ID

39365

Beschrijving

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

Trefwoorden

Versies (1)
  1. 02-01-20 02-01-20 -
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See clinicaltrials.gov

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2 januari 2020

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Head-and-neck Squamous Cell Carcinoma NCT01941992

Engels

Eligibility Head-and-neck Squamous Cell Carcinoma NCT01941992

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

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

Squamous cell carcinoma of the head and neck

Datatype

boolean

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

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

Datatype

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
Beschrijving

Disease TNM clinical staging | Distant metastasis Absent

Datatype

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
Beschrijving

Patients Appropriate Chemoradiotherapy | Induction Chemotherapy Followed by Chemoradiotherapy

Datatype

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
Beschrijving

Age

Datatype

boolean

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

Karnofsky Performance Status

Datatype

boolean

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

Life Expectancy

Datatype

boolean

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

Able to swallow Oral medication | Ability Retain Oral medication

Datatype

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
Beschrijving

Dentition State Good

Datatype

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
Beschrijving

Patients Available Treatment | Patients Available Follow-up

Datatype

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
Beschrijving

Patients Use of Contraceptive methods | Partner Use of Contraceptive methods

Datatype

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
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

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

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

Datatype

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.
Beschrijving

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

Datatype

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
Beschrijving

Steroid use chronic | Immunosuppressive Agents chronic

Datatype

boolean

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

Pregnancy

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
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Similar models

Eligibility Head-and-neck Squamous Cell Carcinoma NCT01941992

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
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