ID

20744

Description

Neuroendocrine Brake for Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT00450710

Link

https://clinicaltrials.gov/show/NCT00450710

Keywords

Versions (1)
  1. 3/14/17 3/14/17 -
Uploaded on

March 14, 2017

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Diabetes NCT00450710

English

Eligibility Diabetes NCT00450710

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00450710
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. - male and female between 18 and 65 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. bmi 25.1 - 34.9.
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
3. type 2 diabetic patients on oral anti-diabetic agents and/or insulin treatment for a minimum of 12 months prior the enrollment.
Description

Diabetes Mellitus, Non-Insulin-Dependent | Antidiabetics Oral | Insulin regime

Data type

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C1527415
UMLS CUI [3]
C0557978
4. diagnosis of t2dm for at least 3 years.
Description

Non-Insulin-Dependent Diabetes Mellitus disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
5. patient has been under routine care of hte study physician or another physician that can supply a reliable medical record for at least 3 years.
Description

patient care Routine supply Medical Record

Data type

boolean

Alias
UMLS CUI [1,1]
C0017313
UMLS CUI [1,2]
C0205547
UMLS CUI [1,3]
C0243163
UMLS CUI [1,4]
C0025102
6. hba1c >/ 7.5 documented for at least 3 months.
Description

Glucohemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0202054
7. stable weight (nor significant weight change (>3%) over the 3 months prior to enrollment.
Description

Stable body weight | Body Weight unchanged

Data type

boolean

Alias
UMLS CUI [1]
C0517386
UMLS CUI [2,1]
C0005910
UMLS CUI [2,2]
C0442739
8. stable medication for at least one month prior to enrollment except for diabetes medications which should be stable for at least 3 months prior to enrollment.
Description

Pharmaceutical Preparations Stable | Antidiabetics Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C0205360
9. ability and willingness to return for all scheduled visits and participate in recommended parameter setting and physician recommended medical/laboratory assessments.
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. prior abdominal surgery, except laparoscopic cholecystectomy.
Description

ABDOMINAL SURGERY, PAST | Cholecystectomy, Laparoscopic

Data type

boolean

Alias
UMLS CUI [1]
C0238564
UMLS CUI [2]
C0162522
2. taking appetite suppressant.
Description

Appetite Depressants

Data type

boolean

Alias
UMLS CUI [1]
C0003620
3. severe eating disorders.
Description

Eating Disorders Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0013473
UMLS CUI [1,2]
C0205082
4. severe pulmonary, renal or cardiac disease.
Description

Lung disease Severe | Kidney Disease Severe | Heart Disease Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0024115
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0022658
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0018799
UMLS CUI [3,2]
C0205082
5. obese due to a clinically diagnosed endocrine disorder.
Description

Obesity Due to Endocrine System Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0028754
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0014130
6. subjects with impaired liver function.
Description

Liver Dysfunction

Data type

boolean

Alias
UMLS CUI [1]
C0086565
7. history of peptic ulcer disease.
Description

Peptic Ulcer

Data type

boolean

Alias
UMLS CUI [1]
C0030920
8. history of malignant disease.
Description

Malignant Neoplasm

Data type

boolean

Alias
UMLS CUI [1]
C0006826
9. use of prescription, over the counter or herbal weight loss products.
Description

Weight-Loss Agents Prescription | Weight-Loss Agents OTC products | HERBAL WEIGHT LOSS AID

Data type

boolean

Alias
UMLS CUI [1,1]
C0376606
UMLS CUI [1,2]
C0033080
UMLS CUI [2,1]
C0376606
UMLS CUI [2,2]
C0013231
UMLS CUI [3]
C1572271
10. pregnant or planning on pregnancy while enrolled in study.
Description

Pregnancy | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
Back to the top of the page

Similar models

Eligibility Diabetes NCT00450710

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00450710
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. - male and female between 18 and 65 years.
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
2. bmi 25.1 - 34.9.
boolean
C1305855 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent | Antidiabetics Oral | Insulin regime
Item
3. type 2 diabetic patients on oral anti-diabetic agents and/or insulin treatment for a minimum of 12 months prior the enrollment.
boolean
C0011860 (UMLS CUI [1])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0557978 (UMLS CUI [3])
Non-Insulin-Dependent Diabetes Mellitus disease length
Item
4. diagnosis of t2dm for at least 3 years.
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
patient care Routine supply Medical Record
Item
5. patient has been under routine care of hte study physician or another physician that can supply a reliable medical record for at least 3 years.
boolean
C0017313 (UMLS CUI [1,1])
C0205547 (UMLS CUI [1,2])
C0243163 (UMLS CUI [1,3])
C0025102 (UMLS CUI [1,4])
Glucohemoglobin measurement
Item
6. hba1c >/ 7.5 documented for at least 3 months.
boolean
C0202054 (UMLS CUI [1])
Stable body weight | Body Weight unchanged
Item
7. stable weight (nor significant weight change (>3%) over the 3 months prior to enrollment.
boolean
C0517386 (UMLS CUI [1])
C0005910 (UMLS CUI [2,1])
C0442739 (UMLS CUI [2,2])
Pharmaceutical Preparations Stable | Antidiabetics Stable
Item
8. stable medication for at least one month prior to enrollment except for diabetes medications which should be stable for at least 3 months prior to enrollment.
boolean
C0013227 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0935929 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
Protocol Compliance
Item
9. ability and willingness to return for all scheduled visits and participate in recommended parameter setting and physician recommended medical/laboratory assessments.
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
ABDOMINAL SURGERY, PAST | Cholecystectomy, Laparoscopic
Item
1. prior abdominal surgery, except laparoscopic cholecystectomy.
boolean
C0238564 (UMLS CUI [1])
C0162522 (UMLS CUI [2])
Appetite Depressants
Item
2. taking appetite suppressant.
boolean
C0003620 (UMLS CUI [1])
Eating Disorders Severe
Item
3. severe eating disorders.
boolean
C0013473 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Lung disease Severe | Kidney Disease Severe | Heart Disease Severe
Item
4. severe pulmonary, renal or cardiac disease.
boolean
C0024115 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0022658 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0018799 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
Obesity Due to Endocrine System Disease
Item
5. obese due to a clinically diagnosed endocrine disorder.
boolean
C0028754 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0014130 (UMLS CUI [1,3])
Liver Dysfunction
Item
6. subjects with impaired liver function.
boolean
C0086565 (UMLS CUI [1])
Peptic Ulcer
Item
7. history of peptic ulcer disease.
boolean
C0030920 (UMLS CUI [1])
Malignant Neoplasm
Item
8. history of malignant disease.
boolean
C0006826 (UMLS CUI [1])
Weight-Loss Agents Prescription | Weight-Loss Agents OTC products | HERBAL WEIGHT LOSS AID
Item
9. use of prescription, over the counter or herbal weight loss products.
boolean
C0376606 (UMLS CUI [1,1])
C0033080 (UMLS CUI [1,2])
C0376606 (UMLS CUI [2,1])
C0013231 (UMLS CUI [2,2])
C1572271 (UMLS CUI [3])
Pregnancy | Pregnancy, Planned
Item
10. pregnant or planning on pregnancy while enrolled in study.
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial