Podcasts about clinical trials

The Dobbs v. Jackson Women's Health Organization decision, which effectively removed the federal constitutional protections for abortion, triggered a series of changes for health care providers and patients alike across the nation with respect to abortion services. What additional implications are there for certain aspects of clinical trials and research? On this episode, Epstein Becker Green attorneys Kate Heffernan, Marylana Helou, and Megan Robertson discuss how the changing state laws and regulations post-Dobbs may impact clinical research in different ways for different stakeholders.   Visit our site for related resources and email contact information: https://www.ebglaw.com/dhc55.   Subscribe for email notifications: https://www.ebglaw.com/subscribe.   Visit: http://diagnosinghealthcare.com.   The EMPLOYMENT LAW THIS WEEK® and DIAGNOSING HEALTH CARE podcasts are presented by Epstein Becker & Green, P.C. All rights are reserved. This audio recording includes information about legal issues and legal developments. Such materials are for informational purposes only and may not reflect the most current legal developments. These informational materials are not intended, and should not be taken, as legal advice on any particular set of facts or circumstances, and these materials are not a substitute for the advice of competent counsel. The content reflects the personal views and opinions of the participants. No attorney-client relationship has been created by this audio recording. This audio recording may be considered attorney advertising in some jurisdictions under the applicable law and ethical rules. The determination of the need for legal services and the choice of a lawyer are extremely important decisions and should not be based solely upon advertisements or self-proclaimed expertise. No representation is made that the quality of the legal services to be performed is greater than the quality of legal services performed by other lawyers.

ONCE UPON A GENE - EPISODE 171 Never Give Up - Two Decades of Struggles From Diagnosing Their Children to Starting a Clinical Trial For Aspartylglucosaminuria with Rare Mom Julia Taravella Julia Taravella is a mom to two adult children, Alexander and Daniel, and she's the founder of the Rare Trait Hope Fund. Julia's sons didn't have a diagnosis for 16 years until she went above and beyond to seek out answers and use the genetic data available to her to reveal a diagnosis of Aspartylglucosaminuria (AGU), a rare, fatal, lysosomal storage disorder.  EPISODE HIGHLIGHTS Can you tell us about your sons and their diagnosis journey? Alexander and Daniel are 22 and 27. In kindergarten and first grade, Daniel was doing below average. Daniel was 5 years old when his brother Alexander was born. Alexander started early intervention, but started to have the same delays as Daniel. Having two children presenting the same developmental delays, I suspected it was genetic, but it was difficult to get genetic testing at that time. I sought consultations with physicians and specialists, the boys underwent testing, and all results revealed they were within the expected range. A direct-to-consumer genetic test came out on the market and I bought two of them for my husband and I, figuring there may be something uncovered through our DNA. We went on to test both kids and close relatives too and the results were inconclusive. I dug deeper by downloading all of the data from the testing website and went back to doctors with it, but I wasn't taken seriously. I found a person in bioinformatics who agreed to analyze and clean up the data. When the data was returned, I took genetics classes for 6 months, wrote a program to analyze the data and determined my sons had AGU. The diagnosis was confirmed by doctors through further blood and urine testing. What did you do after getting a diagnosis?  I attended a conference and connected with new families with other glycoprotein lysosomal diseases and it helped to meet them. I had hope that something could be done and I frantically started writing emails to anyone I could find in the published AGU literature. I wrote about 200 emails and through those emails I connected with a Finnish doctor who invited me to go to Finland to meet with her. We stopped in Germany on the way and connected with a biochemist to discuss potential treatment options.  What should everyone watch out for when developing gene therapy programs? It's important to have a signed sponsorship agreement about how research and funding is handled without knowing what you'll get in return. Take small steps and don't invest everything you've raised at once to test if you'll receive the results you want within the time frame you've set. Step-by-step developments will help develop a rapport with your researcher to develop trust and gain understanding about where funding goes. Also be sure to understand who is working on what and maintain open lines of communication with everyone. LINKS & RESOURCES MENTIONED Rare Trait Hope Fund https://www.raretrait.com/ 23andMe https://www.23andme.com/ ONCE UPON A GENE - EPISODE 154 - A Groundbreaking Gene Therapy In Record Time to Cure His Son with SPG50 Sets a New Course For Future Rare Disease Treatments with Terry Pirovalakis https://effieparks.com/podcast/episode-154-terry-pirovolakis-groundbreaking-gene-therapy CONNECT WITH EFFIE PARKS Website https://effieparks.com/ Twitter https://twitter.com/OnceUponAGene Instagram https://www.instagram.com/onceuponagene.podcast/?hl=en Built Ford Tough Facebook Group https://www.facebook.com/groups/1877643259173346/ Interested in advertising on Once Upon a Gene? Email advertising@bloodstreammedia.com for more information!

Brad Hightower, the founder of Hightower Clinical, clinical research professional and host of the Note to File podcast, sits down with Dr. Michael Koren to discuss clinical research as a care option, decentralized clinical trials and clinical research technology and data collection using EMRs and CTMS such as Clinasyst.Michael J. Koren, MD, is a practicing cardiologist and Chief Executive Officer at Jacksonville Center for Clinical Research, which conducts clinical trials at 7 locations in Florida. He received his medical degree cum laude at Harvard Medical School and completed his residency in internal medicine and fellowship in cardiology at New York Hospital/Memorial Sloan-Kettering Cancer Center/Cornell Medical Center.He is a fellow of the American College of Cardiology, fellow and two-time president of the Academy of Physicians in Clinical Research, and the regional chapter of the American Heart Association. Dr. Koren has served as an Investigator in over 2,000 trials and as the international lead investigator for many multi-centered trials including ALLIANCE, ROLE, TREAT to TARGET, OSLER, and MENDEL studies. He has written and co-authored over 100 peer-reviewed articles and been published in the most prestigious medical journals. Dr. Koren has also designed a research training course for physicians now in its 20th year. On a personal note, Dr. Koren developed a life-long interest in technology and Public Health during his time at The Massachusetts Institute of Technology and The Harvard School of Public Health. He also loves music. He has written two musical plays. Brad Hightower, founder of Hightower Clinical, clinical research professional and host of the Note to File podcast. Brad lives, works and podcasts from Oklahoma City, OK.  He has worked at the site-level in clinical research for 10 years and is the former Executive Director of the Oklahoma Heart Hospital Research Foundation.  Brad has since started his own integrated site network, Hightower Clinical.To learn more about Hightower Clinical, please visit hightowerclinical.com.To connect with Brad, please reach out on LinkedIn.Rate, Review and Subscribe to the MedEvidence! podcast to be notified when new episodes are released.Follow MedEvidence! on Social Media to discover the Truth Behind the Data.FacebookInstagramTwitterLinkedInPowered by ENCORE Research Group at www.ENCOREDOCS.comOriginal Air Date: November 30, 2022#decentralizedclinicaltrials #CTMS #careoptions #demandfordata #medevidence  #futureofresearch #clinincalresearch

Jane Myles is the Vice President of Clinical Trial Innovation at Curebase, a platform at the forefront of "decentralized trials." What does that mean? Well, when a patient qualifies and—hopefully—enrolls in a trial, they usually have to take up residence in a different city and uproot their lives for a few weeks or months. The idea behind decentralizing them means all the medications and protocols come to a patient's local hospital so as not to cause such unnecessary upheaval. Jane is also a musician at heart, so there's a bunch of non-science geekery afoot. Enjoy the show.See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.

