0 Evaluaciones
ID

36693

Descripción

Gastric Sleeve Pilot Study in Morbidly Obese Undergoing Liver Transplantation; ODM derived from: https://clinicaltrials.gov/show/NCT02068872

Link

https://clinicaltrials.gov/show/NCT02068872

Palabras clave

Versiones (1)
  1. 2/6/19 2/6/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

2 de junio de 2019

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
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    Eligibility Obesity NCT02068872

    Inglés

    Eligibility Obesity NCT02068872

    1 formularios  
    1. StudyEvent: Eligibility
      1. Eligibility Obesity NCT02068872
    Inclusion Criteria
    Descripción

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    subjects must be willing to give written informed consent.
    Descripción

    Informed Consent

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    adult subjects 18-75 years of age of any race or gender who are listed for liver transplantation.
    Descripción

    Adult | Age | Racial group | Patient on waiting list Transplantation of liver

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0001675 (Adult)
    SNOMED
    133936004
    LOINC
    LA13524-6
    UMLS CUI [2]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    UMLS CUI [3]
    C0034510 (Racial group)
    SNOMED
    415229000
    LOINC
    LP7528-5
    UMLS CUI [4,1]
    C0422768 (Patient on waiting list (finding))
    SNOMED
    270459005
    UMLS CUI [4,2]
    C0023911 (Transplantation of liver)
    SNOMED
    18027006
    for consideration of sleeve gastrectomy placement patients must meet the following criteria:
    Descripción

    Consideration Sleeve gastrectomy

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0518609 (Consideration)
    UMLS CUI [1,2]
    C3160799 (Sleeve gastrectomy)
    1. class iii obesity (bmi ≥ 40 kg/m2); or 2. class ii obesity (bmi 35-39.9 kg/m2 in conjunction with any of the following severe obesity related co-morbidities): i. obstructive sleep apnea defined as a formal sleep study consistent with this diagnosis with a) an epworth sleepiness scale ≥ 6 and b) polysomnography with respiratory disturbance index ≥ 10 and/or apneic episodes per hour of sleep; or ii. cardiovascular disease defined as prior history of stroke, myocardial infarction, stable or unstable angina pectoris, or prior coronary artery bypass); or iii. medically refractory hypertension defined as blood pressure greater than 140 mmhg systolic and/or 90 mmhg diastolic despite concurrent use of 3 anti-hypertensive agents of different classes iv. type 2 diabetes mellitus, defined as individuals taking insulin or oral hypoglycemic agents or who have a fasting glucose > 126 mg/dl
    Descripción

    Obesity Class | Body mass index | Comorbidity Relationship Severe Obesity | Sleep study Consistent with Obstructive Sleep Apnea | Epworth Sleepiness Scale Questionnaire | Polysomnography: respiratory disturbance index | Apneic episodes hour of sleep | Cardiovascular Disease | Cerebrovascular accident | Myocardial Infarction | Stable angina | Angina, Unstable | Coronary Artery Bypass Surgery | Refractory hypertension | Blood pressure determination | Systolic Pressure | Diastolic blood pressure | Antihypertensive Agents Quantity Class Different | Diabetes Mellitus, Non-Insulin-Dependent | Insulin | Oral hypoglycemic | Glucose measurement, fasting

