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ID

37684

Beschreibung

Lenalidomide, MTX, Ara-C and Rituximab in Relapsed Aggressive B-cell Lymphomas; ODM derived from: https://clinicaltrials.gov/show/NCT01788189

Link

https://clinicaltrials.gov/show/NCT01788189

Stichworte

Versionen (2)
  1. 16.08.19 16.08.19 -
  2. 16.08.19 16.08.19 -
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See clinicaltrials.gov

Hochgeladen am

16. August 2019

DOI

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    Eligibility B-cell Lymphoma NCT01788189

    Englisch

    Eligibility B-cell Lymphoma NCT01788189

    1 Formulare  
    Inclusion Criteria
    Beschreibung

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    age ≥ 18 years
    Beschreibung

    Age

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    performance status ecog 0 - 3
    Beschreibung

    ECOG performance status

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1520224 (ECOG performance status)
    SNOMED
    423740007
    first or subsequent relapse or refractoriness of a biopsy-proven cd20-positive aggressive b cell lymphoma (excluding mantle cell lymphoma)
    Beschreibung

    Recurrent Aggressive Adult Non-Hodgkin Lymphoma B-Cell CD20 positive | Non-Hodgkin's lymphoma aggressive refractory B-Cell CD20 positive | Exception Mantle cell lymphoma

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0677726 (Recurrent Aggressive Adult Non-Hodgkin Lymphoma)
    UMLS CUI [1,2]
    C0004561 (B-Lymphocytes)
    SNOMED
    112130006
    UMLS CUI [1,3]
    C3888518 (CD20 antigen positive)
    UMLS CUI [2,1]
    C0854870 (Non-Hodgkin's lymphoma unspecified histology aggressive refractory)
    UMLS CUI [2,2]
    C0004561 (B-Lymphocytes)
    SNOMED
    112130006
    UMLS CUI [2,3]
    C3888518 (CD20 antigen positive)
    UMLS CUI [3,1]
    C1705847 (Exception - Property or Attribute)
    UMLS CUI [3,2]
    C0334634 (Malignant lymphoma, lymphocytic, intermediate differentiation, diffuse)
    SNOMED
    74654000
    measurable disease
    Beschreibung

    Measurable Disease

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1513041 (Measurable Disease)
    ineligibility or unwillingness to undergo high-dose chemotherapy with autologous stem cell transplantation
    Beschreibung

    Ineligibility High-Dose Chemotherapy with Autologous Stem Cell Transplant | High-Dose Chemotherapy with Autologous Stem Cell Transplant Unwilling

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1512714 (Ineligibility)
    UMLS CUI [1,2]
    C1512429 (High-Dose Chemotherapy with Autologous Stem Cell Transplant)
    UMLS CUI [2,1]
    C1512429 (High-Dose Chemotherapy with Autologous Stem Cell Transplant)
    UMLS CUI [2,2]
    C0558080 (Unwilling)
    SNOMED
    225465005
    ability to understand the aim of the study and act accordingly
    Beschreibung

    Comprehension Study Protocol | Protocol Compliance

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0162340 (Comprehension)
    SNOMED
    66216009
    UMLS CUI [1,2]
    C2348563 (Study Protocol)
    UMLS CUI [2]
    C0525058 (Protocol Compliance)
    effective contraception
    Beschreibung

    Contraceptive methods

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0700589 (Contraceptive methods)
    SNOMED
    13197004
    signed informed consent
    Beschreibung

    Informed Consent

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    Exclusion Criteria
    Beschreibung

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    central nervous system relapse of aggressive lymphoma
    Beschreibung

    Central nervous system lymphoma Aggressive Relapse

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0280803 (Primary central nervous system lymphoma)
    SNOMED
    307649006
    UMLS CUI [1,2]
    C0580822 (Aggressive course)
    UMLS CUI [1,3]
    C0205336 (Relapsing course)
    SNOMED
    255318003
    any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study
    Beschreibung

    Medical condition Study Subject Participation Status Excluded | Laboratory test result abnormal Study Subject Participation Status Excluded | Mental disorder Study Subject Participation Status Excluded

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C3843040 (Other medical condition)
    LOINC
    LA16346-1
    UMLS CUI [1,2]
    C2348568 (Study Subject Participation Status)
    UMLS CUI [1,3]
    C0332196 (Exclude)
    SNOMED
    77765009
    UMLS CUI [2,1]
    C0438215 (Laboratory test result abnormal)
    SNOMED
    165346000
    UMLS CUI [2,2]
    C2348568 (Study Subject Participation Status)
    UMLS CUI [2,3]
    C0332196 (Exclude)
    SNOMED
    77765009
    UMLS CUI [3,1]
    C0004936 (Mental disorders)
    SNOMED
    74732009
    UMLS CUI [3,2]
    C2348568 (Study Subject Participation Status)
    UMLS CUI [3,3]
    C0332196 (Exclude)
    SNOMED
    77765009
    any condition including the presence of laboratory abnormalities which places the subject at unacceptable risk if he/she were to participate in the study
    Beschreibung

