ID

43888

Beschreibung

A Study to Evaluate the Pharmacokinetics and Safety of Levofloxacin in Patients With Varying Degrees of Renal Function.; ODM derived from: https://clinicaltrials.gov/show/NCT00645437

Link

https://clinicaltrials.gov/show/NCT00645437

Stichworte

Versionen (2)
  1. 08.12.16 08.12.16 -
  2. 20.09.21 20.09.21 -
Hochgeladen am

20. September 2021

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Renal Diseases NCT00645437

Englisch

Eligibility Renal Diseases NCT00645437

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
bmi between 18 and 35 kg/m2
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
no prescription or over-the-counter medications for previous 7 days
Beschreibung

Prescription Drugs | Drugs, Non-Prescription

Datentyp

boolean

Alias
UMLS CUI [1]
C0304227
UMLS CUI [2]
C0013231
negative tests for drug and alcohol abuse, hiv, hepatitis b and hepatitis c
Beschreibung

Substance Use Disorders Test Negative | HIV test negative | Hepatitis B test negative | Hepatitis C test negative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C0392366
UMLS CUI [1,3]
C1513916
UMLS CUI [2]
C0854048
UMLS CUI [3]
C1611173
UMLS CUI [4]
C1619717
medically stable based on medical history, physical examination, 12-lead electrocardiograms, toxicology, antigen, and antibody screens, and clinical laboratory evaluations
Beschreibung

Stable status Medical | Medical History | Physical Examination | 12 lead ECG | Toxicology | Antigens screening examination | Antibody screen | Laboratory data interpretation Clinical

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205360
UMLS CUI [1,2]
C0205476
UMLS CUI [2]
C0262926
UMLS CUI [3]
C0031809
UMLS CUI [4]
C0430456
UMLS CUI [5]
C0852616
UMLS CUI [6,1]
C0003320
UMLS CUI [6,2]
C0281974
UMLS CUI [7]
C0368676
UMLS CUI [8,1]
C0262707
UMLS CUI [8,2]
C0205210
stable renal function based on calculated creatine clearance for non-dialysis patients and the same dialysis treatment for at least 6 months prior to screening for dialysis patients
Beschreibung

Renal function Stable | Estimation of creatinine clearance by Cockcroft-Gault formula | Dialysis therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0232804
UMLS CUI [1,2]
C0205360
UMLS CUI [2]
C2711451
UMLS CUI [3]
C0011946
patients with creatinine clearance =80 ml/min who require treatment for renal impairment or other chronic disease (e.g., well-controlled diabetes, hypertension) must be on a stable treatment plan (medicines, doses, and regimens) for at least 2 months prior to day 1 and during the entire study
Beschreibung

Creatinine clearance measurement | Renal Insufficiency Treatment required for | Chronic disease Treatment required for | Diabetes Mellitus Well controlled | Hypertensive disease | Treatment Plan Stable

Datentyp

boolean

Alias
UMLS CUI [1]
C0373595
UMLS CUI [2,1]
C1565489
UMLS CUI [2,2]
C0332121
UMLS CUI [3,1]
C0008679
UMLS CUI [3,2]
C0332121
UMLS CUI [4,1]
C0011849
UMLS CUI [4,2]
C3853142
UMLS CUI [5]
C0020538
UMLS CUI [6,1]
C0599880
UMLS CUI [6,2]
C0205360
hematocrit (hct) within the normal range based on patients' renal function at screening
Beschreibung

Renal function | Hematocrit normal

Datentyp

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0740316
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
allergic reaction to quinolones
Beschreibung

Allergic Reaction Quinolones

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0034428
known or suspected allergy to heparin
Beschreibung

Heparin allergy

Datentyp

boolean

Alias
UMLS CUI [1]
C0571776
clinically significant ecg or clinical laboratory abnormalities
Beschreibung

ECG abnormality Clinical Significance | LABORATORY ABNORMALITIES Clinical Significance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0522055
UMLS CUI [1,2]
C2826293
UMLS CUI [2,1]
C1853129
UMLS CUI [2,2]
C2826293
creatinine clearance <80 ml/min whose medical condition was unstable
Beschreibung