86% Of Clinical Trials Of Drugs Are Industry Funded Dr. John Abramson, M.D• https://hcp.hms.harvard.edu/people/john-david-abramson • Book – Sickening Ian Harris, MD • https://med.unsw.edu.au/our-people/ian-harris • Book - Surgery, The Ultimate Placebo: A Surgeon Cuts through the Evidence Dr. Robert Yoho • http://www.robertyohoauthor.com • Book - Butchered by “Heathcare” Dr. Robert Lustig • http://www.robertlustig.com • Book - Metabolical #BigPharma #AmericanHealthCare #HealthCarePolicy Dr. John Abramson, M.D. is an author and medical doctor and has served as a family physician for over 20 years. His recently release book Sickening  How Big Pharma Broke American Health Care and How We Can Repair It. Is about the inside story of how Big Pharma's relentless pursuit of ever-higher profits corrupts medical knowledge—misleading doctors, misdirecting American health care, and harming our health. John Abramson MD,  He was twice voted “best doctor” in his area by readers of the local newspapers and three times selected by his peers as one of a handful of best family practitioners in Massachusetts. He has been on the faculty at Harvard Medical School for over 15 years, where he has taught primary care and currently teaches health care policy. To Contact Dr John Abramson MD go to hcp.hms.harvard.edu/people/john-david-abramson Dr Ian Harris is a practicing orthopedic surgeon, university professor and an acclaimed author of several books including Hippocrasy: How doctors are betraying their oath. Professor Ian Harris is an orthopedic surgeon who works at Liverpool, St George, St George Private and Sutherland Hospitals in Sydney. His academic affiliation is with UNSW, South Western Sydney Clinical School at Liverpool Hospital, in Sydney. In addition to approximately 200 peer-reviewed publications, he also wroteSurgery, The Ultimate Placebo - an eye-opening evaluation of commonly performed surgical operations that have been tested and shown to be no more effective (and arguably worse) than placebo, or that have never even been tested. He suggests we treat new surgical procedures like new drugs, and only pay for those that are part of a trial to find out if they really work. To Contact Dr Harris go to Email: ianharris@unsw.edu.au Dr. Robert Yoho is an author and accomplished retired Los Angeles cosmetic surgeon. His Book, Butchered by “Heathcare”: What to Do About Doctors, Big Pharma, and Corrupt Government Ruining Your Health and Medical Care. Dr Robert Yoho grew up in Kent Ohio. He was an Eagle Scout and a Judo wrestler. Went to Oberlin College and Case Western Reserve Univ. Medical School. In 2019 Dr Yoho retired from his medical and surgical practice. He now is a full time writer and speaker. No longer responsible for patient care he is able to write full time without conflicts of interest. To Contact Dr Robert Yoho go to  robertyohoauthor.com  Dr. Robert Lustig is a The New York Times bestselling author and author of Metabolical: The Lure and the Lies of Processed Food, Nutrition, and Modern Medicine and a Professor of Pediatric Endocrinology at the University of California, San Francisco. Dr. Robert Lustig, a pediatric neuroendocrinologist who has long been on the cutting edge of medicine and science, challenges our current healthcare paradigm which has gone off the rails under the influence of Big Food, Big Pharma, and Big Government. Dr. Lustig has authored 125 peer-reviewed articles and 73 reviews. He has mentored 20 pediatric endocrine fellows, and trained numerous other allied health professionals. He provides endocrinologic support to several protocols of the Children's Oncology Group.  He is the former Chairman of the Ad hoc Obesity Task Force of the Lawson Wilkins Pediatric Endocrine Society, a member of the Pediatric Obesity Practice Guidelines Subcommittee of The Endocrine Society, a member of the Obesity Task Force of the Endocrine Society, a member of the Pediatric Obesity Devices Committee of the U.S. Food and Drug Administration, a member of the Bay Area Board of Directors of the American Heart Association, and a member of the Steering Committee of Health Foods, Healthy Kids of the Culinary Institute of America. He also consults for several childhood obesity advocacy groups. Dr. Lustig lives in San Francisco with his wife Julie and two daughters. Spare time (what little there is) is spent cooking, theater-going, and traveling. To Contact Dr Robert Lustig, M.D.  go to robertlustig.com Disclaimer:Medical and Health information changes constantly. Therefore, the information provided in this podcast should not be considered current, complete, or exhaustive. Reliance on any information provided in this podcast is solely at your own risk. The Real Truth About Health does not recommend or endorse any specific tests, products, procedures, or opinions referenced in the following podcasts, nor does it exercise any authority or editorial control over that material. The Real Truth About Health provides a forum for discussion of public health issues. The views and opinions of our panelists do not necessarily reflect those of The Real Truth About Health and are provided by those panelists in their individual capacities. The Real Truth About Health has not reviewed or evaluated those statements or claims. 

Minimally invasive surgeries are ideal for reducing recovery time for patients. Biomedical engineers play an important role in figuring out the design requirements needed for developing useful devices for both physicians and other end users. Creasy Clauser, Research Manager for Cook Medical, describes the role of a Biomedical Engineer from identifying problems to developing prototypes that limit risk in the operating room and beyond.

In this episode, Holly Fernandez Lynch and I continue our discussion of clinical research ethics with co-hosts Rahima Ghafoori and Caroline Gozigian (UVA Law '23). In this Part 2 of our interview, we focus on questions of payment, exploitation, and trust. As a reminder, in Part I, Holly introduced the basic regulatory framework governing clinical trials, with a focus on laws and rules impacting payment. She also discussed the benefits of and concerns about human challenge studies, and shared some historical examples. Holly Fernandez Lynch, JD, MBE, is Assistant Professor of Medical Ethics in the Department of Medical Ethics and Health Policy at the Perelman School of Medicine (PSOM), University of Pennsylvania. She has a secondary appointment as an Assistant Professor of Law at the University of Pennsylvania Carey Law School.A lawyer and bioethicist by training, Professor Fernandez Lynch's scholarly work focuses on Food and Drug Administration (FDA) pharmaceutical policy, access to investigational medicines outside clinical trials, clinical research ethics, and the ethics of gatekeeping in health care. Her specific areas of expertise include Institutional Review Board (IRB) quality, payment to research participants, research prioritization, pre-approval access pathways (e.g., Expanded Access, Emergency Use Authorization, and Right to Try), and efforts to balance speed and certainty in drug approvals, including pathways that rely on post-approval trials such as accelerated approval. Links:Lynch HF, Darton TC, Levy J, McCormick F, Ogbogu U, Payne RO, Roth AE, Shah AJ, Smiley T, Largent EA. Promoting Ethical Payment in Human Infection Challenge Studies. Am J Bioeth. 2021 Mar;21(3):11-31. doi: 10.1080/15265161.2020.1854368. Epub 2021 Feb 4. PubMed PMID: 33541252.Shah SK, Miller FG, Darton TC, Duenas D, Emerson C, Lynch HF, Jamrozik E, Jecker NS, Kamuya D, Kapulu M, Kimmelman J, MacKay D, Memoli MJ, Murphy SC, Palacios R, Richie TL, Roestenberg M, Saxena A, Saylor K, Selgelid MJ, Vaswani V, Rid A. Ethics of controlled human infection to address COVID-19. Science. 2020 May 22;368(6493):832-834. doi: 10.1126/science.abc1076. Epub 2020 May 7. PubMed PMID: 32381590.Largent EA, Heffernan KG, Joffe S, Lynch HF. Paying Clinical Trial Participants: Legal Risks and Mitigation Strategies. J Clin Oncol. 2020 Feb 20;38(6):532-537. doi: 10.1200/JCO.19.00250. Epub 2019 Jun 14. PubMed PMID: 31199697.

