0 Bedömningar
ID

43806

Beskrivning

Study of Safety and Tolerability of Intravenous CRS-100 in Adults With Carcinoma and Liver Metastases; ODM derived from: https://clinicaltrials.gov/show/NCT00327652

Länk

https://clinicaltrials.gov/show/NCT00327652

Nyckelord

Versioner (3)
  1. 2017-05-16 2017-05-16 -
  2. 2017-05-16 2017-05-16 -
  3. 2021-09-20 2021-09-20 -
Uppladdad den

20 september 2021

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

  • Senaste
  • Äldsta
  • Önskad
  • Senaste
    • Senaste
    • Äldsta
    • Önskad

    Inga kommentarer

    Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

    Eligibility Neoplasm Metastasis NCT00327652

    Engelsk

    Eligibility Neoplasm Metastasis NCT00327652

    1 Formulär  
    Criteria
    Beskrivning

    Criteria

    1. documented carcinoma refractory to standard treatment (or for whom no standard treatment is available). hepatocellular carcinoma (hcc) is not allowed.
    Beskrivning

    Carcinoma | Standard therapy refractory | Standard therapy Unavailable | Liver carcinoma

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0007097
    UMLS CUI [2,1]
    C2936643
    UMLS CUI [2,2]
    C0205269
    UMLS CUI [3,1]
    C2936643
    UMLS CUI [3,2]
    C0686905
    UMLS CUI [4]
    C2239176
    2. hepatic metastases
    Beskrivning

    Secondary malignant neoplasm of liver

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0494165
    3. ecog performance status of 0 or 1, or karnofsky performance status (kps) of 80% to 100%.
    Beskrivning

    ECOG performance status | Karnofsky Performance Status

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    UMLS CUI [2]
    C0206065
    4. adequate organ function as defined by clinical hematology and chemistry assays.
    Beskrivning

    Organ function

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0678852
    exclusion criteria (abbreviated):
    Beskrivning

    Exclusion Criteria

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0680251
    1. known central nervous system metastases.
    Beskrivning

    CNS metastases

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0686377
    2. history of allergic reactions attributed to sulfa or beta-lactam antibiotics.
    Beskrivning

    Allergy to sulfonamides | BETA LACTAM ALLERGY

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0038757
    UMLS CUI [2]
    C0741476
    3. cardiac conditions associated with high- or moderate-risk of endocarditis.
    Beskrivning

    Condition cardiac | Endocarditis High risk | Endocarditis Risk Moderate

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0348080
    UMLS CUI [1,2]
    C0018787
    UMLS CUI [2,1]
    C0014118
    UMLS CUI [2,2]
    C0332167
    UMLS CUI [3,1]
    C0014118
    UMLS CUI [3,2]
    C0035647
    UMLS CUI [3,3]
    C0205081
    4. intra-arterial hepatic catheter, hepatic cirrhosis, or clinically relevant ascites.
    Beskrivning

    Hepatic artery catheter | Liver Cirrhosis | Ascites

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1321092
    UMLS CUI [2]
    C0023890
    UMLS CUI [3]
    C0003962
    5. artificial (prosthetic) joint or other artificial implant or devices that cannot easily be removed.
    Beskrivning

    Artificial joint | Joint Prosthesis | Artificial Implants | Artificial structure

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0481488
    UMLS CUI [2]
    C0022414
    UMLS CUI [3]
    C0021113
    UMLS CUI [4]
    C0336559
    6. known coagulation disorder or recent thromboembolic event.
    Beskrivning

    Blood Coagulation Disorders | Thromboembolism

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0005779
    UMLS CUI [2]
    C0040038
    7. use of immunosuppressive agent, chemotherapy, or radiation therapy within 28 days prior to crs-100; bone marrow or stem cell transplant or a major organ allograft; autoimmune disease.
    Beskrivning

    Immunosuppressive Agents | Chemotherapy | Therapeutic radiology procedure | CRS-100 | Bone Marrow Transplantation | Stem cell transplant | Organ Major Allograft | Autoimmune Disease

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0021081
    UMLS CUI [2]
    C0392920
    UMLS CUI [3]
    C1522449
    UMLS CUI [4]
    C1831855
    UMLS CUI [5]
    C0005961
    UMLS CUI [6]
    C1504389
    UMLS CUI [7,1]
    C0178784
    UMLS CUI [7,2]
    C0205164
    UMLS CUI [7,3]
    C0040739
    UMLS CUI [8]
    C0004364
    8. current history of gallstones or kidney stones.
    Beskrivning

    Cholelithiasis | Nephrolithiasis

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0008350
    UMLS CUI [2]
    C0392525
    9. infection with hiv, human t-lymphotropic virus type 1 (htlv-1), hepatitis c virus (hcv), or hepatitis b virus (hbv).
    Beskrivning

    HIV Infection | Human T-cell lymphotropic virus 1 infection | Hepatitis C | Hepatitis B

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0019693
    UMLS CUI [2]
    C0020097
    UMLS CUI [3]
    C0019196
    UMLS CUI [4]
    C0019163
    10. pregnant or lactating
    Beskrivning