    Condition Study Subject Participation Status At risk | Laboratory test result abnormal Study Subject Participation Status At risk

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0348080 (Condition)
    SNOMED
    260905004
    LOINC
    LP185404-3
    UMLS CUI [1,2]
    C2348568 (Study Subject Participation Status)
    UMLS CUI [1,3]
    C1444641 (At risk)
    SNOMED
    410519009
    LOINC
    LA19952-3
    UMLS CUI [2,1]
    C0438215 (Laboratory test result abnormal)
    SNOMED
    165346000
    UMLS CUI [2,2]
    C2348568 (Study Subject Participation Status)
    UMLS CUI [2,3]
    C1444641 (At risk)
    SNOMED
    410519009
    LOINC
    LA19952-3
    any condition that confounds the ability to interpret data from the study
    Beschreibung

    Condition Interferes with Interpretation Research data

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0348080 (Condition)
    SNOMED
    260905004
    LOINC
    LP185404-3
    UMLS CUI [1,2]
    C0521102 (Interferes with)
    SNOMED
    78235001
    UMLS CUI [1,3]
    C0459471 (Interpretation Process)
    SNOMED
    280452008
    LOINC
    LP21032-5
    UMLS CUI [1,4]
    C0681873 (research data)
    inadequate organ function not related to aggressive lymphoma:
    Beschreibung

    Organ function Inadequate | Relationship Absent Aggressive Lymphoma

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0678852 (body system or organ function)
    UMLS CUI [1,2]
    C0205412 (Inadequate (qualifier))
    SNOMED
    71978007
    LOINC
    LA8914-9
    UMLS CUI [2,1]
    C0439849 (Relationships)
    SNOMED
    263498003
    LOINC
    LP146886-9
    UMLS CUI [2,2]
    C0332197 (Absent)
    SNOMED
    2667000
    LOINC
    LA9634-2
    UMLS CUI [2,3]
    C1332225 (Aggressive Non-Hodgkin Lymphoma)
    neutrophils < 1.0/nl
    Beschreibung

    Neutrophil count

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0200633 (Neutrophil count (procedure))
    SNOMED
    30630007
    platelets < 75/nl
    Beschreibung

    Platelet Count measurement

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0032181 (Platelet Count measurement)
    SNOMED
    61928009
    creatinine clearance < 60 ml/min
    Beschreibung

    Creatinine clearance measurement

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0373595 (Creatinine clearance measurement)
    SNOMED
    167181009
    bilirubin ≥ 2,5 mg/dl
    Beschreibung

    Bilirubin measurement

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0344395 (Bilirubin measurement)
    SNOMED
    302787001
    serum ast/got or alt/gpt ≥ 4 x upper limit of normal
    Beschreibung

    Aspartate aminotransferase increased | Alanine aminotransferase increased

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0151904 (Aspartate Aminotransferase Increased)
    UMLS CUI [2]
    C0151905 (Alanine Aminotransferase Increased)
    active viral hepatitis (hbv, hcv), hiv infection, any other uncontrolled infection
    Beschreibung

    Viral hepatitis | Hepatitis B | Hepatitis C | HIV Infection | Communicable Disease Uncontrolled

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0042721 (Viral hepatitis)
    SNOMED
    3738000
    LOINC
    MTHU020837
    UMLS CUI [2]
    C0019163 (Hepatitis B)
    SNOMED
    66071002
    LOINC
    LA18126-5
    UMLS CUI [3]
    C0019196 (Hepatitis C)
    SNOMED
    50711007
    LOINC
    LA19423-5
    UMLS CUI [4]
    C0019693 (HIV Infections)
    SNOMED
    86406008
    UMLS CUI [5,1]
    C0009450 (Communicable Diseases)
    SNOMED
    189822004
    UMLS CUI [5,2]
    C0205318 (Uncontrolled)
    SNOMED
    19032002
    pregnancy and nursing period
    Beschreibung

    Pregnancy | Breast Feeding

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    UMLS CUI [2]
    C0006147 (Breast Feeding)
    SNOMED
    169741004
    LOINC
    LP420040-0
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Eligibility B-cell Lymphoma NCT01788189

