ID

44158

Description

Evaluate the Immunogenicity of a Novel Glucagon Formulation; ODM derived from: https://clinicaltrials.gov/show/NCT01959334

Link

https://clinicaltrials.gov/show/NCT01959334

Keywords

Versions (2)
  1. 11/26/19 11/26/19 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Drug-specific Antibodies NCT01959334

English

Eligibility Drug-specific Antibodies NCT01959334

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. availability for the entire study period
Description

Availability Clinical Trial Period

Data type

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C2347804
2. motivated volunteer and absence of intellectual problems likely to limit the validity of consent to participate in the study or the compliance with protocol requirements; ability to cooperate adequately; ability to understand and observe the instructions of the physician or designee
Description

Patient Problem Absent | Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C1254481
UMLS CUI [1,2]
C0332197
UMLS CUI [2]
C0525058
3. male or female patient with a history of type 1 or type 2 diabetes of at least 2 years duration
Description

Gender | Insulin-Dependent Diabetes Mellitus Disease length | Non-Insulin-Dependent Diabetes Mellitus Disease length

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0011854
UMLS CUI [2,2]
C0872146
UMLS CUI [3,1]
C0011860
UMLS CUI [3,2]
C0872146
4. a female volunteer must meet one of the following criteria:
Description

Gender | Criteria Quantity Fulfill

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0243161
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C1550543
1. participant is of childbearing potential and agrees to use one of the accepted contraceptive regimens throughout the entire duration of the study (from the screening visit until study completion). additionally, if the participant is using systemic contraceptives, she must use an additional form of acceptable contraception. an acceptable method of contraception includes one of the following:
Description

Childbearing Potential Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
abstinence from heterosexual intercourse
Description

Abstinence Sexual intercourse

Data type

boolean

Alias
UMLS CUI [1,1]
C0036899
UMLS CUI [1,2]
C0009253
systemic contraceptives (birth control pills, injectable/implant
Description

CONTRACEPTIVES,SYSTEMIC | Contraceptives, Oral | Injectable contraception | Contraceptive implant

Data type

boolean

Alias
UMLS CUI [1]
C1874923
UMLS CUI [2]
C0009905
UMLS CUI [3]
C1262153
UMLS CUI [4]
C1657106
/insertable hormonal birth control products, transdermal patch)
Description

Hormonal contraception | Transdermal patch as birth control method

Data type

boolean

Alias
UMLS CUI [1]
C2985296
UMLS CUI [2]
C2135981
intrauterine device (with and without hormones)
Description

Intrauterine Devices, Medicated | Intrauterine Devices

Data type

boolean

Alias
UMLS CUI [1]
C0021902
UMLS CUI [2]
C0021900
condom with spermicide
Description

Female Condoms | Vaginal Spermicides

Data type

boolean

Alias
UMLS CUI [1]
C0221829
UMLS CUI [2]
C0087145
2. participant is of non-childbearing potential, defined as surgically sterile (i.e. has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation) or in a menopausal state (at least 1 year without menses)
Description

Childbearing Potential Absent | Female Sterilization | Total hysterectomy | Bilateral oophorectomy | Tubal Ligation | Menopausal Status

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0332197
UMLS CUI [2]
C0015787
UMLS CUI [3]
C0677962
UMLS CUI [4]
C0278321
UMLS CUI [5]
C0520483
UMLS CUI [6]
C3829127
5. volunteer aged of at least 18 years but not older than 70 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
6. volunteer with a bmi greater than or equal to 18.50 and below 35.00 kg/m2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
7. light-, non- or ex-smokers. a light smoker is defined as someone smoking 10 cigarettes or less per day for at least 3 months before day 1 of this study. an ex-
Description

Light tobacco smoker Number of cigarettes per day | Non-smoker | Former smoker

Data type

boolean

Alias
UMLS CUI [1,1]
C3494624
UMLS CUI [1,2]
C3694146
UMLS CUI [2]
C0337672
UMLS CUI [3]
C0337671
smoker is defined as someone who completely stopped smoking for at least 6 months before day 1 of this study
Description

