ID

38329

Beschreibung

A Study to Assess the Ability of a Novel Endocrine Treatment for Breast Cancer, Irosustat, to Slow Down Cancer Growth; ODM derived from: https://clinicaltrials.gov/show/NCT01662726

Link

https://clinicaltrials.gov/show/NCT01662726

Stichworte

Versionen (2)
  1. 10.10.19 10.10.19 -
  2. 11.10.19 11.10.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

10. Oktober 2019

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Eligibility Breast Neoplasms NCT01662726

Englisch

Eligibility Breast Neoplasms NCT01662726

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. written informed consent to participate in the trial
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
2. 18 years of age or older
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
3. histologically confirmed er +ve breast cancer (allred ≥ 3)
Beschreibung

Oestrogen receptor positive breast cancer

Datentyp

boolean

Alias
UMLS CUI [1]
C2938924
4. any her2 status
Beschreibung

HER2 Status Any

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1512413
UMLS CUI [1,2]
C1552551
5. tumour measuring ≥ 15mm in longest diameter on ultrasound (us) examination
Beschreibung

Neoplasm Longest Diameter Ultrasonography

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0552406
UMLS CUI [1,3]
C0041618
6. postmenopausal women as defined by any one of the following criteria:
Beschreibung

Postmenopausal state

Datentyp

boolean

Alias
UMLS CUI [1]
C0232970
amenorrhoea > 12 months at the time of diagnosis and an intact uterus or,
Beschreibung

Amenorrhea Duration | Uterus Intact

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0002453
UMLS CUI [1,2]
C0449238
UMLS CUI [2,1]
C0042149
UMLS CUI [2,2]
C0205266
prior bilateral oophorectomy or,
Beschreibung

Bilateral oophorectomy

Datentyp

boolean

Alias
UMLS CUI [1]
C0278321
fsh levels within the postmenopausal range (as per local practice) in women aged < 55years who have undergone hysterectomy or,
Beschreibung

Follicle stimulating hormone measurement Consistent with Postmenopausal state | Gender | Age | Hysterectomy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0202022
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C0232970
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0001779
UMLS CUI [4]
C0020699
fsh levels within the postmenopausal range (as per local practice) in women aged < 55 years who have been on hormone replacement therapy (hrt) within the last 12 months and are therefore not amenorrhoeic
Beschreibung

Follicle stimulating hormone measurement Consistent with Postmenopausal state | Gender | Age | Hormone replacement therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0202022
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C0232970
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0001779
UMLS CUI [4]
C0282402
7. eastern cooperative oncology group (ecog) performance status 0, 1 or 2
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
8. adequate bone marrow function defined by hb ≥ 10 g/dl, wbc ≥ 3.0 x109, plt ≥ 100 x109/l. adequate renal function defined by a serum creatinine ≤ 1.5 x uln. adequate liver function defined by total bilirubin ≤ 1.5 uln (patients with gilbert's syndrome exempted), either alt or ast ≤ 1.5 uln and alp ≤ 1.5 uln
Beschreibung

Bone Marrow function | Hemoglobin measurement | White Blood Cell Count procedure | Platelet Count measurement | Renal function | Creatinine measurement, serum | Liver function | Serum total bilirubin measurement | Exception Gilbert Disease | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Alkaline phosphatase measurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0518015
UMLS CUI [3]
C0023508
UMLS CUI [4]
C0032181
UMLS CUI [5]
C0232804
UMLS CUI [6]
C0201976
UMLS CUI [7]
C0232741
UMLS CUI [8]
C1278039
UMLS CUI [9,1]
C1705847
UMLS CUI [9,2]
C0017551
UMLS CUI [10]
C0201836
UMLS CUI [11]
C0201899
UMLS CUI [12]
C0201850
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. locally advanced/inoperable breast cancer
Beschreibung