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0028754 (Obesity)
    SNOMED
    414915002
    LOINC
    LA6301-1
    UMLS CUI [1,2]
    C0456387 (Class)
    SNOMED
    277046005
    UMLS CUI [2]
    C1305855 (Body mass index)
    SNOMED
    60621009
    LOINC
    LP35925-4
    UMLS CUI [3,1]
    C0009488 (Comorbidity)
    UMLS CUI [3,2]
    C0439849 (Relationships)
    SNOMED
    263498003
    LOINC
    LP146886-9
    UMLS CUI [3,3]
    C0028756 (Morbid obesity)
    SNOMED
    83911000119104
    UMLS CUI [4,1]
    C0162701 (Polysomnography)
    SNOMED
    60554003
    LOINC
    LP32261-7
    UMLS CUI [4,2]
    C0332290 (Consistent with)
    SNOMED
    385433004
    UMLS CUI [4,3]
    C0520679 (Sleep Apnea, Obstructive)
    SNOMED
    78275009
    UMLS CUI [5]
    C3541276 (Epworth Sleepiness Scale Questionnaire)
    SNOMED
    708735004
    UMLS CUI [6]
    C2111853 (polysomnography: respiratory disturbance index (procedure))
    UMLS CUI [7,1]
    C0003578 (Apnea)
    SNOMED
    1023001
    LOINC
    LA17393-2
    UMLS CUI [7,2]
    C2937255 (hours of sleep)
    UMLS CUI [8]
    C0007222 (Cardiovascular Diseases)
    SNOMED
    49601007
    UMLS CUI [9]
    C0038454 (Cerebrovascular accident)
    SNOMED
    230690007
    LOINC
    MTHU020801
    UMLS CUI [10]
    C0027051 (Myocardial Infarction)
    SNOMED
    22298006
    UMLS CUI [11]
    C0340288 (Stable angina)
    SNOMED
    233819005
    LOINC
    LA24432-9
    UMLS CUI [12]
    C0002965 (Angina, Unstable)
    SNOMED
    4557003
    UMLS CUI [13]
    C0010055 (Coronary Artery Bypass Surgery)
    SNOMED
    67166004
    LOINC
    LA14276-2
    UMLS CUI [14]
    C0860493 (Refractory hypertension)
    UMLS CUI [15]
    C0005824 (Blood pressure determination)
    SNOMED
    46973005
    UMLS CUI [16]
    C0871470 (Systolic Pressure)
    SNOMED
    271649006
    UMLS CUI [17]
    C0428883 (Diastolic blood pressure)
    SNOMED
    271650006
    UMLS CUI [18,1]
    C0003364 (Antihypertensive Agents)
    SNOMED
    1182007
    LOINC
    LP31453-1
    UMLS CUI [18,2]
    C1265611 (Quantity)
    SNOMED
    246205007
    LOINC
    LP202968-6
    UMLS CUI [18,3]
    C0456387 (Class)
    SNOMED
    277046005
    UMLS CUI [18,4]
    C1705242 (Different)
    UMLS CUI [19]
    C0011860 (Diabetes Mellitus, Non-Insulin-Dependent)
    SNOMED
    44054006
    UMLS CUI [20]
    C0021641 (Insulin)
    SNOMED
    39487003
    LOINC
    LP70329-5
    UMLS CUI [21]
    C0359086 (oral hypoglycemics)
    UMLS CUI [22]
    C0202045 (Glucose measurement, fasting)
    SNOMED
    52302001
    2. have attempted (and failed) previous weight loss efforts over at least a three month period with diet, exercise, lifestyle changes or medications.
    Descripción

    Weight loss Effort Attempt | Weight loss Attempt failed | Diet therapy | Exercise | Lifestyle changes | Pharmaceutical Preparations

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1262477 (Weight decreased)
    SNOMED
    161832001
    UMLS CUI [1,2]
    C0015264 (Exertion)
    SNOMED
    19487008
    UMLS CUI [1,3]
    C1516084 (Attempt)
    UMLS CUI [2,1]
    C1262477 (Weight decreased)
    SNOMED
    161832001
    UMLS CUI [2,2]
    C1516084 (Attempt)
    UMLS CUI [2,3]
    C0231175 (Failed)
    UMLS CUI [3]
    C0012159 (Diet therapy)
    UMLS CUI [4]
    C0015259 (Exercise)
    SNOMED
    183301007
    LOINC
    LP61581-2
    UMLS CUI [5]
    C0870811 (Lifestyle changes)
    UMLS CUI [6]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    3. show understanding of the risks and benefits of surgery and side effects of the procedure.
    Descripción

    Comprehension Risks and Benefits Operative Surgical Procedures | Comprehension Side effects Procedure

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0162340 (Comprehension)
    SNOMED
    66216009
    UMLS CUI [1,2]
    C0687742 (Risks and Benefits)
    UMLS CUI [1,3]
    C0543467 (Operative Surgical Procedures)
    SNOMED
    257556004
    LOINC
    LP7802-4
    UMLS CUI [2,1]
    C0162340 (Comprehension)
    SNOMED
    66216009
    UMLS CUI [2,2]
    C0879626 (Adverse effects)
    UMLS CUI [2,3]
    C0184661 (Interventional procedure)
    SNOMED
    71388002
    4. be committed to lifestyle changes. all patients will be evaluated by the transplant psychologist as well as the bariatric surgery psychologist prior to consideration for study enrollment to ensure appropriate psychological motivation.
    Descripción

