ID

18405

Descrição

Investigation of Safety and Efficacy of SB Injection in Patients With Advanced and Metastatic Non-small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01305967

Link

https://clinicaltrials.gov/show/NCT01305967

Palavras-chave

Versões (1)
  1. 03/11/2016 03/11/2016 -
Transferido a

3 de novembro de 2016

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Non Small Cell Lung Cancer NCT01305967

Inglês

Eligibility Non Small Cell Lung Cancer NCT01305967

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
age of 18-70 years
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
patients with histologically or cytologically confirmed non-small cell lung cancer
Descrição

Non-Small Cell Lung Carcinoma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0007131
patients who had failed more than 1 cycle of standard therapy with advanced or metasatic stage not available to any of resectable surgery or radiotherapy.
Descrição

Standard of Care Course Quantity failed | advanced disease | Neoplasm Metastasis | Malignant Neoplasm Resectable | Operative Surgical Procedures | Therapeutic radiology procedure

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2936643
UMLS CUI [1,2]
C0750729
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0231175
UMLS CUI [2]
C0679246
UMLS CUI [3]
C0027627
UMLS CUI [4,1]
C0006826
UMLS CUI [4,2]
C1514888
UMLS CUI [5]
C0543467
UMLS CUI [6]
C1522449
patients with measurable lesions
Descrição

Measurable Disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1513041
eatern cooperative oncolgy group status 0 to 2.
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy >/= 5 months
Descrição

Life Expectancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023671
patients with adequate organ(heart, kidney, liver)and bone marrow function, as defined by
Descrição

Organ function | Cardiac function | Renal function | Liver function | Bone Marrow function

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2]
C0232164
UMLS CUI [3]
C0232804
UMLS CUI [4]
C0232741
UMLS CUI [5,1]
C0005953
UMLS CUI [5,2]
C0031843
1. absolute neutrophil count >/= 1.5 x 10^9/l, platelet count >/= 100 x 10^9/l
Descrição

Absolute neutrophil count | Platelet Count measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
2. total bilirubin </= upper limit of normal
Descrição

Serum total bilirubin measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1278039
3. aspartate aminotransferase and/or alanine aminotransferase </= 2 x upeer limit of normal
Descrição

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
4. creatinine </= 1.5 x upeer limit of normal
Descrição

Creatinine measurement, serum

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0201976
patients who have signed the informed consent form.
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
female volunteers admitted to the study must be using a reliable means of contraception
Descrição

Gender Contraceptive methods

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
received radiation therapy within 6 weeks before randomization
Descrição

Therapeutic radiology procedure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1522449
known brain or spinal cord metastases
Descrição

Metastatic malignant neoplasm to brain | Spinal Cord Neoplasm Metastasis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2,1]
C0037925
UMLS CUI [2,2]
C0027627
have acute infection
Descrição

Communicable Disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009450
have active infection or serious concomitant systemic disorder incompatible with the study
Descrição

Communicable Disease Inconsistent Clinical Trial | Systemic disease Serious Inconsistent Clinical Trial

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0442809
UMLS CUI [1,3]
C0008976
UMLS CUI [2,1]
C0442893
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C0442809
UMLS CUI [2,4]
C0008976
presence or history of malignancy other than non-small cell lung cancer
Descrição

Malignant Neoplasms | Non-Small Cell Lung Carcinoma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0007131
have severe neurologic or psychological disorder
Descrição

nervous system disorder | Mental disorder

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0027765
UMLS CUI [2]
C0004936
patients who have to receive other chemo-radiotherapy or immunotherapy
Descrição

Chemoradiotherapy | Immunotherapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0436307
UMLS CUI [2]
C0021083
patients who have received chemotherapy within the previous 30 days
Descrição

Chemotherapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0392920
patients who are candidates for combined modality treatment.
Descrição

Indication Combined Modality Therapy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0009429
patients who have participated in a clinical study within the previous 30 days
Descrição

Study Subject Participation Status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Non Small Cell Lung Cancer NCT01305967

