ID

29572

Description

Bone Marrow Cell Transplantation to Improve Heart Function in Individuals With End-Stage Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT00383630

Link

https://clinicaltrials.gov/show/NCT00383630

Keywords

Versions (1)
  1. 4/6/18 4/6/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 6, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Heart Failure, Congestive NCT00383630

English

Eligibility Heart Failure, Congestive NCT00383630

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
signed informed consent, release of medical information, and health insurance portability and accountability act (hipaa) documents
Description

Informed Consent | Release of information consent | HIPAA Documents

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C3166272
UMLS CUI [3,1]
C0600593
UMLS CUI [3,2]
C1301746
male, postmenopausal female, or female who may become pregnant but is using adequate contraceptive precautions (defined as use of oral contraceptive, intrauterine devices, surgical contraception, or a combination of a condom and a spermicide), with negative pregnancy test
Description

Gender | Postmenopausal state | Childbearing Potential Contraceptive methods | Contraceptives, Oral | Intrauterine Devices | Surgical Contraception | Female Condoms | Vaginal Spermicides | Childbearing Potential Pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0232970
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [4]
C0009905
UMLS CUI [5]
C0021900
UMLS CUI [6]
C2985333
UMLS CUI [7]
C0221829
UMLS CUI [8]
C0087145
UMLS CUI [9,1]
C3831118
UMLS CUI [9,2]
C0427780
admitted to the clinical center at the time of study entry
Description

Admission Medical center

Data type

boolean

Alias
UMLS CUI [1,1]
C0030673
UMLS CUI [1,2]
C0565990
listed with unos for cardiac transplantation
Description

Patient registered UNOS Heart Transplantation

Data type

boolean

Alias
UMLS CUI [1,1]
C0585825
UMLS CUI [1,2]
C3826868
UMLS CUI [1,3]
C0018823
clinical indication and accepted candidate for implantation of an fda approved lvad as a bridge to transplantation
Description

Indication Implantation of left ventricular assist device | Transplantation Anticipated

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0397130
UMLS CUI [2,1]
C0040732
UMLS CUI [2,2]
C3840775
hemoglobin between 9.0 gm/dl and 16.1 gm/dl within 24 hours prior to study entry
Description

Hemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0518015
platelet count between 100,000/ul and 450,000/ul within 24 hours prior to study entry
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
white blood cell count between 2,500/ul and upper limit of normal within 24 hours prior to study entry
Description

White Blood Cell Count procedure

Data type

boolean

Alias
UMLS CUI [1]
C0023508
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
cardiothoracic surgery within 30 days prior to study entry
Description

Cardiothoracic surgery

Data type

boolean

Alias
UMLS CUI [1]
C2242990
myocardial infarction within 6 months prior to study entry
Description

Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0027051
prior cardiac transplantation, lv reduction surgery, or cardiomyoplasty
Description

Heart Transplantation | Ventricular reduction surgery Left | Cardiomyoplasty

Data type

boolean

Alias
UMLS CUI [1]
C0018823
UMLS CUI [2,1]
C1955770
UMLS CUI [2,2]
C0205091
UMLS CUI [3]
C0242637
acute reversible cause of heart failure (e.g., myocarditis, profound hypothyroidism)
Description

Heart failure Cause Reversible | Myocarditis | Hypothyroidism Profound

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0015127
UMLS CUI [1,3]
C0205343
UMLS CUI [2]
C0027059
UMLS CUI [3,1]
C0020676
UMLS CUI [3,2]
C0439808
anticipated requirement for biventricular mechanical support
Description

Patient need for Mechanical Support biventricular

Data type

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C3274791
UMLS CUI [1,3]
C0699808
stroke within 30 days prior to study entry
Description

Cerebrovascular accident

Data type

boolean

Alias
UMLS CUI [1]
C0038454
received investigational intervention within 30 days of study entry
Description

Intervention Investigational

Data type

boolean

Alias
UMLS CUI [1,1]
C0184661
UMLS CUI [1,2]
C1517586
pregnant or breastfeeding at time of study entry
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
hiv positive within 30 days prior to study entry
Description

HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1]
C0019699
active systemic infection within 48 hours prior to study entry
Description

Sepsis

Data type

boolean

Alias
UMLS CUI [1]
C0243026
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Similar models

