ID

31662

Description

Assessment of Amide-Proton-Transfer MRI in Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01705028

Link

https://clinicaltrials.gov/show/NCT01705028

Keywords

  1. 9/18/18 9/18/18 -
  2. 9/18/18 9/18/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 18, 2018

DOI

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License

Creative Commons BY 4.0

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Eligibility Prostate Cancer NCT01705028

Eligibility Prostate Cancer NCT01705028

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with known or suspected prostate disease based on clinical data will be included in the study.
Description

Prostatic Disease | Prostatic Disease Suspected

Data type

boolean

Alias
UMLS CUI [1]
C0033575
UMLS CUI [2,1]
C0033575
UMLS CUI [2,2]
C0750491
patients with intermediate to high grade prostate cancer (gleason's score >/=7 and psa of >10ng/dl) will be referred from the outpatient clinics after evaluation by the treating physicians.
Description

Prostate carcinoma Intermediate Grade | Prostate carcinoma Severe | Gleason score | Prostate specific antigen measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0600139
UMLS CUI [1,2]
C1512863
UMLS CUI [2,1]
C0600139
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C3203027
UMLS CUI [4]
C0201544
male
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
patients must have an estimated glomerular filtration rate of ≥ 30 ml/min/1.73m2 within six weeks of the mri to be included in the study.
Description

Estimated Glomerular Filtration Rate

Data type

boolean

Alias
UMLS CUI [1]
C3811844
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects with any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators
Description

Implants | Cochlear Implants | Artificial cardiac pacemaker | Neurostimulator | Infusion Pump

Data type

boolean

Alias
UMLS CUI [1]
C0021102
UMLS CUI [2]
C0009199
UMLS CUI [3]
C0030163
UMLS CUI [4]
C0582124
UMLS CUI [5]
C0021436
subjects with any type of ferromagnetic bioimplant that could potentially be displaced or damaged.
Description

Implant Magnetic metal

Data type

boolean

Alias
UMLS CUI [1,1]
C0021102
UMLS CUI [1,2]
C0439876
subjects that have vascular or aneurysm clips, or metallic staples from a surgical procedure.
Description

Vascular clip | Aneurysm clip | Staple, Surgical

Data type

boolean

Alias
UMLS CUI [1]
C0179992
UMLS CUI [2]
C0179977
UMLS CUI [3]
C0524724
subjects with permanent tattoo eye liner (may contain metallic coloring).
Description

Tattoo Eye liner

Data type

boolean

Alias
UMLS CUI [1,1]
C1366940
UMLS CUI [1,2]
C0304641
subjects that may have shrapnel imbedded in their bodies, such as from war wounds, metal workers and machinists (metallic fragments in or near eyes), severe auto accident victims.
Description

Shrapnel Body | War Shrapnel wound | Metal worker | Metal foreign body in eye region | Victim Automobile accident Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0522670
UMLS CUI [1,2]
C0460148
UMLS CUI [2,1]
C0043027
UMLS CUI [2,2]
C2204169
UMLS CUI [3]
C0402937
UMLS CUI [4]
C0562528
UMLS CUI [5,1]
C0680681
UMLS CUI [5,2]
C1367973
UMLS CUI [5,3]
C0205082
subjects that exhibit noticeable anxiety and/or claustrophobia.
Description

Anxiety | Claustrophobia

Data type

boolean

Alias
UMLS CUI [1]
C0003467
UMLS CUI [2]
C0008909
subjects who cannot adhere to the experimental protocols for any reason, or have an inability to communicate with the researcher.
Description

Protocol Compliance Unable | Lacking Able to communicate Researcher

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0332268
UMLS CUI [2,2]
C2364293
UMLS CUI [2,3]
C0035173
subjects who have cardiac or known circulatory impairment, and/or the inability to perspire (poor thermoregulatory function).
Description

Impaired cardiac function | Impaired circulatory system function | Perspiration Unable | Thermoregulatory functions Poor

Data type

boolean

Alias
UMLS CUI [1]
C0232166
UMLS CUI [2]
C4509001
UMLS CUI [3,1]
C0038990
UMLS CUI [3,2]
C1299582
UMLS CUI [4,1]
C2371150
UMLS CUI [4,2]
C0542537
subjects with an estimated glomerular filtration rate of < 30 ml/min/1.73m2 within six weeks of the mri.
Description

Estimated Glomerular Filtration Rate

Data type

boolean

Alias
UMLS CUI [1]
C3811844
acute or chronic severe renal insufficiency (estimated glomerular filtration
Description

Renal Insufficiency Severe | Chronic Kidney Insufficiency Severe | Estimated Glomerular Filtration Rate

Data type

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0403447
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C3811844
acute renal dysfunction due to the hepato-renal syndrome or in the perioperative liver transplantation period
Description

Renal dysfunction Due to Hepatorenal Syndrome | Renal dysfunction | Transplantation of liver Perioperative Period

