ID

44437

Description

Detection of Benign and Malignant Thyroid and Breast Tumors by Fourier Transform Infrared Spectrometry; ODM derived from: https://clinicaltrials.gov/show/NCT01668238 Sponsor: XU Zhi Collaborator: Peking University

Link

https://clinicaltrials.gov/show/NCT01668238

Keywords

Versions (4)
  1. 8/26/18 8/26/18 -
  2. 8/27/18 8/27/18 - Sarah Riepenhausen
  3. 8/31/18 8/31/18 -
  4. 9/20/21 9/20/21 -
Copyright Holder

XU Zhi, Professor, Peking University

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Thyroid and Breast Tumors NCT01668238

English

Eligibility Thyroid and Breast Tumors NCT01668238

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
patients undergoing thyroid and breast tumor surgery.
Description

Thyroid and breast tumor surgery

Data type

boolean

Alias
UMLS CUI [1,1]
C0040136
UMLS CUI [1,2]
C0543467
UMLS CUI [2,1]
C1458155
UMLS CUI [2,2]
C0543467
informed consent form is signed.
Description

Signed informed consent form

Data type

boolean

Alias
UMLS CUI [1]
C0021430
an optical fibre and atr probe can be applied to the operation field in process of open or laparoscopic surgery.
Description

Application of optical fibre and atr probe to the operation field

Data type

boolean

Alias
UMLS CUI [1,1]
C0182400
UMLS CUI [1,2]
C0260249
UMLS CUI [1,3]
C3898703
UMLS CUI [1,4]
C1706839
male or female between the age of 18 to 80.
Description

Gender and age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
patients can tolerate surgery and with non of these diseases: severe heart failure, liver failure, renal failure or respiratory failure.
Description

Ability to undergo surgery and lack of severe concomitant diseases

Data type

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C0543467
UMLS CUI [2,1]
C1298908
UMLS CUI [2,2]
C0018801
UMLS CUI [2,3]
C0205082
UMLS CUI [3,1]
C1298908
UMLS CUI [3,2]
C0085605
UMLS CUI [3,3]
C0205082
UMLS CUI [4,1]
C1298908
UMLS CUI [4,2]
C0035078
UMLS CUI [4,3]
C0205082
UMLS CUI [5,1]
C1298908
UMLS CUI [5,2]
C1145670
UMLS CUI [5,3]
C0205082
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
a state of emergency, such as gastrointestinal bleeding, perforation, or acute obstruction.
Description

State of emergency

Data type

boolean

Alias
UMLS CUI [1]
C0013956
UMLS CUI [2]
C0017181
UMLS CUI [3]
C0151664
UMLS CUI [4,1]
C0021843
UMLS CUI [4,2]
C0205178
unstable situation in operation, such as anesthetic accidents or intraoperative cerebral vascular accident.
Description

instability during operation

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C3843040
UMLS CUI [1,3]
C0443343
UMLS CUI [2,1]
C0002932
UMLS CUI [2,2]
C1551358
UMLS CUI [3,1]
C0456904
UMLS CUI [3,2]
C0038454
from investigators' perspective patients do not suitable for the study
Description

Unsuitability for the study from the investigators' perspective

Data type

boolean

Alias
UMLS CUI [1,1]
C1512714
UMLS CUI [1,2]
C1710101
UMLS CUI [1,3]
C0871010
Healthy Volunteers Inclusion Criteria
Description

Healthy Volunteers Inclusion Criteria

Alias
UMLS CUI-1
C1512693
UMLS CUI-2
C1708335
informed consent form is signed.
Description

Signed informed consent form

Data type

boolean

Alias
UMLS CUI [1]
C0021430
no thyroid or breast cancer according to the professional judgment of general surgeon.
Description

Clinical exclusion of thyroid or breast cancer

Data type

boolean

Alias
UMLS CUI [1,1]
C1298908
UMLS CUI [1,2]
C0007115
UMLS CUI [2,1]
C1298908
UMLS CUI [2,2]
C0678222
no thyroid or breast disease according to thyroid function tests and breast type b-ultrasonic test within 3 months.
Description