Former smoker | Stopped smoking

Data type

boolean

Alias
UMLS CUI [1]
C0337671
UMLS CUI [2]
C0425310
8. 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
Description

General health good | Absence Condition Influence Research results | Patient Appropriate Clinical Trial | Medical History | Physical Examination | Laboratory data interpretation

Data type

boolean

Alias
UMLS CUI [1]
C1277245
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0348080
UMLS CUI [2,3]
C4054723
UMLS CUI [2,4]
C0683954
UMLS CUI [3,1]
C0030705
UMLS CUI [3,2]
C1548787
UMLS CUI [3,3]
C0008976
UMLS CUI [4]
C0262926
UMLS CUI [5]
C0031809
UMLS CUI [6]
C0262707
9. willingness to adhere to the protocol requirements as evidenced by the informed consent form (icf) duly read, signed and dated by the volunteer
Description

Adherence Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C1510802
UMLS CUI [1,2]
C2348563
the informed consent form must be signed by all volunteers, prior to their participation in the study.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. females who are pregnant, actively attempting to get pregnant, or are lactating
Description

Pregnancy | Pregnancy intended | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C1283828
UMLS CUI [3]
C0006147
2. history of significant hypersensitivity to glucagon or any related products as well as severe hypersensitivity reactions (such as angioedema) to any drugs
Description

Glucagon allergy | Hypersensitivity Pharmaceutical Preparations Related | Drug Allergy Severe | Angioedema

Data type

boolean

Alias
UMLS CUI [1]
C0571580
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0439849
UMLS CUI [3,1]
C0013182
UMLS CUI [3,2]
C0205082
UMLS CUI [4]
C0002994
3. presence of significant gastrointestinal, liver or kidney disease, or any other conditions which in the judgment of the investigator could interfere with the absorption, distribution, metabolism or excretion of drugs, or could potentiate or predispose to undesired effects
Description

Gastrointestinal Disease | Liver disease | Kidney Disease | Condition Interferes with Drug absorption | Condition Interferes with Substance distribution | Condition Interferes with Drug metabolism | Condition Interferes with Drug elimination | Condition predisposing Adverse effects

Data type

boolean

Alias
UMLS CUI [1]
C0017178
UMLS CUI [2]
C0023895
UMLS CUI [3]
C0022658
UMLS CUI [4,1]
C0348080
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0678745
UMLS CUI [5,1]
C0348080
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C1378698
UMLS CUI [6,1]
C0348080
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C0683140
UMLS CUI [7,1]
C0348080
UMLS CUI [7,2]
C0521102
UMLS CUI [7,3]
C0683141
UMLS CUI [8,1]
C0348080
UMLS CUI [8,2]
C0231203
UMLS CUI [8,3]
C0879626
4. suicidal tendency, history of or disposition to seizures, state of confusion, clinically relevant psychiatric diseases
Description

Suicidal tendency | Seizures | Confusion | Mental disorders

Data type

boolean

Alias
UMLS CUI [1]
C0235196
UMLS CUI [2]
C0036572
UMLS CUI [3]
C0009676
UMLS CUI [4]
C0004936
5. known presence of rare hereditary problems of galactose and /or lactose intolerance
Description

Galactosemia Hereditary | Congenital lactose intolerance

Data type

boolean

Alias
UMLS CUI [1,1]
C0016952
UMLS CUI [1,2]
C0439660
UMLS CUI [2]
C0268179
6. known presence or history of pheochromocytoma (i.e. adrenal gland tumor) or insulinoma (i.e. insulin secreting pancreas tumor)
Description

Pheochromocytoma | insulinoma

Data type

boolean

Alias
UMLS CUI [1]
C0031511
UMLS CUI [2]
C0021670
7. presence of clinically significant findings on nasal examination or bilateral anterior rhinoscopy, such as structural abnormalities, nasal polyps, marked septal deviation, nasal tumors
Description

Findings Clinical Significance | Examination of nose | Endoscopy of nose Anterior Bilateral | MISCELLANEOUS STRUCTURAL ABNORMALITIES | Nasal Polyps | Deviated nasal septum | Nose Neoplasms