In this episode, our hosts are joined by Dr. Titilola Falasinnu, Assistant Professor at the Stanford School of Medicine, epidemiologist, and pain scientist. Dr. Falasinnu shares about the importance of increasing diversity in lupus clinical trials, her research supporting the experience of patients with chronic pain, and the need to address the unique needs of autoimmune patients. "We urgently need guidelines for the management of chronic pain… to address the individual needs of the patients from a biopsychosocial perspective, which is where the physical and emotional well-being of the patients are prioritized. So this requires an interdisciplinary approach where multiple specialties work in concert with rheumatologists to address the complex needs of patients with chronic pain conditions,” says Dr. Falasinnu. Among the highlights in this episode: 1:13: 2022 marked a record for Affordable Care Act enrollment with about 16 million people having enrolled in the health insurance platform 2:05: The CDC expands airport screening: All air passengers 2 years of age and older originating from China will be required to get a COVID-19 test no more than two days before their departure, regardless of their vaccination status 3:55: Dr. Falasinnu elaborates on her career and what led to her research at the Stanford School of Medicine 5:55: Dr. Falasinnu shares the personal story behind her journey to becoming a lupus researcher 6:51: “In 2016, we did a review of the representation of racial minorities in lupus trials. We estimated that black patients comprise about 43% of lupus patients in the United States. However, black patients comprise only 14% of trial participants in lupus, and black representation actually dropped during the study period from 20%... to 10%, between 2012 and 2017,” says Dr. Falasinnu 7:35: “The issues of the lack of diversity in clinical trials is not unique to rheumatology, and we see it in cancer and cardiovascular disease trials as well,” says Dr. Falasinnu 8:48: Dr. Falasinnu shares how we can adapt traditional trial recruitment frameworks while acknowledging the challenge of engaging the lupus patient community as a whole 9:53: “Life with children can be very busy, and schedules of parents may not permit the addition of a clinical trial. I've been there,” says Dr. Falasinnu 11:05: Dr. Falasinnu discusses the study she worked on that aimed at estimating the burden of chronic overlapping pain conditions in patients with autoimmune rheumatic diseases 14:08: What health and patient advocacy mean to Dr. Falasinnu 16:39: What our hosts learned from this episode Contact Our Hosts Steven Newmark, Director of Policy at GHLF: snewmark@ghlf.org Zoe Rothblatt, Associate Director, Community Outreach at GHLF: zrothblatt@ghlf.org We want to hear what you think. Send your comments in the form of an email, video, or audio clip of yourself to thehealthadvocates@ghlf.org Catch up on all our episodes on our website or on your favorite podcast channel.See omnystudio.com/listener for privacy information.

In January 2022, Dr. Amir Fathi, Associate Professor of Medicine at Harvard Medical School, served as faculty for Therapy of B-Cell Acute Lymphoblastic Leukemia (ALL): an Evolving Landscape, presented during the ODACon Rare Hematologic Malignancies Symposium. Recently, numerous significant updates in both ALL and acute myeloid leukemia (AML) were presented at the 2022 American Society of Hematology (ASH) Annual Meeting in New Orleans. In this interview, Dr. Fathi elaborates on these exciting developments in the ever-changing treatment landscape for acute leukemia. Click here to view and claim credit for Therapy of B-Cell Acute Lymphoblastic Leukemia: an Evolving Landscape, an accredited CME/NCPD/CPE activity provided by i3 Health: https://i3health.com/odacon-all

This week, Jeremy explores efforts to increase the number of clinical trials and expand access to those trials with renowned ALS researcher, Dr. Merit Cudkowicz. Learn more about the Clinical Trial Capacity Awards at https://www.als.org/research/funding-opportunities/trial-capacity-awards-2022This episode is brought to you by The ALS Association in partnership with CitizenRacecar.

Dr. Yas, an immunologist, shares her expertise in research related to cancer and transplants. She also corrects misconceptions surrounding our immune system and autoimmune problems. Dr. Yas also provides unique insight into funding new medical treatments as someone who has worked in academia and the biotech industry. Think you know about your immune system? Check out this episode to find out! Music by: DJ DanceAlone and prodlauraceae

There are advantages and disadvantages when it comes to being a standalone clinical trial site.  Standalone clinical trial sites enjoy the freedom of running their own operations. But they may face challenges with executing some parts of a clinical trial.  This is where site networks come in.  For example, a site can run more efficient marketing campaigns, be more systematic in its clinical trial operations, or share patient recruitment and retention resources by being part of a site network. To learn more about site networks, I invited Christian Burns, President of Elligo Health Research and Co-Founder of ClinX, on the show. Christian is a serial entrepreneur, investor, and founder of multiple clinical trial companies, including ClinEdge, BTC Network, and Guidestar Research.  Christian has a track record of success in the pharmaceutical industry, with a particular focus on decentralized and direct-to-patient clinical trials.  With experience across most therapeutic areas and a presence in over 30 languages and 40 countries, Christian's companies have served patients and providers across thousands of research sites globally.  His goal is to accelerate the development of new therapies by creating innovative solutions that connect and empower the clinical trial ecosystem.  A native of Philadelphia, Christian holds a B.A. in Public Health from the University of Tampa. Enjoy! Sponsors: This podcast is brought to you by Veeva. Veeva connects patients, sites, and sponsors, on a single technology ecosystem to make clinical trials easier and faster. I'm particularly excited about Veeva SiteVault. SiteVault gives research sites one place to work with sponsors - to reduce the number of systems and logins used to run clinical trials. To learn more, visit https://sites.veeva.com/. This podcast is brought to you by Slope. Slope's eClinical Supply Chain Management (eCSCM) platform reduces clinical trial risks, reigns in costs, improves the productivity of clinical trial collaborators, and increases subject retention by removing the manual, spreadsheet-driven, and error-prone processes used to manage and track clinical supplies and biological samples to a digital platform. To learn more, visit slope.io.   

A Rare Clinical Research Perspective from Both Sides of the Fence It's uncommon to see those in the clinical research profession move from site-based roles to sponsor-based roles - or vice versa. In this episode, Adrienne Gaggi, Associate Director of Clinical Development at Aldeyra Therapeutics, shares her thoughts on hot topics around clinical research. Adrienne gives her comprehensive, expert opinion about patient enrollment, sites, and sponsors' roles, as well as the different challenges faced, and tactics used to meet the studies' needs. Tune in and listen to what Adrienne Gaggi says about the current Clinical Trial Space and her take on some of its critical operational issues! Click this link to the show notes, transcript, and resources: outcomesrocket.health

