Background: After a new drug or medical device is approved by the US Food and Drug Administration (FDA), physician-patient communication about benefits and risks is critical, including whether the product was approved through an expedited pathway based on limited evidence. In addition, physician reporting of drug- and device-related adverse events in real-world use is necessary to have a complete safety profile. We studied physician-reported communication and safety-reporting practices related to drugs and devices.
View Article and Find Full Text PDFStudies on transcription regulation in platyhelminth development are scarce, especially for parasitic flatworms. Here, we employed single-cell transcriptomics to identify genes involved in reproductive development in the trematode model Schistosoma mansoni. This parasite causes schistosomiasis, a major neglected infectious disease affecting >240 million people worldwide.
View Article and Find Full Text PDFThe purpose of this study is to explore the risk factors for conversion from minimally invasive surgery to thoracotomy in patients with lung cancer through meta-analytic approach, and provide a better evidence-based basis for clinicians to perform surgery. We conducted a comprehensive search across databases including PubMed, Embase, Web of Science, and the Cochrane Library database to identify relevant English-language studies published up to February 2024. The pooled effect estimate was calculated using the odds ratio (OR) and a 95% confidence interval (CI).
View Article and Find Full Text PDFBackground And Objective: Prospective sequential analyses after a new drug approval allow proactive surveillance of new drugs. In the current study, we demonstrate feasibility of frailty-specific sequential analyses for dabigatran, rivaroxaban, and apixaban versus warfarin.
Methods: We partitioned Medicare data from 2011 to 2020 into datasets based on calendar year following the date of drug approval.
For the purpose of improving performance and reducing the fabrication difficulty of terahertz traveling wave tubes (TWTs), this paper proposes a novel single-section high-gain slow wave structure (SWS), which is named the symmetrical quasi-synchronous step-transition (SQSST) folded waveguide (FW). The SQSST-FW SWS has an artificially designed quasi-synchronous region (QSR) to suppress self-oscillations for sustaining a high gain in an untruncated circuit. Simultaneously, a symmetrical design can improve the efficiency performance to some extent.
View Article and Find Full Text PDFPurpose: To examine myocardial perfusion and T1 mapping indicesin individuals with type 2 diabetes mellitus (T2DM) at various stages of glycemic control and whether uncontrolled glycemic levels would worsen myocardial microvascular function.
Method: Cardiac magnetic resonance examinations were performed on 114 T2DM patients without obstructive coronary artery disease and 55 matched controls. Participants were further divided into four subgroups: Q1 (control); Q2 (prediabetes); Q3 (controlled T2DM) and Q4 (uncontrolled T2DM).
Background: The presence of depression related to an increased risk of all-cause and cardiovascular disease (CVD) mortality has been reported. However, studies conducted on certain specific depressive symptoms are scarce. Our purpose was to assess the effect of both depressive symptoms scores and certain specific depressive symptoms on all-cause and CVD mortality.
View Article and Find Full Text PDFBackground: Originator drug manufacturers use several strategies to delay generic competition in the USA, but it remains unclear whether this results in longer market exclusivity compared to other countries.
Objectives: We sought to understand how drug market exclusivity lengths vary between the USA and two comparable countries.
Methods: We focused on drugs approved within 2 years of each other in the USA, France, and Australia from 1995 to 2005, and we compared the lengths of exclusivity from marketing approval through first generic competition or June 2023 using Kaplan-Meier analyses.
A staggered vane-shaped slot-line slow-wave structure (SV-SL SWS) for application in W-band traveling wave tubes (TWTs) is proposed in this article. In contrast to the conventional slot-line SWSs with dielectric substrates, the proposed SWS consists only of a thin metal sheet inscribed with periodic grooves and two half-metal enclosures, which means it can be easily manufactured and assembled and has the potential for mass production. This SWS not only solves the problem of the dielectric loading effect but also improves the heat dissipation capability of such structures.
View Article and Find Full Text PDFZhonghua Wei Zhong Bing Ji Jiu Yi Xue
April 2024
The pathophysiological mechanism of cerebral ischemia/reperfusion injury (CIRI) is complex, and the current treatment methods are limited and the efficacy is not good. Previous therapeutic strategies of CIRI mostly target neurons, but no significant progress has been made. At present, astrocytes are expected to be promising effector cells for the treatment of CIRI.
