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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