    Commitment Lifestyle changes

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0870312 (commitment)
    UMLS CUI [1,2]
    C0870811 (Lifestyle changes)
    5. do not have any medical, psychiatric or emotional condition that would prohibit surgery (e.g. severe irreversible coronary artery disease, untreated schizophrenia, active substance abuse, and/or noncompliance with previous medical care)
    Descripción

    Absence Medical condition Preventing Operative Surgical Procedures | Absence Emotional or mental condition Preventing Operative Surgical Procedures | Coronary Artery Disease Severe | Schizophrenia untreated | Substance Use Disorders | Compliance behavior Lacking Medical care

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0332197 (Absent)
    SNOMED
    2667000
    LOINC
    LA9634-2
    UMLS CUI [1,2]
    C3843040 (Other medical condition)
    LOINC
    LA16346-1
    UMLS CUI [1,3]
    C1292733 (Preventing (action))
    SNOMED
    116699007
    UMLS CUI [1,4]
    C0543467 (Operative Surgical Procedures)
    SNOMED
    257556004
    LOINC
    LP7802-4
    UMLS CUI [2,1]
    C0332197 (Absent)
    SNOMED
    2667000
    LOINC
    LA9634-2
    UMLS CUI [2,2]
    C3843038 (Emotional or mental condition)
    LOINC
    LA16348-7
    UMLS CUI [2,3]
    C1292733 (Preventing (action))
    SNOMED
    116699007
    UMLS CUI [2,4]
    C0543467 (Operative Surgical Procedures)
    SNOMED
    257556004
    LOINC
    LP7802-4
    UMLS CUI [3,1]
    C1956346 (Coronary Artery Disease)
    SNOMED
    53741008
    UMLS CUI [3,2]
    C0205082 (Severe (severity modifier))
    SNOMED
    24484000
    LOINC
    LA6750-9
    UMLS CUI [4,1]
    C0036341 (Schizophrenia)
    SNOMED
    58214004
    LOINC
    MTHU020814
    UMLS CUI [4,2]
    C0332155 (Did not receive therapy or drug for)
    SNOMED
    25265005
    UMLS CUI [5]
    C0038586 (Substance Use Disorders)
    UMLS CUI [6,1]
    C1321605 (Compliance behavior)
    SNOMED
    405078008
    UMLS CUI [6,2]
    C0332268 (Lacking)
    SNOMED
    41277001
    UMLS CUI [6,3]
    C0496675 (Medical care)
    SNOMED
    781087000
    Exclusion Criteria
    Descripción

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    status 1 listing (fulminant hepatic failure) for liver transplant
    Descripción

    Fulminant Liver Failure

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0162557 (Liver Failure, Acute)
    SNOMED
    197270009
    active drug abuse or alcohol use within six months
    Descripción

    Substance Use Disorders

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0038586 (Substance Use Disorders)
    positive urine pregnancy test (females)
    Descripción

    Urine pregnancy test positive

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0430059 (Urine pregnancy test positive)
    SNOMED
    167256004
    diagnosis of active malignancy
    Descripción

    Malignant Neoplasms

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0006826 (Malignant Neoplasms)
    SNOMED
    363346000
    LOINC
    LP100805-3
    history of prior bariatric surgery
    Descripción

    Bariatric Surgery

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1456587 (Bariatric Surgery)
    LOINC
    LA25549-9
    failure to attend the initial patient information sessions or history of noncompliance
    Descripción

    Patient Information failed | Compliance behavior Lacking

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1955348 (Patient Information)
    UMLS CUI [1,2]
    C0231175 (Failed)
    UMLS CUI [2,1]
    C1321605 (Compliance behavior)
    SNOMED
    405078008
    UMLS CUI [2,2]
    C0332268 (Lacking)
    SNOMED
    41277001
    failure to give consent for the study or to understand the proposed consent
    Descripción

    Informed Consent failed | Informed Consent Comprehension Unable

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430 (Informed Consent)
    UMLS CUI [1,2]
    C0231175 (Failed)
    UMLS CUI [2,1]
    C0021430 (Informed Consent)
    UMLS CUI [2,2]
    C0162340 (Comprehension)
    SNOMED
    66216009
    UMLS CUI [2,3]
    C1299582 (Unable)
    SNOMED
    371151008
    LOINC
    LA13868-7
    failure of patient's insurance company to approve surgical intervention so as to avoid extensive cost burden on the patient
    Descripción