Data type

boolean

Alias
UMLS CUI [1,1]
C2607943
UMLS CUI [1,2]
C2826293
UMLS CUI [2]
C0558826
UMLS CUI [3,1]
C0189024
UMLS CUI [3,2]
C0205094
UMLS CUI [3,3]
C0238767
UMLS CUI [4]
C0333310
UMLS CUI [5]
C0027430
UMLS CUI [6]
C0549397
UMLS CUI [7]
C0028433
8. nasal surgery in the previous 28 days before day 1 of this study
Description

Operation on nose

Data type

boolean

Alias
UMLS CUI [1]
C0188970
9. use of a systemic beta-blocker drug, indomethacin, warfarin or anticholinergic drugs in the previous 28 days before day 1 of this study
Description

Adrenergic beta-1 Receptor Antagonists Systemic | Indomethacin | Warfarin | Anticholinergic Agents

Data type

boolean

Alias
UMLS CUI [1,1]
C0304516
UMLS CUI [1,2]
C0205373
UMLS CUI [2]
C0021246
UMLS CUI [3]
C0043031
UMLS CUI [4]
C0242896
10. use of an immunomodulator medication (including steroids, glucocorticoids, tacrolimus, etc.) in the 28 days before day 1 of this study
Description

Immunomodulators | Steroids | Glucocorticoids | Tacrolimus

Data type

boolean

Alias
UMLS CUI [1]
C1527392
UMLS CUI [2]
C0038317
UMLS CUI [3]
C0017710
UMLS CUI [4]
C0085149
11. any other concomitant maintenance therapy that would influence the outcome of the trial or compromise the safety of the patient, at the discretion of the investigator and the sponsor, in the previous 28 days before day 1 of this study
Description

Maintenance therapy Influence Research results | Maintenance therapy compromises Patient safety

Data type

boolean

Alias
UMLS CUI [1,1]
C0677908
UMLS CUI [1,2]
C4054723
UMLS CUI [1,3]
C0683954
UMLS CUI [2,1]
C0677908
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C1113679
12. significant history of drug dependency or alcohol abuse (> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic)
Description

Drug Dependence | Alcohol abuse | Alcohol consumption U/day | Alcohol intake above recommended sensible limits | Alcohol intake above recommended sensible limits chronic

Data type

boolean

Alias
UMLS CUI [1]
C1510472
UMLS CUI [2]
C0085762
UMLS CUI [3,1]
C0001948
UMLS CUI [3,2]
C0456683
UMLS CUI [4]
C0560219
UMLS CUI [5,1]
C0560219
UMLS CUI [5,2]
C0205191
13. any clinically significant illness in the previous 28 days before day 1 of this study
Description

Illness Clinical Significance

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C2826293
14. any history of tuberculosis and/or prophylaxis for tuberculosis
Description

Tuberculosis | Tuberculosis prophylaxis

Data type

boolean

Alias
UMLS CUI [1]
C0041296
UMLS CUI [2]
C0740413
15. positive urine screening of alcohol and/or drugs of abuse
Description

Urine screening Positive Alcohol abuse | Urine drug screen positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0595946
UMLS CUI [1,2]
C1514241
UMLS CUI [1,3]
C0085762
UMLS CUI [2]
C0743300
16. females who are pregnant according to a positive pregnancy test
Description

Pregnancy Pregnancy test positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0240802
17. concurrent participation or intention of participating in another clinical trial during this study
Description

Study Subject Participation Status | Participation Clinical Trial Planned

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0679823
UMLS CUI [2,2]
C0008976
UMLS CUI [2,3]
C1301732
18. volunteers who took an investigational product (in another clinical trial) or donated 50 ml or more of blood in the previous 28 days before day 1 of this study
Description

Study Subject Participation Status | Investigational New Drugs | Blood Donation Amount Timespan

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3,1]
C0005794
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0872291
19. donation of 500 ml or more of blood (canadian blood services, hema-quebec, clinical studies, etc.) in the previous 56 days before day 1 of this study
Description

