ID

43924

Descripción

Mini-Dose Glucagon for Adults With Type 1 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT02411578

Link

https://clinicaltrials.gov/show/NCT02411578

Palabras clave

Versiones (2)
  1. 17-05-16 17-05-16 -
  2. 20-09-21 20-09-21 -
Subido en

20 september 2021

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 1 NCT02411578

Inglés

Eligibility Diabetes Mellitus, Type 1 NCT02411578

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. clinical diagnosis of presumed autoimmune t1d and receiving daily insulin
Descripción

Diabetes Mellitus, Insulin-Dependent | Autoimmune Diabetes Presumptive | Insulin Daily

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2,1]
C0205734
UMLS CUI [2,2]
C3640893
UMLS CUI [3,1]
C0021641
UMLS CUI [3,2]
C0332173
2. age: 18.0 to < 65.0 years
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
3. duration of t1d: ≥2.0 years
Descripción

Duration Diabetes Mellitus, Insulin-Dependent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C0011854
4. body mass index 20.0 to <35.0 kg/m2 and weight 110 to <250 lbs
Descripción

Body mass index | Body Weight

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2]
C0005910
5. hba1c <8.5% (point of care or local lab, within past month)
Descripción

Glycosylated hemoglobin A

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019018
6. using csii therapy (i.e., insulin pump) for at least 3 months, with no plans to discontinue use during the study (and no use of active low glucose suspend feature within the last 4 weeks)
Descripción

Insulin pump Continuous subcutaneous infusion of insulin

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1140609
UMLS CUI [1,2]
C0393124
7. using continuous glucose monitor ≥6 days/week in the last 4 weeks, with no plans to discontinue continuous glucose monitor use during the study
Descripción

Use of Continuous Blood Glucose Monitor

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C1713877
8. continuous glucose monitor glucose level <70 mg/dl during daytime hours (e.g., 8am -
Descripción

Continuous Blood Glucose Monitor Glucose level

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1713877
UMLS CUI [1,2]
C0428548
10pm) on at least 7 of the past 28 days (a modification can be made for participants with non-traditional waking hours) evaluated from downloaded cgm data
Descripción

Evaluation | Continuous Blood Glucose Monitor Data

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0220825
UMLS CUI [2,1]
C1713877
UMLS CUI [2,2]
C1511726
9. females must meet one of the following criteria:
Descripción

Female | Inclusion criteria

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0086287
UMLS CUI [2]
C1512693
of childbearing potential and not currently pregnant (negative pregnancy test) or lactating, and agrees to use an accepted contraceptive regimen as described in the study procedure manual throughout the entire duration of the study (from screening visit until study completion); or
Descripción

Childbearing Potential | Pregnancy | Pregnancy test negative | Breast Feeding | Contraceptive methods | Study Protocol

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0427780
UMLS CUI [4]
C0006147
UMLS CUI [5]
C0700589
UMLS CUI [6]
C2348563
of non-childbearing potential, defined as a female who has had a hysterectomy or tubal ligation, is clinically considered infertile or is in a menopausal state (at least 1 year without menses)
Descripción

Childbearing Potential | Gender | Hysterectomy | Tubal Ligation | Infertility | Menopause | Menstruation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0020699
UMLS CUI [4]
C0520483
UMLS CUI [5]
C0021359
UMLS CUI [6]
C0025320
UMLS CUI [7]
C0025344
10. in good general health with no conditions that could influence the outcome of the trial, and in the judgment of the investigator is a good candidate for the study based on review of available medical history, physical examination and clinical laboratory evaluations
Descripción

Healthy | Disease Affecting research results | health review Medical History Physical Examination Laboratory data interpretation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3898900
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0683954
UMLS CUI [3,1]
C0262501
UMLS CUI [3,2]
C0262926
UMLS CUI [3,3]
C0031809
UMLS CUI [3,4]
C0262707
11. willing to adhere to the protocol requirements for the duration of the study
Descripción

Willing Compliance Study Protocol

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0600109
UMLS CUI [1,2]
C3714738
UMLS CUI [1,3]
C2348563
12. participant has a smart phone available and is able to use it daily
Descripción