    Health Insurance failed

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0021682 (Health Insurance)
    UMLS CUI [1,2]
    C0231175 (Failed)
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    Similar models

    Eligibility Obesity NCT02068872

    1 formularios
    1. StudyEvent: Eligibility
      1. Eligibility Obesity NCT02068872
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Informed Consent
    Item
    subjects must be willing to give written informed consent.
    boolean
    C0021430 (UMLS CUI [1])
    Adult | Age | Racial group | Patient on waiting list Transplantation of liver
    Item
    adult subjects 18-75 years of age of any race or gender who are listed for liver transplantation.
    boolean
    C0001675 (UMLS CUI [1])
    C0001779 (UMLS CUI [2])
    C0034510 (UMLS CUI [3])
    C0422768 (UMLS CUI [4,1])
    C0023911 (UMLS CUI [4,2])
    Consideration Sleeve gastrectomy
    Item
    for consideration of sleeve gastrectomy placement patients must meet the following criteria:
    boolean
    C0518609 (UMLS CUI [1,1])
    C3160799 (UMLS CUI [1,2])
    Obesity Class | Body mass index | Comorbidity Relationship Severe Obesity | Sleep study Consistent with Obstructive Sleep Apnea | Epworth Sleepiness Scale Questionnaire | Polysomnography: respiratory disturbance index | Apneic episodes hour of sleep | Cardiovascular Disease | Cerebrovascular accident | Myocardial Infarction | Stable angina | Angina, Unstable | Coronary Artery Bypass Surgery | Refractory hypertension | Blood pressure determination | Systolic Pressure | Diastolic blood pressure | Antihypertensive Agents Quantity Class Different | Diabetes Mellitus, Non-Insulin-Dependent | Insulin | Oral hypoglycemic | Glucose measurement, fasting
    Item
    1. class iii obesity (bmi ≥ 40 kg/m2); or 2. class ii obesity (bmi 35-39.9 kg/m2 in conjunction with any of the following severe obesity related co-morbidities): i. obstructive sleep apnea defined as a formal sleep study consistent with this diagnosis with a) an epworth sleepiness scale ≥ 6 and b) polysomnography with respiratory disturbance index ≥ 10 and/or apneic episodes per hour of sleep; or ii. cardiovascular disease defined as prior history of stroke, myocardial infarction, stable or unstable angina pectoris, or prior coronary artery bypass); or iii. medically refractory hypertension defined as blood pressure greater than 140 mmhg systolic and/or 90 mmhg diastolic despite concurrent use of 3 anti-hypertensive agents of different classes iv. type 2 diabetes mellitus, defined as individuals taking insulin or oral hypoglycemic agents or who have a fasting glucose > 126 mg/dl
    boolean
    C0028754 (UMLS CUI [1,1])
    C0456387 (UMLS CUI [1,2])
    C1305855 (UMLS CUI [2])
    C0009488 (UMLS CUI [3,1])
    C0439849 (UMLS CUI [3,2])
    C0028756 (UMLS CUI [3,3])
    C0162701 (UMLS CUI [4,1])
    C0332290 (UMLS CUI [4,2])
    C0520679 (UMLS CUI [4,3])
    C3541276 (UMLS CUI [5])
    C2111853 (UMLS CUI [6])
    C0003578 (UMLS CUI [7,1])
    C2937255 (UMLS CUI [7,2])
    C0007222 (UMLS CUI [8])
    C0038454 (UMLS CUI [9])
    C0027051 (UMLS CUI [10])
    C0340288 (UMLS CUI [11])
    C0002965 (UMLS CUI [12])
    C0010055 (UMLS CUI [13])
    C0860493 (UMLS CUI [14])
    C0005824 (UMLS CUI [15])
    C0871470 (UMLS CUI [16])
    C0428883 (UMLS CUI [17])
    C0003364 (UMLS CUI [18,1])
    C1265611 (UMLS CUI [18,2])
    C0456387 (UMLS CUI [18,3])
    C1705242 (UMLS CUI [18,4])
    C0011860 (UMLS CUI [19])
    C0021641 (UMLS CUI [20])
    C0359086 (UMLS CUI [21])
    C0202045 (UMLS CUI [22])
    Weight loss Effort Attempt | Weight loss Attempt failed | Diet therapy | Exercise | Lifestyle changes | Pharmaceutical Preparations
    Item
