ID

39087

Descripción

Dexamethasone in Reducing Oral Pain and Dry Mouth After Surgery in Patients With Oropharyngeal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01748942

Link

https://clinicaltrials.gov/show/NCT01748942

Palabras clave

Versiones (1)
  1. 29/11/19 29/11/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

29 de noviembre de 2019

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
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Eligibility Dysphagia NCT01748942

Inglés

Eligibility Dysphagia NCT01748942

1 formularios  
  1. StudyEvent: Eligibility
    1. Eligibility Dysphagia NCT01748942
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must be diagnosed with oropharyngeal squamous cell carcinoma (scc) that are surgical candidates
Descripción

Squamous cell carcinoma of oropharynx | Patients Appropriate Operative Surgical Procedures

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0280313
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1548787
UMLS CUI [2,3]
C0543467
macroscopic resection of the tumor via tors must be planned with curative intent
Descripción

Tumor excision Macroscopic Planned | Transoral Robotic Surgery Curative

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1299802
UMLS CUI [1,2]
C0439806
UMLS CUI [1,3]
C1301732
UMLS CUI [2,1]
C2986516
UMLS CUI [2,2]
C1276305
patient must be willing to remain on corticosteroid therapy for 4 days postoperatively
Descripción

Steroid therapy Remaining Postoperative

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0149783
UMLS CUI [1,2]
C1527428
UMLS CUI [1,3]
C0032790
ability to understand and the willingness to sign a written informed consent document
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with known distant metastases or other malignancies
Descripción

Distant metastasis | Cancer Other

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1269798
UMLS CUI [2]
C1707251
patients with a history of allergy or adverse reaction to corticosteroids
Descripción

Hypersensitivity Adrenal Cortex Hormones | Allergic Reaction Adrenal Cortex Hormones

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0001617
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0001617
patients with a history of diabetes
Descripción

Diabetes Mellitus

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011849
patients with fasting capillary blood glucose of > 140 on the day of surgery
Descripción

Fasting blood glucose measurement capillary

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0428568
UMLS CUI [1,2]
C0006901
patients on chronic corticosteroids
Descripción

Adrenal Cortex Hormones chronic

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C0205191
chronic alcohol abuse (> 6 alcoholic beverages daily)
Descripción

Alcoholic Intoxication, Chronic | Alcoholic Beverages Quantity Daily

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001973
UMLS CUI [2,1]
C0001967
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0332173
patients with a history of severe chronic pain on high dose narcotics (> 25 mg of oxycodone or equivalent daily) preceding diagnosis of cancer
Descripción

Severe pain chronic | Narcotics High dose | Oxycodone Daily Dose | Equivalent Daily Dose | Status pre- Cancer diagnosis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0278140
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0027415
UMLS CUI [2,2]
C0444956
UMLS CUI [3,1]
C0030049
UMLS CUI [3,2]
C2348070
UMLS CUI [4,1]
C0205163
UMLS CUI [4,2]
C2348070
UMLS CUI [5,1]
C0332152
UMLS CUI [5,2]
C0920688
patients taking significant cytochrome p450 family 3, subfamily a, polypeptide 4 (cyp3a4) inhibitors or inducers, i.e. protease inhibitors (ritonavir, nelfinavir, etc), clarithromycin, ketoconazole, fluconazole, verapamil, diltiazem, carbamazepine, phenytoin, phenobarbital, rifampin, efavirenz, nevirapine
Descripción

CYP3A4 Inhibitors | CYP3A4 Inducers | Protease Inhibitors | Ritonavir | Nelfinavir | Clarithromycin | Ketoconazole | Fluconazole | Verapamil | Diltiazem | Carbamazepine | Phenytoin | Phenobarbital | Rifampin | efavirenz | Nevirapine

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3850053
UMLS CUI [2]
C3850041
UMLS CUI [3]
C0033607
UMLS CUI [4]
C0292818
UMLS CUI [5]
C0525005
UMLS CUI [6]
C0055856
UMLS CUI [7]
C0022625
UMLS CUI [8]
C0016277
UMLS CUI [9]
C0042523
UMLS CUI [10]
C0012373
UMLS CUI [11]
C0006949
UMLS CUI [12]
C0031507
UMLS CUI [13]
C0031412
UMLS CUI [14]
C0035608
UMLS CUI [15]
C0674428
UMLS CUI [16]
C0132326
patients who have received any investigational medication within 6 weeks of enrollment, or who are scheduled to receive an investigational drug during the course of the study
Descripción

Investigational New Drugs | Investigational New Drugs Scheduled

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2,1]
C0013230
UMLS CUI [2,2]
C0205539
patients who will undergo complex head and neck surgery in addition to the tors procedure requiring reconstruction with a free flap
Descripción

Complex head and neck surgery In addition to Transoral Robotic Surgery | Requirement Free flap Reconstruction