Availability of Smartphone | Daily Use of Smartphone

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C3204335
UMLS CUI [2,1]
C0332173
UMLS CUI [2,2]
C1524063
UMLS CUI [2,3]
C3204335
13. must be enrolled in the t1d exchange clinic registry or willing to join the clinic registry
Descripción

Diabetes Mellitus, Insulin-Dependent | Clinic Registry

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2,1]
C0442592
UMLS CUI [2,2]
C0034975
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. more than 1 severe hypoglycemic episode in the past 12 months (as defined by an episode that required third party assistance for treatment)
Descripción

Hypoglycaemic episode Requirement Therapeutic procedure

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0745153
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0087111
2. more than 1 episode of diabetic ketoacidosis in the past 12 months (as defined by an episode diagnosed as diabetic ketoacidosis that required treatment in an emergency department or hospitalization)
Descripción

Episode of Diabetic Ketoacidosis | Requirement Therapeutic procedure Accident and Emergency department | Hospitalization

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0332189
UMLS CUI [1,2]
C0011880
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C0562508
UMLS CUI [3]
C0019993
3. presence of cardiovascular, gastrointestinal, liver or kidney disease, or any medical condition which, in the judgment of the investigator, could potentiate or predispose to undesired effects or could interfere with the absorption, distribution, metabolism, or excretion of glucagon or ability to respond appropriately to mild to moderate hypoglycemia.
Descripción

Cardiovascular Diseases | Gastrointestinal Diseases | Liver diseases | Kidney Diseases | Medical condition Adverse effects | Interferes with Glucagon Absorption Distribution Metabolism Drug elimination | Hypoglycemia Mild | Hypoglycemia Moderate

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0017178
UMLS CUI [3]
C0023895
UMLS CUI [4]
C0022658
UMLS CUI [5,1]
C1699700
UMLS CUI [5,2]
C0001688
UMLS CUI [6,1]
C0521102
UMLS CUI [6,2]
C0017687
UMLS CUI [6,3]
C0000854
UMLS CUI [6,4]
C1378698
UMLS CUI [6,5]
C0025519
UMLS CUI [6,6]
C0683141
UMLS CUI [7,1]
C0020615
UMLS CUI [7,2]
C2945599
UMLS CUI [8,1]
C0020615
UMLS CUI [8,2]
C0205081
4. known presence of hereditary problems of glycogen storage disease, galactose and/or lactose intolerance
Descripción

Hereditary Diseases | Glycogen Storage Disease | Galactosemias | Lactose Intolerance

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019247
UMLS CUI [2]
C0017919
UMLS CUI [3]
C0016952
UMLS CUI [4]
C0022951
5. males with alcohol use in excess of 3 or more drinks per day, on average and females with alcohol use in excess of 2 or more drinks per day, on average
Descripción

Alcohol intake above recommended sensible limits

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0560219
6. use of non-insulin anti-diabetic medications
Descripción

Antidiabetics | Insulin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0935929
UMLS CUI [2]
C0021641
7. use of daily systemic beta-blocker
Descripción

Adrenergic beta-Antagonists Systemic Daily

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0001645
UMLS CUI [1,2]
C0205373
UMLS CUI [1,3]
C0332173
8. use of beta-adrenergic agonists, theophylline (or other methylxanthines)
Descripción

Adrenergic beta-Agonists | Theophylline | Methylxanthine

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001644
UMLS CUI [2]
C0039771
UMLS CUI [3]
C0066447
9. use of 1st generation anticholinergic drugs (such as brompheniramine, chlorpheniramine, dimenhydrinate, diphenhydramine, and doxylamine)
Descripción

Anticholinergic Agents | Brompheniramine | Chlorpheniramine | Dimenhydrinate | Diphenhydramine | Doxylamine

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0242896
UMLS CUI [2]
C0006246
UMLS CUI [3]
C0008281
UMLS CUI [4]
C0012381
UMLS CUI [5]
C0012522
UMLS CUI [6]
C0013092
10. use of systemic corticosteroids
Descripción

systemic steroids

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2825233
11. history of hypersensitivity to glucagon or any related product or excipient or severe hypersensitivity reactions (such as angioedema) to any drugs
Descripción

Hypersensitivity Glucagon | Hypersensitivity Glucagon Excipient | Hypersensitivity Severe Pharmaceutical Preparations | Angioedema