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age
    Item
    age ≥ 18 years
    boolean
    C0001779 (UMLS CUI [1])
    ECOG performance status
    Item
    performance status ecog 0 - 3
    boolean
    C1520224 (UMLS CUI [1])
    Recurrent Aggressive Adult Non-Hodgkin Lymphoma B-Cell CD20 positive | Non-Hodgkin's lymphoma aggressive refractory B-Cell CD20 positive | Exception Mantle cell lymphoma
    Item
    first or subsequent relapse or refractoriness of a biopsy-proven cd20-positive aggressive b cell lymphoma (excluding mantle cell lymphoma)
    boolean
    C0677726 (UMLS CUI [1,1])
    C0004561 (UMLS CUI [1,2])
    C3888518 (UMLS CUI [1,3])
    C0854870 (UMLS CUI [2,1])
    C0004561 (UMLS CUI [2,2])
    C3888518 (UMLS CUI [2,3])
    C1705847 (UMLS CUI [3,1])
    C0334634 (UMLS CUI [3,2])
    Measurable Disease
    Item
    measurable disease
    boolean
    C1513041 (UMLS CUI [1])
    Ineligibility High-Dose Chemotherapy with Autologous Stem Cell Transplant | High-Dose Chemotherapy with Autologous Stem Cell Transplant Unwilling
    Item
    ineligibility or unwillingness to undergo high-dose chemotherapy with autologous stem cell transplantation
    boolean
    C1512714 (UMLS CUI [1,1])
    C1512429 (UMLS CUI [1,2])
    C1512429 (UMLS CUI [2,1])
    C0558080 (UMLS CUI [2,2])
    Comprehension Study Protocol | Protocol Compliance
    Item
    ability to understand the aim of the study and act accordingly
    boolean
    C0162340 (UMLS CUI [1,1])
    C2348563 (UMLS CUI [1,2])
    C0525058 (UMLS CUI [2])
    Contraceptive methods
    Item
    effective contraception
    boolean
    C0700589 (UMLS CUI [1])
    Informed Consent
    Item
    signed informed consent
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Central nervous system lymphoma Aggressive Relapse
    Item
    central nervous system relapse of aggressive lymphoma
    boolean
    C0280803 (UMLS CUI [1,1])
    C0580822 (UMLS CUI [1,2])
    C0205336 (UMLS CUI [1,3])
    Medical condition Study Subject Participation Status Excluded | Laboratory test result abnormal Study Subject Participation Status Excluded | Mental disorder Study Subject Participation Status Excluded
    Item
    any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study
    boolean
    C3843040 (UMLS CUI [1,1])
    C2348568 (UMLS CUI [1,2])
    C0332196 (UMLS CUI [1,3])
    C0438215 (UMLS CUI [2,1])
    C2348568 (UMLS CUI [2,2])
    C0332196 (UMLS CUI [2,3])
    C0004936 (UMLS CUI [3,1])
    C2348568 (UMLS CUI [3,2])
    C0332196 (UMLS CUI [3,3])
    Condition Study Subject Participation Status At risk | Laboratory test result abnormal Study Subject Participation Status At risk
    Item
    any condition including the presence of laboratory abnormalities which places the subject at unacceptable risk if he/she were to participate in the study
    boolean
    C0348080 (UMLS CUI [1,1])
    C2348568 (UMLS CUI [1,2])
    C1444641 (UMLS CUI [1,3])
    C0438215 (UMLS CUI [2,1])
    C2348568 (UMLS CUI [2,2])
    C1444641 (UMLS CUI [2,3])
    Condition Interferes with Interpretation Research data
    Item
    any condition that confounds the ability to interpret data from the study
    boolean
    C0348080 (UMLS CUI [1,1])
    C0521102 (UMLS CUI [1,2])
    C0459471 (UMLS CUI [1,3])
    C0681873 (UMLS CUI [1,4])
    Organ function Inadequate | Relationship Absent Aggressive Lymphoma
    Item
    inadequate organ function not related to aggressive lymphoma:
    boolean
    C0678852 (UMLS CUI [1,1])
    C0205412 (UMLS CUI [1,2])
    C0439849 (UMLS CUI [2,1])
    C0332197 (UMLS CUI [2,2])
    C1332225 (UMLS CUI [2,3])
    Neutrophil count
    Item
    neutrophils < 1.0/nl
    boolean
    C0200633 (UMLS CUI [1])
    Platelet Count measurement
    Item
    platelets < 75/nl
    boolean
    C0032181 (UMLS CUI [1])
    Creatinine clearance measurement
    Item
    creatinine clearance < 60 ml/min
    boolean
    C0373595 (UMLS CUI [1])
    Bilirubin measurement
    Item
    bilirubin ≥ 2,5 mg/dl
    boolean
    C0344395 (UMLS CUI [1])
    Aspartate aminotransferase increased | Alanine aminotransferase increased
    Item
    serum ast/got or alt/gpt ≥ 4 x upper limit of normal
    boolean
    C0151904 (UMLS CUI [1])
    C0151905 (UMLS CUI [2])
    Viral hepatitis | Hepatitis B | Hepatitis C | HIV Infection | Communicable Disease Uncontrolled
    Item
    active viral hepatitis (hbv, hcv), hiv infection, any other uncontrolled infection
    boolean
    C0042721 (UMLS CUI [1])
    C0019163 (UMLS CUI [2])
    C0019196 (UMLS CUI [3])
    C0019693 (UMLS CUI [4])
    C0009450 (UMLS CUI [5,1])
    C0205318 (UMLS CUI [5,2])
    Pregnancy | Breast Feeding
    Item
    pregnancy and nursing period
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Zum Seitenanfang zurückkehren 

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