Please join author Pieter Martens and Associate Editor Justin Grodin as they discuss the article "Decongestion With Acetazolamide in Acute Decompensated Heart Failure Across the Spectrum of Left Ventricular Ejection Fraction: A Prespecified Analysis From the ADVOR Trial." Dr. Greg Hundley: Welcome listeners to this January 17th issue of Circulation on the Run. And I am Dr. Greg Hundley, Director at the Pauley Heart Center at VCU Health in Richmond, Virginia. Dr. Peder Myhre: And I'm Dr. Peder Myhre from Akershus University Hospital and University of Oslo, in Norway. And today, Greg, we have such an exciting feature paper. It comes to us from the ADVOR trialists. And the ADVOR trial examined the effect of acetazolamide in acute decompensated heart failure. And in this paper we're going to discuss how that treatment effect was across the left ventricular ejection fraction, across the spectrum. Greg, what do you think? Dr. Greg Hundley: Oh, wow. Sounds very interesting. But we might have some other articles in the issue. How about we grab a cup of coffee and Peder maybe this week, I'll go first and we'll start with preclinical science. How about that? Dr. Peder Myhre: Let's do preclinical science, Greg. Dr. Greg Hundley: Well, Peder, this particular paper focuses on the relationship between cardiac fibroblasts and cardiomyocytes. Remember that myocytes sit on a lattice of network of fibroblasts. And when the myocytes die, the fibroblasts then proliferates, secrete collagen and form this thick scar. Now, if we're going to try to regenerate, how are we going to get myocytes to get back into that thick scar when there's really a complete absence? And so as adult cardiomyocytes have little regenerative capacity, resident cardiac fibroblasts synthesize extracellular matrix, post myocardial infarction to form fibrosis, leading to cardiac dysfunction and heart failure. And therapies that can regenerate the myocardium and reverse fibrosis in the setting of a chronic myocardial infarction are lacking. Now, these investigators led by Professor Masaki Ieda from University of Tsukuba, were going to evaluate this process. The overexpression of cardiac transcription factors, including Mef2c, Gata4, Tbx5, Han2, all combined as MGTH. They can directly reprogram cardiac fibroblasts into induced cardiomyocytes and improve cardiac function in and under the setting of an acute myocardial infarction. However, the ability of an in vivo cardiac reprogramming to repair chronic myocardial infarction with established scars, well, that is really undetermined. Dr. Peder Myhre: Oh, what a wonderful introduction, Greg. And the way you described to us how cardiomyocytes and fibroblasts interact was really fascinating. Thank you. And now let's hear what the authors found and don't forget the clinical implications. Dr. Greg Hundley: Thanks, Peder. So these authors developed a novel transgenic mouse system where cardiac reprogramming and fibroblasts lineage tracing could be regulated spatiotemporally with tamoxifen treatment to analyze in vivo cardiac reprogramming in the setting of chronic MI. Then with this new model, the authors found in vivo cardiac reprogramming generates new induced cardiomyocytes from resident cardiac fibroblasts that improves cardiac function and reduces fibrosis in chronic myocardial infarction in mice. Wow. And additionally, they found that overexpression of cardiac reprogramming factors converts profibrotic cardio fibroblasts to a quiescent state, and that reverses fibrosis in chronic myocardial infarction. And therefore, Peder, direct cardiac reprogramming may be a promising therapy for chronic ischemic cardiomyopathies and heart failure. Really exciting work, converting scar tissue to actual functional cardiomyocytes. Dr. Peder Myhre: That was such a fantastic summary, Greg, and a very interesting paper. And I'm now going to take us back to clinical science and epidemiology. Because Greg, we all know that social and psychosocial factors are associated with cardiovascular disease risk. But the relative contributions of these factors to racial and ethnic differences in cardiovascular health has not been quantified. So these authors, led by the corresponding author, Nilay Shah from Northwestern University Feinberg School of Medicine in Chicago, used data from NHANES to examine the contributions of individual level social and psychosocial factors to racial and ethnic differences in population cardiovascular health. And that was measured by something called the cardiovascular health score, CVH score, which ranges from zero to 14, and it counts for diet, smoking, physical activity, body mass index, blood pressure, cholesterol, and blood glucose. Dr. Greg Hundley: Wow, really interesting, Peder. So what did they find here? Dr. Peder Myhre: So Greg, among males, the mean cardiovascular health score was 7.5 in Hispanic, 8.7 in non-Hispanic Asian, 7.5 in non-Hispanic black, and 7.6 in non-Hispanic white adults. And the authors found that the education explained the largest component of cardiovascular health differences among males. And now what about females? In females, the mean score was 8.0 in Hispanic, 9.3 in non-Hispanic Asian, 7.4 in non-Hispanic black, and 8.0 in non-Hispanic white adults. And for women, education explained the largest competence of cardiovascular health difference in non-Hispanic black. And place of birth, and that is US born versus born outside the US, explained the largest component of cardiovascular health difference in Hispanic and non-Hispanic Asian females. So Greg, the authors conclude that education and place of birth conferred the largest statistical contributions to the racial and ethnic differences in cardiovascular health among US adults. Dr. Greg Hundley: Very nice, Peder. What a beautiful description and outline that so well highlighting the differences in men versus women. Well, now we're going to turn back to the world of preclinical science, listeners. And we will continue with the paper by Dr. Amit Khera from Verve Therapeutics. Now, Peder, VERVE-101, this is an investigational in vivo CRISPR base editing medicine designed to alter a single DNA base in the PCSK9 gene. And that permanently turns off hepatic protein production and thereby, durably lowers LDL cholesterol. In this study, the investigators tested the efficacy, durability, tolerability, and potential for germline editing of VERVE-101 in studies of non-human primates and also in a murine F1 progeny study. Dr. Peder Myhre: So more on PCSK9s, and this time CRISPR technology. Very exciting. Greg, what did they find? Dr. Greg Hundley: Right, Peder. So VERVE-101 was well tolerated in non-human primates and led to, listen to this, an 83% lower blood PCSK9 protein and 69% lowering of LDL-C with durable effects up to 476 days following the dosing. These results have supported initiation of a first inhuman clinical trial. That's what needs to come next in patients with heterozygous familial hypercholesterolemia and atherosclerotic cardiovascular disease. Wow. Dr. Peder Myhre: Even greater reductions from this therapy on PCSK9 than the previous PCSK9 inhibitor therapies. Wow. Okay, Greg, and now we go from one fascinating study to another. And this time we actually have the primary results from a large randomized clinical trial, Greg. Isn't that exciting? Dr. Greg Hundley: Yes. Dr. Peder Myhre: And this paper describes the primary results of a trial testing in Indobufen versus aspirin on top of clopidogrel in patients undergoing PCI with drug-eluting stent DES who did not have elevated troponin. So that is patients without mycardial infarction. And in fact, fact, this is the first large randomized control trial to explore the efficacy and safety of aspirin replacement on top of P2Y12 inhibitor in patients receiving PCI with death. And Greg, I suppose you like I wonder what Indobufen is, and I just learned that that is a reversible inhibitor of platelet Cox-1 activity and it has comparable biochemical and functional effects to dose of aspirin. And previous data indicate that Indobufen could lessen the unwanted side effects of aspirin and that includes allergy intolerance and most importantly, aspirin resistance, while it retains the antithrombotic efficacy. Dr. Greg Hundley: Wow, Peder. Really interesting and great explanation. Indobufen. So how did they design this trial and what were the primary results? Dr. Peder Myhre: So Greg, the investigators of this trial, called OPTION, led by corresponding authors, Drs. Ge, Quian, and Wu from Fudan University in Shanghai, randomized 4,551 patients from 103 center to either indobufen based DAPT or conventional, and that is aspirin based DAPT for 12 months after DES implementation. And the trial was open label and with a non-inferiority design, which is important to keep in mind. And the primary endpoint was a one year composite of cardiovascular death, non-fatal MI, ischemic stroke, definite or probable stent thrombosis or bleeding, defined as BARC criteria type 2, 3, or 5. And now Greg, the primary endpoint occurred in 101, that is 4.5% of patients in the indobufen based DAPT group compared to 140, that is 6.1% patients, in the conventional DAPT group. And that yields an absolute difference of 1.6%. And the P for non-inferiority was less than 0.01. And the hazard ratio was 0.73 with confidence intervals ranging from 0.56 to 0.94. And Greg, the occurrence of bleeding was particularly interesting and that was also lower in the indobufen based DAPT group compared to the conventional DAPT group. And that was 3.0% versus 4.0% with the hazard ratio of 0.63. And that was primarily driven by a decrease in BARC type two bleeding. So Greg, the authors conclude that in Chinese patients with negative cardiac troponin undergoing DES implementation, indobufen plus clopidogrel DAPT compared with aspirin plus clopidogrel DAPT significantly reduced the risk of one year net clinical outcomes, which was mainly driven by reduction in bleeding events without an increase in ischemic events. Dr. Greg Hundley: Very nice, Peder. So another reversible inhibitor of platelet COX-1 activity, indobufen. And seems to be very, have high utility in individuals of Chinese ethnicity and Asian race. Well, perhaps more to come on that particular drug. Peder, how about we dive into some of the other articles in the issue? And I'll go first. So first, there's a Frontiers article by Professor Beatty entitled “A New Era and Cardiac Rehabilitation Delivery: Research Gaps, Questions, Strategies and Priorities.” And then there's a Research Letter by Professor Zuurbier entitled, “SGLT-2 inhibitor, Empagliflozin, reduces Infarct Size Independent of SGLT-2.” Dr. Peder Myhre: And then Greg, we have a new ECG challenge by Drs. Haghighat, Goldschlager and Oesterle entitled, “AV Block or Something Else?” And then there is a Perspective piece by Dr. Patrick Lawler entitled, “Models for Evidence Generation During the COVID-19 Pandemic: New Opportunities for Clinical Trials in Cardiovascular Medicine.” And Greg, there's definitely so much to learn from all the research that has been done through the pandemic. And finally, we have our own Molly Robbins giving us Highlights from the Circulation Family of Journals. And first, there is a paper describing the characteristics of postoperative heart block in patients undergoing congenital heart surgery described in Circulation: Arrhythmia Electrophysiology. Next, the impact of socioeconomic disadvantages on heart failure outcomes reported in Circulation: Heart Failure. Then there is social and physical barriers to healthy food explored in circulation, cardiovascular quality and outcomes. And then there is the association of culprit-plaque morphology with varying degrees of infarct, myocardial injury size reported in Circulation: Cardiovascular Imaging. And finally, the impact of optical coherence tomography on PCI decisions reported in circulation cardiovascular interventions. Dr. Greg Hundley: Fantastic, Peder. Well, how about we get off to that feature discussion? Dr. Peder Myhre: Let's go. Dr. Mercedes