    Pregnancy | Breast Feeding

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    Tillbaka till toppen

    Similar models

    Eligibility Neoplasm Metastasis NCT00327652

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Carcinoma | Standard therapy refractory | Standard therapy Unavailable | Liver carcinoma
    Item
    1. documented carcinoma refractory to standard treatment (or for whom no standard treatment is available). hepatocellular carcinoma (hcc) is not allowed.
    boolean
    C0007097 (UMLS CUI [1])
    C2936643 (UMLS CUI [2,1])
    C0205269 (UMLS CUI [2,2])
    C2936643 (UMLS CUI [3,1])
    C0686905 (UMLS CUI [3,2])
    C2239176 (UMLS CUI [4])
    Secondary malignant neoplasm of liver
    Item
    2. hepatic metastases
    boolean
    C0494165 (UMLS CUI [1])
    ECOG performance status | Karnofsky Performance Status
    Item
    3. ecog performance status of 0 or 1, or karnofsky performance status (kps) of 80% to 100%.
    boolean
    C1520224 (UMLS CUI [1])
    C0206065 (UMLS CUI [2])
    Organ function
    Item
    4. adequate organ function as defined by clinical hematology and chemistry assays.
    boolean
    C0678852 (UMLS CUI [1])
    Exclusion Criteria
    Item
    exclusion criteria (abbreviated):
    boolean
    C0680251 (UMLS CUI [1])
    CNS metastases
    Item
    1. known central nervous system metastases.
    boolean
    C0686377 (UMLS CUI [1])
    Allergy to sulfonamides | BETA LACTAM ALLERGY
    Item
    2. history of allergic reactions attributed to sulfa or beta-lactam antibiotics.
    boolean
    C0038757 (UMLS CUI [1])
    C0741476 (UMLS CUI [2])
    Condition cardiac | Endocarditis High risk | Endocarditis Risk Moderate
    Item
    3. cardiac conditions associated with high- or moderate-risk of endocarditis.
    boolean
    C0348080 (UMLS CUI [1,1])
    C0018787 (UMLS CUI [1,2])
    C0014118 (UMLS CUI [2,1])
    C0332167 (UMLS CUI [2,2])
    C0014118 (UMLS CUI [3,1])
    C0035647 (UMLS CUI [3,2])
    C0205081 (UMLS CUI [3,3])
    Hepatic artery catheter | Liver Cirrhosis | Ascites
    Item
    4. intra-arterial hepatic catheter, hepatic cirrhosis, or clinically relevant ascites.
    boolean
    C1321092 (UMLS CUI [1])
    C0023890 (UMLS CUI [2])
    C0003962 (UMLS CUI [3])
    Artificial joint | Joint Prosthesis | Artificial Implants | Artificial structure
    Item
    5. artificial (prosthetic) joint or other artificial implant or devices that cannot easily be removed.
    boolean
    C0481488 (UMLS CUI [1])
    C0022414 (UMLS CUI [2])
    C0021113 (UMLS CUI [3])
    C0336559 (UMLS CUI [4])
    Blood Coagulation Disorders | Thromboembolism
    Item
    6. known coagulation disorder or recent thromboembolic event.
    boolean
    C0005779 (UMLS CUI [1])
    C0040038 (UMLS CUI [2])
    Immunosuppressive Agents | Chemotherapy | Therapeutic radiology procedure | CRS-100 | Bone Marrow Transplantation | Stem cell transplant | Organ Major Allograft | Autoimmune Disease
    Item
    7. use of immunosuppressive agent, chemotherapy, or radiation therapy within 28 days prior to crs-100; bone marrow or stem cell transplant or a major organ allograft; autoimmune disease.
    boolean
    C0021081 (UMLS CUI [1])
    C0392920 (UMLS CUI [2])
    C1522449 (UMLS CUI [3])
    C1831855 (UMLS CUI [4])
    C0005961 (UMLS CUI [5])
    C1504389 (UMLS CUI [6])
    C0178784 (UMLS CUI [7,1])
    C0205164 (UMLS CUI [7,2])
    C0040739 (UMLS CUI [7,3])
    C0004364 (UMLS CUI [8])
    Cholelithiasis | Nephrolithiasis
    Item
    8. current history of gallstones or kidney stones.
    boolean
    C0008350 (UMLS CUI [1])
    C0392525 (UMLS CUI [2])
    HIV Infection | Human T-cell lymphotropic virus 1 infection | Hepatitis C | Hepatitis B
    Item
    9. infection with hiv, human t-lymphotropic virus type 1 (htlv-1), hepatitis c virus (hcv), or hepatitis b virus (hbv).
    boolean
    C0019693 (UMLS CUI [1])
    C0020097 (UMLS CUI [2])
    C0019196 (UMLS CUI [3])
    C0019163 (UMLS CUI [4])
    Pregnancy | Breast Feeding
    Item
    10. pregnant or lactating
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Tillbaka till toppen 

    Hjälp

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial