ID

19375

Beschrijving

Molecular Effects of Short-Term Celecoxib Treatment on Head and Neck Squamous Cell Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00596219

Link

https://clinicaltrials.gov/show/NCT00596219

Trefwoorden

Versies (1)
  1. 23-12-16 23-12-16 -
Geüploaded op

23 december 2016

DOI

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Creative Commons BY 4.0
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Eligibility Squamous Cell Carcinoma NCT00596219

Engels

Eligibility Squamous Cell Carcinoma NCT00596219

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
untreated squamous cell carcinoma of the oral cavity or oropharynx.
Beschrijving

Squamous cell carcinoma of the oral cavity | Squamous cell carcinoma of oropharynx

Datatype

boolean

Alias
UMLS CUI [1]
C0585362
UMLS CUI [2]
C0280313
older than 18 years of age.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
understand and sign informed consent.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
any prior treatment of the index cancer (chemotherapy, immunotherapy, hormonal therapy or radiation therapy) or similar treatment of an unrelated malignancy within 6 weeks of enrollment into this study.
Beschrijving

Therapeutic procedure Malignant Neoplasm Affected | Chemotherapy | Immunotherapy | Hormone Therapy | Therapeutic radiology procedure | Therapeutic procedure Similar Malignant Neoplasms

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0006826
UMLS CUI [1,3]
C0392760
UMLS CUI [2]
C0392920
UMLS CUI [3]
C0021083
UMLS CUI [4]
C0279025
UMLS CUI [5]
C1522449
UMLS CUI [6,1]
C0087111
UMLS CUI [6,2]
C2348205
UMLS CUI [6,3]
C0006826
breast-feeding, pregnancy or of childbearing potential (including at least two years post menopause) and unable to confirm adequate contraception (abstinence, iud, birth control pills, or spermicidal gel with diaphragm or condom) since last menses.
Beschrijving

Breast Feeding | Pregnancy | Postmenopausal state | Childbearing Potential Contraceptive methods Inadequate | Sexual Abstinence | Intrauterine Devices | Contraceptives, Oral | Vaginal Spermicides | Vaginal contraceptive diaphragm | Female Condoms | Menstruation

Datatype

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0232970
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C0205412
UMLS CUI [5]
C0036899
UMLS CUI [6]
C0021900
UMLS CUI [7]
C0009905
UMLS CUI [8]
C0087145
UMLS CUI [9]
C0042241
UMLS CUI [10]
C0221829
UMLS CUI [11]
C0025344
history of esophageal, gastric or duodenal ulceration within 6 weeks of enrollment.
Beschrijving

Ulcer of esophagus | Gastric ulcer | Duodenal Ulcer

Datatype

boolean

Alias
UMLS CUI [1]
C0151970
UMLS CUI [2]
C0038358
UMLS CUI [3]
C0013295
history of acute or chronic renal disorder (blood creatinine level > 1.5 mg/dl).
Beschrijving

Kidney Diseases | Chronic Kidney Diseases | Creatinine measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C1561643
UMLS CUI [3]
C0201975
history of acute or chronic hepatic disorder or a significant bleeding disorder.
Beschrijving

Liver diseases | Chronic liver disease | Blood Coagulation Disorders Significant

Datatype

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0341439
UMLS CUI [3,1]
C0005779
UMLS CUI [3,2]
C0750502
history of chronic inflammatory disease (e.g. ulcerative colitis, crohn's disease,rheumatoid arthritis or pancreatitis).
Beschrijving

Chronic inflammatory disorder | Ulcerative Colitis | Crohn Disease | Rheumatoid Arthritis | Pancreatitis

Datatype

boolean

Alias
UMLS CUI [1]
C1290886
UMLS CUI [2]
C0009324
UMLS CUI [3]
C0010346
UMLS CUI [4]
C0003873
UMLS CUI [5]
C0030305
history of myocardial infarction, angina, or coronary artery disease within the past 6 months, or active cardiac disease.
Beschrijving

