0 Avaliações
ID

29585

Descrição

Protein Intake, Nutrition and Cardiovascular Diseases in Stage V CKD; ODM derived from: https://clinicaltrials.gov/show/NCT00566670

Link

https://clinicaltrials.gov/show/NCT00566670

Palavras-chave

Versões (2)
  1. 08/04/2018 08/04/2018 -
  2. 08/04/2018 08/04/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

8 de abril de 2018

DOI

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Licença

Creative Commons BY 4.0
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    Eligibility Hemodialysis NCT00566670

    Inglês

    Eligibility Hemodialysis NCT00566670

    1 Formulários  
    Inclusion Criteria
    Descrição

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    the study will be comprised of adult (≥18 years) chronic hemodialysis patients.
    Descrição

    Adult | Age | Chronic haemodialysis

    Tipo de dados

    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]
    C1740835 (Chronic haemodialysis)
    appetite often change with initiation of dialysis and kidney function recover sometimes from acute renal failure; hence only patients on dialysis at least for three months will be included.
    Descrição

    Altered appetite Associated with Initiation Dialysis | Renal function Recovering from Kidney Failure | Patients Dialysis

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0426587 (Altered appetite)
    SNOMED
    249473004
    UMLS CUI [1,2]
    C0332281 (Associated with)
    SNOMED
    47429007
    UMLS CUI [1,3]
    C1704686 (Initiation)
    UMLS CUI [1,4]
    C0011946 (Dialysis procedure)
    SNOMED
    108241001
    UMLS CUI [2,1]
    C0232804 (Renal function)
    SNOMED
    11953005
    LOINC
    LP31398-8
    UMLS CUI [2,2]
    C0521108 (Recovering from)
    SNOMED
    74822006
    UMLS CUI [2,3]
    C0035078 (Kidney Failure)
    SNOMED
    723188008
    UMLS CUI [3,1]
    C0030705 (Patients)
    SNOMED
    116154003
    UMLS CUI [3,2]
    C0011946 (Dialysis procedure)
    SNOMED
    108241001
    as urinary losses of urea could affect the estimation of protein intake from the urea kinetic modeling, we initially planned to exclude patients with urine output > 200 ml/day. however, this might exclude many potential participants. therefore, we plan to include those participants with upo > 200 ml/day but willing to collect 44-hr urine collection between dialysis treatments for measurement of urinary urea.
    Descrição

    Urine volume function mL/day | Urine Collection Urea measurement urinary

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0232856 (Urine volume function)
    SNOMED
    130953005
    UMLS CUI [1,2]
    C0439446 (Milliliter per Day)
    SNOMED
    258861009
    UMLS CUI [2,1]
    C0200354 (Urine Specimen Collection)
    SNOMED
    57617002
    UMLS CUI [2,2]
    C0523961 (Urea measurement)
    SNOMED
    105010007
    UMLS CUI [2,3]
    C1524119 (urinary)
    Exclusion Criteria
    Descrição

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    patients with persistent volume overload (substantial pedal edema) despite attempts at achieving dry weight will be excluded as hydration status might affect estimation of muscle mass. -
    Descrição

    Fluid overload persistent | Pedal edema Severe | Hydration status Affecting Estimation Muscle mass

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0546817 (Fluid overload)
    SNOMED
    21639008
    LOINC
    MTHU013364
    UMLS CUI [1,2]
    C0205322 (Persistent)
    UMLS CUI [2,1]
    C0574002 (Edema of foot (finding))
    SNOMED
    102576009
    UMLS CUI [2,2]
    C0205082 (Severe (severity modifier))
    SNOMED
    24484000
    LOINC
    LA6750-9
    UMLS CUI [3,1]
    C1321013 (Hydration status)
    SNOMED
    405006006
    LOINC
    LP212126-9
    UMLS CUI [3,2]
    C0392760 (Affecting)
    SNOMED
    247591002
    UMLS CUI [3,3]
    C0750572 (Estimated)
    SNOMED
    414135002
    LOINC
    LP6260-6
    UMLS CUI [3,4]
    C0240417 (Muscle mass)
    patients with inability to walk or those who use wheel-chair might have reduced mid-thigh muscle mass despite good protein intake because of disuse, and hence these patients will be excluded.
    Descrição

    Unable to walk | Wheelchair bound | Reduced muscle mass Mid thigh Due to Disuse | Protein intake Good

