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3. AKT and EZH2 inhibitors kill TNBCs by hijacking mechanisms of involution

Author

Schade, Amy E., Perurena, Naiara, Yang, Yoona, Rodriguez, Carrie L., Krishnan, Anjana, Gardner, Alycia, Loi, Patrick, Xu, Yilin, Nguyen, Van T. M., Mastellone, G. M., Pilla, Natalie F., Watanabe, Marina, Ota, Keiichi, Davis, Rachel A., Mattioli, Kaia, Xiang, Dongxi, Zoeller, Jason J., Lin, Jia-Ren, Morganti, Stefania, Garrido-Castro, Ana C., Tolaney, Sara M., Li, Zhe, Barbie, David A., Sorger, Peter K., Helin, Kristian, Santagata, Sandro, Knott, Simon R. V., and Cichowski, Karen

Published
2024
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4. Regulating the Off-Label Use of Artificial Intelligence and Machine Learning-Enabled Medical Devices.

Author

Davis, Rachel E.

Subjects
Medical equipment -- Labeling -- Technology application -- Laws, regulations and rules, Artificial intelligence -- Health aspects -- Laws, regulations and rules, Harm principle (Ethics) -- Analysis, Medical personnel -- Malpractice, Warning labels -- Laws, regulations and rules, Machine learning -- Health aspects -- Laws, regulations and rules, Products liability -- Laws, regulations and rules, Physiological apparatus -- Labeling -- Technology application -- Laws, regulations and rules, Product safety -- Laws, regulations and rules, Government regulation, Artificial intelligence, Technology application, Food, Drug and Cosmetic Act
Abstract

TABLE OF CONTENTS I. BACKGROUND 775 A. Artificial Intelligence in Medicine 776 B. Medical Device Regulation 778 C. Off-Label Use 781 III. ANALYSIS 784 A. Federal Regulators 785 1. The [...], Through machine learning (ML) developments, medical devices are gaining more autonomous functions and taking on more central roles in medical care. Many scholars believe that artificial intelligence (AI) will revolutionize the healthcare industry, but the technology brings several concerns that implicate data privacy, patient security and safety, and professional responsibility. The Federal Drug Administration (FDA) acknowledged this fact, publishing proposed guidance in 2023 on artificial intelligence and machine learning (AI/ML) medical device approval that would tighten device regulation upfront and enhance supervision throughout the regulatory process. While some have addressed the premarket approval process or tort liability frameworks for artificial intelligence-enabled devices, this Note focuses on the regulatory concerns arising from off-label use of AI/ML-enabled medical devices. This Note agrees with FDA and other scholars that the current legal system does not support the proper use of AI/ML-enabled medical devices. To remedy that lack of systemic support, this Note considers which agencies, if any, have the proper regulatory authority to handle the matter and challenges the idea that nonbinding guidance is the proper regulatory vehicle for enforcement. Ultimately, this Note argues for a multilevel regulatory framework promulgated under the formal rulemaking process, state regulatory procedure, and private regulation.

Published
2024

5. A qualitative exploration of active ingredients and mechanisms of action of an online singing programme with mothers experiencing postnatal depression during the COVID-19 pandemic: SHAPER-PNDO study

Author

Burton, Alexandra, Bind, Rebecca H., Davis, Rachel, Greenwood, Lorna, Lee, Ching Yin, Estevao, Carolina, Hazelgrove, Katie, Miller, Celeste, Priestley, Kristi, Rebecchini, Lavinia, Osborn, Tim, Dye, Hannah, Dazzan, Paola, Woods, Anthony, Crane, Nikki, Pariante, Carmine M., and Fancourt, Daisy

Published
2024
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8. Correction: Tilapia venturing into high-salinity environments: A cause for concern?

