ID

28933

Descripción

Hyperbaric Oxygen Therapy (HBOT) for Chronic Diabetic Lower Limb Ulcers; ODM derived from: https://clinicaltrials.gov/show/NCT00621608

Link

https://clinicaltrials.gov/show/NCT00621608

Palabras clave

Versiones (1)
  1. 17/2/18 17/2/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

17 de febrero de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus NCT00621608

Inglés

Eligibility Diabetes Mellitus NCT00621608

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
age > 18 years
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
type 1 or 2 diabetes mellitus
Descripción

Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0011860
wagner grading of foot lesions 3 or 4 on lower limb not healing for 4 weeks.
Descripción

Foot Injuries Lower Extremity Non-healed Grade

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0149697
UMLS CUI [1,2]
C0023216
UMLS CUI [1,3]
C0205301
UMLS CUI [1,4]
C0441800
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
impending urgent amputation due to ongoing or exacerbated infection;
Descripción

Amputation Urgent Impending | Cause Infection Continuous | Cause Infection Exacerbated

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0002688
UMLS CUI [1,2]
C0439609
UMLS CUI [1,3]
C0332190
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C3714514
UMLS CUI [2,3]
C0549178
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C3714514
UMLS CUI [3,3]
C1444749
exposed calcaneus bone with no prospect of weight bearing potential even if defect has been healed;
Descripción

Calcaneus Exposed | Weight-Bearing state Negative

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0006655
UMLS CUI [1,2]
C0332157
UMLS CUI [2,1]
C1318107
UMLS CUI [2,2]
C1513916
dialysis-dependent renal failure;
Descripción

Kidney Failure | Dependence on renal dialysis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0035078
UMLS CUI [2]
C0524376
any of the following medical conditions which preclude safe treatment in a monoplace chamber: clinical depression; severe dementia; claustrophobia; seizure disorder; active asthma; severe chronic obstructive pulmonary disease; previous thoracic surgery; previous spontaneous or trauma induced pneumothorax; history of severe congestive heart failure with left ventricular ejection fraction less than 20%; unstable angina; chronic sinusitis; chronic or acute otitis media or major ear drum trauma; severe kyphoscoliosis; arthritis; or morbid obesity;
Descripción

Medical condition Therapeutic procedure Difficult | Clinical depression | Severe dementia | Claustrophobia | Epilepsy | Asthma | Severe chronic obstructive pulmonary disease | Thoracic Surgical Procedures | Spontaneous pneumothorax | Pneumothorax Due to Trauma | Congestive heart failure Severe | Left ventricular ejection fraction | Angina, Unstable | Chronic sinusitis | Chronic otitis media | Otitis Media | Injury of tympanic membrane Major | Kyphoscoliosis, severe | Arthritis | Obesity, Morbid

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0332218
UMLS CUI [2]
C2362914
UMLS CUI [3]
C3494652
UMLS CUI [4]
C0008909
UMLS CUI [5]
C0014544
UMLS CUI [6]
C0004096
UMLS CUI [7]
C0730607
UMLS CUI [8]
C0524832
UMLS CUI [9]
C0149781
UMLS CUI [10,1]
C0032326
UMLS CUI [10,2]
C0678226
UMLS CUI [10,3]
C3714660
UMLS CUI [11,1]
C0018802
UMLS CUI [11,2]
C0205082
UMLS CUI [12]
C0428772
UMLS CUI [13]
C0002965
UMLS CUI [14]
C0149516
UMLS CUI [15]
C0271441
UMLS CUI [16]
C0029882
UMLS CUI [17,1]
C0560646
UMLS CUI [17,2]
C0205164
UMLS CUI [18]
C3553759
UMLS CUI [19]
C0003864
UMLS CUI [20]
C0028756
history of chemotherapy with use of bleomycin;
Descripción

Chemotherapy | Bleomycin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0005740
participation in another investigative drug or device trial currently or within the last 30 days;
Descripción

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
current candidates for vascular surgery, angioplasty or stenting;
Descripción

Patients Appropriate Vascular Surgical Procedures | Patients Appropriate Angioplasty | Patients Appropriate Stenting

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C0042381
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1548787
UMLS CUI [2,3]
C0162577
UMLS CUI [3,1]
C0030705
UMLS CUI [3,2]
C1548787
UMLS CUI [3,3]
C2348535
major large vessel disease;
Descripción

Large vessel Major Disease

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1284325
UMLS CUI [1,2]
C0205164
UMLS CUI [1,3]
C0012634
undergone vascular surgery or angioplasty within the last 3 months;
Descripción

Vascular Surgical Procedures | Angioplasty

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0042381
UMLS CUI [2]
C0162577
women who are currently pregnant or are breast feeding or women of childbearing potential who are not currently taking adequate birth control.
Descripción

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Lacking

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332268
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Similar models

