ID

129

Descrição

ODM derived from http://clinicaltrials.gov/show/NCT00185393

Link

http://clinicaltrials.gov/show/NCT00185393

Palavras-chave

  1. 09/12/2011 09/12/2011 -
  2. 04/06/2017 04/06/2017 - Martin Dugas
Transferido a

9 de dezembro de 2011

DOI

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Licença

Creative Commons BY-NC 3.0

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Eligibility NCT00185393 Lymphoma, Non-Hodgkin

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Descrição

Inclusion Criteria

18 Years and older
Descrição

Age

Tipo de dados

boolean

Non Hodgkin Lymphoma stage III or IV at timepoint of diagnosis
Descrição

NHL III/IV

Tipo de dados

boolean

Patients who have achieved a remission after first line chemotherapy
Descrição

remission after first line chemotherapy

Tipo de dados

boolean

No less than 6 weeks and no more than 12 weeks since last dose of chemotherapy
Descrição

6-12 weeks since last dose of chemotherapy

Tipo de dados

boolean

written informed consent
Descrição

consent

Tipo de dados

boolean

Exclusion Criteria
Descrição

Exclusion Criteria

Any other anticancer treatment for NHL except the preceding first line chemotherapy
Descrição

Any other anticancer treatment for NHL except the preceding first line chemotherapy

Tipo de dados

boolean

Prior radiation therapy
Descrição

Prior radiation therapy

Tipo de dados

boolean

Patients who have not recovered from the toxic effects of the first line chemotherapy
Descrição

no recovery from chemotherapy

Tipo de dados

boolean

Any other cancer or history of cancer less than 10 years ago
Descrição

other cancer

Tipo de dados

boolean

Patients with known HIV positivity
Descrição

HIV

Tipo de dados

boolean

patients with pleural effusion or ascites
Descrição

pleural effusion or ascites

Tipo de dados

boolean

female patients who are pregnant or breast feeding (women of childbearing potential must have a negative serum pregnancy test at study entry)
Descrição

pregnant or breast feeding

Tipo de dados

boolean

Adults not employing an effective method of birth control during study treatment and 12 months thereafter
Descrição

no contraception

Tipo de dados

boolean

Patients unable or unwilling to comply with protocol
Descrição

non-compliance

Tipo de dados

boolean

Medical concepts
Descrição

Medical concepts

Age
Descrição

Age

Tipo de dados

string

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
102518004
Diagnosis
Descrição

Diagnosis

Tipo de dados

string

Alias
UMLS CUI
C0011900
SNOMED CT 2010_0731
439401001
LOINC Version 232
MTHU008876
Lymphoma, Non-Hodgkin (Non-Hodgkins lymphoma)
Descrição

NHL

Tipo de dados

string

Alias
UMLS CUI
C0024305
SNOMED CT 2010_0731
118601006
MedDRA 13.1
10029547
ICD-10-CM Version 2010
C85.9
Diagnostic Neoplasm Staging
Descrição

Tumor Staging

Tipo de dados

string

Alias
UMLS CUI
C0027646
SNOMED CT 2010_0731
254292007
LOINC Version 232
LP78422-0
Disease remission
Descrição

Remission

Tipo de dados

string

Alias
UMLS CUI
C0544452
SNOMED CT 2010_0731
277022003
Medication
Descrição

Pharmaceutical Preparations

Tipo de dados

string

Alias
UMLS CUI
C0013227
Chemotherapy
Descrição

Chemotherapy

Tipo de dados

string

Alias
UMLS CUI
C0392920
SNOMED CT 2010_0731
150415003
Informed Consent
Descrição

Informed Consent

Tipo de dados

string

Alias
UMLS CUI
C0021430
First-Line Treatment (primary treatment)
Descrição

First-Line Therapy (primary therapy)

Tipo de dados

string

Alias
UMLS CUI
C1708063
Radiotherapy
Descrição

Radiotherapy

Tipo de dados

string

Alias
UMLS CUI
C1522449
SNOMED CT 2010_0731
302505005
Recovery - healing process
Descrição

Recovery

Tipo de dados

string

Alias
UMLS CUI
C2004454
Malignant Neoplasms
Descrição

Cancer

Tipo de dados

string

Alias
UMLS CUI
C0006826
SNOMED CT 2010_0731
363346000
MedDRA 13.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
HIV negative
Descrição

HIV negative

Tipo de dados

string

Alias
UMLS CUI
C0481430
SNOMED CT 2010_0731
143223008
MedDRA 13.1
10020179
Pleural effusion disorder
Descrição

Pleural effusion

Tipo de dados

string

Alias
UMLS CUI
C0032227
SNOMED CT 2010_0731
60046008
MedDRA 13.1
10035598
ICD-10-CM Version 2010
J90
ICD-9-CM Version 2011
511.9
CTCAE Version 4.03
E13486
Ascites
Descrição

Ascites

Tipo de dados

string

Alias
UMLS CUI
C0003962
SNOMED CT 2010_0731
389026000
MedDRA 13.1
10003445
ICD-10-CM Version 2010
R18
ICD-9-CM Version 2011
789.5
CTCAE Version 4.03
E10502
pregnant
Descrição

pregnant

Tipo de dados

string

Alias
UMLS CUI
C0549206
MedDRA 13.1
10036586
Breast feeding, Nursing
Descrição

Lactation

Tipo de dados

string

Alias
UMLS CUI
C0006147
MedDRA 13.1
10006247
Serum pregnancy test (B-HCG)
Descrição

