ID

35353

Beskrivning

Typhoid Vaccine in Testing Response to Immune Stress in Patients With Stage I-IIIA Breast Cancer Who Received Chemotherapy; ODM derived from: https://clinicaltrials.gov/show/NCT02415387

Länk

https://clinicaltrials.gov/show/NCT02415387

Nyckelord

Versioner (1)
  1. 2019-03-01 2019-03-01 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

1 mars 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Cognitive Side Effects of Cancer Therapy NCT02415387

Engelsk

Eligibility Cognitive Side Effects of Cancer Therapy NCT02415387

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
women who have been diagnosed with stage i-iiia breast cancer will be recruited 1-8 years after the completion of all primary cancer treatment except for longer-term hormonal therapies (tamoxifen, aromatase inhibitors)
Beskrivning

Gender | Breast Carcinoma TNM Breast tumor staging | Status post Treatment completed Primary tumor | Exception Hormone Therapy Long-term | Exception Tamoxifen | Exception Aromatase Inhibitors

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C0474926
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0580352
UMLS CUI [3,3]
C0677930
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0279025
UMLS CUI [4,3]
C0443252
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0039286
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0593802
all women will have received chemotherapy
Beskrivning

Gender | Chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0392920
all women will be postmenopausal
Beskrivning

Postmenopausal state

Datatyp

boolean

Alias
UMLS CUI [1]
C0232970
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
a prior history of any other malignancy except basal or squamous cell skin cancers, strokes, diabetes, current heart disease or uncontrolled hypertension, peripheral vascular disease, liver disease, autoimmune and/or inflammatory diseases including rheumatoid arthritis and ulcerative colitis, and other medical conditions that would limit participation in the assessments (e.g., pulmonary disease, orthopedic problems, major psychiatric illness, major cognitive dysfunction, or an acute medical problem)
Beskrivning

Cancer Other | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin | Cerebrovascular accident | Diabetes Mellitus | Heart Diseases | Uncontrolled hypertension | Peripheral Vascular Diseases | Liver diseases | Autoimmune Diseases | Inflammatory disorder | Rheumatoid Arthritis | Ulcerative Colitis | Other medical condition Limiting Assessment | Lung diseases | Orthopedic problem | Major psychiatric illness | Cognitive dysfunction Major | Medical Problem

Datatyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [4]
C0038454
UMLS CUI [5]
C0011849
UMLS CUI [6]
C0018799
UMLS CUI [7]
C1868885
UMLS CUI [8]
C0085096
UMLS CUI [9]
C0023895
UMLS CUI [10]
C0004364
UMLS CUI [11]
C1290884
UMLS CUI [12]
C0003873
UMLS CUI [13]
C0009324
UMLS CUI [14,1]
C3843040
UMLS CUI [14,2]
C0439801
UMLS CUI [14,3]
C1516048
UMLS CUI [15]
C0024115
UMLS CUI [16]
C0029354
UMLS CUI [17]
C4534351
UMLS CUI [18,1]
C0338656
UMLS CUI [18,2]
C0205164
UMLS CUI [19]
C1254481
anemia
Beskrivning

Anemia

Datatyp

boolean

Alias
UMLS CUI [1]
C0002871
alcohol or drug abuse
Beskrivning

Substance Use Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
smoking
Beskrivning

Tobacco use

Datatyp

boolean

Alias
UMLS CUI [1]
C0543414
individuals who routinely take fish oil, krill oil, or flaxseed (oil, pills, or powder) or consume more than two portions of oily fish per week
Beskrivning

Fish Oils | Krill oil | Linseed Oil | Flaxseed powder | Fatty fish Consumption Weekly

Datatyp

boolean

Alias
UMLS CUI [1]
C0016157
UMLS CUI [2]
C2725341
UMLS CUI [3]
C0023754
UMLS CUI [4]
C0976940
UMLS CUI [5,1]
C0453017
UMLS CUI [5,2]
C0009830
UMLS CUI [5,3]
C0332174
women with blood pressures above 180/100 or below 80/50
Beskrivning

Gender | Blood pressure determination

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0005824
medication exclusions will include steroids as well as statins and other medications with anti-inflammatory actions
Beskrivning

Steroids | Statins | Anti-Inflammatory Agents

Datatyp

boolean

Alias
UMLS CUI [1]
C0038317
UMLS CUI [2]
C0360714
UMLS CUI [3]
C0003209
women who have ever received typhoid vaccine or have received any other vaccine within three months
Beskrivning

