ID

35770

Beskrivning

Lifestyle and Glucose Lowering Medication in T2DM; ODM derived from: https://clinicaltrials.gov/show/NCT02417012

Länk

https://clinicaltrials.gov/show/NCT02417012

Nyckelord

Versioner (1)
  1. 2019-03-21 2019-03-21 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

21 mars 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT02417012

Engelsk

Eligibility Diabetes Mellitus, Type 2 NCT02417012

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
less than three anti-diabetic medications.
Beskrivning

Antidiabetics Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1265611
diabetes 2 duration of max 10 years
Beskrivning

Non-Insulin-Dependent Diabetes Mellitus Disease length

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
bmi >25 but <40 kg/m2,
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
accept of medical regulation by the uturn endocrinologists only
Beskrivning

Life Style Intervention With intensity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023676
UMLS CUI [1,2]
C0184661
UMLS CUI [1,3]
C0522510
accept of purchasing a fitness club membership through u-turn collaborator
Beskrivning

Physical Fitness Fitness Center

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0031812
UMLS CUI [1,2]
C0600623
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
hba1c> 9% (75 mmol/mol)
Beskrivning

Hemoglobin A1c measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0474680
insulin usage
Beskrivning

Insulin use

Datatyp

boolean

Alias
UMLS CUI [1]
C0240016
presence of one or more of the following micro- and macrovascular complications of t2dm; a.diabetic retinopathy (except mild nonproliferative retinopathy or early proliferative retinopathy) b. macro-albuminuria or nephropathy c. diabetic neuropathy (except mild affected vibratory testing (<50 volt)) d. arterial insufficiency e. ischemic heart disease
Beskrivning

Non-Insulin-Dependent Diabetes Mellitus Complications Microvascular | Non-Insulin-Dependent Diabetes Mellitus Complications Large vessels | Diabetic Retinopathy | Exception Mild non-proliferative diabetic retinopathy | Exception Early proliferative diabetic retinopathy | High urine albumin levels | Kidney Disease | Diabetic Neuropathy | Exception Vibratory sense function Testing Mild | Arterial insufficiency | Myocardial Ischemia

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0009566
UMLS CUI [1,3]
C0443258
UMLS CUI [2,1]
C0011860
UMLS CUI [2,2]
C0009566
UMLS CUI [2,3]
C0225990
UMLS CUI [3]
C0011884
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0730276
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0730279
UMLS CUI [6]
C1654921
UMLS CUI [7]
C0022658
UMLS CUI [8]
C0011882
UMLS CUI [9,1]
C1705847
UMLS CUI [9,2]
C0234198
UMLS CUI [9,3]
C0039593
UMLS CUI [9,4]
C2945599
UMLS CUI [10]
C0003834
UMLS CUI [11]
C0151744
steroid treatment (inhalation) until three months before the medical examination
Beskrivning

Steroid therapy by Inhalation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0149783
UMLS CUI [1,2]
C0205535
tsh raised/below the normal range
Beskrivning

Raised TSH level | Decreased thyroid stimulating hormone level

Datatyp

boolean

Alias
UMLS CUI [1]
C0586553
UMLS CUI [2]
C1295607
liver disease (alat/asat thrice normal range)
Beskrivning

Liver disease | Alanine aminotransferase increased | Aspartate aminotransferase increased

Datatyp

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0151904
inability or contraindication to increased levels of physical activity (pedersen bk and saltin b)
Beskrivning

Increased physical activity levels Unable | Medical contraindication Increased physical activity levels

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0851792
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0851792
evidence of anaemia
Beskrivning

Anemia

Datatyp

boolean

Alias
UMLS CUI [1]
C0002871
lung disease (except mild asthma and mild chronic obstructive pulmonary disease)
Beskrivning

Lung disease | Exception Mild chronic obstructive pulmonary disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0024115
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0730604
heart disease
Beskrivning

Heart Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0018799
kidney disease (creatinine above 130 µm or macro albuminuria)
Beskrivning