No findings of thyroid or breast diseases by function tests and ultrasonic examination

Data type

boolean

Alias
UMLS CUI [1]
C0740378
UMLS CUI [2,1]
C0080264
UMLS CUI [2,2]
C0006141
UMLS CUI [2,3]
C0205307
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Similar models

Eligibility Thyroid and Breast Tumors NCT01668238

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Thyroid and breast tumor surgery
Item
patients undergoing thyroid and breast tumor surgery.
boolean
C0040136 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C1458155 (UMLS CUI [2,1])
C0543467 (UMLS CUI [2,2])
Signed informed consent form
Item
informed consent form is signed.
boolean
C0021430 (UMLS CUI [1])
Application of optical fibre and atr probe to the operation field
Item
an optical fibre and atr probe can be applied to the operation field in process of open or laparoscopic surgery.
boolean
C0182400 (UMLS CUI [1,1])
C0260249 (UMLS CUI [1,2])
C3898703 (UMLS CUI [1,3])
C1706839 (UMLS CUI [1,4])
Gender and age
Item
male or female between the age of 18 to 80.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Ability to undergo surgery and lack of severe concomitant diseases
Item
patients can tolerate surgery and with non of these diseases: severe heart failure, liver failure, renal failure or respiratory failure.
boolean
C0085732 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C1298908 (UMLS CUI [2,1])
C0018801 (UMLS CUI [2,2])
C0205082 (UMLS CUI [2,3])
C1298908 (UMLS CUI [3,1])
C0085605 (UMLS CUI [3,2])
C0205082 (UMLS CUI [3,3])
C1298908 (UMLS CUI [4,1])
C0035078 (UMLS CUI [4,2])
C0205082 (UMLS CUI [4,3])
C1298908 (UMLS CUI [5,1])
C1145670 (UMLS CUI [5,2])
C0205082 (UMLS CUI [5,3])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
State of emergency
Item
a state of emergency, such as gastrointestinal bleeding, perforation, or acute obstruction.
boolean
C0013956 (UMLS CUI [1])
C0017181 (UMLS CUI [2])
C0151664 (UMLS CUI [3])
C0021843 (UMLS CUI [4,1])
C0205178 (UMLS CUI [4,2])
instability during operation
Item
unstable situation in operation, such as anesthetic accidents or intraoperative cerebral vascular accident.
boolean
C0543467 (UMLS CUI [1,1])
C3843040 (UMLS CUI [1,2])
C0443343 (UMLS CUI [1,3])
C0002932 (UMLS CUI [2,1])
C1551358 (UMLS CUI [2,2])
C0456904 (UMLS CUI [3,1])
C0038454 (UMLS CUI [3,2])
Unsuitability for the study from the investigators' perspective
Item
from investigators' perspective patients do not suitable for the study
boolean
C1512714 (UMLS CUI [1,1])
C1710101 (UMLS CUI [1,2])
C0871010 (UMLS CUI [1,3])
Item Group
Healthy Volunteers Inclusion Criteria
C1512693 (UMLS CUI-1)
C1708335 (UMLS CUI-2)
Signed informed consent form
Item
informed consent form is signed.
boolean
C0021430 (UMLS CUI [1])
Clinical exclusion of thyroid or breast cancer
Item
no thyroid or breast cancer according to the professional judgment of general surgeon.
boolean
C1298908 (UMLS CUI [1,1])
C0007115 (UMLS CUI [1,2])
C1298908 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
No findings of thyroid or breast diseases by function tests and ultrasonic examination
Item
no thyroid or breast disease according to thyroid function tests and breast type b-ultrasonic test within 3 months.
boolean
C0740378 (UMLS CUI [1])
C0080264 (UMLS CUI [2,1])
C0006141 (UMLS CUI [2,2])
C0205307 (UMLS CUI [2,3])
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