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1512343
UMLS CUI [1,2]
C0439855
UMLS CUI [1,3]
C0332287
UMLS CUI [1,4]
C2986516
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0441031
UMLS CUI [2,3]
C0524865
patients who have had any previous head and neck surgery that has affected swallowing, voice or speech or who have had previous radiation to the head or neck
Descripción

Head and neck surgery Affecting Deglutition | Head and neck surgery Affecting Voice | Head and neck surgery Affecting Speech | Radiation therapy to the head and neck

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1512343
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0011167
UMLS CUI [2,1]
C1512343
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0042939
UMLS CUI [3,1]
C1512343
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C0037817
UMLS CUI [4]
C4540910
patients who have any confounding medical or neurological conditions that have the potential to affect cognition, speech or swallowing function; i.e. stroke, neurodegenerative disease, neuromuscular movement disorders, head injury, etcetera
Descripción

Medical condition Affecting Cognition | Medical condition Affecting Speech | Medical condition Affecting Deglutition | Condition Neurological Affecting Cognition | Condition Neurological Affecting Speech | Condition Neurological Affecting Deglutition | Cerebrovascular accident | Neurodegenerative Disorders | Neuromuscular Diseases | Craniocerebral Trauma

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0009240
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0037817
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C0011167
UMLS CUI [4,1]
C0348080
UMLS CUI [4,2]
C0205494
UMLS CUI [4,3]
C0392760
UMLS CUI [4,4]
C0009240
UMLS CUI [5,1]
C0348080
UMLS CUI [5,2]
C0205494
UMLS CUI [5,3]
C0392760
UMLS CUI [5,4]
C0037817
UMLS CUI [6,1]
C0348080
UMLS CUI [6,2]
C0205494
UMLS CUI [6,3]
C0392760
UMLS CUI [6,4]
C0011167
UMLS CUI [7]
C0038454
UMLS CUI [8]
C0524851
UMLS CUI [9]
C0027868
UMLS CUI [10]
C0018674
psychiatric illness/social situations that would limit compliance with study requirements
Descripción

Mental disorder Limiting Protocol Compliance | Social situation Limiting Protocol Compliance

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C0748872
UMLS CUI [2,2]
C0439801
UMLS CUI [2,3]
C0525058
excluded patients will be allowed to participate in the trial on an observational basis only
Descripción

Patients Excluded | Study Subject Participation Status Observation allowed

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0332196
UMLS CUI [2,1]
C2348568
UMLS CUI [2,2]
C0302523
UMLS CUI [2,3]
C0683607
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Similar models

