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The use of nonhuman primates in studies of noise injury and treatment.
Burton JA, Valero MD, Hackett TA, Ramachandran R
(2019) J Acoust Soc Am 146: 3770
MeSH Terms: Animals, Disease Models, Animal, Hearing Loss, Noise-Induced, Humans, Primates, Psychoacoustics, Translational Medical Research
Show Abstract · Added March 3, 2020
Exposure to prolonged or high intensity noise increases the risk for permanent hearing impairment. Over several decades, researchers characterized the nature of harmful noise exposures and worked to establish guidelines for effective protection. Recent laboratory studies, primarily conducted in rodent models, indicate that the auditory system may be more vulnerable to noise-induced hearing loss (NIHL) than previously thought, driving renewed inquiries into the harmful effects of noise in humans. To bridge the translational gaps between rodents and humans, nonhuman primates (NHPs) may serve as key animal models. The phylogenetic proximity of NHPs to humans underlies tremendous similarity in many features of the auditory system (genomic, anatomical, physiological, behavioral), all of which are important considerations in the assessment and treatment of NIHL. This review summarizes the literature pertaining to NHPs as models of hearing and noise-induced hearing loss, discusses factors relevant to the translation of diagnostics and therapeutics from animals to humans, and concludes with some of the practical considerations involved in conducting NHP research.
0 Communities
1 Members
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7 MeSH Terms
Androgenic Effects on Ventricular Repolarization: A Translational Study From the International Pharmacovigilance Database to iPSC-Cardiomyocytes.
Salem JE, Yang T, Moslehi JJ, Waintraub X, Gandjbakhch E, Bachelot A, Hidden-Lucet F, Hulot JS, Knollmann BC, Lebrun-Vignes B, Funck-Brentano C, Glazer AM, Roden DM
(2019) Circulation 140: 1070-1080
MeSH Terms: Androgens, Antineoplastic Agents, Cell Differentiation, Cells, Cultured, Databases, Factual, Humans, Hypogonadism, Induced Pluripotent Stem Cells, International Cooperation, Long QT Syndrome, Male, Myocytes, Cardiac, Pharmacovigilance, Phenylthiohydantoin, Risk, Torsades de Pointes, Translational Medical Research
Show Abstract · Added November 12, 2019
BACKGROUND - Male hypogonadism, arising from a range of etiologies including androgen-deprivation therapies (ADTs), has been reported as a risk factor for acquired long-QT syndrome (aLQTS) and torsades de pointes (TdP). A full description of the clinical features of aLQTS associated with ADT and of underlying mechanisms is lacking.
METHODS - We searched the international pharmacovigilance database VigiBase for men (n=6 560 565 individual case safety reports) presenting with aLQTS, TdP, or sudden death associated with ADT. In cardiomyocytes derived from induced pluripotent stem cells from men, we studied electrophysiological effects of ADT and dihydrotestosterone.
RESULTS - Among subjects receiving ADT in VigiBase, we identified 184 cases of aLQTS (n=168) and/or TdP (n=68; 11% fatal), and 99 with sudden death. Of the 10 ADT drugs examined, 7 had a disproportional association (reporting odds ratio=1.4-4.7; <0.05) with aLQTS, TdP, or sudden death. The minimum and median times to sudden death were 0.25 and 92 days, respectively. The androgen receptor antagonist enzalutamide was associated with more deaths (5430/31 896 [17%]; <0.0001) than other ADT used for prostate cancer (4208/52 089 [8.1%]). In induced pluripotent stem cells, acute and chronic enzalutamide (25 µM) significantly prolonged action potential durations (action potential duration at 90% when paced at 0.5 Hz; 429.7±27.1 (control) versus 982.4±33.2 (acute, <0.001) and 1062.3±28.9 ms (chronic; <0.001), and generated afterdepolarizations and/or triggered activity in drug-treated cells (11/20 acutely and 8/15 chronically). Enzalutamide acutely and chronically inhibited delayed rectifier potassium current, and chronically enhanced late sodium current. Dihydrotestosterone (30 nM) reversed enzalutamide electrophysiological effects on induced pluripotent stem cells.