Author

Franco, Ana Clara Sampaio, Azevedo-Santos, Valter M., Nogueira, Marluce Aparecida Mattos de Paula, Giarrizzo, Tommaso, Hauser-Davis, Rachel Ann, Guimarães, Erick Cristofore, Dalcin, Roger Henrique, Soeth, Marcelo, Freitas, Matheus Oliveira, Bertoncini, Áthila A., Abilhoa, Vinícius, Cunico, Almir Manoel, Adelir-Alves, Johnatas, Bentes, Bianca, Novaes, José Luís Costa, Hostim-Silva, Mauricio, Leite, Jonas Rodrigues, dos Santos, Vagner Leonardo Macêdo, and Vitule, Jean Ricardo Simões

Published
2024
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11. Rare Earth Element Accumulation in Fiddler Crabs (Minuca rapax) from the Rio Doce Tropical Estuary Strongly Affected by Mine Tailings Following the Fundão Disaster

Author

Sales Junior, Sidney Fernandes, Gabriel, Fabrício Ângelo, Soares, Lorena Oliveira Souza, Rocha, Rafael Christian Chávez, Saint’Pierre, Tatiana Dillenburg, Saggioro, Enrico Mendes, Correia, Fábio Veríssimo, Ferreira, Tiago Osório, Hauser-Davis, Rachel Ann, and Bernardino, Angelo Fraga

Published
2024
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12. Incidence of HIV and hepatitis C virus among people who inject drugs, and associations with age and sex or gender: a global systematic review and meta-analysis

Author

Artenie, Adelina, Stone, Jack, Fraser, Hannah, Stewart, Daniel, Arum, Chiedozie, Lim, Aaron G, McNaughton, Anna L, Trickey, Adam, Ward, Zoe, Abramovitz, Daniela, Alary, Michel, Astemborski, Jacquie, Bruneau, Julie, Clipman, Steven J, Coffin, Carla S, Croxford, Sara, DeBeck, Kora, Emanuel, Eva, Hayashi, Kanna, Hermez, Joumana G, Low-Beer, Daniel, Luhmann, Niklas, Macphail, Gisela, Maher, Lisa, Palmateer, Norah E, Patel, Eshan U, Sacks-Davis, Rachel, Van Den Boom, Wijnand, van Santen, Daniela K, Walker, Josephine G, Hickman, Matthew, Vickerman, Peter, Group, HIV and HCV Incidence Review Collaborative, Aladashvili, Malvina, Azim, Tasnim, Dietze, Paul, Dumchev, Kostyantyn, Havens, Jennifer R, Hellard, Margaret, Hutchinson, Sharon, Iversen, Jennifer, Judd, Ali, Kåberg, Martin, Kurth, Ann E, Mehta, Shruti H, Mravčík, Viktor, Prins, Maria, Solomon, Sunil S, Strathdee, Steffanie A, Sypsa, Vana, Todd, Catherine S, Valencia, Jorge, and Wisse, Ernst

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Hepatitis, Infectious Diseases, Social Determinants of Health, Digestive Diseases, Chronic Liver Disease and Cirrhosis, Hepatitis - C, Sexually Transmitted Infections, Women's Health, Drug Abuse (NIDA only), Emerging Infectious Diseases, Substance Misuse, HIV/AIDS, Liver Disease, Infection, Good Health and Well Being, Male, Humans, Female, Hepacivirus, Substance Abuse, Intravenous, Drug Users, Incidence, HIV Infections, Canada, Hepatitis C, HIV and HCV Incidence Review Collaborative Group, Clinical sciences
Abstract

