Protocol Summary Clause Samples
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Protocol Summary. Study Sponsor Verily Life Sciences LLC Study Description This study seeks to understand patient diagnostic and treatment journey and positive airway pressure (PAP) therapy compliance for Verily Sleep Apnea (VSA) program/app users. Participants will enroll remotely and may undergo a home sleep test (HST). Upon confirmation of obstructive sleep apnea (OSA) and prescription of PAP therapy, the participant will begin using the VSA app to supplement PAP treatment. After 90 days of active participation, the participant will be given instructions for follow-up care, as indicated. This study will take a decentralized approach. Recruitment, enrollment, consultation, testing, coaching and active participation with the VSA app will take place remotely.
Protocol Summary. Principal Investigator Information: (Name, Institution, Address, Telephone/Fax Number, E-mail Address)
Protocol Summary. This protocol describes an immunologic study of response to influenza and SARS-CoV-2 vaccination across four of the US Influenza Vaccine Effectiveness (Flu VE) Network study sites. This protocol meets the objectives of component D in the Flu VE Network Cooperative Agreement (IP16-004), including enrollment of eligible persons into a cohort, administration of a licensed or authorized under emergency use authorization (EUA) mRNA COVID-19 vaccine (Moderna COVID-19 Vaccine) and licensed quadrivalent cell culture-based influenza vaccine (Flucelvax; ccIIV4), collection and testing of blood specimens, administration of enrollment surveys, protection of personally identifiable information, transfer of a HIPAA-limited dataset to the Network Coordinating Center (NCC) and CDC, and creation of a coded individual-level dataset according to a data management agreement.
Protocol Summary. The Protocol Summary for the Combined Therapy Study is attached hereto.
Protocol Summary. This study is a prospective, single-center and non-comparative study. The study will include subjects must be ≥ 20 years of age with cataract who would be eligible to receive a TFNT20 lens in at least one eye based on a new Alcon Toric calculator that incorporates ocular trends in Toric IOL planning. Subject with no ocular pathology that could confound study outcome, must require clear cornea cataract extraction, and must desire an IOL that provides the potential for near, intermediate and distance vision and corrects astigmatism. Potential subjects will be screened for enrollment into this clinical trial. Those qualifying will attend a total 5 visits. If the investigational products will be implanted to both eye, the maximum number of visits is total 9 visits. Primary endpoint data will be collected at the final visit, Visit3/3A (30-60 days post implantation). No interim analysis is planned. Investigational product type Device Study type Interventional Investigational products Test Product: AcrySof IQ PanOptix Toric Intraocular Lens Model TFNT20 (hereinafter called "TFNT20") Control Product: Not applicable Purpose and rationale The purpose of this study is to evaluate effectiveness and safety of the TFNT20 when implanted to replace the natural lens following cataract removal. this is intended to confirm the safety of the test product and examine its effectiveness as a Toric lens by examining the subject’s astigmatism power.