CONCLUSIONS - QT prolongation and TdP are a risk in men receiving enzalutamide and other ADTs.
CLINICAL TRIAL REGISTRATION - URL: https://www.clinicaltrials.gov. Unique identifier: NCT03193138.
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2 Members
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17 MeSH Terms
Empowering ASCI's support of physician-scientists through stronger institutional connections.
Marr KA, Rathmell WK, Hawley JB, Guth KD
(2019) J Clin Invest 129: 1516-1518
MeSH Terms: Biomedical Research, Humans, Leadership, Societies, Medical, Translational Medical Research, United States
Show Abstract · Added October 30, 2019
The American Society for Clinical Investigation (ASCI), a nonprofit honorary society, was established to support physician-scientists by serving as a benchmark of excellence in medical research, a forum to celebrate advances in medicine, and a vehicle to communicate advances that bridge basic and translational research and their implementation across the growing myriad of medical specialties. A core intention of the Society is to engage the medical research community broadly through transparent communications of our activities and initiatives with the institutions that comprise the base for our membership. Recognizing the importance in identifying and actuating a strategy to support the Society's broad mission, the current leadership has undertaken a strategic plan that initiates with the goal of revamping its Institutional Representatives program. While the Society has grown with the historical privilege of close connections to institutions through an informal web created largely by the elected membership, we aim to improve institutional engagement towards overall goals of embracing and enhancing diversity of our community and implementing future collaborative programs to support physician-scientists. We briefly review ASCI's history, mission, and structure, and present the blueprint of the new Institutional Representatives program.
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1 Members
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6 MeSH Terms
Translating preclinical MRI methods to clinical oncology.
Hormuth DA, Sorace AG, Virostko J, Abramson RG, Bhujwalla ZM, Enriquez-Navas P, Gillies R, Hazle JD, Mason RP, Quarles CC, Weis JA, Whisenant JG, Xu J, Yankeelov TE
(2019) J Magn Reson Imaging 50: 1377-1392
MeSH Terms: Animals, Brain Neoplasms, Diffusion Magnetic Resonance Imaging, Humans, Hydrogen-Ion Concentration, Hypoxia, Image Processing, Computer-Assisted, Immunotherapy, Macromolecular Substances, Magnetic Resonance Imaging, Medical Oncology, Neoplasm Metastasis, Neoplasm Transplantation, Neoplasms, Oxygen, Reproducibility of Results, Theranostic Nanomedicine, Translational Medical Research
Show Abstract · Added March 30, 2020
The complexity of modern in vivo magnetic resonance imaging (MRI) methods in oncology has dramatically changed in the last 10 years. The field has long since moved passed its (unparalleled) ability to form images with exquisite soft-tissue contrast and morphology, allowing for the enhanced identification of primary tumors and metastatic disease. Currently, it is not uncommon to acquire images related to blood flow, cellularity, and macromolecular content in the clinical setting. The acquisition of images related to metabolism, hypoxia, pH, and tissue stiffness are also becoming common. All of these techniques have had some component of their invention, development, refinement, validation, and initial applications in the preclinical setting using in vivo animal models of cancer. In this review, we discuss the genesis of quantitative MRI methods that have been successfully translated from preclinical research and developed into clinical applications. These include methods that interrogate perfusion, diffusion, pH, hypoxia, macromolecular content, and tissue mechanical properties for improving detection, staging, and response monitoring of cancer. For each of these techniques, we summarize the 1) underlying biological mechanism(s); 2) preclinical applications; 3) available repeatability and reproducibility data; 4) clinical applications; and 5) limitations of the technique. We conclude with a discussion of lessons learned from translating MRI methods from the preclinical to clinical setting, and a presentation of four fundamental problems in cancer imaging that, if solved, would result in a profound improvement in the lives of oncology patients. Level of Evidence: 5 Technical Efficacy: Stage 3 J. Magn. Reson. Imaging 2019;50:1377-1392.
© 2019 International Society for Magnetic Resonance in Medicine.
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1 Members
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18 MeSH Terms
Cardio-oncology: a novel platform for basic and translational cardiovascular investigation driven by clinical need.