BackgroundMeasuring the incidence of HIV and hepatitis C virus (HCV) infection among people who inject drugs (PWID) is key to track progress towards elimination. We aimed to summarise global data on HIV and primary HCV incidence among PWID and associations with age and sex or gender.MethodsIn this systematic review and meta-analysis, we updated an existing database of HIV and HCV incidence studies among PWID by searching MEDLINE, Embase, and PsycINFO, capturing studies published between Jan 1, 2000, and Dec 12, 2022, with no language or study design restrictions. We contacted authors of identified studies for unpublished or updated data. We included studies that estimated incidence by longitudinally re-testing people at risk of infection or by using assays for recent infection. We pooled incidence and relative risk (RR; young [generally defined as ≤25 years] vs older PWID; women vs men) estimates using random-effects meta-analysis and assessed risk of bias with a modified Newcastle-Ottawa scale. This study is registered with PROSPERO, CRD42020220884.FindingsOur updated search identified 9493 publications, of which 211 were eligible for full-text review. An additional 377 full-text records from our existing database and five records identified through cross-referencing were assessed. Including 28 unpublished records, 125 records met the inclusion criteria. We identified 64 estimates of HIV incidence (30 from high-income countries [HICs] and 34 from low-income or middle-income countries [LMICs]) and 66 estimates of HCV incidence (52 from HICs and 14 from LMICs). 41 (64%) of 64 HIV and 42 (64%) of 66 HCV estimates were from single cities rather than being multi-city or nationwide. Estimates were measured over 1987-2021 for HIV and 1992-2021 for HCV. Pooled HIV incidence was 1·7 per 100 person-years (95% CI 1·3-2·3; I2=98·4%) and pooled HCV incidence was 12·1 per 100 person-years (10·0-14·6; I2=97·2%). Young PWID had a greater risk of HIV (RR 1·5, 95% CI 1·2-1·8; I2=66·9%) and HCV (1·5, 1·3-1·8; I2=70·6%) acquisition than older PWID. Women had a greater risk of HIV (RR 1·4, 95% CI 1·1-1·6; I2=55·3%) and HCV (1·2, 1·1-1·3; I2=43·3%) acquisition than men. For both HIV and HCV, the median risk-of-bias score was 6 (IQR 6-7), indicating moderate risk.InterpretationAlthough sparse, available HIV and HCV incidence estimates offer insights into global levels of HIV and HCV transmission among PWID. Intensified efforts are needed to keep track of the HIV and HCV epidemics among PWID and to expand access to age-appropriate and gender-appropriate prevention services that serve young PWID and women who inject drugs.FundingCanadian Institutes of Health Research, Fonds de recherche du Québec-Santé, Canadian Network on Hepatitis C, UK National Institute for Health and Care Research, and WHO.

Published
2023

13. Future directions in psychiatric neurosurgery: Proceedings of the 2022 American Society for Stereotactic and Functional Neurosurgery meeting on surgical neuromodulation for psychiatric disorders

Author

Hitti, Frederick L, Widge, Alik S, Riva-Posse, Patricio, Malone, Donald A, Okun, Michael S, Shanechi, Maryam M, Foote, Kelly D, Lisanby, Sarah H, Ankudowich, Elizabeth, Chivukula, Srinivas, Chang, Edward F, Gunduz, Aysegul, Hamani, Clement, Feinsinger, Ashley, Kubu, Cynthia S, Chiong, Winston, Chandler, Jennifer A, Carbunaru, Rafael, Cheeran, Binith, Raike, Robert S, Davis, Rachel A, Halpern, Casey H, Vanegas-Arroyave, Nora, Markovic, Dejan, Bick, Sarah K, McIntyre, Cameron C, Richardson, R Mark, Dougherty, Darin D, Kopell, Brian H, Sweet, Jennifer A, Goodman, Wayne K, Sheth, Sameer A, and Pouratian, Nader

Subjects
Biomedical and Clinical Sciences, Brain Disorders, Rehabilitation, Neurosciences, Neurological, Good Health and Well Being, Humans, United States, Neurosurgery, Deep Brain Stimulation, Neurosurgical Procedures, Mental Disorders, Psychosurgery, Deep brain stimulation, Treatment resistant depression, Obsessive compulsive disorder, Tourette syndrome, Neuromodulation, Medical and Health Sciences, Neurology & Neurosurgery, Biomedical and clinical sciences, Health sciences
Abstract

