ID

37290

Description

Pharmacokinetics of Ultra-Rapid-Acting Insulin Lispro (URAL) in Type 1 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT02206568

Link

https://clinicaltrials.gov/show/NCT02206568

Keywords

Versions (1)
  1. 7/14/19 7/14/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 14, 2019

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 Type 1 Diabetes Mellitus NCT02206568

English

Eligibility Type 1 Diabetes Mellitus NCT02206568

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. signed informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
2. male subects age 18-65 years inclusive
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
3. type 1 diabetes mellitus diagnosed clinically >= 12 months
Description

Insulin-Dependent Diabetes Mellitus Disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0872146
4. treatment with multiple daily insulin injections or csii >= 12 months
Description

Insulin injection Multiple Daily | Continuous subcutaneous infusion of insulin

Data type

boolean

Alias
UMLS CUI [1,1]
C0199782
UMLS CUI [1,2]
C0439064
UMLS CUI [1,3]
C0332173
UMLS CUI [2]
C0393124
5. current total daily insulin treatment <1.2 (i)u/kg/day
Description

Insulin regime Total Daily Dose

Data type

boolean

Alias
UMLS CUI [1,1]
C0557978
UMLS CUI [1,2]
C2348070
6. current total daily bolus insulin treatment <0.7 (i)u/kg/day
Description

Bolus Insulin Total Daily Dose

Data type

boolean

Alias
UMLS CUI [1,1]
C1705509
UMLS CUI [1,2]
C0021641
UMLS CUI [1,3]
C2348070
7. body mass index 18.0-30.0 kg/m2 inclusive
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
8. hba1c =<9.0% by local laboratory analysis (one retest within a week is permitted with the result of the last test being conclusive)
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
9. c-peptide =< 0.30 nmol/l
Description

Insulin C-peptide measurement

Data type

boolean

Alias
UMLS CUI [1]
C0202100
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. known or suspected hypersensitivity to trial products or related products
Description

Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Related

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0439849
2. previous participation in this trial. .
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
3. receipt of any non-marketed investigational product within 3 months
Description

Non-Prescription Drugs Investigational

Data type

boolean

Alias
UMLS CUI [1,1]
C0013231
UMLS CUI [1,2]
C1517586
4. clinically significant abnormal haematology, biochemistry, liver enzymes, or coagulation screening tests
Description

Haematology test abnormal | Abnormal biochemistry finding | Liver enzymes abnormal | Coagulation test abnormal

Data type

boolean

Alias
UMLS CUI [1]
C1112712
UMLS CUI [2]
C0586680
UMLS CUI [3]
C0438237
UMLS CUI [4]
C1504379
5. suffer from or history of a life threatening disease or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal , neurological, psychiatric diseases or other major disorders
Description

Life threatening illness | Cardiovascular Diseases | Respiration Disorders | Metabolic Diseases | Kidney Diseases | Liver diseases | Gastrointestinal Diseases | Endocrine System Diseases | Hematological Disease | Dermatologic disorders | Sexually Transmitted Diseases | Nervous system disorder | Mental disorders | Disease Major

Data type

boolean

Alias
UMLS CUI [1]
C3846017
UMLS CUI [2]
C0007222
UMLS CUI [3]
C0035204
UMLS CUI [4]
C0025517
UMLS CUI [5]
C0022658
UMLS CUI [6]
C0023895
UMLS CUI [7]
C0017178
UMLS CUI [8]
C0014130
UMLS CUI [9]
C0018939
UMLS CUI [10]
C0037274
UMLS CUI [11]
C0036916
UMLS CUI [12]
C0027765
UMLS CUI [13]
C0004936
UMLS CUI [14]
C0012634
UMLS CUI [15]
C0205164
6. history of deep leg vein thrombosis or a frequent appearance of deep leg veinthrombosis in 1st degree relatives
Description

Deep vein thrombosis of lower limb | Deep vein thrombosis of lower limb First Degree Relative