Creatinine clearance measurement | Medical condition Unstable

Datentyp

boolean

Alias
UMLS CUI [1]
C0373595
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0443343
creatinine clearance >= 80 ml/min who required concomitant medication during the study
Beschreibung

Creatinine clearance measurement | Pharmaceutical Preparations Patient need for

Datentyp

boolean

Alias
UMLS CUI [1]
C0373595
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0686904
poorly controlled type 1 or type 2 diabetes
Beschreibung

Insulin-Dependent Diabetes Mellitus Poorly controlled | Non-Insulin-Dependent Diabetes Mellitus Poorly controlled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C3853134
UMLS CUI [2,1]
C0011860
UMLS CUI [2,2]
C3853134
patients with creatinine clearance >= 50 ml/min with screening blood pressure outside the normal range (sitting systolic blood pressure <90 or >140 mm mercury [hg] or diastolic blood pressure <60 or >90 mm hg)
Beschreibung

Creatinine clearance measurement | Abnormal blood pressure | Sitting systolic blood pressure | Diastolic blood pressure

Datentyp

boolean

Alias
UMLS CUI [1]
C0373595
UMLS CUI [2]
C0005826
UMLS CUI [3]
C1319893
UMLS CUI [4]
C0428883
patients with clcr <50 ml/min who had sitting systolic blood pressure <90 or >160 mm hg, or diastolic blood pressure <60 or >90 mm hg
Beschreibung

Creatinine clearance measurement | Sitting systolic blood pressure | Diastolic blood pressure

Datentyp

boolean

Alias
UMLS CUI [1]
C0373595
UMLS CUI [2]
C1319893
UMLS CUI [3]
C0428883
required warfarin treatment
Beschreibung

Warfarin Patient need for

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0043031
UMLS CUI [1,2]
C0686904
required immunosuppressive medications for treatment of immune-mediated renal disease or kidney transplant
Beschreibung

Immunosuppressive Agents Kidney Disease Immune system Related | Immunosuppressive Agents Kidney Transplantation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021081
UMLS CUI [1,2]
C0022658
UMLS CUI [1,3]
C0020962
UMLS CUI [1,4]
C0439849
UMLS CUI [2,1]
C0021081
UMLS CUI [2,2]
C0022671
pregnant or breastfeeding.
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Ähnliche Modelle

