POPULARITY
22 episodes with dsmb
4 episodes with dsmb
2 episodes with dsmb
3 episodes with dsmb
2 episodes with dsmb
2 episodes with dsmb
2 episodes with dsmb
This week we release a member-exclusive episode for you all to see what you're missing on our Patreon. Every other week, we record an episode like this one discussing a piece of equipment, a tool, or a practice we use in diving and how we like to use it. This can be anything from the different kinds of BCDs to the various ways to launch a DSMB on a dive. We love the chance to discuss important topics about diving with you all and would love more of our listeners to get involved in the conversation. head over to our Patreon where for $1/month you not only get access to these episodes, but also to full length interview episodes and extended Fish Tales! These perks allow you to hear more from our amazing guests about their life and their thoughts on the world. It's always so hard to fit it all into an hour, and with Patreon, you can hear it all! This week's trivia question is: What is your favorite way to launch a DSMB? Head to our social media platforms or the comments section below this episode for a chance to win a Waterlust giftcard! For more content related to this week's episode, head over to Instagram and Facebook and follow us sat @todiveforpodcast for updates on episodes and more! Find merch on our website at https://slbartco.com/pages/to-dive-for-podcast Don't forget to send us Fish Tales via email at todiveforpodcast@gmail.com or on our Google form here.
JAMA. 2013;309(12):1241-1250Background Case reports as early as the 1950s suggested chelation of lead might reduce angina. The popularity of chelation accelerated around the turn of the century. Small underpowered trials of chelation were inconclusive. Mainstream medicine considered chelation unproven and potentially hazardous.Cardiology Trial's Substack is a reader-supported publication. To receive new posts and support my work, consider becoming a free or paid subscriber.Chelation with disodium EDTA binds divalent and some trivalent cations, including calcium, magnesium, lead, cadmium, zinc, iron, aluminum, and copper, which facilitates their urinary excretion. High dose vitamins are often co-administered with chelation.The NIH-funded Trial to Assess Chelation Therapy (TACT) trial was conducted to respond to the public health problem posed by EDTA chelation therapy: namely, that large numbers of patients could be exposed to undefined risks for unproven benefits. TACT was a double-blind placebo-controlled 2x2 factorial randomized trial enrolling 1708 patients to test chelation therapy.Patients Eligibility for TACT required patients be older than 50 years, have a creatinine of < 2 mg/dl, and have survived a previous myocardial infarction. Exclusion criteria included platelet count less than 100 000/μL, abnormal liver function, BP > 160/100 mm Hg, past intolerance to the chelation or vitamin components, chelation therapy within 5 years, coronary or carotid revascularization planned or having taken place within 6 months, cigarette smoking within 3 months, active heart failure or heart failure hospitalization within 6 months, or inability to tolerate 500-mL infusions weekly. Enrollment began in 2003 and follow-up continued until 2011. There were 134 sites; 60% of which were established chelation centers.Baseline Characteristics The median age of patients was 65 years, 18% were women and the median body mass index was 30. More than 90% of patients had had either percutaneous coronary intervention or coronary bypass surgery. Approximately 31% of patients had diabetes. Use of guideline directed medications was typical of a well-treated population of post-MI patients. Procedures The active 10-component chelation solution consisted of up to 3 g of disodium EDTA; 7 g of ascorbic acid; 2 g of magnesium chloride; 100 mg of procaine; 2500 U of unfractionated heparin; 2 mEq of potassium chloride; 840 mg of sodium bicarbonate; 250 mg of pantothenic acid; 100 mg of thiamine; 100 mg of pyridoxine; and sterile water to make up 500 mL of solution. The identical-appearing placebo solution consisted of 500 mL of normal saline and 1.2% dextrose (2.5 g total).The chelation or placebo infusions were administered through a peripheral intravenous line, weekly for the first 30 infusions, followed by an additional 10 infusions 2 to 8 weeks apart. Patient also received an oral vitamin-mineral regimen vs an oral placebo. In this review, we focus on the intention-to-treat comparison of EDTA chelation vs placebo.Endpoints The primary endpoint was a composite of death, reinfarction, stroke, coronary revascularization, or hospitalization for angina.TACT trialists had planned to enroll 2300 patients over three years with a follow-up of one year. Enrollment was slow, and with permission from the data safety monitoring board (DSMB) enrollment was decreased to 1700 patients and follow-up was extended. The resultant power was 85% to detect a 25% reduction in the primary endpoint assuming a 2.5% per year event rate in the placebo arm.Over the course of the trial, the DSMB requested 11 interim analyses of the data. Because of the increased monitoring, the level of statistical significance required for the primary endpoint was enhanced to a P value of less than 0.036.Results After a median follow-up of 55 months, a primary end point occurred in 222 (26%) of the chelation group and 261 (30%) of the placebo group (hazard ratio [HR]: 0.82 [95% CI: 0.69-0.99]; p= .035). There was no effect on total mortality (10% vs 11%, HR: 0.93, 95% CI: 0.70-1.25; p= 0.64). Myocardial infarction and coronary revascularization favored chelation (6% vs 8% and 15% vs 18%, respectively), however this did not reach statistical significance for either endpoints.Subgroup analysis revealed a potentially important heterogenous treatment effect. In patients with diabetes (about a third of patients) there was an approximate 40% reduction in the primary endpoint (HR: 0.61, 95% CI: 0.45-0.83; p= 0.002).There were no significant differences in adverse effects between the two groups.The trialists did sensitivity analyses centering on patients who withdrew from the trial or were lost to follow-up. The comparison of the 2 groups remained significant even if the percentage of events among withdrawn/lost patients in the active group was 25% higher than in the placebo group.Conclusions The results of the TACT trial surprised the cardiology community. Prior beliefs were pessimistic because heavy metals was not a proven causal factor in atherosclerosis. What's more, the majority of patients were enrolled from non-traditional medical centers.Yet the effect size was both clinically important and statistically significant. The effect size in the diabetes subgroup, which was pre-specified, was even larger and more robust statistically than the general results. In fact, there was essentially no signal of benefit from chelation in non-diabetic patients. If this was confirmed, it would be a major finding both therapeutically and scientifically, as it would have discovered heavy metal exposure as an important cause of atherosclerosis.The Journal of the American Medical Association published the manuscript along with an explanatory letter from the editors, and an accompanying editorial from Dr. Steve Nissen, which challenged the internal validity of the trial.The results of TACT did not lead to widespread adoption of chelation, but it did lead primary investigator Gervasio Lamas to seek (and obtain) funding for a TACT 2 trial to study chelation in patients with diabetes. Experts often refer to subgroup findings as “hypothesis-generating” and so it was with the TACT 1 and TACT 2 trials.Cardiology Trial's Substack is a reader-supported publication. To receive new posts and support my work, consider becoming a free or paid subscriber. Get full access to Cardiology Trial's Substack at cardiologytrials.substack.com/subscribe
CNS Pharmaceuticals (NASDAQ: CNSP) (“CNS” or the “Company”), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, recently announced the recommendation of the independent Data Safety Monitoring Board (DSMB) that the Company's ongoing global, potentially pivotal trial of the investigational agent, Berubicin for the treatment of glioblastoma multiforme (GBM) continue without any modification. The recommendation follows the DSMB's pre-specified futility analysis of unblinded (to the DSMB only) efficacy and safety data in the Company's trial of Berubicin versus Lomustine, a standard of care in patients with recurrent GBM. More specifically, the DSMB reviewed the primary endpoint of overall survival (OS) and secondary efficacy measures progression-free survival (PFF) and overall response rate (ORR), as well as safety data in evaluable patients. In order to support continuing the trial, Berubicin's efficacy had to be at least comparable to Lomustine's on the primary endpoint (OS). To read the original press release, visit: https://www.nnw.fm/Sj7iP Please see full terms of use and disclaimers on the IBN website applicable to all content provided by IBN, wherever published or re-published: https://IBN.fm/Disclaimer
CNS Pharmaceuticals (NASDAQ: CNSP) (“CNS” or the “Company”), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, recently announced the recommendation of the independent Data Safety Monitoring Board (DSMB) that the Company's ongoing global, potentially pivotal trial of the investigational agent, Berubicin for the treatment of glioblastoma multiforme (GBM) continue without any modification. The recommendation follows the DSMB's pre-specified futility analysis of unblinded (to the DSMB only) efficacy and safety data in the Company's trial of Berubicin versus Lomustine, a standard of care in patients with recurrent GBM. More specifically, the DSMB reviewed the primary endpoint of overall survival (OS) and secondary efficacy measures progression-free survival (PFF) and overall response rate (ORR), as well as safety data in evaluable patients. In order to support continuing the trial, Berubicin's efficacy had to be at least comparable to Lomustine's on the primary endpoint (OS). To read the original press release, visit: https://www.nnw.fm/Sj7iP Please see full terms of use and disclaimers on the IBN website applicable to all content provided by IBN, wherever published or re-published: https://IBN.fm/Disclaimer
In this episode, host Shikha Jain, MD, speaks with St. Jude's Steven Gottschalk, MD, and Paulina Velasquez, MD, about the evolution of bone marrow transplant and cell therapy, increasing accessibility to CAR T-cell therapy and more. • Welcome to another exciting episode of Oncology Overdrive :58 • About Gottschalk 1:12 • About Velasquez 1:57 • The interview 2:23 • About Gottschalk's journey and how he ended up in this space. 2:56 • About Velasquez's journey and how she ended up in this space. 4:16 • Gottschalk on the history of severe combined immune deficiency (SCID), or “bubble boy disease” and his work on developing the cure. 5:04 • When you think about what we have learned about immunotherapy, immune systems and cancer treatment over the last fifty years, did you think we would be where we are today in cancer care? 7:27 • How have CAR T-cells transformed health care so far, and what will they do for the future? 8:53 • What are you currently working on, and what excites you most about that work? 9:57 • Do you think that we can expect a transformation in CAR T-cells being used in solid tumors in the future? 12:34 • How do we prioritize enhanced CAR T-cells in clinical studies? 13:38 • How can we address the challenges facing the delivery of CAR T-cell therapy and make it more accessible to patients? 17:04 • Where do you see CAR T-cell therapy going in cancer care and in immunodeficiencies? 21:03 • If you were interviewed again in five years, what do you think you will be doing then, and what do you think we will be talking about? 25:42 • If someone could only listen to the last two minutes of this episode, what would you want them to take away? 30:31 • How to contact Gottschalk and Velasquez 31:22 • Thanks for listening 31:51 Stephen Gottschalk, MD, St. Jude Department of bone marrow transplantation and cellular therapy chair, focuses his research on cancer immunotherapy, cell therapy and stem cell transplantation. The Gottschalk laboratory focuses on Epstein-Barr virus-specific T cells for treating EBV-associated cancers and using genetically modified T cells for cancer immunotherapy. Paulina Velasquez, MD, St. Jude Department of bone marrow transplantation and cellular therapy, has made significant contributions to the field of immunotherapy, developing novel T-cell therapy platforms for pediatric hematological malignancies. Her team is pursuing projects that address antigen discovery, tumor immune evasion, persistence and efficacy of CAR T cells and cell-cell interaction within the tumor microenvironment. We'd love to hear from you! Send your comments/questions to Dr. Jain at oncologyoverdrive@healio.com. Follow Healio on X, formerly known as Twitter, and LinkedIn: @HemOncToday and https://www.linkedin.com/company/hemonctoday/. Follow Dr. Jain on X, formerly known as Twitter: @ShikhaJainMD. Gottschalk can be reached via email stephen.gottschalk@stjude.org. Velasquez can be reached via email paulina.velasquez@stjude.org. Disclosures: Jain reports no relevant financial disclosures. Gottschalk reports he is co-inventor on patents and patent applications in the fields of cell or gene therapy for cancer, a member of the scientific advisory board of Be Biopharma and CARGO, and the data and safety monitoring board (DSMB) of Immatics and has received honoraria from TESSA Therapeutics. Velasquez reports patent applications in the field of T-cell immunotherapy.
Dr. Christopher O'Connor interviews the founding members of the data safety monitoring board (DSMB) training team, Dr. David DeMets, Dr. Janet Wittes, and Dr. Thomas Flemming, to continue discussing the importance of training the next generation in clinical trial leadership. Using their extensive experience in clinical trials, they address which practices will best serve future members, and the critical shortage of trained experts.
Drs. Janet Wittes, Mona Fiuzat, Maria Rosa Costanzo, Ana Barac, Barry Greenberg, Vanessa Blumer, and Michael Bristow come together on this episode with Dr. Christopher O'Connor to discuss initiatives to train the next generation of DSMB members. How do we pass on the experience and knowledge of seasoned DSMB members and properly train the next generation?
