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REVIEW
Elke Anklam, Martin Iain Bahl, Robert Ball, Richard D Beger, Jonathan Cohen, Suzanne Fitzpatrick, Philippe Girard, Blanka Halamoda-Kenzaoui, Denise Hinton, Akihiko Hirose, Arnd Hoeveler, Masamitsu Honma, Marta Hugas, Seichi Ishida, George En Kass, Hajime Kojima, Ira Krefting, Serguei Liachenko, Yan Liu, Shane Masters, Uwe Marx, Timothy McCarthy, Tim Mercer, Anil Patri, Carmen Pelaez, Munir Pirmohamed, Stefan Platz, Alexandre Js Ribeiro, Joseph V Rodricks, Ivan Rusyn, Reza M Salek, Reinhilde Schoonjans, Primal Silva, Clive N Svendsen, Susan Sumner, Kyung Sung, Danilo Tagle, Li Tong, Weida Tong, Janny van den Eijnden-van-Raaij, Neil Vary, Tao Wang, John Waterton, May Wang, Hairuo Wen, David Wishart, Yinyin Yuan, William Slikker
There is an evolution and increasing need for the utilization of emerging cellular, molecular and in silico technologies and novel approaches for safety assessment of food, drugs, and personal care products. Convergence of these emerging technologies is also enabling rapid advances and approaches that may impact regulatory decisions and approvals. Although the development of emerging technologies may allow rapid advances in regulatory decision making, there is concern that these new technologies have not been thoroughly evaluated to determine if they are ready for regulatory application, singularly or in combinations...
January 2022: Experimental Biology and Medicine
#22
REVIEW
Valory N Pavlik, Samantha C Burnham, Joseph S Kass, Catherine Helmer, Sebastian Palmqvist, Maria Vassilaki, Jean-François Dartigues, Oskar Hansson, Colin L Masters, Karine Pérès, Ronald C Petersen, Erik Stomrud, Lesley Butler, Preciosa M Coloma, Xavier M Teitsma, Rachelle Doody, Mary Sano
Longitudinal observational cohort studies are being conducted worldwide to understand cognition, biomarkers, and the health of the aging population better. Cross-cohort comparisons and networks of registries in Alzheimer's disease (AD) foster scientific exchange, generate insights, and contribute to the evolving clinical science in AD. A scientific working group was convened with invited investigators from established cohort studies in AD, in order to form a research collaboration network as a resource to address important research questions...
November 8, 2021: Journal of Alzheimer's Disease: JAD
#23
JOURNAL ARTICLE
Jane Weitzel, Horacio Pappa, Gregory M Banik, Amy R Barker, Elizabeth Bladen, Narendra Chirmule, Joseph DeFeo, Jennifer Devine, Steven Emrick, Taha Kass Hout, Michael S Levy, Gugu N Mahlangu, Barbara Rellahan, Jaap Venema, Wesley Workman
Recent changes in the pharmaceutical industry have led to significant paradigm shifts in the pharmaceutical quality environment. Globalization of the pharmaceutical industry, increasingly rapid development of novel therapies, and adoption of new manufacturing techniques have presented numerous challenges for the established regulatory framework and quality environment and are impacting the approaches utilized to ensure the quality of pharmaceutical products. Regulators, industry, and standards-setting organizations have begun to recognize the need to rely more on integrated risk-based approaches and to create more nimble and flexible standards to complement these efforts...
October 15, 2021: AAPS Journal
#24
MULTICENTER STUDY
James C Grotta, Jose-Miguel Yamal, Stephanie A Parker, Suja S Rajan, Nicole R Gonzales, William J Jones, Anne W Alexandrov, Babak B Navi, May Nour, Ilana Spokoyny, Jason Mackey, David Persse, Asha P Jacob, Mengxi Wang, Noopur Singh, Andrei V Alexandrov, Matthew E Fink, Jeffrey L Saver, Joey English, Nobl Barazangi, Patti L Bratina, Michael Gonzalez, Brandi D Schimpf, Kim Ackerson, Carla Sherman, Mackenzie Lerario, Saad Mir, Jenny Im, Josh Z Willey, David Chiu, Michael Eisshofer, Janice Miller, David Ornelas, James P Rhudy, Kevin M Brown, Bryan M Villareal, Marianne Gausche-Hill, Nichole Bosson, Greg Gilbert, Sarah Q Collins, Kelly Silnes, Jay Volpi, Vivek Misra, James McCarthy, Tom Flanagan, Chethan P V Rao, Joseph S Kass, Laura Griffin, Nicole Rangel-Gutierrez, Edgar Lechuga, Jonathan Stephenson, Kenny Phan, Yvette Sanders, Elizabeth A Noser, Ritvij Bowry
BACKGROUND: Mobile stroke units (MSUs) are ambulances with staff and a computed tomographic scanner that may enable faster treatment with tissue plasminogen activator (t-PA) than standard management by emergency medical services (EMS). Whether and how much MSUs alter outcomes has not been extensively studied. METHODS: In an observational, prospective, multicenter, alternating-week trial, we assessed outcomes from MSU or EMS management within 4.5 hours after onset of acute stroke symptoms...