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0017687
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0017687
UMLS CUI [2,3]
C0015237
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0205082
UMLS CUI [3,3]
C0013227
UMLS CUI [4]
C0002994
12. history of epilepsy or seizure disorder
Descripción

Epilepsy | Seizures

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0014544
UMLS CUI [2]
C0036572
13. uncontrolled hypertension, >160 mmhg systolic or >100 mmhg diastolic
Descripción

Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
14. currently a high endurance exerciser or plans to perform high endurance exercise during study (from screening visit until study completion)
Descripción

Muscular endurance development exercise High | Muscular endurance development exercise High Planned

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0419120
UMLS CUI [1,2]
C0205250
UMLS CUI [2,1]
C0419120
UMLS CUI [2,2]
C0205250
UMLS CUI [2,3]
C1301732
high endurance exerciser defined as a person who regularly competes in running, cycling, rowing, swimming or any other endurance-based activity for the purpose of competition (>2100 met minutes per week [i.e. 7 mets x 60 minutes x 5 days a week, where 7 mets is equivalent to jogging])
Descripción

Muscular endurance development exercise High | Running | Bicycling | Aquatic rowing exercises | Swimming | Sports

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0419120
UMLS CUI [1,2]
C0205250
UMLS CUI [2]
C0035953
UMLS CUI [3]
C0005377
UMLS CUI [4]
C2147874
UMLS CUI [5]
C0039003
UMLS CUI [6]
C0038039
15. currently following a very low calorie or other weight-loss diet
Descripción

Very low energy diet | Reducing diet

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0452268
UMLS CUI [2]
C0012167
16. participation in other studies involving administration of an investigational drug or device within 30 days or 5 half-lives, whichever is longer, before screening for the current study or planning to participate in another such study during participation in the current study
Descripción

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
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Eligibility Diabetes Mellitus, Type 1 NCT02411578