What is dSMB Etiquette? | Deco Stop Podcast | @simplyscuba https://www.simplyscuba.com/Apeks-Thermiq-87mm-Wetsuit/ss58220312.htm?colour=Black+Grey Orca Swimwear https://www.simplyscuba.com/Orca/ssb2572.htm Wishlist https://www.simplyscuba.com/New-In/sssd1354.htm Mares Atlas https://www.mares.com/en_GB/catalog/product/view/id/6346/s/atlas-adj-62x-416268/category/291/ Check out THE BEST Scuba Diving Store online: https://www.simplyscuba.com Links: WasteSharks in Plymouth: https://www.plymouthherald.co.uk/news/plymouth-news/sharks-been-released-plymouths-waters-6863424 Diver Rescues Possum: https://www.yahoo.com/entertainment/scuba-diver-rescues-terrified-possum-195815218.html Hung Jury for Dive Master: https://www.leicestermercury.co.uk/news/local-news/jury-fails-reach-verdict-scuba-6883501 AskMark: https://youtu.be/RLbyRv575hY Answered: https://youtu.be/OFG-72PAcno Dive Brief: https://youtu.be/H4U1LdJV_0A ___________________ Here at Simply Scuba, we're all about giving you the best advice, information and news about the awesome world of scuba diving. Subscribe to our channel and keep up to date with the latest news, product drops and the best scuba advice on the internet! Masks - simplyscuba.com/Masks/ssdsl15544.htm Fins - simplyscuba.com/Fins/sssd1389.htm Regulators - simplyscuba.com/Regulators/sssd1382.htm Dive Computers - simplyscuba.com/Dive-Computers/sssd1360.htm BCDs - simplyscuba.com/BCDs/sssd1359.htm Join us on Facebook: https://www.facebook.com/simplyscubauk/ Follow us on Instagram: https://www.instagram.com/simplyscuba/ Listen to us on Spotify: https://spoti.fi/3uDpHZH Surface Interval Blog - https://mpora.com/tag/surface-interva ... #decostop #decostoppodcast #scubanews #spotifypodcast #youtubepodcast #scubadivingpodcast #applepodcast #podcast #scubadiving #scuba #diving #scubaadvice #simplyscuba
On Episode 10 of the Stroke Alert Podcast, host Dr. Negar Asdaghi highlights two articles from the November 2021 issue of Stroke: “Biomarkers of Coagulation and Inflammation in COVID-19–Associated Ischemic Stroke” and “Treatment-Associated Stroke in Patients Undergoing Endovascular Therapy in the ARUBA Trial.” She also interviews Dr. S. Claiborne Johnston about “Ischemic Benefit and Hemorrhage Risk of Ticagrelor-Aspirin Versus Aspirin in Patients With Acute Ischemic Stroke or Transient Ischemic Attack.” Dr. Negar Asdaghi: 1) What is the net ischemic benefit derived from combination of ticagrelor and aspirin treatment in patients with mild ischemic stroke or transient ischemic attack? 2) Is the ischemic stroke in patients hospitalized with COVID-19 associated with the rise in biomarkers of inflammation and coagulopathy? 3) What are the characteristics associated with periprocedural stroke in patients treated endovascularly for an unruptured AVM? We'll discuss these topics and much more at today's podcast. Stay with us. Dr. Negar Asdaghi: Welcome back to the Stroke Alert Podcast. My name is Negar Asdaghi. I'm an Associate Professor of Neurology at the University of Miami Miller School of Medicine and your host for the monthly Stroke Alert Podcast. For the November 2021 issue of Stroke, we have a large selection of topics, from peanut consumption reducing the risk of ischemic stroke, and the decline in the rate of progression of coronary atherosclerosis in patients on a Mediterranean diet, to how the efficacy of endovascular thrombectomy diminishes in patients with more pervious thrombus composition, which I encourage you to review in addition to our podcast today. Dr. Negar Asdaghi: Later in the podcast, I have the distinct honor of interviewing Dr. Claiborne Johnston from Dell Medical School at UT Austin on his latest work with data from the THALES trial to clarify the net ischemic benefits derived from a combination of ticagrelor and aspirin therapy in comparison with the risks of hemorrhage associated with this treatment in patients with mild and moderate stroke and TIA. But first with these two articles. Dr. Negar Asdaghi: COVID-19–associated ischemic stroke, or CAIS, is a new term that, unfortunately, stroke physicians need to be familiar with. While acute ischemic stroke can occur in parallel from, say, traditional causes of stroke in patients infected with coronavirus, ischemic stroke and other thrombotic events, such as myocardial infarction, pulmonary embolism, deep vein thrombosis, and acute limb thrombosis, can occur in the setting of overt hyperinflammation and subsequent coagulopathy that is observed in patients hospitalized with severe COVID-19 illness. Dr. Negar Asdaghi: Elevated D-dimer, although quite non-specific, has emerged as a marker of COVID-19–associated coagulopathy, but whether an elevated D-dimer in isolation or in combination with various other inflammatory and coagulation markers is associated with development of acute in-hospital ischemic stroke in those hospitalized with COVID is not known. Dr. Negar Asdaghi: So, in the current issue of the journal, in the article titled "Biomarkers of Coagulation and Inflammation in COVID-19–Associated Ischemic Stroke,” Dr. Charles Esenwa from the Department of Neurology at Montefiore Medical Center and colleagues did an interesting analysis of over 5,000 patients with COVID-19 who were admitted to one of the Montefiore Health System hospitals between March 1, 2020 and May 8, 2020. This was a retrospective analysis, so they had to work with the available biomarkers for each patient and use a machine learning cluster analysis of these biomarkers to divide the patients basically based on five biomarkers to four clusters. Dr. Negar Asdaghi: The following five biomarkers were chosen by this machine learning cluster analysis. These included CRP, D-dimer, LDH, white BC, and PTT. So, they had to come up with some arbitrary rules to exclude biomarkers that were either missing in over 30% of their population, and they also excluded those patients that were hospitalized for a long period of time, and they chose a 30-day hospitalization and over. And they also only used the first reading for each biomarker. Again, these were arbitrary rules that were set forth by the authors, and they found some alarming findings. When they clustered patients based on similarities in these biomarkers, they came up with predicted models for combined thrombotic events and acute ischemic stroke. Dr. Negar Asdaghi: For example, in the cluster where the patients had the highest mean values for CRP, D-dimer, LDH, and white BC, and a relatively low PTT, these patients had the highest prevalence of acute ischemic stroke. They had the highest prevalence of in-hospital strokes and severe strokes and highest percentage of total thrombotic events. In contrast, the cluster with the lowest mean of all of these five biomarkers had no cases of in-hospital acute ischemic strokes; they had the lowest prevalence of composite, all thrombotic events, and patients had the least severe complications. Dr. Negar Asdaghi: So, they also tested the effects of biomarkers individually for prediction of acute ischemic stroke. And it turns out that when they used a lone marker, only D-dimer again was associated with acute ischemic stroke. Very interestingly, D-dimer was specifically elevated in those COVID-19 patients in whom the stroke was ultimately classified as cryptogenic. Dr. Negar Asdaghi: So, what does that mean? That means that it's more likely that a stroke had occurred in the setting of severe COVID-19 hyperinflammatory response, and less likely associated with other classical causes of stroke. Dr. Negar Asdaghi: So, what did we learn overall from this study? Well, hospitalized COVID-19 patients with a combination of high CRP, D-dimer, LDH, and white BC, and slight reduction in their PTT, had a 4.5-fold increase in the risk of in-hospital mortality and a fivefold increase in the risk of in-hospital stroke as compared to the COVID-19 patients with the lowest mean values for all the five biomarkers mentioned above. So, important information to keep in mind as we treat hospitalized COVID-19 patients, and we await more prospective data on this topic. Dr. Negar Asdaghi: Arteriovenous malformations, or AVMs, are congenital vascular lesions that are associated with long-term excess mortality and morbidity, essentially almost all related to their risk of intracerebral hemorrhage. Roughly half the patients with brain AVMs present with intracerebral hemorrhage, resulting in a first-ever hemorrhage rate of about 0.5 per 100,000 person years. Dr. Negar Asdaghi: Annual risk of hemorrhage is estimated at 1 to 4% for all comers with AVMs, but varies significantly, and can be as low as 0.9% in patients with unruptured, superficially located brain AVMs with superficial drainage, but may be as high as over 34% in patients with ruptured, deeply seated brain AVMs with deep venous drainage. So, treatment would entirely be dependent on the type of presentations and characteristics of each patient with an AVM. Dr. Negar Asdaghi: Whether unruptured AVMs should be managed clinically or treated either endovascularly or surgically is the subject of the ARUBA trial that is a randomized trial of unruptured brain AVMs. The enrollment of ARUBA was halted by the study's DSMB board, but medical management was found to be superior to treatment arm for the primary outcome of symptomatic stroke and death. Dr. Negar Asdaghi: Since then, there's been a lot of focus in the literature and comparison of outcomes between treated and untreated patients with unruptured AVMs, but less has been published on characteristics of patients who suffered from periprocedural stroke, an important part of the primary outcome of ARUBA. So, in the current issue of the journal, we have the study titled “Treatment-Associated Stroke in Patients Undergoing Endovascular Therapy in the ARUBA Trial.” Dr. Negar Asdaghi: Dr. Joshua Burks and colleagues from the Department of Neurosurgery at the University of Miami and colleagues evaluated 64 patients with unruptured AVMs enrolled in the ARUBA trial who underwent endovascular treatment as part of the trial and looked at the characteristics of those who suffered a perioperative stroke, defined as a stroke recorded at or within 48 hours of intervention, as this would represent a direct procedure-related complication rather than sequelae of, say, treated or partially treated AVM itself. Dr. Negar Asdaghi: All patients who initiated endovascular intervention, including attempted interventions in cases where therapy was aborted secondary to technical or anatomical limitations, were included regardless of randomization or subsequent withdrawal from the study beyond 48 hours following the intervention. So, what they found was that 16% of interventions resulted in stroke, 11% hemorrhagic, and 5% ischemic strokes. And they had no perioperative mortality, which is good news. Dr. Negar Asdaghi: In univariate analysis, they found many factors that were more commonly seen in patients that suffered from perioperative stroke as compared to those who did not have a stroke perioperatively. Those factors included, for instance, female sex. Over half of these patients were female. Close to half were enrolled in France. And over 40% of those who suffered a stroke in the perioperative timeframe had Spetzler-Martin grade two AVMs. Dr. Negar Asdaghi: When they accounted for all confounding variables, they found that endovascularly treated unruptured AVMs that are supplied by the posterior cerebral artery cortical feeders and those with Spetzler-Martin grade two and three had a higher perioperative stroke risk as compared to their counterparts without these characteristics. Interestingly, there are also significant geographical disparities in the risk of stroke in that patients treated in the United States or Germany had a significantly lower stroke risk than patients treated in other countries. Dr. Negar Asdaghi: So, what did we learn from this study? There are patients and lesion characteristics that increase the risk of stroke associated with endovascular treatment of unruptured AVMs. The current study suggests that AVMs with cortical arterial feeders from posterior cerebral artery and those with grade two and three Spetzler-Martin were associated with a higher risk of procedural and periprocedural stroke. Dr. Negar Asdaghi: And very importantly, as with every surgical intervention, the risk of a procedure is operator-dependent, as well as center-dependent. And these are important factors to keep in mind as technology evolves and more treatments become available to decide whether to keep or to refer patients with unruptured AVMs to a more experienced center. Dr. Negar Asdaghi: Patients with mild ischemic stroke and transient ischemic attack are at high risk of having recurrent ischemic events, especially in the immediate aftermath of their symptom onset. Early diagnosis and initiation of secondary preventive measures, such as antiplatelet or anticoagulation therapies, in the appropriate setting considerably reduce this recurrent risk. Dr. Negar Asdaghi: Multiple randomized trials have shown that as compared to treatment with a single antiplatelet agent, dual antiplatelet treatment is more effective in reducing the risk of stroke and other major vascular events in the TIA mild stroke population, a benefit that comes with an expected increase in the risk of hemorrhage. Dr. Negar Asdaghi: THALES trial is one of the latest trials to determine the efficacy of dual, which is combination of ticagrelor and aspirin, versus mono-antiplatelet therapy, that is aspirin alone, in eligible patients with non-cardioembolic acute ischemic stroke and TIA. Now, it's important to keep in mind that the primary outcome of THALES is a composite of stroke or death, which included both ischemic and hemorrhagic events. Dr. Negar Asdaghi: Now, it's important to understand that while in the setting of a clinical trial, combining the risks associated with dual antiplatelet therapy, which is hemorrhage, and the potential treatment benefit, that is reduction of recurrent ischemic events, is appropriate as part of the outcome selection. In routine practice, this type of primary outcome can obscure the actual trade-offs between the benefits of dual antiplatelet treatment and its inherent hemorrhagic risk. Dr. Negar Asdaghi: So, in this issue of the journal, in the study titled "Ischemic Benefit and Hemorrhage Risk of Ticagrelor-Aspirin Versus Aspirin in Patients With Acute Ischemic Stroke or Transient Ischemic Attack," the THALES investigators led by Dr. Claiborne Johnston sought to separate the ischemic benefits of combination of ticagrelor and aspirin therapy from its hemorrhagic risks in patients enrolled in the trial. Dr. Negar Asdaghi: I'm joined today by Professor Johnston to discuss the findings of this paper. Dr. Johnston absolutely needs no introduction to the stroke community and our readership. He's a Professor of Neurology at Dell Medical School at the University of Texas at Austin. He's a leader in the field of cerebrovascular disorders, has served as the primary investigator of multiple randomized trials and large prospective studies to evaluate the preventive treatment outcomes in TIA and mild stroke, and has pioneered the development and validation of predictive models for recurrent stroke in this population. He's authored over 700 peer-reviewed manuscripts, has won several awards for research and teaching, and is recognized for his leadership in the field of medicine and healthcare. Dr. Negar Asdaghi: Good morning, Clay. We're delighted that you could join us on the podcast. Dr. S. Claiborne Johnston: Well, thank you. It's wonderful to be here. Thank you for having me. Dr. Negar Asdaghi: Thank you. So, THALES is an exciting new addition to the most recent trials of dual antiplatelet therapy that studied mostly the role of clopidogrel and aspirin combination therapy. Can you please start us off by telling us why did we need a new trial in a very similar patient population? Dr. S. Claiborne Johnston: Well, the primary reason was, yes, clopidogrel works in combination with aspirin in the setting, but clopidogrel is actually a prodrug. It requires conversion in the liver to its active form. And polymorphisms in CYP2C19 and Cyt P450 pathways are really common and associated with an inability or limited ability to convert that prodrug into its active form. So, there are a number of people who may not benefit much, if at all, from clopidogrel. So, it's kind of surprising that it works as well as it does. Dr. S. Claiborne Johnston: Ticagrelor doesn't have that problem. It's not a prodrug. It acts directly on the P2Y12 inhibitor. And so, the hope was that we would have a more consistent and pronounced effect on risk reduction in patients after TIA and mild to moderate strokes. Dr. Negar Asdaghi: Primary efficacy outcome in THALES was different from the primary efficacy outcome chosen for the POINT trial, that was major ischemic events and death from ischemic vascular events, and that of the CHANCE trial, that was a combination of ischemic and hemorrhagic strokes in 90 days. Can you please tell us about the thought process behind choosing this particular primary efficacy outcome in THALES? Dr. S. Claiborne Johnston: Yeah, so this was encouraged by the regulatory authorities. And so the primary efficacy outcome in THALES is all stroke, hemorrhagic and ischemic, and all death, hemorrhagic and ischemic. And we teased apart just the ischemic etiologies in POINT. Dr. S. Claiborne Johnston: The rationale was that we were including all the major outcomes that the drug could impact. The problem is that people forget that it includes hemorrhagic events, and then they weigh that efficacy outcome against the safety outcome. And so there's confusion. There's sort of double-counting of safety elements in doing that comparison. Dr. Negar Asdaghi: Okay, great. And now, before we hear about how you disentangled the two safety and efficacy outcomes, can you please remind our listeners about the primary results of THALES, which was published obviously a few months ago? Dr. S. Claiborne Johnston: Yeah, sure. So, it showed that the combination of ticagrelor and aspirin works. It reduced the stroke and death by about 17% over the 30-day period of treatment. So robust effect. There were some increased hemorrhages, and looking at severe hemorrhage as defined by the GUSTO definition, there was almost a fourfold increase, but it was tiny in absolute terms of 0.4% increase. Dr. Negar Asdaghi: Okay. So, now it's very important, as you mentioned, this disentangling of recurrent ischemic, again, safety from efficacy outcomes. Your current study that is published in the November issue of Stroke clarified these results. And we're excited to hear about those results. Dr. S. Claiborne Johnston: That's right. So, there were two problems with the way people have interpreted the results of the THALES trial. One is this entanglement of safety events and both efficacy outcome and the safety outcome. The other was the use of relative risks as opposed to absolute risks, because a high relative risk for a rare event is less important than a small relative risk for a more difference between more common events. And so we wanted to deal with both of those issues. Dr. S. Claiborne Johnston: So, we defined new outcomes that were not entangled. So, we defined major ischemic events, similar to what we had done in POINT, and then we defined major hemorrhage as being basically irreversible hemorrhage, and compared outcomes in the two groups. And what we found was that when we did it that way, for every 1,000 patients treated, we avoided 12 major ischemic events and produced three major hemorrhages. So, about a four-to-one ratio of ischemic benefit to hemorrhage risk. And that was true at various cutpoints for disability. Dr. S. Claiborne Johnston: So, if we said, "Okay, yes, you had an event, and are you disabled at last follow-up at 30 days?" Then if we said that, there was also a four-to-one difference in disabling events, ischemic versus hemorrhagic. And if we said a two or greater, so moderate disability or worse, it was the same ratio, four-to-one. Dr. Negar Asdaghi: Okay, so four-to-one ratio of