Locally advanced breast cancer Inoperable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3495949
UMLS CUI [1,2]
C0205187
2. clinical evidence of metastatic disease
Beschreibung

Neoplasm Metastasis

Datentyp

boolean

Alias
UMLS CUI [1]
C0027627
3. diffuse or inflammatory tumours
Beschreibung

Diffuse tumor configuration | Inflammatory carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C1276429
UMLS CUI [2]
C0334385
4. any history of invasive malignancy within 5 years of starting study treatment (other than adequately treated basal cell carcinoma or squamous cell carcinoma of the skin and cervical carcinoma in situ)
Beschreibung

Invasive cancer | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated

Datentyp

boolean

Alias
UMLS CUI [1]
C0677898
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
UMLS CUI [4,3]
C1522326
5. evidence of bleeding diathesis and ptt and pt ≤ 1.5 x upper limit of normal
Beschreibung

Bleeding tendency | Activated Partial Thromboplastin Time measurement | Prothrombin time assay

Datentyp

boolean

Alias
UMLS CUI [1]
C1458140
UMLS CUI [2]
C0030605
UMLS CUI [3]
C0033707
6. concomitant use (defined as use within 4 weeks prior to entry) of hrt or any other oestrogen-containing medication or supplement (including vaginal oestrogens and phytoestrogens)
Beschreibung

Hormone replacement therapy | Pharmaceutical Preparations Containing Estrogens | Supplements Containing Estrogens | Vaginal estrogens | Phytoestrogens

Datentyp

boolean

Alias
UMLS CUI [1]
C0282402
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0332256
UMLS CUI [2,3]
C0014939
UMLS CUI [3,1]
C0242295
UMLS CUI [3,2]
C0332256
UMLS CUI [3,3]
C0014939
UMLS CUI [4]
C1875126
UMLS CUI [5]
C0071011
7. previous use of oestrogen implants at any time.
Beschreibung

Estrogen implants

Datentyp

boolean

Alias
UMLS CUI [1]
C0848157
8. concomitant use of:
Beschreibung

Use of

Datentyp

boolean

Alias
UMLS CUI [1]
C1524063
rifampicin and other cyp2c and 3a inducers such as rifabutin, rifapentine, carbamazepine, phenobarbital, phenytoin and st. john's wort
Beschreibung

Rifampin | CYP2C Inducer | CYP3A Inducers | Rifabutin | rifapentine | Carbamazepine | Phenobarbital | Phenytoin | ST. JOHN'S WORT EXTRACT

Datentyp

boolean

Alias
UMLS CUI [1]
C0035608
UMLS CUI [2,1]
C0910126
UMLS CUI [2,2]
C3898767
UMLS CUI [3]
C3850044
UMLS CUI [4]
C0140575
UMLS CUI [5]
C0073372
UMLS CUI [6]
C0006949
UMLS CUI [7]
C0031412
UMLS CUI [8]
C0031507
UMLS CUI [9]
C0813171
systemic carbonic anhydrase inhibitors
Beschreibung

Carbonic Anhydrase Inhibitors Systemic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007036
UMLS CUI [1,2]
C0205373
9. any of the following cardiac criteria:
Beschreibung

Criteria cardiac

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C0018787
mean resting corrected qt interval (qtcf) > 450 ms obtained from 3 electrocardiograms (ecgs)
Beschreibung

QTcF Resting mean | ECG Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1882513
UMLS CUI [1,2]
C0035253
UMLS CUI [1,3]
C0444504
UMLS CUI [2,1]
C0013798
UMLS CUI [2,2]
C1265611
any clinically important abnormalities in rhythm, conduction or morphology of resting ecg e.g. complete left bundle branch block, third degree heart block
Beschreibung

Resting ECG Changes Abnormal | ECG complete left bundle branch block | Complete atrioventricular block