Eligibility Dysphagia NCT01748942

1 formularios
  1. StudyEvent: Eligibility
    1. Eligibility Dysphagia NCT01748942
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Squamous cell carcinoma of oropharynx | Patients Appropriate Operative Surgical Procedures
Item
patients must be diagnosed with oropharyngeal squamous cell carcinoma (scc) that are surgical candidates
boolean
C0280313 (UMLS CUI [1])
C0030705 (UMLS CUI [2,1])
C1548787 (UMLS CUI [2,2])
C0543467 (UMLS CUI [2,3])
Tumor excision Macroscopic Planned | Transoral Robotic Surgery Curative
Item
macroscopic resection of the tumor via tors must be planned with curative intent
boolean
C1299802 (UMLS CUI [1,1])
C0439806 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C2986516 (UMLS CUI [2,1])
C1276305 (UMLS CUI [2,2])
Steroid therapy Remaining Postoperative
Item
patient must be willing to remain on corticosteroid therapy for 4 days postoperatively
boolean
C0149783 (UMLS CUI [1,1])
C1527428 (UMLS CUI [1,2])
C0032790 (UMLS CUI [1,3])
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)
Distant metastasis | Cancer Other
Item
patients with known distant metastases or other malignancies
boolean
C1269798 (UMLS CUI [1])
C1707251 (UMLS CUI [2])
Hypersensitivity Adrenal Cortex Hormones | Allergic Reaction Adrenal Cortex Hormones
Item
patients with a history of allergy or adverse reaction to corticosteroids
boolean
C0020517 (UMLS CUI [1,1])
C0001617 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C0001617 (UMLS CUI [2,2])
Diabetes Mellitus
Item
patients with a history of diabetes
boolean
C0011849 (UMLS CUI [1])
Fasting blood glucose measurement capillary
Item
patients with fasting capillary blood glucose of > 140 on the day of surgery
boolean
C0428568 (UMLS CUI [1,1])
C0006901 (UMLS CUI [1,2])
Adrenal Cortex Hormones chronic
Item
patients on chronic corticosteroids
boolean
C0001617 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
Alcoholic Intoxication, Chronic | Alcoholic Beverages Quantity Daily
Item
chronic alcohol abuse (> 6 alcoholic beverages daily)
boolean
C0001973 (UMLS CUI [1])
C0001967 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0332173 (UMLS CUI [2,3])
Severe pain chronic | Narcotics High dose | Oxycodone Daily Dose | Equivalent Daily Dose | Status pre- Cancer diagnosis
Item
patients with a history of severe chronic pain on high dose narcotics (> 25 mg of oxycodone or equivalent daily) preceding diagnosis of cancer
boolean
C0278140 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0027415 (UMLS CUI [2,1])
C0444956 (UMLS CUI [2,2])
C0030049 (UMLS CUI [3,1])
C2348070 (UMLS CUI [3,2])
C0205163 (UMLS CUI [4,1])
C2348070 (UMLS CUI [4,2])
C0332152 (UMLS CUI [5,1])
C0920688 (UMLS CUI [5,2])
CYP3A4 Inhibitors | CYP3A4 Inducers | Protease Inhibitors | Ritonavir | Nelfinavir | Clarithromycin | Ketoconazole | Fluconazole | Verapamil | Diltiazem | Carbamazepine | Phenytoin | Phenobarbital | Rifampin | efavirenz | Nevirapine
Item
patients taking significant cytochrome p450 family 3, subfamily a, polypeptide 4 (cyp3a4) inhibitors or inducers, i.e. protease inhibitors (ritonavir, nelfinavir, etc), clarithromycin, ketoconazole, fluconazole, verapamil, diltiazem, carbamazepine, phenytoin, phenobarbital, rifampin, efavirenz, nevirapine
boolean
C3850053 (UMLS CUI [1])
C3850041 (UMLS CUI [2])
C0033607 (UMLS CUI [3])
C0292818 (UMLS CUI [4])
C0525005 (UMLS CUI [5])
C0055856 (UMLS CUI [6])
C0022625 (UMLS CUI [7])
C0016277 (UMLS CUI [8])
C0042523 (UMLS CUI [9])
C0012373 (UMLS CUI [10])
C0006949 (UMLS CUI [11])
C0031507 (UMLS CUI [12])
C0031412 (UMLS CUI [13])
C0035608 (UMLS CUI [14])
C0674428 (UMLS CUI [15])
C0132326 (UMLS CUI [16])
Investigational New Drugs | Investigational New Drugs Scheduled
Item
patients who have received any investigational medication within 6 weeks of enrollment, or who are scheduled to receive an investigational drug during the course of the study
boolean
C0013230 (UMLS CUI [1])
C0013230 (UMLS CUI [2,1])
C0205539 (UMLS CUI [2,2])
Complex head and neck surgery In addition to Transoral Robotic Surgery | Requirement Free flap Reconstruction
Item
patients who will undergo complex head and neck surgery in addition to the tors procedure requiring reconstruction with a free flap
boolean
C1512343 (UMLS CUI [1,1])
C0439855 (UMLS CUI [1,2])
C0332287 (UMLS CUI [1,3])
C2986516 (UMLS CUI [1,4])
C1514873 (UMLS CUI [2,1])
C0441031 (UMLS CUI [2,2])
C0524865 (UMLS CUI [2,3])
Head and neck surgery Affecting Deglutition | Head and neck surgery Affecting Voice | Head and neck surgery Affecting Speech | Radiation therapy to the head and neck
Item
patients who have had any previous head and neck surgery that has affected swallowing, voice or speech or who have had previous radiation to the head or neck
boolean
C1512343 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0011167 (UMLS CUI [1,3])
C1512343 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0042939 (UMLS CUI [2,3])
C1512343 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0037817 (UMLS CUI [3,3])
C4540910 (UMLS CUI [4])
Medical condition Affecting Cognition | Medical condition Affecting Speech | Medical condition Affecting Deglutition | Condition Neurological Affecting Cognition | Condition Neurological Affecting Speech | Condition Neurological Affecting Deglutition | Cerebrovascular accident | Neurodegenerative Disorders | Neuromuscular Diseases | Craniocerebral Trauma
Item
patients who have any confounding medical or neurological conditions that have the potential to affect cognition, speech or swallowing function; i.e. stroke, neurodegenerative disease, neuromuscular movement disorders, head injury, etcetera
boolean
C3843040 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0009240 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0037817 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0011167 (UMLS CUI [3,3])
C0348080 (UMLS CUI [4,1])
C0205494 (UMLS CUI [4,2])
C0392760 (UMLS CUI [4,3])
C0009240 (UMLS CUI [4,4])
C0348080 (UMLS CUI [5,1])
C0205494 (UMLS CUI [5,2])
C0392760 (UMLS CUI [5,3])
C0037817 (UMLS CUI [5,4])
C0348080 (UMLS CUI [6,1])
C0205494 (UMLS CUI [6,2])
C0392760 (UMLS CUI [6,3])
C0011167 (UMLS CUI [6,4])
C0038454 (UMLS CUI [7])
C0524851 (UMLS CUI [8])
C0027868 (UMLS CUI [9])
C0018674 (UMLS CUI [10])
Mental disorder Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
psychiatric illness/social situations that would limit compliance with study requirements
boolean
C0004936 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0748872 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
Patients Excluded | Study Subject Participation Status Observation allowed
Item
excluded patients will be allowed to participate in the trial on an observational basis only
boolean
C0030705 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C2348568 (UMLS CUI [2,1])
C0302523 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
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