ID

16813

Description

Celebrex With Preoperative Chemoradiation - Rectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00188565

Lien

https://clinicaltrials.gov/show/NCT00188565

Mots-clés

  1. 08/08/2016 08/08/2016 -
Téléchargé le

8 août 2016

DOI

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Licence

Creative Commons BY 4.0

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    Eligibility Colorectal Neoplasms NCT00188565

    Eligibility Colorectal Neoplasms NCT00188565

    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    patients with resectable or potentially resectable adenocarcinoma of the rectum
    Description

    Adenocarcinoma of rectum Resectable | Adenocarcinoma of rectum Resectable potential

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0149978
    UMLS CUI [1,2]
    C1514888
    UMLS CUI [2,1]
    C0149978
    UMLS CUI [2,2]
    C1514888
    UMLS CUI [2,3]
    C3245505
    clinical stage t2 n1-2 or t3-4 n0-2 (patients who require diverting loop colostomy are eligible)
    Description

    TNM clinical staging | Loop colostomy - stoma Patient need for

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C3258246
    UMLS CUI [2,1]
    C0444911
    UMLS CUI [2,2]
    C0686904
    age greater than 18 years, ecog performance status < 2 (appendix, section 13.1)
    Description

    Age | ECOG performance status

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    UMLS CUI [2]
    C1520224
    biopsy proven adenocarcinoma, superior margin of the tumour within 15cm of the anal verge on rigid sigmoidoscopy
    Description

    Adenocarcinoma | Biopsy | Tumor margin Upper Distance from anal verge | Rigid sigmoidoscopy

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0001418
    UMLS CUI [2]
    C0005558
    UMLS CUI [3,1]
    C1269830
    UMLS CUI [3,2]
    C1282910
    UMLS CUI [3,3]
    C1317308
    UMLS CUI [4]
    C0399626
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    distant metastasis, prior pelvic irradiation, inflammatory bowel disease, medical conditions which preclude radical therapy
    Description

    distant metastasis | irradiation of pelvis | Inflammatory Bowel Diseases | medical condition Exclusion Radical therapy

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1269798
    UMLS CUI [2]
    C0747411
    UMLS CUI [3]
    C0021390
    UMLS CUI [4,1]
    C3843040
    UMLS CUI [4,2]
    C2828389
    UMLS CUI [4,3]
    C0260176
    history of malignancy within five years (except nonmelanoma skin cancer, cin cervix)
    Description

    Malignant Neoplasms | Skin carcinoma | Carcinoma in situ of uterine cervix

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    UMLS CUI [2]
    C0699893
    UMLS CUI [3]
    C0851140
    pregnancy
    Description

    Pregnancy

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    hypersensitivity to celecoxib, nsaid, sulfonamides or 5-fu
    Description

    Hypersensitivity celecoxib | Hypersensitivity Anti-Inflammatory Agents, Non-Steroidal | Hypersensitivity Sulfonamides | Hypersensitivity Fluorouracil

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0538927
    UMLS CUI [2,1]
    C0020517
    UMLS CUI [2,2]
    C0003211
    UMLS CUI [3,1]
    C0020517
    UMLS CUI [3,2]
    C0038760
    UMLS CUI [4,1]
    C0020517
    UMLS CUI [4,2]
    C0016360
    significant comorbid illness
    Description

    Comorbidity Significant

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0009488
    UMLS CUI [1,2]
    C0750502
    history of peptic ulcer disease or nsaid-related gastrointestinal bleeding
    Description

    Peptic Ulcer | Gastrointestinal Hemorrhage NSAID Related

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0030920
    UMLS CUI [2,1]
    C0017181
    UMLS CUI [2,2]
    C0003211
    UMLS CUI [2,3]
    C0439849
    use of aspirin, other nsaid or coxib in the two weeks prior to study entry
    Description

    Aspirin | Anti-Inflammatory Agents, Non-Steroidal | Cyclooxygenase 2 Inhibitors

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0004057
    UMLS CUI [2]
    C0003211
    UMLS CUI [3]
    C1257954
    neutrophil count <1.5x109/l, platelet count <100x109/l, serum bilirubin >1.25xuln (upper limit of normal), ast/alt >3xuln, serum creatinine >1.25xuln
    Description

    Absolute neutrophil count | Platelet Count measurement | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Creatinine measurement, serum

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0948762
    UMLS CUI [2]
    C0032181
    UMLS CUI [3]
    C1278039
    UMLS CUI [4]
    C0201899
    UMLS CUI [5]
    C0201836
    UMLS CUI [6]
    C0201976

