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ID

12845

Descrizione

A Phase II Trial of Leuprolide + Flutamide + Suramin in Untreated Poor Prognosis Prostate Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00001266

collegamento

https://clinicaltrials.gov/show/NCT00001266

Keywords

  1. 29/12/15 29/12/15 -
Caricato su

29 dicembre 2015

DOI

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Licenza

Creative Commons BY 4.0

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    Eligibility Prostatic Neoplasm NCT00001266

    Eligibility Prostatic Neoplasm NCT00001266

    Inclusion Criteria
    Descrizione

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    patients must have a histologic diagnosis of carcinoma of the prostate and must not have had a trial of hormonal therapy or chemotherapy.
    Descrizione

    patients must have a histologic diagnosis of carcinoma of the prostate and must not have had a trial of hormonal therapy or chemotherapy.

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0600139
    UMLS CUI [2]
    C0279025
    UMLS CUI [3]
    C0392920
    patients must be 18 years of age
    Descrizione

    patients must be 18 years of age

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    an sgot/sgpt within 2 times of normal.
    Descrizione

    an sgot/sgpt within 2 times of normal.

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0001899
    UMLS CUI [2]
    C0004002
    patients must have stage d2 prostate carcinoma or state d1 disease with a gleason grade 7 or above (poorly differentiated).
    Descrizione

    patients must have stage d2 prostate carcinoma or state d1 disease with a gleason grade 7 or above (poorly differentiated).

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0027646
    UMLS CUI [2]
    C0332332
    no other malignancy except curatively treated basal cell cancer of the skin.
    Descrizione

    no other malignancy except curatively treated basal cell cancer of the skin.

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    performance status ecog of 0-3.
    Descrizione

    performance status ecog of 0-3.

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    ability to give informed consent.
    Descrizione

    ability to give informed consent.

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    no history of bleeding diathesis. patients with a history of peptic ulcer disease will be eligible if the ulcer is shown to be resolved by a barium study.
    Descrizione

    no history of bleeding diathesis. patients with a history of peptic ulcer disease will be eligible if the ulcer is shown to be resolved by a barium study.

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0005779
    UMLS CUI [2]
    C0030920
    no history of cerebrovascular event, either thrombotic or hemorrhagic.
    Descrizione

    no history of cerebrovascular event, either thrombotic or hemorrhagic.

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0852396
    no current clinical signs of congestive heart failure, angina pectoris or myocardial infarction. patient cannot be on calcium channel blockers such as nifedipine, diltiazem, or verapamil.
    Descrizione

    no current clinical signs of congestive heart failure, angina pectoris or myocardial infarction. patient cannot be on calcium channel blockers such as nifedipine, diltiazem, or verapamil.

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0018802
    UMLS CUI [2]
    C0002962
    UMLS CUI [3]
    C0027051
    UMLS CUI [4]
    C0006684
    no clinical or radiographic evidence of brain metastases.
    Descrizione

    no clinical or radiographic evidence of brain metastases.

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0220650
    patients with extensive liver replacement (greater than 50%) by tumor will be ineligible.
    Descrizione

    patients with extensive liver replacement (greater than 50%) by tumor will be ineligible.

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C1883411
    UMLS CUI [1,2]
    C0023884
    UMLS CUI [1,3]
    C0205231
    patients must have a creatinine lest than or equal 2.5 mg/dl or creatinine clearance of greater than or equal to 40 ml/min.
    Descrizione

    patients must have a creatinine lest than or equal 2.5 mg/dl or creatinine clearance of greater than or equal to 40 ml/min.

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0201976
    UMLS CUI [2]
    C0010294
    patients must have adequate hepatic function (bilirubin less than 1.5mg%).
    Descrizione

    patients must have adequate hepatic function (bilirubin less than 1.5mg%).

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C1278039
    if the patient has white cells in his urinalysis or other evidence of a urinary tract infection, this must be evaluated and appropriate therapy initiation prior to the initiation of therapy.
    Descrizione

    if the patient has white cells in his urinalysis or other evidence of a urinary tract infection, this must be evaluated and appropriate therapy initiation prior to the initiation of therapy.

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0042029
    patients must not have received chemotherapy.
    Descrizione

    patients must not have received chemotherapy.

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0392920
    an absolute granulocyte count greater than 1,500; platelet count greater than 100,000; fibrinogen greater than 200 mg/dl; hgb greater than or equal to 9 gm/dl.
    Descrizione

    an absolute granulocyte count greater than 1,500; platelet count greater than 100,000; fibrinogen greater than 200 mg/dl; hgb greater than or equal to 9 gm/dl.