Data type

boolean

Alias
UMLS CUI [1]
C0340708
UMLS CUI [2,1]
C0340708
UMLS CUI [2,2]
C1517194
7. cardiac problems defined as decompensated heart failure (new york heart association class iii and iv) at any time and/or angina pectoris within the last 12 months and/or acute myocardial infarction at any time.
Description

Cardiac problem | Decompensated cardiac failure New York Heart Association Classification | Angina Pectoris | Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0262402
UMLS CUI [2,1]
C0581377
UMLS CUI [2,2]
C1275491
UMLS CUI [3]
C0002962
UMLS CUI [4]
C0027051
8. supine blood pressure at screening outside the range of 90-140 mmhg for systollic or 50-90 mmhg for diastolic . pulse outside 50 to 90 bpm.
Description

Lying systolic blood pressure | Lying diastolic blood pressure | Pulse Rate

Data type

boolean

Alias
UMLS CUI [1]
C1319895
UMLS CUI [2]
C1319896
UMLS CUI [3]
C0232117
9. clinically significant abnormal ecg at screening.
Description

ECG abnormal Screening

Data type

boolean

Alias
UMLS CUI [1,1]
C0522055
UMLS CUI [1,2]
C0220908
10. proliferative retinopathy or maculopathy and/or severe neuropathy, in particular autonomic neuropathy.
Description

Proliferative retinopathy | Disorder of macula of retina Proliferating | Neuropathy Severe | Autonomic neuropathy

Data type

boolean

Alias
UMLS CUI [1]
C0339467
UMLS CUI [2,1]
C0730362
UMLS CUI [2,2]
C1514485
UMLS CUI [3,1]
C0442874
UMLS CUI [3,2]
C0205082
UMLS CUI [4]
C0259749
11. any disease or condition that, inthe opinion of the investigator, would represent an unacceptable risk for the subject's safety.
Description

Disease At risk Patient safety | Condition At risk Patient safety

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C1113679
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C1113679
12. subject positive for hbs-ag, hcv-ab
Description

Hepatitis B surface antigen positive | Hepatitis C antibody positive

Data type

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2]
C0281863
13. positive result to the screening test for hiv-1 antibodies, hiv-2 antibodies, or hiv-1 antigen according to locally used diagnostic testing.
Description

HIV-1 antibody Screening test Positive | HIV-2 Antibodies Screening test Positive | HIV-1 antigen Screening test Positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0369497
UMLS CUI [1,2]
C0871311
UMLS CUI [1,3]
C1514241
UMLS CUI [2,1]
C1255639
UMLS CUI [2,2]
C0871311
UMLS CUI [2,3]
C1514241
UMLS CUI [3,1]
C0369498
UMLS CUI [3,2]
C0871311
UMLS CUI [3,3]
C1514241
14. history of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
Description

Drug Allergy multiple | Food Allergy multiple | Drug Allergy Severe | Food Allergy Severe | Anaphylaxis Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0013182
UMLS CUI [1,2]
C0439064
UMLS CUI [2,1]
C0016470
UMLS CUI [2,2]
C0439064
UMLS CUI [3,1]
C0013182
UMLS CUI [3,2]
C0205082
UMLS CUI [4,1]
C0016470
UMLS CUI [4,2]
C0205082
UMLS CUI [5,1]
C0002792
UMLS CUI [5,2]
C0205082
15. subject who has donated blood or plasma in the past month or more than 500 ml within 3 months.
Description

Blood Donation | Plasma Donation | Blood Donation Amount | Plasma Donation Amount

Data type

boolean

Alias
UMLS CUI [1]
C0005794
UMLS CUI [2,1]
C0032105
UMLS CUI [2,2]
C0680854
UMLS CUI [3,1]
C0005794
UMLS CUI [3,2]
C1265611
UMLS CUI [4,1]
C0032105
UMLS CUI [4,2]
C0680854
UMLS CUI [4,3]
C1265611
16. surgery or trauma with significant blood loss (more than 500 ml) within 3 months.
Description

Operative Surgical Procedure Associated with Blood Loss Amount | Trauma Associated with Blood Loss Amount

