ID

39365

Description

Role of SAMITAL® in the Relief of Chemo-radiation (CT-RT) Induced Oral Mucositis in Head and Neck Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01941992

Link

https://clinicaltrials.gov/show/NCT01941992

Keywords

Versions (1)
  1. 1/2/20 1/2/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 2, 2020

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Head-and-neck Squamous Cell Carcinoma NCT01941992

English

Eligibility Head-and-neck Squamous Cell Carcinoma NCT01941992

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically proven squamous cell carcinomas of the head-and-neck
Description

Squamous cell carcinoma of the head and neck

Data type

boolean

Alias
UMLS CUI [1]
C1168401
eligible primary tumor sites: oral cavity, oropharynx, larynx, hypopharynx
Description

Primary tumor site | Oral cavity | Oropharynx | Larynx | Hypopharynx

Data type

boolean

Alias
UMLS CUI [1]
C0475447
UMLS CUI [2]
C0226896
UMLS CUI [3]
C0521367
UMLS CUI [4]
C0023078
UMLS CUI [5]
C0020629
stage iii or iv disease without evidence of distant metastases
Description

Disease TNM clinical staging | Distant metastasis Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C1269798
UMLS CUI [2,2]
C0332197
patients candidate to definitive concurrent chemo-radiotherapy or induction chemotherapy followed by chemo-radiotherapy
Description

Patients Appropriate Chemoradiotherapy | Induction Chemotherapy Followed by Chemoradiotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C0436307
UMLS CUI [2,1]
C3179010
UMLS CUI [2,2]
C0332283
UMLS CUI [2,3]
C0436307
age ≥ 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
karnofsky performance status ≥70
Description

Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
life expectancy ≥6 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
able to swallow and retain oral medication
Description

Able to swallow Oral medication | Ability Retain Oral medication

Data type

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0175795
UMLS CUI [2,1]
C0085732
UMLS CUI [2,2]
C0333118
UMLS CUI [2,3]
C0175795
good state of dentition
Description

Dentition State Good

Data type

boolean

Alias
UMLS CUI [1,1]
C0011443
UMLS CUI [1,2]
C1442792
UMLS CUI [1,3]
C0205170
patients must be available for treatment and follow-up
Description

Patients Available Treatment | Patients Available Follow-up

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0470187
UMLS CUI [1,3]
C0087111
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0470187
UMLS CUI [2,3]
C3274571
confirmation of adequate contraception use by the patient and/or partner
Description

Patients Use of Contraceptive methods | Partner Use of Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1524063
UMLS CUI [1,3]
C0700589
UMLS CUI [2,1]
C0682323
UMLS CUI [2,2]
C1524063
UMLS CUI [2,3]
C0700589
signed informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous radiotherapy of the oral cavity, and/or oropharynx, larynx, hypopharynx
Description

Radiotherapy to oral cavity | Prior radiation therapy Oropharynx | Prior radiation therapy Larynx | Prior radiation therapy Hypopharynx

Data type

boolean

Alias
UMLS CUI [1]
C3888858
UMLS CUI [2,1]
C0279134
UMLS CUI [2,2]
C0521367
UMLS CUI [3,1]
C0279134
UMLS CUI [3,2]
C0023078
UMLS CUI [4,1]
C0279134
UMLS CUI [4,2]
C0020629
serious co-morbidities: uncontrolled heart disease, heart failure within 6 months prior to study participation, history of serious neurological and/or psychiatric abnormalities.
Description

Comorbidity Serious | Heart Disease Uncontrolled | Heart failure | Neurological anomalies Serious | Psychiatric abnormalities Serious

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0018799
UMLS CUI [2,2]
C0205318
UMLS CUI [3]
C0018801
UMLS CUI [4,1]
C0497552
UMLS CUI [4,2]
C0205404
UMLS CUI [5,1]
C4013650
UMLS CUI [5,2]
C0205404
chronic administration of steroids or immunosuppressants
Description