September 9, 2021: New England Journal of Medicine
#25
JOURNAL ARTICLE
Tareq Kass-Hout, Jungwha Lee, Katie Tataris, Christopher T Richards, Eddie Markul, Joseph Weber, Scott Mendelson, Kathleen O'Neill, Renee M Sednew, Shyam Prabhakaran
Importance: Endovascular therapy (EVT) improves functional outcomes in acute ischemic stroke (AIS) with large vessel occlusion (LVO). Whether implementation of a regional prehospital transport policy for comprehensive stroke center triage increases use of EVT is uncertain. Objective: To evaluate the association of a regional prehospital transport policy that directly triages patients with suspected LVO stroke to the nearest comprehensive stroke center with rates of EVT...
October 1, 2021: JAMA Neurology
#26
REVIEW
Rachel V Rose, Joseph S Kass
The US Department of Health and Human Services Office of the Inspector General identifies the five most important federal fraud and abuse laws that are most applicable to physicians: the False Claims Act, the Anti-Kickback Statute, the Physician Self-Referral Law (Stark Law), the Exclusion Authorities, and the Civil Monetary Penalties LawThe False Claims Act is the US government's primary tool for combating fraud perpetrated through the filing of false claims for federal government reimbursement. Neurologists and companies serving the needs of neurologic patients have not been immune from False Claims Act-related legal action...
June 1, 2021: Continuum: Lifelong Learning in Neurology
#27
JOURNAL ARTICLE
Holly A Taylor, Daphne Washington, Nae-Yuh Wang, Hiten Patel, Daniel Ford, Nancy E Kass, Joseph Ali
BACKGROUND/AIMS: Many investigators have tested interventions to improve research participant understanding of information shared during the informed consent process, using a variety of methods and with mixed results. A valid criticism of most consent research is that studies are often conducted in simulated research settings rather than ongoing clinical studies. The present study rigorously tested two simple and easily adoptable strategies for presenting key consent information to participants eligible to enroll in six actual clinical trials (i...
April 23, 2021: Clinical Trials: Journal of the Society for Clinical Trials
#28
JOURNAL ARTICLE
Dan Tong, Gabriele G Schiattarella, Nan Jiang, Francisco Altamirano, Pamela A Szweda, Abdallah Elnwasany, Dong I Lee, Heesoo Yoo, David A Kass, Luke I Szweda, Sergio Lavandero, Eric Verdin, Thomas G Gillette, Joseph A Hill
[Figure: see text].
May 28, 2021: Circulation Research
#29
JOURNAL ARTICLE
Yingze Zhang, John Tedrow, Mehdi Nouraie, Xiaoyun Li, Divay Chandra, Jessica Bon, Daniel J Kass, Carl R Fuhrman, Joseph K Leader, Steven R Duncan, Naftali Kaminski, Frank C Sciurba
BACKGROUND: Pentraxin 3 (PTX3) influences innate immunity and inflammation, host defence, the complement cascade and angiogenesis. PTX3 expression in lung and blood of subjects with tobacco exposure, and its potential relationship with disease pattern and clinical outcome are poorly understood. METHODS: Using independent platforms and cohorts, we identified associations of PTX3 gene expression in lung tissue and plasma from current and former tobacco smokers (with and without chronic obstructive pulmonary disease, COPD) to disease phenotypes including quantitative CT determined emphysema, lung function, symptoms and survival...