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C3163616
UMLS CUI [1,4]
C1265611
UMLS CUI [2,1]
C3714660
UMLS CUI [2,2]
C0332281
UMLS CUI [2,3]
C3163616
UMLS CUI [2,4]
C1265611
17. current treatment with systemic (oral, iv, or inhaled) corticosteroids, monoamine oxidase inhibitors, nsaid, prostaglandin blockers, systemic non-selective beta-blockers, growth hormone (last 3 months), non-routine vitamins or herbal products (last 2 weeks). yhyroid hormons are not allowed unless the use of these has been stable during the last 3 months. routine vitamins are permitted up to 48 hours prior to dosing.
Description

CORTICOSTEROIDS FOR SYSTEMIC USE | Adrenal Cortex Hormones Oral | Adrenal Cortex Hormones Intravenous | Adrenal Cortex Hormones by Inhalation | Monoamine Oxidase Inhibitors | Anti-Inflammatory Agents, Non-Steroidal | Prostaglandin Antagonists | Non-selective beta-blocking agent Systemic | Growth Hormone | Vitamins | Herbal product | Thyroid Hormones

Data type

boolean

Alias
UMLS CUI [1]
C3653708
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C1527415
UMLS CUI [3,1]
C0001617
UMLS CUI [3,2]
C1522726
UMLS CUI [4,1]
C0001617
UMLS CUI [4,2]
C0205535
UMLS CUI [5]
C0026457
UMLS CUI [6]
C0003211
UMLS CUI [7]
C0033529
UMLS CUI [8,1]
C0304515
UMLS CUI [8,2]
C0205373
UMLS CUI [9]
C0037663
UMLS CUI [10]
C0042890
UMLS CUI [11]
C2240391
UMLS CUI [12]
C0040135
18. significant history of alcoholism and/or drug/chemical abuse as per investigator's judgement or a positive result in the urine drug/alcohol breath test screen at the screening visit.
Description

Alcoholic Intoxication, Chronic | Substance Use Disorders | Urine drug screen positive | Breath alcohol test positive

Data type

boolean

Alias
UMLS CUI [1]
C0001973
UMLS CUI [2]
C0038586
UMLS CUI [3]
C0743300
UMLS CUI [4]
C1112499
19. heavy smoker
Description

Heavy smoker

Data type

boolean

Alias
UMLS CUI [1]
C0857118
20. not able or willing to refrain from smoking and use of nicotine.
Description

Refrain from Smoking Unable | Refrain from Smoking Unwilling | Use of Nicotine Discontinue Unable | Use of Nicotine Discontinue Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C4086797
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C4086797
UMLS CUI [2,2]
C0558080
UMLS CUI [3,1]
C1524063
UMLS CUI [3,2]
C0028040
UMLS CUI [3,3]
C1444662
UMLS CUI [3,4]
C1299582
UMLS CUI [4,1]
C1524063
UMLS CUI [4,2]
C0028040
UMLS CUI [4,3]
C1444662
UMLS CUI [4,4]
C0558080
21. recurrent severe hypoglycaemia (more than 1 severe hypoglycaemia event during the last 12 months) or hypoglycaemic unawareness.
Description

Recurrent severe hypoglycemia | Loss of hypoglycemic warning

Data type

boolean

Alias
UMLS CUI [1]
C0342316
UMLS CUI [2]
C0342317
22. subject with mental incapacity or language barriers precluding adequate understanding.
Description

Mental impairment Excludes Comprehension | Language Barriers Exclude Comprehension

Data type

boolean

Alias
UMLS CUI [1,1]
C0683322
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0162340
UMLS CUI [2,1]
C0237167
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0162340
23. potentially non-compliant or uncooperative during the trial.
Description

Compliance behavior Lacking | Uncooperative behavior

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0332268
UMLS CUI [2]
C0424350
24. any condition that would interfere with trial participation or evaluation of results.
Description

Condition Interferes with Study Subject Participation Status | Condition Interferes with Evaluation Research results

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C1261322
UMLS CUI [2,4]
C0683954
25. no relevant lipodystrophy within the area of drug administration and doppler sonography.
Description

