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Consolidated Clinical Trials Inc. 25 Woodside Rd Pittsburgh, PA 15221 ALLEGHENY-PA Tax ID / EIN: xx-xxx5423 Represented By. Kenneth Steidl Steidl & Steinberg Suite 2830 Gulf Tower 707 Grant Street Pittsburgh, PA 15219 412-391-8000 Email: [email protected]. Trustee. Jeffrey J. Sikirica 121 Northbrook Drive Pine Township
https://clinicaltrials.gov/ct2/show/NCT02275481
Subjects who meet the eligibility criteria will be randomized to 1 of 2 treatments. Arformoterol tartrate inhalation solution 15 mcg (BROVANA) will be administered BID (morning and evening, approximately 12 hours between doses) using a standard jet nebulizer with a face mask or mouthpiece connected to an air compressor.
https://clinicaltrials.gov/ct2/show/NCT00236080
The patient must work night shifts that include at least 6 hours between 2200 and 0800 (+30 minutes) and be no longer than 12 hours (+30 minutes) in duration. The patient has a mean sleep latency of 6 minutes or less as determined by the MSLT (average of naps at 0100, 0300, 0500, and 0700).
https://clinicaltrials.gov/ct2/show/NCT01163032
Clinical response is defined as the coincident demonstration of entrainment (aMT6) and a score ≥ 3 on the Non-24 Clinical Response Scale (N24CRS). N24CRS measures improvement in sleep-wake measures and overall functioning (LQ-nTST, UQ-dTSD, MoST and CGI-C). Each assessment is scored as a 1 or 0 depending on the pre-specified threshold (see ...
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