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3897699
UMLS CUI [1,2]
C0205161
UMLS CUI [2]
C4518442
UMLS CUI [3]
C0151517
any factors that increase the risk of qtc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long qt syndrome, family history of long qt syndrome or unexplained sudden death under 40 years of age or any concomitant medication known to prolong the qt interval
Beschreibung

Factor At risk Prolonged QTc interval | Factor At risk Cardiac Arrhythmia | Heart failure | Hypokalemia | Congenital long QT syndrome | Unexplained sudden death Relationship Age | Pharmaceutical Preparations Causing Prolonged QT interval

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1521761
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C1560305
UMLS CUI [2,1]
C1521761
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C0003811
UMLS CUI [3]
C0018801
UMLS CUI [4]
C0020621
UMLS CUI [5]
C1141890
UMLS CUI [6,1]
C0520806
UMLS CUI [6,2]
C0439849
UMLS CUI [6,3]
C0001779
UMLS CUI [7,1]
C0013227
UMLS CUI [7,2]
C0678227
UMLS CUI [7,3]
C0151878
10. uncontrolled abnormalities of serum potassium, sodium, calcium or magnesium levels
Beschreibung

Abnormality Uncontrolled Serum potassium measurement | Abnormality Uncontrolled Sodium measurement | Abnormality Uncontrolled Calcium measurement | Abnormality Uncontrolled Magnesium measurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0205318
UMLS CUI [1,3]
C0302353
UMLS CUI [2,1]
C1704258
UMLS CUI [2,2]
C0205318
UMLS CUI [2,3]
C0337443
UMLS CUI [3,1]
C1704258
UMLS CUI [3,2]
C0205318
UMLS CUI [3,3]
C0201925
UMLS CUI [4,1]
C1704258
UMLS CUI [4,2]
C0205318
UMLS CUI [4,3]
C0373675
11. evidence of uncontrolled active infection
Beschreibung

Communicable Disease Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
12. evidence of significant medical condition or laboratory finding which, in the opinion of the investigator, makes it undesirable for the patient to participate in the trial
Beschreibung

Medical condition Study Subject Participation Status Unfavorable | Laboratory test finding Study Subject Participation Status Unfavorable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C3640815
UMLS CUI [2,1]
C0587081
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C3640815
13. subjects unable to lie flat or fit into the scanner
Beschreibung