Blood Donation Amount Timespan

Data type

boolean

Alias
UMLS CUI [1,1]
C0005794
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0872291
no patients will be allowed to enroll in this study more than once (i.e. if the study is conducted with more than 1 group).
Description

Enrollment Quantity Determination

Data type

boolean

Alias
UMLS CUI [1,1]
C1516879
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0521095
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Eligibility Drug-specific Antibodies NCT01959334

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Availability Clinical Trial Period
Item
1. availability for the entire study period
boolean
C0470187 (UMLS CUI [1,1])
C2347804 (UMLS CUI [1,2])
Patient Problem Absent | Protocol Compliance
Item
2. motivated volunteer and absence of intellectual problems likely to limit the validity of consent to participate in the study or the compliance with protocol requirements; ability to cooperate adequately; ability to understand and observe the instructions of the physician or designee
boolean
C1254481 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2])
Gender | Insulin-Dependent Diabetes Mellitus Disease length | Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
3. male or female patient with a history of type 1 or type 2 diabetes of at least 2 years duration
boolean
C0079399 (UMLS CUI [1])
C0011854 (UMLS CUI [2,1])
C0872146 (UMLS CUI [2,2])
C0011860 (UMLS CUI [3,1])
C0872146 (UMLS CUI [3,2])
Gender | Criteria Quantity Fulfill
Item
4. a female volunteer must meet one of the following criteria:
boolean
C0079399 (UMLS CUI [1])
C0243161 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1550543 (UMLS CUI [2,3])
Childbearing Potential Contraceptive methods
Item
1. participant is of childbearing potential and agrees to use one of the accepted contraceptive regimens throughout the entire duration of the study (from the screening visit until study completion). additionally, if the participant is using systemic contraceptives, she must use an additional form of acceptable contraception. an acceptable method of contraception includes one of the following:
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Abstinence Sexual intercourse
Item
abstinence from heterosexual intercourse
boolean
C0036899 (UMLS CUI [1,1])
C0009253 (UMLS CUI [1,2])
CONTRACEPTIVES,SYSTEMIC | Contraceptives, Oral | Injectable contraception | Contraceptive implant
Item
systemic contraceptives (birth control pills, injectable/implant
boolean
C1874923 (UMLS CUI [1])
C0009905 (UMLS CUI [2])
C1262153 (UMLS CUI [3])
C1657106 (UMLS CUI [4])
Hormonal contraception | Transdermal patch as birth control method
Item
/insertable hormonal birth control products, transdermal patch)
boolean
C2985296 (UMLS CUI [1])
C2135981 (UMLS CUI [2])
Intrauterine Devices, Medicated | Intrauterine Devices
Item
intrauterine device (with and without hormones)
boolean
C0021902 (UMLS CUI [1])
C0021900 (UMLS CUI [2])
Female Condoms | Vaginal Spermicides
Item
condom with spermicide
boolean
C0221829 (UMLS CUI [1])
C0087145 (UMLS CUI [2])
Childbearing Potential Absent | Female Sterilization | Total hysterectomy | Bilateral oophorectomy | Tubal Ligation | Menopausal Status
Item
2. participant is of non-childbearing potential, defined as surgically sterile (i.e. has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation) or in a menopausal state (at least 1 year without menses)
boolean
C3831118 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0015787 (UMLS CUI [2])
C0677962 (UMLS CUI [3])
C0278321 (UMLS CUI [4])
C0520483 (UMLS CUI [5])
C3829127 (UMLS CUI [6])
Age
Item
5. volunteer aged of at least 18 years but not older than 70 years
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
6. volunteer with a bmi greater than or equal to 18.50 and below 35.00 kg/m2
boolean
C1305855 (UMLS CUI [1])
Light tobacco smoker Number of cigarettes per day | Non-smoker | Former smoker
Item
7. light-, non- or ex-smokers. a light smoker is defined as someone smoking 10 cigarettes or less per day for at least 3 months before day 1 of this study. an ex-
