ID

31140

Descrição

Enoxaparin Low Molecular Weight Heparin (LMWH) in Advanced Non Small Cell Lung Cancer: Effect on Survival and Symptom Control in Patients Undergoing First Line Chemotherapy (SYRINGES); ODM derived from: https://clinicaltrials.gov/show/NCT00771563

Link

https://clinicaltrials.gov/show/NCT00771563

Palavras-chave

Versões (1)
  1. 23/07/2018 23/07/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

23 de julho de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Non-Small Cell Lung Cancer NCT00771563

Inglês

Eligibility Non-Small Cell Lung Cancer NCT00771563

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
locally advanced or metastatic nsclc (stage iiib or iv)
Descrição

Non-Small Cell Lung Carcinoma Advanced Locally TNM clinical staging | Non-small cell lung cancer metastatic TNM clinical staging

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C1517927
UMLS CUI [1,4]
C3258246
UMLS CUI [2,1]
C0278987
UMLS CUI [2,2]
C3258246
patients who are not candidates for radical combined modality treatments or high-dose radiation therapy
Descrição

Patients Inappropriate Combined Modality Therapy Radical | Patients Inappropriate High dose radiation

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C0009429
UMLS CUI [1,4]
C0439807
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1548788
UMLS CUI [2,3]
C1514710
at least one measurable lesion according to recist criteria
Descrição

Measurable lesion Quantity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
good performance status
Descrição

Performance status Good

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1518965
UMLS CUI [1,2]
C0205170
adequate haematological, renal and liver function
Descrição

Hematologic function | Renal function | Liver function

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
written informed consent
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous chemotherapy for nsclc
Descrição

Prior Chemotherapy Non-Small Cell Lung Carcinoma

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0007131
brain metastasis
Descrição

Metastatic malignant neoplasm to brain

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0220650
history of cerebral haemorrhage, neurosurgery within 3 previous months or surgery within the past 6 months
Descrição

Cerebral Hemorrhage | Neurosurgical Procedures | Operative Surgical Procedures

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2937358
UMLS CUI [2]
C0524850
UMLS CUI [3]
C0543467
indication for anticoagulant therapy, thrombolytic therapy or antiplatelet therapy for cardiovascular disease
Descrição

Indication Anticoagulant therapy Cardiovascular Diseases | Indication Thrombolytic Therapy Cardiovascular Diseases | Indication Antiplatelet therapy Cardiovascular Diseases

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0150457
UMLS CUI [1,3]
C0007222
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0040044
UMLS CUI [2,3]
C0007222
UMLS CUI [3,1]
C3146298
UMLS CUI [3,2]
C1096021
UMLS CUI [3,3]
C0007222
concomitant therapy with an anti-angiogenesis agent
Descrição

Angiogenesis Inhibitors

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0596087
contra-indication for lmwh
Descrição

Medical contraindication Low-Molecular-Weight Heparin

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0019139
life expectancy of < 3 months
Descrição

Life Expectancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023671
serious concomitant systemic disease, uncontrolled arterial hypertension, active peptic ulcer or other condition which does not permit study treatment or follow-up required to comply with the study protocol
Descrição

Comorbidity Systemic Serious | Uncontrolled hypertension | Peptic Ulcer | Condition Protocol Compliance Excluded

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205373
UMLS CUI [1,3]
C0205404
UMLS CUI [2]
C1868885
UMLS CUI [3]
C0030920
UMLS CUI [4,1]
C0348080
UMLS CUI [4,2]
C0525058
UMLS CUI [4,3]
C0332196
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Similar models

Eligibility Non-Small Cell Lung Cancer NCT00771563

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma Advanced Locally TNM clinical staging | Non-small cell lung cancer metastatic TNM clinical staging
Item
locally advanced or metastatic nsclc (stage iiib or iv)
boolean
C0007131 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
C3258246 (UMLS CUI [1,4])
C0278987 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
Patients Inappropriate Combined Modality Therapy Radical | Patients Inappropriate High dose radiation
Item
patients who are not candidates for radical combined modality treatments or high-dose radiation therapy
boolean
C0030705 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0009429 (UMLS CUI [1,3])
C0439807 (UMLS CUI [1,4])
C0030705 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C1514710 (UMLS CUI [2,3])
Measurable lesion Quantity
Item
at least one measurable lesion according to recist criteria
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Performance status Good
Item
good performance status
boolean
C1518965 (UMLS CUI [1,1])
C0205170 (UMLS CUI [1,2])
Hematologic function | Renal function | Liver function
Item
adequate haematological, renal and liver function
boolean
C0221130 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Prior Chemotherapy Non-Small Cell Lung Carcinoma
Item
previous chemotherapy for nsclc
boolean
C1514457 (UMLS CUI [1,1])
C0007131 (UMLS CUI [1,2])
Metastatic malignant neoplasm to brain
Item
brain metastasis
boolean
C0220650 (UMLS CUI [1])
Cerebral Hemorrhage | Neurosurgical Procedures | Operative Surgical Procedures
Item
history of cerebral haemorrhage, neurosurgery within 3 previous months or surgery within the past 6 months
boolean
C2937358 (UMLS CUI [1])
C0524850 (UMLS CUI [2])
C0543467 (UMLS CUI [3])
Indication Anticoagulant therapy Cardiovascular Diseases | Indication Thrombolytic Therapy Cardiovascular Diseases | Indication Antiplatelet therapy Cardiovascular Diseases
Item
indication for anticoagulant therapy, thrombolytic therapy or antiplatelet therapy for cardiovascular disease
boolean
C3146298 (UMLS CUI [1,1])
C0150457 (UMLS CUI [1,2])
C0007222 (UMLS CUI [1,3])
C3146298 (UMLS CUI [2,1])
C0040044 (UMLS CUI [2,2])
C0007222 (UMLS CUI [2,3])
C3146298 (UMLS CUI [3,1])
C1096021 (UMLS CUI [3,2])
C0007222 (UMLS CUI [3,3])
Angiogenesis Inhibitors
Item
concomitant therapy with an anti-angiogenesis agent
boolean
C0596087 (UMLS CUI [1])
Medical contraindication Low-Molecular-Weight Heparin
Item
contra-indication for lmwh
boolean
C1301624 (UMLS CUI [1,1])
C0019139 (UMLS CUI [1,2])
Life Expectancy
Item
life expectancy of < 3 months
boolean
C0023671 (UMLS CUI [1])
Comorbidity Systemic Serious | Uncontrolled hypertension | Peptic Ulcer | Condition Protocol Compliance Excluded
Item
serious concomitant systemic disease, uncontrolled arterial hypertension, active peptic ulcer or other condition which does not permit study treatment or follow-up required to comply with the study protocol
boolean
C0009488 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0205404 (UMLS CUI [1,3])
C1868885 (UMLS CUI [2])
C0030920 (UMLS CUI [3])
C0348080 (UMLS CUI [4,1])
C0525058 (UMLS CUI [4,2])
C0332196 (UMLS CUI [4,3])
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