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0857490
    UMLS CUI [2]
    C0005821
    UMLS CUI [3]
    C0016006
    UMLS CUI [4]
    C0019046
    reliability of the patient to take oral medication, go home and return for follow-up and treatment.
    Descrizione

    reliability of the patient to take oral medication, go home and return for follow-up and treatment.

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C1321605

    Similar models

    Eligibility Prostatic Neoplasm NCT00001266

    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    C1512693 (UMLS CUI)
    carcinoma of the prostate
    Item
    patients must have a histologic diagnosis of carcinoma of the prostate and must not have had a trial of hormonal therapy or chemotherapy.
    boolean
    C0600139 (UMLS CUI [1])
    C0279025 (UMLS CUI [2])
    C0392920 (UMLS CUI [3])
    age
    Item
    patients must be 18 years of age
    boolean
    C0001779 (UMLS CUI [1])
    ALT and AST
    Item
    an sgot/sgpt within 2 times of normal.
    boolean
    C0001899 (UMLS CUI [1])
    C0004002 (UMLS CUI [2])
    tumor staging
    Item
    patients must have stage d2 prostate carcinoma or state d1 disease with a gleason grade 7 or above (poorly differentiated).
    boolean
    C0027646 (UMLS CUI [1])
    C0332332 (UMLS CUI [2])
    other malignancy
    Item
    no other malignancy except curatively treated basal cell cancer of the skin.
    boolean
    C0006826 (UMLS CUI [1])
    performance status
    Item
    performance status ecog of 0-3.
    boolean
    C1520224 (UMLS CUI [1])
    informed consent
    Item
    ability to give informed consent.
    boolean
    C0021430 (UMLS CUI [1])
    bleeding diathesis
    Item
    no history of bleeding diathesis. patients with a history of peptic ulcer disease will be eligible if the ulcer is shown to be resolved by a barium study.
    boolean
    C0005779 (UMLS CUI [1])
    C0030920 (UMLS CUI [2])
    cerebrovascular event
    Item
    no history of cerebrovascular event, either thrombotic or hemorrhagic.
    boolean
    C0852396 (UMLS CUI [1])
    congestive heart failure
    Item
    no current clinical signs of congestive heart failure, angina pectoris or myocardial infarction. patient cannot be on calcium channel blockers such as nifedipine, diltiazem, or verapamil.
    boolean
    C0018802 (UMLS CUI [1])
    C0002962 (UMLS CUI [2])
    C0027051 (UMLS CUI [3])
    C0006684 (UMLS CUI [4])
    brain metastases
    Item
    no clinical or radiographic evidence of brain metastases.
    boolean
    C0220650 (UMLS CUI [1])
    extensive liver replacement
    Item
    patients with extensive liver replacement (greater than 50%) by tumor will be ineligible.
    boolean
    C1883411 (UMLS CUI [1,1])
    C0023884 (UMLS CUI [1,2])
    C0205231 (UMLS CUI [1,3])
    creatinine
    Item
    patients must have a creatinine lest than or equal 2.5 mg/dl or creatinine clearance of greater than or equal to 40 ml/min.
    boolean
    C0201976 (UMLS CUI [1])
    C0010294 (UMLS CUI [2])
    hepatic function
    Item
    patients must have adequate hepatic function (bilirubin less than 1.5mg%).
    boolean
    C1278039 (UMLS CUI [1])
    urinalysis
    Item
    if the patient has white cells in his urinalysis or other evidence of a urinary tract infection, this must be evaluated and appropriate therapy initiation prior to the initiation of therapy.
    boolean
    C0042029 (UMLS CUI [1])
    chemotherapy
    Item
    patients must not have received chemotherapy.
    boolean
    C0392920 (UMLS CUI [1])
    blood results
    Item
    an absolute granulocyte count greater than 1,500; platelet count greater than 100,000; fibrinogen greater than 200 mg/dl; hgb greater than or equal to 9 gm/dl.
    boolean
    C0857490 (UMLS CUI [1])
    C0005821 (UMLS CUI [2])
    C0016006 (UMLS CUI [3])
    C0019046 (UMLS CUI [4])
    patient compliance
    Item
    reliability of the patient to take oral medication, go home and return for follow-up and treatment.
    boolean
    C1321605 (UMLS CUI [1])

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