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent | Autoimmune Diabetes Presumptive | Insulin Daily
Item
1. clinical diagnosis of presumed autoimmune t1d and receiving daily insulin
boolean
C0011854 (UMLS CUI [1])
C0205734 (UMLS CUI [2,1])
C3640893 (UMLS CUI [2,2])
C0021641 (UMLS CUI [3,1])
C0332173 (UMLS CUI [3,2])
Age
Item
2. age: 18.0 to < 65.0 years
boolean
C0001779 (UMLS CUI [1])
Duration Diabetes Mellitus, Insulin-Dependent
Item
3. duration of t1d: ≥2.0 years
boolean
C0449238 (UMLS CUI [1,1])
C0011854 (UMLS CUI [1,2])
Body mass index | Body Weight
Item
4. body mass index 20.0 to <35.0 kg/m2 and weight 110 to <250 lbs
boolean
C1305855 (UMLS CUI [1])
C0005910 (UMLS CUI [2])
Glycosylated hemoglobin A
Item
5. hba1c <8.5% (point of care or local lab, within past month)
boolean
C0019018 (UMLS CUI [1])
Insulin pump Continuous subcutaneous infusion of insulin
Item
6. using csii therapy (i.e., insulin pump) for at least 3 months, with no plans to discontinue use during the study (and no use of active low glucose suspend feature within the last 4 weeks)
boolean
C1140609 (UMLS CUI [1,1])
C0393124 (UMLS CUI [1,2])
Use of Continuous Blood Glucose Monitor
Item
7. using continuous glucose monitor ≥6 days/week in the last 4 weeks, with no plans to discontinue continuous glucose monitor use during the study
boolean
C1524063 (UMLS CUI [1,1])
C1713877 (UMLS CUI [1,2])
Continuous Blood Glucose Monitor Glucose level
Item
8. continuous glucose monitor glucose level <70 mg/dl during daytime hours (e.g., 8am -
boolean
C1713877 (UMLS CUI [1,1])
C0428548 (UMLS CUI [1,2])
Evaluation | Continuous Blood Glucose Monitor Data
Item
10pm) on at least 7 of the past 28 days (a modification can be made for participants with non-traditional waking hours) evaluated from downloaded cgm data
boolean
C0220825 (UMLS CUI [1])
C1713877 (UMLS CUI [2,1])
C1511726 (UMLS CUI [2,2])
Female | Inclusion criteria
Item
9. females must meet one of the following criteria:
boolean
C0086287 (UMLS CUI [1])
C1512693 (UMLS CUI [2])
Childbearing Potential | Pregnancy | Pregnancy test negative | Breast Feeding | Contraceptive methods | Study Protocol
Item
of childbearing potential and not currently pregnant (negative pregnancy test) or lactating, and agrees to use an accepted contraceptive regimen as described in the study procedure manual throughout the entire duration of the study (from screening visit until study completion); or
boolean
C3831118 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0427780 (UMLS CUI [3])
C0006147 (UMLS CUI [4])
C0700589 (UMLS CUI [5])
C2348563 (UMLS CUI [6])
Childbearing Potential | Gender | Hysterectomy | Tubal Ligation | Infertility | Menopause | Menstruation
Item
of non-childbearing potential, defined as a female who has had a hysterectomy or tubal ligation, is clinically considered infertile or is in a menopausal state (at least 1 year without menses)
boolean
C3831118 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0020699 (UMLS CUI [3])
C0520483 (UMLS CUI [4])
C0021359 (UMLS CUI [5])
C0025320 (UMLS CUI [6])
C0025344 (UMLS CUI [7])
Healthy | Disease Affecting research results | health review Medical History Physical Examination Laboratory data interpretation
Item
10. in good general health with no conditions that could influence the outcome of the trial, and in the judgment of the investigator is a good candidate for the study based on review of available medical history, physical examination and clinical laboratory evaluations
boolean
C3898900 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0683954 (UMLS CUI [2,3])
C0262501 (UMLS CUI [3,1])
C0262926 (UMLS CUI [3,2])
C0031809 (UMLS CUI [3,3])
C0262707 (UMLS CUI [3,4])
Willing Compliance Study Protocol
Item
11. willing to adhere to the protocol requirements for the duration of the study
boolean
C0600109 (UMLS CUI [1,1])
C3714738 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
Availability of Smartphone | Daily Use of Smartphone
Item
12. participant has a smart phone available and is able to use it daily
boolean
C0470187 (UMLS CUI [1,1])
C3204335 (UMLS CUI [1,2])
C0332173 (UMLS CUI [2,1])
C1524063 (UMLS CUI [2,2])
C3204335 (UMLS CUI [2,3])
Diabetes Mellitus, Insulin-Dependent | Clinic Registry
Item
13. must be enrolled in the t1d exchange clinic registry or willing to join the clinic registry
boolean
C0011854 (UMLS CUI [1])
C0442592 (UMLS CUI [2,1])
C0034975 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Hypoglycaemic episode Requirement Therapeutic procedure
Item
1. more than 1 severe hypoglycemic episode in the past 12 months (as defined by an episode that required third party assistance for treatment)
boolean
C0745153 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
Episode of Diabetic Ketoacidosis | Requirement Therapeutic procedure Accident and Emergency department | Hospitalization
Item
2. more than 1 episode of diabetic ketoacidosis in the past 12 months (as defined by an episode diagnosed as diabetic ketoacidosis that required treatment in an emergency department or hospitalization)
boolean
C0332189 (UMLS CUI [1,1])
