ID

43641

Description

Safety and Pharmacokinetics of Orally Administered Gallium Maltolate in Various Refractory Malignancies; ODM derived from: https://clinicaltrials.gov/show/NCT00050687

Link

https://clinicaltrials.gov/show/NCT00050687

Keywords

  1. 6/4/16 6/4/16 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0

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Eligibility Prostatic Neoplasms NCT00050687

Eligibility Prostatic Neoplasms NCT00050687

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with hormone refractory prostate cancer, refractory multiple myeloma, refractory bladder cancer, or malignant lymphoma;
Description

hormone refractory prostate cancer

Data type

boolean

Alias
UMLS CUI [1]
C1328504
UMLS CUI [2]
C0278620
UMLS CUI [3]
C0024299
life expectancy of ≥6 months,
Description

life expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
zubrod performance status of ≤2,
Description

zubrod performance status

Data type

boolean

Alias
UMLS CUI [1]
C3714786
adequate bone marrow function, renal function, liver function and pulmonary function;
Description

adequate bone marrow function

Data type

boolean

Alias
UMLS CUI [1]
C0005953
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
UMLS CUI [4]
C0231921
age ≥ 18 years;
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
willing and able to give informed consent; and
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
effective contraceptive use or non child-bearing potential.
Description

contraceptive use

Data type

boolean

Alias
UMLS CUI [1]
C1999124
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
10% weight loss in the previous 3 months;
Description

Weight loss

Data type

boolean

Alias
UMLS CUI [1]
C1262477
active serious infection not controlled by antibiotics;
Description

active serious infection

Data type

boolean

Alias
UMLS CUI [1]
C0009450
initiation of bisphosphonates treatment within 30 days;
Description

bisphosphonates

Data type

boolean

Alias
UMLS CUI [1]
C0012544
participation in other research study within 30 days;
Description

participation in other research

Data type

boolean

Alias
UMLS CUI [1]
C2348568
uncontrolled brain metastasis,
Description

brain metastasis

Data type

boolean

Alias
UMLS CUI [1]
C0220650
prior intrathecal chemotherapy or whole-brain radiotherapy,
Description

intrathecal chemotherapy or whole-brain radiotherapy

Data type

boolean

Alias
UMLS CUI [1]
C1517560
UMLS CUI [2]
C1520143
inability to comply with protocol or undergo specified tests;
Description

compliance behavior

Data type

boolean

Alias
UMLS CUI [1]
C1321605
other active malignancy;
Description

other malignancy

Data type

boolean

Alias
UMLS CUI [1]
C0006826
optic neuritis, and
Description

optic neuritis

Data type

boolean

Alias
UMLS CUI [1]
C0029134
routine use of diuretics (for initial phase of study only).
Description

diuretics

Data type

boolean

Alias
UMLS CUI [1]
C0012798

Similar models

Eligibility Prostatic Neoplasms NCT00050687

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
hormone refractory prostate cancer
Item
patients with hormone refractory prostate cancer, refractory multiple myeloma, refractory bladder cancer, or malignant lymphoma;
boolean
C1328504 (UMLS CUI [1])
C0278620 (UMLS CUI [2])
C0024299 (UMLS CUI [3])
life expectancy
Item
life expectancy of ≥6 months,
boolean
C0023671 (UMLS CUI [1])
zubrod performance status
Item
zubrod performance status of ≤2,
boolean
C3714786 (UMLS CUI [1])
adequate bone marrow function
Item
adequate bone marrow function, renal function, liver function and pulmonary function;
boolean
C0005953 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
C0231921 (UMLS CUI [4])
age
Item
age ≥ 18 years;
boolean
C0001779 (UMLS CUI [1])
informed consent
Item
willing and able to give informed consent; and
boolean
C0021430 (UMLS CUI [1])
contraceptive use
Item
effective contraceptive use or non child-bearing potential.
boolean
C1999124 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Weight loss
Item
10% weight loss in the previous 3 months;
boolean
C1262477 (UMLS CUI [1])
active serious infection
Item
active serious infection not controlled by antibiotics;
boolean
C0009450 (UMLS CUI [1])
bisphosphonates
Item
initiation of bisphosphonates treatment within 30 days;
boolean
C0012544 (UMLS CUI [1])
participation in other research
Item
participation in other research study within 30 days;
boolean
C2348568 (UMLS CUI [1])
brain metastasis
Item
uncontrolled brain metastasis,
boolean
C0220650 (UMLS CUI [1])
intrathecal chemotherapy or whole-brain radiotherapy
Item
prior intrathecal chemotherapy or whole-brain radiotherapy,
boolean
C1517560 (UMLS CUI [1])
C1520143 (UMLS CUI [2])
compliance behavior
Item
inability to comply with protocol or undergo specified tests;
boolean
C1321605 (UMLS CUI [1])
other malignancy
Item
other active malignancy;
boolean
C0006826 (UMLS CUI [1])
optic neuritis
Item
optic neuritis, and
boolean
C0029134 (UMLS CUI [1])
diuretics
Item
routine use of diuretics (for initial phase of study only).
boolean
C0012798 (UMLS CUI [1])

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