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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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12 December 2020 |
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Main ID: |
NCT02880735 |
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Date of registration:
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12/08/2016 |
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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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Ventilatory Response After Non Invasive Ventilation in Type 1 Myotonic Dystrophy
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Scientific title:
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Effect of Noninvasive Mechanical Ventilation on Ventilatory Response in Patients With Myotonic Dystrophy Type 1 |
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Date of first enrolment:
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September 2016 |
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Target sample size:
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27 |
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Recruitment status: |
Unknown status |
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URL:
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https://clinicaltrials.gov/show/NCT02880735 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Mexico
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Contacts
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Name:
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Martha G Torres Fraga, MD |
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Address:
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Telephone:
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(52)5556668640 |
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Email:
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dra_marthagtf@hotmail.com |
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Affiliation:
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Name:
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Martha G Torres Fraga, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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National Institute of Respiratory Diseases, Mexico |
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Name:
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Martha G Torres Fraga, MD |
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Address:
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Telephone:
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(52) 5556668640 |
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Email:
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dra_marthagtf@hotmail.com |
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Affiliation:
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Name:
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Rogelio Perez Padilla, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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National Institute of Respiratory Diseases, Mexico |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Classic variety of Myotonic Dystrophy Type 1
- Molecular confirmation through the standard method
Exclusion Criteria:
- Using currently invasive mechanical ventilation.
- Acute decompensation of respiratory or cardiac origin in the last 6 months, which
required hospital care.
- Drugs that may alter the ventilatory response: benzodiazepines, neuroleptics,
corticosteroids, theophylline, acetazolamide
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Myotonic Dystrophy 1
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Steinert Disease
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Intervention(s)
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Device: Non Invasive Ventilation.
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Primary Outcome(s)
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Ventilatory Response to Chemical Stimuli
[Time Frame: Three months]
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Secondary Outcome(s)
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Dyspnoea evaluated by the modified scale of the Medical Research Council (mMRC)
[Time Frame: Three months]
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Sleep Quality assessed by The Pittsburgh Sleep Quality Index (PSQI)
[Time Frame: three months]
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Health Related Quality of Life Measured by Short Form 36 (SF-36)
[Time Frame: Three months]
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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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