ID

39377

Descrição

Evaluation of 18F-FP-DTBZ Pancreatic PET Scanning as a Tool to Measure Beta Cell Mass; ODM derived from: https://clinicaltrials.gov/show/NCT02236754

Link

https://clinicaltrials.gov/show/NCT02236754

Palavras-chave

Versões (1)
  1. 04/01/2020 04/01/2020 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

4 de janeiro de 2020

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Healthy Volunteers NCT02236754

Inglês

Eligibility Healthy Volunteers NCT02236754

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with type 1 diabetes may be enrolled if they meet all of the following criteria:
Descrição

Diabetes Mellitus, Insulin-Dependent | Criteria Fulfill

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2,1]
C0243161
UMLS CUI [2,2]
C1550543
1. are males or females between 18 and 70 years of age, inclusive
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
2. have a diagnosis of type 1 diabetes mellitus as defined by ada criteria or by diagnosed as per their endocrinologist; duration >5 years; insulin dose requirements <0.8 units/kg/day
Descrição

Insulin-Dependent Diabetes Mellitus Duration | Requirement Insulin Dose U/kg/day

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0449238
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0021641
UMLS CUI [2,3]
C0178602
UMLS CUI [2,4]
C1532634
3. hba1c level between 5% and 8.5%
Descrição

Hemoglobin A1c measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0474680
4. have fasting c-peptide < 0.1 ng/ml
Descrição

Fasting C-peptide level

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2208720
5. have a bmi between 18 and 32 kg/m2
Descrição

Body mass index

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1305855
6. able to tolerate pet imaging
Descrição

Ability Receive PET Imaging

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C0032743
7. in the judgment of the physician, are capable of fasting 4 to 6 hours prior to screening and day 1 imaging procedures
Descrição

Ability Fasting Duration

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C0015663
UMLS CUI [1,3]
C0449238
8. give informed consent
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
healthy volunteers may be enrolled if they meeting all of the following criteria:
Descrição

Healthy Volunteers | Criteria Fulfill

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1708335
UMLS CUI [2,1]
C0243161
UMLS CUI [2,2]
C1550543
1. are males or females between 18 and 70 years of age, inclusive
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
2. have no history of type 1 or type 2 diabetes in a first degree relative
Descrição

Insulin-Dependent Diabetes Mellitus First Degree Relative Absent | Non-Insulin-Dependent Diabetes Mellitus First Degree Relative Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C1517194
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0011860
UMLS CUI [2,2]
C1517194
UMLS CUI [2,3]
C0332197
3. fasting blood glucose less than 100 mg/dl
Descrição

Fasting blood glucose measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0428568
4. hba1c level less than 6%
Descrição

Hemoglobin A1c measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0474680
5. normal mixed meal tolerance test at screening visit
Descrição

Meal Mixed Tolerance test Normal

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1998602
UMLS CUI [1,2]
C0205430
UMLS CUI [1,3]
C0201777
UMLS CUI [1,4]
C0205307
6. bmi between 18 and 32 kg/m2
Descrição

Body mass index

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1305855
7. able to tolerate pet imaging
Descrição

Ability Receive PET Imaging

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C0032743
8. in the judgment of the physician, are capable of fasting 4 to 6 hours prior to screening and day 1 imaging procedures, and
Descrição

Ability Fasting Duration

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C0015663
UMLS CUI [1,3]
C0449238
9. give informed consent
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
potential participants must not have any of the following exclusion criteria:
Descrição

Exclusion Criteria Any

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1552551
1. clinically significant renal dysfunction
Descrição

Renal dysfunction

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3279454
2. clinically significant liver dysfunction as determined by history, physical examination, and standard liver function testing at screening (ast, alt, total/direct bilirubin, alkaline phosphatase)
Descrição

Liver Dysfunction Medical History | Liver Dysfunction Physical Examination | Liver Function Tests | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum total bilirubin measurement | Bilirubin, direct measurement | Alkaline phosphatase measurement