Moslehi J, Fujiwara K, Guzik T
(2019) Cardiovasc Res 115: 819-823
MeSH Terms: Animals, Antineoplastic Agents, Cardiology, Cardiotoxicity, Cardiovascular Diseases, Diffusion of Innovation, Forecasting, Humans, Medical Oncology, Risk Factors, Translational Medical Research
Added November 12, 2019
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1 Members
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11 MeSH Terms
Limited achievement of NIH research independence by pediatric K award recipients.
Good M, McElroy SJ, Berger JN, Moore DJ, Wynn JL
(2018) Pediatr Res 84: 479-480
MeSH Terms: Achievement, Awards and Prizes, Career Mobility, Child, Female, Humans, Male, Mentors, National Institutes of Health (U.S.), Pediatrics, Physicians, Research Personnel, Research Support as Topic, Translational Medical Research, United States
Added June 17, 2018
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1 Members
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15 MeSH Terms
Overcoming Translational Barriers in Acute Kidney Injury: A Report from an NIDDK Workshop.
Zuk A, Palevsky PM, Fried L, Harrell FE, Khan S, McKay DB, Devey L, Chawla L, de Caestecker M, Kaufman JS, Thompson BT, Agarwal A, Greene T, Okusa MD, Bonventre JV, Dember LM, Liu KD, Humphreys BD, Gossett D, Xie Y, Norton JM, Kimmel PL, Star RA
(2018) Clin J Am Soc Nephrol 13: 1113-1123
MeSH Terms: Acute Kidney Injury, Animals, Congresses as Topic, Disease Models, Animal, Humans, National Institute of Diabetes and Digestive and Kidney Diseases (U.S.), Translational Medical Research, United States
Show Abstract · Added October 23, 2018
AKI is a complex clinical condition associated with high mortality, morbidity, and health care costs. Despite improvements in methodology and design of clinical trials, and advances in understanding the underlying pathophysiology of rodent AKI, no pharmacologic agent exists for the prevention or treatment of AKI in humans. To address the barriers that affect successful clinical translation of drug targets identified and validated in preclinical animal models of AKI in this patient population, the National Institute of Diabetes and Digestive and Kidney Diseases convened the "AKI Outcomes: Overcoming Barriers in AKI" workshop on February 10-12, 2015. The workshop used a reverse translational medicine approach to identify steps necessary to achieve clinical success. During the workshop, breakout groups were charged first to design feasible, phase 2, proof-of-concept clinical trials for delayed transplant graft function, prevention of AKI (primary prevention), and treatment of AKI (secondary prevention and recovery). Breakout groups then were responsible for identification of preclinical animal models that would replicate the pathophysiology of the phase 2 proof-of-concept patient population, including primary and secondary end points. Breakout groups identified considerable gaps in knowledge regarding human AKI, our understanding of the pathophysiology of AKI in preclinical animal models, and the fidelity of cellular and molecular targets that have been evaluated preclinically to provide information regarding human AKI of various etiologies. The workshop concluded with attendees defining a new path forward to a better understanding of the etiology, pathology, and pathophysiology of human AKI.
Copyright © 2018 by the American Society of Nephrology.
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8 MeSH Terms
Perspective on the interpretation of research and translation to clinical care with therapy-associated metastatic breast cancer progression as an example.
Fingleton B, Lange K, Caldwell B, Bankaitis KV, Board of the Metastasis Research Society
(2017) Clin Exp Metastasis 34: 443-447
MeSH Terms: Biomedical Research, Breast Neoplasms, Decision Making, Disease Progression, Evidence-Based Medicine, Female, Humans, Translational Medical Research
Show Abstract · Added March 21, 2018
This commentary was written as a collaboration between the Board of the Metastasis Research Society and two patients with metastatic breast cancer. It was conceived in response to how preclinical scientific research is sometimes presented to non-scientists in a way that can cause stress and confusion. Translation of preclinical findings to the clinic requires overcoming multiple barriers. This is irrespective of whether the findings relate to exciting responses to new therapies or problematic effects of currently used therapies. It is important that these barriers are understood and acknowledged when research findings are summarized for mainstream reporting. To minimize confusion, patients should continue to rely on their oncology care team to help them interpret whether research findings presented in mainstream media have relevance for their individual care. Researchers, both bench and clinical, should work together where possible to increase options for patients with metastatic disease, which is still in desperate need of effective therapeutic approaches.
