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Informações:
Falhas:
ID
39073
Descrição
Evaluate the Immunogenicity of a Novel Glucagon Formulation; ODM derived from: https://clinicaltrials.gov/show/NCT01959334
Link
https://clinicaltrials.gov/show/NCT01959334
Palavras-chave
Versões (2)
- 26/11/19 26/11/19 -
- 20/9/21 20/9/21 -
Titular dos direitos
See clinicaltrials.gov
Transferido a
26 de noviembre de 2019
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Drug-specific Antibodies NCT01959334
Eligibility Drug-specific Antibodies NCT01959334
- StudyEvent: Eligibility
Similar models
Eligibility Drug-specific Antibodies NCT01959334
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Availability Clinical Trial Period
Item
1. availability for the entire study period
boolean
C0470187 (UMLS CUI [1,1])
C2347804 (UMLS CUI [1,2])
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])
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])
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])
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])
C0700589 (UMLS CUI [1,2])
Abstinence Sexual intercourse
Item
abstinence from heterosexual intercourse
boolean
C0036899 (UMLS CUI [1,1])
C0009253 (UMLS CUI [1,2])
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])
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])
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])
C0021900 (UMLS CUI [2])
Female Condoms | Vaginal Spermicides
Item
condom with spermicide
boolean
C0221829 (UMLS CUI [1])
C0087145 (UMLS CUI [2])
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])
C1513126 (UMLS CUI [6])
C0332197 (UMLS CUI [1,2])
C0015787 (UMLS CUI [2])
C0677962 (UMLS CUI [3])
C0278321 (UMLS CUI [4])
C0520483 (UMLS CUI [5])
C1513126 (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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
C1265611 (UMLS CUI [1,2])
C0521095 (UMLS CUI [1,3])