ID

18132

Beskrivning

MRI Study of BAY 43-9006 in Metastatic Renal Cell Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00606866

Länk

https://clinicaltrials.gov/show/NCT00606866

Nyckelord

Versioner (1)
  1. 2016-10-21 2016-10-21 -
Uppladdad den

21 oktober 2016

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Metastatic Renal Cell Carcinoma NCT00606866

Engelsk

Eligibility Metastatic Renal Cell Carcinoma NCT00606866

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed metastatic clear cell renal cell cancer;
Beskrivning

Clear Cell Renal Cell Carcinoma Metastatic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0279702
UMLS CUI [1,2]
C0036525
at least one lesion that can be accurately measured in at least one dimension;
Beskrivning

Measurable Disease Linear Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0205132
UMLS CUI [1,3]
C1265611
patients must not have been treated with prior anti-timor kinase inhibitors or vegf pathway inhibitors;
Beskrivning

Kinase Inhibitors Against Malignant Neoplasms | VEGF Signaling Pathway inhibitors

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1152564
UMLS CUI [1,2]
C0521124
UMLS CUI [1,3]
C0006826
UMLS CUI [2,1]
C2984329
UMLS CUI [2,2]
C0243077
age 18 and older;
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status 0-2;
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
blood pressure higher than 140/90 on 2 separate occasions not more than 6 weeks prior to enrollment and not less than 24 hours apart;
Beskrivning

Blood pressure finding Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1271104
UMLS CUI [1,2]
C1265611
normal organ function: total bilirubin less than upper limit of normal, ast less than 2.5 x upper limit of normal, creatinine less than 2.8 mg/dl;
Beskrivning

organ function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Creatinine measurement, serum

Datatyp

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201976
women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation;
Beskrivning

Childbearing Potential Contraceptive methods | Gender Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0700589
ability to understand and the willingness to sign a written informed consent document.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
chemotherapy or radiotherapy within 4 weeks prior to entering the study;
Beskrivning

Chemotherapy | Therapeutic radiology procedure

Datatyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
any other investigational agents;
Beskrivning

Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
known brain metastases;
Beskrivning

Metastatic malignant neoplasm to brain

Datatyp

boolean

Alias
UMLS CUI [1]
C0220650
uncontrolled intercurrent illness including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements;
Beskrivning

Illness Uncontrolled | Communicable Diseases | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Compliance behavior Limited | social situation Compliance behavior Limited

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0742758
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0003811
UMLS CUI [6,1]
C0004936
UMLS CUI [6,2]
C1321605
UMLS CUI [6,3]
C0439801
UMLS CUI [7,1]
C0748872
UMLS CUI [7,2]
C1321605
UMLS CUI [7,3]
C0439801
pregnancy.
Beskrivning

Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
Tillbaka till toppen

Similar models

Eligibility Metastatic Renal Cell Carcinoma NCT00606866

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Clear Cell Renal Cell Carcinoma Metastatic
Item
histologically or cytologically confirmed metastatic clear cell renal cell cancer;
boolean
C0279702 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
Measurable Disease Linear Quantity
Item
at least one lesion that can be accurately measured in at least one dimension;
boolean
C1513041 (UMLS CUI [1,1])
C0205132 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Kinase Inhibitors Against Malignant Neoplasms | VEGF Signaling Pathway inhibitors
Item
patients must not have been treated with prior anti-timor kinase inhibitors or vegf pathway inhibitors;
boolean
C1152564 (UMLS CUI [1,1])
C0521124 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
C2984329 (UMLS CUI [2,1])
C0243077 (UMLS CUI [2,2])
Age
Item
age 18 and older;
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0-2;
boolean
C1520224 (UMLS CUI [1])
Blood pressure finding Quantity
Item
blood pressure higher than 140/90 on 2 separate occasions not more than 6 weeks prior to enrollment and not less than 24 hours apart;
boolean
C1271104 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
organ function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Creatinine measurement, serum
Item
normal organ function: total bilirubin less than upper limit of normal, ast less than 2.5 x upper limit of normal, creatinine less than 2.8 mg/dl;
boolean
C0678852 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201976 (UMLS CUI [4])
Childbearing Potential Contraceptive methods | Gender Contraceptive methods
Item
women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation;
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Informed Consent
Item
ability to understand and the willingness to sign a written informed consent document.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Chemotherapy | Therapeutic radiology procedure
Item
chemotherapy or radiotherapy within 4 weeks prior to entering the study;
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
Investigational New Drugs
Item
any other investigational agents;
boolean
C0013230 (UMLS CUI [1])
Metastatic malignant neoplasm to brain
Item
known brain metastases;
boolean
C0220650 (UMLS CUI [1])
Illness Uncontrolled | Communicable Diseases | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Compliance behavior Limited | social situation Compliance behavior Limited
Item
uncontrolled intercurrent illness including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements;
boolean
C0221423 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0742758 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
C0004936 (UMLS CUI [6,1])
C1321605 (UMLS CUI [6,2])
C0439801 (UMLS CUI [6,3])
C0748872 (UMLS CUI [7,1])
C1321605 (UMLS CUI [7,2])
C0439801 (UMLS CUI [7,3])
Pregnancy
Item
pregnancy.
boolean
C0032961 (UMLS CUI [1])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

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