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ID

18405

Description

Investigation of Safety and Efficacy of SB Injection in Patients With Advanced and Metastatic Non-small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01305967

Lien

https://clinicaltrials.gov/show/NCT01305967

Mots-clés

  1. 03/11/2016 03/11/2016 -
Téléchargé le

3 novembre 2016

DOI

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Licence

Creative Commons BY 4.0

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    Eligibility Non Small Cell Lung Cancer NCT01305967

    Eligibility Non Small Cell Lung Cancer NCT01305967

    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    age of 18-70 years
    Description

    Age

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    patients with histologically or cytologically confirmed non-small cell lung cancer
    Description

    Non-Small Cell Lung Carcinoma

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0007131
    patients who had failed more than 1 cycle of standard therapy with advanced or metasatic stage not available to any of resectable surgery or radiotherapy.
    Description

    Standard of Care Course Quantity failed | advanced disease | Neoplasm Metastasis | Malignant Neoplasm Resectable | Operative Surgical Procedures | Therapeutic radiology procedure

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C2936643
    UMLS CUI [1,2]
    C0750729
    UMLS CUI [1,3]
    C1265611
    UMLS CUI [1,4]
    C0231175
    UMLS CUI [2]
    C0679246
    UMLS CUI [3]
    C0027627
    UMLS CUI [4,1]
    C0006826
    UMLS CUI [4,2]
    C1514888
    UMLS CUI [5]
    C0543467
    UMLS CUI [6]
    C1522449
    patients with measurable lesions
    Description

    Measurable Disease

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1513041
    eatern cooperative oncolgy group status 0 to 2.
    Description

    ECOG performance status

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    life expectancy >/= 5 months
    Description

    Life Expectancy

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0023671
    patients with adequate organ(heart, kidney, liver)and bone marrow function, as defined by
    Description

    Organ function | Cardiac function | Renal function | Liver function | Bone Marrow function

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0678852
    UMLS CUI [2]
    C0232164
    UMLS CUI [3]
    C0232804
    UMLS CUI [4]
    C0232741
    UMLS CUI [5,1]
    C0005953
    UMLS CUI [5,2]
    C0031843
    1. absolute neutrophil count >/= 1.5 x 10^9/l, platelet count >/= 100 x 10^9/l
    Description

    Absolute neutrophil count | Platelet Count measurement

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0948762
    UMLS CUI [2]
    C0032181
    2. total bilirubin </= upper limit of normal
    Description

    Serum total bilirubin measurement

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1278039
    3. aspartate aminotransferase and/or alanine aminotransferase </= 2 x upeer limit of normal
    Description

    Aspartate aminotransferase measurement | Alanine aminotransferase measurement

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0201899
    UMLS CUI [2]
    C0201836
    4. creatinine </= 1.5 x upeer limit of normal
    Description

    Creatinine measurement, serum

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0201976
    patients who have signed the informed consent form.
    Description

    Informed Consent

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    female volunteers admitted to the study must be using a reliable means of contraception
    Description

    Gender Contraceptive methods

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0079399
    UMLS CUI [1,2]
    C0700589
    received radiation therapy within 6 weeks before randomization
    Description

    Therapeutic radiology procedure

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1522449
    known brain or spinal cord metastases
    Description

    Metastatic malignant neoplasm to brain | Spinal Cord Neoplasm Metastasis

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0220650
    UMLS CUI [2,1]
    C0037925
    UMLS CUI [2,2]
    C0027627
    have acute infection
    Description

    Communicable Disease

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0009450
    have active infection or serious concomitant systemic disorder incompatible with the study
    Description

    Communicable Disease Inconsistent Clinical Trial | Systemic disease Serious Inconsistent Clinical Trial

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0009450
    UMLS CUI [1,2]
    C0442809
    UMLS CUI [1,3]
    C0008976
    UMLS CUI [2,1]
    C0442893
    UMLS CUI [2,2]
    C0205404
    UMLS CUI [2,3]
    C0442809
    UMLS CUI [2,4]
    C0008976
    presence or history of malignancy other than non-small cell lung cancer
    Description

    Malignant Neoplasms | Non-Small Cell Lung Carcinoma

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    UMLS CUI [2]
    C0007131
    have severe neurologic or psychological disorder
    Description

    nervous system disorder | Mental disorder

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0027765
    UMLS CUI [2]
    C0004936
    patients who have to receive other chemo-radiotherapy or immunotherapy
    Description

    Chemoradiotherapy | Immunotherapy

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0436307
    UMLS CUI [2]
    C0021083
    patients who have received chemotherapy within the previous 30 days
    Description

    Chemotherapy

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0392920
    patients who are candidates for combined modality treatment.
    Description

    Indication Combined Modality Therapy

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C3146298
    UMLS CUI [1,2]
    C0009429
    patients who have participated in a clinical study within the previous 30 days
    Description