View Article and Find Full Text PDFBuilding trust in public health agencies like the US Food and Drug Administration (FDA) has become a key government priority. Understanding the roots of FDA mistrust is important if the agency is to develop targeted messaging and reforms aimed at building confidence in the agency. We conducted a survey of 2,021 respondents in the US probing attitudes toward the FDA.
View Article and Find Full Text PDFIt has been widely recognized that electroacupuncture (EA) inducing the release of β-endorphin represents a crucial mechanism of EA analgesia. The arcuate nucleus (ARC) in the hypothalamus is a vital component of the endogenous opioid peptide system. Serving as an integration center, the periaqueductal gray (PAG) receives neural fiber projections from the frontal cortex, insular cortex, and ARC.
View Article and Find Full Text PDFTo investigate the predictive value of baseline platelet count and its short-term dynamic changes in the prognosis of patients with acute heart failure (AHF) in the intensive care unit. Patients diagnosed with AHF in the medical information mart for intensive care III and their clinical data were retrospectively filtered. Patients were divided into survivor and non-survivor groups based on their prognosis during hospitalization, and differences in baseline data between groups were compared.
View Article and Find Full Text PDFArtificial sweeteners (ASs) have been widely added to food and beverages because of their properties of low calories and sweet taste. However, whether the consumption of ASs is causally associated with cancer risk is not clear. Here, we utilized the two-sample Mendelian randomization (MR) method to study the potential causal association.
View Article and Find Full Text PDFSchistosomiasis is a major Neglected Tropical Disease, caused by the infection with blood flukes in the genus Schistosoma. To complete the life cycle, the parasite undergoes asexual and sexual reproduction within an intermediate snail host and a definitive mammalian host, respectively. The intra-molluscan phase provides a critical amplification step that ensures a successful transmission.
View Article and Find Full Text PDFAims: Ischemic stroke accounts for 87% of all strokes, and its death and disability bring a huge burden to society. Brain injury caused by ischemia-reperfusion (I/R) is also a major difficulty in clinical treatment and prognosis. Sophoricoside (SOP) is an isoflavone glycoside isolated from the seed of medical herb Sophora japonica L.
View Article and Find Full Text PDFThe primary aim of this study was to investigate the boron leaching process from alkali-activated ludwigite ore. Initially, the ore underwent activation through roasting at 1050 °C for 60 min with 20% sodium carbonate. Subsequently, the study examined the influence of leaching parameters, including temperature, time, liquid-to-solid ratio, and particle size, using the activated ore as the raw material.
View Article and Find Full Text PDFThe US Food and Drug Administration can require risk evaluation and mitigation strategy (REMS) programs for prescription drugs to ensure the benefits of use outweigh the risks. We conducted a national survey of physicians' experiences prescribing eight REMS-covered drugs: (1) ambrisentan; (2) bosentan; (3) clozapine; (4) isotretinoin; (5-7) the multiple myeloma (MM) drugs lenalidomide, pomalidomide, thalidomide; and (8) sodium oxybate. Between May 2022 and January 2023, we surveyed 5,331 physician prescribers of these drugs, and 1,295 (24%) returned surveys (range: 149 for bosentan to 226 for MM drugs).
View Article and Find Full Text PDFPhysicians' knowledge of Food and Drug Administration (FDA) approval processes is important in informing clinical decisions and patient discussions. Among a randomly selected national sample of 509 internists, cardiologists, and oncologists, 41 percent reported moderate or better understanding of the FDA's drug approval process, and 17 percent reported moderate or better understanding of the FDA's medical device approval process. Nearly all physicians thought that randomized, blinded trials that met primary endpoints should be very important factors required to secure regulatory approval.
View Article and Find Full Text PDFThe flatworm Schistosoma mansoni is an important but neglected pathogen that causes the disease schistosomiasis in millions of people worldwide. The parasite has a complex life cycle, undergoing sexual reproduction in a mammalian host and asexual replication in a snail host. Understanding the molecular mechanisms that the parasite uses to transition between hosts and develop into dimorphic reproductively competent adults may reveal new strategies for control.
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