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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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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02179684 |
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Date of registration:
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30/06/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Surgery or Clincial Follow up, in Patients With Bell' s Palsy
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Scientific title:
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Surgery or Clinical Follow-up in Patients With Bell's Palsy. A Prospective, Parallell, Single Center, Randomized , Open Surgery Clinical Study. |
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Date of first enrolment:
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November 2013 |
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Target sample size:
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150 |
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Recruitment status: |
Enrolling by invitation |
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URL:
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http://clinicaltrials.gov/show/NCT02179684 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Malou Hultcrantz, M.D prof. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Karolinska Institutet |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Patients with Bell´s Palsy
2. Men and women aged 18-55 y
3. Score < 70 according to Sunny Brook scale (SB)
4. Signed informed consent
Exclusion Criteria:
1. High bloodpressure
2. Diabetes
3. Pregnancy
4. Currently on immunodepressive treatment
5. Smoker
6. Psychiatric disorder
7. Cor incomp, according to NYHA grade: IV, kidney or liver disorder, that greatly
influence patienst ability to receive surgery
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Bell Palsy
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Intervention(s)
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Other: Conventional treatment and follow-up
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Procedure: Baby-sitter surgery N. fascialis
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Primary Outcome(s)
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Sunny Brook (SB) score > 70
[Time Frame: 1 year]
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Secondary Outcome(s)
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Facial Disability Index
[Time Frame: 15 month]
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FaCe
[Time Frame: 15 month]
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Secondary ID(s)
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Bell´sPalsy
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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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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