ID

39161

Description

Effects of High Cut-off (HCO) Hemodialysis on Central Memory CD4+ T and Treg Cells in Patients With End-stage Kidney Disease; ODM derived from: https://clinicaltrials.gov/show/NCT01103076

Link

https://clinicaltrials.gov/show/NCT01103076

Keywords

  1. 12/6/19 12/6/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 6, 2019

DOI

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License

Creative Commons BY 4.0

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Eligibility End-stage Kidney Disease NCT01103076

Eligibility End-stage Kidney Disease NCT01103076

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with eskd (ckd stage 5d according to k/doqi guidelines) regularly treated by bicarbonate hd 3 times a week for at least 4 h at a blood flow rate of 300 ml/min will be included
Description

Kidney Failure, Chronic | Chronic kidney disease stage | Bicarbonate Hemodialysis times per week | Hemodialysis blood flow rate

Data type

boolean

Alias
UMLS CUI [1]
C0022661
UMLS CUI [2]
C2074731
UMLS CUI [3,1]
C0005367
UMLS CUI [3,2]
C0019004
UMLS CUI [3,3]
C0456698
UMLS CUI [4]
C2030556
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
only non-smokers will be enrolled in the study
Description

Tobacco use

Data type

boolean

Alias
UMLS CUI [1]
C0543414
patients with recent (< 3 mo) major trauma, surgery, myocardial infarction, coronary revascularization (coronary angioplasty or bypass surgery), or stroke will be excluded from the study
Description

Major injury | Operative Surgical Procedures | Myocardial Infarction | Coronary revascularisation | Coronary angioplasty | Coronary Artery Bypass Surgery | Cerebrovascular accident

Data type

boolean

Alias
UMLS CUI [1]
C0332677
UMLS CUI [2]
C0543467
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0877341
UMLS CUI [5]
C0190211
UMLS CUI [6]
C0010055
UMLS CUI [7]
C0038454
diabetes mellitus
Description

Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0011849
the presence of an acute or chronic inflammatory process, infection
Description

Inflammatory disorder | Chronic inflammatory disorder | Communicable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1290884
UMLS CUI [2]
C1290886
UMLS CUI [3]
C0009450
malnutrition (determined by subjective global nutritional assessment)
Description

Malnutrition

Data type

boolean

Alias
UMLS CUI [1]
C0162429
the use of immunosuppressive drugs or evidence of malignancy
Description

Immunosuppressive Agents | Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0021081
UMLS CUI [2]
C0006826
pregnant women, women who are breast feeding or are of child-bearing potential and not using adequate contraceptive precautions are excluded
Description

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332197
a pregnancy test will be performed in female patients before the inclusion
Description

Requirement | Gender Pregnancy Test

Data type

boolean

Alias
UMLS CUI [1]
C1514873
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0032976
except for aspirin and statin, those patients taking anti-inflammatory medications in the prior 4 weeks will be excluded.
Description

Exception Aspirin | Exception Statins | Anti-Inflammatory Agents

Data type

boolean

Alias
UMLS CUI [1,1]
C1705847
UMLS CUI [1,2]
C0004057
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0360714
UMLS CUI [3]
C0003209
all patients have to be negative for circulating hepatitis b antigen, hepatitis c antibody (ab) and hiv
Description

Requirement | Hepatitis B Antigens Circulating Negative | Hepatitis C antibody negative | HIV negative

Data type

boolean

Alias
UMLS CUI [1]
C1514873
UMLS CUI [2,1]
C0019165
UMLS CUI [2,2]
C0175630
UMLS CUI [2,3]
C1513916
UMLS CUI [3]
C0853904
UMLS CUI [4]
C0481430
they will have no active liver disease
Description

Liver disease

Data type

boolean

Alias
UMLS CUI [1]
C0023895
no patient will be nephrectomized
Description

Nephrectomy

Data type

boolean

Alias
UMLS CUI [1]
C0027695
arterial blood ph will be between 7.38 and 7.42
Description

Arterial blood pH measurement

Data type

boolean

Alias
UMLS CUI [1]
C0428199
no patient will receive a blood transfusion in the 6 mo before the study
Description