April 2021: Thorax
#30
JOURNAL ARTICLE
Gershom Chongwe, Bornwell Sikateyo, Linda Kampata, Joseph Ali, Kristina Hallez, Adnan A Hyder, Nancy Kass, Charles Michelo
In many settings, and perhaps especially in low-middle income countries, training institutions do not adequately prepare their students for the ethical challenges that confront them in professional life. We conducted a survey to assess the training needs in research ethics among the faculty at the University of Zambia, School of Medicine (UNZASoM) using a structured questionnaire distributed to faculty members in January 2015. The study was approved by the University of Zambia Biomedical Research Ethics Committee...
December 2, 2020: Global Bioethics
#31
JOURNAL ARTICLE
Monica Schoch-Spana, Emily K Brunson, Rex Long, Alexandra Ruth, Sanjana J Ravi, Marc Trotochaud, Luciana Borio, Janesse Brewer, Joseph Buccina, Nancy Connell, Laura Lee Hall, Nancy Kass, Anna Kirkland, Lisa Koonin, Heidi Larson, Brooke Fisher Lu, Saad B Omer, Walter A Orenstein, Gregory A Poland, Lois Privor-Dumm, Sandra Crouse Quinn, Daniel Salmon, Alexandre White
Given the social and economic upheavals caused by the COVID-19 pandemic, political leaders, health officials, and members of the public are eager for solutions. One of the most promising, if they can be successfully developed, is vaccines. While the technological development of such countermeasures is currently underway, a key social gap remains. Past experience in routine and crisis contexts demonstrates that uptake of vaccines is more complicated than simply making the technology available. Vaccine uptake, and especially the widespread acceptance of vaccines, is a social endeavor that requires consideration of human factors...
October 29, 2020: Vaccine
#32
JOURNAL ARTICLE
Joseph S Kass, Rachel V Rose
Rapid eye movement (REM) sleep behavior disorder (RBD) may result in a patient injuring a bed partner while acting out a dream. This article examines the complexities associated with RBD as a criminal defense strategy as well as the legal implications for physicians and their duty to patients and their families to mitigate risks associated with possible injuries related to RBD.
August 2020: Continuum: Lifelong Learning in Neurology
#33
JOURNAL ARTICLE
Sonu Bhaskar, Akansha Sinha, Maciej Banach, Shikha Mittoo, Robert Weissert, Joseph S Kass, Santhosh Rajagopal, Anupama R Pai, Shelby Kutty
Cytokine storm is an acute hyperinflammatory response that may be responsible for critical illness in many conditions including viral infections, cancer, sepsis, and multi-organ failure. The phenomenon has been implicated in critically ill patients infected with SARS-CoV-2, the novel coronavirus implicated in COVID-19. Critically ill COVID-19 patients experiencing cytokine storm are believed to have a worse prognosis and increased fatality rate. In SARS-CoV-2 infected patients, cytokine storm appears important to the pathogenesis of several severe manifestations of COVID-19: acute respiratory distress syndrome, thromboembolic diseases such as acute ischemic strokes caused by large vessel occlusion and myocardial infarction, encephalitis, acute kidney injury, and vasculitis (Kawasaki-like syndrome in children and renal vasculitis in adult)...
2020: Frontiers in Immunology
#34
JOURNAL ARTICLE
Joseph S Kass, Rachel V Rose
Stroke is one of the most common conditions neurologists treat in emergency situations. This article examines the issues of surrogate decision makers and the physician's potential legal liability in the context of the administration or nonadministration of recombinant tissue plasminogen activator (rtPA) in a common emergency department scenario.
April 2020: Continuum: Lifelong Learning in Neurology
#35
Joseph A Lewcun, Colette Pameijer, Rena Kass, Leah Cream, Diane Hershock, Ashton J Brooks, Daleela G Dodge
INTRODUCTION: Angiosarcoma is a rare soft tissue malignancy of endothelial cells, generally associated with a poor prognosis. Due to its rarity, randomized trials are difficult to conduct and a consensus on the treatment of angiosarcoma has not been reached. The role, efficacy, and timing of chemotherapy in AS treatment remain uncertain, and as stated, no large-scale trials have been able to establish definitive recommendations. CASE DESCRIPTIONS: Here we describe the successful use of chemotherapy followed by radiation for a case of lower extremity angiosarcoma, and a case of breast angiosarcoma treated with neoadjuvant chemotherapy followed by surgical resection...
