Results 21 to 30 of about 315,340 (245)

Regulatory approval for autologous human cells and tissue products in the United States, the European Union, and Japan

open access: yesRegenerative Therapy, 2015
Human cells and tissue products belong to a relatively new class of medical products. Therefore, limited information is available on the classification and premarket evaluation of human cells and tissue products in the United States (US), the European ...
Kazuo Yano   +5 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

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

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

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

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

A Cost-Effective Pulse Oximeter Designed in Response to the COVID-19 Pandemic

open access: yesJournal of Open Hardware, 2021
This paper introduces the design of a small and cost-effective optical pulse oximeter, including a finger clip, sensor readout electronics, and associated firmware.
Benjamin Metcalfe   +5 more
doaj   +1 more source

Intraoperative Collection of Ascitic Fluid With Intra‐ or Postoperative Reinfusion in Ovarian Cancer: Safety and Feasibility of a Roller Pumping Method

open access: yesTherapeutic Apheresis and Dialysis, EarlyView.
ABSTRACT Introduction Patients with ovarian cancer often present with massive ascites, leading to significant protein loss during surgical procedures. Although cell‐free concentrated ascites reinfusion therapy (CART) is used in palliative settings to mitigate protein loss, its application in intraoperative settings remains unexplored.
Yutaka Yoneoka   +7 more
wiley   +1 more source

Trigeminal nerve stimulation: a recently approved treatment approach in attention deficit hyperactivity disorder

open access: yesThe Egyptian Journal of Neurology, Psychiatry and Neurosurgery, 2021
Attention-deficit hyperactivity disorder (ADHD) with its high prevalence is a growing area of concern and research, whereas exact underlying pathophysiology remains unknown. Behavioral therapy and multiple medications include methylphenidate, atomoxetine,
Mazlum Çöpür, Sidar Çöpür
doaj   +1 more source

Dual targeting of RET and SRC synergizes in RET fusion‐positive cancer cells

open access: yesMolecular Oncology, EarlyView.
Despite the strong activity of selective RET tyrosine kinase inhibitors (TKIs), resistance of RET fusion‐positive (RET+) lung cancer and thyroid cancer frequently occurs and is mainly driven by RET‐independent bypass mechanisms. Son et al. show that SRC TKIs significantly inhibit PAK and AKT survival signaling and enhance the efficacy of RET TKIs in ...
Juhyeon Son   +13 more
wiley   +1 more source

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