ObjectiveDespite advances in the treatment of psychiatric diseases, currently available therapies do not provide sufficient and durable relief for as many as 30-40% of patients. Neuromodulation, including deep brain stimulation (DBS), has emerged as a potential therapy for persistent disabling disease, however it has not yet gained widespread adoption. In 2016, the American Society for Stereotactic and Functional Neurosurgery (ASSFN) convened a meeting with leaders in the field to discuss a roadmap for the path forward. A follow-up meeting in 2022 aimed to review the current state of the field and to identify critical barriers and milestones for progress.DesignThe ASSFN convened a meeting on June 3, 2022 in Atlanta, Georgia and included leaders from the fields of neurology, neurosurgery, and psychiatry along with colleagues from industry, government, ethics, and law. The goal was to review the current state of the field, assess for advances or setbacks in the interim six years, and suggest a future path forward. The participants focused on five areas of interest: interdisciplinary engagement, regulatory pathways and trial design, disease biomarkers, ethics of psychiatric surgery, and resource allocation/prioritization. The proceedings are summarized here.ConclusionThe field of surgical psychiatry has made significant progress since our last expert meeting. Although weakness and threats to the development of novel surgical therapies exist, the identified strengths and opportunities promise to move the field through methodically rigorous and biologically-based approaches. The experts agree that ethics, law, patient engagement, and multidisciplinary teams will be critical to any potential growth in this area.

Published
2023

15. Tilapia venturing into high-salinity environments: A cause for concern?

Author

Franco, Ana Clara Sampaio, Azevedo-Santos, Valter M., Nogueira, Marluce Aparecida Mattos de Paula, Giarrizzo, Tommaso, Hauser-Davis, Rachel Ann, Guimarães, Erick Cristofore, Dalcin, Roger Henrique, Soeth, Marcelo, Freitas, Matheus Oliveira, Bertoncini, Áthila A., Abilhoa, Vinícius, Cunico, Almir Manoel, Adelir-Alves, Johnatas, Bentes, Bianca, Novaes, José Luís Costa, Hostim-Silva, Mauricio, Leite, Jonas Rodrigues, dos Santos, Vagner Leonardo Macêdo, and Vitule, Jean Ricardo Simões

Published
2024
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21. Prospective study of the effect of auricular percutaneous electrical nerve field stimulation on quality of life in children with pain related disorders of gut-brain interaction.

Author

Chogle, Ashish, Visnagra, Kaajal, Janchoi, Jamie, Tran, Tammy, Davis, Rachel, Callas, Nicole, and Ornelas, Elisa

Subjects
auricular, disorder of gut brain interaction, functional abdominal pain disorder, gastrointestinal disorder, irritable bowel syndrome, percutaneous electrical nerve field stimulation, quality of life
Abstract

BACKGROUND: Disorders of the Gut-Brain Interaction (DGBIs) account for 50% of pediatric gastrointestinal (GI) consultations. Children with DGBIs have worse quality of life (QoL) than those with organic GI disorders such as inflammatory bowel disease and gastroesophageal reflux disease. Pediatric DGBIs patients, especially those with chronic abdominal pain (AP), have impaired QoL and increased psychological distress in the form of anxiety and depression. Percutaneous Electrical Nerve Field Stimulation (PENFS) therapy has been shown to be effective in improving symptoms and functioning in children with DGBIs. The treatments impact on these patients QoL is unknown. METHODS: This prospective study evaluated changes in QoL, gastrointestinal symptoms, functional disability, somatization, global health, anxiety, and depression in patients aged 11-18 years who received PENFS therapy (IB-stim, NeurAxis, Versailles, IN) for treatment of pain related DGBIs, once a week for four consecutive weeks. RESULTS: This study included 31 patients with an average age of 15.7 years (SD = 2); 80.6% were female. After PENFS therapy, patients reported significant reductions in abdominal pain, nausea severity, functional disability, somatization, and anxiety from baseline to week 4 (p

Published
2023

37. Increasing Utilization of Student Mental Health Services on a College Campus: Eight Actionable Tips

Author

Davis, Rachel A., Wolfe, Julie, and Heiman, Noa

Abstract

Undergraduate and graduate students have a higher risk of mental illness than the general population. Multiple barriers may contribute to decreased help-seeking, including mental health stigma, lack of awareness of available resources, lack of prioritization of self-care, busy class schedules, and different preferences in communication styles. Over the past six years, we have increased the utilization of our Student and Resident Mental Health Clinic on the University of Colorado Anschutz Medial Campus by more than 100%. This viewpoint article highlights eight initiatives that address some of the barriers that mental health clinics on undergraduate and graduate campuses may face. These initiatives include involving students to reduce stigma and increase engagement, matching capacity of clinic services to demand, using technology, being as visible as possible, modeling vulnerability and self-care, adapting services to your audience needs, providing food (other than pizza!), and building a team and promoting collegiality.