C0011880 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0562508 (UMLS CUI [2,3])
C0019993 (UMLS CUI [3])
Cardiovascular Diseases | Gastrointestinal Diseases | Liver diseases | Kidney Diseases | Medical condition Adverse effects | Interferes with Glucagon Absorption Distribution Metabolism Drug elimination | Hypoglycemia Mild | Hypoglycemia Moderate
Item
3. presence of cardiovascular, gastrointestinal, liver or kidney disease, or any medical condition which, in the judgment of the investigator, could potentiate or predispose to undesired effects or could interfere with the absorption, distribution, metabolism, or excretion of glucagon or ability to respond appropriately to mild to moderate hypoglycemia.
boolean
C0007222 (UMLS CUI [1])
C0017178 (UMLS CUI [2])
C0023895 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
C1699700 (UMLS CUI [5,1])
C0001688 (UMLS CUI [5,2])
C0521102 (UMLS CUI [6,1])
C0017687 (UMLS CUI [6,2])
C0000854 (UMLS CUI [6,3])
C1378698 (UMLS CUI [6,4])
C0025519 (UMLS CUI [6,5])
C0683141 (UMLS CUI [6,6])
C0020615 (UMLS CUI [7,1])
C2945599 (UMLS CUI [7,2])
C0020615 (UMLS CUI [8,1])
C0205081 (UMLS CUI [8,2])
Hereditary Diseases | Glycogen Storage Disease | Galactosemias | Lactose Intolerance
Item
4. known presence of hereditary problems of glycogen storage disease, galactose and/or lactose intolerance
boolean
C0019247 (UMLS CUI [1])
C0017919 (UMLS CUI [2])
C0016952 (UMLS CUI [3])
C0022951 (UMLS CUI [4])
Alcohol intake above recommended sensible limits
Item
5. males with alcohol use in excess of 3 or more drinks per day, on average and females with alcohol use in excess of 2 or more drinks per day, on average
boolean
C0560219 (UMLS CUI [1])
Antidiabetics | Insulin
Item
6. use of non-insulin anti-diabetic medications
boolean
C0935929 (UMLS CUI [1])
C0021641 (UMLS CUI [2])
Adrenergic beta-Antagonists Systemic Daily
Item
7. use of daily systemic beta-blocker
boolean
C0001645 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0332173 (UMLS CUI [1,3])
Adrenergic beta-Agonists | Theophylline | Methylxanthine
Item
8. use of beta-adrenergic agonists, theophylline (or other methylxanthines)
boolean
C0001644 (UMLS CUI [1])
C0039771 (UMLS CUI [2])
C0066447 (UMLS CUI [3])
Anticholinergic Agents | Brompheniramine | Chlorpheniramine | Dimenhydrinate | Diphenhydramine | Doxylamine
Item
9. use of 1st generation anticholinergic drugs (such as brompheniramine, chlorpheniramine, dimenhydrinate, diphenhydramine, and doxylamine)
boolean
C0242896 (UMLS CUI [1])
C0006246 (UMLS CUI [2])
C0008281 (UMLS CUI [3])
C0012381 (UMLS CUI [4])
C0012522 (UMLS CUI [5])
C0013092 (UMLS CUI [6])
systemic steroids
Item
10. use of systemic corticosteroids
boolean
C2825233 (UMLS CUI [1])
Hypersensitivity Glucagon | Hypersensitivity Glucagon Excipient | Hypersensitivity Severe Pharmaceutical Preparations | Angioedema
Item
11. history of hypersensitivity to glucagon or any related product or excipient or severe hypersensitivity reactions (such as angioedema) to any drugs
boolean
C0020517 (UMLS CUI [1,1])
C0017687 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0017687 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0013227 (UMLS CUI [3,3])
C0002994 (UMLS CUI [4])
Epilepsy | Seizures
Item
12. history of epilepsy or seizure disorder
boolean
C0014544 (UMLS CUI [1])
C0036572 (UMLS CUI [2])
Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure
Item
13. uncontrolled hypertension, >160 mmhg systolic or >100 mmhg diastolic
boolean
C1868885 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Muscular endurance development exercise High | Muscular endurance development exercise High Planned
Item
14. currently a high endurance exerciser or plans to perform high endurance exercise during study (from screening visit until study completion)
boolean
C0419120 (UMLS CUI [1,1])
C0205250 (UMLS CUI [1,2])
C0419120 (UMLS CUI [2,1])
C0205250 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
Muscular endurance development exercise High | Running | Bicycling | Aquatic rowing exercises | Swimming | Sports
Item
high endurance exerciser defined as a person who regularly competes in running, cycling, rowing, swimming or any other endurance-based activity for the purpose of competition (>2100 met minutes per week [i.e. 7 mets x 60 minutes x 5 days a week, where 7 mets is equivalent to jogging])
boolean
C0419120 (UMLS CUI [1,1])
C0205250 (UMLS CUI [1,2])
C0035953 (UMLS CUI [2])
C0005377 (UMLS CUI [3])
C2147874 (UMLS CUI [4])
C0039003 (UMLS CUI [5])
C0038039 (UMLS CUI [6])
Very low energy diet | Reducing diet
Item
15. currently following a very low calorie or other weight-loss diet
boolean
C0452268 (UMLS CUI [1])
C0012167 (UMLS CUI [2])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
16. participation in other studies involving administration of an investigational drug or device within 30 days or 5 half-lives, whichever is longer, before screening for the current study or planning to participate in another such study during participation in the current study
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
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