ID

39311

Beskrivning

Effect of Acupuncture on Patients With Mild Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT01701726

Länk

https://clinicaltrials.gov/show/NCT01701726

Nyckelord

Versioner (1)
  1. 2019-12-18 2019-12-18 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

18 december 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Essential Hypertension NCT01701726

Engelsk

Eligibility Essential Hypertension NCT01701726

1 Formulär  
Criteria
Beskrivning

Criteria

1. patients whose age between 40 and 75 years old, male and female;
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
2. patients who meet the diagnostic criteria of mild hypertension according to jnc-7 and china's prevention and cure guide of hypertension. mild hypertension (who/ish criteria stage i) systolic blood pressure 159≥(sbp) ≥140 and/or diastolic blood pressure 99≥(dbp) ≥90 .
Beskrivning

Mild hypertension Stage | Systolic Pressure | Diastolic blood pressure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3276943
UMLS CUI [1,2]
C1306673
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
3. patients who are initially diagnosed as mild hypertension or have been diagnosed as mild hypertension before but have not taken any antihypertensive drugs.
Beskrivning

Hypertension, mild | Antihypertensive Agents Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C3276943
UMLS CUI [2,1]
C0003364
UMLS CUI [2,2]
C0332197
4. patients who are diagnosed as yue-yin style (yin-deficiency accompany with hyperactivity of yang) or yang-ming style (obstruction of phlegm and dampness) according to meridian syndrome differentiation
Beskrivning

Other Coding | Yin Deficiency | Yang Active Very | Obstruction Phlegm

Datatyp

boolean

Alias
UMLS CUI [1]
C3846158
UMLS CUI [2]
C0085257
UMLS CUI [3,1]
C2945617
UMLS CUI [3,2]
C0205177
UMLS CUI [3,3]
C0442824
UMLS CUI [4,1]
C0028778
UMLS CUI [4,2]
C0225378
5. patients who have a good understanding of our study. and willing to comply with our study protocol.
Beskrivning

Comprehension Study Protocol | Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [2]
C0525058
6. informed consent form must be signed by patient or lineal relative.
Beskrivning

Informed Consent | Informed Consent Relative

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0080103
7. all the tips are matched will be included.
Beskrivning

Criteria Fulfill

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients who have been diagnosed as secondary hypertension or malignant hypertension(e.g. cushing's syndrome, coarctation of the aorta，phaeochromocytoma, renal parenchymal disease，primary aldosteronism， renovascular hypertension, obstructive sleep apnoea，drug induced hypertension et al )
Beskrivning

Secondary hypertension | Malignant Hypertension | Cushing Syndrome | Aortic coarctation | Pheochromocytoma | Renal parenchymal disease | Conn Syndrome | Hypertension, Renovascular | Sleep Apnea, Obstructive | Hypertensive disease Drug-induced

Datatyp

boolean

Alias
UMLS CUI [1]
C0155616
UMLS CUI [2]
C0020540
UMLS CUI [3]
C0010481
UMLS CUI [4]
C0003492
UMLS CUI [5]
C0031511
UMLS CUI [6]
C1841992
UMLS CUI [7]
C1384514
UMLS CUI [8]
C0020545
UMLS CUI [9]
C0520679
UMLS CUI [10,1]
C0020538
UMLS CUI [10,2]
C0458082
2. patients who accompany with other severe medical conditions (e.g. endocrine disorders, cardiovascular disease. digestive disease. hepatic dysfunction，cerebral vascular disease. renal disease. haematologic disease et al). who may be not safe to join our study.
Beskrivning

Medical condition Severe | Endocrine System Diseases | Cardiovascular Diseases | Digestive System Disorders | Liver Dysfunction | Cerebrovascular Disorders | Kidney Diseases | Hematological Disease | Study Subject Participation Status Uncertain

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0014130
UMLS CUI [3]
C0007222
UMLS CUI [4]
C0012242
UMLS CUI [5]
C0086565
UMLS CUI [6]
C0007820
UMLS CUI [7]
C0022658
UMLS CUI [8]
C0018939
UMLS CUI [9,1]
C2348568
UMLS CUI [9,2]
C0087130
3. patients with a chronic disease which might not suitable for our study. e.g: epilepsy
Beskrivning

Chronic disease Inappropriate Clinical Trial | Epilepsy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0008679
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C0008976
UMLS CUI [2]
C0014544
,severe depression or anxiety (sas≥70,sds≥70) ,psychosis, allergic constitution, accompany with any infection.
Beskrivning

Severe depression | Anxiety Severe | Zung's self-rating anxiety scale | Zung self-rating depression scale | Psychotic Disorder | Patient constitution allergic | Communicable Diseases

Datatyp

boolean

Alias
UMLS CUI [1]
C0588008
UMLS CUI [2,1]
C0003467
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0451595
UMLS CUI [4]
C0451593
UMLS CUI [5]
C0033975
UMLS CUI [6,1]
C0683521
UMLS CUI [6,2]
C0700624
UMLS CUI [7]
C0009450
4. pregnant women or women in lactation or women of child bearing potential plan to conceive in the recent six months.
Beskrivning

Pregnancy | Breast Feeding | Pregnancy, Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
5. patients who currently participate in another clinical trial.
Beskrivning

Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
6. patients who had been treated with acupuncture during the previous three months
Beskrivning