Published
2023
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41. Changes in incidence of hepatitis C virus reinfection and access to direct-acting antiviral therapies in people with HIV from six countries, 2010–19: an analysis of data from a consortium of prospective cohort studies

Author

Hellard, Margaret E, Sacks-Davis, Rachel, van Santen, Daniela K, Stewart, Ashleigh, Ke, Tianhui, Zhang, Yanqin, Stoove, Mark, Guy, Rebecca, Pedrana, Alisa, Asselin, Jason, Dawe, Joshua, Wilkinson, Anna, Boyd, Anders, Smit, Colette, van der Valk, Marc, Schinkel, Janke, Wittkop, Linda, Salmon, Dominique, Sogni, Philippe, Esterle, Laure, Gilbert, Camille, Merchadou, Laurence, Gillet, Stephanie, Khan, Coralie, Bonnet, Fabrice, Leleux, Olivier, Le Marec, Fabien, Perrier, Adelaide, Matthews, Gail, Shaw, Ineke, Martinello, Marianne, Applegate, Tanya, Carson, Joanne, Doyle, Joseph S, Harney, Brendan, Bryant, Melissa, Jarrin Vera, Inmaculada, Berenguer, Juan, Alejos, Belen, Lazarus, Jeffrey V, Moreno, Cristina, Izquierdo, Rebecca, Rava, Marta, Klein, Marina, Wang, Shouao, Lumia, Jessica, Pexos, Costa, Peiris, Hansi, Saeed, Sahar, Moodie, Erica, Young, Jim, Pick, Neora, Conway, Brian, Hull, Mark, Wong, Alex, Gill, John, Barrett, Lisa, Cohen, Jeff, Cox, Joseph, Cote, Pierre, Haider, Shariq, Rouleau, Danielle, Vachon, Marie-Louise, Rachlis, Anita, Sandre, Roger, Walmsley, Sharon, Sadr, Aida, Cooper, Curtis, Sanche, Steve, Rauch, Andri, Mugglin, Catrina, Salazar-Viscaya, Luisa, Kusejko, Katharina, Prins, Maria, Hage, Kris, Lacombe, Karine, Requena, Maria-Bernada, Girard, Pierre-Marie, Brucker, Matthieu, Vincensini, Jean-Paul, Jarrin, Inmaculada, Requena, Maria-Bernarda, Matthews, Gail V, Martin, Natasha K, Spelman, Tim, and Hellard, Margaret

Published
2024
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42. All-cause mortality before and after DAA availability among people living with HIV and HCV: An international comparison between 2010 and 2019

Author

Requena, Maria-Bernarda, Protopopescu, Camelia, Stewart, Ashleigh C., van Santen, Daniela K., Klein, Marina B., Jarrin, Inmaculada, Berenguer, Juan, Wittkop, Linda, Salmon, Dominique, Rauch, Andri, Prins, Maria, van der Valk, Marc, Sacks-Davis, Rachel, Hellard, Margaret E, Carrieri, Patrizia, and Lacombe, Karine

Published
2024
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48. Feasibility, clinical efficacy, and well-being outcomes of an online singing intervention for postnatal depression in the UK: SHAPER-PNDO, a single-arm clinical trial

Author

Bind, Rebecca H., Sawyer, Kristi, Hazelgrove, Katie, Rebecchini, Lavinia, Miller, Celeste, Ahmed, Subeyda, Dazzan, Paola, Sevdalis, Nick, Bakolis, Ioannis, Davis, Rachel, Lopez, Maria Baldellou, Woods, Anthony, Crane, Nikki, Manoharan, Manonmani, Burton, Alexandra, Dye, Hannah, Osborn, Tim, Greenwood, Lorna, Perkins, Rosie, Fancourt, Daisy, Pariante, Carmine M., and Estevao, Carolina

Published
2023
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