February 21, 2020: International Journal of Surgery Case Reports
#36
LETTER
David McCall, Priti Tewari, Joseph D A Kass, Branko Cuglievan
No abstract text is available yet for this article.
August 2020: Journal of Pediatric Hematology/oncology
#37
JOURNAL ARTICLE
Koffi N'Guessan, Renata Grzywa, Seda Seren, Guillaume Gabant, Maria A Juliano, Marc Moniatte, Alain van Dorsselaer, Joseph Bieth, Christine Kellenberger, Francis Gauthier, Magdalena Wysocka, Adam Lesner, Marcin Sienczyk, Martine Cadene, Brice Korkmaz
Neutrophils contain at least four serine endopeptidases namely elastase (NE), proteinase 3 (PR3), cathepsin G (CatG) and NSP4, which contribute to the regulation of infection and of inflammatory processes. In physiological conditions, endogenous inhibitors including α2-macroglobulin (α2-M), serpins (α1-proteinase inhibitor (α1-PI)), monocyte neutrophil elastase inhibitor (MNEI), α1-antichymotrypsin) and locally produced chelonianins (elafin, SLPI) control excessive proteolytic activity of neutrophilic serine proteinases...
January 29, 2020: FEBS Journal
#38
JOURNAL ARTICLE
Carlo J Iasella, Spencer A Winters, Abigail Kois, Jaehee Cho, Stefanie J Hannan, Ritchie Koshy, Cody A Moore, Christopher R Ensor, Elizabeth A Lendermon, Matthew R Morrell, Joseph M Pilewski, Pablo G Sanchez, Daniel J Kass, Jonathan K Alder, S Mehdi Nouraie, John F McDyer
Epstein-Barr virus (EBV)-associated posttransplant lymphoproliferative disorder (EBV-PTLD) is a serious complication in lung transplant recipients (LTRs) associated with significant mortality. We performed a single-center retrospective study to evaluate the risks for PTLD in LTRs over a 7-year period. Of 611 evaluable LTRs, we identified 28 cases of PTLD, with an incidence of 4.6%. Kaplan-Meier analysis showed a decreased freedom from PTLD in idiopathic pulmonary fibrosis (IPF)-LTRs (P < .02). Using a multivariable Cox proportional hazards model, we found IPF (hazard ratio [HR] 3...
May 2020: American Journal of Transplantation
#39
JOURNAL ARTICLE
Davide Cappon, Mazda Beigi, Zinovia Kefalopoulou, Ludvic Zrinzo, Joseph Candelario, Catherine Milabo, Harith Akram, Viswas Dayal, Jonathan Hyam, Lewis Kass-Iliyya, Monty Silverdale, Julian Evans, Patricia Limousin, Marwan Hariz, Eileen Joyce, Thomas Foltynie, Marjan Jahanshahi
INTRODUCTION: In a double-blind randomized crossover trial, we previously established that bilateral deep brain stimulation of the anteromedial globus pallidus internus (GPiam-DBS) is effective in significantly reducing tic severity in patients with refractory Tourette syndrome (TS). Here, we report the effects of bilateral GPiam-DBS on cognitive function in 11 of the 13 patients who had participated in our double-blind cross-over trial of GPi-DBS. METHODS: Patients were assessed at baseline (4 weeks prior to surgery) and at the end of each of the three-month blinded periods, with stimulation either ON or OFF...
October 14, 2019: Parkinsonism & related Disorders
#40
JOURNAL ARTICLE
Joseph C Masdeu, Allen J Aksamit, Alan C Carver, Kathleen M Foley, Joseph S Kass, Raymond A Martin, Elizabeth A McCusker, Michael P McQuillen, Raja Mehanna, Richard Payne, Stephen J Victor, Steven Warach
In legal physician-hastened death, a physician prescribes medication with the primary intent of causing the death of a willing terminally ill patient. This practice differs radically from palliative sedation, intended to relieve a patient's suffering rather than cause a patient's death. In this position paper, we argue that the practice of physician-hastened death is contrary to the interests of patients, their families, and the sound ethical practice of medicine. Therefore, the American Academy of Neurology should advise its members against this practice, as it had done until 2018...
October 22, 2019: Neurology
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