    Similar models

    Eligibility Colorectal Neoplasms NCT00188565

    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Adenocarcinoma of rectum Resectable | Adenocarcinoma of rectum Resectable potential
    Item
    patients with resectable or potentially resectable adenocarcinoma of the rectum
    boolean
    C0149978 (UMLS CUI [1,1])
    C1514888 (UMLS CUI [1,2])
    C0149978 (UMLS CUI [2,1])
    C1514888 (UMLS CUI [2,2])
    C3245505 (UMLS CUI [2,3])
    TNM clinical staging | Loop colostomy - stoma Patient need for
    Item
    clinical stage t2 n1-2 or t3-4 n0-2 (patients who require diverting loop colostomy are eligible)
    boolean
    C3258246 (UMLS CUI [1])
    C0444911 (UMLS CUI [2,1])
    C0686904 (UMLS CUI [2,2])
    Age | ECOG performance status
    Item
    age greater than 18 years, ecog performance status < 2 (appendix, section 13.1)
    boolean
    C0001779 (UMLS CUI [1])
    C1520224 (UMLS CUI [2])
    Adenocarcinoma | Biopsy | Tumor margin Upper Distance from anal verge | Rigid sigmoidoscopy
    Item
    biopsy proven adenocarcinoma, superior margin of the tumour within 15cm of the anal verge on rigid sigmoidoscopy
    boolean
    C0001418 (UMLS CUI [1])
    C0005558 (UMLS CUI [2])
    C1269830 (UMLS CUI [3,1])
    C1282910 (UMLS CUI [3,2])
    C1317308 (UMLS CUI [3,3])
    C0399626 (UMLS CUI [4])
    Item Group
    C0680251 (UMLS CUI)
    distant metastasis | irradiation of pelvis | Inflammatory Bowel Diseases | medical condition Exclusion Radical therapy
    Item
    distant metastasis, prior pelvic irradiation, inflammatory bowel disease, medical conditions which preclude radical therapy
    boolean
    C1269798 (UMLS CUI [1])
    C0747411 (UMLS CUI [2])
    C0021390 (UMLS CUI [3])
    C3843040 (UMLS CUI [4,1])
    C2828389 (UMLS CUI [4,2])
    C0260176 (UMLS CUI [4,3])
    Malignant Neoplasms | Skin carcinoma | Carcinoma in situ of uterine cervix
    Item
    history of malignancy within five years (except nonmelanoma skin cancer, cin cervix)
    boolean
    C0006826 (UMLS CUI [1])
    C0699893 (UMLS CUI [2])
    C0851140 (UMLS CUI [3])
    Pregnancy
    Item
    pregnancy
    boolean
    C0032961 (UMLS CUI [1])
    Hypersensitivity celecoxib | Hypersensitivity Anti-Inflammatory Agents, Non-Steroidal | Hypersensitivity Sulfonamides | Hypersensitivity Fluorouracil
    Item
    hypersensitivity to celecoxib, nsaid, sulfonamides or 5-fu
    boolean
    C0020517 (UMLS CUI [1,1])
    C0538927 (UMLS CUI [1,2])
    C0020517 (UMLS CUI [2,1])
    C0003211 (UMLS CUI [2,2])
    C0020517 (UMLS CUI [3,1])
    C0038760 (UMLS CUI [3,2])
    C0020517 (UMLS CUI [4,1])
    C0016360 (UMLS CUI [4,2])
    Comorbidity Significant
    Item
    significant comorbid illness
    boolean
    C0009488 (UMLS CUI [1,1])
    C0750502 (UMLS CUI [1,2])
    Peptic Ulcer | Gastrointestinal Hemorrhage NSAID Related
    Item
    history of peptic ulcer disease or nsaid-related gastrointestinal bleeding
    boolean
    C0030920 (UMLS CUI [1])
    C0017181 (UMLS CUI [2,1])
    C0003211 (UMLS CUI [2,2])
    C0439849 (UMLS CUI [2,3])
    Aspirin | Anti-Inflammatory Agents, Non-Steroidal | Cyclooxygenase 2 Inhibitors
    Item
    use of aspirin, other nsaid or coxib in the two weeks prior to study entry
    boolean
    C0004057 (UMLS CUI [1])
    C0003211 (UMLS CUI [2])
    C1257954 (UMLS CUI [3])
    Absolute neutrophil count | Platelet Count measurement | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Creatinine measurement, serum
    Item
    neutrophil count <1.5x109/l, platelet count <100x109/l, serum bilirubin >1.25xuln (upper limit of normal), ast/alt >3xuln, serum creatinine >1.25xuln
    boolean
    C0948762 (UMLS CUI [1])
    C0032181 (UMLS CUI [2])
    C1278039 (UMLS CUI [3])
    C0201899 (UMLS CUI [4])
    C0201836 (UMLS CUI [5])
    C0201976 (UMLS CUI [6])

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