benefit. That's an important number to keep in mind. Also reassuring to see that this net clinical benefit or net clinical impact of the combination of therapy was practically the same across all the pre-specified subgroups in the trial. Were you at all surprised by the subgroup analysis? Dr. S. Claiborne Johnston: Well you know if you do enough subgroup analyses, you're going to find differences, right? And thankfully, we have the looking at interaction terms to keep us honest, but even so, you look at 20 and you're going to have some significant interaction terms, as well. But yeah, it was reassuring that the effects were so consistent across groups. Dr. S. Claiborne Johnston: I think there's been a tendency to over-interpret results from subgroup analyses. We don't have any evidence to suggest that we should be doing that here. I'm sure we can pick out groups that do better, and we've done that actually. The group with atherosclerosis does particularly well, but is that a chance event or is that real? I think we just have to be super-cautious about subgroup analyses. Dr. Negar Asdaghi: So, absolutely. One of the subgroups that I'm personally very interested in is just the time subgroup. So, all of the patients in THALES were enrolled within the first 24 hours, and the subgroup analysis did not show that there were any differences in terms of the net benefit between those that were enrolled earlier, within the first 12 hours, and those that were enrolled later, between 12 and 24 hours. But in routine clinical practice, we often see patients with TIA and mild stroke actually presented to us later than that timeframe entirely. Should we be giving them dual antiplatelet treatment? Dr. S. Claiborne Johnston: That's a great question. So, we did an analysis in POINT where we modeled out, would we still have an important significant net benefit if we had started the trial later? And we didn't start the trial later, right? So, this was just pretending like anybody who had an event early on was not in the study in starting at a later timepoint and modeling that out. And basically what we found was that for out to three days, there was still a benefit. And, in fact, if you look at that data and look at those tables, you could even say, even out to five days. Dr. S. Claiborne Johnston: I would say it's not unreasonable to do that given that the risks are so small and they're going to be even later with later treatment. But I would say, too, that even though we're not seeing greater impact within that first 24 hours versus 12 to 24, it just makes sense with event rates being as great as they are early on that if you don't treat with a preventive medication before an event occurs, it doesn't work. So, it just makes sense that as much as possible we ought to treat people as early as possible after their events. Dr. Negar Asdaghi: Very important findings and things to keep in mind. I want to ask you about the top two takeaway messages from the study. Dr. S. Claiborne Johnston: One is that there's a favorable benefit-to-risk ratio for ticagrelor/aspirin in mild to moderate actually ischemic stroke and high-risk TIA from THALES. So that would be number one. Dr. S. Claiborne Johnston: And then number two is watch your endpoints carefully. Think carefully, too, about whether balancing safety to efficacy events really makes sense and also whether focusing on relative risks really makes sense. I would encourage us, even though our journals tend to push us towards relative risks and we're more familiar with those, I'd encourage us to get more comfortable with using absolute risks in the way we look at data, but also in the way we talk to patients about their impact. Dr. Negar Asdaghi: Fair enough. I remember a few years ago, you visited us here at the University of Miami to deliver the annual Cerebrovascular Scheinberg Lecture. And you had mentioned that the idea of dual antiplatelet therapy treatment of patients with TIA mild stroke had come to you many years back when you were still in training, but it took many years for that idea to turn into reality, into randomized trials, and now translated into clinical practice. Dr. Negar Asdaghi: At the time, if you recall, this was right before you went to Europe to present the primary results of POINT at the European conference. And the trial results were not publicly available, so you were sworn to secrecy. You couldn't tell us about the results. It's been a few years since then. You've already completed yet another trial on this topic. Can I ask what's next for you and your team as it pertains to acute treatment of patients with TIA and mild stroke? Dr. S. Claiborne Johnston: Well, there are a few things. So, CHANCE-2 is a really interesting trial. My role in that was peripheral, just really advisory, but it's an exciting trial. So, basically it's looking at people with those CYP2C19 polymorphisms that I mentioned before, people who don't rapidly and readily convert clopidogrel to its active form, and randomizing them to clopidogrel versus ticagrelor. Dr. S. Claiborne Johnston: So, it's going to give us some head-to-head data on the two drugs and the people who may benefit the most from ticagrelor. And that is complete, and that will be published in the next few months. So, I that's going to be an important trial in people's thinking about how best to approach these patients. Dr. S. Claiborne Johnston: The second is, you know, we're not done. We still have a 5% risk of events, even in those three dual antiplatelet therapy. And so we need more agents. And we need to think about secondary prevention extending to other groups as well, just as you said, longer periods of time, more severe strokes, people after thrombolysis/thrombectomy. Those are big groups of patients at extreme risk for secondary events, and we have no agents and no data right now. Dr. S. Claiborne Johnston: I would be concerned about dual antiplatelet therapy in those patients, just given what we've seen about the risks of hemorrhage in the existing groups, which are again manageable and shouldn't change people's decision about treatment. But for the groups I just mentioned, risks of hemorrhage start to get greater. And so one worries about whether dual antiplatelet therapy's the right thing or whether other agents make more sense. So, yeah, we're interested in looking at other agents, some novel, for those other indications as well. Dr. Negar Asdaghi: Professor Johnston, thank you for your time, and we look forward to covering more of your research in the future. Dr. S. Claiborne Johnston: Well, thank you. It's been a pleasure. Dr. Negar Asdaghi: Thank you. Dr. Negar Asdaghi: And this concludes our podcast for the November 2021 issue of Stroke. Please be sure to check out the November table of contents for a full list of publications, including two important topical review articles, one on thrombus composition after thrombectomy, and one on pearls and pitfalls of perfusion imaging in acute ischemic stroke, as advanced neuroimaging continues to play a critical role in decision-making for acute stroke therapies. Dr. Negar Asdaghi: Now, speaking of advanced neuroimaging and the immense role that neuroimaging plays in our day-to-day practice, let's take a moment as we end our November podcast to remember how the concept of medical imaging first began over 120 years ago with the discovery of X-ray by German professor of physics Wilhelm Röntgen. Dr. Negar Asdaghi: On Friday, November 8, 1895, while experimenting with electricity, Röntgen accidentally discovered a new kind of rays that he referred to as X-rays. He soon realized that X-rays were capable of passing through most substances, including the soft tissues of the body, but left bones and metals visible. Dr. Negar Asdaghi: One of his earliest photographic plates of his experiments was a film of his wife Bertha's hand with her wedding ring clearly visible. This was the first time that the inside of human body was seen without performing surgery. Dr. Negar Asdaghi: From Röntgen's first X-ray image to the advanced neuroimaging that we review today on our portable devices, I can't help but wonder, what will your accidental discovery on a Friday fall afternoon in November do to advance the field of science and stroke 100 years from now, as we continue to stay alert with Stroke Alert. Dr. Negar Asdaghi: This program is copyright of the American Heart Association, 2021. 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, visit AHAjournals.org.
You use STELLA when you're about to ascend to make sure that you're covering everything and you don't ascend before forgetting something. So, thumb your buddy, complete your stops, send up your dSMB and then STELLA, not the drink...
So are hikers stealing scuba diving gear? Did Mark go naked on his 100th dive? How do you use a dSMB? & how do you keep buoyant when breathing? Mark answers these questions and a couple of others too in this weeks #askmark.
In our last episode of season 1, listen as George and Andrew discuss messages sent to the DSMB social media as well as hear George and Jennifer Bucholtz presentation at Crime Con 2021. Andrew also announces his new podcast: The Professionals. We will be back this fall for Season 2!
When would an open-ended dSMB ever be a better choice? Mark answers this question and plenty of others in this weeks #askmark
La 8e #ConfPortzamparc dédiée aux #valeursMidAndSmall se tient du 29 mars au 1er avril en format 100% digital. 55 émetteurs iront à la rencontre des investisseurs. LA BOURSE ET LA VIE TV est partenaire de l’évènement et Didier Testot son fondateur a interrogé plusieurs entreprises sur leurs stratégies et perspectives. Abivax SA (Euronext Paris : FR0012333284 – ABVX) est une société de biotechnologie au stade clinique développant des nouveaux médicaments modulant le système immunitaire afin de traiter les maladies inflammatoires, le cancer et les maladies virales. La société a annoncé début mars qu’elle “arrêtait l’étude miR-AGE de phase 2b/3 chez les patients Covid-19 à risque élevé conformément à la recommandation du Data Safety and Monitoring Board (DSMB) pour raison de manque d’efficacité“. Cette annonce suscita des ventes du titre en Bourse. Selon Abivax, “l’étude internationale miR-AGE de phase 2b/3 (ABX464-401) avait d’ores et déjà recruté 500 patients Covid-19 à risque élevé, sur les 1 034 prévus et avait été désignée « Priorité Nationale de Recherche » par le gouvernement français en décembre 2020. L’essai clinique à la méthodologie rigoureuse, conduit de manière randomisée, en double aveugle et contrôlé contre placebo évaluait la capacité d’ABX464 de prévenir la progression vers la forme grave de la maladie chez les patients. La recommandation du DSMB est basée sur une analyse intermédiaire évaluant les données de 305 patients Covid-19 à risque élevé qui ont terminé le traitement. La comparaison des données générées chez les patients traités avec ABX464 versus le groupe placebo n’a pas démontré de différence sur le taux de progression vers une maladie sévère entre le groupe placebo et le groupe ABX464. Par ailleurs, ABX464 s’est relevé sûr et bien toléré chez ces patients Covid-19 à risque élevé.” Retour sur les dernières actualités de l’entreprise, sa stratégie avec le ABX464 et les perspectives. Didier Blondel Directeur Financier Abivax est mon invité. Vidéos Abivax déjà diffusées sur la Web TV : Biotech .pf-button.pf-button-excerpt { display: none; }L’article Didier Blondel Directeur Financier Abivax : “On rentre dans le coeur de la stratégie d’Abivax avec le ABX464” : 8e #ConfPortzamparc dédiée aux #valeursMidAndSmall est apparu en premier sur La Bourse et la Vie TV L'information éco à valeur ajoutée.
In an unusual statement released early Tuesday local time, the National Institute of Allergy and Infectious Diseases said the independent board that reviews data from multiple Covid-19 vaccine candidates has raised concerns about AstraZeneca's announcement of efficacy data from its vaccine trial."The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data," said the NIAID statement released early Tuesday."We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible."On Monday, AstraZeneca had issued a press release saying its Covid-19 vaccine showed 79% efficacy against symptomatic disease and 100% efficacy against severe disease and hospitalization, citing long-awaited US trial data. The latter figure was based on five total cases of severe disease or hospitalization in people who received the placebo, NIAID Director Dr. Anthony Fauci said during a coronavirus briefing Monday.In a statement Tuesday, AstraZeneca said the numbers shared Monday were based on a pre-specified interim analysis with a data cutoff of February 17. It said it has reviewed an early assessment of its primary analysis, and those results were consistent with the interim analysis."We will immediately engage with the independent data safety monitoring board (DSMB) to share our primary analysis with the most up to date efficacy data," the statement said. "We intend to issue results of the primary analysis within 48 hours."The DSMB is an independent expert group that sees trial data before the pharmaceutical companies, the doctors running the trials, or even the US Food and Drug Administration. It has the power advise a company of positive interim findings, or to halt a trial over safety concerns. That's what happened to the AstraZeneca trial in September after a study participant developed neurological symptoms, for example.Last year, the National Institutes of Health appointed a common DSMB to monitor Covid-19 vaccine clinical trials that were being funded by the federal government -- including AstraZeneca, Moderna and Johnson & Johnson. This DSMB has 10 to 15 members with specialties including vaccine development, statistics and ethics.Fauci said on Good Morning America on Tuesday that when the DSMB saw AstraZeneca's press release, "they got concerned and wrote a rather harsh note to them -- and with a copy to me -- saying that in fact they felt that the data that was in the press release were somewhat outdated and might in fact be misleading a bit, and wanted them to straighten it out."'Unforced error' could create doubt about vaccineThe press release from AstraZeneca was "an unforced error" that may create doubt about what "is very likely a very good vaccine," Fauci said. The data are "really quite good, but when they put it into the press release, it wasn't completely accurate."The fact that the DSMB picked up on the discrepancy was an example of a safeguard around vaccines, Fauci said.But having seen the monitoring board's letter, "we could not just let it go unanswered.""We just felt we could not remain silent," Fauci told STAT on Tuesday. "Because if we did remain silent, we could be understandably accused of covering something up. And we definitely didn't want to be in that position."Still, a public statement questioning AstraZeneca's data is unusual.DSMBs sometimes disagree with investigators over the interpretation of trial results, Stephen Evans, a professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine, said in a statement to the Science Media Centre in the UK. But that's usually done in private, he said, "so this is unprecedented in my opinion."Dr. Peter Hotez, a vaccine expert and dean of tropical medicine at Baylor school of medicine, told CNN the NIAID statement was "totally stra...
PROVIDENCE – The breaking news overnight that the National Institutes of Health has concerns about the data used by AstraZeneca to prove the reported high effectiveness of its COVID-19 vaccine is not only troubling in its own right but may discourage more people who already were hesitant about getting a shot to get inoculated. That was Brown University School of Public Health dean Dr. Ashish Jha’s reaction Tuesday morning after the NIH’s National Institute of Allergy and Infectious Diseases, which is headed by Dr. Anthony S. Fauci, issued a cautionary statement from an independent monitoring board that informs the NIH. That board, Fauci’s division of the NIH wrote, “expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data. We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible.” Jha said AstraZeneca “has managed to mess up communication both with the public and with regulatory agencies over and over again… You’ve got to get the facts and data right before you make it public. So it's been very frustrating because they're taking a good vaccine and they're tarnishing it not because the science is bad, but because the communication is so bad.” Practically speaking, Jha said, the NIH caution will have no immediate impact on residents of the U.S., where the Pfizer, Moderna and Johnson & Johnson vaccines are going into millions of arms each week. AstraZeneca has not received U.S. emergency use authorization. Nonetheless, Jha said, the latest news could prove further disincentive to Americans who already were reluctant to be vaccinated. And that could have ramifications in months to come. “AstraZeneca messing things up in this way doesn't help,” Jha said on Tuesday during the 22nd taping of the weekly national “COVID: What Comes Next” podcast. “It doesn't help people feel confident about their vaccine and it doesn't help people feel confident about other vaccines.” During the taping, Jha also delved into the profound short- and long-term impacts of the coronavirus pandemic on mental health. Substance and alcohol use, suicidal thoughts, depression and anxiety are among the manifestations of the so-called “Second Pandemic,” with roots in the isolation, stress, economic crises and other negative effects of COVID-19. “A lot of us have been very worried about this,” Jha said. “We are seeing the tip of the iceberg now because people are still in kind of stress mode, ‘get-through-this-crisis’ mode. And we all know that we can get through a crisis by just kind of hunkering down, but when that crisis abates we are going to see this explosion of sentiment and also of effects on mood. I am very worried that we are going to be dealing with the mental health ramifications of this for years and years and years.” Jha’s advice to people with mental-health challenges? Seek intervention through a primary-care practitioner, psychiatrist, therapist or other qualified healthcare professional. And in an emergency, dial 911. More broadly speaking, Jha said states need to prepare, along with physicians and nurses. “I've been talking to healthcare providers across the country and saying ‘you've got to develop a strategy now because you're going to be inundated in three to six months.’ ” During taping of the podcast, available exclusively from The Providence Journal and the USA TODAY NETWORK, Jha answered three audience questions: -- “I wonder what he thought of Emily Oster’s article in The Atlantic [last] week, titled “your unvaccinated kid is like a vaccinated grandma.” Jha thought the substance of the piece with its advice on older peoples’ relationships with children and grandchildren was sound. Jha asserted, however, that the headline left much to be desired. -- “What do we know about the vaccine and its protection from scenarios where mild or moderate COVID-19 leads to this ‘Long COVID’ phenomena where people are suffering from (sometimes debilitating) symptoms long-term? Will the vaccines protect us from ‘Long COVID’ as well?” Jha answered in part by saying “We don't know a lot but I will say this: We have not seen much in the way of Long COVID symptoms in people who've gotten vaccinated so far.” -- A third audience member wanted to know Jha’s guidance for “a vaccinated person with kids who wants to resume social activities with other kids” and for “a vaccinated person who lives with an unvaccinated person.” The pandemic expert gave a detailed response, urging a degree of caution in various scenarios and concluding “in general, I wouldn’t worry excessively.” This weekly podcast is hosted by G. Wayne Miller, health reporter for The Providence Journal. To get a deeper understanding of the issues and questions addressed during this 22nd episode, please download the podcast. See omnystudio.com/listener for privacy information.