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1 Members
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8 MeSH Terms
SJS/TEN 2017: Building Multidisciplinary Networks to Drive Science and Translation.
White KD, Abe R, Ardern-Jones M, Beachkofsky T, Bouchard C, Carleton B, Chodosh J, Cibotti R, Davis R, Denny JC, Dodiuk-Gad RP, Ergen EN, Goldman JL, Holmes JH, Hung SI, Lacouture ME, Lehloenya RJ, Mallal S, Manolio TA, Micheletti RG, Mitchell CM, Mockenhaupt M, Ostrov DA, Pavlos R, Pirmohamed M, Pope E, Redwood A, Rosenbach M, Rosenblum MD, Roujeau JC, Saavedra AP, Saeed HN, Struewing JP, Sueki H, Sukasem C, Sung C, Trubiano JA, Weintraub J, Wheatley LM, Williams KB, Worley B, Chung WH, Shear NH, Phillips EJ
(2018) J Allergy Clin Immunol Pract 6: 38-69
MeSH Terms: Aged, Child, Congresses as Topic, Early Diagnosis, Electronic Health Records, Expert Testimony, Female, Humans, Interdisciplinary Communication, Male, Pregnancy, Stevens-Johnson Syndrome, Translational Medical Research, United States
Show Abstract · Added March 14, 2018
Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) is a life-threatening, immunologically mediated, and usually drug-induced disease with a high burden to individuals, their families, and society with an annual incidence of 1 to 5 per 1,000,000. To effect significant reduction in short- and long-term morbidity and mortality, and advance clinical care and research, coordination of multiple medical, surgical, behavioral, and basic scientific disciplines is required. On March 2, 2017, an investigator-driven meeting was held immediately before the American Academy of Dermatology Annual meeting for the central purpose of assembling, for the first time in the United States, clinicians and scientists from multiple disciplines involved in SJS/TEN clinical care and basic science research. As a product of this meeting, this article summarizes the current state of knowledge and expert opinion related to SJS/TEN covering a broad spectrum of topics including epidemiology and pharmacogenomic networks; clinical management and complications; special populations such as pediatrics, the elderly, and pregnant women; regulatory issues and the electronic health record; new agents that cause SJS/TEN; pharmacogenomics and immunopathogenesis; and the patient perspective. Goals include the maintenance of a durable and productive multidisciplinary network that will significantly further scientific progress and translation into prevention, early diagnosis, and management of SJS/TEN.
Copyright © 2017 American Academy of Allergy, Asthma & Immunology. All rights reserved.
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2 Members
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14 MeSH Terms
Translating Knowledge Into Therapy for Acute Kidney Injury.
de Caestecker M, Harris R
(2018) Semin Nephrol 38: 88-97
MeSH Terms: Acute Kidney Injury, Biopsy, Clinical Trials as Topic, Humans, Kidney, Patient Selection, Phenotype, Precision Medicine, Translational Medical Research
Show Abstract · Added October 23, 2018
No therapies have been shown to improve outcomes in patients with acute kidney injury (AKI). Given the high morbidity and mortality associated with AKI this represents an important unmet medical need. A common feature of all of the therapeutic development efforts for AKI is that none were driven by target selection or preclinical modeling that was based primarily on human data. This is important when considering a heterogeneous and dynamic condition such as AKI, in which in the absence of more accurate molecular classifications, clinical cohorts are likely to include patients with different types of injury at different stages in the injury and repair continuum. The National Institutes of Health precision medicine initiative offers an opportunity to address this. By creating a molecular tissue atlas of AKI, defining patient subgroups, and identifying critical cells and pathways involved in human AKI, this initiative has the potential to transform our current approach to therapeutic discovery. In this review, we discuss the opportunities and challenges that this initiative presents, with a specific focus on AKI, what additional efforts will be needed to apply these discoveries to therapeutic development, and how we believe this effort might lead to the development of new therapeutics for subsets of patients with AKI.
Copyright © 2017. Published by Elsevier Inc.
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9 MeSH Terms