Carnethon: Well, thank you and welcome to this episode of the Circulation on the Run Podcast. I'm really excited today to host this show. My name is Mercedes Carnethon. I'm an associate editor at Circulation and Professor and Vice Chair of Preventive Medicine at the Northwestern University Feinberg School of Medicine. I'm really excited to learn from the lead author of a new study on decongestion with Acetazolamide and acute decompensated heart failure across the spectrum of LV ejection fraction. And I've got the lead author with me today, Pieter Martens, as well as my colleague and associate editor Justin Grodin, who handled the paper. So I'd love to start off with just welcoming you, Dr. Martens. Dr. Pieter Martens: Thank you for having me. It's a pleasure to be here today. Dr. Mercedes Carnethon: Yes. And thank you so much for submitting your important work to the journal, Circulation. I'd love to start to hear a little bit about what was your rationale for carrying out this trial and tell us a little bit about what you found. Dr. Pieter Martens: So the ADVOR trial was a double blind placebo controlled randomized trial, which was performed in Belgium. And it set out to assess the effect of acetazolamide in acute decompensated heart failure and this on top of standardized loop diuretic therapy and patients with heart failure. And the goal of the current analysis was to assess whether the treatment effect of acetazolamide in acute heart failure differs amongst patients with a different ejection fraction at baseline at randomization. So we looked specifically at patients with heart failure, reduced, mildly reduced and preserved ejection fraction to determine whether acetazolamide works equally well in those patients. Dr. Mercedes Carnethon: Well, thank you so much. Tell me a little more. What did you find? Did your findings surprise you? Dr. Pieter Martens: All patients that were randomized in the ADVOR trial, we registered a baseline left ventricular ejection fraction at baseline. And what we saw was at the multiple endpoints that we collected in the ADVOR trial, that randomization towards acetazolamide was associated with a pronounced and preserved treatment effect. And different endpoints that we looked at was a primary endpoint which was successful, which is an important endpoint, which we all strive towards in acute decompensated heart failure. And we saw that irrespective of what your baseline ejection fraction was, that randomization towards acetazolamide was associated with a higher odds ratio for having successful decongestion. And also looking at other endpoints which we find important in the treatment of patients with acute compensated heart failure, such as renal endpoints such as the diuresis, the amount of urine that they make, or the natruresis, the amount of sodium that they excrete, we again saw that randomization towards acetazolamide was associated with a higher treatment effect, so more diuresis, more natruresis, which was not effective, whether you had heart failure, reduced, mildly reduced or preserved eject fraction. We did see a slight increase in the creatinine, which was a little bit more pronounced in patients with heart failure with reduced ejection fraction. Dr. Mercedes Carnethon: Thank you so much for that excellent summary. I'm an epidemiologist, so I'm certainly aware that of the cardiovascular diseases and their changes over time, heart failure is one that is going up over time and affecting more of the population. So I know I really enjoyed hearing about an additional therapy that helps to improve quality of life and improve clinical outcomes in individuals who are experiencing heart failure. And I'm really curious as I turn to you, Justin, what attracted you to this particular article and why did you find it to be such a good fit for our audience here at Circulation? Dr. Justin Grodin: Well, Mercedes, I mean, I think you hit the nail on the head with your comment. And clearly when we look at Medicare beneficiaries in the United States, hospitalization for decompensated heart failure is the number one or most common cause for hospitalization. And up to this time, we really haven't had any multi-center randomized control clinical trials that have really informed clinical care with a positive result or a novel strategy that says, "Hey, this might be a better way to treat someone in comparison with something else." And so when we have a clinical trial like ADVOR, one of the crucial things that we want to understand is how does this work and does it work for everybody? And now when we look at the population hospitalized with heart failure, we know that approximately half of them have a weak heart or low ejection fraction, and the other half have a stiff heart, a normal ejection fraction. And so since we've got this 50/50 makeup, it is a crucially important question to understand if we have an important study like ADVOR, does this apply? Are these benefits enjoyed by all these individuals across the spectrum? Dr. Mercedes Carnethon: Thank you so much for really putting that in context. And I believe you had some additional questions for Dr. Martens. Dr. Justin Grodin: Yes. Yeah, thank you. So Pieter, I mean obviously this was a terrific study. One question I had for you guys is, you and your colleagues and the ADVOR research team is whether you had expected these results. Because we know at least historically, that there might be different cardiorenal implications for individuals that have a weak heart or heart failure with reduced ejection fraction in comparison with a stiff heart or heart failure with preserved ejection fraction. Dr. Pieter Martens: Thank you for that comment. And thank you also for the nice feedback on the paper. I think we were not really completely surprised by the results. I think from a pathophysiologic perspective, we do wonder whether heart failure with reduced ejection fraction from a kind of renal perspective is different from heart failure with preserved ejection fraction. Clearly, there are a lot of pathophysiological differences between heart failure with reduced, mildly reduced and preserved ejection fraction. But when it comes to congestion and acute heart failure, they seem to behave, or at least similarly in terms of response to acetazolamide, which was very interesting. We do think there are neurohormonal differences between heart failure reduced ejection fraction, preserved ejection fraction. But at least how acetazolamide works seems relatively unaffected by the ejection fraction. Dr. Justin Grodin: And Pieter, another question that comes to mind, and this is getting a little bit technical, but there have been studies that have shown that people that present to the hospital with decompensated heart failure, that have HFpEF, have a very different perhaps congestion phenotype where they might not have as much blood volume expansion. And so I, for one, was pretty curious as to how these results were going to play out. And I wonder what your thoughts are on that, or maybe that's perhaps more niche and less widely applicable than what you observed. Dr. Pieter Martens: Now, I can completely agree that when we are thinking about congestion, the congestion itself is a sort of pressure based phenomenon. And the pressure based phenomenon is based on what your volume is and the compliance within your cardiovascular system. But I think one of the important things to remember is that how we enrolled patients in the ADVOR trial was that we enrolled patients who had clear signs of volume overload. Remember, we used a volume score to assess clinical decongestion or actually getting rid of the volume. Volume assessment isn't really necessarily a pressure based assessment. And pressures might be the genesis of elevated pressures might be different amongst heart failure with reduced versus preserved ejection fraction. But what was really clear was that all these patients were volume overloaded. And when you think about the volume axis, then it's really about getting rid of that additional sodium, water, and that's where really acetazolamide works. So I do think we differ a little bit from historical acute decompensated heart failure trials in which they sometimes use signs and symptoms of more congestion, a pressure based phenomenon, where our endpoint was truly at volume endpoint. And we do believe that diuretics work really on a volume component of heart failure. Dr. Mercedes Carnethon: Thank you so much, especially for explaining that in a way that even non-clinicians such as myself can understand the potential implications. A big picture question that I have, and I really enjoy these discussions because they give us an opportunity to speculate beyond what we read in the paper. And that question is we do clinical trials and we identify effective therapies. And one of the bigger challenges we often face is getting those therapies out to the people who need them. Do you perceive any barriers in uptake of the use of acetazolamide in clinical practice? Dr. Pieter Martens: That's an excellent question. So one of the, I think beauties about acetazolamide is that this drug has been on the market for about 70 years. So I think everybody has access to it. This is not a novel compound which needs to go through different steps of getting marketing approval and getting a sort of reimbursement before it becomes available in clinical practice. And in theory, everybody should have access to this relatively cheap agent and can use it in its clinical practice. And I think it was very interested when we came out with the initial paper. I think already the day afterwards, we were getting messages from across the world that people have been using acetazolamide. So I think it is an agent which is available in current clinical practice and should not be too many barriers to its current implementation and clinical practice. Dr. Mercedes Carnethon: Well, that's fantastic to hear. So I hope Justin, that you will certainly help to ring the bell to get the information out about this wonderful study. I do want to turn to you, Pieter, to find out whether or not there are any final points that you didn't have an opportunity to discuss with us today. Dr. Pieter Martens: Think some of the other end points we didn't discuss were the effect, for instance, on length of stay. I think length of stay is a very important endpoint because hospital admissions, like Justin said, heart failure is the number one reason why elderly patients are being admitted. And just shortening the length of stay from a financial perspective might be important. So it was also very interesting to see that the use of acetazolamide in the study also translated into a shorter length of stay, which was also was unaffected, whether you had heart failure, reduced, mildly reduced or preserved ejection fraction, Dr. Mercedes Carnethon: Well, I certainly know people appreciate being in their own homes and being able to discharge is certainly a major benefit. So thank you so much for sharing that final point. I really want to thank you so much for a stimulating discussion today. I know that I learned a lot from you, Pieter, and the hard work of your research team as well as from you, Justin, for putting these findings in context and really helping our listeners and the readers of our journal understand why this paper is so important and how it's really moving the field forward for a clinically important problem. So thank you both so much for joining us here today on Circulation on the Run. Dr. Justin Grodin: Thank you. Dr. Pieter Martens: Thank you for having me. Dr. Mercedes Carnethon: I really want to thank our listeners for joining us today for this episode of Circulation on the Run. I hope you will join us again next week for more exciting discussions with our authors. Dr. Greg Hundley: This program is copyright of the American Heart Association 2023. The opinions expressed by speakers in this podcast are their own and not necessarily those of the editors or of the American Heart Association. For more, please visit ahajournals.org.