The race is on for a Covid-19 vaccine, but behind the scenes there’s a secretive group that has the power to stop a vaccine trial in its tracks. That’s the Data and Safety Monitoring Board, or DSMB, and they’re the only ones who get a look at the data during the trials. CNN’s Chief Medical Correspondent Dr. Sanjay Gupta speaks with Susan Ellenberg about her work with Covid-19 DSMBs. To learn more about how CNN protects listener privacy, visit cnn.com/privacy
In Part 2 of this 2 Part podcast, Dr. Mark Cruz discusses the interdisciplinary nature of treating airway conditions, common treatment modalities, as well as educational resources such as the Airway and Facial Development Collaborative, his Airway Mini Residency developed with Dr. Barry Raphael and the global Advanced Airway Membership forum. Mark A Cruz graduated from the UCLA School of Dentistry in 1986 and started a dental practice in Monarch Beach, CA upon graduation. He has lectured nationally and internationally and is a member of various dental organizations. He was a part-time lecturer at UCLA and member of the faculty group practice and was past assistant director of the UCLA Center for Esthetic Dentistry. He has served on the National Institute of Health/NIDCR (National Institute of Dental & Craniofacial Research) Grant review Committee in Washington D.C. as well as on the editorial board for the Journal of Evidence Based Dental Practice (Elsevier) and is currently serving on the DSMB (data safety management board) for the NPBRN (national practice-based research network.The Dental Clinical Companion Podcast (DCCP) is provided for general informational purposes only. The DCCP, MounceEndo, LLC, and Dr. Richard Mounce personally have no liability for any clinical, management, or financial decisions or actions taken or made by you based on the information provided in this program. The DCCP is not intended to offer dental, medical, legal, management, investment, surgical, tax, clinical, or any other professional advice. Reliance on the information in the DCCP is done entirely at the listeners own risk. No guarantees, representations, or warrantees are made with regard to the completeness, accuracy, and/or quality of the DCCP. The DCCP takes no responsibility for, does not endorse, and does not imply a relationship/affiliation to any websites, products, services, devices, individuals, organizations which are hyperlinked to any DCCP component or mentioned in the DCCP. Third party materials, hyperlinks, and/or DCCP content does not reflect the opinions, standards, and policies of MounceEndo, LLC (owner of the DCCP, Dr. Richard Mounce, the guest, or show sponsors). The DCCP makes no warranty that the Podcast and its server are free of computer viruses or other destructive or contaminating code elements. The Dental Clinical Companion Podcast expressly disclaims any and all liability or responsibility for any direct, indirect, incidental, special consequential or other damages arising out of any individuals use of, reference to, reliance on, or inability to use, this podcast or the information presented in this podcast. http://www.dentalclinicalcompanion.com/ Support the show (http://mounceendo.com/)
In Part 1 of this 2 part podcast, Dr. Mark Cruz discusses sleep disordered breathing, obstructive sleep apnea, the recognition and diagnosis airway challenges, and treatment modalities related to these conditions. Mark A Cruz graduated from the UCLA School of Dentistry in 1986 and started a dental practice in Monarch Beach, CA upon graduation. He has lectured nationally and internationally and is a member of various dental organizations. He was a part-time lecturer at UCLA and member of the faculty group practice and was past assistant director of the UCLA Center for Esthetic Dentistry. He has served on the National Institute of Health/NIDCR (National Institute of Dental & Craniofacial Research) Grant review Committee in Washington D.C. as well as on the editorial board for the Journal of Evidence Based Dental Practice (Elsevier) and is currently serving on the DSMB (data safety management board) for the NPBRN (national practice-based research network.The Dental Clinical Companion Podcast (DCCP) is provided for general informational purposes only. The DCCP, MounceEndo, LLC, and Dr. Richard Mounce personally have no liability for any clinical, management, or financial decisions or actions taken or made by you based on the information provided in this program. The DCCP is not intended to offer dental, medical, legal, management, investment, surgical, tax, clinical, or any other professional advice. Reliance on the information in the DCCP is done entirely at the listeners own risk. No guarantees, representations, or warrantees are made with regard to the completeness, accuracy, and/or quality of the DCCP. The DCCP takes no responsibility for, does not endorse, and does not imply a relationship/affiliation to any websites, products, services, devices, individuals, organizations which are hyperlinked to any DCCP component or mentioned in the DCCP. Third party materials, hyperlinks, and/or DCCP content does not reflect the opinions, standards, and policies of MounceEndo, LLC (owner of the DCCP, Dr. Richard Mounce, the guest, or show sponsors). The DCCP makes no warranty that the Podcast and its server are free of computer viruses or other destructive or contaminating code elements. The Dental Clinical Companion Podcast expressly disclaims any and all liability or responsibility for any direct, indirect, incidental, special consequential or other damages arising out of any individuals use of, reference to, reliance on, or inability to use, this podcast or the information presented in this podcast. http://www.dentalclinicalcompanion.com/Support the show (http://mounceendo.com/)
Dr Carolyn Lam: Well, the Circulation on the Run, your weekly podcast summary and backstage pass to the journal and its editors. I'm Dr Carolyn Lam, associate editor from the National Heart Centre and Duke National University of Singapore. Dr Greg Hundley: And I'm Dr Greg Hundley, associate editor from the Pauley Heart Center at VCU Health in Richmond, Virginia. Well, Carolyn, this week's feature involves the Compass trial, and we'll be talking about a comparison of low-dose rivaroxaban plus aspirin compared to aspirin alone in patients with chronic vascular disease. But before we get to that, how about if we break away and discuss a few other papers. And I'll go first this time, because this week we're going to introduce another new feature in addition to Carolyn's Quiz. Dr Carolyn Lam: Wait a minute. This was not on the script. What's going on, Greg? Dr Greg Hundley: It's on the script! Carolyn, let me get to my first paper. It's from Professor Junling Liu from Shanghai Jiao Tong University School of Medicine, and it involves branched-chain amino acid catabolism and how that may promote thrombosis risk by enhancing tropomodulin-3 propionylation in platelets. But first, we've got a new feature to add to Carolyn's Quiz. It's called Way or No Way. Dr Carolyn Lam: Just so everybody knows. This was a one-way decision to add this new component of Carolyn's Quiz, but okay, I'm all for it. Go, Greg! Dr Greg Hundley: Okay. All right. It's a fast, quick question where our listeners seek your guidance regarding an important scientific discovery from one of our published manuscripts. Are you ready? Dr Carolyn Lam: No. Dr Greg Hundley: Okay. Here's your question. Do branched-chain amino acids promote arterial thrombosis. Way or no way? Dr Carolyn Lam: Maybe? Dr Greg Hundley: Okay, Carolyn. Dr Carolyn Lam: I have a feeling you're going to tell us yes, although I wouldn't have guessed that straight away. Dr Greg Hundley: Okay. Remember that branched-chain amino acids are essential nutrients, including leucine, isoleucine, and valine, and they serve as a resource for energy production and the regulator of important nutrient and metabolic signals. In this study, the activity of human platelets from healthy subjects before and after ingestion of branched-chain amino acids were measured. PP2Cm-deficient mice were used to elucidate the impacts of BCAA catabolism on platelet activation and thrombus formation. Dr Carolyn Lam: Now okay, okay. So what did they find? Way or no way? Dr Greg Hundley: Ingestion of branched-chain amino acids significantly enhanced the activity of platelets in response to agonists and increased the risk of arterial thrombosis. The branched-chain amino acid catabolic pathway-driven propionylation of tropomodulin-3 at K255 was found to be an important mechanism underlying the branched-chain amino acid-facilitated platelet activation, and elevated levels of branched-chain amino acids and enhanced expression of positive regulators of branched-chain amino acid catabolism in platelets were found probably responsible for the high platelet activity in type 2 diabetes mellitus. Dr Carolyn Lam: Very interesting. So yes, it is possible. And what is the clinical implications? Dr Greg Hundley: Right, Carolyn. Branched-chain amino acids, or their catabolites, enhance the risk of arterial thrombosis in small animals, and perhaps future human subject studies, that restrict branched-chain amino acid intake or target branched-chain amino acid catabolism may serve as a novel strategy for anti-thrombosis therapy. Dr Carolyn Lam: Interesting. Okay, Greg. Here you go. Question for me. Have you heard of Home Time? Dr Greg Hundley: Home Time? Yes. Home Time. It's not like time out for our kids, but we've been having a lot of Home Time in this COVID-19 with our families. Dr Carolyn Lam: All right. Touché. Touché. Home Time! Did you know it is a patient-centered outcome measure that accounts for rehospitalization mortality and post-discharge care? In the paper I want to talk about, Dr Pandey from UT Southwestern and colleagues aim to characterize risk-adjusted 30-day Home Time in patients with acute myocardial infarction as a hospital-level performance metric, and to evaluate associations with risk-standardized readmission rates. The study included almost 985,000 patients with AMI hospitalization across almost 2,400 hospitals between 2009 and 2015 derived from a hundred percent of Medicare claims data. And they found that 30-day home time for patients with AMI can be assessed as a hospital-level performance metric using Medicare claims data. It varied across hospitals, was associated with post-discharge readmission and mortality outcomes, and meaningfully reclassified hospital performance compared with the 30-day readmission and mortality metric. Dr Greg Hundley: Very nice, Carolyn. Well, I'm coming back at you again with another quiz. But first, this paper is from Kamal Khabbaz from Beth Israel Deaconess Medical Center and the Harvard Medical School, and it's going to assess whether left atrial appendage closure or exclusion during bypass surgery has impact on short-term outcomes. So, Carolyn, here's your quiz. Do you think that patients receiving CABG with atrial fibrillation should undergo ligation of their left atrial appendage? Dr Carolyn Lam: Well, I think there's definitely equipoise there. On the one hand, you're already in a surgery. Why not just ligate it? It's not like we need a left atrial appendage. And then on the other hand, I suppose it extends the surgery, it involves some risk, and we don't know if it actually prevents further events. Did I answer that right? Dr Greg Hundley: Yes. Quite the politically correct answer, I think. Now, the objective of this study was to evaluate the impact of left atrial appendage exclusion on short-term outcomes in patients with atrial fibrillation undergoing isolated coronary artery bypass graft surgery. The study analyzed 250,287 CABG patients, of whom 7% received left atrial appendage closure. Only patients with a history of atrial fibrillation were included in the analysis, and the primary outcome was 30-day readmissions following discharge. Secondary outcomes included hospital mortality and stroke. And to assess the postoperative outcomes, the team utilized multivariable logistic regression models, and they adjusted for clinical and demographic co-variables. Dr Carolyn Lam: Great. So what did they find, Greg? Dr Greg Hundley: Okay. Couple of conclusions. First, left atrial appendage exclusion was associated with a greater risk of postoperative respiratory failure, acute kidney injury, but it did not significantly change the rate of blood transfusions or the occurrence of cardiac tamponade. Second, left atrial appendage exclusion was associated with a nonsignificant reduction in stroke, no difference in in-hospital mortality, and a greater risk of 30-day readmissions. Number three, after adjusting for these co-variables, left atrial appendage ligation remained a significant predictor of this 30-day readmissions. And so, Carolyn, in this study, it looks like left atrial appendage exclusion during isolated CABG in patients with AFib is associated with a higher rate of 30-day readmissions. Dr Carolyn Lam: Thanks, Greg. Well, let me talk about what else is in this issue. First is a pair of letters, one from Kai Wu regarding the article, "Effects of Sacubitril-Valsartan Versus Valsartan in Women Compared to Men With HFpEF: Insights From PARAGON-HF" and the response from Dr John McMurry. There are also two On My Mind pieces, one entitled "COVID-19 Arrhythmic Risk and Inflammation: Mind the Gap" by Dr Lazzerini, and another entitled, "Obesity, A Risk Factor for Severe COVID-19 Infection: Multiple Potential Mechanisms" by Dr Naveed Sattar. There are two perspective pieces, "Establishment and Management of Mechanical Circulatory Support During COVID-19 Pandemic" by Dr Pham, and "The COVID-19 Pandemic: A Global Natural Experiment" by Dr Blake Thomson. There's an in-depth paper entitled "The Science Underlying COVID-19: Implications for the Cardiovascular System" by Dr Peter Liu. This is important. This one's an editor's pick, so don't forget to read this. There's an ECG challenge by Dr Praveen Gupta on "Chest Pain with ST Elevation: Looking Behind the Masquerade." In Cardiology News by Tracy Hampton, she reviews the literature and highlights three papers, one, "A Cardiovascular Disease-Linked Gut Microbial Metabolite Acts via Adrenergic Receptors" in Cell 2020; two, "Noninvasive Localization of Cardiac Arrhythmias Using Electromechanical Wave Imaging" in Science and Translational Medicine 2020; and three, "Somatic Gene Editing Ameliorates Skeletal and Cardiac Muscle Failure in Pig and Human Models of Duchenne Muscular Dystrophy", and that in Nature Medicine 2020. For the President's Page, we have a piece by Keith Churchill, who's the Executive Vice President and CEO of Yale New Haven Hospital entitled "The Compelling Need to Address Uncertainty, Anxiety, and Financial Peril for Patients". There's Highlights from Circulation Family of Journals by Sara O'Brien, including "Factors Associated With Large Improvements in Health-Related Quality of Life in Patients with Atrial Fibrillation: Results From the ORBIT-AF" from Circulation Arrhythmia and Electrophysiology. There's "Association Between Sleep Disordered Breathing and Left Ventricular Function: A Cross-Sectional Analysis of the ECHO-SOL Ancillary Study" from Circulation Cardiovascular Imaging. There's also "The Impact of a 10 Rules Protocol on COVID-19 Hospital-Related Transmission: Insights from Padua University Hospital in Italy" from Circulation Cardiovascular Interventions. There's "The Association of an AMI Readmission-Reduction Program with Mortality and Readmission" from Circulation Cardiovascular Qualities and Outcomes. And finally, "Treatment Differences in Chronic Heart Failure Patients with Reduced Ejection Fraction According to Blood Pressure" in Check HF, and that's in Circulation Heart Failure. Dr Greg Hundley: Very nice, Carolyn. Well, I've got just a few Research Letters that I reviewed. First is from Professor Puck Peltenburg, and the Research Letter involves children and adolescents from Brugada syndrome families in which only the SCN5A mutation carriers develop a type one ECG pattern induced by fever. And the second research letter is from Dr David Saadoun, and this evaluates the long-term outcome and prognosis factors associated with isolated aortitis. And then finally, Carolyn, there's a very nice piece related to the current status of cardiovascular medicine in Israel from Professor Ran Kornowski at the Rabin Medical Center. Well, Carolyn, what a packed issue we have, and how about now we get on to that feature discussion? Dr Carolyn Lam: Let's go, Greg. Dr Greg Hundley: Well, listeners, we have a wonderful feature discussion for you in this next segment. We have Professor Keith Fox from Edinburgh and our own associate editor, Professor Stefan James from Uppsala. And we're going to discuss anticoagulation and antiplatelet therapy and rivaroxaban and aspirin and results from the COMPASS trial. Keith, could you tell us what was the background information and what was the hypothesis that you wanted to test with your study? Professor Keith Fox: The hypothesis was whether the combination of a very small dose, a quarter of the dose tested here, of a NOAC alongside an antiplatelet would be superior to aspirin alone, or we also tested a half dose of the NOAC by itself. And the overall trial showed that the quarter dose of rivaroxaban plus aspirin was substantially superior to aspirin alone in preventing cardiovascular death, MI, and stroke, with its biggest impact on strokes and cardiovascular death. So that's the trial as a whole. But our specific goal here was to look at the question of net clinical benefit because clinicians are challenged by any therapy that has a balance of both potential hazard, like bleeding risk, and benefit. So what we analyzed here were the pre-specified characteristics of net clinical benefit in terms of life-threatening and major bleeding into a critical organ, plus cardiovascular death, MI, and stroke. And I asked the question, what was the net clinical benefit? Dr Greg Hundley: Net clinical benefit. Now, tell us a little bit about what population you were looking to understand net clinical benefit, and then what was the study design? Professor Keith Fox: This is the whole