Steroid use chronic | Immunosuppressive Agents chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C0281991
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0021081
UMLS CUI [2,2]
C0205191
pregnancy.
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
Back to the top of the page

Similar models

Eligibility Head-and-neck Squamous Cell Carcinoma NCT01941992

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Squamous cell carcinoma of the head and neck
Item
histologically proven squamous cell carcinomas of the head-and-neck
boolean
C1168401 (UMLS CUI [1])
Primary tumor site | Oral cavity | Oropharynx | Larynx | Hypopharynx
Item
eligible primary tumor sites: oral cavity, oropharynx, larynx, hypopharynx
boolean
C0475447 (UMLS CUI [1])
C0226896 (UMLS CUI [2])
C0521367 (UMLS CUI [3])
C0023078 (UMLS CUI [4])
C0020629 (UMLS CUI [5])
Disease TNM clinical staging | Distant metastasis Absent
Item
stage iii or iv disease without evidence of distant metastases
boolean
C0012634 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C1269798 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Patients Appropriate Chemoradiotherapy | Induction Chemotherapy Followed by Chemoradiotherapy
Item
patients candidate to definitive concurrent chemo-radiotherapy or induction chemotherapy followed by chemo-radiotherapy
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0436307 (UMLS CUI [1,3])
C3179010 (UMLS CUI [2,1])
C0332283 (UMLS CUI [2,2])
C0436307 (UMLS CUI [2,3])
Age
Item
age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Karnofsky Performance Status
Item
karnofsky performance status ≥70
boolean
C0206065 (UMLS CUI [1])
Life Expectancy
Item
life expectancy ≥6 months
boolean
C0023671 (UMLS CUI [1])
Able to swallow Oral medication | Ability Retain Oral medication
Item
able to swallow and retain oral medication
boolean
C2712086 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
C0085732 (UMLS CUI [2,1])
C0333118 (UMLS CUI [2,2])
C0175795 (UMLS CUI [2,3])
Dentition State Good
Item
good state of dentition
boolean
C0011443 (UMLS CUI [1,1])
C1442792 (UMLS CUI [1,2])
C0205170 (UMLS CUI [1,3])
Patients Available Treatment | Patients Available Follow-up
Item
patients must be available for treatment and follow-up
boolean
C0030705 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C0470187 (UMLS CUI [2,2])
C3274571 (UMLS CUI [2,3])
Patients Use of Contraceptive methods | Partner Use of Contraceptive methods
Item
confirmation of adequate contraception use by the patient and/or partner
boolean
C0030705 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
C0682323 (UMLS CUI [2,1])
C1524063 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
Informed Consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Radiotherapy to oral cavity | Prior radiation therapy Oropharynx | Prior radiation therapy Larynx | Prior radiation therapy Hypopharynx
Item
previous radiotherapy of the oral cavity, and/or oropharynx, larynx, hypopharynx
boolean
C3888858 (UMLS CUI [1])
C0279134 (UMLS CUI [2,1])
C0521367 (UMLS CUI [2,2])
C0279134 (UMLS CUI [3,1])
C0023078 (UMLS CUI [3,2])
C0279134 (UMLS CUI [4,1])
C0020629 (UMLS CUI [4,2])
Comorbidity Serious | Heart Disease Uncontrolled | Heart failure | Neurological anomalies Serious | Psychiatric abnormalities Serious
Item
serious co-morbidities: uncontrolled heart disease, heart failure within 6 months prior to study participation, history of serious neurological and/or psychiatric abnormalities.
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0018799 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0018801 (UMLS CUI [3])
C0497552 (UMLS CUI [4,1])
C0205404 (UMLS CUI [4,2])
C4013650 (UMLS CUI [5,1])
C0205404 (UMLS CUI [5,2])
Steroid use chronic | Immunosuppressive Agents chronic
Item
chronic administration of steroids or immunosuppressants
boolean
C0281991 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0021081 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
Pregnancy
Item
pregnancy.
boolean
C0032961 (UMLS CUI [1])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

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