ID

37344

Beschrijving

Memory Aid by Intranasal Insulin in Diabetes (MemAID); ODM derived from: https://clinicaltrials.gov/show/NCT02415556

Link

https://clinicaltrials.gov/show/NCT02415556

Trefwoorden

Versies (1)
  1. 18-07-19 18-07-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

18 juli 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT02415556

Engels

Eligibility Type 2 Diabetes Mellitus NCT02415556

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
men and women aged 50-85 years old
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
able to walk for 6 minutes
Beschrijving

Able to walk Minutes Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C2712089
UMLS CUI [1,2]
C0439232
UMLS CUI [1,3]
C1265611
diabetes type 2 (dm) group: diagnosis and treatment for type 2 dm with non-insulin oral or injectable agents or insulin
Beschrijving

Diabetes Mellitus, Non-Insulin-Dependent | Oral medication Except Insulin | Injectables Except Insulin | Insulin regime

Datatype

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0175795
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C0021641
UMLS CUI [3,1]
C0086466
UMLS CUI [3,2]
C0332300
UMLS CUI [3,3]
C0021641
UMLS CUI [4]
C0557978
non-dm group with similar age range as the dm group, non-diabetic fasting plasma glucose (<126 mg/dl) and hemoglobin a1c (hba1c) (<6.5%)
Beschrijving

Group Without Diabetes Mellitus | Age | Plasma fasting glucose measurement | Hemoglobin A1c measurement

Datatype

boolean

Alias
UMLS CUI [1,1]
C0441833
UMLS CUI [1,2]
C0332288
UMLS CUI [1,3]
C0011849
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0583513
UMLS CUI [4]
C0474680
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
type 1 dm
Beschrijving

Diabetes Mellitus, Insulin-Dependent

Datatype

boolean

Alias
UMLS CUI [1]
C0011854
intolerance to insulin
Beschrijving

Intolerance to Insulin

Datatype

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0021641
history of severe hypoglycemia
Beschrijving

Hypoglycemia Severe

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020615
UMLS CUI [1,2]
C0205082
participants who have >1 asymptomatic and/or symptomatic episode of hypoglycemia (glucose < 70 mg/dl) during continuous glucose monitoring (cgm) or home measurements
Beschrijving

Episode Quantity Hypoglycemia | Episode Asymptomatic Hypoglycemia | Episode Symptomatic Hypoglycemia | Glucose measurement | Continuous glucose monitoring

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332189
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0020615
UMLS CUI [2,1]
C0332189
UMLS CUI [2,2]
C0231221
UMLS CUI [2,3]
C0020615
UMLS CUI [3,1]
C0332189
UMLS CUI [3,2]
C0231220
UMLS CUI [3,3]
C0020615
UMLS CUI [4]
C0337438
UMLS CUI [5]
C4523945
acute medical condition that required either hospitalization or surgery within the past 6 months (e.g., severe hypoglycemia, malignancies, myocardial infarction,stroke)
Beschrijving

Medical condition Hospitalization Required | Medical condition Requirement Operative Surgical Procedures | Hypoglycemia Severe | Malignant Neoplasms | Myocardial Infarction | Cerebrovascular accident

Datatype

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1708385
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0543467
UMLS CUI [3,1]
C0020615
UMLS CUI [3,2]
C0205082
UMLS CUI [4]
C0006826
UMLS CUI [5]
C0027051
UMLS CUI [6]
C0038454
severe chronic sinus problems or allergies
Beschrijving

Sinus problem severe chronic | Sinus Allergy severe chronic

Datatype

boolean

Alias
UMLS CUI [1,1]
C0577887
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0205191
UMLS CUI [2,1]
C0718388
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0205191
liver or renal failure or transplant
Beschrijving

Liver Failure | Kidney Failure | Transplantation of liver | Kidney Transplantation

Datatype

boolean

Alias
UMLS CUI [1]
C0085605
UMLS CUI [2]
C0035078
UMLS CUI [3]
C0023911
UMLS CUI [4]
C0022671
dementia (mini mental state examination [mmse] scores ≤20)
Beschrijving

Dementia Mini-mental state examination

Datatype

boolean

Alias
UMLS CUI [1,1]
C0497327
UMLS CUI [1,2]
C0451306
current recreational drug or alcohol abuse
Beschrijving

Substance Use Disorders

Datatype

boolean

Alias
UMLS CUI [1]
C0038586
morbid obesity (body mass index [bmi] >45)
Beschrijving

Obesity, Morbid | Body mass index

Datatype

boolean

Alias
UMLS CUI [1]
C0028756
UMLS CUI [2]
C1305855
serious systemic disease that would interfere with conduction of clinical trial
Beschrijving

Systemic disease Serious Interferes with Completion of clinical trial

Datatype

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C2732579
magnetic resonance imaging (mri) substudy: claustrophobia and implants incompatible with 3-tesla mri
Beschrijving

MRI Clinical Trial | Claustrophobia Inconsistent 3 Tesla MRI | Implants Inconsistent 3 Tesla MRI