of the COMPASS trial without the arm that tested rivaroxaban alone, because that did not show significant benefit. So this is the remaining 18,000 patients, double-blind randomized trial. And the trial, as a whole, was stopped early on the recommendation of the DSMB because it met the criteria for benefit by four standard deviations. Now, what's unusual about this is the population of our patients and vascular risk. So these are people who in the past would just be treated with aspirin. So they're not post-MI. They are people with chronic vascular disease, either peripheral or coronary. And in the past, on top of standard secondary prevention care, they would only have got aspirin. Dr Greg Hundley: And what were the results? Professor Keith Fox: There was a 20% reduction in terms of the net clinical benefit favoring the combination of rivaroxaban and aspirin, and that net clinical benefit being the combined impact of cardiovascular death, MI, stroke, fatal bleeding, or bleeding into a critical organ. Dr Greg Hundley: And did you find the same results in, for example, older versus some of the younger patients? Or were there any other high-risk subgroups, those with impaired renal function or those with heart failure where you saw particular differences? Professor Keith Fox: Yes, Greg. This is a really important issue. If one looked at the whole trial, the number needed to treat to prevent one of these adverse events, N equals 52. But then if we looked at some of the higher-risk cohorts, which we defined prospectively ... For example, these were the risk factors like polyvascular disease, impaired renal function, ambulant heart failure, or diabetes. And if you had all four risk factors, the number needed to treat was nine. If you had three risk factors, it was 12. Two risk factors, 31. So I think there's clearly a message for clinicians to be able to identify people with a combination of these risk factors, one or more, in order to get the most benefit and the least hazard. Dr Greg Hundley: Very interesting. Any speculation on mechanism? Professor Keith Fox: Yes. One of the things that we've done in the past is we've hammered one antithrombotic pathway. Like, for example, we've used more and more potent anti-platelets or combination of anti-platelets. But perhaps one of the things that we've forgotten is the fact that the platelet activation pathway is triggered by thrombin activation and vice versa. So the concept that was new behind the whole COMPASS study was that augmentation of the antithrombotic effects by combining a very small dose of a novel anticoagulant would be beneficial. And the critical question is, would it be sufficiently beneficial without producing a lot of bleeding? So that's why we did this particular analysis. Dr Greg Hundley: So lower doses of some of these drugs. Well, Stefan, can you help us put these study results into context with what we know today about using aspirin alone, rivaroxaban, et cetera? Professor Stefan James: The reason I think this study's so important and interesting is that, first, it's a very common population that we see now in the practice, patients with a stable phase of atherosclerotic disease, both coronary and peripheral vascular. And we need to take care of these patients better. Until now, we have not had very great alternatives for these patients. Now, we've learned what Keith said, that if you combine a low dose of both anti-platelet and antithrombin, you can inhibit and reduce the risk of ischemic events. And the other important finding here is that, I think conceptually very interesting, that if you are able to reduce their number of ischemic complications or thrombotic complications, but not doing that to such an extent that bleeding increases too much, not to an extent that bleeding causes fatal events, then you can find a nice balance between safety and efficacy that can lead to substantial reductions and improvements in terms of the clinical benefit. And that's what we see here in this trial. You can see that there is a reduction of thrombotic events, ischemic events, and there is also some bleeding, but not to such an extent that it affects overall survival and the overall event rate in these patients. And particularly in patients at high risk that you pointed out, these patients have a very high event rate. Although the relative benefit is similar, the absolute benefit is quite impressive. Dr Greg Hundley: Just very exciting to me. Very low doses of some of these common drugs. What's the next study in this field, Keith? Professor Keith Fox: We've got a big gap because we know that modern dual antiplatelet therapy works really well after an acute coronary syndrome and it's highly effective. In the longer term, we know, for example, from some of the studies with ticagrelor that there are cohorts that do well for a period of time after ACS, but really we don't know the bridge between this period and the long term and what role this therapy may have after essential dual antiplatelet therapy. Dr Greg Hundley: Stefan, do you have any thoughts? Professor Stefan James: I agree with Keith. This transition period, when is patient transitioned from being an acute coronary syndrome patient to a chronic coronary syndrome patient? When does that happen? And then probably it differs between individuals and type of events, and so we need to understand more of when is this patient acutely affected and when do we need potent dual antiplatelet therapy? And when can we transition to a more stable phase in which we can inhibit thrombotic events, ischemic events, but not increased bleeding to such a degree that it affects overall survival? And so I think we need to learn a lot more about that transition period and these subgroups of patients of different risks and risks of ischemic events and bleeding events. Dr Greg Hundley: Keith, how would you go about conducting a study in that regard? Professor Keith Fox: I think really one of the very interesting questions is whether the combination of the standard of care of, for example, aspirin and ticagrelor may be better, worse, or the same than this therapy instituted at the end of the period of essential dual antiplatelet therapy. And we need to know that. Dr Greg Hundley: In closing and summing up, Keith, are there any concepts that we want to take home here? Professor Keith Fox: I think that there are two key concepts. One is the synergy between the anticoagulation system and the antiplatelet system, with the potential to use very low doses, to minimize bleeding risk, yet have the benefits. That is the first concept. The second concept is that these chronic vascular disease patients Stefan has described are at continuing risk of vascular events, especially stroke, myocardial infarction, and cardiovascular death. And these can be modified. Dr Greg Hundley: And Stefan, any thoughts from you in closing? Professor Stefan James: I think this paper and the work that Keith has described is fantastic and fascinating to think about because these populations are incredibly large, and they are not doing well. They have a high risk of events, and we tend to forget that, and so we need to both identify them and start treating them now, as we have some evidence, but we'll also need to learn more of how to identify them, how to select them appropriately, and how to identify the transition from acute events to chronic events or current chronic phase of the disease. Dr Greg Hundley: Well, listeners, I want to thank both Professor Keith Fox and our own associate editor, Professor Stefan James, for this very interesting presentation of lower doses of anticoagulant and antiplatelet therapy in patients with chronic vascular disease and really being able to reduce events and diminish bleeding. On behalf of Carolyn and myself, we want to wish you a great week and look forward to catching you next week. Take care. This program is copyright of the American Heart Association 2020.
Hiện đang có hàng trăm cuộc thử nghiệm các loại thuốc trị Covid-19 trên thế giới, thế nhưng cho tới nay chỉ mới lóe một vài tia hy vọng thật sự, ấy là chưa kể một số chương trình nghiên cứu đang gặp nhiều khó khăn, nếu không muốn nói là thất bại, như chương trình Discovery của châu Âu. Làm sao ngặn chận virus corona chủng mới xâm nhập các tế bào, không cho chúng nhân ra gấp bội trong cơ thể, kiểm soát được phản ứng của hệ miễn dịch trước sự tấn công của virus. Các nhà khoa học đang cấp tốc nghiên cứu theo nhiều hướng khác nhau, cố tìm ra một liều thuốc công hiệu để trị một căn bệnh mà nay đã khiến hơn 300.000 người chết trên toàn thế giới Theo tạp chí y khoa The Lancet, hiện có hơn 800 cuộc thử nghiệm lâm sàng đang được tiến hành ở nhiều nước khác nhau để thẩm định hiệu quả của hàng chục loại thuốc trị Covid-19. Khoảng hơn 300 thử nghiệm được tiến hành ở Trung Quốc, nơi xuất phát dịch bệnh, 125 thử nghiệm ở Hoa Kỳ, quốc gia bị dịch nặng nhất hiện nay. Riêng tại Pháp thì có khoảng 45 cuộc thử nghiệm. Nhưng nhiều nhà nghiên cứu đang kêu gọi các đồng nghiệp không nên vì quá gấp rút mà bỏ quên tính chất nghiêm túc khoa học của các cuộc thử nghiệm, để không làm dấy lên những hy vọng hão huyền. Tại Pháp cũng như tại Mỹ, không ít viện nghiên cứu lớn đã gây tranh cãi khi vội vã thông báo các kết quả « khả quan » ngay cả trước khi công bố toàn bộ công trình nghiên cứu. Nhà truyền nhiễm học Florence Ader, người chỉ đạo cuộc thử nghiệm châu Âu Discovery, đã từng lên tiếng cảnh báo về cái mà bà gọi là « dịch nghiên cứu », vì có rất nhiều thử nghiệm thất bại « ngay từ trong trứng nước », do có quá ít bệnh nhân tham gia, hoặc được tiến hành với những phương pháp không có gì bảo đảm. Bà Ader khuyên là nên tập trung nỗ lực vào một số nghiên cứu lớn. Các loại thuốc đang được thử nghiệm Bây giờ chúng ta hãy điểm qua những loại thuốc chính yếu đang được thử nghiệm. Trước hết là remdesivir, do hãng dược phẩm Gilead của Mỹ phát triển để trị bệnh Ebola, nhưng đã tỏ ra không công hiệu đối với bệnh này. Tuy vậy, trong phòng thí nghiệm, remdesivir đã chứng tỏ khả năng ngăn chận các virus khác. Vấn đề là các dữ liệu về công hiệu của thuốc này đối với Covid-19 vẫn còn mâu thuẫn với nhau và vẫn còn tản mác. Hoa Kỳ trông chờ rất nhiều vào remdevisir, cho nên ngày 01/05 vừa qua, Cơ quan Quản lý Thực phẩm và Dược phẩm FDA đã cấp tốc cấp phép sử dụng loại thuốc này ngoài thử nghiệm lâm sàng trong các bệnh viện, trên cơ sở thử nghiệm rộng rãi trong công chúng. Kết quả cho thấy là tính trung bình, các bệnh nhân Covid-19 nặng hồi phục nhanh hơn 4 ngày so với các bệnh nhân nặng khác ( trong vòng 11 ngày thay vì 15 ngày ). Nhiều nhà nghiên cứu cho rằng kết quả này còn quá « khiêm tốn », tuy một số nhà nghiên cứu khác thì thấy dầu sao remdesivir cũng là một phương tiện để giảm bớt tình trạng quá tải của các bệnh viện. Giới khoa học cũng chỉ trích việc các kết quả của nghiên cứu về thử nghiệm remdesivir không được công bố toàn bộ. Mặt khác, nghiên cứu cũng không cho thấy là remdesivir đã thật sự làm giảm tỷ lệ tử vong, bởi vì sự cách biệt về tỷ lệ tử vong giữa nhóm bệnh nhân được cho uống thử thuốc ( 8% ) và nhóm đối chứng ( 11,6% ) là quá thấp so với ngưỡng cần thiết để kết quả thử nghiệm có thể được xem là chuẩn xác. Thứ hai là thuốc tocilizumab, được coi là niềm hy vọng cho những ca Covid-19 nặng, vì thuốc này điều hòa phản ứng của hệ miễn dịch, để không gây thêm tác hại cho cơ thể người bệnh. Vào cuối tháng 4, hệ thống bệnh viện Paris thông báo là thuốc tocilizumab giảm « đáng kể » nguy cơ tử vong hoặc nguy cơ phải vào khoa hồi sức nơi các bệnh nhân Covid -19 nặng, nhưng họ lại không đưa ra các số liệu cụ thể và cũng không công bố nội dung công trình nghiên cứu. Các cuộc thử nghiệm khác đang được tiến hành với thuốc tocilizumab. Nhưng cho dù thật sự có công hiệu, chi phí quá cao của loại thuốc này, cũng như cách điều trị bằng tiêm tĩnh mạch khiến cho rất khó sử dụng phổ biến. Thứ ba là thuốc trị sốt rét hydroxychloroquine, một loại thuốc đã làm hao tốn rất nhiều giấy mực trong những tháng qua. Theo hai công trình nghiên cứu được đăng trên tạp chí y khoa Anh Quốc BMJ ngày 15/05/2020, hydroxychloroquine dường như không có công hiệu trị Covid-19, cho dù là đối với các bệnh nhân nặng hay nhẹ. Công trình nghiên cứu thứ nhất, do các nhà nghiên cứu Pháp tiến hành, đã đi đến kết luận là loại thuốc chống sốt rét này không làm giảm đáng kể nguy cơ phải vào khoa hồi sức hoặc nguy cơ tử vong đối với các bệnh nhân nhập viện vì bị viêm phổi do Covid-19. Công trình nghiên cứu thứ hai, do một ê kíp nhà nghiên cứu Trung Quốc tiến hành, cho thấy là thuốc hydroxychloroquine không giúp diệt trừ virus nhanh hơn so với các thuốc chuẩn ở các bệnh nhân Covid-19 nhẹ, thậm chí các phản ứng phụ của thuốc chống sốt rét này còn nặng hơn các thuốc kia. Dựa trên hai kết quả nghiên cứu nói trên, tạp chí BMJ đánh giá là không nên sử dụng hydroxychloroquine như là một loại thuốc phổ biến để trị Covid-19. Thứ tư là thuốc chống HIV. Các cuộc thử nghiệm kết hợp hai loại thuốc điều trị HIV, lopinavir và ritonavir, vẫn chưa mang lại các kết quả được hứa hẹn. Một nghiên cứu của Trung Quốc được công bố ngày 19/03 đã kết luận là điều trị bệnh nhân Covid-19 bằng thuốc chống HIV không giúp giảm bớt nguy cơ tử vong cũng như không rút ngắn thời gian bình phục. Tuy nhiên, một số dữ liệu cho thấy là thuốc chống HIV có hiệu quả nếu cho bệnh nhân uống sớm. Discovery thất bại ? Được khởi động từ cuối tháng 3 với hy vọng nhanh chóng tìm ra một loại thuốc công hiệu để trị Covid-19, cho tới nay chương trình thử nghiệm lâm sàng Discovery của châu Âu vẫn chưa đạt được kết quả nào, do không có hợp tác chặt chẽ giữa các nước châu Âu và do hiệu quả của 4 loại thuốc được thử nghiệm không như là người ta hy vọng lúc ban đầu. Thật ra, nguyên nhân chủ yếu đó là số bệnh nhân được thử nghiệm hiện giờ còn quá ít, chỉ có 750 người, gần như toàn bộ là ở Pháp, trong khi mục tiêu đề ra là quy tụ đến 3.200 bệnh nhân ở châu Âu, trong đó có ít nhất 800 người ở Pháp. Lúc đầu có ít nhất 7 quốc gia châu Âu tuyên bố tham gia Discovery, trong đó có Anh, Đức, Tây Ban Nha, Bỉ, nhưng hiện chỉ có duy nhất một bệnh nhân bên ngoài Pháp, ở Luxembourg. Trả lời RFI Pháp ngữ ngày 12/05, bác sĩ Jean-Philippe Lanoix, khoa bệnh truyền nhiễm, bệnh viện Amiens, Pháp, nơi mà hai chương trình thử nghiệm trong khuôn khổ Discovery đang được tiến hành, cho biết : « Hiện nay chúng tôi có gần 750 bệnh nhân tham gia cuộc thử nghiệm, trên 800 bệnh nhân được dự kiến, tại Pháp. Đây là một điều rất tốt. Chúng tôi chưa có đủ các kết quả để có thể quyết định là nên ngưng thử nghiệm nào, bởi vì có thể đối với nhóm này thuốc có công hiệu hơn nhóm kia, cho nên phải ngưng thử nghiệm đối với nhóm mà thuốc hoàn toàn không có công hiệu. Trong thử nghiệm, bao giờ cũng có một nhóm bệnh nhân không được cho uống loại thuốc nào khác ngoài thuốc trị các triệu chứng, gọi là nhóm « chuẩn » và bốn nhóm kia được cho uống các loại thuốc hydroxychloroquine, remdesivir và hai loại thuốc chống virus khác. » Thật ra ban đầu thuốc chống sốt rét không được dự trù trong chương trình thử nghiệm Discovery, nhưng vì sao loại thuốc này đã được đưa vào, bác sĩ Lanoix giải thích : « Một trong những đặc điểm của chương trình thử nghiệm Discovery là thích ứng với diễn biến của dịch virus corona, vì thật sự là chúng ta chưa biết nhiều về dịch bệnh này. Những người khởi xướng chương trình đã dự trù sẽ bao gồm những loại thuốc lúc đầu họ không nghĩ là sẽ có công hiệu. Họ để mở ngỏ cánh cửa, để nếu có những loại thuốc nào xuất hiện trên thị trường, điều mà hiện nay vẫn còn có thể xảy ra, thì sẽ thêm một nhóm bệnh nhân thứ 5, thứ 6 vào các cuộc thử nghiệm lâm sàng. Thuốc hydroxychloroquine, sau khi đã chứng tỏ có phần nào công hiệu đối với một số bệnh nhân, đã được thêm vào để thử nghiệm trên nhóm bệnh nhân thứ 5 trong chương trình này. » Một khó khăn khác đối với chương trình thử nghiệm Discovery, đó là không có những quy định đồng nhất giữa các nước châu Âu tham gia chương trình này, theo lời bác sĩ Lanoix : « Trong việc xử lý các dữ liệu của bệnh nhân, nước này có thể có những quy định bó buộc hơn những nước khác, tùy theo các dữ liệu đó có thuộc diện bí mật thông tin sức khỏe hay không, ai được quyền xử lý các dữ liệu đó. Ví dụ như tôi thêm một bệnh nhân người Bỉ, một bệnh nhân người Đức vào chương trình thử nghiệm, trong những điều kiện nào, tôi có thể chuyển các dữ liệu y khoa đến các nhân viên thống kê ở những nước khác. Tôi nghĩ là mỗi nước có những quy định khác nhau và rõ ràng là không có một sự đồng nhất trong vấn đề này. Ấy là chưa kể là định nghĩa của mỗi nước cũng khác nhau. Trong chương trình Discovery có 5 nhóm, trong đó có một nhóm gọi là nhóm chuẩn, nhưng các nước và các bệnh viện không hẳn là có chung một định nghĩa về nhóm điều trị chuẩn. Chẳng hạn như tại Ý, một số bệnh viện và một số vùng đưa thuốc hydroxychloriquine và thuốc remdesivir vào nhóm điều trị chuẩn. Như vậy nhóm chuẩn của nước này lại khác với của những nước kia, điều này chắc chắn gây ra các vấn đề. » Những khó khăn của chương trình Discovery cũng phản ánh một thực tế : các nước châu Âu không thể có hành động chung, nhất là khi khi đối đầu với một khủng hoảng y tế khẩn cấp như dịch Covid-19. Đối với bác sĩ Lanoix, chương trình Discovery chưa đạt kết quả mong muốn, nhưng không hẳn là một thất bại : « Một trong những đặc điểm của chương trình thử nghiệm này, đó là đã được thiết lập trong một thời gian rất ngắn, và huy động các bệnh nhân thật là nhanh. Đúng là phải hoan nghênh các ê kíp đã tham gia vào việc khởi động chương trình Discovery. Nhưng ở cấp độ châu Âu thì việc tiến hành phải mất nhiều thời gian, vì phải đáp ứng những yêu cầu về hành chính. Đối với tôi, đó là điều không có gì đáng ngạc nhiên và không thể nói là chương trình thất bại. Tôi hy vọng là lần sau chúng ta sẽ chuẩn bị tốt hơn ở cấp độ châu Âu, để có phản ứng nhanh hơn, nếu có một đợt dịch thứ hai. Tôi nghĩ đây là cơ hội để các nước châu Âu làm việc với nhau, tuy là tốc độ còn chậm so với đà lây lan nhanh chóng của dịch Covid-19. » Kể từ khi chương trình Discovery được tiến hành, một ủy ban chuyên gia ở bên ngoài, có tên là Data Safety Monitoring Board (DSMB), vẫn họp định kỳ để phân tích các dữ liệu và cố vấn cho các nhà nghiên cứu. Theo khuyến cáo của DSMB, nên tiếp tục chương trình thử nghiệm Discovery, nhưng các nước châu Âu phải tích cực tuyển thêm nhiều bệnh nhân cho chương trình này.