Myocardial Infarction | Angina Pectoris | Coronary Artery Disease | Heart Diseases

Datatype

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0002962
UMLS CUI [3]
C1956346
UMLS CUI [4]
C0018799
the subject is of new york heart association (nyha) class 3 or 4 cardiac status.
Beschrijving

Cardiac Status New York Heart Association Classification

Datatype

boolean

Alias
UMLS CUI [1,1]
C1999091
UMLS CUI [1,2]
C1275491
corticosteroid use within 6 weeks of enrollment, excluding topical nasal sprays.
Beschrijving

Adrenal Cortex Hormones | Nasal Sprays Topical

Datatype

boolean

Alias
UMLS CUI [1]
C0001617
UMLS CUI [2,1]
C2608293
UMLS CUI [2,2]
C1522168
nsaid (including celecoxib) or aspirin (> 81 mg/day) use within 1 week of enrollment.
Beschrijving

Anti-Inflammatory Agents, Non-Steroidal | celecoxib | Aspirin U/day

Datatype

boolean

Alias
UMLS CUI [1]
C0003211
UMLS CUI [2]
C0538927
UMLS CUI [3,1]
C0004057
UMLS CUI [3,2]
C0456683
history of hypersensitivity to cox-2 inhibitors, nsaids, salicylates, or sulfonamides.
Beschrijving

allergy to COX-2 inhibitors | allergy to nonsteroidal anti-inflammatory agents | Salicylate allergy | Allergy to sulfonamides

Datatype

boolean

Alias
UMLS CUI [1]
C2136452
UMLS CUI [2]
C0746949
UMLS CUI [3]
C0570514
UMLS CUI [4]
C0038757
currently taking fluconazole or lithium.
Beschrijving

Fluconazole | Lithium

Datatype

boolean

Alias
UMLS CUI [1]
C0016277
UMLS CUI [2]
C0023870
investigational medication use within 6 weeks of enrollment or is scheduled to receive an investigational drug during the course of the study.
Beschrijving

Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C0013230
principal investigator deems subject to be at high risk for non-compliance.
Beschrijving

Compliance behavior Lacking High risk

Datatype

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0332268
UMLS CUI [1,3]
C0332167
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Similar models