Gender | Vaccines, Typhoid | Vaccines

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0041469
UMLS CUI [3]
C0042210
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Similar models

Eligibility Cognitive Side Effects of Cancer Therapy NCT02415387

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Breast Carcinoma TNM Breast tumor staging | Status post Treatment completed Primary tumor | Exception Hormone Therapy Long-term | Exception Tamoxifen | Exception Aromatase Inhibitors
Item
women who have been diagnosed with stage i-iiia breast cancer will be recruited 1-8 years after the completion of all primary cancer treatment except for longer-term hormonal therapies (tamoxifen, aromatase inhibitors)
boolean
C0079399 (UMLS CUI [1])
C0678222 (UMLS CUI [2,1])
C0474926 (UMLS CUI [2,2])
C0231290 (UMLS CUI [3,1])
C0580352 (UMLS CUI [3,2])
C0677930 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0279025 (UMLS CUI [4,2])
C0443252 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0039286 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0593802 (UMLS CUI [6,2])
Gender | Chemotherapy
Item
all women will have received chemotherapy
boolean
C0079399 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
Postmenopausal state
Item
all women will be postmenopausal
boolean
C0232970 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cancer Other | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin | Cerebrovascular accident | Diabetes Mellitus | Heart Diseases | Uncontrolled hypertension | Peripheral Vascular Diseases | Liver diseases | Autoimmune Diseases | Inflammatory disorder | Rheumatoid Arthritis | Ulcerative Colitis | Other medical condition Limiting Assessment | Lung diseases | Orthopedic problem | Major psychiatric illness | Cognitive dysfunction Major | Medical Problem
Item
a prior history of any other malignancy except basal or squamous cell skin cancers, strokes, diabetes, current heart disease or uncontrolled hypertension, peripheral vascular disease, liver disease, autoimmune and/or inflammatory diseases including rheumatoid arthritis and ulcerative colitis, and other medical conditions that would limit participation in the assessments (e.g., pulmonary disease, orthopedic problems, major psychiatric illness, major cognitive dysfunction, or an acute medical problem)
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C0038454 (UMLS CUI [4])
C0011849 (UMLS CUI [5])
C0018799 (UMLS CUI [6])
C1868885 (UMLS CUI [7])
C0085096 (UMLS CUI [8])
C0023895 (UMLS CUI [9])
C0004364 (UMLS CUI [10])
C1290884 (UMLS CUI [11])
C0003873 (UMLS CUI [12])
C0009324 (UMLS CUI [13])
C3843040 (UMLS CUI [14,1])
C0439801 (UMLS CUI [14,2])
C1516048 (UMLS CUI [14,3])
C0024115 (UMLS CUI [15])
C0029354 (UMLS CUI [16])
C4534351 (UMLS CUI [17])
C0338656 (UMLS CUI [18,1])
C0205164 (UMLS CUI [18,2])
C1254481 (UMLS CUI [19])
Anemia
Item
anemia
boolean
C0002871 (UMLS CUI [1])
Substance Use Disorders
Item
alcohol or drug abuse
boolean
C0038586 (UMLS CUI [1])
Tobacco use
Item
smoking
boolean
C0543414 (UMLS CUI [1])
Fish Oils | Krill oil | Linseed Oil | Flaxseed powder | Fatty fish Consumption Weekly
Item
individuals who routinely take fish oil, krill oil, or flaxseed (oil, pills, or powder) or consume more than two portions of oily fish per week
boolean
C0016157 (UMLS CUI [1])
C2725341 (UMLS CUI [2])
C0023754 (UMLS CUI [3])
C0976940 (UMLS CUI [4])
C0453017 (UMLS CUI [5,1])
C0009830 (UMLS CUI [5,2])
C0332174 (UMLS CUI [5,3])
Gender | Blood pressure determination
Item
women with blood pressures above 180/100 or below 80/50
boolean
C0079399 (UMLS CUI [1])
C0005824 (UMLS CUI [2])
Steroids | Statins | Anti-Inflammatory Agents
Item
medication exclusions will include steroids as well as statins and other medications with anti-inflammatory actions
boolean
C0038317 (UMLS CUI [1])
C0360714 (UMLS CUI [2])
C0003209 (UMLS CUI [3])
Gender | Vaccines, Typhoid | Vaccines
Item
women who have ever received typhoid vaccine or have received any other vaccine within three months
boolean
C0079399 (UMLS CUI [1])
C0041469 (UMLS CUI [2])
C0042210 (UMLS CUI [3])
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