1.Physical activity, common brain pathologies, and cognition in community-dwelling older adults 2. [What’s Trending]: Deep space medicine. In the first segment, Dr. Jeff Burns talks with Dr. Aron Buchman about his paper on physical activity, common brain pathologies, and cognition in community-dwelling older adults. In the second part of the podcast, Dr. Jason Crowell focuses his interview with Dr. Alejandro Rabinstein on the medicine of deep space. Dr. Jeff Burns has served on the DSMB for three NIH-funded trials; has received honorarium and travel for speaking at an Astra-Zeneca symposium; has served on the editorial board of Journal of Alzheimer's Disease; has served as a consultant for protocol development for Stage 2 Innovations; has received commercial research support from Lilly, Avid Radiopharmaceuticals, Toyama Chemical Company, Merck, Biogen, AbbVie, vTv Therapeutics, Janssen, and Roche and for investigator-initiated studies from Eli Lilly and Astra-Zeneca; has received governmental research support from the National Institutes of Health; and has provided expert witness testimony in legal cases. Dr. Aron Buchman has received government research support from the National Institutes of Health. Dr. Jason Crowell reports no disclosures. Dr. Alejandro Rabinstein has served as a member of the external committee for adverse event adjudication for PREVAIL trial/CAP2 registry; has served on the editorial boards of Neurology, Neurocritical Care, Stroke, CONTINUUM , and UpToDate; and has received publishing royalties from Elsevier and Oxford.
1.Quality of Life Outcomes in Patients Presenting for Evaluation of Central Nervous System Tumors 2. [What’s Trending]: 'Landmark study’ shows brain cells revamp their DNA, perhaps sparking Alzheimer’s disease. In the first segment, Dr. Ted Burns talks with Dr. Irene Katzan about her paper on quality of life outcomes in patients presenting for evaluation of central nervous system tumors. In the second part of the podcast, Dr. Jeff Burns focuses his interview with Dr. Jerold Chun on a 'Landmark study’ showing brain cells revamp their DNA, perhaps sparking Alzheimer’s disease.Dr. Ted Burns has served on scientific advisory boards for Argenx, Momenta, received travel funding or speaker honoraria from Argenx, Alexion and received support for consulting activities from UCB Pharma, CSL Behring, Momenta, Argenx. Dr. Irene Katzan has served on editorial boards for Stroke (American Stroke Association), 2014-present Editorial Board - Circulation: Cardiovascular Quality & Outcomes (American Heart Association) 2013 – present. Dr. Irene Katzan has received research from one commercial entity including Novartis Pharmaceuticals and received research support from the following government entity: Ohio Department of Health - Physician Lead for the Ohio Paul Coverdell Stroke Registry, 2007-2020. Dr. Burns has served on the DSMB for NIH-funded trials (non-profit entities); serves on the editorial board for Journal of Alzheimer's Disease; has consulted for Grifols, USA; has served on Eli Lilly Amyvid Speaker's Bureau; and has received research support from Eli Lilly, Avid Radiopharmaceuticals, Toyama Chemical Company, Merck, Biogen, AbbVie, Novartis, vTv Therapeutics, Janssen, and NIH (R01AG058557, R01AG053312, R01AG034614, R01AG03367, R01AG043962, P30AG035982, U10NS077356, UL1TR000001).Dr. Jerold Chun reports no disclosures.
1. Early predictors of mortality in parkinsonism and Parkinson’s disease: a population-based study 2. [What’s Trending]: Data from the Largest Natural History Study of Stiff Person Syndrome. In the first segment, Dr. Jeffery Ratliff talks with Dr. David Bäckström about his paper on Early predictors of mortality in parkinsonism and Parkinson’s disease. In the second part of the podcast, Dr. Jeffery Ratliff focuses his interview with Marinos Dalakas on Stiff Person Syndrome. DISCLOSURES:Dr. Jeff Ratliff has received speaker honoraria from Teva and US WorldMeds LLC; is the deputy editor for the Neurology Podcast; has been a consultant for UCB Pharmaceuticals, US WorldMeds LLC, Medscape, and Retrophin Inc; and has served on speakers' bureaus for Teva and US WorldMeds LLC. Dr. David C Bäckström holds patents for chemical compounds that may be developed as treatments for premenstrual dysphoric disorder, but has not received any personal compensation for the patents. Dr. David C Bäckström has received Research Support from Swedish Medical Research Council, grant number (K2013- 62X-15224-10-4) and unrestricted grant for Parkinson's disease research and has received foundation and societies research support from Erling Persson Foundation, Umeå University, Västerbotten County Council, King Gustaf V and Queen Victoria Freemason Foundation, Swedish Parkinson Foundation, Kempe Foundation, and Swedish Parkinson’s Disease Association. Dr. Marinos Dalakas serves the CIDP steering committee for Novartis and on DSMB for Baxalta and Octapharma, has received funding or served as a travel speaker honoraria for Merck/Serono, OCTAPHARMA, PFIZER AG. Dr. Marinos Dalakas has served on editorial board including Neurology, editorial board (5 years, not compensated), BMC Neurology (Section Editor, 5 years not compensated), Acta Myologica, editorial board (5 years, not compensated), Acta Neurologica Scandinavica editorial board (5 years, not compensated), and Therapeutic Advances in Neurology (Associate Editor; 4 years, compensated). Dr. Marinos Dalakas consultancies include work with Therapath, Baxter, Octapharma, CSL, Dysimmune Diseases Foundation and he has received research and institutional support from Thomas Jefferson University Neurology department or to Neuroimmunology Unit, University of Athens Medical School for research and education from: Merck-Serono, Genzyme, Novartis, Guillain-Barre/CIDP Foundation, Dysimmune diseases Foundation, CSL, Biogen and Newfactor.
1. Practice guideline recommendations summary: Disorders of consciousness2. Multiscale Analysis of Independent Alzheimer’s Cohorts Finds Disruption of Molecular, Genetic, and Clinical Networks by Human HerpesvirusIn the first segment, Dr. Jeff Burns talks with Dr. Joseph Giacino about the AAN Guideline update on disorders of consciousness. In the second part of the podcast, we are featuring a discussion with Dr. Jason Crowell and Dr. Joel Dudley discuss the detection of human herpesvirus genes in in a large cohort patients with Alzheimer disease.DISCLOSURES: Dr. Burns has served on the DSMB for NIH-funded trials (non-profit entities); serves on the editorial board for Journal of Alzheimer's Disease; has consulted for Grifols, USA; has served on Eli Lilly Amyvid Speaker's Bureau; and has received research support from Eli Lilly, Avid Radiopharmaceuticals, Toyama Chemical Company, Merck, Biogen, AbbVie, Novartis, vTv Therapeutics, Janssen, and NIH (R01AG058557, R01AG053312, R01AG034614, R01AG03367, R01AG043962, P30AG035982, U10NS077356, UL1TR000001). Dr. Giacino has served on the scientific advisory board for the Traumatic Brain Injury Model Systems National Data and Statistical Center (federal agency); serves on the editorial board for Journal of Head Trauma Rehabilitation; serves as Director of the Spaulding Rehabilitation Network Disorders of Consciousness Program; has received research support from the U.S. Department of Defense, (Co-Investigator, W81XWH-11- 2-0210; Co-Investigator, W81XWH- 08-2-0159; Co-PI, W81XWH-14-2-0176), National Institute on Disability and Rehabilitation Research, (PI, H133A120085; site PI, 90DP0060; PI 4, 90DPTB0011), National Institutes of Health (Co-PI, 1U01NS086090-01; Co-PI, UH3NS095554), James S. McDonnell Foundation, and the The Barbara Epstein Foundation, Inc; and served as expert witness in legal proceedings for DeCorato Cohen Sheehan & Federico. Dr. Crowell and Dr. Dudley report no disclosures.
1. Featured Article: Relapse occurrence in women with multiple sclerosis during pregnancy in the new treatment era2. What’s Trending: Sleep architecture and risk of dementiaThis podcast begins and closes with Dr. Robert Gross, Editor-in-Chief, briefly discussing highlighted articles from the March 6, 2018, issue of Neurology. In the first segment, Dr. Stacey Clardy talks with Dr. Raed Alroughani about his article on relapse recurrence during pregnancy in women with multiple sclerosis. In the second part of the podcast, you’ll hear Dr. Jeff Burns interviews Dr. Sudha Seshadri about sleep and dementia risk.DISCLOSURES: Dr. Clardy has received research support from Western Institute for Biomedical Research (WIBR). Dr. Alroughani served in scientific advisory boards of Novartis, Bayer, Merck-Sorono, Roche, Biogen, Sanofi-Geznyme; has received speaker and travel honoraria from Novartis, Bayer, Merck-Sorono, Biogen, Roche, Sanofi-Genzyme and GSK; and has received research grants from Biogen, Novartis and Sanofi-Genzyme.Dr. Burns has served on the DSMB for NIH-funded trials (non-profit entities); serves on the editorial board for Journal of Alzheimer's Disease; has consulted for Grifols, USA; has served on Eli Lilly Amyvid Speaker's Bureau; and has received research support from Eli Lilly, Avid Radiopharmaceuticals, Toyama Chemical Company, Merck, Biogen, AbbVie, Novartis, vTv Therapeutics, Janssen, and NIH (R01AG058557, R01AG053312, R01AG034614, R01AG03367, R01AG043962, P30AG035982, U10NS077356, UL1TR000001).Dr. Seshadri serves on editorial boards for Journal of Alzheimer's Disease, Stroke, and Neurology; and has received research support from NIA (AG008122, AG033040, AG049505, AG033193, AG049607, AG054076).
Liston Witherill teaches you how to cultivate marketing partnerships that get your work, ideas, book, etc. exposed to a much larger audience than you have access to on your own.
1. Featured Article: Practice guideline update summary: Mild cognitive impairment2. Lesson of the Week: Migraine and hormonesThis Neurology® Podcast begins and closes with Dr. Robert Gross, Editor-in-Chief, briefly discussing highlighted articles from the January 16, 2018, print issue of Neurology. In the first segment, Dr. Jeff Burns talks with Dr. Ronald Petersen about the updated 2001 AAN guideline on prevalence, prognosis, and treatment of MCI. For the Lesson of the Week, Dr. Teshamae Monteith speaks with Dr. Jelena Pavlovic about the association between hormones and migraine. DISCLOSURES: Dr. Burns has served on the DSMB for NIH-funded trials (non-profit entities); serves on the editorial board for Journal of Alzheimer's Disease; has consulted for Grifols, USA; has served on Eli Lilly Amyvid Speaker's Bureau; and has received research support from Eli Lilly, Avid Radiopharmaceuticals, Toyama Chemical Company, Merck, Biogen, AbbVie, Novartis, vTv Therapeutics, Janssen, and NIH (R01AG058557, R01AG053312, R01AG034614, R01AG03367, R01AG043962, P30AG035982, U10NS077356, UL1TR000001).Dr. Petersen receives publishing royalties from Mild Cognitive Impairment (Oxford University Press, 2003); has consulted for Roche Incorporated, Merck, Genentech, and Biogen; and receives research support from National Institute on Aging (U01-AG006786, P50-AG016574, U01-AG024904, and U01-AG016976). Dr. Monteith serves as an editorial advisory board member for Neurology Now and receives research support from the NIH.Dr. Pavlovic has received consulting honoraria and travel support from Allergan, Inc. and travel/conference registration support from The American Headache Society.
I have a soft spot for training because a big part of my background is in technical training for adults.So I'm always enthusiastic about the idea of devs diversifying their income and increasing profitability by offering training services in addition to development work.Reuven Lerner is the ideal person to teach you about getting started in training because he's done it himself. He's landed recurring training clients, some of which are household tech names. He builds and refines his own curriculum from scratch. He runs a Facebook group for devs who are interested in getting into technical training: https://www.facebook.com/groups/techtraining/From a profitability perspective, training is very attractive because of how deterministic the pricing can be. Strictly productized services aside, training is priced more like a product than almost any other service I can think of except for services like massages, haircuts, etc. Pricing is usually set on a per student per day basis. For example, you might charge $300 per student per day, and collect $9,000 for a 3-day class with 10 students attending.Compared to a software project that might just as easily take 9 months to complete as 3, that is highly predictable revenue once the sale is made, and that predictability has a beneficial effect in planning your other revenue-generating activities.
1) Midlife systemic inflammatory markers are associated with late-life brain volume: The ARIC study2) What’s Trending: Neurology paper on breast feeding, ovulatory years, and risk of multiple sclerosisThis podcast begins and closes with Dr. Robert Gross, Editor-in-Chief, briefly discussing highlighted articles from the November 28, 2017 issue of Neurology In the first segment, Dr. Jeff Burns talks with Dr. Keenan Walker about his paper on the association between systemic inflammation and brain volume over time. For our What’s Trending segment, Dr. Stacey Clardy focuses her interview with Dr. Annette Langer-Gould about her recent Neurology article on breast feeding, ovulatory years, and risk of multiple sclerosis.DISCLOSURES: Dr. Burns has served on the DSMB for NIH-funded trials (non-profit entities); serves on the editorial board for Journal of Alzheimer's Disease; has consulted for Grifols, USA; has served on Eli Lilly Amyvid Speaker's Bureau; and has received research support from Eli Lilly, Avid Radiopharmaceuticals, Toyama Chemical Company, Merck, Biogen, AbbVie, Novartis, vTv Therapeutics, Janssen, and NIH (R01AG058557, R01AG053312, R01AG034614, R01AG03367, R01AG043962, P30AG035982, U10NS077356, UL1TR000001)Dr. Walker has received research support from the National Institute of Aging (AG027668, postdoc fellow, 2016-17).Dr. Clardy has received research support from Western Institute for Biomedical Research (WIBR).Dr. Langer-Gould has received research support from Biogen, Roche, NIH, PCORI, and the National Multiple Sclerosis Society.
