ID

40344

Beskrivning

Treatment of Resistant Hypertension by Prevention of T-Cell Co-Stimulation; ODM derived from: https://clinicaltrials.gov/show/NCT02232880

Länk

https://clinicaltrials.gov/show/NCT02232880

Nyckelord

Versioner (1)
  1. 2020-04-10 2020-04-10 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

10 april 2020

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Hypertension NCT02232880

Engelsk

Eligibility Hypertension NCT02232880

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
men and women 18 to 65 years of age with hypertension, treated with three or more anti-hypertensive drugs, one being a diuretic, and
Beskrivning

Age | Hypertensive disease | Antihypertensive Agents Quantity | Diuretics Quantity

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0020538
UMLS CUI [3,1]
C0003364
UMLS CUI [3,2]
C1265611
UMLS CUI [4,1]
C0012798
UMLS CUI [4,2]
C1265611
having a systolic blood pressure >150 mmhg in the clinic and daytime average >150 mmhg on ambulatory blood pressure monitoring
Beskrivning

Systolic Pressure Clinic | Systolic Pressure Daytime Average Ambulatory Blood Pressure Monitoring

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0442592
UMLS CUI [2,1]
C0871470
UMLS CUI [2,2]
C0332169
UMLS CUI [2,3]
C1510992
UMLS CUI [2,4]
C0242876
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
medical history of secondary cause of hypertension, severe obesity (bmi >35), severe psychiatric disorders, cancer in the last 5 years other than nonmelanoma skin cell cancers, herpes zoster or cytomegalovirus that resolved less than 2 months before
Beskrivning

Secondary hypertension | Obesity Severe | Body mass index | Mental Disorders, Severe | Malignant Neoplasms | Exception Skin carcinoma | Herpes zoster disease | Cytomegalovirus Resolved Recent

Datatyp

boolean

Alias
UMLS CUI [1]
C0155616
UMLS CUI [2,1]
C0028754
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C1305855
UMLS CUI [4]
C4046029
UMLS CUI [5]
C0006826
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0699893
UMLS CUI [7]
C0019360
UMLS CUI [8,1]
C0010825
UMLS CUI [8,2]
C1514893
UMLS CUI [8,3]
C0332185
inability to return for abatacept treatment and follow-up for 24 weeks.
Beskrivning

Abatacept therapy Continue Unable | Follow-up Continue Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4302766
UMLS CUI [1,2]
C0549178
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C3274571
UMLS CUI [2,2]
C0549178
UMLS CUI [2,3]
C1299582
inability to understand or complete study-related assessments.
Beskrivning

Evaluation Comprehension Unable | Completion Evaluation Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1261322
UMLS CUI [1,2]
C0162340
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0205197
UMLS CUI [2,2]
C1261322
UMLS CUI [2,3]
C1299582
current abuse of drugs or alcohol.
Beskrivning

Substance Use Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
receipt of any live vaccines within 3 months of the anticipated first dose of study medication.
Beskrivning

Vaccines, Attenuated

Datatyp

boolean

Alias
UMLS CUI [1]
C0042211
evidence of active or latent bacterial or viral infections at the time of potential enrollment, including human immunodeficiency virus (hiv)
Beskrivning

Bacterial Infections | Latent bacterial disease | Virus Diseases | Latent virus infection | HIV Infection | HIV Infection Latent

Datatyp

boolean

Alias
UMLS CUI [1]
C0004623
UMLS CUI [2]
C0596823
UMLS CUI [3]
C0042769
UMLS CUI [4]
C0596824
UMLS CUI [5]
C0019693
UMLS CUI [6,1]
C0019693
UMLS CUI [6,2]
C0205275
risk for tuberculosis
Beskrivning

At risk Tuberculosis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1444641
UMLS CUI [1,2]
C0041296
abnormal laboratory values including positive hepatitis b surface antigen, hemoglobin < 8.5 g/dl, white blood cell count < 3000/mm3, platelets < 100,000/mm3, creatinine > 2.5 times the upper limit of normal (uln), alanine aminotransferase or aspartate aminotransferase > 2 times the uln.
Beskrivning

Laboratory test result abnormal | Hepatitis B surface antigen positive | Hemoglobin measurement | White Blood Cell Count procedure | Platelet Count measurement | Serum creatinine raised | Alanine aminotransferase increased | Aspartate aminotransferase increased

