0 Ratings
ID

35886

Description

Dexamethasone for Treatment of Radiation-related Fatigue in Patients Receiving RT for Head-neck and Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02410382

Link

https://clinicaltrials.gov/show/NCT02410382

Keywords

Versions (1)
  1. 4/1/19 4/1/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 1, 2019

DOI

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License

Creative Commons BY 4.0
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    Eligibility Head and Neck Cancer NCT02410382

    English

    Eligibility Head and Neck Cancer NCT02410382

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    confirmation of head & neck cancer (stage i-iv) or non-small cell lung cancer (stage ii & iii)
    Description

    Malignant Head and Neck Neoplasm TNM clinical staging | Non-Small Cell Lung Carcinoma TNM clinical staging

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0278996
    UMLS CUI [1,2]
    C3258246
    UMLS CUI [2,1]
    C0007131
    UMLS CUI [2,2]
    C3258246
    undergoing treatment with either radiation alone or in combination with chemotherapy
    Description

    Therapeutic radiology procedure | Combined Modality Therapy | Chemotherapy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1522449
    UMLS CUI [2]
    C0009429
    UMLS CUI [3]
    C0392920
    normal cognition and willingness to complete fatigue and quality of life forms, patient observation form, and pill diary
    Description

    Normal Cognition | Fatigue form Completion | Quality of life form Completion | Patient observation form Completion | Pill Diary Completion

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2712133
    UMLS CUI [2,1]
    C0015672
    UMLS CUI [2,2]
    C0582687
    UMLS CUI [2,3]
    C0205197
    UMLS CUI [3,1]
    C0034380
    UMLS CUI [3,2]
    C0582687
    UMLS CUI [3,3]
    C0205197
    UMLS CUI [4,1]
    C0700325
    UMLS CUI [4,2]
    C0582687
    UMLS CUI [4,3]
    C0205197
    UMLS CUI [5,1]
    C0994475
    UMLS CUI [5,2]
    C3890583
    UMLS CUI [5,3]
    C0205197
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    hypersensitivity to dexamethasone or corticosteroids or equal sugar substitute
    Description

    Dexamethasone allergy | Allergy to corticosteroid | Hypersensitivity Sugar Substitute Equal

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0571611
    UMLS CUI [2]
    C0571586
    UMLS CUI [3,1]
    C0020517
    UMLS CUI [3,2]
    C0282360
    UMLS CUI [3,3]
    C0205163
    corticosteroid within the past 30 days prior to study enrollment for greater than one week duration
    Description

    Adrenal Cortex Hormones

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001617
    planned stereotactic body radiation therapy (sbrt)
    Description

    Stereotactic Body Radiation Therapy Planned

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3896609
    UMLS CUI [1,2]
    C1301732
    active psychosis
    Description

    Psychotic Disorders

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0033975
    current pregnancy
    Description

    Pregnancy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    active peptic ulcer disease or evidence of gastrointestinal bleed
    Description

    Peptic Ulcer | Gastrointestinal Hemorrhage

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0030920
    UMLS CUI [2]
    C0017181
    current active tuberculosis or systemic fungal infection
    Description

    Tuberculosis | Systemic mycosis

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0041296
    UMLS CUI [2]
    C0553576
    previous diagnosis of diabetes mellitus
    Description

    Diabetes Mellitus

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0011849
    acute febrile illness
    Description

    Acute febrile illness

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0743842
    known human immunodeficiency virus or acquired immunodeficiency syndrome
    Description

    HIV Infection | Acquired Immunodeficiency Syndrome

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019693
    UMLS CUI [2]
    C0001175
    major surgery within two weeks of study enrollment of which the patient has not recovered
    Description

    Major surgery | Recovery Lacking

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0679637
    UMLS CUI [2,1]
    C2004454
    UMLS CUI [2,2]
    C0332268
    psychostimulant use in the past 30 days prior to registration
    Description

    Psychostimulant

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0304403
    history of phenylketonuria (pku)
    Description

    Phenylketonuria

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0031485
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    Similar models

