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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ChiCTR |
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Last refreshed on:
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23 March 2020 |
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Main ID: |
ChiCTR1900021901 |
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Date of registration:
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2019-03-15 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Efficacy and Safety of Thalidomide for the Treatment of Arteriovenous Malformations in Central Nervous System: Pilot Study
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Scientific title:
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Efficacy and Safety of Thalidomide for the Treatment of Arteriovenous Malformations in Central Nervous System: Pilot Study |
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Date of first enrolment:
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2019-03-20 |
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Target sample size:
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Case series:30; |
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Recruitment status: |
Completed |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=36787 |
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Study type:
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Observational study |
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Study design:
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Cohort study
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Phase:
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0
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Countries of recruitment
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China
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Contacts
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Name:
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Jiaxing Yu
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Address:
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45 Changchun Street, Xicheng District, Beijing, China
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Telephone:
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+86 15311435081 |
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Email:
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15311435081@163.com |
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Affiliation:
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Xuanwu Hospital, Capital Medical University |
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Name:
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Hongqi Zhang
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Address:
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45 Changchun Street, Xicheng District, Beijing, China
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Telephone:
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+86 13011858081 |
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Email:
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xwzhanghq@163.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Patients with central nervous system AVMs who can not who can not benefit from current treatment methods.
2. Patients with central nervous system AVM who can refuse to receive current treatment methods.
3. Written informed consent to participate in the study prior to any study procedures.
Exclusion criteria: 1. Pregnant and lactating female patients.
2. Patients younger than 2 years old.
3. Patients who is preparing for pregnancy.
4. Patients with high risks of thrombogenesis (diabetes, severe infection, malignant tumor, history of thrombogenesis, deep vein catheterization and coagulation disorders)
5. Patients with severe comorbidities of cardiac, pulmonary, renal, liver, hematological diseases
6. Patients who is diagnosed as hereditary hemorrhagic telangiectasia (HHT).
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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central nervous system arteriovenous malformations
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Intervention(s)
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Case series:Oral thalidomide;
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Primary Outcome(s)
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radiological change;
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Secondary Outcome(s)
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Pathological test;Neurological outcome;Biomarkers of the blood ;Averse effect;
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Source(s) of Monetary Support
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self-financing
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Ethics review
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Status: Approved
Approval date: 07/12/2018
Contact:
Zhuoran Zhang
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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