Eligibility Heart Failure, Congestive NCT00383630

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent | Release of information consent | HIPAA Documents
Item
signed informed consent, release of medical information, and health insurance portability and accountability act (hipaa) documents
boolean
C0021430 (UMLS CUI [1])
C3166272 (UMLS CUI [2])
C0600593 (UMLS CUI [3,1])
C1301746 (UMLS CUI [3,2])
Gender | Postmenopausal state | Childbearing Potential Contraceptive methods | Contraceptives, Oral | Intrauterine Devices | Surgical Contraception | Female Condoms | Vaginal Spermicides | Childbearing Potential Pregnancy test negative
Item
male, postmenopausal female, or female who may become pregnant but is using adequate contraceptive precautions (defined as use of oral contraceptive, intrauterine devices, surgical contraception, or a combination of a condom and a spermicide), with negative pregnancy test
boolean
C0079399 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0009905 (UMLS CUI [4])
C0021900 (UMLS CUI [5])
C2985333 (UMLS CUI [6])
C0221829 (UMLS CUI [7])
C0087145 (UMLS CUI [8])
C3831118 (UMLS CUI [9,1])
C0427780 (UMLS CUI [9,2])
Admission Medical center
Item
admitted to the clinical center at the time of study entry
boolean
C0030673 (UMLS CUI [1,1])
C0565990 (UMLS CUI [1,2])
Patient registered UNOS Heart Transplantation
Item
listed with unos for cardiac transplantation
boolean
C0585825 (UMLS CUI [1,1])
C3826868 (UMLS CUI [1,2])
C0018823 (UMLS CUI [1,3])
Indication Implantation of left ventricular assist device | Transplantation Anticipated
Item
clinical indication and accepted candidate for implantation of an fda approved lvad as a bridge to transplantation
boolean
C3146298 (UMLS CUI [1,1])
C0397130 (UMLS CUI [1,2])
C0040732 (UMLS CUI [2,1])
C3840775 (UMLS CUI [2,2])
Hemoglobin measurement
Item
hemoglobin between 9.0 gm/dl and 16.1 gm/dl within 24 hours prior to study entry
boolean
C0518015 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count between 100,000/ul and 450,000/ul within 24 hours prior to study entry
boolean
C0032181 (UMLS CUI [1])
White Blood Cell Count procedure
Item
white blood cell count between 2,500/ul and upper limit of normal within 24 hours prior to study entry
boolean
C0023508 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cardiothoracic surgery
Item
cardiothoracic surgery within 30 days prior to study entry
boolean
C2242990 (UMLS CUI [1])
Myocardial Infarction
Item
myocardial infarction within 6 months prior to study entry
boolean
C0027051 (UMLS CUI [1])
Heart Transplantation | Ventricular reduction surgery Left | Cardiomyoplasty
Item
prior cardiac transplantation, lv reduction surgery, or cardiomyoplasty
boolean
C0018823 (UMLS CUI [1])
C1955770 (UMLS CUI [2,1])
C0205091 (UMLS CUI [2,2])
C0242637 (UMLS CUI [3])
Heart failure Cause Reversible | Myocarditis | Hypothyroidism Profound
Item
acute reversible cause of heart failure (e.g., myocarditis, profound hypothyroidism)
boolean
C0018801 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0205343 (UMLS CUI [1,3])
C0027059 (UMLS CUI [2])
C0020676 (UMLS CUI [3,1])
C0439808 (UMLS CUI [3,2])
Patient need for Mechanical Support biventricular
Item
anticipated requirement for biventricular mechanical support
boolean
C0686904 (UMLS CUI [1,1])
C3274791 (UMLS CUI [1,2])
C0699808 (UMLS CUI [1,3])
Cerebrovascular accident
Item
stroke within 30 days prior to study entry
boolean
C0038454 (UMLS CUI [1])
Intervention Investigational
Item
received investigational intervention within 30 days of study entry
boolean
C0184661 (UMLS CUI [1,1])
C1517586 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnant or breastfeeding at time of study entry
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
HIV Seropositivity
Item
hiv positive within 30 days prior to study entry
boolean
C0019699 (UMLS CUI [1])
Sepsis
Item
active systemic infection within 48 hours prior to study entry
boolean
C0243026 (UMLS CUI [1])
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