Kidney Disease | Creatinine measurement, serum | High urine albumin levels

Datatyp

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0201976
UMLS CUI [3]
C1654921
pregnancy
Beskrivning

Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT02417012

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Antidiabetics Quantity
Item
less than three anti-diabetic medications.
boolean
C0935929 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
diabetes 2 duration of max 10 years
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Body mass index
Item
bmi >25 but <40 kg/m2,
boolean
C1305855 (UMLS CUI [1])
Life Style Intervention With intensity
Item
accept of medical regulation by the uturn endocrinologists only
boolean
C0023676 (UMLS CUI [1,1])
C0184661 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,3])
Physical Fitness Fitness Center
Item
accept of purchasing a fitness club membership through u-turn collaborator
boolean
C0031812 (UMLS CUI [1,1])
C0600623 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Hemoglobin A1c measurement
Item
hba1c> 9% (75 mmol/mol)
boolean
C0474680 (UMLS CUI [1])
Insulin use
Item
insulin usage
boolean
C0240016 (UMLS CUI [1])
Non-Insulin-Dependent Diabetes Mellitus Complications Microvascular | Non-Insulin-Dependent Diabetes Mellitus Complications Large vessels | Diabetic Retinopathy | Exception Mild non-proliferative diabetic retinopathy | Exception Early proliferative diabetic retinopathy | High urine albumin levels | Kidney Disease | Diabetic Neuropathy | Exception Vibratory sense function Testing Mild | Arterial insufficiency | Myocardial Ischemia
Item
presence of one or more of the following micro- and macrovascular complications of t2dm; a.diabetic retinopathy (except mild nonproliferative retinopathy or early proliferative retinopathy) b. macro-albuminuria or nephropathy c. diabetic neuropathy (except mild affected vibratory testing (<50 volt)) d. arterial insufficiency e. ischemic heart disease
boolean
C0011860 (UMLS CUI [1,1])
C0009566 (UMLS CUI [1,2])
C0443258 (UMLS CUI [1,3])
C0011860 (UMLS CUI [2,1])
C0009566 (UMLS CUI [2,2])
C0225990 (UMLS CUI [2,3])
C0011884 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0730276 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0730279 (UMLS CUI [5,2])
C1654921 (UMLS CUI [6])
C0022658 (UMLS CUI [7])
C0011882 (UMLS CUI [8])
C1705847 (UMLS CUI [9,1])
C0234198 (UMLS CUI [9,2])
C0039593 (UMLS CUI [9,3])
C2945599 (UMLS CUI [9,4])
C0003834 (UMLS CUI [10])
C0151744 (UMLS CUI [11])
Steroid therapy by Inhalation
Item
steroid treatment (inhalation) until three months before the medical examination
boolean
C0149783 (UMLS CUI [1,1])
C0205535 (UMLS CUI [1,2])
Raised TSH level | Decreased thyroid stimulating hormone level
Item
tsh raised/below the normal range
boolean
C0586553 (UMLS CUI [1])
C1295607 (UMLS CUI [2])
Liver disease | Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
liver disease (alat/asat thrice normal range)
boolean
C0023895 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
Increased physical activity levels Unable | Medical contraindication Increased physical activity levels
Item
inability or contraindication to increased levels of physical activity (pedersen bk and saltin b)
boolean
C0851792 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0851792 (UMLS CUI [2,2])
Anemia
Item
evidence of anaemia
boolean
C0002871 (UMLS CUI [1])
Lung disease | Exception Mild chronic obstructive pulmonary disease
Item
lung disease (except mild asthma and mild chronic obstructive pulmonary disease)
boolean
C0024115 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0730604 (UMLS CUI [2,2])
Heart Disease
Item
heart disease
boolean
C0018799 (UMLS CUI [1])
Kidney Disease | Creatinine measurement, serum | High urine albumin levels
Item
kidney disease (creatinine above 130 µm or macro albuminuria)
boolean
C0022658 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C1654921 (UMLS CUI [3])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
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