    Eligibility Head and Neck Cancer NCT02410382

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Malignant Head and Neck Neoplasm TNM clinical staging | Non-Small Cell Lung Carcinoma TNM clinical staging
    Item
    confirmation of head & neck cancer (stage i-iv) or non-small cell lung cancer (stage ii & iii)
    boolean
    C0278996 (UMLS CUI [1,1])
    C3258246 (UMLS CUI [1,2])
    C0007131 (UMLS CUI [2,1])
    C3258246 (UMLS CUI [2,2])
    Therapeutic radiology procedure | Combined Modality Therapy | Chemotherapy
    Item
    undergoing treatment with either radiation alone or in combination with chemotherapy
    boolean
    C1522449 (UMLS CUI [1])
    C0009429 (UMLS CUI [2])
    C0392920 (UMLS CUI [3])
    Normal Cognition | Fatigue form Completion | Quality of life form Completion | Patient observation form Completion | Pill Diary Completion
    Item
    normal cognition and willingness to complete fatigue and quality of life forms, patient observation form, and pill diary
    boolean
    C2712133 (UMLS CUI [1])
    C0015672 (UMLS CUI [2,1])
    C0582687 (UMLS CUI [2,2])
    C0205197 (UMLS CUI [2,3])
    C0034380 (UMLS CUI [3,1])
    C0582687 (UMLS CUI [3,2])
    C0205197 (UMLS CUI [3,3])
    C0700325 (UMLS CUI [4,1])
    C0582687 (UMLS CUI [4,2])
    C0205197 (UMLS CUI [4,3])
    C0994475 (UMLS CUI [5,1])
    C3890583 (UMLS CUI [5,2])
    C0205197 (UMLS CUI [5,3])
    Item Group
    C0680251 (UMLS CUI)
    Dexamethasone allergy | Allergy to corticosteroid | Hypersensitivity Sugar Substitute Equal
    Item
    hypersensitivity to dexamethasone or corticosteroids or equal sugar substitute
    boolean
    C0571611 (UMLS CUI [1])
    C0571586 (UMLS CUI [2])
    C0020517 (UMLS CUI [3,1])
    C0282360 (UMLS CUI [3,2])
    C0205163 (UMLS CUI [3,3])
    Adrenal Cortex Hormones
    Item
    corticosteroid within the past 30 days prior to study enrollment for greater than one week duration
    boolean
    C0001617 (UMLS CUI [1])
    Stereotactic Body Radiation Therapy Planned
    Item
    planned stereotactic body radiation therapy (sbrt)
    boolean
    C3896609 (UMLS CUI [1,1])
    C1301732 (UMLS CUI [1,2])
    Psychotic Disorders
    Item
    active psychosis
    boolean
    C0033975 (UMLS CUI [1])
    Pregnancy
    Item
    current pregnancy
    boolean
    C0032961 (UMLS CUI [1])
    Peptic Ulcer | Gastrointestinal Hemorrhage
    Item
    active peptic ulcer disease or evidence of gastrointestinal bleed
    boolean
    C0030920 (UMLS CUI [1])
    C0017181 (UMLS CUI [2])
    Tuberculosis | Systemic mycosis
    Item
    current active tuberculosis or systemic fungal infection
    boolean
    C0041296 (UMLS CUI [1])
    C0553576 (UMLS CUI [2])
    Diabetes Mellitus
    Item
    previous diagnosis of diabetes mellitus
    boolean
    C0011849 (UMLS CUI [1])
    Acute febrile illness
    Item
    acute febrile illness
    boolean
    C0743842 (UMLS CUI [1])
    HIV Infection | Acquired Immunodeficiency Syndrome
    Item
    known human immunodeficiency virus or acquired immunodeficiency syndrome
    boolean
    C0019693 (UMLS CUI [1])
    C0001175 (UMLS CUI [2])
    Major surgery | Recovery Lacking
    Item
    major surgery within two weeks of study enrollment of which the patient has not recovered
    boolean
    C0679637 (UMLS CUI [1])
    C2004454 (UMLS CUI [2,1])
    C0332268 (UMLS CUI [2,2])
    Psychostimulant
    Item
    psychostimulant use in the past 30 days prior to registration
    boolean
    C0304403 (UMLS CUI [1])
    Phenylketonuria
    Item
    history of phenylketonuria (pku)
    boolean
    C0031485 (UMLS CUI [1])
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