ID

28183

Beskrivning

Nelfinavir, a Phase I/Phase II Rectal Cancer Study; ODM derived from: https://clinicaltrials.gov/show/NCT00704600

Länk

https://clinicaltrials.gov/show/NCT00704600

Nyckelord

Versioner (1)
  1. 2017-12-27 2017-12-27 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

27 december 2017

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 Colorectal Cancer NCT00704600

Engelsk

Eligibility Colorectal Cancer NCT00704600

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically proven adenocarcinoma of the rectum (tumor <15cm from anal verge)
Beskrivning

Adenocarcinoma of rectum | Tumor Distance from anal verge

Datatyp

boolean

Alias
UMLS CUI [1]
C0149978
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C1317308
age >= 18 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
uicc t3-4 n0-2 m0
Beskrivning

UICC (tumor staging)

Datatyp

boolean

Alias
UMLS CUI [1]
C0441914
who performance status 0-2
Beskrivning

WHO performance status scale

Datatyp

boolean

Alias
UMLS CUI [1]
C1298650
less than 10 % weight loss the last 6 months
Beskrivning

Weight decreased Percentage

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1262477
UMLS CUI [1,2]
C0439165
no recent (< 3 months) severe cardiac disease (arrhythmia, congestive heart failure, infarction)
Beskrivning

Heart Disease Severe Absent | Cardiac Arrhythmia Absent | Congestive heart failure Absent | Myocardial Infarction Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0003811
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0018802
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0027051
UMLS CUI [4,2]
C0332197
serum bilirubin = or < 3x normal
Beskrivning

Serum total bilirubin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C1278039
asat and alat = or < 2,5x normal
Beskrivning

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
creatinin clearance >50 ml/min
Beskrivning

Creatinine clearance measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0373595
willing and able to comply with the study prescriptions
Beskrivning

Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
no history of prior pelvic radiotherapy
Beskrivning

Radiotherapy to pelvis Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1536155
UMLS CUI [1,2]
C0332197
no known hiv infection
Beskrivning

HIV Infection Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019693
UMLS CUI [1,2]
C0332197
no hemophilia
Beskrivning

Hemophilia Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0684275
UMLS CUI [1,2]
C0332197
no concurrent medication that is metabolized by the cyp3a4 isoenzyme (calcium channel blockers, antifungal agents, macrolide antibiotics, gastrointestinal prokinetics, terfenadin, midazolam)
Beskrivning

Absence Pharmaceutical Preparations CYP3A4 Metabolized | Calcium Channel Blockers Absent | Antifungal Agents Absent | Macrolide Antibiotics Absent | Prokinetic Agents gastrointestinal Absent | Terfenadine Absent | Midazolam Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C3714798
UMLS CUI [1,4]
C1524026
UMLS CUI [2,1]
C0006684
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0003308
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0003240
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C1268865
UMLS CUI [5,2]
C0521362
UMLS CUI [5,3]
C0332197
UMLS CUI [6,1]
C0085173
UMLS CUI [6,2]
C0332197
UMLS CUI [7,1]
C0026056
UMLS CUI [7,2]
C0332197
statins should be stopped (except pravastatin and fluvastatin),
Beskrivning

Statins To be stopped | Exception Pravastatin | Exception Fluvastatin

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0360714
UMLS CUI [1,2]
C1272691
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0085542
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0082608
no concurrent use of st. john's wort (hypericum perforatum)
Beskrivning

Hypericum perforatum Excluded

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0936242
UMLS CUI [1,2]
C2828389
women should not be pregnant or lactating
Beskrivning

Pregnancy Excluded | Breast Feeding Excluded

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C2828389
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C2828389
being willing and able to undergo one extra biopsy
Beskrivning

Biopsy extra Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C1883702
UMLS CUI [1,3]
C1265611
have given written informed consent before patient registration
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
the opposite of the above
Beskrivning

Inclusion criteria Opposite

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1521805
Tillbaka till toppen

Similar models

Eligibility Colorectal Cancer NCT00704600

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of rectum | Tumor Distance from anal verge
Item
histologically proven adenocarcinoma of the rectum (tumor <15cm from anal verge)
boolean
C0149978 (UMLS CUI [1])
C0027651 (UMLS CUI [2,1])
C1317308 (UMLS CUI [2,2])
Age
Item
age >= 18 years
boolean
C0001779 (UMLS CUI [1])
UICC (tumor staging)
Item
uicc t3-4 n0-2 m0
boolean
C0441914 (UMLS CUI [1])
WHO performance status scale
Item
who performance status 0-2
boolean
C1298650 (UMLS CUI [1])
Weight decreased Percentage
Item
less than 10 % weight loss the last 6 months
boolean
C1262477 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
Heart Disease Severe Absent | Cardiac Arrhythmia Absent | Congestive heart failure Absent | Myocardial Infarction Absent
Item
no recent (< 3 months) severe cardiac disease (arrhythmia, congestive heart failure, infarction)
boolean
C0018799 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0003811 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0018802 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0027051 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Serum total bilirubin measurement
Item
serum bilirubin = or < 3x normal
boolean
C1278039 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
asat and alat = or < 2,5x normal
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Creatinine clearance measurement
Item
creatinin clearance >50 ml/min
boolean
C0373595 (UMLS CUI [1])
Protocol Compliance
Item
willing and able to comply with the study prescriptions
boolean
C0525058 (UMLS CUI [1])
Radiotherapy to pelvis Absent
Item
no history of prior pelvic radiotherapy
boolean
C1536155 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
HIV Infection Absent
Item
no known hiv infection
boolean
C0019693 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Hemophilia Absent
Item
no hemophilia
boolean
C0684275 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Absence Pharmaceutical Preparations CYP3A4 Metabolized | Calcium Channel Blockers Absent | Antifungal Agents Absent | Macrolide Antibiotics Absent | Prokinetic Agents gastrointestinal Absent | Terfenadine Absent | Midazolam Absent
Item
no concurrent medication that is metabolized by the cyp3a4 isoenzyme (calcium channel blockers, antifungal agents, macrolide antibiotics, gastrointestinal prokinetics, terfenadin, midazolam)
boolean
C0332197 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C3714798 (UMLS CUI [1,3])
C1524026 (UMLS CUI [1,4])
C0006684 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0003308 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0003240 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C1268865 (UMLS CUI [5,1])
C0521362 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
C0085173 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
C0026056 (UMLS CUI [7,1])
C0332197 (UMLS CUI [7,2])
Statins To be stopped | Exception Pravastatin | Exception Fluvastatin
Item
statins should be stopped (except pravastatin and fluvastatin),
boolean
C0360714 (UMLS CUI [1,1])
C1272691 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0085542 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0082608 (UMLS CUI [3,2])
Hypericum perforatum Excluded
Item
no concurrent use of st. john's wort (hypericum perforatum)
boolean
C0936242 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
Pregnancy Excluded | Breast Feeding Excluded
Item
women should not be pregnant or lactating
boolean
C0032961 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
Biopsy extra Quantity
Item
being willing and able to undergo one extra biopsy
boolean
C0005558 (UMLS CUI [1,1])
C1883702 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Informed Consent
Item
have given written informed consent before patient registration
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Inclusion criteria Opposite
Item
the opposite of the above
boolean
C1512693 (UMLS CUI [1,1])
C1521805 (UMLS CUI [1,2])
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