Eligibility Renal Diseases NCT00645437

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Body mass index
Item
bmi between 18 and 35 kg/m2
boolean
C1305855 (UMLS CUI [1])
Prescription Drugs | Drugs, Non-Prescription
Item
no prescription or over-the-counter medications for previous 7 days
boolean
C0304227 (UMLS CUI [1])
C0013231 (UMLS CUI [2])
Substance Use Disorders Test Negative | HIV test negative | Hepatitis B test negative | Hepatitis C test negative
Item
negative tests for drug and alcohol abuse, hiv, hepatitis b and hepatitis c
boolean
C0038586 (UMLS CUI [1,1])
C0392366 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,3])
C0854048 (UMLS CUI [2])
C1611173 (UMLS CUI [3])
C1619717 (UMLS CUI [4])
Stable status Medical | Medical History | Physical Examination | 12 lead ECG | Toxicology | Antigens screening examination | Antibody screen | Laboratory data interpretation Clinical
Item
medically stable based on medical history, physical examination, 12-lead electrocardiograms, toxicology, antigen, and antibody screens, and clinical laboratory evaluations
boolean
C0205360 (UMLS CUI [1,1])
C0205476 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2])
C0031809 (UMLS CUI [3])
C0430456 (UMLS CUI [4])
C0852616 (UMLS CUI [5])
C0003320 (UMLS CUI [6,1])
C0281974 (UMLS CUI [6,2])
C0368676 (UMLS CUI [7])
C0262707 (UMLS CUI [8,1])
C0205210 (UMLS CUI [8,2])
Renal function Stable | Estimation of creatinine clearance by Cockcroft-Gault formula | Dialysis therapy
Item
stable renal function based on calculated creatine clearance for non-dialysis patients and the same dialysis treatment for at least 6 months prior to screening for dialysis patients
boolean
C0232804 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C2711451 (UMLS CUI [2])
C0011946 (UMLS CUI [3])
Creatinine clearance measurement | Renal Insufficiency Treatment required for | Chronic disease Treatment required for | Diabetes Mellitus Well controlled | Hypertensive disease | Treatment Plan Stable
Item
patients with creatinine clearance =80 ml/min who require treatment for renal impairment or other chronic disease (e.g., well-controlled diabetes, hypertension) must be on a stable treatment plan (medicines, doses, and regimens) for at least 2 months prior to day 1 and during the entire study
boolean
C0373595 (UMLS CUI [1])
C1565489 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])
C0008679 (UMLS CUI [3,1])
C0332121 (UMLS CUI [3,2])
C0011849 (UMLS CUI [4,1])
C3853142 (UMLS CUI [4,2])
C0020538 (UMLS CUI [5])
C0599880 (UMLS CUI [6,1])
C0205360 (UMLS CUI [6,2])
Renal function | Hematocrit normal
Item
hematocrit (hct) within the normal range based on patients' renal function at screening
boolean
C0232804 (UMLS CUI [1])
C0740316 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Allergic Reaction Quinolones
Item
allergic reaction to quinolones
boolean
C1527304 (UMLS CUI [1,1])
C0034428 (UMLS CUI [1,2])
Heparin allergy
Item
known or suspected allergy to heparin
boolean
C0571776 (UMLS CUI [1])
ECG abnormality Clinical Significance | LABORATORY ABNORMALITIES Clinical Significance
Item
clinically significant ecg or clinical laboratory abnormalities
boolean
C0522055 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C1853129 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
Creatinine clearance measurement | Medical condition Unstable
Item
creatinine clearance <80 ml/min whose medical condition was unstable
boolean
C0373595 (UMLS CUI [1])
C3843040 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
Creatinine clearance measurement | Pharmaceutical Preparations Patient need for
Item
creatinine clearance >= 80 ml/min who required concomitant medication during the study
boolean
C0373595 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0686904 (UMLS CUI [2,2])
Insulin-Dependent Diabetes Mellitus Poorly controlled | Non-Insulin-Dependent Diabetes Mellitus Poorly controlled
Item
poorly controlled type 1 or type 2 diabetes
boolean
C0011854 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
C0011860 (UMLS CUI [2,1])
C3853134 (UMLS CUI [2,2])
Creatinine clearance measurement | Abnormal blood pressure | Sitting systolic blood pressure | Diastolic blood pressure
Item
patients with creatinine clearance >= 50 ml/min with screening blood pressure outside the normal range (sitting systolic blood pressure <90 or >140 mm mercury [hg] or diastolic blood pressure <60 or >90 mm hg)
boolean
C0373595 (UMLS CUI [1])
C0005826 (UMLS CUI [2])
C1319893 (UMLS CUI [3])
C0428883 (UMLS CUI [4])
Creatinine clearance measurement | Sitting systolic blood pressure | Diastolic blood pressure
Item
patients with clcr <50 ml/min who had sitting systolic blood pressure <90 or >160 mm hg, or diastolic blood pressure <60 or >90 mm hg
boolean
C0373595 (UMLS CUI [1])
C1319893 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Warfarin Patient need for
Item
required warfarin treatment
boolean
C0043031 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
Immunosuppressive Agents Kidney Disease Immune system Related | Immunosuppressive Agents Kidney Transplantation
Item
required immunosuppressive medications for treatment of immune-mediated renal disease or kidney transplant
boolean
C0021081 (UMLS CUI [1,1])
C0022658 (UMLS CUI [1,2])
C0020962 (UMLS CUI [1,3])
C0439849 (UMLS CUI [1,4])
C0021081 (UMLS CUI [2,1])
C0022671 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
pregnant or breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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