Results 21 to 30 of about 331,695 (261)

Registration, publication, and outcome reporting among pivotal clinical trials that supported FDA approval of high-risk cardiovascular devices before and after FDAAA

open access: yesTrials, 2021
Background Selective registration, publication, and outcome reporting of clinical trials distort the primary clinical evidence that is available to patients and clinicians regarding the safety and efficacy of US Food and Drug Administration (FDA ...
Matthew J. Swanson   +2 more
doaj   +1 more source

Mobility and freedom of movement: A novel out-of-hospital treatment for pediatric patients with terminal cardiac insufficiency and a ventricular assist device

open access: yesFrontiers in Cardiovascular Medicine, 2022
BackgroundDue to rapid medical and technological progress, more and more pediatric patients with terminal cardiac insufficiency are being implanted with a ventricular assist device as a bridge to transplant without legal approval for hospital discharge ...
Kathrin Rottermann   +7 more
doaj   +1 more source

Design and analysis of crossover trials for investigating high-risk medical devices: A review

open access: yesContemporary Clinical Trials Communications, 2022
During evaluation of new investigational medical devices, the FDA recommends that investigators design a crossover clinical trial, in which the patients are arranged to cross over from one treatment arm to another. The FDA annually receives the premarket
Bo Zhang, Jing Guo, Hui Zhang
doaj   +1 more source

Bottlenecks to Clinical Translation of Direct Brain-Computer Interfaces

open access: yesFrontiers in Systems Neuroscience, 2014
Despite several decades of research into novel brain-implantable devices to treat a range of diseases, only two- cochlear implants for sensorineural hearing loss and deep brain stimulation for movement disorders- have yielded any appreciable clinical ...
Mijail Demian Serruya
doaj   +1 more source

Safety and effectiveness of bycross rotational atherectomy and aspiration device: a prospective, multi-center pre-market approval study

open access: yesCVIR Endovascular, 2023
Purpose To demonstrate safety and effectiveness of the novel ByCross® atherectomy system for treatment of complex femorodistal > 80% arterial stenosis.
Jörg Tessarek, Ralf Kolvenbach
doaj   +1 more source

Bronchial thermoplasty-an update

open access: yesAnnals of Thoracic Medicine, 2018
Bronchial Thermoplasty is a procedure that involves the delivery of radiofrequency energy during bronchoscopy to airways in order to selectively ablate airway smooth muscles.
Faria Nasim, Vivek N Iyer
doaj   +1 more source

Feasibility and Safety of Somato‐Cognitive Coordination Therapy for Cerebellar Ataxia Following Pediatric Brain Tumor Treatment

open access: yesPediatric Blood &Cancer, EarlyView.
ABSTRACT Background Cerebellar ataxia after pediatric brain tumor treatment can cause persistent gait, balance, and speech impairment, yet no established rehabilitation strategy exists. Somato‐cognitive coordination therapy (SCCT) is a virtual reality–guided intervention designed to promote sensorimotor integration through visually constrained reaching
Masanobu Takeuchi   +10 more
wiley   +1 more source

Guidelines for Pediatric Radiotherapy Simulation: A Report From the Children's Oncology Group Radiation Oncology Discipline

open access: yesPediatric Blood &Cancer, EarlyView.
ABSTRACT Pediatric radiation therapy presents unique challenges compared to adult treatments, including those of immobilization, potential need for sedation, and the critical importance of accurate, reproducible positioning. Additionally, heightened attention to imaging doses is necessary to minimize long‐term toxicity in survivors.
Parham Alaei   +17 more
wiley   +1 more source

Seeking a common human factors language for the development and testing of injection devices

open access: yesDrug Delivery
Injection devices include drug–device combination products incorporating a needle for subcutaneous medication delivery. Often utilized by patients and caregivers, it is important for injection device user interface (UI) design to be intuitive to use ...
Megan O. Conrad   +4 more
doaj   +1 more source

Davids versus Goliaths: Pharma and academia threats to individual scientists and clinicians

open access: yesThe Journal of Scientific Practice and Integrity, 2022
# Background We previously described experiences of clinicians who published adverse drug reaction reports. We now report on threats and intimidations leveled against clinicians and scientists who received publicly documented threats after communicating
Charles L. Bennett   +19 more
doaj   +1 more source

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