ID

22177

Descripción

A Feasibility Study of Oral Adjuvant Chemotherapy With S-1; ODM derived from: https://clinicaltrials.gov/show/NCT01459185

Link

https://clinicaltrials.gov/show/NCT01459185

Palabras clave

Versiones (2)
  1. 21/5/17 21/5/17 -
  2. 22/5/17 22/5/17 -
Subido en

22 de mayo de 2017

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 NCT01459185

Inglés

Eligibility Non-small Cell Lung Cancer NCT01459185

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. nsclc with histological proof.
Descripción

Non-Small Cell Lung Carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0007131
2. pathological stage ib, ii, or iiia nsclc (fifth edition of uicc/ajcc 1997) after complete resection.
Descripción

Non-Small Cell Lung Carcinoma TNM clinical staging Post Complete excision

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
UMLS CUI [1,3]
C0687676
UMLS CUI [1,4]
C0015250
3. no prior treatment except for surgery.
Descripción

Therapy naive | Operative Surgical Procedures

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0919936
UMLS CUI [2]
C0543467
4. sufficient oral intake.
Descripción

Oral food intake Sufficient

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0518037
UMLS CUI [1,2]
C0205410
5. performance status (ps) 0 or 1.
Descripción

performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1518965
6. patients also had to have adequate organ function (3500 <leukocytes < 12,000/mm3; thrombocytes, >100,000/mm3; total bilirubin,<1.5 mg/dl; ast and alt, less than twice the normal limits at each institution; bun, <25 mg/dl; creatinine, less than the normal limits at each institution; and creatinine clearance (ccr))
Descripción

Organ function | White Blood Cell Count procedure | Platelet Count measurement | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Blood urea nitrogen measurement | Creatinine measurement, serum | Creatinine clearance measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2]
C0023508
UMLS CUI [3]
C0032181
UMLS CUI [4]
C1278039
UMLS CUI [5]
C0201899
UMLS CUI [6]
C0201836
UMLS CUI [7]
C0005845
UMLS CUI [8]
C0201976
UMLS CUI [9]
C0373595
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. history of drug hypersensitivity.
Descripción

Drug Allergy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013182
2. contraindication of oral s-1 administration (refer appended paper).
Descripción

Medical contraindication S-1 Oral

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0879262
UMLS CUI [1,3]
C1527415
3. serious surgical or non-surgical complications
Descripción

Complication of surgical procedure Serious | Complication Serious

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0274311
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0009566
UMLS CUI [2,2]
C0205404
4. active secondary cancer.
Descripción

Secondary Malignant Neoplasm

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3266877
5. watery diarrhea.
Descripción

Watery diarrhoea

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0239182
6. pregnant or lactating women.
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
7. male who has intention to make pregnant
Descripción

Gender Intent Reproduction

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C1283828
UMLS CUI [1,3]
C0035150
8. patient to whom primary doctor judged inadequate to register.
Descripción

Study Subject Participation Status Inadequate

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0205412
Volver a la parte superior de la página

Similar models

Eligibility Non-small Cell Lung Cancer NCT01459185

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma
Item
1. nsclc with histological proof.
boolean
C0007131 (UMLS CUI [1])
Non-Small Cell Lung Carcinoma TNM clinical staging Post Complete excision
Item
2. pathological stage ib, ii, or iiia nsclc (fifth edition of uicc/ajcc 1997) after complete resection.
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0687676 (UMLS CUI [1,3])
C0015250 (UMLS CUI [1,4])
Therapy naive | Operative Surgical Procedures
Item
3. no prior treatment except for surgery.
boolean
C0919936 (UMLS CUI [1])
C0543467 (UMLS CUI [2])
Oral food intake Sufficient
Item
4. sufficient oral intake.
boolean
C0518037 (UMLS CUI [1,1])
C0205410 (UMLS CUI [1,2])
performance status
Item
5. performance status (ps) 0 or 1.
boolean
C1518965 (UMLS CUI [1])
Organ function | White Blood Cell Count procedure | Platelet Count measurement | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Blood urea nitrogen measurement | Creatinine measurement, serum | Creatinine clearance measurement
Item
6. patients also had to have adequate organ function (3500 <leukocytes < 12,000/mm3; thrombocytes, >100,000/mm3; total bilirubin,<1.5 mg/dl; ast and alt, less than twice the normal limits at each institution; bun, <25 mg/dl; creatinine, less than the normal limits at each institution; and creatinine clearance (ccr))
boolean
C0678852 (UMLS CUI [1])
C0023508 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C1278039 (UMLS CUI [4])
C0201899 (UMLS CUI [5])
C0201836 (UMLS CUI [6])
C0005845 (UMLS CUI [7])
C0201976 (UMLS CUI [8])
C0373595 (UMLS CUI [9])
Item Group
C0680251 (UMLS CUI)
Drug Allergy
Item
1. history of drug hypersensitivity.
boolean
C0013182 (UMLS CUI [1])
Medical contraindication S-1 Oral
Item
2. contraindication of oral s-1 administration (refer appended paper).
boolean
C1301624 (UMLS CUI [1,1])
C0879262 (UMLS CUI [1,2])
C1527415 (UMLS CUI [1,3])
Complication of surgical procedure Serious | Complication Serious
Item
3. serious surgical or non-surgical complications
boolean
C0274311 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0009566 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
Secondary Malignant Neoplasm
Item
4. active secondary cancer.
boolean
C3266877 (UMLS CUI [1])
Watery diarrhoea
Item
5. watery diarrhea.
boolean
C0239182 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
6. pregnant or lactating women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Gender Intent Reproduction
Item
7. male who has intention to make pregnant
boolean
C0079399 (UMLS CUI [1,1])
C1283828 (UMLS CUI [1,2])
C0035150 (UMLS CUI [1,3])
Study Subject Participation Status Inadequate
Item
8. patient to whom primary doctor judged inadequate to register.
boolean
C2348568 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
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