Eligibility Squamous Cell Carcinoma NCT00596219

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Squamous cell carcinoma of the oral cavity | Squamous cell carcinoma of oropharynx
Item
untreated squamous cell carcinoma of the oral cavity or oropharynx.
boolean
C0585362 (UMLS CUI [1])
C0280313 (UMLS CUI [2])
Age
Item
older than 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
understand and sign informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Therapeutic procedure Malignant Neoplasm Affected | Chemotherapy | Immunotherapy | Hormone Therapy | Therapeutic radiology procedure | Therapeutic procedure Similar Malignant Neoplasms
Item
any prior treatment of the index cancer (chemotherapy, immunotherapy, hormonal therapy or radiation therapy) or similar treatment of an unrelated malignancy within 6 weeks of enrollment into this study.
boolean
C0087111 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
C0392920 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
C0279025 (UMLS CUI [4])
C1522449 (UMLS CUI [5])
C0087111 (UMLS CUI [6,1])
C2348205 (UMLS CUI [6,2])
C0006826 (UMLS CUI [6,3])
Breast Feeding | Pregnancy | Postmenopausal state | Childbearing Potential Contraceptive methods Inadequate | Sexual Abstinence | Intrauterine Devices | Contraceptives, Oral | Vaginal Spermicides | Vaginal contraceptive diaphragm | Female Condoms | Menstruation
Item
breast-feeding, pregnancy or of childbearing potential (including at least two years post menopause) and unable to confirm adequate contraception (abstinence, iud, birth control pills, or spermicidal gel with diaphragm or condom) since last menses.
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0232970 (UMLS CUI [3])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0205412 (UMLS CUI [4,3])
C0036899 (UMLS CUI [5])
C0021900 (UMLS CUI [6])
C0009905 (UMLS CUI [7])
C0087145 (UMLS CUI [8])
C0042241 (UMLS CUI [9])
C0221829 (UMLS CUI [10])
C0025344 (UMLS CUI [11])
Ulcer of esophagus | Gastric ulcer | Duodenal Ulcer
Item
history of esophageal, gastric or duodenal ulceration within 6 weeks of enrollment.
boolean
C0151970 (UMLS CUI [1])
C0038358 (UMLS CUI [2])
C0013295 (UMLS CUI [3])
Kidney Diseases | Chronic Kidney Diseases | Creatinine measurement
Item
history of acute or chronic renal disorder (blood creatinine level > 1.5 mg/dl).
boolean
C0022658 (UMLS CUI [1])
C1561643 (UMLS CUI [2])
C0201975 (UMLS CUI [3])
Liver diseases | Chronic liver disease | Blood Coagulation Disorders Significant
Item
history of acute or chronic hepatic disorder or a significant bleeding disorder.
boolean
C0023895 (UMLS CUI [1])
C0341439 (UMLS CUI [2])
C0005779 (UMLS CUI [3,1])
C0750502 (UMLS CUI [3,2])
Chronic inflammatory disorder | Ulcerative Colitis | Crohn Disease | Rheumatoid Arthritis | Pancreatitis
Item
history of chronic inflammatory disease (e.g. ulcerative colitis, crohn's disease,rheumatoid arthritis or pancreatitis).
boolean
C1290886 (UMLS CUI [1])
C0009324 (UMLS CUI [2])
C0010346 (UMLS CUI [3])
C0003873 (UMLS CUI [4])
C0030305 (UMLS CUI [5])
Myocardial Infarction | Angina Pectoris | Coronary Artery Disease | Heart Diseases
Item
history of myocardial infarction, angina, or coronary artery disease within the past 6 months, or active cardiac disease.
boolean
C0027051 (UMLS CUI [1])
C0002962 (UMLS CUI [2])
C1956346 (UMLS CUI [3])
C0018799 (UMLS CUI [4])
Cardiac Status New York Heart Association Classification
Item
the subject is of new york heart association (nyha) class 3 or 4 cardiac status.
boolean
C1999091 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Adrenal Cortex Hormones | Nasal Sprays Topical
Item
corticosteroid use within 6 weeks of enrollment, excluding topical nasal sprays.
boolean
C0001617 (UMLS CUI [1])
C2608293 (UMLS CUI [2,1])
C1522168 (UMLS CUI [2,2])
Anti-Inflammatory Agents, Non-Steroidal | celecoxib | Aspirin U/day
Item
nsaid (including celecoxib) or aspirin (> 81 mg/day) use within 1 week of enrollment.
boolean
C0003211 (UMLS CUI [1])
C0538927 (UMLS CUI [2])
C0004057 (UMLS CUI [3,1])
C0456683 (UMLS CUI [3,2])
allergy to COX-2 inhibitors | allergy to nonsteroidal anti-inflammatory agents | Salicylate allergy | Allergy to sulfonamides
Item
history of hypersensitivity to cox-2 inhibitors, nsaids, salicylates, or sulfonamides.
boolean
C2136452 (UMLS CUI [1])
C0746949 (UMLS CUI [2])
C0570514 (UMLS CUI [3])
C0038757 (UMLS CUI [4])
Fluconazole | Lithium
Item
currently taking fluconazole or lithium.
boolean
C0016277 (UMLS CUI [1])
C0023870 (UMLS CUI [2])
Investigational New Drugs
Item
investigational medication use within 6 weeks of enrollment or is scheduled to receive an investigational drug during the course of the study.
boolean
C0013230 (UMLS CUI [1])
Compliance behavior Lacking High risk
Item
principal investigator deems subject to be at high risk for non-compliance.
boolean
C1321605 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C0332167 (UMLS CUI [1,3])
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