    Study Subject Participation Status

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C2348568

    Similar models

    Eligibility Non Small Cell Lung Cancer NCT01305967

    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age
    Item
    age of 18-70 years
    boolean
    C0001779 (UMLS CUI [1])
    Non-Small Cell Lung Carcinoma
    Item
    patients with histologically or cytologically confirmed non-small cell lung cancer
    boolean
    C0007131 (UMLS CUI [1])
    Standard of Care Course Quantity failed | advanced disease | Neoplasm Metastasis | Malignant Neoplasm Resectable | Operative Surgical Procedures | Therapeutic radiology procedure
    Item
    patients who had failed more than 1 cycle of standard therapy with advanced or metasatic stage not available to any of resectable surgery or radiotherapy.
    boolean
    C2936643 (UMLS CUI [1,1])
    C0750729 (UMLS CUI [1,2])
    C1265611 (UMLS CUI [1,3])
    C0231175 (UMLS CUI [1,4])
    C0679246 (UMLS CUI [2])
    C0027627 (UMLS CUI [3])
    C0006826 (UMLS CUI [4,1])
    C1514888 (UMLS CUI [4,2])
    C0543467 (UMLS CUI [5])
    C1522449 (UMLS CUI [6])
    Measurable Disease
    Item
    patients with measurable lesions
    boolean
    C1513041 (UMLS CUI [1])
    ECOG performance status
    Item
    eatern cooperative oncolgy group status 0 to 2.
    boolean
    C1520224 (UMLS CUI [1])
    Life Expectancy
    Item
    life expectancy >/= 5 months
    boolean
    C0023671 (UMLS CUI [1])
    Organ function | Cardiac function | Renal function | Liver function | Bone Marrow function
    Item
    patients with adequate organ(heart, kidney, liver)and bone marrow function, as defined by
    boolean
    C0678852 (UMLS CUI [1])
    C0232164 (UMLS CUI [2])
    C0232804 (UMLS CUI [3])
    C0232741 (UMLS CUI [4])
    C0005953 (UMLS CUI [5,1])
    C0031843 (UMLS CUI [5,2])
    Absolute neutrophil count | Platelet Count measurement
    Item
    1. absolute neutrophil count >/= 1.5 x 10^9/l, platelet count >/= 100 x 10^9/l
    boolean
    C0948762 (UMLS CUI [1])
    C0032181 (UMLS CUI [2])
    Serum total bilirubin measurement
    Item
    2. total bilirubin </= upper limit of normal
    boolean
    C1278039 (UMLS CUI [1])
    Aspartate aminotransferase measurement | Alanine aminotransferase measurement
    Item
    3. aspartate aminotransferase and/or alanine aminotransferase </= 2 x upeer limit of normal
    boolean
    C0201899 (UMLS CUI [1])
    C0201836 (UMLS CUI [2])
    Creatinine measurement, serum
    Item
    4. creatinine </= 1.5 x upeer limit of normal
    boolean
    C0201976 (UMLS CUI [1])
    Informed Consent
    Item
    patients who have signed the informed consent form.
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Gender Contraceptive methods
    Item
    female volunteers admitted to the study must be using a reliable means of contraception
    boolean
    C0079399 (UMLS CUI [1,1])
    C0700589 (UMLS CUI [1,2])
    Therapeutic radiology procedure
    Item
    received radiation therapy within 6 weeks before randomization
    boolean
    C1522449 (UMLS CUI [1])
    Metastatic malignant neoplasm to brain | Spinal Cord Neoplasm Metastasis
    Item
    known brain or spinal cord metastases
    boolean
    C0220650 (UMLS CUI [1])
    C0037925 (UMLS CUI [2,1])
    C0027627 (UMLS CUI [2,2])
    Communicable Disease
    Item
    have acute infection
    boolean
    C0009450 (UMLS CUI [1])
    Communicable Disease Inconsistent Clinical Trial | Systemic disease Serious Inconsistent Clinical Trial
    Item
    have active infection or serious concomitant systemic disorder incompatible with the study
    boolean
    C0009450 (UMLS CUI [1,1])
    C0442809 (UMLS CUI [1,2])
    C0008976 (UMLS CUI [1,3])
    C0442893 (UMLS CUI [2,1])
    C0205404 (UMLS CUI [2,2])
    C0442809 (UMLS CUI [2,3])
    C0008976 (UMLS CUI [2,4])
    Malignant Neoplasms | Non-Small Cell Lung Carcinoma
    Item
    presence or history of malignancy other than non-small cell lung cancer
    boolean
    C0006826 (UMLS CUI [1])
    C0007131 (UMLS CUI [2])
    nervous system disorder | Mental disorder
    Item
    have severe neurologic or psychological disorder
    boolean
    C0027765 (UMLS CUI [1])
    C0004936 (UMLS CUI [2])
    Chemoradiotherapy | Immunotherapy
    Item
    patients who have to receive other chemo-radiotherapy or immunotherapy
    boolean
    C0436307 (UMLS CUI [1])
    C0021083 (UMLS CUI [2])
    Chemotherapy
    Item
    patients who have received chemotherapy within the previous 30 days
    boolean
    C0392920 (UMLS CUI [1])
    Indication Combined Modality Therapy
    Item
    patients who are candidates for combined modality treatment.
    boolean
    C3146298 (UMLS CUI [1,1])
    C0009429 (UMLS CUI [1,2])
    Study Subject Participation Status
    Item
    patients who have participated in a clinical study within the previous 30 days
    boolean
    C2348568 (UMLS CUI [1])

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