ID

31402

Descripción

Taxotere-Enoxaparin-(ENOXA)-Study; ODM derived from: https://clinicaltrials.gov/show/NCT01058759

Link

https://clinicaltrials.gov/show/NCT01058759

Palabras clave

Versiones (1)
  1. 19/8/18 19/8/18 -
Titular de derechos de autor

see clinicaltrials.gov

Subido en

19 de agosto de 2018

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Eligibility Non-small Cell Lung Cancer NCT01058759

Inglés

Eligibility Non-small Cell Lung Cancer NCT01058759

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
signed informed consent
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
men and women aged 18 and older
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
locally advanced or metastatic non-small cell lung cancer stage iiib/iv without any previous therapy
Descripción

Small cell carcinoma of lung; Locally Advanced Malignant Neoplasm | Small cell carcinoma of lung; metastatic qualifier | Tumor stage | previous therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0149925
UMLS CUI [1,2]
C0677984
UMLS CUI [2,1]
C0149925
UMLS CUI [2,2]
C1522484
UMLS CUI [3]
C1300072
UMLS CUI [4]
C2114510
life expectancy at least 12 weeks
Descripción

Life Expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023671
ecog performance < 1
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
appropriate renal and hepatic function
Descripción

Renal function; Appropriate | Liver function; Appropriate

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0232804
UMLS CUI [1,2]
C1548787
UMLS CUI [2,1]
C0232741
UMLS CUI [2,2]
C1548787
appropriate hematology
Descripción

Hematological system; Appropriate

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0279810
UMLS CUI [1,2]
C1548787
no bleeding events within 4 weeks prior to randomization
Descripción

Hemorrhage; Time

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C0040223
no indication for prophylactic or therapeutic anticoagulation therapy
Descripción

Indication; Anticoagulation Therapy; Therapeutic procedure | Indication; Anticoagulation Therapy; Prophylactic treatment

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0003281
UMLS CUI [1,3]
C0087111
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0003281
UMLS CUI [2,3]
C0199176
appropriate methods of contraception (both: men and women) for women of childbearing potential negative urine pregnancy test within 7 day prior to randomization
Descripción

Contraceptive methods; Gender | Childbearing Potential; Urine pregnancy test; Negative

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0079399
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0430056
UMLS CUI [2,3]
C0205160
capability for s.c. injection of enoxaparin every 24 hrs
Descripción

Enoxaparin; Injection of therapeutic agent; Ability

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0206460
UMLS CUI [1,2]
C0021485
UMLS CUI [1,3]
C0085732
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of cancer other than nsclc
Descripción

Malignant Neoplasms; Medical History | Non-Small Cell Lung Carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0262926
UMLS CUI [2]
C0007131
known contraindication for enoxaparin e.g. hit,
Descripción

Medical contraindication; Enoxaparin | Heparin-induced thrombocytopenia

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0206460
UMLS CUI [2]
C0272285
known contraindication for docetaxel, cisplatin, carboplatin or co-medication
Descripción

Medical contraindication; docetaxel | Medical contraindication; Cisplatin | Medical contraindication; Concomitant Agent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0246415
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0008838
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C2347852
participation in any other clinical trials within 30 days prior to randomization
Descripción

Study Subject Participation Status; Time

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0040223
any known medical condition that does not allow therapy according to study protocol
Descripción

Disease; Medical contraindication; Study Protocol; Therapeutic procedure

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1301624
UMLS CUI [1,3]
C2348563
UMLS CUI [1,4]
C0087111
seizure disorder
Descripción

Epilepsy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0014544
Volver a la parte superior de la página

Similar models

Eligibility Non-small Cell Lung Cancer NCT01058759

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Age
Item
men and women aged 18 and older
boolean
C0001779 (UMLS CUI [1])
Small cell carcinoma of lung; Locally Advanced Malignant Neoplasm | Small cell carcinoma of lung; metastatic qualifier | Tumor stage | previous therapy
Item
locally advanced or metastatic non-small cell lung cancer stage iiib/iv without any previous therapy
boolean
C0149925 (UMLS CUI [1,1])
C0677984 (UMLS CUI [1,2])
C0149925 (UMLS CUI [2,1])
C1522484 (UMLS CUI [2,2])
C1300072 (UMLS CUI [3])
C2114510 (UMLS CUI [4])
Life Expectancy
Item
life expectancy at least 12 weeks
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
ecog performance < 1
boolean
C1520224 (UMLS CUI [1])
Renal function; Appropriate | Liver function; Appropriate
Item
appropriate renal and hepatic function
boolean
C0232804 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2,1])
C1548787 (UMLS CUI [2,2])
Hematological system; Appropriate
Item
appropriate hematology
boolean
C0279810 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
Hemorrhage; Time
Item
no bleeding events within 4 weeks prior to randomization
boolean
C0019080 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Indication; Anticoagulation Therapy; Therapeutic procedure | Indication; Anticoagulation Therapy; Prophylactic treatment
Item
no indication for prophylactic or therapeutic anticoagulation therapy
boolean
C3146298 (UMLS CUI [1,1])
C0003281 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C3146298 (UMLS CUI [2,1])
C0003281 (UMLS CUI [2,2])
C0199176 (UMLS CUI [2,3])
Contraceptive methods; Gender | Childbearing Potential; Urine pregnancy test; Negative
Item
appropriate methods of contraception (both: men and women) for women of childbearing potential negative urine pregnancy test within 7 day prior to randomization
boolean
C0700589 (UMLS CUI [1,1])
C0079399 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430056 (UMLS CUI [2,2])
C0205160 (UMLS CUI [2,3])
Enoxaparin; Injection of therapeutic agent; Ability
Item
capability for s.c. injection of enoxaparin every 24 hrs
boolean
C0206460 (UMLS CUI [1,1])
C0021485 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Malignant Neoplasms; Medical History | Non-Small Cell Lung Carcinoma
Item
history of cancer other than nsclc
boolean
C0006826 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0007131 (UMLS CUI [2])
Medical contraindication; Enoxaparin | Heparin-induced thrombocytopenia
Item
known contraindication for enoxaparin e.g. hit,
boolean
C1301624 (UMLS CUI [1,1])
C0206460 (UMLS CUI [1,2])
C0272285 (UMLS CUI [2])
Medical contraindication; docetaxel | Medical contraindication; Cisplatin | Medical contraindication; Concomitant Agent
Item
known contraindication for docetaxel, cisplatin, carboplatin or co-medication
boolean
C1301624 (UMLS CUI [1,1])
C0246415 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0008838 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C2347852 (UMLS CUI [3,2])
Study Subject Participation Status; Time
Item
participation in any other clinical trials within 30 days prior to randomization
boolean
C2348568 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Disease; Medical contraindication; Study Protocol; Therapeutic procedure
Item
any known medical condition that does not allow therapy according to study protocol
boolean
C0012634 (UMLS CUI [1,1])
C1301624 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
Epilepsy
Item
seizure disorder
boolean
C0014544 (UMLS CUI [1])
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

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