Eligibility Diabetes Mellitus NCT00621608

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age > 18 years
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent
Item
type 1 or 2 diabetes mellitus
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
Foot Injuries Lower Extremity Non-healed Grade
Item
wagner grading of foot lesions 3 or 4 on lower limb not healing for 4 weeks.
boolean
C0149697 (UMLS CUI [1,1])
C0023216 (UMLS CUI [1,2])
C0205301 (UMLS CUI [1,3])
C0441800 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
Amputation Urgent Impending | Cause Infection Continuous | Cause Infection Exacerbated
Item
impending urgent amputation due to ongoing or exacerbated infection;
boolean
C0002688 (UMLS CUI [1,1])
C0439609 (UMLS CUI [1,2])
C0332190 (UMLS CUI [1,3])
C0015127 (UMLS CUI [2,1])
C3714514 (UMLS CUI [2,2])
C0549178 (UMLS CUI [2,3])
C0015127 (UMLS CUI [3,1])
C3714514 (UMLS CUI [3,2])
C1444749 (UMLS CUI [3,3])
Calcaneus Exposed | Weight-Bearing state Negative
Item
exposed calcaneus bone with no prospect of weight bearing potential even if defect has been healed;
boolean
C0006655 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
C1318107 (UMLS CUI [2,1])
C1513916 (UMLS CUI [2,2])
Kidney Failure | Dependence on renal dialysis
Item
dialysis-dependent renal failure;
boolean
C0035078 (UMLS CUI [1])
C0524376 (UMLS CUI [2])
Medical condition Therapeutic procedure Difficult | Clinical depression | Severe dementia | Claustrophobia | Epilepsy | Asthma | Severe chronic obstructive pulmonary disease | Thoracic Surgical Procedures | Spontaneous pneumothorax | Pneumothorax Due to Trauma | Congestive heart failure Severe | Left ventricular ejection fraction | Angina, Unstable | Chronic sinusitis | Chronic otitis media | Otitis Media | Injury of tympanic membrane Major | Kyphoscoliosis, severe | Arthritis | Obesity, Morbid
Item
any of the following medical conditions which preclude safe treatment in a monoplace chamber: clinical depression; severe dementia; claustrophobia; seizure disorder; active asthma; severe chronic obstructive pulmonary disease; previous thoracic surgery; previous spontaneous or trauma induced pneumothorax; history of severe congestive heart failure with left ventricular ejection fraction less than 20%; unstable angina; chronic sinusitis; chronic or acute otitis media or major ear drum trauma; severe kyphoscoliosis; arthritis; or morbid obesity;
boolean
C3843040 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0332218 (UMLS CUI [1,3])
C2362914 (UMLS CUI [2])
C3494652 (UMLS CUI [3])
C0008909 (UMLS CUI [4])
C0014544 (UMLS CUI [5])
C0004096 (UMLS CUI [6])
C0730607 (UMLS CUI [7])
C0524832 (UMLS CUI [8])
C0149781 (UMLS CUI [9])
C0032326 (UMLS CUI [10,1])
C0678226 (UMLS CUI [10,2])
C3714660 (UMLS CUI [10,3])
C0018802 (UMLS CUI [11,1])
C0205082 (UMLS CUI [11,2])
C0428772 (UMLS CUI [12])
C0002965 (UMLS CUI [13])
C0149516 (UMLS CUI [14])
C0271441 (UMLS CUI [15])
C0029882 (UMLS CUI [16])
C0560646 (UMLS CUI [17,1])
C0205164 (UMLS CUI [17,2])
C3553759 (UMLS CUI [18])
C0003864 (UMLS CUI [19])
C0028756 (UMLS CUI [20])
Chemotherapy | Bleomycin
Item
history of chemotherapy with use of bleomycin;
boolean
C0392920 (UMLS CUI [1])
C0005740 (UMLS CUI [2])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
participation in another investigative drug or device trial currently or within the last 30 days;
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
Patients Appropriate Vascular Surgical Procedures | Patients Appropriate Angioplasty | Patients Appropriate Stenting
Item
current candidates for vascular surgery, angioplasty or stenting;
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0042381 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C1548787 (UMLS CUI [2,2])
C0162577 (UMLS CUI [2,3])
C0030705 (UMLS CUI [3,1])
C1548787 (UMLS CUI [3,2])
C2348535 (UMLS CUI [3,3])
Large vessel Major Disease
Item
major large vessel disease;
boolean
C1284325 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
Vascular Surgical Procedures | Angioplasty
Item
undergone vascular surgery or angioplasty within the last 3 months;
boolean
C0042381 (UMLS CUI [1])
C0162577 (UMLS CUI [2])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Lacking
Item
women who are currently pregnant or are breast feeding or women of childbearing potential who are not currently taking adequate birth control.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332268 (UMLS CUI [3,3])
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