In 2022, Dr. Mark Kris, the William and Joy Ruane Chair in Thoracic Oncology at Memorial Sloan Kettering Cancer Center, served as chair of Optimizing Management of Metastatic Squamous Non–Small Cell Lung Cancer (NSCLC), a continuing medical education (CME)/nursing continuing professional development (NCPD) activity. A year later, Dr. Kris sat down again with Oncology Data Advisor to share the progress that has occurred in this field and the important considerations to keep in mind when treating patients with squamous NSCLC in 2023.

Diagnostic and Screening Tools for Gynecologic Cancers with guest Dr. Peter Dottino January 15, 2023 Yale Cancer Center visit: http://www.yalecancercenter.org email: canceranswers@yale.edu call: 203-785-4095

Marie Nelson, M.D., is originally from Michigan, attended college at the University of Notre Dame and earned her medical degree from Loyola University Chicago Stritch School of Medicine. She finished her residency in Pediatrics at Ann & Robert H. Lurie Children's Hospital of Chicago prior to completing a fellowship in Pediatric Hematology, Oncology, and Bone Marrow Transplantation at Children's National Hospital in Washington, D.C. Dr. Nelson is a member of the solid tumor faculty and Assistant Professor of Pediatrics at Children's National Hospital where she also leads the Adolescent and Young Adult Oncology Program. Her research focuses on combining local therapies and immunotherapy in order to improve the outcomes and reduce the side effects of treatment for pediatric patients with solid tumors. She is the principal investigator of a phase II trial combining cryoablation and immune checkpoint inhibitors in pediatric solid tumors. --- What We Do at MIB Agents: PROGRAMS: ✨ End-of-Life MISSIONS ✨ Gamer Agents ✨ Agent Writers ✨ Prayer Agents ✨ Healing Hearts - Bereaved Parent Support ✨ Ambassador Agents - Peer Support ✨ Warrior Mail ✨ Young Adult Survivorship Support Group ✨ EDUCATION for physicians, researchers and families: ✨ OsteoBites, weekly webinar & podcast with thought leaders and innovators in Osteosarcoma ✨ MIB Book: Osteosarcoma: From our Families to Yours ✨ RESEARCH: Annual MIB FACTOR Research Conference ✨ Funding $100,000 annually for OS research ✨ MIB Testing & Research Directory ✨ The Osteosarcoma Project partner with Broad Institute of MIT and Harvard ... Kids are still dying with 40+ year old treatments. Help us MakeItBetter.

Host: Richard Young, VP, Strategy, Veeva Vault CDMS Guest: Luis E. Torres, Head of Clinical Programming FSPx, Labcorp This week, Richard Young speaks to Luis E. Torres, head of Clinical Programming FSPx at LabCorp. They discuss how data managers can prepare for the future of clinical trials by adopting new technologies and skills to keep decentralized clinical teams connected. Richard and Luis share their thoughts on designing studies and processes that support end-user needs; the shifting goal posts of data cleanliness and database build expectations; and why data managers are uniquely positioned to solve the “Rubik's Cube” of challenges involving people, processes, and technology. Subscribe to State of Digital Clinical Trials, a Veeva podcast, to get new episodes as soon as they are released.

“I know it's hard for people to think about holding on if they're in despair, but there's the possibility of healing coming ahead. Don't give up hope,” says Dr. Rick Doblin, who has devoted his career to getting MDMA and other psychedelics approved by the FDA.  As you'll hear in this episode of Raise the Line, he could be on the verge of seeing his decades-long dream come true.  On the day host Shiv Gaglani spoke to Doblin (January 5, 2023) successful results from a Phase 3 clinical trial of MDMA to treat PTSD were released by the Multidisciplinary Association for Psychedelic Studies – an organization Doblin founded thirty-six years ago. This sets in motion a process that could result in FDA approval of MDMA for this use in 2024. That's very good news for the millions of Americans with PTSD – and hundreds of millions worldwide – whose disease is resistant to other treatments. One of the next big steps is training therapists to incorporate these drugs into their work, something MAPS and other organizations are moving quickly to accomplish. Tune into this fascinating conversation about the political and social factors that have held up legalization of psychedelics for decades, other promising applications of MDMA, what fuels Doblin's passion for normalizing the use of these promising medications, and the largest ever conference on psychedelics coming to Denver, Colorado in June.  Mentioned in this episode:https://maps.org/https://psychedelicscience.org/