Datatype

boolean

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C0008976
UMLS CUI [2,1]
C0008909
UMLS CUI [2,2]
C0442809
UMLS CUI [2,3]
C2985394
UMLS CUI [3,1]
C0021102
UMLS CUI [3,2]
C0442809
UMLS CUI [3,3]
C2985394
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT02415556

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
men and women aged 50-85 years old
boolean
C0001779 (UMLS CUI [1])
Able to walk Minutes Quantity
Item
able to walk for 6 minutes
boolean
C2712089 (UMLS CUI [1,1])
C0439232 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Diabetes Mellitus, Non-Insulin-Dependent | Oral medication Except Insulin | Injectables Except Insulin | Insulin regime
Item
diabetes type 2 (dm) group: diagnosis and treatment for type 2 dm with non-insulin oral or injectable agents or insulin
boolean
C0011860 (UMLS CUI [1])
C0175795 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C0021641 (UMLS CUI [2,3])
C0086466 (UMLS CUI [3,1])
C0332300 (UMLS CUI [3,2])
C0021641 (UMLS CUI [3,3])
C0557978 (UMLS CUI [4])
Group Without Diabetes Mellitus | Age | Plasma fasting glucose measurement | Hemoglobin A1c measurement
Item
non-dm group with similar age range as the dm group, non-diabetic fasting plasma glucose (<126 mg/dl) and hemoglobin a1c (hba1c) (<6.5%)
boolean
C0441833 (UMLS CUI [1,1])
C0332288 (UMLS CUI [1,2])
C0011849 (UMLS CUI [1,3])
C0001779 (UMLS CUI [2])
C0583513 (UMLS CUI [3])
C0474680 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent
Item
type 1 dm
boolean
C0011854 (UMLS CUI [1])
Intolerance to Insulin
Item
intolerance to insulin
boolean
C1744706 (UMLS CUI [1,1])
C0021641 (UMLS CUI [1,2])
Hypoglycemia Severe
Item
history of severe hypoglycemia
boolean
C0020615 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Episode Quantity Hypoglycemia | Episode Asymptomatic Hypoglycemia | Episode Symptomatic Hypoglycemia | Glucose measurement | Continuous glucose monitoring
Item
participants who have >1 asymptomatic and/or symptomatic episode of hypoglycemia (glucose < 70 mg/dl) during continuous glucose monitoring (cgm) or home measurements
boolean
C0332189 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0020615 (UMLS CUI [1,3])
C0332189 (UMLS CUI [2,1])
C0231221 (UMLS CUI [2,2])
C0020615 (UMLS CUI [2,3])
C0332189 (UMLS CUI [3,1])
C0231220 (UMLS CUI [3,2])
C0020615 (UMLS CUI [3,3])
C0337438 (UMLS CUI [4])
C4523945 (UMLS CUI [5])
Medical condition Hospitalization Required | Medical condition Requirement Operative Surgical Procedures | Hypoglycemia Severe | Malignant Neoplasms | Myocardial Infarction | Cerebrovascular accident
Item
acute medical condition that required either hospitalization or surgery within the past 6 months (e.g., severe hypoglycemia, malignancies, myocardial infarction,stroke)
boolean
C3843040 (UMLS CUI [1,1])
C1708385 (UMLS CUI [1,2])
C3843040 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0543467 (UMLS CUI [2,3])
C0020615 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0006826 (UMLS CUI [4])
C0027051 (UMLS CUI [5])
C0038454 (UMLS CUI [6])
Sinus problem severe chronic | Sinus Allergy severe chronic
Item
severe chronic sinus problems or allergies
boolean
C0577887 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
C0718388 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0205191 (UMLS CUI [2,3])
Liver Failure | Kidney Failure | Transplantation of liver | Kidney Transplantation
Item
liver or renal failure or transplant
boolean
C0085605 (UMLS CUI [1])
C0035078 (UMLS CUI [2])
C0023911 (UMLS CUI [3])
C0022671 (UMLS CUI [4])
Dementia Mini-mental state examination
Item
dementia (mini mental state examination [mmse] scores ≤20)
boolean
C0497327 (UMLS CUI [1,1])
C0451306 (UMLS CUI [1,2])
Substance Use Disorders
Item
current recreational drug or alcohol abuse
boolean
C0038586 (UMLS CUI [1])
Obesity, Morbid | Body mass index
Item
morbid obesity (body mass index [bmi] >45)
boolean
C0028756 (UMLS CUI [1])
C1305855 (UMLS CUI [2])
Systemic disease Serious Interferes with Completion of clinical trial
Item
serious systemic disease that would interfere with conduction of clinical trial
boolean
C0442893 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C2732579 (UMLS CUI [1,4])
MRI Clinical Trial | Claustrophobia Inconsistent 3 Tesla MRI | Implants Inconsistent 3 Tesla MRI
Item
magnetic resonance imaging (mri) substudy: claustrophobia and implants incompatible with 3-tesla mri
boolean
C0024485 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0008909 (UMLS CUI [2,1])
C0442809 (UMLS CUI [2,2])
C2985394 (UMLS CUI [2,3])
C0021102 (UMLS CUI [3,1])
C0442809 (UMLS CUI [3,2])
C2985394 (UMLS CUI [3,3])
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