    2. have attempted (and failed) previous weight loss efforts over at least a three month period with diet, exercise, lifestyle changes or medications.
    boolean
    C1262477 (UMLS CUI [1,1])
    C0015264 (UMLS CUI [1,2])
    C1516084 (UMLS CUI [1,3])
    C1262477 (UMLS CUI [2,1])
    C1516084 (UMLS CUI [2,2])
    C0231175 (UMLS CUI [2,3])
    C0012159 (UMLS CUI [3])
    C0015259 (UMLS CUI [4])
    C0870811 (UMLS CUI [5])
    C0013227 (UMLS CUI [6])
    Comprehension Risks and Benefits Operative Surgical Procedures | Comprehension Side effects Procedure
    Item
    3. show understanding of the risks and benefits of surgery and side effects of the procedure.
    boolean
    C0162340 (UMLS CUI [1,1])
    C0687742 (UMLS CUI [1,2])
    C0543467 (UMLS CUI [1,3])
    C0162340 (UMLS CUI [2,1])
    C0879626 (UMLS CUI [2,2])
    C0184661 (UMLS CUI [2,3])
    Commitment Lifestyle changes
    Item
    4. be committed to lifestyle changes. all patients will be evaluated by the transplant psychologist as well as the bariatric surgery psychologist prior to consideration for study enrollment to ensure appropriate psychological motivation.
    boolean
    C0870312 (UMLS CUI [1,1])
    C0870811 (UMLS CUI [1,2])
    Absence Medical condition Preventing Operative Surgical Procedures | Absence Emotional or mental condition Preventing Operative Surgical Procedures | Coronary Artery Disease Severe | Schizophrenia untreated | Substance Use Disorders | Compliance behavior Lacking Medical care
    Item
    5. do not have any medical, psychiatric or emotional condition that would prohibit surgery (e.g. severe irreversible coronary artery disease, untreated schizophrenia, active substance abuse, and/or noncompliance with previous medical care)
    boolean
    C0332197 (UMLS CUI [1,1])
    C3843040 (UMLS CUI [1,2])
    C1292733 (UMLS CUI [1,3])
    C0543467 (UMLS CUI [1,4])
    C0332197 (UMLS CUI [2,1])
    C3843038 (UMLS CUI [2,2])
    C1292733 (UMLS CUI [2,3])
    C0543467 (UMLS CUI [2,4])
    C1956346 (UMLS CUI [3,1])
    C0205082 (UMLS CUI [3,2])
    C0036341 (UMLS CUI [4,1])
    C0332155 (UMLS CUI [4,2])
    C0038586 (UMLS CUI [5])
    C1321605 (UMLS CUI [6,1])
    C0332268 (UMLS CUI [6,2])
    C0496675 (UMLS CUI [6,3])
    Item Group
    C0680251 (UMLS CUI)
    Fulminant Liver Failure
    Item
    status 1 listing (fulminant hepatic failure) for liver transplant
    boolean
    C0162557 (UMLS CUI [1])
    Substance Use Disorders
    Item
    active drug abuse or alcohol use within six months
    boolean
    C0038586 (UMLS CUI [1])
    Urine pregnancy test positive
    Item
    positive urine pregnancy test (females)
    boolean
    C0430059 (UMLS CUI [1])
    Malignant Neoplasms
    Item
    diagnosis of active malignancy
    boolean
    C0006826 (UMLS CUI [1])
    Bariatric Surgery
    Item
    history of prior bariatric surgery
    boolean
    C1456587 (UMLS CUI [1])
    Patient Information failed | Compliance behavior Lacking
    Item
    failure to attend the initial patient information sessions or history of noncompliance
    boolean
    C1955348 (UMLS CUI [1,1])
    C0231175 (UMLS CUI [1,2])
    C1321605 (UMLS CUI [2,1])
    C0332268 (UMLS CUI [2,2])
    Informed Consent failed | Informed Consent Comprehension Unable
    Item
    failure to give consent for the study or to understand the proposed consent
    boolean
    C0021430 (UMLS CUI [1,1])
    C0231175 (UMLS CUI [1,2])
    C0021430 (UMLS CUI [2,1])
    C0162340 (UMLS CUI [2,2])
    C1299582 (UMLS CUI [2,3])
    Health Insurance failed
    Item
    failure of patient's insurance company to approve surgical intervention so as to avoid extensive cost burden on the patient
    boolean
    C0021682 (UMLS CUI [1,1])
    C0231175 (UMLS CUI [1,2])
    Volver a la parte superior de la página 

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