ID

31660

Descripción

3-Tesla MRI in Finding Tumors in Patients With Known or Suspected Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01653093

Link

https://clinicaltrials.gov/show/NCT01653093

Palabras clave

Versiones (2)
  1. 18/9/18 18/9/18 -
  2. 18/9/18 18/9/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

18 de septiembre de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT01653093

Inglés

Eligibility Prostate Cancer NCT01653093

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with known or suspected prostate disease based on clinical data will be included in the study; patients with intermediate to high grade prostate cancer (gleason's score >= 7 and prostate-specific antigen [psa] of > 10ng/dl) will be referred from the outpatient clinics after evaluation by the treating physicians
Descripción

Prostatic Disease | Prostatic Disease Suspected | Prostate carcinoma Intermediate Grade | Prostate carcinoma Severe | Gleason score | Prostate specific antigen measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0033575
UMLS CUI [2,1]
C0033575
UMLS CUI [2,2]
C0750491
UMLS CUI [3,1]
C0600139
UMLS CUI [3,2]
C1512863
UMLS CUI [4,1]
C0600139
UMLS CUI [4,2]
C0205082
UMLS CUI [5]
C3203027
UMLS CUI [6]
C0201544
written informed consent will be signed by the patients before the mri based on the guidelines approved by the ohio state university institutional review board
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
patients must have an estimated glomerular filtration rate of >= 30 ml/min/1.73m^2 within six weeks of the mri to be included in the study
Descripción

Estimated Glomerular Filtration Rate

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3811844
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulators, electronic infusion pumps, etc.)
Descripción

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

Tipo de datos

boolean

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

Implant Magnetic metal

Tipo de datos

boolean

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

Vascular clip | Aneurysm clip | Staple, Surgical

Tipo de datos

boolean

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

Tattoo Eye liner

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1366940
UMLS CUI [1,2]
C0304641
patients 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
Descripción

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

Tipo de datos

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
patients that exhibit noticeable anxiety and/or claustrophobia
Descripción

Anxiety | Claustrophobia

Tipo de datos

boolean

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

Protocol Compliance Unable | Lacking Able to communicate Researcher

Tipo de datos

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
patients who have cardiac or known circulatory impairment, and/or the inability to perspire (poor thermoregulatory function)
Descripción

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

Tipo de datos

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
patients with an estimated glomerular filtration rate of < 30 ml/min/1.73m^2 within six weeks of the mri
Descripción

Estimated Glomerular Filtration Rate

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3811844
acute or chronic severe renal insufficiency (estimated glomerular filtration rate < 30 ml/min/1.73m^2)
Descripción

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

Tipo de datos

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
Descripción

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

Tipo de datos

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
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Similar models

Eligibility Prostate Cancer NCT01653093

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Prostatic Disease | Prostatic Disease Suspected | Prostate carcinoma Intermediate Grade | Prostate carcinoma Severe | Gleason score | Prostate specific antigen measurement
Item
patients with known or suspected prostate disease based on clinical data will be included in the study; patients with intermediate to high grade prostate cancer (gleason's score >= 7 and prostate-specific antigen [psa] of > 10ng/dl) will be referred from the outpatient clinics after evaluation by the treating physicians
boolean
C0033575 (UMLS CUI [1])
C0033575 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0600139 (UMLS CUI [3,1])
C1512863 (UMLS CUI [3,2])
C0600139 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C3203027 (UMLS CUI [5])
C0201544 (UMLS CUI [6])
Informed Consent
Item
written informed consent will be signed by the patients before the mri based on the guidelines approved by the ohio state university institutional review board
boolean
C0021430 (UMLS CUI [1])
Estimated Glomerular Filtration Rate
Item
patients must have an estimated glomerular filtration rate of >= 30 ml/min/1.73m^2 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
patients with any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulators, electronic infusion pumps, etc.)
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
patients 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
patients 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
patients 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
patients 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
patients 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
patients 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
patients 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
patients with an estimated glomerular filtration rate of < 30 ml/min/1.73m^2 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 rate < 30 ml/min/1.73m^2)
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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