Lipodystrophy Area Drug Administration | Lipodystrophy Area Doppler Ultrasound

Data type

boolean

Alias
UMLS CUI [1,1]
C0023787
UMLS CUI [1,2]
C0205146
UMLS CUI [1,3]
C3469597
UMLS CUI [2,1]
C0023787
UMLS CUI [2,2]
C0205146
UMLS CUI [2,3]
C0162481
Back to the top of the page

Similar models

Eligibility Type 1 Diabetes Mellitus NCT02206568

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. signed informed consent
boolean
C0021430 (UMLS CUI [1])
Gender | Age
Item
2. male subects age 18-65 years inclusive
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Insulin-Dependent Diabetes Mellitus Disease length
Item
3. type 1 diabetes mellitus diagnosed clinically >= 12 months
boolean
C0011854 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Insulin injection Multiple Daily | Continuous subcutaneous infusion of insulin
Item
4. treatment with multiple daily insulin injections or csii >= 12 months
boolean
C0199782 (UMLS CUI [1,1])
C0439064 (UMLS CUI [1,2])
C0332173 (UMLS CUI [1,3])
C0393124 (UMLS CUI [2])
Insulin regime Total Daily Dose
Item
5. current total daily insulin treatment <1.2 (i)u/kg/day
boolean
C0557978 (UMLS CUI [1,1])
C2348070 (UMLS CUI [1,2])
Bolus Insulin Total Daily Dose
Item
6. current total daily bolus insulin treatment <0.7 (i)u/kg/day
boolean
C1705509 (UMLS CUI [1,1])
C0021641 (UMLS CUI [1,2])
C2348070 (UMLS CUI [1,3])
Body mass index
Item
7. body mass index 18.0-30.0 kg/m2 inclusive
boolean
C1305855 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
8. hba1c =<9.0% by local laboratory analysis (one retest within a week is permitted with the result of the last test being conclusive)
boolean
C0474680 (UMLS CUI [1])
Insulin C-peptide measurement
Item
9. c-peptide =< 0.30 nmol/l
boolean
C0202100 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Related
Item
1. known or suspected hypersensitivity to trial products or related products
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
Study Subject Participation Status
Item
2. previous participation in this trial. .
boolean
C2348568 (UMLS CUI [1])
Non-Prescription Drugs Investigational
Item
3. receipt of any non-marketed investigational product within 3 months
boolean
C0013231 (UMLS CUI [1,1])
C1517586 (UMLS CUI [1,2])
Haematology test abnormal | Abnormal biochemistry finding | Liver enzymes abnormal | Coagulation test abnormal
Item
4. clinically significant abnormal haematology, biochemistry, liver enzymes, or coagulation screening tests
boolean
C1112712 (UMLS CUI [1])
C0586680 (UMLS CUI [2])
C0438237 (UMLS CUI [3])
C1504379 (UMLS CUI [4])
Life threatening illness | Cardiovascular Diseases | Respiration Disorders | Metabolic Diseases | Kidney Diseases | Liver diseases | Gastrointestinal Diseases | Endocrine System Diseases | Hematological Disease | Dermatologic disorders | Sexually Transmitted Diseases | Nervous system disorder | Mental disorders | Disease Major
Item
5. suffer from or history of a life threatening disease or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal , neurological, psychiatric diseases or other major disorders
boolean
C3846017 (UMLS CUI [1])
C0007222 (UMLS CUI [2])
C0035204 (UMLS CUI [3])
C0025517 (UMLS CUI [4])
C0022658 (UMLS CUI [5])
C0023895 (UMLS CUI [6])
C0017178 (UMLS CUI [7])
C0014130 (UMLS CUI [8])
C0018939 (UMLS CUI [9])
C0037274 (UMLS CUI [10])
C0036916 (UMLS CUI [11])
C0027765 (UMLS CUI [12])
C0004936 (UMLS CUI [13])
C0012634 (UMLS CUI [14])
C0205164 (UMLS CUI [15])
Deep vein thrombosis of lower limb | Deep vein thrombosis of lower limb First Degree Relative
Item
6. history of deep leg vein thrombosis or a frequent appearance of deep leg veinthrombosis in 1st degree relatives
boolean
C0340708 (UMLS CUI [1])
C0340708 (UMLS CUI [2,1])