boolean
C3494624 (UMLS CUI [1,1])
C3694146 (UMLS CUI [1,2])
C0337672 (UMLS CUI [2])
C0337671 (UMLS CUI [3])
Former smoker | Stopped smoking
Item
smoker is defined as someone who completely stopped smoking for at least 6 months before day 1 of this study
boolean
C0337671 (UMLS CUI [1])
C0425310 (UMLS CUI [2])
General health good | Absence Condition Influence Research results | Patient Appropriate Clinical Trial | Medical History | Physical Examination | Laboratory data interpretation
Item
8. 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
C1277245 (UMLS CUI [1])
C0332197 (UMLS CUI [2,1])
C0348080 (UMLS CUI [2,2])
C4054723 (UMLS CUI [2,3])
C0683954 (UMLS CUI [2,4])
C0030705 (UMLS CUI [3,1])
C1548787 (UMLS CUI [3,2])
C0008976 (UMLS CUI [3,3])
C0262926 (UMLS CUI [4])
C0031809 (UMLS CUI [5])
C0262707 (UMLS CUI [6])
Adherence Study Protocol
Item
9. willingness to adhere to the protocol requirements as evidenced by the informed consent form (icf) duly read, signed and dated by the volunteer
boolean
C1510802 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Informed Consent
Item
the informed consent form must be signed by all volunteers, prior to their participation in the study.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Pregnancy intended | Breast Feeding
Item
1. females who are pregnant, actively attempting to get pregnant, or are lactating
boolean
C0032961 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C1283828 (UMLS CUI [2,2])
C0006147 (UMLS CUI [3])
Glucagon allergy | Hypersensitivity Pharmaceutical Preparations Related | Drug Allergy Severe | Angioedema
Item
2. history of significant hypersensitivity to glucagon or any related products as well as severe hypersensitivity reactions (such as angioedema) to any drugs
boolean
C0571580 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
C0013182 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0002994 (UMLS CUI [4])
Gastrointestinal Disease | Liver disease | Kidney Disease | Condition Interferes with Drug absorption | Condition Interferes with Substance distribution | Condition Interferes with Drug metabolism | Condition Interferes with Drug elimination | Condition predisposing Adverse effects
Item
3. presence of significant gastrointestinal, liver or kidney disease, or any other conditions which in the judgment of the investigator could interfere with the absorption, distribution, metabolism or excretion of drugs, or could potentiate or predispose to undesired effects
boolean
C0017178 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0348080 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0678745 (UMLS CUI [4,3])
C0348080 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C1378698 (UMLS CUI [5,3])
C0348080 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C0683140 (UMLS CUI [6,3])
C0348080 (UMLS CUI [7,1])
C0521102 (UMLS CUI [7,2])
C0683141 (UMLS CUI [7,3])
C0348080 (UMLS CUI [8,1])
C0231203 (UMLS CUI [8,2])
C0879626 (UMLS CUI [8,3])
Suicidal tendency | Seizures | Confusion | Mental disorders
Item
4. suicidal tendency, history of or disposition to seizures, state of confusion, clinically relevant psychiatric diseases
boolean
C0235196 (UMLS CUI [1])
C0036572 (UMLS CUI [2])
C0009676 (UMLS CUI [3])
C0004936 (UMLS CUI [4])
Galactosemia Hereditary | Congenital lactose intolerance
Item
5. known presence of rare hereditary problems of galactose and /or lactose intolerance
boolean
C0016952 (UMLS CUI [1,1])
C0439660 (UMLS CUI [1,2])
C0268179 (UMLS CUI [2])
Pheochromocytoma | insulinoma
Item
6. known presence or history of pheochromocytoma (i.e. adrenal gland tumor) or insulinoma (i.e. insulin secreting pancreas tumor)
boolean
C0031511 (UMLS CUI [1])
C0021670 (UMLS CUI [2])
Findings Clinical Significance | Examination of nose | Endoscopy of nose Anterior Bilateral | MISCELLANEOUS STRUCTURAL ABNORMALITIES | Nasal Polyps | Deviated nasal septum | Nose Neoplasms
Item
7. presence of clinically significant findings on nasal examination or bilateral anterior rhinoscopy, such as structural abnormalities, nasal polyps, marked septal deviation, nasal tumors
boolean