Serum pregnancy test

Tipo de dados

string

Alias
UMLS CUI
C0430060
SNOMED CT 2010_0731
166434005
Contraception
Descrição

Contraception

Tipo de dados

string

Alias
UMLS CUI
C0700589
SNOMED CT 2010_0731
146680009
MedDRA 13.1
10010808
Compliance
Descrição

Compliance

Tipo de dados

string

Alias
UMLS CUI
C1321605
SNOMED CT 2010_0731
405078008

Similar models

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Inclusion Criteria
Age
Item
18 Years and older
boolean
NHL III/IV
Item
Non Hodgkin Lymphoma stage III or IV at timepoint of diagnosis
boolean
remission after first line chemotherapy
Item
Patients who have achieved a remission after first line chemotherapy
boolean
6-12 weeks since last dose of chemotherapy
Item
No less than 6 weeks and no more than 12 weeks since last dose of chemotherapy
boolean
consent
Item
written informed consent
boolean
Item Group
Exclusion Criteria
Any other anticancer treatment for NHL except the preceding first line chemotherapy
Item
Any other anticancer treatment for NHL except the preceding first line chemotherapy
boolean
Prior radiation therapy
Item
Prior radiation therapy
boolean
no recovery from chemotherapy
Item
Patients who have not recovered from the toxic effects of the first line chemotherapy
boolean
other cancer
Item
Any other cancer or history of cancer less than 10 years ago
boolean
HIV
Item
Patients with known HIV positivity
boolean
pleural effusion or ascites
Item
patients with pleural effusion or ascites
boolean
pregnant or breast feeding
Item
female patients who are pregnant or breast feeding (women of childbearing potential must have a negative serum pregnancy test at study entry)
boolean
no contraception
Item
Adults not employing an effective method of birth control during study treatment and 12 months thereafter
boolean
non-compliance
Item
Patients unable or unwilling to comply with protocol
boolean
Item Group
Medical concepts
Age
Item
Age
string
C0001779 (UMLS CUI)
102518004 (SNOMED CT 2010_0731)
Diagnosis
Item
Diagnosis
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
MTHU008876 (LOINC Version 232)
NHL
Item
Lymphoma, Non-Hodgkin (Non-Hodgkins lymphoma)
string
C0024305 (UMLS CUI)
118601006 (SNOMED CT 2010_0731)
10029547 (MedDRA 13.1)
C85.9 (ICD-10-CM Version 2010)
Tumor Staging
Item
Diagnostic Neoplasm Staging
string
C0027646 (UMLS CUI)
254292007 (SNOMED CT 2010_0731)
LP78422-0 (LOINC Version 232)
Remission
Item
Disease remission
string
C0544452 (UMLS CUI)
277022003 (SNOMED CT 2010_0731)
Pharmaceutical Preparations
Item
Medication
string
C0013227 (UMLS CUI)
Chemotherapy
Item
Chemotherapy
string
C0392920 (UMLS CUI)
150415003 (SNOMED CT 2010_0731)
Informed Consent
Item
Informed Consent
string
C0021430 (UMLS CUI)
First-Line Therapy (primary therapy)
Item
First-Line Treatment (primary treatment)
string
C1708063 (UMLS CUI)
Radiotherapy
Item
Radiotherapy
string
C1522449 (UMLS CUI)
302505005 (SNOMED CT 2010_0731)
Recovery
Item
Recovery - healing process
string
C2004454 (UMLS CUI)
Cancer
Item
Malignant Neoplasms
string
C0006826 (UMLS CUI)
363346000 (SNOMED CT 2010_0731)
10028997 (MedDRA 13.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
HIV negative
Item
HIV negative
string
C0481430 (UMLS CUI)
143223008 (SNOMED CT 2010_0731)
10020179 (MedDRA 13.1)
Pleural effusion
Item
Pleural effusion disorder
string
C0032227 (UMLS CUI)
60046008 (SNOMED CT 2010_0731)
10035598 (MedDRA 13.1)
J90 (ICD-10-CM Version 2010)
511.9 (ICD-9-CM Version 2011)
E13486 (CTCAE Version 4.03)
Ascites
Item
Ascites
string
C0003962 (UMLS CUI)
389026000 (SNOMED CT 2010_0731)
10003445 (MedDRA 13.1)
R18 (ICD-10-CM Version 2010)
789.5 (ICD-9-CM Version 2011)
E10502 (CTCAE Version 4.03)
pregnant
Item
pregnant
string
C0549206 (UMLS CUI)
10036586 (MedDRA 13.1)
Lactation
Item
Breast feeding, Nursing
string
C0006147 (UMLS CUI)
10006247 (MedDRA 13.1)
Serum pregnancy test
Item
Serum pregnancy test (B-HCG)
string
C0430060 (UMLS CUI)
166434005 (SNOMED CT 2010_0731)
Contraception
Item
Contraception
string
C0700589 (UMLS CUI)
146680009 (SNOMED CT 2010_0731)
10010808 (MedDRA 13.1)
Compliance
Item
Compliance
string
C1321605 (UMLS CUI)
405078008 (SNOMED CT 2010_0731)

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