ID.30

Datentyp

boolean

14. patients on occupational monitoring for radiation exposure
Beschreibung

ID.31

Datentyp

boolean

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Ähnliche Modelle

Eligibility Breast Neoplasms NCT01662726

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. written informed consent to participate in the trial
boolean
C0021430 (UMLS CUI [1])
Age
Item
2. 18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Oestrogen receptor positive breast cancer
Item
3. histologically confirmed er +ve breast cancer (allred ≥ 3)
boolean
C2938924 (UMLS CUI [1])
HER2 Status Any
Item
4. any her2 status
boolean
C1512413 (UMLS CUI [1,1])
C1552551 (UMLS CUI [1,2])
Neoplasm Longest Diameter Ultrasonography
Item
5. tumour measuring ≥ 15mm in longest diameter on ultrasound (us) examination
boolean
C0027651 (UMLS CUI [1,1])
C0552406 (UMLS CUI [1,2])
C0041618 (UMLS CUI [1,3])
Postmenopausal state
Item
6. postmenopausal women as defined by any one of the following criteria:
boolean
C0232970 (UMLS CUI [1])
Amenorrhea Duration | Uterus Intact
Item
amenorrhoea > 12 months at the time of diagnosis and an intact uterus or,
boolean
C0002453 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0042149 (UMLS CUI [2,1])
C0205266 (UMLS CUI [2,2])
Bilateral oophorectomy
Item
prior bilateral oophorectomy or,
boolean
C0278321 (UMLS CUI [1])
Follicle stimulating hormone measurement Consistent with Postmenopausal state | Gender | Age | Hysterectomy
Item
fsh levels within the postmenopausal range (as per local practice) in women aged < 55years who have undergone hysterectomy or,
boolean
C0202022 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0232970 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C0020699 (UMLS CUI [4])
Follicle stimulating hormone measurement Consistent with Postmenopausal state | Gender | Age | Hormone replacement therapy
Item
fsh levels within the postmenopausal range (as per local practice) in women aged < 55 years who have been on hormone replacement therapy (hrt) within the last 12 months and are therefore not amenorrhoeic
boolean
C0202022 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0232970 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C0282402 (UMLS CUI [4])
ECOG performance status
Item
7. eastern cooperative oncology group (ecog) performance status 0, 1 or 2
boolean
C1520224 (UMLS CUI [1])
Bone Marrow function | Hemoglobin measurement | White Blood Cell Count procedure | Platelet Count measurement | Renal function | Creatinine measurement, serum | Liver function | Serum total bilirubin measurement | Exception Gilbert Disease | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Alkaline phosphatase measurement
Item
8. adequate bone marrow function defined by hb ≥ 10 g/dl, wbc ≥ 3.0 x109, plt ≥ 100 x109/l. adequate renal function defined by a serum creatinine ≤ 1.5 x uln. adequate liver function defined by total bilirubin ≤ 1.5 uln (patients with gilbert's syndrome exempted), either alt or ast ≤ 1.5 uln and alp ≤ 1.5 uln
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0518015 (UMLS CUI [2])
C0023508 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
C0232804 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
C0232741 (UMLS CUI [7])
C1278039 (UMLS CUI [8])
C1705847 (UMLS CUI [9,1])
C0017551 (UMLS CUI [9,2])
C0201836 (UMLS CUI [10])
C0201899 (UMLS CUI [11])
C0201850 (UMLS CUI [12])
Item Group
C0680251 (UMLS CUI)
Locally advanced breast cancer Inoperable
Item
1. locally advanced/inoperable breast cancer
boolean
C3495949 (UMLS CUI [1,1])
C0205187 (UMLS CUI [1,2])
Neoplasm Metastasis
Item
2. clinical evidence of metastatic disease
boolean
C0027627 (UMLS CUI [1])
Diffuse tumor configuration | Inflammatory carcinoma
Item
3. diffuse or inflammatory tumours
boolean
C1276429 (UMLS CUI [1])
C0334385 (UMLS CUI [2])
Invasive cancer | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated
Item
4. any history of invasive malignancy within 5 years of starting study treatment (other than adequately treated basal cell carcinoma or squamous cell carcinoma of the skin and cervical carcinoma in situ)
boolean
C0677898 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
Bleeding tendency | Activated Partial Thromboplastin Time measurement | Prothrombin time assay
Item
5. evidence of bleeding diathesis and ptt and pt ≤ 1.5 x upper limit of normal
boolean
C1458140 (UMLS CUI [1])
C0030605 (UMLS CUI [2])
C0033707 (UMLS CUI [3])
Hormone replacement therapy | Pharmaceutical Preparations Containing Estrogens | Supplements Containing Estrogens | Vaginal estrogens | Phytoestrogens
