS CUI [3])
C0019196 (UMLS CUI [4])
Malignant Neoplasms
Item
6. any malignancy;
boolean
C0006826 (UMLS CUI [1])
Plasma triglyceride measurement | Plasma LDL cholesterol measurement
Item
7. plasma triglycerides >400 mg/dl, plasma ldl-cholesterol > 250 mg/dl.
boolean
C0583329 (UMLS CUI [1])
C1278149 (UMLS CUI [2])
Tillbaka till toppen 

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