David Harel is the Co-Founder and CEO of CytoReason, providing researchers and drug developers with a complex database and predictive computational disease models to conduct synthetic clinical trials. Their mission is to integrate all the information available on a specific disease in a particular population to support faster and more efficient drug development. David explains, "Computational disease models are the core technology that we've developed, and it is a method to incorporate all the available information, specifically omics and molecular data, that is available in one disease, in one place, in a way that is useful. But people who have been involved in the molecular data space for a while know that the integration of multiple data types and multiple data sets is very difficult, and it needs to be done in a certain context. The context in which we are incorporating the data is allowing the users to run those synthetic trials on their own or using our teams." "One of the features that we have is the ability to run synthetic basket trials. So, take one drug, assuming the drug you want to evaluate, and run it across multiple indications in these dozens of indications. To conduct that with human subjects is prohibitive for cost and ethical reasons. And the same way, when we are conducting synthetic umbrella trials, where we're taking a specific patient population, and we are evaluating the efficacy of many different compounds in a specific patient population. Again, this would be very difficult to conduct in a clinical setting with human subjects. These are things that synthetic in silico trials allow you to do that clinical endeavors would not." @CytoReason #DiseaseModels #ComputationalDiseaseModels #SyntheticClinicalTrials #ClinicalTrials #ComputationalBiology #DrugDevelopment #DrugDiscovery #AI #RareDiseases CytoReason.com Download the transcript here

With Adrienne Kovacs, Equilibria Psychological Health, Ontario - Canada & Keila Lopez, Texas Children's Hospital/Baylor College of Medicine, Houston - USA Link to editorial Link to paper

David Harel is the Co-Founder and CEO of CytoReason, providing researchers and drug developers with a complex database and predictive computational disease models to conduct synthetic clinical trials. Their mission is to integrate all the information available on a specific disease in a particular population to support faster and more efficient drug development. David explains, "Computational disease models are the core technology that we've developed, and it is a method to incorporate all the available information, specifically omics and molecular data, that is available in one disease, in one place, in a way that is useful. But people who have been involved in the molecular data space for a while know that the integration of multiple data types and multiple data sets is very difficult, and it needs to be done in a certain context. The context in which we are incorporating the data is allowing the users to run those synthetic trials on their own or using our teams." "One of the features that we have is the ability to run synthetic basket trials. So, take one drug, assuming the drug you want to evaluate, and run it across multiple indications in these dozens of indications. To conduct that with human subjects is prohibitive for cost and ethical reasons. And the same way, when we are conducting synthetic umbrella trials, where we're taking a specific patient population, and we are evaluating the efficacy of many different compounds in a specific patient population. Again, this would be very difficult to conduct in a clinical setting with human subjects. These are things that synthetic in silico trials allow you to do that clinical endeavors would not." @CytoReason #DiseaseModels #ComputationalDiseaseModels #SyntheticClinicalTrials #ClinicalTrials #ComputationalBiology #DrugDevelopment #DrugDiscovery #AI #RareDiseases CytoReason.com Listen to the podcast here

Last week, in Episode 279 of RealTalk MS we talked with Professor Tanja Kuhlmann about a new framework for researching, diagnosing, and treating MS that was proposed by the International Advisory Committee on Clinical Trials in Multiple Sclerosis. This proposed framework represents the next evolutionary step in diagnosing and treating MS. Joining me this week to talk about how this proposed framework will impact people living with MS is the National MS Society's Chief Advocacy, Services, and Science Officer, Dr. Tim Coetzee. For many people, the new year inspires familiar resolutions to start a diet. If you're searching for the "MS Diet", we're sharing an update on what the experts have learned about diet and MS, and what they recommend. The National MS Society's Pathways to Wellness virtual program takes place February 9th. We'll give you the details and tell you how to register for this free event.  And you'll hear about Frequency Therapeutics' remyelination project for people living with MS. Clinical trials are planned to begin this year! We have a lot to talk about! Are you ready for RealTalk MS??! This Week: What the proposed framework for diagnosing, and treating MS means for people living with MS  :22 What experts have learned about diet and MS  1:50 Why you'll want to register for Pathways to Wellness in MS   4:56 Frequency Therapeutics remyelination project  6:02 Dr. Tim Coetzee discusses how the proposed framework for diagnosing, and treating MS will take MS care to the next level  8:43 Share this episode  30:19 Have you downloaded the free RealTalk MS app?  30:40 SHARE THIS EPISODE OF REALTALK MS Just copy this link & paste it into your text or email: https://realtalkms.com/280 ADD YOUR VOICE TO THE CONVERSATION I've always thought about the RealTalk MS podcast as a conversation. And this is your opportunity to join the conversation by sharing your feedback, questions, and suggestions for topics that we can discuss in future podcast episodes. Please shoot me an email or call the RealTalk MS Listener Hotline and share your thoughts! Email: jon@realtalkms.com Phone: (310) 526-2283 And don't forget to join us in the RealTalk MS Facebook group! LINKS If your podcast app doesn't allow you to click on these links, you'll find them in the show notes in the RealTalk MS app or at www.RealTalkMS.com RealTalk MS Episode 279: A New Framework for Researching, Diagnosing, and Treating MS with Professor Tanja Kuhlmann https://realtalkms.com/279 National MS Society: Diet and MS https://nationalmssociety.org/Research/Research-News-Progress/Diet Pathways to Wellness: Emotional, Spiritual, and Social Wellness Virtual Program https://nationalmssociety.org/Resources-Support/Library-Education-Programs/PathwaystoWellness Frequency Therapeutics Multiple Sclerosis Project https://frequencytherapeuticstx.com/pipeline-programs/multiple-sclerosis-program Take the iConquer MS Caregiver Survey https://realtalkms.com/caregiver Join the RealTalk MS Facebook Group https://facebook.com/groups/realtalkms Download the RealTalk MS App for iOS Devices https://itunes.apple.com/us/app/realtalk-ms/id1436917200 Download the RealTalk MS App for Android Deviceshttps://play.google.com/store/apps/details?id=tv.wizzard.android.realtalk Give RealTalk MS a rating and review http://www.realtalkms.com/review Follow RealTalk MS on Twitter, @RealTalkMS_jon, and subscribe to our newsletter at our website, RealTalkMS.com. RealTalk MS Episode 280 Guest: Dr. Tim Coetzee Tags: MS, MultipleSclerosis, MSResearch, MSSociety, RealTalkMS Privacy Policy

Dr. Maysa Alavi, MD is a board-certified physician and internationally recognized speaker, practitioner, and teacher of Psychedelic Therapies, Ketamine Administration, and Integrative Medicine. She unites cutting-edge Western science with Eastern wellness philosophies to heal mind, body and spirit in what she terms ‘Functional-Psychedelic Medicine,' addressing the psycho-spiritual as well as the material.She has studied at best-in-class institutions and organizations including The University of Southern California, University of Texas, UCLA, Institute for Functional Medicine, and Dr. Andrew Weil Center for Integrative Medicine. Dr. Maysa is certified in MDMA Assisted Therapy by the Multidisciplinary Association for Psychedelic Studies (MAPS), and she is trained in psilocybin assisted therapy with COMPASS Pathways.Among her many roles are Study-Site Physician and Therapist for the MAPS Phase 3 Clinical Trials investigating the use of MDMA Assisted Therapy for the treatment of PTSD. She will be among the first providers to bring this form of therapy to the general public pending FDA approval. Dr. Maysa teaches for Fluence in the field of Ketamine Assisted Therapy (KAP) and she conducts small group trainings for medical professionals looking to start their own ketamine practice, teaching the fundamentals of psychedelic preparation and integration, and how to medically screen for and administer ketamine by its various routes. She is a consultant for start-up practices entering the psychedelic market and she serves on the Board of Advisors for the Veteran's Alliance for Holistic Alternatives (VAHA). She has given many lectures on the topics of psychedelics, cannabis, and ketamine for the New Orleans Psychedelic Society and Cultivating Self, a non-profit continuing education platform for licensed healthcare professionals and RNs. Dr. Maysa humanizes health care by developing trusted personal relationships with her clients, empowering them to understand the root causes of their dis-ease and helping them connect with their own inner healing intelligence for long-term wellness. This goes above and beyond typical “symptom management medicine” by identifying and bringing awareness to the issue's origin and its perpetuating and mediating factors.She incorporates multiple modalities into her practice—from functional labs, nutraceuticals and IV infusions to energy work, plant and psychedelic medicines and mind-body techniques. She works with clients to develop balanced healing plans that combine mind-manifesting therapies and advanced laboratory analysis with wellness approaches that nurture wholeness. Her plans include customized guidance on hydration, nutrition, breath-work, meditation, movement, stress-reduction, sleep optimization, supplementation, medication reconciliation and/or tapering for those on pharmaceuticals, and laboratory analysis. She applies her in-depth knowledge of traditional and indigenous plant medicines like psychedelic mushrooms, cannabis, ayahuasca, rapeh, kambo, salvia and sananga by educating clients on the safe and appropriate usage of these and other medicines. Dr. Maysa believes that simple changes yield meaningful results, namely: proper salt/mineral and water balance in the body, utilization of the light/energy spectrum, awareness of breath and optimizing airway and sleep, joyful movement, conscious consumption, and connection with community and one's own inner world. She believes regular reboots of our “inner computer” are critical and can be accessed through mind-manifesting therapies including, but not limited to psychedelics and entheogens (heart openers). She is a huge proponent of daily meditation and Blessing of The Energy Centers. Visit Dr. Maysa's website www.DrMaysa.com for more information about her, her offerings, and to book in-person or remote visits. 