Item
6. concomitant use (defined as use within 4 weeks prior to entry) of hrt or any other oestrogen-containing medication or supplement (including vaginal oestrogens and phytoestrogens)
boolean
C0282402 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0332256 (UMLS CUI [2,2])
C0014939 (UMLS CUI [2,3])
C0242295 (UMLS CUI [3,1])
C0332256 (UMLS CUI [3,2])
C0014939 (UMLS CUI [3,3])
C1875126 (UMLS CUI [4])
C0071011 (UMLS CUI [5])
Estrogen implants
Item
7. previous use of oestrogen implants at any time.
boolean
C0848157 (UMLS CUI [1])
Use of
Item
8. concomitant use of:
boolean
C1524063 (UMLS CUI [1])
Rifampin | CYP2C Inducer | CYP3A Inducers | Rifabutin | rifapentine | Carbamazepine | Phenobarbital | Phenytoin | ST. JOHN'S WORT EXTRACT
Item
rifampicin and other cyp2c and 3a inducers such as rifabutin, rifapentine, carbamazepine, phenobarbital, phenytoin and st. john's wort
boolean
C0035608 (UMLS CUI [1])
C0910126 (UMLS CUI [2,1])
C3898767 (UMLS CUI [2,2])
C3850044 (UMLS CUI [3])
C0140575 (UMLS CUI [4])
C0073372 (UMLS CUI [5])
C0006949 (UMLS CUI [6])
C0031412 (UMLS CUI [7])
C0031507 (UMLS CUI [8])
C0813171 (UMLS CUI [9])
Carbonic Anhydrase Inhibitors Systemic
Item
systemic carbonic anhydrase inhibitors
boolean
C0007036 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
Criteria cardiac
Item
9. any of the following cardiac criteria:
boolean
C0243161 (UMLS CUI [1,1])
C0018787 (UMLS CUI [1,2])
QTcF Resting mean | ECG Quantity
Item
mean resting corrected qt interval (qtcf) > 450 ms obtained from 3 electrocardiograms (ecgs)
boolean
C1882513 (UMLS CUI [1,1])
C0035253 (UMLS CUI [1,2])
C0444504 (UMLS CUI [1,3])
C0013798 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Resting ECG Changes Abnormal | ECG complete left bundle branch block | Complete atrioventricular block
Item
any clinically important abnormalities in rhythm, conduction or morphology of resting ecg e.g. complete left bundle branch block, third degree heart block
boolean
C3897699 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C4518442 (UMLS CUI [2])
C0151517 (UMLS CUI [3])
Factor At risk Prolonged QTc interval | Factor At risk Cardiac Arrhythmia | Heart failure | Hypokalemia | Congenital long QT syndrome | Unexplained sudden death Relationship Age | Pharmaceutical Preparations Causing Prolonged QT interval
Item
any factors that increase the risk of qtc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long qt syndrome, family history of long qt syndrome or unexplained sudden death under 40 years of age or any concomitant medication known to prolong the qt interval
boolean
C1521761 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C1560305 (UMLS CUI [1,3])
C1521761 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C0003811 (UMLS CUI [2,3])
C0018801 (UMLS CUI [3])
C0020621 (UMLS CUI [4])
C1141890 (UMLS CUI [5])
C0520806 (UMLS CUI [6,1])
C0439849 (UMLS CUI [6,2])
C0001779 (UMLS CUI [6,3])
C0013227 (UMLS CUI [7,1])
C0678227 (UMLS CUI [7,2])
C0151878 (UMLS CUI [7,3])
Abnormality Uncontrolled Serum potassium measurement | Abnormality Uncontrolled Sodium measurement | Abnormality Uncontrolled Calcium measurement | Abnormality Uncontrolled Magnesium measurement
Item
10. uncontrolled abnormalities of serum potassium, sodium, calcium or magnesium levels
boolean
C1704258 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0302353 (UMLS CUI [1,3])
C1704258 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0337443 (UMLS CUI [2,3])
C1704258 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0201925 (UMLS CUI [3,3])
C1704258 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C0373675 (UMLS CUI [4,3])
Communicable Disease Uncontrolled
Item
11. evidence of uncontrolled active infection
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Medical condition Study Subject Participation Status Unfavorable | Laboratory test finding Study Subject Participation Status Unfavorable
Item
12. evidence of significant medical condition or laboratory finding which, in the opinion of the investigator, makes it undesirable for the patient to participate in the trial
boolean
C3843040 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C3640815 (UMLS CUI [1,3])
C0587081 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C3640815 (UMLS CUI [2,3])
ID.30
Item
13. subjects unable to lie flat or fit into the scanner
boolean
ID.31
Item
14. patients on occupational monitoring for radiation exposure
boolean
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