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0560046 (Unable to walk (finding))
    SNOMED
    282145008
    UMLS CUI [2]
    C0558195 (Wheelchair bound)
    SNOMED
    225612007
    UMLS CUI [3,1]
    C1849578 (Reduced muscle mass)
    UMLS CUI [3,2]
    C1288637 (Entire mid thigh region)
    SNOMED
    368104004
    UMLS CUI [3,3]
    C0678226 (Due to)
    SNOMED
    42752001
    UMLS CUI [3,4]
    C4062565 (Disuse)
    UMLS CUI [4,1]
    C0489617 (protein intake)
    UMLS CUI [4,2]
    C0205170 (Good)
    SNOMED
    20572008
    LOINC
    LA8967-7
    persons with pacemakers and cochlear implants are excluded because of the magnetic field of mri. certain types of materials used in breast augmentation could be affected by the strong magnetic field and hence breast augmentation is an exclusion criteria. artificial hips could interfere with mid-thigh muscle mass measurements whereas lumbar spine hardware could interfere with visceral fat measurements and hence, individuals with these will be excluded.-
    Descrição

    Artificial cardiac pacemaker | Cochlear Implants | Augmentation mammoplasty | Hip Implant Interferes with Mid thigh Muscle mass Measurement | Lumbar spine Hardware Interferes with Visceral Fat Measurement

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0030163 (Artificial cardiac pacemaker)
    SNOMED
    14106009
    LOINC
    LP31558-7
    UMLS CUI [2]
    C0009199 (Cochlear Implants)
    SNOMED
    43252007
    UMLS CUI [3]
    C0191925 (Augmentation mammoplasty)
    SNOMED
    22890008
    UMLS CUI [4,1]
    C0019560 (Hip Joint Implantable Prostheses (device))
    SNOMED
    67270000
    UMLS CUI [4,2]
    C0521102 (Interferes with)
    SNOMED
    78235001
    UMLS CUI [4,3]
    C1288637 (Entire mid thigh region)
    SNOMED
    368104004
    UMLS CUI [4,4]
    C0240417 (Muscle mass)
    UMLS CUI [4,5]
    C0242485 (Measurement)
    SNOMED
    272391002
    LOINC
    LP7412-2
    UMLS CUI [5,1]
    C3887615 (Lumbar spine structure)
    SNOMED
    122496007
    UMLS CUI [5,2]
    C0336577 (ORTHOPEDIC DEVICES AND HARDWARE)
    UMLS CUI [5,3]
    C0521102 (Interferes with)
    SNOMED
    78235001
    UMLS CUI [5,4]
    C1563740 (Visceral Fat)
    UMLS CUI [5,5]
    C0242485 (Measurement)
    SNOMED
    272391002
    LOINC
    LP7412-2
    persons > 300 lbs will be excluded because of the weight limit of the mri table. atrial fibrillation could interfere with measurement of pwv.
    Descrição

    Body Weight Pounds | Atrial Fibrillation Interferes with Pulse Wave Velocity Measurement

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0005910 (Body Weight)
    SNOMED
    27113001
    UMLS CUI [1,2]
    C0439219 (Pounds)
    SNOMED
    258693003
    UMLS CUI [2,1]
    C0004238 (Atrial Fibrillation)
    SNOMED
    49436004
    UMLS CUI [2,2]
    C0521102 (Interferes with)
    SNOMED
    78235001
    UMLS CUI [2,3]
    C3494431 (Pulse Wave Velocity)
    UMLS CUI [2,4]
    C0242485 (Measurement)
    SNOMED
    272391002
    LOINC
    LP7412-2
    patients who are unlikely or unable (in the opinion of the nephrologists, nurses or dieticians taking care of the patient) to comply with research protocol will be excluded.
    Descrição

    Protocol Compliance Unlikely | Protocol Compliance Unable

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0525058 (Protocol Compliance)
    UMLS CUI [1,2]
    C0750558 (Unlikely)
    LOINC
    LA15588-9
    UMLS CUI [2,1]
    C0525058 (Protocol Compliance)
    UMLS CUI [2,2]
    C1299582 (Unable)
    SNOMED
    371151008
    LOINC
    LA13868-7
    patients with symptomatic heart failure, current active malignancy (excluding squamous and basal cell skin cancers), active aids, chronic lung disease requiring supplemental oxygen therapy and cirrhosis will be excluded.
    Descrição