Data type

boolean

Alias
UMLS CUI [1,1]
C3279454
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0019212
UMLS CUI [2]
C3279454
UMLS CUI [3,1]
C0023911
UMLS CUI [3,2]
C2712230

Similar models

Eligibility Prostate Cancer NCT01705028

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Prostatic Disease | Prostatic Disease Suspected
Item
patients with known or suspected prostate disease based on clinical data will be included in the study.
boolean
C0033575 (UMLS CUI [1])
C0033575 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
Prostate carcinoma Intermediate Grade | Prostate carcinoma Severe | Gleason score | Prostate specific antigen measurement
Item
patients with intermediate to high grade prostate cancer (gleason's score >/=7 and psa of >10ng/dl) will be referred from the outpatient clinics after evaluation by the treating physicians.
boolean
C0600139 (UMLS CUI [1,1])
C1512863 (UMLS CUI [1,2])
C0600139 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C3203027 (UMLS CUI [3])
C0201544 (UMLS CUI [4])
Gender
Item
male
boolean
C0079399 (UMLS CUI [1])
Estimated Glomerular Filtration Rate
Item
patients must have an estimated glomerular filtration rate of ≥ 30 ml/min/1.73m2 within six weeks of the mri to be included in the study.
boolean
C3811844 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Implants | Cochlear Implants | Artificial cardiac pacemaker | Neurostimulator | Infusion Pump
Item
subjects with any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators
boolean
C0021102 (UMLS CUI [1])
C0009199 (UMLS CUI [2])
C0030163 (UMLS CUI [3])
C0582124 (UMLS CUI [4])
C0021436 (UMLS CUI [5])
Implant Magnetic metal
Item
subjects with any type of ferromagnetic bioimplant that could potentially be displaced or damaged.
boolean
C0021102 (UMLS CUI [1,1])
C0439876 (UMLS CUI [1,2])
Vascular clip | Aneurysm clip | Staple, Surgical
Item
subjects that have vascular or aneurysm clips, or metallic staples from a surgical procedure.
boolean
C0179992 (UMLS CUI [1])
C0179977 (UMLS CUI [2])
C0524724 (UMLS CUI [3])
Tattoo Eye liner
Item
subjects with permanent tattoo eye liner (may contain metallic coloring).
boolean
C1366940 (UMLS CUI [1,1])
C0304641 (UMLS CUI [1,2])
Shrapnel Body | War Shrapnel wound | Metal worker | Metal foreign body in eye region | Victim Automobile accident Severe
Item
subjects that may have shrapnel imbedded in their bodies, such as from war wounds, metal workers and machinists (metallic fragments in or near eyes), severe auto accident victims.
boolean
C0522670 (UMLS CUI [1,1])
C0460148 (UMLS CUI [1,2])
C0043027 (UMLS CUI [2,1])
C2204169 (UMLS CUI [2,2])
C0402937 (UMLS CUI [3])
C0562528 (UMLS CUI [4])
C0680681 (UMLS CUI [5,1])
C1367973 (UMLS CUI [5,2])
C0205082 (UMLS CUI [5,3])
Anxiety | Claustrophobia
Item
subjects that exhibit noticeable anxiety and/or claustrophobia.
boolean
C0003467 (UMLS CUI [1])
C0008909 (UMLS CUI [2])
Protocol Compliance Unable | Lacking Able to communicate Researcher
Item
subjects who cannot adhere to the experimental protocols for any reason, or have an inability to communicate with the researcher.
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0332268 (UMLS CUI [2,1])
C2364293 (UMLS CUI [2,2])
C0035173 (UMLS CUI [2,3])
Impaired cardiac function | Impaired circulatory system function | Perspiration Unable | Thermoregulatory functions Poor
Item
subjects who have cardiac or known circulatory impairment, and/or the inability to perspire (poor thermoregulatory function).
boolean
C0232166 (UMLS CUI [1])
C4509001 (UMLS CUI [2])
C0038990 (UMLS CUI [3,1])
C1299582 (UMLS CUI [3,2])
C2371150 (UMLS CUI [4,1])
C0542537 (UMLS CUI [4,2])
Estimated Glomerular Filtration Rate
Item
subjects with an estimated glomerular filtration rate of < 30 ml/min/1.73m2 within six weeks of the mri.
boolean
C3811844 (UMLS CUI [1])
Renal Insufficiency Severe | Chronic Kidney Insufficiency Severe | Estimated Glomerular Filtration Rate
Item
acute or chronic severe renal insufficiency (estimated glomerular filtration
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0403447 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C3811844 (UMLS CUI [3])
Renal dysfunction Due to Hepatorenal Syndrome | Renal dysfunction | Transplantation of liver Perioperative Period
Item
acute renal dysfunction due to the hepato-renal syndrome or in the perioperative liver transplantation period
boolean
C3279454 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0019212 (UMLS CUI [1,3])
C3279454 (UMLS CUI [2])
C0023911 (UMLS CUI [3,1])
C2712230 (UMLS CUI [3,2])

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