ID

28243

Description

Ursodiol, Combination Chemotherapy, and Bevacizumab in Treating Patients With Stage IV Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00873275

Link

https://clinicaltrials.gov/show/NCT00873275

Keywords

Versions (1)
  1. 12/29/17 12/29/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 29, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Colorectal Cancer NCT00873275

English

Eligibility Colorectal Cancer NCT00873275

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with advanced, biopsy proven metastatic colorectal cancer
Description

Colorectal cancer metastatic Advanced

Data type

boolean

Alias
UMLS CUI [1,1]
C0948380
UMLS CUI [1,2]
C0205179
karnofsky performance status >= 80
Description

Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
prior therapy completed at least 3 weeks before protocol treatment initiation with recovery from any side-effects
Description

Prior Therapy Completed | Side effects Patient recovered

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0205197
UMLS CUI [2,1]
C0879626
UMLS CUI [2,2]
C1115804
serum albumin and prealbumin within normal limits
Description

Serum albumin normal | Serum prealbumin Normal

Data type

boolean

Alias
UMLS CUI [1]
C0580492
UMLS CUI [2,1]
C0518013
UMLS CUI [2,2]
C0205307
alanine aminotransferase (alt) within 3 x upper limit of normal
Description

Alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201836
alkaline phosphatase within 3 x upper limit of normal
Description

Alkaline phosphatase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201850
serum bilirubin within normal limits
Description

Serum bilirubin normal

Data type

boolean

Alias
UMLS CUI [1]
C0428443
absolute neutrophil count >= 1500/ul
Description

Absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0948762
serum creatinine within 1.5 x upper limit of normal
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
ability to understand and sign an institutional review board (irb) approved informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
ability to use appropriate contraception and no evidence of pregnancy in female patients of reproductive potential
Description

Contraceptive methods | Childbearing Potential Pregnancy Absent

Data type

boolean

Alias
UMLS CUI [1]
C0700589
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0032961
UMLS CUI [2,3]
C0332197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
significant medical or psychiatric condition that would make treatment unsafe
Description

Medical condition Therapeutic procedure At risk | Mental disorders Therapeutic procedure At risk

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C1444641
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C1444641
use of systemic steroids use within 7 days from start of trial
Description

Systemic steroids

Data type

boolean

Alias
UMLS CUI [1]
C2825233
nursing women
Description

Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0006147
patients unable to comply with protocol related studies and follow up
Description

Protocol Compliance Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
weight loss of greater than 10% in the last 6 months
Description

Weight decreased Percentage

Data type

boolean

Alias
UMLS CUI [1,1]
C1262477
UMLS CUI [1,2]
C0439165
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Similar models

Eligibility Colorectal Cancer NCT00873275

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Colorectal cancer metastatic Advanced
Item
patients with advanced, biopsy proven metastatic colorectal cancer
boolean
C0948380 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
Karnofsky Performance Status
Item
karnofsky performance status >= 80
boolean
C0206065 (UMLS CUI [1])
Prior Therapy Completed | Side effects Patient recovered
Item
prior therapy completed at least 3 weeks before protocol treatment initiation with recovery from any side-effects
boolean
C1514463 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0879626 (UMLS CUI [2,1])
C1115804 (UMLS CUI [2,2])
Serum albumin normal | Serum prealbumin Normal
Item
serum albumin and prealbumin within normal limits
boolean
C0580492 (UMLS CUI [1])
C0518013 (UMLS CUI [2,1])
C0205307 (UMLS CUI [2,2])
Alanine aminotransferase measurement
Item
alanine aminotransferase (alt) within 3 x upper limit of normal
boolean
C0201836 (UMLS CUI [1])
Alkaline phosphatase measurement
Item
alkaline phosphatase within 3 x upper limit of normal
boolean
C0201850 (UMLS CUI [1])
Serum bilirubin normal
Item
serum bilirubin within normal limits
boolean
C0428443 (UMLS CUI [1])
Absolute neutrophil count
Item
absolute neutrophil count >= 1500/ul
boolean
C0948762 (UMLS CUI [1])
Creatinine measurement, serum
Item
serum creatinine within 1.5 x upper limit of normal
boolean
C0201976 (UMLS CUI [1])
Informed Consent
Item
ability to understand and sign an institutional review board (irb) approved informed consent
boolean
C0021430 (UMLS CUI [1])
Contraceptive methods | Childbearing Potential Pregnancy Absent
Item
ability to use appropriate contraception and no evidence of pregnancy in female patients of reproductive potential
boolean
C0700589 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0032961 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Medical condition Therapeutic procedure At risk | Mental disorders Therapeutic procedure At risk
Item
significant medical or psychiatric condition that would make treatment unsafe
boolean
C3843040 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C0004936 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
Systemic steroids
Item
use of systemic steroids use within 7 days from start of trial
boolean
C2825233 (UMLS CUI [1])
Breast Feeding
Item
nursing women
boolean
C0006147 (UMLS CUI [1])
Protocol Compliance Unable
Item
patients unable to comply with protocol related studies and follow up
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Weight decreased Percentage
Item
weight loss of greater than 10% in the last 6 months
boolean
C1262477 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
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