C1517194 (UMLS CUI [2,2])
Cardiac problem | Decompensated cardiac failure New York Heart Association Classification | Angina Pectoris | Myocardial Infarction
Item
7. cardiac problems defined as decompensated heart failure (new york heart association class iii and iv) at any time and/or angina pectoris within the last 12 months and/or acute myocardial infarction at any time.
boolean
C0262402 (UMLS CUI [1])
C0581377 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0002962 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
Lying systolic blood pressure | Lying diastolic blood pressure | Pulse Rate
Item
8. supine blood pressure at screening outside the range of 90-140 mmhg for systollic or 50-90 mmhg for diastolic . pulse outside 50 to 90 bpm.
boolean
C1319895 (UMLS CUI [1])
C1319896 (UMLS CUI [2])
C0232117 (UMLS CUI [3])
ECG abnormal Screening
Item
9. clinically significant abnormal ecg at screening.
boolean
C0522055 (UMLS CUI [1,1])
C0220908 (UMLS CUI [1,2])
Proliferative retinopathy | Disorder of macula of retina Proliferating | Neuropathy Severe | Autonomic neuropathy
Item
10. proliferative retinopathy or maculopathy and/or severe neuropathy, in particular autonomic neuropathy.
boolean
C0339467 (UMLS CUI [1])
C0730362 (UMLS CUI [2,1])
C1514485 (UMLS CUI [2,2])
C0442874 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0259749 (UMLS CUI [4])
Disease At risk Patient safety | Condition At risk Patient safety
Item
11. any disease or condition that, inthe opinion of the investigator, would represent an unacceptable risk for the subject's safety.
boolean
C0012634 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
Hepatitis B surface antigen positive | Hepatitis C antibody positive
Item
12. subject positive for hbs-ag, hcv-ab
boolean
C0149709 (UMLS CUI [1])
C0281863 (UMLS CUI [2])
HIV-1 antibody Screening test Positive | HIV-2 Antibodies Screening test Positive | HIV-1 antigen Screening test Positive
Item
13. positive result to the screening test for hiv-1 antibodies, hiv-2 antibodies, or hiv-1 antigen according to locally used diagnostic testing.
boolean
C0369497 (UMLS CUI [1,1])
C0871311 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
C1255639 (UMLS CUI [2,1])
C0871311 (UMLS CUI [2,2])
C1514241 (UMLS CUI [2,3])
C0369498 (UMLS CUI [3,1])
C0871311 (UMLS CUI [3,2])
C1514241 (UMLS CUI [3,3])
Drug Allergy multiple | Food Allergy multiple | Drug Allergy Severe | Food Allergy Severe | Anaphylaxis Severe
Item
14. history of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
boolean
C0013182 (UMLS CUI [1,1])
C0439064 (UMLS CUI [1,2])
C0016470 (UMLS CUI [2,1])
C0439064 (UMLS CUI [2,2])
C0013182 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0016470 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0002792 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
Blood Donation | Plasma Donation | Blood Donation Amount | Plasma Donation Amount
Item
15. subject who has donated blood or plasma in the past month or more than 500 ml within 3 months.
boolean
C0005794 (UMLS CUI [1])
C0032105 (UMLS CUI [2,1])
C0680854 (UMLS CUI [2,2])
C0005794 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0032105 (UMLS CUI [4,1])
C0680854 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
Operative Surgical Procedure Associated with Blood Loss Amount | Trauma Associated with Blood Loss Amount
Item
16. surgery or trauma with significant blood loss (more than 500 ml) within 3 months.
boolean
C0543467 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C3163616 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
C3714660 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C3163616 (UMLS CUI [2,3])
C1265611 (UMLS CUI [2,4])