Jake Jorgovan teaches you how to generate leads on LinkedIn. Only works for specialized companies!
Show description/summary:1) Longitudinal diffusion changes following postoperative delirium in older people without dementia2) What’s Trending: Poor sleep is associated with CSF biomarkers of amyloid pathology in cognitively normal adultsThis podcast begins and closes with Dr. Robert Gross, Editor-in-Chief, briefly discussing highlighted articles from the September 5, 2017 issue of Neurology. In the first segment, Dr. Pearce Korb talks with Dr. Michele Cavallari and Dr. David Alsop about their paper on longitudinal diffusion changes following postoperative delirium in people without dementia. In the second part of the podcast, Dr. Jeff Burns focuses his interview with Dr. Barbara Bendlin on poor sleep and biomarkers of amyloid pathology in cognitively normal adults. Disclosures can be found at Neurology.org.DISCLOSURES: Dr. Alsop serves as associate editor for Magnetic Resonance in Medicine; has received research support from GE Healthcare Technologies, NIH (P01 AG031720, R01 MH080729, R01 NS047029, R21 EB014471, R01 CA169470, P20 DK108276, R44 DK111260); and receives royalty payments for Patent 7,545,142 (arterial spin labeling with pulsed radio frequency sequences) and from GE Healthcare, Philips Healthcare, Siemens Medical, Hitachi Medical, and Animage Technology.Dr. Cavallari has received research support from NIA (P01AG03172).Dr. Burns has served on the DSMB for NIH-funded trials (non-profit entities); serves on the editorial board for Journal of Alzheimer's Disease; has consulted for Grifols, USA; has served on Eli Lilly Amyvid Speaker's Bureau; and has received research support from Eli Lilly, Avid Radiopharmaceuticals, Toyama Chemical Company, Merck, Biogen, AbbVie, Novartis, vTv Therapeutics, Janssen, and NIH (R01AG058557, R01AG053312, R01AG034614, R01AG03367, R01AG043962, P30AG035982, U10NS077356, UL1TR000001). Dr. Bendlin serves as associate editor for Journal of Alzheimer's Disease; and has received research support from NIH/NIA (Alzheimer's Disease Connectome Project, U01AG051216, P50 AG033514, R01AG037639, R56AG052698, R21AG053738, P50 AG033514, 1U54AI117924).Dr. Korb reports no disclosures.
Show description/summary:1) Evidence-based guideline summary: Reducing brain injury following cardiopulmonary resuscitation2) Neurology Today® paper: “Prolonged Holter-ECG monitoring found to improve detection of atrial fibrillation after acute stroke”This podcast begins and closes with Dr. Robert Gross, Editor-in-Chief, briefly discussing highlighted articles from the May 30, 2017 issue of Neurology. In the first segment, Dr. Andrew Schomer talks with Dr. Romergryko Geocadin about the AAN practice guideline on reducing brain injury following cardiopulmonary resuscitation. In the next part of the podcast Dr. Matthew Ehrlich focuses his interview with Dr. Rolf Wachter on the Neurology Today feature, “Prolonged Holter-ECG monitoring found to improve detection of atrial fibrillation after acute stroke.” Disclosures can be found at Neurology.org. DISCLOSURES:Dr. Geocadin serves on the DSMB for the PEARL Study: “A Randomized Pilot Clinical Trial of Early Coronary Angiography Versus No Early Coronary Angiography for Post-Cardiac Arrest Patients with No ST Segment Elevation on the ECG” funded by the State of Arizona Biomedical Research Commission; serves on editorial boards for Neurocritical Care and Resuscitation; receives research support from NIH (grant R01 HL071568); and is co-author of "Post-Cardiac Arrest Care: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care."All other participants report no disclosures.
Show description/summary:1) Serum neurofilament light chain as a biomarker for mild traumatic brain injury in contact sports2) What's Trending: Biomarker validation and precision medicine in Parkinson disease.This podcast begins and closes with Dr. Robert Gross, Editor-in-Chief, briefly discussing highlighted articles from the May 9, 2017 issue of Neurology. In the first segment, Dr. Kristen Heinan talks with Dr. Pashtun Shahim about his paper on serum neurofilament light chain as a biomarker for mild traumatic brain injury in contact sports. In the next part of the podcast Dr. Alberto Espay focuses his discussion with Dr. David Standaert on biomarker validation and precision medicine in Parkinson disease. Disclosures can be found at Neurology.org.DISCLOSURES: Dr. Espay serves as Associate Editor for the Journal of Clinical Movement Disorders; serves as an editorial board member of Parkinsonism and Related Disorders and The European Neurological Journal; serves on the scientific advisory board for Solvay Pharmaceuticals, Inc. (now Abbvie), Chelsea Therapeutics International, Ltd., Teva Pharmaceutical Industries Ltd., Impax, Merz Pharmaceuticals, Inc., Pfizer Inc, Solstice Neurosciences, Eli Lilly and Company, ACADIA Pharmaceuticals, Inc. and USWorldMeds; is a consultant for Chelsea Therapeutics International, Ltd., Solvay Pharmaceuticals, Inc. (now Abbvie), ACADIA Pharmaceuticals, Inc., Cynapsus and Lundbeck, Inc; receives royalties for publications of books from Lippincott, Williams & Wilkins and Cambridge University Press; serves on the speakers' bureau of UCB, Teva Pharmaceutical Industries Ltd., American Academy of Neurology and Movement Disorders Society; receives research support from the CleveMed/Great Lake Neurotechnilogies, Michael J. Fox Foundation and the NIH.Dr. Standaert serves on scientific advisory boards for the American Parkinson Disease Association; serves on the DSMB for Shire/Biropharma; received honoraria from the Movement Disorder Society and Georgia Regents University; is Associate Editor for Movement Disorders; receives publishing royalties for Movement Disorders (McGraw-Hill Publishers, 3rd ed.); consulted for Serina Therapeutics, Kirchner Group, Teva Neuroscience, Abbvie, and the U.S. Attorney's Office; receives research support from Abbvie, Acerta Pharmaceuticals, Ceregene, Quintiles, NIH, Alabama Department of Commerce, American Parkinson Disease Association, Michael J. Fox Foundation for Parkinson Research, Bachmann-Strauss Dystonia & Parkinson Foundation, and the Dystonia Medical Research Foundation.All other participants report no disclosures.
1) Relationship between Risk Factor Control and Vascular Events in the SAMMPRIS Trial 2) What's Trending: 2017 AAN Annual Meeting3) Topic of the Month: neuromuscular medicineThis podcast begins and closes with Dr. Robert Gross, Editor-in-Chief, briefly discussing highlighted articles from the January 24, 2017 issue of Neurology. In the first segment, Dr. Joseph Carrera talks with Dr. Tanya Turan about her paper on risk factor control and vascular events in the SAMMPRIS trial. Dr. Ted Burns talks with Christy Phelps about the 2017 AAN Annual Meeting for our “What's Trending” feature of the week. In the next part of the podcast Dr. Ted Burns focuses his interview with Dr. Anthony Amato on myositis. Disclosures can be found at Neurology.org.DISCLOSURES:Dr. Turan serves on a scientific advisory board for Boehringer Ingelheim; serves on blinded Neurological Events Adjudication Committees for Boehringer Ingelheim and W.L. Gore and Associates; is Review Editor for Frontiers in Endovascular and Interventional Neurology and specialty editor of Frontiers in Neurology; serves on editorial boards for World Journal of Neurology, Brain and Behavior, and Annals of Translational Medicine; and received research support from NIH/NINDS K23 award for activities in the SAMMPRIS trial.Dr. Burns serves as Podcast Editor for Neurology; and has received research support for consulting activities with UCB, CSL Behring, Walgreens and Alexion Pharmaceuticals, Inc.Dr. Amato serves on medical advisory boards for MedImmune, Amgen, Novartis, DART, Biogen, Acceleron, and DSMB for NIH; is Associate Editor for Neurology and Muscle & Nerve; possesses publishing royalties for Neuromuscular Disease (McGraw-Hill 2016); serves as medical consultant for MedImmune, Amgen, Biogen, Novartis, Acceleron, Analgesic Solutions, Up-to-Date, and Best Doctors; and receives research support from Novartis, Alexion, and Amgen.Christy Phelps serves as Deputy Executive Director for the AAN.Dr. Carrera reports no disclosures.
1) Glucocorticoid-associated worsening in reversible cerebral vasoconstriction syndrome2) What's Trending: Upcoming changes regarding the Neurology® Resident & Fellow section 3) Topic of the Month: Neuromuscular topicsThis podcast begins and closes with Dr. Robert Gross, Editor-in-Chief, briefly discussing highlighted articles from the January 17, 2017 issue of Neurology. In the first segment, Dr. Andy Southerland talks with Dr. Aneesh Singhal about his paper on glucocorticoid-associated worsening of reversible cerebral vasoconstriction syndrome. Dr. Ted Burns talks with Dr. Roy Strowd about upcoming changes regarding the Neurology Resident & Fellow section for our “What's Trending” feature of the week. In the next part of the podcast, Dr. Ted Burns focuses his interview with Dr. Volker Straub on limb-girdle dystrophy. Disclosures can be found at Neurology.org.DISCLOSURES: Dr. Southerland serves as Podcast Deputy Editor for Neurology; receives research support from the American Heart Association-American Stroke Association National Clinical Research Program, American Academy of Neurology, American Board of Psychiatry and Neurology, Health Resources Services Administration and the NIH; has a provisional patent application titled: “Method, system and computer readable medium for improving treatment times for rapid evaluation of acute stroke via mobile telemedicine;” and gave legal expert review. Dr. Aneesh Singhal has served on the scientific advisory boards of Biogen and DSMB; has served on the editorial board of Medical Gas Research; has received publishing royalties for the book Reversible Cerebral Vasoconstriction Syndromes; has been a consultant to Biogen; has acted as an event adjudicator for the Thrombolysis in Myocardial Infarction (TIMI) Trial Group; has received research support from Boehringer Ingelheim, NIH-NINDS, the American Academy of Neurology, UpToDate, and Medlink; and has served as a medicolegal expert witness for individual cases concerning stroke. Dr. Burns serves as Podcast Editor for Neurology®; and has received research support for consulting activities with UCB, CSL Behring, Walgreens and Alexion Pharmaceuticals, Inc. Dr. Strowd serves on the editorial team for the Neurology® Resident and Fellow Section. Dr. Straub has served on the scientific advisory boards for Pfizer, Italfarmaco, Audentes Therapeutics, Bristol-Myer Squibb, Summit Therapeutics, Tivorsan, and the Nationwide Children's Hospital; has received travel funding and speaker honoraria from Sanofi Genzyme; has served on the editorial boards of Neuromuscular Disorders, the Journal of Neuromuscular Diseases, and PLoS Currents Muscular Dystrophy; has been a consultant for Sanofi Genzyme; and has received research support from Sanofi Genzyme, BioMarin, Ionis Pharmaceuticals, Sarepta Therapeutics, Ultragenyx, the European Commission, the UK Medical Research Council, Newcastle University, the Parent Project Muscular Dystrophy, the Association Fracaise Contre les Myopathies, the LGMD2I Research Fund, the Wellcome Trust, the Sylvia Aitken Charitable Trust, Muscular Dystrophy UK, and Action Medical Research.All other participants have no disclosures.
1) Efficacy and safety of deflazacort versus prednisone and placebo for Duchenne muscular dystrophy2) e-Pearl topic: Alien limb phenomenon3) Topic of the month: How to examine and approach movement disordersThis podcast for the Neurology Journal begins and closes with Dr. Robert Gross, Editor-in-Chief, briefly discussing highlighted articles from the print issue of Neurology. In the second segment Dr. Kelly Gwathmey interviews Dr. Robert Griggs about his the efficacy and safety of deflazacort versus prednisone for boys with Duchenne muscular dystrophy. Dr. Ilena George is reading our e-Pearl of the week about alien limb phenomenon. In the next part of the podcast Dr. Alberto Espay interviews Dr. Don Gilbert on the topic of tics.DISCLOSURES: Dr. Griggs serves as Correspondence Editor for Neurology®; serves as an editorial board member of NeuroTherapeutics and Current Treatment Opinions in Neurology; serves on the scientific advisory board for SAB for National Hospital Queen Square, Marathon Pharmaceuticals, PTC Therapeutics, Inc., DSMB, Taro Pharm and Sarepta Pharmaceuticals; is a consultant for Marathon, PTC Therapeutics, Sarepta, Taro Pharm and Idera Pharmaceuticals;receives royalties for data of previous studies from Taro Pharm and Marathon Pharmaceuticals; receives royalties from the publication of the books: Andreoli and Carpenter's Cecil Essentials of Medicine, Eighth Edition, Cecil Textbook of Medicine, multiple editions and Evaluation and Treatment of Myopathies; receives research support from Taro Pharma, Marathon Pharmaceuticals, Parent Project Muscular Dystrophy, Inc., Muscular Dystrophy Association, Novel Molecular Mechanisms of Neuromuscular Disease: Implications for Therapy and the NIH.Dr. George serves on the editorial team for the Neurology® Resident and Fellow Section. Dr. Espay serves as Associate Editor for the Journal of Clinical Movement Disorders; serves as an editorial board member of Parkinsonism and Related Disorders and The European Neurological Journal; serves on the scientific advisory board for Solvay Pharmaceuticals, Inc. (now Abbvie), Chelsea Therapeutics International, Ltd., Teva Pharmaceutical Industries Ltd., Impax, Merz Pharmaceuticals, Inc., Pfizer Inc, Solstice Neurosciences, Eli Lilly and Company, ACADIA Pharmaceuticals, Inc. and USWorldMeds; is a consultant for Chelsea Therapeutics International, Ltd., Solvay Pharmaceuticals, Inc. (now Abbvie), ACADIA Pharmaceuticals, Inc., Cynapsus and Lundbeck, Inc; receives royalties for publications of books from Lippincott, Williams & Wilkins and Cambridge University Press; serves on the speakers' bureau of UCB, Teva Pharmaceutical Industries Ltd., American Academy of Neurology and Movement Disorders Society; receives research support from the CleveMed/Great Lake Neurotechnilogies, Michael J. Fox Foundation and the NIH.Dr. Gilbert serves on the scientific advisory boards of Investigations of Neuroplasticity Mechanisms in Autism Spectrum Disorders, the Berenson-Allen Center for Noninvasive Brain Stimulation, and Beth Israel Deaconess Medical Center; received honoraria from the Tourette Association of America, the Centers for Disease Control and Prevention, and the Hong Kong Society of Child Neurology and Developmental Pediatrics; received funding for travel for educational talks to physicians and affected patients and families;receives royalties from the publication of the book Movement Disorders in Childhood, 2nd edition; receives research support from Ecopipam Pharmaceuticals, Neurocrine Pharmaceuticals, EryDel Pharmaceuticals, and NIH; and has provided expert testimony for the Health Resources and Services Administration, Department of Health and Human Services regarding Division of Vaccine Injury Compensation Programs.
Medicine is powered by knowledge, but how do we know what is true and what is not? How do we deal with uncertainty in a setting where outcomes are not closely related to known variables? For example, although there are a few people who have survived jumping or falling from an airplane at high altitude (http://zidbits.com/2010/12/can-you-survive-a-freefall-without-a-parachute/), it is a rare event. Thus, a test to determine how to prevent death from such a disaster would only take a small number of participants to see if a particular method works. In contrast, when considering a medical condition where a large fraction of people might seemingly "recover" without treatment, such as tuberculosis (http://www.who.int/mediacentre/factsheets/who104/en/print.html), how does one determine if a treatment is effective? In this talk, I will examine how we gained knowledge about tuberculosis as an example of a disease where a combination of observational scientific findings and clinical trial data are linked to advance knowledge. I will also discuss other examples of clinical trials challenges and the solutions to these challenges.
