ID

18484

Descripción

Safety and Pharmacokinetics of Jin Fu Kang in Comb w/Docetaxel for Patients w/Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00260026

Link

https://clinicaltrials.gov/show/NCT00260026

Palabras clave

Versiones (1)
  1. 7/11/16 7/11/16 -
Subido en

7 de noviembre de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Non-Small Cell Lung Cancer NCT00260026

Inglés

Eligibility Non-Small Cell Lung Cancer NCT00260026

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must meet all of the following inclusion criteria:
Descripción

Inclusion criteria Fulfill

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1550543
pathologic confirmation of stage iii or iv nsclc.
Descripción

Non-Small Cell Lung Carcinoma | TNM clinical staging

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0007131
UMLS CUI [2]
C3258246
docetaxel therapy for cancer is clinically indicated.
Descripción

Indication docetaxel cancer treatment

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0246415
UMLS CUI [1,3]
C0920425
kps>=60% *anc<1,000/mcl and platelets<100/mcl
Descripción

Karnofsky Performance Status | Absolute neutrophil count | Platelet Count measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0206065
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients must meet none of the following exclusion criteria:
Descripción

Exclusion Criteria None Fulfill

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0549184
UMLS CUI [1,3]
C1550543
wbc< 4,000/µl, hemoglobin < 10 g/dl, platelet count < 100,000/µl, total bilirubin > uln, ast >1.5 x uln, alkaline phosphatase > 2.5 x uln, creatinine > 1.5 mg/dl or creatinine clearance < 50 ml/min/1.7 m2), (anc > 10,000/µl)
Descripción

White Blood Cell Count procedure | Hemoglobin | Platelet Count measurement | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alkaline phosphatase measurement | Creatinine measurement, serum | Creatinine clearance measurement | Absolute neutrophil count

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0019046
UMLS CUI [3]
C0032181
UMLS CUI [4]
C1278039
UMLS CUI [5]
C0201899
UMLS CUI [6]
C0201850
UMLS CUI [7]
C0201976
UMLS CUI [8]
C0373595
UMLS CUI [9]
C0948762
prior docetaxel
Descripción

docetaxel Previous

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0246415
UMLS CUI [1,2]
C0205156
patient must have recovered from all previous treatment-related toxicity
Descripción

Toxic effect Prior Therapy Related | Patient Recovered

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C1514463
UMLS CUI [1,3]
C0439849
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0521108
concurrent use of any botanicals for anticancer intent
Descripción

Botanicals Cancer treatment intent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1456557
UMLS CUI [1,2]
C0920425
UMLS CUI [1,3]
C1283828
use of jin fu kang or any of its constituent botanicals in the previous three weeks.
Descripción

Jin Fu Kang | Jin Fu Kang Botanicals Constituent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1831812
UMLS CUI [2,1]
C1831812
UMLS CUI [2,2]
C1456557
UMLS CUI [2,3]
C0729650
history of allergy to any of the constituent botanicals in jin fu kang.
Descripción

Hypersensitivity Jin Fu Kang Botanicals Constituent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1831812
UMLS CUI [1,3]
C1456557
UMLS CUI [1,4]
C0729650
pregnant or lactating women or women of childbearing potential not using effective contraception. a negative pregnancy test must be documented during the screening period for women of childbearing potential.
Descripción

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Inadequate | Childbearing Potential Pregnancy test negative

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0205412
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0427780
concurrent active cancer.
Descripción

Malignant Neoplasms

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006826
concurrent use of immunosuppressives: as an immunostimulant, astragalus-containing products are contraindicated for patients on immunosuppressive therapy.
Descripción

Immunosuppressive Agents | Medical contraindication Immunologic Adjuvants | Medical contraindication Astragalus preparation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021081
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0001551
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C1095897
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Similar models

Eligibility Non-Small Cell Lung Cancer NCT00260026

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Inclusion criteria Fulfill
Item
patients must meet all of the following inclusion criteria:
boolean
C1512693 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Non-Small Cell Lung Carcinoma | TNM clinical staging
Item
pathologic confirmation of stage iii or iv nsclc.
boolean
C0007131 (UMLS CUI [1])
C3258246 (UMLS CUI [2])
Indication docetaxel cancer treatment
Item
docetaxel therapy for cancer is clinically indicated.
boolean
C3146298 (UMLS CUI [1,1])
C0246415 (UMLS CUI [1,2])
C0920425 (UMLS CUI [1,3])
Karnofsky Performance Status | Absolute neutrophil count | Platelet Count measurement
Item
kps>=60% *anc<1,000/mcl and platelets<100/mcl
boolean
C0206065 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Exclusion Criteria None Fulfill
Item
patients must meet none of the following exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C0549184 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
White Blood Cell Count procedure | Hemoglobin | Platelet Count measurement | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alkaline phosphatase measurement | Creatinine measurement, serum | Creatinine clearance measurement | Absolute neutrophil count
Item
wbc< 4,000/µl, hemoglobin < 10 g/dl, platelet count < 100,000/µl, total bilirubin > uln, ast >1.5 x uln, alkaline phosphatase > 2.5 x uln, creatinine > 1.5 mg/dl or creatinine clearance < 50 ml/min/1.7 m2), (anc > 10,000/µl)
boolean
C0023508 (UMLS CUI [1])
C0019046 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C1278039 (UMLS CUI [4])
C0201899 (UMLS CUI [5])
C0201850 (UMLS CUI [6])
C0201976 (UMLS CUI [7])
C0373595 (UMLS CUI [8])
C0948762 (UMLS CUI [9])
docetaxel Previous
Item
prior docetaxel
boolean
C0246415 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Toxic effect Prior Therapy Related | Patient Recovered
Item
patient must have recovered from all previous treatment-related toxicity
boolean
C0600688 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C0521108 (UMLS CUI [2,2])
Botanicals Cancer treatment intent
Item
concurrent use of any botanicals for anticancer intent
boolean
C1456557 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C1283828 (UMLS CUI [1,3])
Jin Fu Kang | Jin Fu Kang Botanicals Constituent
Item
use of jin fu kang or any of its constituent botanicals in the previous three weeks.
boolean
C1831812 (UMLS CUI [1])
C1831812 (UMLS CUI [2,1])
C1456557 (UMLS CUI [2,2])
C0729650 (UMLS CUI [2,3])
Hypersensitivity Jin Fu Kang Botanicals Constituent
Item
history of allergy to any of the constituent botanicals in jin fu kang.
boolean
C0020517 (UMLS CUI [1,1])
C1831812 (UMLS CUI [1,2])
C1456557 (UMLS CUI [1,3])
C0729650 (UMLS CUI [1,4])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Inadequate | Childbearing Potential Pregnancy test negative
Item
pregnant or lactating women or women of childbearing potential not using effective contraception. a negative pregnancy test must be documented during the screening period for women of childbearing potential.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0205412 (UMLS CUI [3,3])
C3831118 (UMLS CUI [4,1])
C0427780 (UMLS CUI [4,2])
Malignant Neoplasms
Item
concurrent active cancer.
boolean
C0006826 (UMLS CUI [1])
Immunosuppressive Agents | Medical contraindication Immunologic Adjuvants | Medical contraindication Astragalus preparation
Item
concurrent use of immunosuppressives: as an immunostimulant, astragalus-containing products are contraindicated for patients on immunosuppressive therapy.
boolean
C0021081 (UMLS CUI [1])
C1301624 (UMLS CUI [2,1])
C0001551 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C1095897 (UMLS CUI [3,2])
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