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0086565
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C0086565
UMLS CUI [2,2]
C0031809
UMLS CUI [3]
C0023901
UMLS CUI [4]
C0201899
UMLS CUI [5]
C0201836
UMLS CUI [6]
C1278039
UMLS CUI [7]
C0201916
UMLS CUI [8]
C0201850
3. coagulopathy
Descrição

Blood Coagulation Disorders

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0005779
4. use medications known to affect dopaminergic function, including mao inhibitors, tetrabenazine, or levodopa
Descrição

Pharmaceutical Preparations Affecting Dopamine function | Monoamine Oxidase Inhibitors | Tetrabenazine | Levodopa

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0013030
UMLS CUI [1,4]
C0031843
UMLS CUI [2]
C0026457
UMLS CUI [3]
C0039623
UMLS CUI [4]
C0023570
5. recent (within 3 months) or current treatment with drugs influencing beta cell function or insulin sensitivity (e.g. glucocorticoids, reserpine) medications known to affect dopaminergic function, including mao inhibitors, tetrabenazine, or levodopa
Descrição

Pharmaceutical Preparations Influence Beta Cell Function | Pharmaceutical Preparations Influence Insulin Sensitivity | Glucocorticoids | Reserpine | Pharmaceutical Preparations Affecting Dopamine Function | Monoamine Oxidase Inhibitors | Tetrabenazine | Levodopa

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C4054723
UMLS CUI [1,3]
C0030281
UMLS CUI [1,4]
C0031843
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C4054723
UMLS CUI [2,3]
C0920563
UMLS CUI [3]
C0017710
UMLS CUI [4]
C0035179
UMLS CUI [5,1]
C0013227
UMLS CUI [5,2]
C0392760
UMLS CUI [5,3]
C0013030
UMLS CUI [5,4]
C0031843
UMLS CUI [6]
C0026457
UMLS CUI [7]
C0039623
UMLS CUI [8]
C0023570
6. have polycystic ovarian syndrome
Descrição

Polycystic Ovary Syndrome

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032460
7. history of movement disorder such as parkinson's disease, huntington's disease
Descrição

Movement Disorders | Parkinson Disease | Huntington Disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0026650
UMLS CUI [2]
C0030567
UMLS CUI [3]
C0020179
8. clinically significant psychiatric disease or history of psychiatric illness such as depression, bipolar disease, anxiety or schizophrenia
Descrição

Mental disorders | Depressive disorder | Bipolar Disorder | Anxiety | Schizophrenia

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0004936
UMLS CUI [2]
C0011581
UMLS CUI [3]
C0005586
UMLS CUI [4]
C0003467
UMLS CUI [5]
C0036341
9. current use (within past year) of cocaine, methamphetamine, and/or ecstasy (mdma,3,4methylenedioxymethamphetamine)
Descrição

Cocaine | Methamphetamine | Ecstasy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009170
UMLS CUI [2]
C0025611
UMLS CUI [3]
C0115471
10. have a recent history of alcohol or substance abuse or dependence
Descrição

Substance Use Disorders | Substance Dependence

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0038580
11. clinically significant cardiovascular disease or clinically significant abnormalities on screening ecg (including but not limited to qtc > 450 msec)
Descrição

Cardiovascular Diseases | ECG abnormal | Prolonged QTc interval

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0522055
UMLS CUI [3]
C1560305
12. clinically significant pulmonary, renal or hepatic impairment, or cancer
Descrição

Pulmonary function impairment | Renal Insufficiency | Hepatic impairment | Malignant Neoplasms

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0858943
UMLS CUI [2]
C1565489
UMLS CUI [3]
C0948807
UMLS CUI [4]
C0006826
13. have clinically significant infectious disease, including aids or hiv infection or previous positive test for hepatitis b, hepatitis c, hiv1, or hiv2
Descrição

Communicable Diseases | AIDS | HIV Infections | Hepatitis B test positive | Hepatitis C test positive | HIV-1 test positive | HIV-2 test positive

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0001175
UMLS CUI [3]
C0019693
UMLS CUI [4]
C1608966
UMLS CUI [5]
C1609517
UMLS CUI [6]
C1328593
UMLS CUI [7]
C1168371
14. are women of childbearing potential not refraining from sexual activity or not using adequate contraception.
Descrição