Acupuncture Recent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0394664
UMLS CUI [1,2]
C0332185
7. if one of the tips mentioned above is matched will be excluded.
Beskrivning

Criteria Fulfill

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
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Similar models

Eligibility Essential Hypertension NCT01701726

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Age
Item
1. patients whose age between 40 and 75 years old, male and female;
boolean
C0001779 (UMLS CUI [1])
Mild hypertension Stage | Systolic Pressure | Diastolic blood pressure
Item
2. patients who meet the diagnostic criteria of mild hypertension according to jnc-7 and china's prevention and cure guide of hypertension. mild hypertension (who/ish criteria stage i) systolic blood pressure 159≥(sbp) ≥140 and/or diastolic blood pressure 99≥(dbp) ≥90 .
boolean
C3276943 (UMLS CUI [1,1])
C1306673 (UMLS CUI [1,2])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Hypertension, mild | Antihypertensive Agents Absent
Item
3. patients who are initially diagnosed as mild hypertension or have been diagnosed as mild hypertension before but have not taken any antihypertensive drugs.
boolean
C3276943 (UMLS CUI [1])
C0003364 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Other Coding | Yin Deficiency | Yang Active Very | Obstruction Phlegm
Item
4. patients who are diagnosed as yue-yin style (yin-deficiency accompany with hyperactivity of yang) or yang-ming style (obstruction of phlegm and dampness) according to meridian syndrome differentiation
boolean
C3846158 (UMLS CUI [1])
C0085257 (UMLS CUI [2])
C2945617 (UMLS CUI [3,1])
C0205177 (UMLS CUI [3,2])
C0442824 (UMLS CUI [3,3])
C0028778 (UMLS CUI [4,1])
C0225378 (UMLS CUI [4,2])
Comprehension Study Protocol | Protocol Compliance
Item
5. patients who have a good understanding of our study. and willing to comply with our study protocol.
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2])
Informed Consent | Informed Consent Relative
Item
6. informed consent form must be signed by patient or lineal relative.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0080103 (UMLS CUI [2,2])
Criteria Fulfill
Item
7. all the tips are matched will be included.
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Secondary hypertension | Malignant Hypertension | Cushing Syndrome | Aortic coarctation | Pheochromocytoma | Renal parenchymal disease | Conn Syndrome | Hypertension, Renovascular | Sleep Apnea, Obstructive | Hypertensive disease Drug-induced
Item
1. patients who have been diagnosed as secondary hypertension or malignant hypertension(e.g. cushing's syndrome, coarctation of the aorta，phaeochromocytoma, renal parenchymal disease，primary aldosteronism， renovascular hypertension, obstructive sleep apnoea，drug induced hypertension et al )
boolean
C0155616 (UMLS CUI [1])
C0020540 (UMLS CUI [2])
C0010481 (UMLS CUI [3])
C0003492 (UMLS CUI [4])
C0031511 (UMLS CUI [5])
C1841992 (UMLS CUI [6])
C1384514 (UMLS CUI [7])
C0020545 (UMLS CUI [8])
C0520679 (UMLS CUI [9])
C0020538 (UMLS CUI [10,1])
C0458082 (UMLS CUI [10,2])
Medical condition Severe | Endocrine System Diseases | Cardiovascular Diseases | Digestive System Disorders | Liver Dysfunction | Cerebrovascular Disorders | Kidney Diseases | Hematological Disease | Study Subject Participation Status Uncertain
Item
2. patients who accompany with other severe medical conditions (e.g. endocrine disorders, cardiovascular disease. digestive disease. hepatic dysfunction，cerebral vascular disease. renal disease. haematologic disease et al). who may be not safe to join our study.
boolean
C3843040 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0014130 (UMLS CUI [2])
C0007222 (UMLS CUI [3])
C0012242 (UMLS CUI [4])
C0086565 (UMLS CUI [5])
C0007820 (UMLS CUI [6])
C0022658 (UMLS CUI [7])
C0018939 (UMLS CUI [8])
C2348568 (UMLS CUI [9,1])
C0087130 (UMLS CUI [9,2])
Chronic disease Inappropriate Clinical Trial | Epilepsy
Item
3. patients with a chronic disease which might not suitable for our study. e.g: epilepsy
boolean
C0008679 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0014544 (UMLS CUI [2])
Severe depression | Anxiety Severe | Zung's self-rating anxiety scale | Zung self-rating depression scale | Psychotic Disorder | Patient constitution allergic | Communicable Diseases
Item
,severe depression or anxiety (sas≥70,sds≥70) ,psychosis, allergic constitution, accompany with any infection.
boolean
C0588008 (UMLS CUI [1])
C0003467 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0451595 (UMLS CUI [3])
C0451593 (UMLS CUI [4])
C0033975 (UMLS CUI [5])
C0683521 (UMLS CUI [6,1])
C0700624 (UMLS CUI [6,2])
C0009450 (UMLS CUI [7])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
4. pregnant women or women in lactation or women of child bearing potential plan to conceive in the recent six months.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Study Subject Participation Status
Item
5. patients who currently participate in another clinical trial.
boolean
C2348568 (UMLS CUI [1])
Acupuncture Recent
Item
6. patients who had been treated with acupuncture during the previous three months
boolean
C0394664 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Criteria Fulfill
Item
7. if one of the tips mentioned above is matched will be excluded.
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
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