CORTICOSTEROIDS FOR SYSTEMIC USE | Adrenal Cortex Hormones Oral | Adrenal Cortex Hormones Intravenous | Adrenal Cortex Hormones by Inhalation | Monoamine Oxidase Inhibitors | Anti-Inflammatory Agents, Non-Steroidal | Prostaglandin Antagonists | Non-selective beta-blocking agent Systemic | Growth Hormone | Vitamins | Herbal product | Thyroid Hormones
Item
17. current treatment with systemic (oral, iv, or inhaled) corticosteroids, monoamine oxidase inhibitors, nsaid, prostaglandin blockers, systemic non-selective beta-blockers, growth hormone (last 3 months), non-routine vitamins or herbal products (last 2 weeks). yhyroid hormons are not allowed unless the use of these has been stable during the last 3 months. routine vitamins are permitted up to 48 hours prior to dosing.
boolean
C3653708 (UMLS CUI [1])
C0001617 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0001617 (UMLS CUI [3,1])
C1522726 (UMLS CUI [3,2])
C0001617 (UMLS CUI [4,1])
C0205535 (UMLS CUI [4,2])
C0026457 (UMLS CUI [5])
C0003211 (UMLS CUI [6])
C0033529 (UMLS CUI [7])
C0304515 (UMLS CUI [8,1])
C0205373 (UMLS CUI [8,2])
C0037663 (UMLS CUI [9])
C0042890 (UMLS CUI [10])
C2240391 (UMLS CUI [11])
C0040135 (UMLS CUI [12])
Alcoholic Intoxication, Chronic | Substance Use Disorders | Urine drug screen positive | Breath alcohol test positive
Item
18. significant history of alcoholism and/or drug/chemical abuse as per investigator's judgement or a positive result in the urine drug/alcohol breath test screen at the screening visit.
boolean
C0001973 (UMLS CUI [1])
C0038586 (UMLS CUI [2])
C0743300 (UMLS CUI [3])
C1112499 (UMLS CUI [4])
Heavy smoker
Item
19. heavy smoker
boolean
C0857118 (UMLS CUI [1])
Refrain from Smoking Unable | Refrain from Smoking Unwilling | Use of Nicotine Discontinue Unable | Use of Nicotine Discontinue Unwilling
Item
20. not able or willing to refrain from smoking and use of nicotine.
boolean
C4086797 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C4086797 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
C1524063 (UMLS CUI [3,1])
C0028040 (UMLS CUI [3,2])
C1444662 (UMLS CUI [3,3])
C1299582 (UMLS CUI [3,4])
C1524063 (UMLS CUI [4,1])
C0028040 (UMLS CUI [4,2])
C1444662 (UMLS CUI [4,3])
C0558080 (UMLS CUI [4,4])
Recurrent severe hypoglycemia | Loss of hypoglycemic warning
Item
21. recurrent severe hypoglycaemia (more than 1 severe hypoglycaemia event during the last 12 months) or hypoglycaemic unawareness.
boolean
C0342316 (UMLS CUI [1])
C0342317 (UMLS CUI [2])
Mental impairment Excludes Comprehension | Language Barriers Exclude Comprehension
Item
22. subject with mental incapacity or language barriers precluding adequate understanding.
boolean
C0683322 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0162340 (UMLS CUI [1,3])
C0237167 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0162340 (UMLS CUI [2,3])
Compliance behavior Lacking | Uncooperative behavior
Item
23. potentially non-compliant or uncooperative during the trial.
boolean
C1321605 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C0424350 (UMLS CUI [2])
Condition Interferes with Study Subject Participation Status | Condition Interferes with Evaluation Research results
Item
24. any condition that would interfere with trial participation or evaluation of results.
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C1261322 (UMLS CUI [2,3])
C0683954 (UMLS CUI [2,4])
Lipodystrophy Area Drug Administration | Lipodystrophy Area Doppler Ultrasound
Item
25. no relevant lipodystrophy within the area of drug administration and doppler sonography.
boolean
C0023787 (UMLS CUI [1,1])
C0205146 (UMLS CUI [1,2])
C3469597 (UMLS CUI [1,3])
C0023787 (UMLS CUI [2,1])
C0205146 (UMLS CUI [2,2])
C0162481 (UMLS CUI [2,3])
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