Childbearing Potential Sexually active | Childbearing Potential Contraceptive methods Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0241028
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0332197
women must not be pregnant (negative serum hcg at the time of screen) or breastfeeding at screening, and must agree to take appropriate steps not to become pregnant during for 30 days following the clinical trial
Descrição

Gender | Pregnancy Absent | Serum pregnancy test (B-HCG) Negative | Breast Feeding Absent | Gender Contraceptive methods Willing

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0430060
UMLS CUI [3,2]
C1513916
UMLS CUI [4,1]
C0006147
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0079399
UMLS CUI [5,2]
C0700589
UMLS CUI [5,3]
C0600109
15. require medications with a narrow therapeutic window (e.g., warfarin), are receiving any investigational medications, or have participated in a trial with investigational medications within the last 30 days
Descrição

Warfarin | Study Subject Participation Status | Investigational New Drugs

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0043031
UMLS CUI [2]
C2348568
UMLS CUI [3]
C0013230
16. weigh more than the manufacturer recommended limit for the pet/ct camera being used
Descrição

Body Weight Inappropriate PET/CT scan

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0005910
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C1699633
17. any prior participation in other research protocols within the past month that involved radiation, with the exception of plain radiography studies (i.e., chest x-rays); and
Descrição

Study Subject Participation Status | Clinical Trials Therapeutic radiology procedure Involved | Exception Plain chest X-ray

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C1522449
UMLS CUI [2,3]
C1314939
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0039985
18. have received a diagnostic or therapeutic radiopharmaceutical within the past week
Descrição

Radiopharmaceuticals

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0182638
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Eligibility Healthy Volunteers NCT02236754