    Heart failure Symptomatic | Malignant Neoplasms | Exception Squamous cell carcinoma of skin | Exception Basal cell carcinoma | Acquired Immunodeficiency Syndrome | Chronic lung disease Requirement Oxygen Therapy Care | Liver Cirrhosis

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0018801 (Heart failure)
    SNOMED
    84114007
    LOINC
    LP269421-6
    UMLS CUI [1,2]
    C0231220 (Symptomatic)
    SNOMED
    264931009
    LOINC
    LA17766-9
    UMLS CUI [2]
    C0006826 (Malignant Neoplasms)
    SNOMED
    363346000
    LOINC
    LP100805-3
    UMLS CUI [3,1]
    C1705847 (Exception - Property or Attribute)
    UMLS CUI [3,2]
    C0553723 (Squamous cell carcinoma of skin)
    SNOMED
    254651007
    UMLS CUI [4,1]
    C1705847 (Exception - Property or Attribute)
    UMLS CUI [4,2]
    C0007117 (Basal cell carcinoma)
    SNOMED
    1338007
    UMLS CUI [5]
    C0001175 (Acquired Immunodeficiency Syndrome)
    SNOMED
    62479008
    LOINC
    LA10430-9
    UMLS CUI [6,1]
    C0746102 (Chronic lung disease)
    SNOMED
    413839001
    UMLS CUI [6,2]
    C1514873 (Requirement)
    UMLS CUI [6,3]
    C0184633 (Oxygen Therapy Care)
    SNOMED
    57485005
    LOINC
    MTHU020390
    UMLS CUI [7]
    C0023890 (Liver Cirrhosis)
    SNOMED
    19943007
    patients enrolled in interventional trials will be excluded.
    Descrição

    Study Subject Participation Status | Interventional procedure

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C2348568 (Study Subject Participation Status)
    UMLS CUI [2]
    C0184661 (Interventional procedure)
    SNOMED
    71388002
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    Similar models

    Eligibility Hemodialysis NCT00566670

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Adult | Age | Chronic haemodialysis
    Item
    the study will be comprised of adult (≥18 years) chronic hemodialysis patients.
    boolean
    C0001675 (UMLS CUI [1])
    C0001779 (UMLS CUI [2])
    C1740835 (UMLS CUI [3])
    Altered appetite Associated with Initiation Dialysis | Renal function Recovering from Kidney Failure | Patients Dialysis
    Item
    appetite often change with initiation of dialysis and kidney function recover sometimes from acute renal failure; hence only patients on dialysis at least for three months will be included.
    boolean
    C0426587 (UMLS CUI [1,1])
    C0332281 (UMLS CUI [1,2])
    C1704686 (UMLS CUI [1,3])
    C0011946 (UMLS CUI [1,4])
    C0232804 (UMLS CUI [2,1])
    C0521108 (UMLS CUI [2,2])
    C0035078 (UMLS CUI [2,3])
    C0030705 (UMLS CUI [3,1])
    C0011946 (UMLS CUI [3,2])
    Urine volume function mL/day | Urine Collection Urea measurement urinary
    Item
    as urinary losses of urea could affect the estimation of protein intake from the urea kinetic modeling, we initially planned to exclude patients with urine output > 200 ml/day. however, this might exclude many potential participants. therefore, we plan to include those participants with upo > 200 ml/day but willing to collect 44-hr urine collection between dialysis treatments for measurement of urinary urea.
    boolean
    C0232856 (UMLS CUI [1,1])
    C0439446 (UMLS CUI [1,2])
    C0200354 (UMLS CUI [2,1])
    C0523961 (UMLS CUI [2,2])
    C1524119 (UMLS CUI [2,3])
    Item Group
    C0680251 (UMLS CUI)
    Fluid overload persistent | Pedal edema Severe | Hydration status Affecting Estimation Muscle mass
    Item
    patients with persistent volume overload (substantial pedal edema) despite attempts at achieving dry weight will be excluded as hydration status might affect estimation of muscle mass. -
    boolean
    C0546817 (UMLS CUI [1,1])
    C0205322 (UMLS CUI [1,2])
    C0574002 (UMLS CUI [2,1])
    C0205082 (UMLS CUI [2,2])
    C1321013 (UMLS CUI [3,1])
    C0392760 (UMLS CUI [3,2])
    C0750572 (UMLS CUI [3,3])
    C0240417 (UMLS CUI [3,4])
    Unable to walk | Wheelchair bound | Reduced muscle mass Mid thigh Due to Disuse | Protein intake Good
    Item
    patients with inability to walk or those who use wheel-chair might have reduced mid-thigh muscle mass despite good protein intake because of disuse, and hence these patients will be excluded.
    boolean
    C0560046 (UMLS CUI [1])
    C0558195 (UMLS CUI [2])
    C1849578 (UMLS CUI [3,1])
    C1288637 (UMLS CUI [3,2])
    C0678226 (UMLS CUI [3,3])
    C4062565 (UMLS CUI [3,4])
    C0489617 (UMLS CUI [4,1])
    C0205170 (UMLS CUI [4,2])
    Artificial cardiac pacemaker | Cochlear Implants | Augmentation mammoplasty | Hip Implant Interferes with Mid thigh Muscle mass Measurement | Lumbar spine Hardware Interferes with Visceral Fat Measurement
    Item
    persons with pacemakers and cochlear implants are excluded because of the magnetic field of mri. certain types of materials used in breast augmentation could be affected by the strong magnetic field and hence breast augmentation is an exclusion criteria. artificial hips could interfere with mid-thigh muscle mass measurements whereas lumbar spine hardware could interfere with visceral fat measurements and hence, individuals with these will be excluded.-
    boolean
    C0030163 (UMLS CUI [1])
    C0009199 (UMLS CUI [2])
    C0191925 (UMLS CUI [3])
    C0019560 (UMLS CUI [4,1])
    C0521102 (UMLS CUI [4,2])
    C1288637 (UMLS CUI [4,3])
    C0240417 (UMLS CUI [4,4])
    C0242485 (UMLS CUI [4,5])
    C3887615 (UMLS CUI [5,1])
    C0336577 (UMLS CUI [5,2])
    C0521102 (UMLS CUI [5,3])
    C1563740 (UMLS CUI [5,4])
    C0242485 (UMLS CUI [5,5])
    Body Weight Pounds | Atrial Fibrillation Interferes with Pulse Wave Velocity Measurement
    Item
    persons > 300 lbs will be excluded because of the weight limit of the mri table. atrial fibrillation could interfere with measurement of pwv.
    boolean
    C0005910 (UMLS CUI [1,1])
    C0439219 (UMLS CUI [1,2])
    C0004238 (UMLS CUI [2,1])
    C0521102 (UMLS CUI [2,2])
    C3494431 (UMLS CUI [2,3])
    C0242485 (UMLS CUI [2,4])
    Protocol Compliance Unlikely | Protocol Compliance Unable
    Item
    patients who are unlikely or unable (in the opinion of the nephrologists, nurses or dieticians taking care of the patient) to comply with research protocol will be excluded.
    boolean
    C0525058 (UMLS CUI [1,1])
    C0750558 (UMLS CUI [1,2])
    C0525058 (UMLS CUI [2,1])
    C1299582 (UMLS CUI [2,2])
    Heart failure Symptomatic | Malignant Neoplasms | Exception Squamous cell carcinoma of skin | Exception Basal cell carcinoma | Acquired Immunodeficiency Syndrome | Chronic lung disease Requirement Oxygen Therapy Care | Liver Cirrhosis
    Item
    patients with symptomatic heart failure, current active malignancy (excluding squamous and basal cell skin cancers), active aids, chronic lung disease requiring supplemental oxygen therapy and cirrhosis will be excluded.
    boolean
    C0018801 (UMLS CUI [1,1])
    C0231220 (UMLS CUI [1,2])
    C0006826 (UMLS CUI [2])
    C1705847 (UMLS CUI [3,1])
    C0553723 (UMLS CUI [3,2])
    C1705847 (UMLS CUI [4,1])
    C0007117 (UMLS CUI [4,2])
    C0001175 (UMLS CUI [5])
    C0746102 (UMLS CUI [6,1])
    C1514873 (UMLS CUI [6,2])
    C0184633 (UMLS CUI [6,3])
    C0023890 (UMLS CUI [7])
    Study Subject Participation Status | Interventional procedure
    Item
    patients enrolled in interventional trials will be excluded.
    boolean
    C2348568 (UMLS CUI [1])
    C0184661 (UMLS CUI [2])
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