C2607943 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0558826 (UMLS CUI [2])
C0189024 (UMLS CUI [3,1])
C0205094 (UMLS CUI [3,2])
C0238767 (UMLS CUI [3,3])
C0333310 (UMLS CUI [4])
C0027430 (UMLS CUI [5])
C0549397 (UMLS CUI [6])
C0028433 (UMLS CUI [7])
Operation on nose
Item
8. nasal surgery in the previous 28 days before day 1 of this study
boolean
C0188970 (UMLS CUI [1])
Adrenergic beta-1 Receptor Antagonists Systemic | Indomethacin | Warfarin | Anticholinergic Agents
Item
9. use of a systemic beta-blocker drug, indomethacin, warfarin or anticholinergic drugs in the previous 28 days before day 1 of this study
boolean
C0304516 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0021246 (UMLS CUI [2])
C0043031 (UMLS CUI [3])
C0242896 (UMLS CUI [4])
Immunomodulators | Steroids | Glucocorticoids | Tacrolimus
Item
10. use of an immunomodulator medication (including steroids, glucocorticoids, tacrolimus, etc.) in the 28 days before day 1 of this study
boolean
C1527392 (UMLS CUI [1])
C0038317 (UMLS CUI [2])
C0017710 (UMLS CUI [3])
C0085149 (UMLS CUI [4])
Maintenance therapy Influence Research results | Maintenance therapy compromises Patient safety
Item
11. any other concomitant maintenance therapy that would influence the outcome of the trial or compromise the safety of the patient, at the discretion of the investigator and the sponsor, in the previous 28 days before day 1 of this study
boolean
C0677908 (UMLS CUI [1,1])
C4054723 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
C0677908 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
Drug Dependence | Alcohol abuse | Alcohol consumption U/day | Alcohol intake above recommended sensible limits | Alcohol intake above recommended sensible limits chronic
Item
12. significant history of drug dependency or alcohol abuse (> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic)
boolean
C1510472 (UMLS CUI [1])
C0085762 (UMLS CUI [2])
C0001948 (UMLS CUI [3,1])
C0456683 (UMLS CUI [3,2])
C0560219 (UMLS CUI [4])
C0560219 (UMLS CUI [5,1])
C0205191 (UMLS CUI [5,2])
Illness Clinical Significance
Item
13. any clinically significant illness in the previous 28 days before day 1 of this study
boolean
C0221423 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Tuberculosis | Tuberculosis prophylaxis
Item
14. any history of tuberculosis and/or prophylaxis for tuberculosis
boolean
C0041296 (UMLS CUI [1])
C0740413 (UMLS CUI [2])
Urine screening Positive Alcohol abuse | Urine drug screen positive
Item
15. positive urine screening of alcohol and/or drugs of abuse
boolean
C0595946 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C0085762 (UMLS CUI [1,3])
C0743300 (UMLS CUI [2])
Pregnancy Pregnancy test positive
Item
16. females who are pregnant according to a positive pregnancy test
boolean
C0032961 (UMLS CUI [1,1])
C0240802 (UMLS CUI [1,2])
Study Subject Participation Status | Participation Clinical Trial Planned
Item
17. concurrent participation or intention of participating in another clinical trial during this study
boolean
C2348568 (UMLS CUI [1])
C0679823 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
Study Subject Participation Status | Investigational New Drugs | Blood Donation Amount Timespan
Item
18. volunteers who took an investigational product (in another clinical trial) or donated 50 ml or more of blood in the previous 28 days before day 1 of this study
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C0005794 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0872291 (UMLS CUI [3,3])
Blood Donation Amount Timespan
Item
19. donation of 500 ml or more of blood (canadian blood services, hema-quebec, clinical studies, etc.) in the previous 56 days before day 1 of this study
boolean
C0005794 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0872291 (UMLS CUI [1,3])
Enrollment Quantity Determination
Item
no patients will be allowed to enroll in this study more than once (i.e. if the study is conducted with more than 1 group).
boolean
C1516879 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0521095 (UMLS CUI [1,3])
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