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent | Criteria Fulfill
Item
patients with type 1 diabetes may be enrolled if they meet all of the following criteria:
boolean
C0011854 (UMLS CUI [1])
C0243161 (UMLS CUI [2,1])
C1550543 (UMLS CUI [2,2])
Age
Item
1. are males or females between 18 and 70 years of age, inclusive
boolean
C0001779 (UMLS CUI [1])
Insulin-Dependent Diabetes Mellitus Duration | Requirement Insulin Dose U/kg/day
Item
2. have a diagnosis of type 1 diabetes mellitus as defined by ada criteria or by diagnosed as per their endocrinologist; duration >5 years; insulin dose requirements <0.8 units/kg/day
boolean
C0011854 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C0021641 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C1532634 (UMLS CUI [2,4])
Hemoglobin A1c measurement
Item
3. hba1c level between 5% and 8.5%
boolean
C0474680 (UMLS CUI [1])
Fasting C-peptide level
Item
4. have fasting c-peptide < 0.1 ng/ml
boolean
C2208720 (UMLS CUI [1])
Body mass index
Item
5. have a bmi between 18 and 32 kg/m2
boolean
C1305855 (UMLS CUI [1])
Ability Receive PET Imaging
Item
6. able to tolerate pet imaging
boolean
C0085732 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C0032743 (UMLS CUI [1,3])
Ability Fasting Duration
Item
7. in the judgment of the physician, are capable of fasting 4 to 6 hours prior to screening and day 1 imaging procedures
boolean
C0085732 (UMLS CUI [1,1])
C0015663 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
Informed Consent
Item
8. give informed consent
boolean
C0021430 (UMLS CUI [1])
Healthy Volunteers | Criteria Fulfill
Item
healthy volunteers may be enrolled if they meeting all of the following criteria:
boolean
C1708335 (UMLS CUI [1])
C0243161 (UMLS CUI [2,1])
C1550543 (UMLS CUI [2,2])
Age
Item
1. are males or females between 18 and 70 years of age, inclusive
boolean
C0001779 (UMLS CUI [1])
Insulin-Dependent Diabetes Mellitus First Degree Relative Absent | Non-Insulin-Dependent Diabetes Mellitus First Degree Relative Absent
Item
2. have no history of type 1 or type 2 diabetes in a first degree relative
boolean
C0011854 (UMLS CUI [1,1])
C1517194 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0011860 (UMLS CUI [2,1])
C1517194 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Fasting blood glucose measurement
Item
3. fasting blood glucose less than 100 mg/dl
boolean
C0428568 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
4. hba1c level less than 6%
boolean
C0474680 (UMLS CUI [1])
Meal Mixed Tolerance test Normal
Item
5. normal mixed meal tolerance test at screening visit
boolean
C1998602 (UMLS CUI [1,1])
C0205430 (UMLS CUI [1,2])
C0201777 (UMLS CUI [1,3])
C0205307 (UMLS CUI [1,4])
Body mass index
Item
6. bmi between 18 and 32 kg/m2
boolean
C1305855 (UMLS CUI [1])
Ability Receive PET Imaging
Item
7. able to tolerate pet imaging
boolean
C0085732 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C0032743 (UMLS CUI [1,3])
Ability Fasting Duration
Item
8. in the judgment of the physician, are capable of fasting 4 to 6 hours prior to screening and day 1 imaging procedures, and
boolean
C0085732 (UMLS CUI [1,1])
C0015663 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
Informed Consent
Item
9. give informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Exclusion Criteria Any
Item
potential participants must not have any of the following exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1552551 (UMLS CUI [1,2])
Renal dysfunction
Item
1. clinically significant renal dysfunction
boolean
C3279454 (UMLS CUI [1])
Liver Dysfunction Medical History | Liver Dysfunction Physical Examination | Liver Function Tests | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum total bilirubin measurement | Bilirubin, direct measurement | Alkaline phosphatase measurement
Item
2. clinically significant liver dysfunction as determined by history, physical examination, and standard liver function testing at screening (ast, alt, total/direct bilirubin, alkaline phosphatase)
boolean
C0086565 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0086565 (UMLS CUI [2,1])
C0031809 (UMLS CUI [2,2])
C0023901 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C0201836 (UMLS CUI [5])
C1278039 (UMLS CUI [6])
C0201916 (UMLS CUI [7])
C0201850 (UMLS CUI [8])
Blood Coagulation Disorders
Item
3. coagulopathy
boolean
C0005779 (UMLS CUI [1])
Pharmaceutical Preparations Affecting Dopamine function | Monoamine Oxidase Inhibitors | Tetrabenazine | Levodopa
Item
4. use medications known to affect dopaminergic function, including mao inhibitors, tetrabenazine, or levodopa
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0013030 (UMLS CUI [1,3])
C0031843 (UMLS CUI [1,4])
C0026457 (UMLS CUI [2])
C0039623 (UMLS CUI [3])
C0023570 (UMLS CUI [4])
Pharmaceutical Preparations Influence Beta Cell Function | Pharmaceutical Preparations Influence Insulin Sensitivity | Glucocorticoids | Reserpine | Pharmaceutical Preparations Affecting Dopamine Function | Monoamine Oxidase Inhibitors | Tetrabenazine | Levodopa
