ID

30117

Description

Mesenchymal Stem Cell Transplantation in the Treatment of Chronic Allograft Nephropathy; ODM derived from: https://clinicaltrials.gov/show/NCT00659620

Link

https://clinicaltrials.gov/show/NCT00659620

Keywords

Versions (1)
  1. 5/12/18 5/12/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 12, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Kidney Transplant NCT00659620

English

Eligibility Kidney Transplant NCT00659620

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
recipients of a renal allograft, male and female patients age 18 to 60 years of age.
Description

Recipient Allograft kidney | Age

Data type

boolean

Alias
UMLS CUI [1,1]
C1709854
UMLS CUI [1,2]
C0564454
UMLS CUI [2]
C0001779
ability to provide written informed consent.
Description

Informed Consent Ability

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0085732
the serum creatinine form 176umol/l(2mg/ml) to 440umol/l(5mg/ml)
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
renal biopsy criteria: chronic allograft nephropathy (banff i-ii).
Description

Kidney biopsy Criteria | Chronic allograft nephropathy Grade Other Coding

Data type

boolean

Alias
UMLS CUI [1,1]
C0194073
UMLS CUI [1,2]
C0243161
UMLS CUI [2,1]
C0403592
UMLS CUI [2,2]
C0441800
UMLS CUI [2,3]
C3846158
immunosuppressant:cni and mmf and sirolimus
Description

Immunosuppressive Agents | Calcineurin inhibitor | Mycophenolate mofetil | Sirolimus

Data type

boolean

Alias
UMLS CUI [1]
C0021081
UMLS CUI [2]
C1562036
UMLS CUI [3]
C0209368
UMLS CUI [4]
C0072980
written informed consent, compliant with local regulations.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
recipients with leucopenia (wbc < 3000/mm³), thrombocytopenia (thr < 100.000/mm³),or hyperlipidemia (tot chol > 300 mg/dl or triglycerides > 300 mg/dl).
Description

Recipient | Leukopenia | White Blood Cell Count procedure | Thrombocytopenia | Platelet Count measurement | Hyperlipidemia | Serum total cholesterol measurement | Triglycerides measurement

Data type

boolean

Alias
UMLS CUI [1]
C1709854
UMLS CUI [2]
C0023530
UMLS CUI [3]
C0023508
UMLS CUI [4]
C0040034
UMLS CUI [5]
C0032181
UMLS CUI [6]
C0020473
UMLS CUI [7]
C1445957
UMLS CUI [8]
C0202236
recipients of multiple organs.
Description

Recipient Organ multiple

Data type

boolean

Alias
UMLS CUI [1,1]
C1709854
UMLS CUI [1,2]
C0178784
UMLS CUI [1,3]
C0439064
pregnant women.
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
previous history of malignancy
Description

Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826
active infection including hepatitis b, hepatitis c, hiv, or tb as determined by a positive skin test or clinical presentation, or under treatment for suspected tb.
Description

Communicable Disease | Hepatitis B | Hepatitis C | HIV Infection | Tuberculosis | Skin test positive | Clinical presentation | Therapeutic procedure Tuberculosis Suspected

Data type

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
UMLS CUI [4]
C0019693
UMLS CUI [5]
C0041296
UMLS CUI [6]
C0542213
UMLS CUI [7]
C2708283
UMLS CUI [8,1]
C0087111
UMLS CUI [8,2]
C0041296
UMLS CUI [8,3]
C0750491
evidence of cardiovascular disease, existing congestive cardiac failure on physical exam and/or acute coronary syndrome in past 6 months.
Description

Cardiovascular Disease | Congestive heart failure Physical Examination | Acute Coronary Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2,1]
C0018802
UMLS CUI [2,2]
C0031809
UMLS CUI [3]
C0948089
inadequate compliance to treatment.
Description

Compliance behavior Inadequate

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0205412
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Similar models

Eligibility Kidney Transplant NCT00659620

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Recipient Allograft kidney | Age
Item
recipients of a renal allograft, male and female patients age 18 to 60 years of age.
boolean
C1709854 (UMLS CUI [1,1])
C0564454 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2])
Informed Consent Ability
Item
ability to provide written informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
Creatinine measurement, serum
Item
the serum creatinine form 176umol/l(2mg/ml) to 440umol/l(5mg/ml)
boolean
C0201976 (UMLS CUI [1])
Kidney biopsy Criteria | Chronic allograft nephropathy Grade Other Coding
Item
renal biopsy criteria: chronic allograft nephropathy (banff i-ii).
boolean
C0194073 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C0403592 (UMLS CUI [2,1])
C0441800 (UMLS CUI [2,2])
C3846158 (UMLS CUI [2,3])
Immunosuppressive Agents | Calcineurin inhibitor | Mycophenolate mofetil | Sirolimus
Item
immunosuppressant:cni and mmf and sirolimus
boolean
C0021081 (UMLS CUI [1])
C1562036 (UMLS CUI [2])
C0209368 (UMLS CUI [3])
C0072980 (UMLS CUI [4])
Informed Consent
Item
written informed consent, compliant with local regulations.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Recipient | Leukopenia | White Blood Cell Count procedure | Thrombocytopenia | Platelet Count measurement | Hyperlipidemia | Serum total cholesterol measurement | Triglycerides measurement
Item
recipients with leucopenia (wbc < 3000/mm³), thrombocytopenia (thr < 100.000/mm³),or hyperlipidemia (tot chol > 300 mg/dl or triglycerides > 300 mg/dl).
boolean
C1709854 (UMLS CUI [1])
C0023530 (UMLS CUI [2])
C0023508 (UMLS CUI [3])
C0040034 (UMLS CUI [4])
C0032181 (UMLS CUI [5])
C0020473 (UMLS CUI [6])
C1445957 (UMLS CUI [7])
C0202236 (UMLS CUI [8])
Recipient Organ multiple
Item
recipients of multiple organs.
boolean
C1709854 (UMLS CUI [1,1])
C0178784 (UMLS CUI [1,2])
C0439064 (UMLS CUI [1,3])
Pregnancy
Item
pregnant women.
boolean
C0032961 (UMLS CUI [1])
Malignant Neoplasms
Item
previous history of malignancy
boolean
C0006826 (UMLS CUI [1])
Communicable Disease | Hepatitis B | Hepatitis C | HIV Infection | Tuberculosis | Skin test positive | Clinical presentation | Therapeutic procedure Tuberculosis Suspected
Item
active infection including hepatitis b, hepatitis c, hiv, or tb as determined by a positive skin test or clinical presentation, or under treatment for suspected tb.
boolean
C0009450 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
C0019693 (UMLS CUI [4])
C0041296 (UMLS CUI [5])
C0542213 (UMLS CUI [6])
C2708283 (UMLS CUI [7])
C0087111 (UMLS CUI [8,1])
C0041296 (UMLS CUI [8,2])
C0750491 (UMLS CUI [8,3])
Cardiovascular Disease | Congestive heart failure Physical Examination | Acute Coronary Syndrome
Item
evidence of cardiovascular disease, existing congestive cardiac failure on physical exam and/or acute coronary syndrome in past 6 months.
boolean
C0007222 (UMLS CUI [1])
C0018802 (UMLS CUI [2,1])
C0031809 (UMLS CUI [2,2])
C0948089 (UMLS CUI [3])
Compliance behavior Inadequate
Item
inadequate compliance to treatment.
boolean
C1321605 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
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