ID

18484

Beschrijving

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

Trefwoorden

Versies (1)
  1. 07-11-16 07-11-16 -
Geüploaded op

7 november 2016

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Non-Small Cell Lung Cancer NCT00260026

Engels

Eligibility Non-Small Cell Lung Cancer NCT00260026

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

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

Inclusion criteria Fulfill

Datatype

boolean

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

Non-Small Cell Lung Carcinoma | TNM clinical staging

Datatype

boolean

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

Indication docetaxel cancer treatment

Datatype

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
Beschrijving

Karnofsky Performance Status | Absolute neutrophil count | Platelet Count measurement

Datatype

boolean

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

Exclusion Criteria

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

Exclusion Criteria None Fulfill

Datatype

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)
Beschrijving

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

Datatype

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
Beschrijving

docetaxel Previous

Datatype

boolean

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

Toxic effect Prior Therapy Related | Patient Recovered

Datatype

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
Beschrijving

Botanicals Cancer treatment intent

Datatype

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.
Beschrijving

Jin Fu Kang | Jin Fu Kang Botanicals Constituent

Datatype

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.
Beschrijving

Hypersensitivity Jin Fu Kang Botanicals Constituent

Datatype

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.
Beschrijving

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

Datatype

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.
Beschrijving

Malignant Neoplasms

Datatype

boolean

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

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

Datatype

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
Terug naar het begin van de pagina

Similar models

Eligibility Non-Small Cell Lung Cancer NCT00260026

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial