ID

18125

Description

Phase II Trial of Docetaxel and Celecoxib in Patients With Androgen Independent Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00494338

Link

https://clinicaltrials.gov/show/NCT00494338

Keywords

  1. 10/21/16 10/21/16 -
Uploaded on

October 21, 2016

DOI

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License

Creative Commons BY 4.0

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    Eligibility Metastatic Prostate Cancer NCT00494338

    Eligibility Metastatic Prostate Cancer NCT00494338

    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    patients with histologically confirmed maipc
    Description

    Androgen Insensitive Prostatic Neoplasms Metastatic

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3658267
    UMLS CUI [1,2]
    C0036525
    documented progressive disease in bone, soft tissue or psa despite castrate levels of testosterone
    Description

    Progressive Disease bone | Progressive Disease soft tissue | Prostate-Specific Antigen | Testosterone level

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1335499
    UMLS CUI [1,2]
    C0262950
    UMLS CUI [2,1]
    C1335499
    UMLS CUI [2,2]
    C0225317
    UMLS CUI [3]
    C0138741
    UMLS CUI [4]
    C0428412
    if lhrh agonist were used previously it must be kept
    Description

    Luteinizing Hormone-releasing Hormone Agonist

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1518041
    previous anti-androgen should be held at least 4 weeks for flutamida or cyproterone and 6 weeks for bycalumida
    Description

    Androgen Antagonists | Flutamide | Cyproterone

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0002842
    UMLS CUI [2]
    C0016384
    UMLS CUI [3]
    C0010621
    previous des should be held for at least 4 weeks before partcipating in the trial
    Description

    Diethylstilbestrol

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0012203
    chemotherapy naive patients
    Description

    Chemotherapy naive

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3665472
    UMLS CUI [1,2]
    C0919936
    no prior radioisotope
    Description

    Radioisotopes

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0034595
    less than 25% of bone marrow should be irradiated for prior palliative radiotherapy
    Description

    Palliative course of radiotherapy Bone Marrow Percentage

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0475092
    UMLS CUI [1,2]
    C0005953
    UMLS CUI [1,3]
    C0439165
    kps> 70%
    Description

    Karnofsky Performance Status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0206065
    adequate hematologic, hepatic and renal function
    Description

    Hematologic function | Liver function | Renal function

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0221130
    UMLS CUI [2]
    C0232741
    UMLS CUI [3]
    C0232804
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    patients with serious medical illness
    Description

    Illness Serious

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0221423
    UMLS CUI [1,2]
    C0205404
    history of significant active cardiac disease
    Description

    Heart Disease Significant

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0018799
    UMLS CUI [1,2]
    C0750502
    history of gastrointestinal ulceration, bleeding or perforation
    Description

    Gastrointestinal ulceration | Gastrointestinal Hemorrhage | Gastrointestinal perforation

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1963975
    UMLS CUI [2]
    C0017181
    UMLS CUI [3]
    C0151664
    history of myocardial infarctin within past 12 months
    Description

    Myocardial Infarction

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0027051
    allergy to sulfonamides or to celecoxib or history of urticaria to any nsaid
    Description

    Allergy to sulfonamides | Hypersensitivity celecoxib | Urticaria Due to NSAIDS

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0038757
    UMLS CUI [2,1]
    C0020517
    UMLS CUI [2,2]
    C0538927
    UMLS CUI [3,1]
    C0042109
    UMLS CUI [3,2]
    C0678226
    UMLS CUI [3,3]
    C0003211
    the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
    Description

    Study Subject Participation Status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2348568

    Similar models

    Eligibility Metastatic Prostate Cancer NCT00494338

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Androgen Insensitive Prostatic Neoplasms Metastatic
    Item
    patients with histologically confirmed maipc
    boolean
    C3658267 (UMLS CUI [1,1])
    C0036525 (UMLS CUI [1,2])
    Progressive Disease bone | Progressive Disease soft tissue | Prostate-Specific Antigen | Testosterone level
    Item
    documented progressive disease in bone, soft tissue or psa despite castrate levels of testosterone
    boolean
    C1335499 (UMLS CUI [1,1])
    C0262950 (UMLS CUI [1,2])
    C1335499 (UMLS CUI [2,1])
    C0225317 (UMLS CUI [2,2])
    C0138741 (UMLS CUI [3])
    C0428412 (UMLS CUI [4])
    Luteinizing Hormone-releasing Hormone Agonist
    Item
    if lhrh agonist were used previously it must be kept
    boolean
    C1518041 (UMLS CUI [1])
    Androgen Antagonists | Flutamide | Cyproterone
    Item
    previous anti-androgen should be held at least 4 weeks for flutamida or cyproterone and 6 weeks for bycalumida
    boolean
    C0002842 (UMLS CUI [1])
    C0016384 (UMLS CUI [2])
    C0010621 (UMLS CUI [3])
    Diethylstilbestrol
    Item
    previous des should be held for at least 4 weeks before partcipating in the trial
    boolean
    C0012203 (UMLS CUI [1])
    Chemotherapy naive
    Item
    chemotherapy naive patients
    boolean
    C3665472 (UMLS CUI [1,1])
    C0919936 (UMLS CUI [1,2])
    Radioisotopes
    Item
    no prior radioisotope
    boolean
    C0034595 (UMLS CUI [1])
    Palliative course of radiotherapy Bone Marrow Percentage
    Item
    less than 25% of bone marrow should be irradiated for prior palliative radiotherapy
    boolean
    C0475092 (UMLS CUI [1,1])
    C0005953 (UMLS CUI [1,2])
    C0439165 (UMLS CUI [1,3])
    Karnofsky Performance Status
    Item
    kps> 70%
    boolean
    C0206065 (UMLS CUI [1])
    Hematologic function | Liver function | Renal function
    Item
    adequate hematologic, hepatic and renal function
    boolean
    C0221130 (UMLS CUI [1])
    C0232741 (UMLS CUI [2])
    C0232804 (UMLS CUI [3])
    Item Group
    C0680251 (UMLS CUI)
    Illness Serious
    Item
    patients with serious medical illness
    boolean
    C0221423 (UMLS CUI [1,1])
    C0205404 (UMLS CUI [1,2])
    Heart Disease Significant
    Item
    history of significant active cardiac disease
    boolean
    C0018799 (UMLS CUI [1,1])
    C0750502 (UMLS CUI [1,2])
    Gastrointestinal ulceration | Gastrointestinal Hemorrhage | Gastrointestinal perforation
    Item
    history of gastrointestinal ulceration, bleeding or perforation
    boolean
    C1963975 (UMLS CUI [1])
    C0017181 (UMLS CUI [2])
    C0151664 (UMLS CUI [3])
    Myocardial Infarction
    Item
    history of myocardial infarctin within past 12 months
    boolean
    C0027051 (UMLS CUI [1])
    Allergy to sulfonamides | Hypersensitivity celecoxib | Urticaria Due to NSAIDS
    Item
    allergy to sulfonamides or to celecoxib or history of urticaria to any nsaid
    boolean
    C0038757 (UMLS CUI [1])
    C0020517 (UMLS CUI [2,1])
    C0538927 (UMLS CUI [2,2])
    C0042109 (UMLS CUI [3,1])
    C0678226 (UMLS CUI [3,2])
    C0003211 (UMLS CUI [3,3])
    Study Subject Participation Status
    Item
    the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
    boolean
    C2348568 (UMLS CUI [1])

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