ID

35729

Beschreibung

Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered in Patients With Type II Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01453751

Link

https://clinicaltrials.gov/show/NCT01453751

Stichworte

Versionen (1)
  1. 19.03.19 19.03.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

19. März 2019

DOI

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Creative Commons BY 4.0
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Eligibility Diabetes Mellitus Type II NCT01453751

Englisch

Eligibility Diabetes Mellitus Type II NCT01453751

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
males and females between age 18 and 80 years.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
type 2 diabetes mellitus (as guideline who, 1999);
Beschreibung

Diabetes Mellitus, Non-Insulin-Dependent

Datentyp

boolean

Alias
UMLS CUI [1]
C0011860
body mass index (bmi)≤35㎏/㎡;
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
fast blood glucose (fbg)≥7.0 mmol/l, and hemoglobin a1c (hgba1c)≥7％;
Beschreibung

Fasting blood glucose measurement | Hemoglobin A1c measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0428568
UMLS CUI [2]
C0474680
up to date on all age and gender appropriate cancer screening per american cancer society.
Beschreibung

Age | Gender | Screening for cancer Appropriate

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0079399
UMLS CUI [3,1]
C0199230
UMLS CUI [3,2]
C1548787
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
Beschreibung

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Unwilling

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0558080
life expectancy < 6 months due to concomitant illnesses.
Beschreibung

Life Expectancy Due to Comorbidity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023671
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0009488
exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study.
Beschreibung

Exposure to Investigational New Drugs | Exposure to Procedure | Study Subject Participation Status Interferes with Research results

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0332157
UMLS CUI [2,2]
C0184661
UMLS CUI [3,1]
C2348568
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0683954
active infectious disease. if patients have tested positive, they will be consulted as to patient eligibility based on the patient's infectious status
Beschreibung

Communicable Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0009450
any illness which, in the investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
Beschreibung

Illness Interferes with Protocol Compliance | Illness compromises Patient safety | Illness Interferes with Interpretation Research results

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C1113679
UMLS CUI [3,1]
C0221423
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0459471
UMLS CUI [3,4]
C0683954
patients on chronic immunosuppressive transplant therapy
Beschreibung

Immunosuppressive therapy for transplant chronic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0521304
UMLS CUI [1,2]
C0205191
systolic blood pressure (supine) ≤90 mmhg or >180mmhg
Beschreibung

Lying systolic blood pressure

Datentyp

boolean

Alias
UMLS CUI [1]
C1319895
resting heart rate > 100 bpm;
Beschreibung

RESTING HEART RATE

Datentyp

boolean

Alias
UMLS CUI [1]
C1821417
active clinical infection within one week of enrollment.
Beschreibung

Communicable Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0009450
known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate.
Beschreibung

Substance Dependence | Factor Interferes with Completion of clinical trial | Factor Interferes with Interpretation Research results | Factor Study Subject Participation Status Inappropriate

Datentyp

boolean

Alias
UMLS CUI [1]
C0038580
UMLS CUI [2,1]
C1521761
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C2732579
UMLS CUI [3,1]
C1521761
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0459471
UMLS CUI [3,4]
C0683954
UMLS CUI [4,1]
C1521761
UMLS CUI [4,2]
C2348568
UMLS CUI [4,3]
C1548788
history of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years.
Beschreibung

Malignant Neoplasms | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
unwilling and/or not able to give written informed consent.
Beschreibung

Informed Consent Unwilling | Informed Consent Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1299582
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Ähnliche Modelle

Eligibility Diabetes Mellitus Type II NCT01453751

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
males and females between age 18 and 80 years.
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent
Item
type 2 diabetes mellitus (as guideline who, 1999);
boolean
C0011860 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi)≤35㎏/㎡;
boolean
C1305855 (UMLS CUI [1])
Fasting blood glucose measurement | Hemoglobin A1c measurement
Item
fast blood glucose (fbg)≥7.0 mmol/l, and hemoglobin a1c (hgba1c)≥7％;
boolean
C0428568 (UMLS CUI [1])
C0474680 (UMLS CUI [2])
Age | Gender | Screening for cancer Appropriate
Item
up to date on all age and gender appropriate cancer screening per american cancer society.
boolean
C0001779 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0199230 (UMLS CUI [3,1])
C1548787 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Unwilling
Item
females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0558080 (UMLS CUI [3,3])
Life Expectancy Due to Comorbidity
Item
life expectancy < 6 months due to concomitant illnesses.
boolean
C0023671 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
Exposure to Investigational New Drugs | Exposure to Procedure | Study Subject Participation Status Interferes with Research results
Item
exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study.
boolean
C0332157 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0332157 (UMLS CUI [2,1])
C0184661 (UMLS CUI [2,2])
C2348568 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0683954 (UMLS CUI [3,3])
Communicable Disease
Item
active infectious disease. if patients have tested positive, they will be consulted as to patient eligibility based on the patient's infectious status
boolean
C0009450 (UMLS CUI [1])
Illness Interferes with Protocol Compliance | Illness compromises Patient safety | Illness Interferes with Interpretation Research results
Item
any illness which, in the investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
boolean
C0221423 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0221423 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
C0221423 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0459471 (UMLS CUI [3,3])
C0683954 (UMLS CUI [3,4])
Immunosuppressive therapy for transplant chronic
Item
patients on chronic immunosuppressive transplant therapy
boolean
C0521304 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
Lying systolic blood pressure
Item
systolic blood pressure (supine) ≤90 mmhg or >180mmhg
boolean
C1319895 (UMLS CUI [1])
RESTING HEART RATE
Item
resting heart rate > 100 bpm;
boolean
C1821417 (UMLS CUI [1])
Communicable Disease
Item
active clinical infection within one week of enrollment.
boolean
C0009450 (UMLS CUI [1])
Substance Dependence | Factor Interferes with Completion of clinical trial | Factor Interferes with Interpretation Research results | Factor Study Subject Participation Status Inappropriate
Item
known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate.
boolean
C0038580 (UMLS CUI [1])
C1521761 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2732579 (UMLS CUI [2,3])
C1521761 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0459471 (UMLS CUI [3,3])
C0683954 (UMLS CUI [3,4])
C1521761 (UMLS CUI [4,1])
C2348568 (UMLS CUI [4,2])
C1548788 (UMLS CUI [4,3])
Malignant Neoplasms | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix
Item
history of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years.
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
Informed Consent Unwilling | Informed Consent Unable
Item
unwilling and/or not able to give written informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
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