Item
5. recent (within 3 months) or current treatment with drugs influencing beta cell function or insulin sensitivity (e.g. glucocorticoids, reserpine) medications known to affect dopaminergic function, including mao inhibitors, tetrabenazine, or levodopa
boolean
C0013227 (UMLS CUI [1,1])
C4054723 (UMLS CUI [1,2])
C0030281 (UMLS CUI [1,3])
C0031843 (UMLS CUI [1,4])
C0013227 (UMLS CUI [2,1])
C4054723 (UMLS CUI [2,2])
C0920563 (UMLS CUI [2,3])
C0017710 (UMLS CUI [3])
C0035179 (UMLS CUI [4])
C0013227 (UMLS CUI [5,1])
C0392760 (UMLS CUI [5,2])
C0013030 (UMLS CUI [5,3])
C0031843 (UMLS CUI [5,4])
C0026457 (UMLS CUI [6])
C0039623 (UMLS CUI [7])
C0023570 (UMLS CUI [8])
Polycystic Ovary Syndrome
Item
6. have polycystic ovarian syndrome
boolean
C0032460 (UMLS CUI [1])
Movement Disorders | Parkinson Disease | Huntington Disease
Item
7. history of movement disorder such as parkinson's disease, huntington's disease
boolean
C0026650 (UMLS CUI [1])
C0030567 (UMLS CUI [2])
C0020179 (UMLS CUI [3])
Mental disorders | Depressive disorder | Bipolar Disorder | Anxiety | Schizophrenia
Item
8. clinically significant psychiatric disease or history of psychiatric illness such as depression, bipolar disease, anxiety or schizophrenia
boolean
C0004936 (UMLS CUI [1])
C0011581 (UMLS CUI [2])
C0005586 (UMLS CUI [3])
C0003467 (UMLS CUI [4])
C0036341 (UMLS CUI [5])
Cocaine | Methamphetamine | Ecstasy
Item
9. current use (within past year) of cocaine, methamphetamine, and/or ecstasy (mdma,3,4methylenedioxymethamphetamine)
boolean
C0009170 (UMLS CUI [1])
C0025611 (UMLS CUI [2])
C0115471 (UMLS CUI [3])
Substance Use Disorders | Substance Dependence
Item
10. have a recent history of alcohol or substance abuse or dependence
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
Cardiovascular Diseases | ECG abnormal | Prolonged QTc interval
Item
11. clinically significant cardiovascular disease or clinically significant abnormalities on screening ecg (including but not limited to qtc > 450 msec)
boolean
C0007222 (UMLS CUI [1])
C0522055 (UMLS CUI [2])
C1560305 (UMLS CUI [3])
Pulmonary function impairment | Renal Insufficiency | Hepatic impairment | Malignant Neoplasms
Item
12. clinically significant pulmonary, renal or hepatic impairment, or cancer
boolean
C0858943 (UMLS CUI [1])
C1565489 (UMLS CUI [2])
C0948807 (UMLS CUI [3])
C0006826 (UMLS CUI [4])
Communicable Diseases | AIDS | HIV Infections | Hepatitis B test positive | Hepatitis C test positive | HIV-1 test positive | HIV-2 test positive
Item
13. have clinically significant infectious disease, including aids or hiv infection or previous positive test for hepatitis b, hepatitis c, hiv1, or hiv2
boolean
C0009450 (UMLS CUI [1])
C0001175 (UMLS CUI [2])
C0019693 (UMLS CUI [3])
C1608966 (UMLS CUI [4])
C1609517 (UMLS CUI [5])
C1328593 (UMLS CUI [6])
C1168371 (UMLS CUI [7])
Childbearing Potential Sexually active | Childbearing Potential Contraceptive methods Absent
Item
14. are women of childbearing potential not refraining from sexual activity or not using adequate contraception.
boolean
C3831118 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Gender | Pregnancy Absent | Serum pregnancy test (B-HCG) Negative | Breast Feeding Absent | Gender Contraceptive methods Willing
Item
women must not be pregnant (negative serum hcg at the time of screen) or breastfeeding at screening, and must agree to take appropriate steps not to become pregnant during for 30 days following the clinical trial
boolean
C0079399 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0430060 (UMLS CUI [3,1])
C1513916 (UMLS CUI [3,2])
C0006147 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0079399 (UMLS CUI [5,1])
C0700589 (UMLS CUI [5,2])
C0600109 (UMLS CUI [5,3])
Warfarin | Study Subject Participation Status | Investigational New Drugs
Item
15. require medications with a narrow therapeutic window (e.g., warfarin), are receiving any investigational medications, or have participated in a trial with investigational medications within the last 30 days
boolean
C0043031 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
Body Weight Inappropriate PET/CT scan
Item
16. weigh more than the manufacturer recommended limit for the pet/ct camera being used
boolean
C0005910 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C1699633 (UMLS CUI [1,3])
Study Subject Participation Status | Clinical Trials Therapeutic radiology procedure Involved | Exception Plain chest X-ray
Item
17. any prior participation in other research protocols within the past month that involved radiation, with the exception of plain radiography studies (i.e., chest x-rays); and
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C1522449 (UMLS CUI [2,2])
C1314939 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0039985 (UMLS CUI [3,2])
Radiopharmaceuticals
Item
18. have received a diagnostic or therapeutic radiopharmaceutical within the past week
boolean
C0182638 (UMLS CUI [1])
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