Blood Transfusion Recent

Data type

boolean

Alias
UMLS CUI [1,1]
C0005841
UMLS CUI [1,2]
C0332185

Similar models

Eligibility End-stage Kidney Disease NCT01103076

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Kidney Failure, Chronic | Chronic kidney disease stage | Bicarbonate Hemodialysis times per week | Hemodialysis blood flow rate
Item
patients with eskd (ckd stage 5d according to k/doqi guidelines) regularly treated by bicarbonate hd 3 times a week for at least 4 h at a blood flow rate of 300 ml/min will be included
boolean
C0022661 (UMLS CUI [1])
C2074731 (UMLS CUI [2])
C0005367 (UMLS CUI [3,1])
C0019004 (UMLS CUI [3,2])
C0456698 (UMLS CUI [3,3])
C2030556 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Tobacco use
Item
only non-smokers will be enrolled in the study
boolean
C0543414 (UMLS CUI [1])
Major injury | Operative Surgical Procedures | Myocardial Infarction | Coronary revascularisation | Coronary angioplasty | Coronary Artery Bypass Surgery | Cerebrovascular accident
Item
patients with recent (< 3 mo) major trauma, surgery, myocardial infarction, coronary revascularization (coronary angioplasty or bypass surgery), or stroke will be excluded from the study
boolean
C0332677 (UMLS CUI [1])
C0543467 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0877341 (UMLS CUI [4])
C0190211 (UMLS CUI [5])
C0010055 (UMLS CUI [6])
C0038454 (UMLS CUI [7])
Diabetes Mellitus
Item
diabetes mellitus
boolean
C0011849 (UMLS CUI [1])
Inflammatory disorder | Chronic inflammatory disorder | Communicable Disease
Item
the presence of an acute or chronic inflammatory process, infection
boolean
C1290884 (UMLS CUI [1])
C1290886 (UMLS CUI [2])
C0009450 (UMLS CUI [3])
Malnutrition
Item
malnutrition (determined by subjective global nutritional assessment)
boolean
C0162429 (UMLS CUI [1])
Immunosuppressive Agents | Malignant Neoplasms
Item
the use of immunosuppressive drugs or evidence of malignancy
boolean
C0021081 (UMLS CUI [1])
C0006826 (UMLS CUI [2])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent
Item
pregnant women, women who are breast feeding or are of child-bearing potential and not using adequate contraceptive precautions are excluded
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Requirement | Gender Pregnancy Test
Item
a pregnancy test will be performed in female patients before the inclusion
boolean
C1514873 (UMLS CUI [1])
C0079399 (UMLS CUI [2,1])
C0032976 (UMLS CUI [2,2])
Exception Aspirin | Exception Statins | Anti-Inflammatory Agents
Item
except for aspirin and statin, those patients taking anti-inflammatory medications in the prior 4 weeks will be excluded.
boolean
C1705847 (UMLS CUI [1,1])
C0004057 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0360714 (UMLS CUI [2,2])
C0003209 (UMLS CUI [3])
Requirement | Hepatitis B Antigens Circulating Negative | Hepatitis C antibody negative | HIV negative
Item
all patients have to be negative for circulating hepatitis b antigen, hepatitis c antibody (ab) and hiv
boolean
C1514873 (UMLS CUI [1])
C0019165 (UMLS CUI [2,1])
C0175630 (UMLS CUI [2,2])
C1513916 (UMLS CUI [2,3])
C0853904 (UMLS CUI [3])
C0481430 (UMLS CUI [4])
Liver disease
Item
they will have no active liver disease
boolean
C0023895 (UMLS CUI [1])
Nephrectomy
Item
no patient will be nephrectomized
boolean
C0027695 (UMLS CUI [1])
Arterial blood pH measurement
Item
arterial blood ph will be between 7.38 and 7.42
boolean
C0428199 (UMLS CUI [1])
Blood Transfusion Recent
Item
no patient will receive a blood transfusion in the 6 mo before the study
boolean
C0005841 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])

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