Informed Consent Action Network (icandecide.org) funded Lead Attorney, Aaron Siri, Esq., to depose and later cross-examine world-leading Vaccinologist, Dr. Kathyrn Edwards in 2020. Within the hours-long cross-examination she gave a shocking answer to the question; “Do childhood vaccine trials support the CDC's claim that vaccines do not cause autism?” Regardless of your stance on the issue of Vaccines and Autism, her answer is a must-see.#EdwardsDeposition #GodmotherOfVaccines #VaccinesAndAutism #UntilProvenOtherwise #ICANlegal

In this episode of the Life Science Success podcast my guest is Raj Indupuri.  Raj is the CEO of eClinical Solutions.  He is also a technologist with significant industry experience, passionate about fostering innovation to revolutionize the Life Sciences industry with ground-breaking technologies that will modernize clinical trials and bring treatments to patients faster.  

In a riveting debut of Season 4 on Surfing the NASH Tsunami, the podcast offers real time coverage of the highly anticipated NASH-TAG 2023. This episode includes two recordings. In the first conversation, NASH-TAG 2023 co-course director Stephen Harrison, scientific advisory board committee member Jörn Schattenberg and fellow Key Opinion Leader Mazen Noureddin join Roger Green to review presentations and themes from the Friday afternoon session. This conversation centers largely around Friday afternoon's presentation on NITs. The group focuses on the expansion in NIT knowledge in terms of the number of NITs available, the breadth of knowledge they cover and the ways NITs can be used to manage patients wisely today. The conversation also focuses on the features that make NASH-TAG such a unique meeting.In the second conversation, Fatty Liver Alliance Founder Michael Betel and NASH kNOWledge Founder Tony Villiotti join Roger and Louise Campbell. This discussion highlights how the momentum of recent pivotal trials in NASH drug development is changing patient advocacy today. The main insight: as more information becomes available and as we see successful Phase 3 drug trials, the number of stakeholders needing information increases and what each group needs to know varies. All this portends an exciting future for patients and their caregivers.To discover the energy for yourself, surf on to the episode and stay tuned with our continued coverage. 

In this session, GSK shares how they delivered on patient and caregiver engagements, especially with communities experiencing the highest COVID burden. They gained insights on study designs, educational pieces and captured patient experiences to enhance HCP/public COVID awareness. GSK will discuss: Value of COVID engagements Novel approaches and mechanisms for finding patients who don't belong to an organized patient community Overcoming challenges How this initiative could be modeled to help find future patients when the pathway is not clear Patient Perspectives-In their own words Susan Burriss, Patient Engagement Lead, GSK Learn more about the Patients as Partners in Clinical Research conference at www.patientsaspartners.org

In this session, Janssen shares how they are collaboratively working with patients and sites to advance DCTs and will share engagement methodologies, what they have learned from the perspective of participants and sites, and the direction this has taken them in DCTs. Alyson Gregg, Director Patient Insights, GMA Commercial Operations, Janssen Morgan Wooten, Investigator & Patient Engagement Program Team Leader, Janssen Learn more about the Patients as Partners in Clinical Research conference at www.patientsaspartners.org

Merck's iLab53 (a modular 39-foot mobile unit) was used to bring clinical research into community settings as an effort to increase clinical trial awareness and engagement. More specifically: How the iLab53 was created and implemented How Merck is continuing to work to help build trust within communities, and provide increased access to clinical research Challenges, learnings and successes to date How this initiative can be scaled and adapted Susan Manoff, MD, MPH, Executive Director, Office of the Chief Patient Officer, Merck Kai Bode, Director, Digital Innovation and Patient Strategy, Global Digital Analytics & Technologies Team, Merck Learn more about the Patients as Partners in Clinical Research conference at www.patientsaspartners.org

Nurse practitioners (NPs) have an important role to play in informing their patients about the availability and benefits of clinical trial participation. The outcomes of clinical trials have led to increased knowledge, improved health status and new treatments. In this podcast episode, Drs. Leslie Davis and Paula Tucker discuss details of the research process, provide helpful examples and share resources so you can leverage your role as a clinical trial participation champion for your patients.     Podcast Resources: National Institutes of Health (NIH). Inclusion Outreach Toolkit: How to Engage, Recruit and Retain Women in Clinical Research — https://orwh.od.nih.gov/toolkit/recruitment/history. Review of the Literature: Primary Barriers and Facilitators to Participation in Clinical Research —https://orwh.od.nih.gov/sites/orwh/files/docs/orwh_outreach_toolkit_litreview.pdf. Clinical Trials Database — https://clinicaltrials.gov. S. Department of Health and Human Services. The Belmont Report — https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html. Office of the Assistant Secretary for Health: Policy of Inclusion of Women in Clinical Trials — https://www.womenshealth.gov/30-achievements/04. Cell Press: Advancing the Inclusion of Underrepresented Women in Clinical Research — https://www.cell.com/cell-reports-medicine/pdf/S2666-3791(22)00059-3.pdf. S. Food and Drug Administration patient brochure: Research Needs You — https://www.fda.gov/media/147001/download.

Dr. Stefanie Russman Block (University of Michigan, Ann Arbor) discusses a trial looking at whether connectivity patterns in the brain can be used to predict treatment response in patients with obsessive-compulsive disorder.  Afterwards, AJP Editor-in-Chief Dr. Ned Kalin discusses childhood and neurodeveloment-related psychiatric disorders explored in the January issue. Russman Block interview [00:51] Exposure and response prevention versus stress management therapy [05:46] Investigating adolescents and adults [07:02] Clinical implications [08:29] Limitations [10:02] Further research [11:56] Kalin interview [12:57] Russman Block et al. [13:12] Webb et al. [14:57] Floris et al. [17:45] Shimelis et al. [21:27] Brikell et al. [26:04] Transcript Be sure to let your colleagues know about the podcast, and please rate and review it on Apple Podcasts, Google Podcasts, Stitcher, Spotify, or wherever you listen to it. Subscribe to the podcast here. Listen to other podcasts produced by the American Psychiatric Association. Browse articles online. How authors may submit their work. Follow the journals of APA Publishing on Twitter. E-mail us at ajp@psych.org