Datatyp

boolean

Alias
UMLS CUI [1]
C0438215
UMLS CUI [2]
C0149709
UMLS CUI [3]
C0518015
UMLS CUI [4]
C0023508
UMLS CUI [5]
C0032181
UMLS CUI [6]
C0700225
UMLS CUI [7]
C0151905
UMLS CUI [8]
C0151904
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Similar models

Eligibility Hypertension NCT02232880

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age | Hypertensive disease | Antihypertensive Agents Quantity | Diuretics Quantity
Item
men and women 18 to 65 years of age with hypertension, treated with three or more anti-hypertensive drugs, one being a diuretic, and
boolean
C0001779 (UMLS CUI [1])
C0020538 (UMLS CUI [2])
C0003364 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0012798 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
Systolic Pressure Clinic | Systolic Pressure Daytime Average Ambulatory Blood Pressure Monitoring
Item
having a systolic blood pressure >150 mmhg in the clinic and daytime average >150 mmhg on ambulatory blood pressure monitoring
boolean
C0871470 (UMLS CUI [1,1])
C0442592 (UMLS CUI [1,2])
C0871470 (UMLS CUI [2,1])
C0332169 (UMLS CUI [2,2])
C1510992 (UMLS CUI [2,3])
C0242876 (UMLS CUI [2,4])
Item Group
C0680251 (UMLS CUI)
Secondary hypertension | Obesity Severe | Body mass index | Mental Disorders, Severe | Malignant Neoplasms | Exception Skin carcinoma | Herpes zoster disease | Cytomegalovirus Resolved Recent
Item
medical history of secondary cause of hypertension, severe obesity (bmi >35), severe psychiatric disorders, cancer in the last 5 years other than nonmelanoma skin cell cancers, herpes zoster or cytomegalovirus that resolved less than 2 months before
boolean
C0155616 (UMLS CUI [1])
C0028754 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C1305855 (UMLS CUI [3])
C4046029 (UMLS CUI [4])
C0006826 (UMLS CUI [5])
C1705847 (UMLS CUI [6,1])
C0699893 (UMLS CUI [6,2])
C0019360 (UMLS CUI [7])
C0010825 (UMLS CUI [8,1])
C1514893 (UMLS CUI [8,2])
C0332185 (UMLS CUI [8,3])
Abatacept therapy Continue Unable | Follow-up Continue Unable
Item
inability to return for abatacept treatment and follow-up for 24 weeks.
boolean
C4302766 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C3274571 (UMLS CUI [2,1])
C0549178 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
Evaluation Comprehension Unable | Completion Evaluation Unable
Item
inability to understand or complete study-related assessments.
boolean
C1261322 (UMLS CUI [1,1])
C0162340 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0205197 (UMLS CUI [2,1])
C1261322 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
Substance Use Disorders
Item
current abuse of drugs or alcohol.
boolean
C0038586 (UMLS CUI [1])
Vaccines, Attenuated
Item
receipt of any live vaccines within 3 months of the anticipated first dose of study medication.
boolean
C0042211 (UMLS CUI [1])
Bacterial Infections | Latent bacterial disease | Virus Diseases | Latent virus infection | HIV Infection | HIV Infection Latent
Item
evidence of active or latent bacterial or viral infections at the time of potential enrollment, including human immunodeficiency virus (hiv)
boolean
C0004623 (UMLS CUI [1])
C0596823 (UMLS CUI [2])
C0042769 (UMLS CUI [3])
C0596824 (UMLS CUI [4])
C0019693 (UMLS CUI [5])
C0019693 (UMLS CUI [6,1])
C0205275 (UMLS CUI [6,2])
At risk Tuberculosis
Item
risk for tuberculosis
boolean
C1444641 (UMLS CUI [1,1])
C0041296 (UMLS CUI [1,2])
Laboratory test result abnormal | Hepatitis B surface antigen positive | Hemoglobin measurement | White Blood Cell Count procedure | Platelet Count measurement | Serum creatinine raised | Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
abnormal laboratory values including positive hepatitis b surface antigen, hemoglobin < 8.5 g/dl, white blood cell count < 3000/mm3, platelets < 100,000/mm3, creatinine > 2.5 times the upper limit of normal (uln), alanine aminotransferase or aspartate aminotransferase > 2 times the uln.
boolean
C0438215 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
C0023508 (UMLS CUI [4])
C0032181 (UMLS CUI [5])
C0700225 (UMLS CUI [6])
C0151905 (UMLS CUI [7])
C0151904 (UMLS CUI [8])
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