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age of 18-70 years
boolean
C0001779 (UMLS CUI [1])
Non-Small Cell Lung Carcinoma
Item
patients with histologically or cytologically confirmed non-small cell lung cancer
boolean
C0007131 (UMLS CUI [1])
Standard of Care Course Quantity failed | advanced disease | Neoplasm Metastasis | Malignant Neoplasm Resectable | Operative Surgical Procedures | Therapeutic radiology procedure
Item
patients who had failed more than 1 cycle of standard therapy with advanced or metasatic stage not available to any of resectable surgery or radiotherapy.
boolean
C2936643 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0231175 (UMLS CUI [1,4])
C0679246 (UMLS CUI [2])
C0027627 (UMLS CUI [3])
C0006826 (UMLS CUI [4,1])
C1514888 (UMLS CUI [4,2])
C0543467 (UMLS CUI [5])
C1522449 (UMLS CUI [6])
Measurable Disease
Item
patients with measurable lesions
boolean
C1513041 (UMLS CUI [1])
ECOG performance status
Item
eatern cooperative oncolgy group status 0 to 2.
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy >/= 5 months
boolean
C0023671 (UMLS CUI [1])
Organ function | Cardiac function | Renal function | Liver function | Bone Marrow function
Item
patients with adequate organ(heart, kidney, liver)and bone marrow function, as defined by
boolean
C0678852 (UMLS CUI [1])
C0232164 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
C0232741 (UMLS CUI [4])
C0005953 (UMLS CUI [5,1])
C0031843 (UMLS CUI [5,2])
Absolute neutrophil count | Platelet Count measurement
Item
1. absolute neutrophil count >/= 1.5 x 10^9/l, platelet count >/= 100 x 10^9/l
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
Serum total bilirubin measurement
Item
2. total bilirubin </= upper limit of normal
boolean
C1278039 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
3. aspartate aminotransferase and/or alanine aminotransferase </= 2 x upeer limit of normal
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Creatinine measurement, serum
Item
4. creatinine </= 1.5 x upeer limit of normal
boolean
C0201976 (UMLS CUI [1])
Informed Consent
Item
patients who have signed the informed consent form.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Gender Contraceptive methods
Item
female volunteers admitted to the study must be using a reliable means of contraception
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Therapeutic radiology procedure
Item
received radiation therapy within 6 weeks before randomization
boolean
C1522449 (UMLS CUI [1])
Metastatic malignant neoplasm to brain | Spinal Cord Neoplasm Metastasis
Item
known brain or spinal cord metastases
boolean
C0220650 (UMLS CUI [1])
C0037925 (UMLS CUI [2,1])
C0027627 (UMLS CUI [2,2])
Communicable Disease
Item
have acute infection
boolean
C0009450 (UMLS CUI [1])
Communicable Disease Inconsistent Clinical Trial | Systemic disease Serious Inconsistent Clinical Trial
Item
have active infection or serious concomitant systemic disorder incompatible with the study
boolean
C0009450 (UMLS CUI [1,1])
C0442809 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0442893 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0442809 (UMLS CUI [2,3])
C0008976 (UMLS CUI [2,4])
Malignant Neoplasms | Non-Small Cell Lung Carcinoma
Item
presence or history of malignancy other than non-small cell lung cancer
boolean
C0006826 (UMLS CUI [1])
C0007131 (UMLS CUI [2])
nervous system disorder | Mental disorder
Item
have severe neurologic or psychological disorder
boolean
C0027765 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
Chemoradiotherapy | Immunotherapy
Item
patients who have to receive other chemo-radiotherapy or immunotherapy
boolean
C0436307 (UMLS CUI [1])
C0021083 (UMLS CUI [2])
Chemotherapy
Item
patients who have received chemotherapy within the previous 30 days
boolean
C0392920 (UMLS CUI [1])
Indication Combined Modality Therapy
Item
patients who are candidates for combined modality treatment.
boolean
C3146298 (UMLS CUI [1,1])
C0009429 (UMLS CUI [1,2])
Study Subject Participation Status
Item
patients who have participated in a clinical study within the previous 30 days
boolean
C2348568 (UMLS CUI [1])
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