Medicine is powered by knowledge, but how do we know what is true and what is not? How do we deal with uncertainty in a setting where outcomes are not closely related to known variables? For example, although there are a few people who have survived jumping or falling from an airplane at high altitude (http://zidbits.com/2010/12/can-you-survive-a-freefall-without-a-parachute/), it is a rare event. Thus, a test to determine how to prevent death from such a disaster would only take a small number of participants to see if a particular method works. In contrast, when considering a medical condition where a large fraction of people might seemingly "recover" without treatment, such as tuberculosis (http://www.who.int/mediacentre/factsheets/who104/en/print.html), how does one determine if a treatment is effective? In this talk, I will examine how we gained knowledge about tuberculosis as an example of a disease where a combination of observational scientific findings and clinical trial data are linked to advance knowledge. I will also discuss other examples of clinical trials challenges and the solutions to these challenges.
1) Predictive value of ABCD2 and ABCD3-1 scores in TIA and minor stroke in the Stroke Unit Setting2) e-Pearl topic: Alternating hemiplegia of childhood3) Topic of the month: Neurology Today story about his book review on: “The Laws of Medicine: Field Notes from an Uncertain Science.”This podcast for the Neurology Journal begins and closes with Dr. Robert Gross, Editor-in-Chief, briefly discussing highlighted articles from the print issue of Neurology. In the second segment Dr. Anna Ranta interviews Dr. Michael Knoflach about his paper on the predictive value of ABCD2 and ABCD3-1 scores in transient ischemic attack and minor stroke in the Stroke Unit Setting. Dr. Steve O'Donnell is reading our e-Pearl of the week about alternating hemiplegia of childhood. Dr. Ted Burns interviews Jose Merino about a Neurology Today story about his book review on: “The Laws of Medicine: Field Notes from an Uncertain Science.”DISCLOSURES: Dr. Ranta receives research support from the New Zealand Health Research Council.Dr. O'Donnell serves on the editorial team for the Neurology® Resident and Fellow Section.Dr. Ted Burns serves as Podcast Editor for Neurology®; and has received research support for consulting activities with UCB, CSL Behring, Walgreens and Alexion Pharmaceuticals, Inc.Dr. Merino serves as US Clinical Research Editor for the BMJ; serves as Co-editor, blogging stroke (A Stroke journal blog); receives stroke outcomes adjudicator for the WHI study (NIH-funded); and DSMB of a PCORI-funded trial to evaluate depression in caregivers of patients with Alzheimer disease.
1) Impaired self-agency in functional movement disorders2) What's Trending: Interview with James Sejvar about possible links between Zika virus, microcephaly, and Guillain–Barre syndrome3) Topic of the month: Neurology Today story about where advances are revolutionizing stroke treatmentThis podcast for the Neurology Journal begins and closes with Dr. Robert Gross, Editor-in-Chief, briefly discussing highlighted articles from the print issue of Neurology. In the second segment Dr. Michelle Fullard interviews Dr. Carine Maurer about her paper on impaired self-agency in functional movement disorders Dr. Andy Southerland is interviewing Dr. James Sejvar for our “What's Trending” feature of the week on the topic of possible links between Zika virus, microcephaly, and Guillain–Barre syndrome. Dr. Andy Southerland interviews Dr. Ralph Sacco about a Neurology Today story on the topic of where advances are revolutionizing stroke treatment.DISCLOSURES: Dr. Maurer receives research support from the NINDS Intramural Program.Dr. Southerland serves as Podcast Deputy Editor for Neurology; receives research support from the American Heart Association-American Stroke Association National Clinical Research Program, American Academy of Neurology, American Board of Psychiatry and Neurology, Health Resources Services Administration and the NIH; has a provisional patent application titled: “Method, system and computer readable medium for improving treatment times for rapid evaluation of acute stroke via mobile telemedicine;” and gave legal expert review.Dr. Sacco serves as an editorial board member of Stroke and Neuroepidemiology; serves on the scientific advisory board for DSMB for SOCRATES Trial through UCSF(indirect sponsor Astra Zeneca) and EUCLID trial through Duke Clinical Research Institute (indirect sponsor Astra Zeneca); receives research support from Boehringer Ingelheim, Evelyn McKnight Brain Institute, American Heart Association Burgher Foundation and the NIH.
1) Low-cost, tablet-based option for prehospital neurologic assessment: the iTREAT Study2) What's Trending: Interview with Dafne Horovitz about her paper on cranial bone collapse in microcephalic infants prenatally exposed to Zika virus infection3) Topic of the month: Controversies in Neurology Plenary Session at the AAN meeting about the pro and con effects of cognitive enhancing activities and their effects on preventing dementiaThis podcast for the Neurology Journal begins and closes with Dr. Robert Gross, Editor-in-Chief, briefly discussing highlighted articles from the print issue of Neurology. In the second segment Dr. Kevin Barrett interviews Dr. Andy Southerland about his paper on a low-cost, tablet-based option for prehospital neurologic assessment. Dr. Ted Burns is interviewing Dr. Dafne Horovitz for our “What's Trending” feature of the week about her paper on cranial bone collapse in microcephalic infants prenatally exposed to Zika virus infection. Dr. Alberto Espay interviews Drs. Dave Knopman and Kaycee Sink about their Controversies in Neurology Plenary Session at the AAN meeting about the pro and con effects of cognitive enhancing activities and their effects on preventing dementia.DISCLOSURES: Dr. Barrett serves as Associate Editor for Neurohospitalist; serves as an editorial board member for Neurology®; receives royalties from the publications of the books Stroke and Neurology in Practice [Edited book]; and receives research support from the NIH.Dr. Southerland serves as Podcast Deputy Editor for Neurology®; receives research support from the American Heart Association-American Stroke Association National Clinical Research Program, American Academy of Neurology, American Board of Psychiatry and Neurology, Health Resources Services Administration and the NIH; has a provisional patent application titled: “Method, system and computer readable medium for improving treatment times for rapid evaluation of acute stroke via mobile telemedicine;” and gave legal expert review.Dr. Ted Burns serves as Podcast Editor for Neurology®; and has received research support for consulting activities with UCB, CSL Behring, Walgreens and Alexion Pharmaceuticals, Inc.Dr. Horovitz serves as Associate Editor for Journal of Community Genetics; received speaker honoraria from Biomarin Pharmaceutical, Genzyme-Sanofi, Shire Pharmaceuticals, Inc. and Alexion Pharmaceuticals, Inc.; received funding for travel to medical meeting from Genzyme-Sanofi and Shire Pharmaceuticals, Inc.Dr. Espay serves as Associate Editor for the Journal of Clinical Movement Disorders; serves as an editorial board member of Parkinsonism and Related Disorders and The European Neurological Journal; serves on the scientific advisory board for Solvay Pharmaceuticals, Inc. (now Abbvie), Chelsea Therapeutics International, Ltd., Teva Pharmaceutical Industries Ltd., Impax, Merz Pharmaceuticals, Inc., Pfizer Inc, Solstice Neurosciences, Eli Lilly and Company, ACADIA Pharmaceuticals, Inc. and USWorldMeds; is a consultant for Chelsea Therapeutics International, Ltd., Solvay Pharmaceuticals, Inc. (now Abbvie), ACADIA Pharmaceuticals, Inc., Cynapsus and Lundbeck, Inc; receives royalties for publications of books from Lippincott, Williams & Wilkins and Cambridge University Press; serves on the speakers' bureau of UCB, Teva Pharmaceutical Industries Ltd., American Academy of Neurology and Movement Disorders Society; receives research support from the CleveMed/Great Lake Neurotechnilogies, Michael J. Fox Foundation and the NIH.Dr. Knopman serves on the scientific advisory board for Consultant Bluefield project, Lundbeck Pharmaceuticals Inc., DIAN study DSMB; served as Associate Editor for Neurology® until October 2015; receives research support from the NIH, Mayo Alzheimer's Disease Research Center, Mayo Alzheimer Disease Patient Registry, ARIC Dementia Study and Chronic Kidney Disease and Cognitive functioning; received funding for travel to two lectures Alzheimer Conference, Seoul Korea and Behavioral Neurology Conference, Hyderabad, India.Dr. Sink served on the data safety monitoring board for two NIH funded clinical trials; initiated grants from the Alzheimer's Association and the Donald W. Reynolds Foundation as an investigator; received research support from the NIH.
1) Natural history of cavernous malformation: Systematic review and meta-analysis of 25 studies2) e-Pearl topic: Neurologic manifestations of hereditary hemorrhagic telangiectasia3) Topic of the month: Neurology Today story about new Center for Disease Control guidelines on prescribing opioids (Part 1)This podcast for the Neurology Journal begins and closes with Dr. Robert Gross, Editor-in-Chief, briefly discussing highlighted articles from the print issue of Neurology. In the second segment Dr. Matthew Flaherty interviews Dr. Loch Macdonald about his paper on review and meta-analysis of 25 studies about the natural history of cavernous malformation. Dr. Adam Numis is reading our e-Pearl of the week about neurologic manifestations of hereditary hemorrhagic telangiectasia. Dr. Ted Burns interviews Dr. Gary Franklin about a Neurology Today story on the topic of the new Center for Disease Control guidelines on prescribing opioids (Part 1).DISCLOSURES: Dr. Flaherty serves on the scientific advisory board for DSMB member, I-DEF Trial (NINDS sponsored ICH treatment trial); has a patent pending, non-invasive CNS monitor; owns company stock as co-founder of SENSE Diagnostics, LLC (our product is currently investigational and not on the market); serves on the speakers' bureau of CSL Behring and Janssen; receives research support from American Heart Association, Pfizer Inc, Bristol-Myers Squibb, NIH and as Principal Investigator of a phase II, NINDS funded trial testing recombinant activated factor VII for treatment of intracerebral hemorrhage where study drug is supplied by Novo Nordisk.Dr. Macdonald serves as an editorial board member of Stroke, Journal of Neurosurgery, Neurosurgery, Journal of cerebral blood flow and metabolism, Neurocritical care, World Neurosurgery, Surgical Neurology International, Translational stroke research and Cerebrovascular diseases; treats unruptured aneurysm patients (1% effort); holds stock options in Edge Therapeutics, Inc; has a patent for treatment of delayed cerebral ischemia and subdural hemorrhage, intracranial drug delivery systems; receives research support from Canadian Institutes of Health Research, Brain Aneurysm Foundation, Heart and Stroke Foundation of Canada and Physicians Services Incorporated Foundation.Dr. Numis serves on the editorial team for the Neurology® Resident and Fellow Section.Dr. Ted Burns serves as Podcast Editor for Neurology®; and has received research support for consulting activities with UCB, CSL Behring, Walgreens and Alexion Pharmaceuticals, Inc.Dr. Franklin serves as an editorial board member of Neuroepidemiology; serves on the Levels of Evidence Team for Neurology®; is a consultant for the California State Compensation Insurance Fund; receives research support from the Centers for Disease Control and Prevention.
1) Infection, vaccination and childhood arterial ischemic stroke and 2) Topic of the month: Neurology Today: Recent Publications. This podcast for the Neurology Journal begins and closes with Dr. Robert Gross, Editor-in-Chief, briefly discussing highlighted articles from the print issue of Neurology. In the second segment Dr. Mark McAllister interviews Dr. Heather Fullerton about her paper on infection, vaccination and childhood arterial ischemic stroke. Dr. Adam Numis is reading our e-Pearl of the week about Lafora body disease. In the next part of the podcast Dr. Ted Burns interviews Dr. Jim Bernat about his Neurology Today book review about “The Digital Doctor.” The participants had nothing to disclose except Drs. Fullerton, Numis, Burns and Bernat.Dr. Fullerton serves as an editorial board member of Stroke; serves on a DSMB for the NIH for clinical trials related to sickle cell disease and stroke; and receives research support from American Heart Association Established Investigator Award.Dr. Numis serves on the editorial team for the Neurology® Resident and Fellow Section. Dr. Ted Burns serves as Podcast Editor for Neurology®; and has received research support for consulting activities with UCB, CSL Behring, Walgreens and Alexion Pharmaceuticals, Inc.Dr. Bernat serves as an editorial board member of Neurocritical Care, Neurology Today, The Physician's Index for Ethics and Medicine and Multiple Sclerosis and Related Diseases; receives royalties from the publication of the books Ethical and Legal Issues in Neurology, Ethical Issues in Neurology, 3rd ed. and Palliative Care in Neurology.
1) Opioids for chronic non-cancer pain and 2) Topic of the month: Plenary sessions AAN Meeting April 2015. This podcast for the Neurology Journal begins and closes with Dr. Robert Gross, Editor-in-Chief, briefly discussing highlighted articles from the print issue of Neurology. In the second segment Dr. Ted Burns interviews Drs. Stephen Nadeau and Gary Franklin about their papers on opioids for chronic non-cancer pain and the policy behind prescribing them. Dr. Adam Numis is reading our e-Pearl of the week about vaccinations and seizures. In the next part of the podcast Dr. Alberto Espay interviews Dr. Virginia Lee about her Frontiers in Neuroscience Lecture at the AAN Meeting about the topic of transmission of alpha-Synuclein in Parkinson disease: Pathogenesis and implications for therapy. The participants had nothing to disclose except Drs. Burns, Nadeau, Franklin, Numis, Espay and Lee.Dr. Ted Burns serves as Podcast Editor for Neurology®; and has received research support for consulting activities with CSL Behring and Alexion Pharmaceuticals, Inc.Dr. Nadeau served on the DSMB for the National Institute of Neurological Disorders and Stroke and National Institute of Child Health and Human Development funded Interdisciplinary Comprehensive Arm Rehab Evaluation, DSMB ; served as an Associate Editor of the Journal of the International Neuropsychological Society; received honoraria and funding for travel for an International Neuropsychological Society meeting; received funding for travel for an American Neuropsychiatric Association meeting; receives royalties from the publication of the book The Neural Architecture of Grammar ; and receives research support from a VA Rehabilitation R&D Grant and University of Florida McKnight Brain Institute Brain and Spinal Cord Injury Research Trust Fund Grant.Dr. Franklin serves as an editorial board member of Neurology® Levels of Evidence Team and Neuroepidemiology; is a consultant for the California State Compensation Insurance Fund and receives research support from the Centers for Disease Control and Prevention (CDC).Dr. Numis serves on the editorial team for the Neurology® Resident and Fellow Section. Dr. Espay serves as an Associate Editor of Movement Disorders, Frontiers in Movement Disorders and Journal of Clinical Movement Disorders; serves as an editorial board member of Parkinsonism and Related Disorders and The European Neurological Journal; receives royalties for publications of books from Lippincott, Williams & Wilkins and from Cambridge University Press; serves on the scientific advisory board for Solvay Pharmaceuticals, Inc. (now Abbvie), Chelsea Therapeutics, Teva Pharmaceutical Industries Ltd., Impax Pharmaceuticals, Merz, Pfizer Inc, Solstice Neurosciences, LLC, Eli Lilly and Company, US WorldMeds; is a consultant for Chelsea Therapeutics, Solvay Pharmaceuticals, Inc. (now Abbvie); serves on the speakers' bureaus of UCB, Teva Pharmaceutical Industries Ltd., American Academy of Neurology, Movement Disorders Society; receives research support from CleveMed/Great Lakes Neurotechnologies, Michael J. Fox Foundation and the NIH.Dr. Lee serves as an editorial board member of Laboratory Investigation, Neurorehabilitation and Neural Repair, NeuroSignals, Neuron, Experimental Neurology, Science Magazine; receives research support from Ware Benaroya and the NIH; receives revenue for the following patent: "Compositions and Methods for Producing and Using Homogeneous Neuronal Cell Transplants" Penn G1120, Patent # 5,792,900.
1) ASA/clopidogrel combination confers better long term vascular protection in ASA failure and 2) Topic of the month: Review of new oral anticoagulants for stroke. This podcast for the Neurology Journal begins and closes with Dr. Robert Gross, Editor-in-Chief, briefly discussing highlighted articles from the print issue of Neurology. In the second segment Dr. Justin Sattin interviews Dr. Robert Cote about his paper on whether the combination of ASA/clopidogrel confers better long term vascular protection in ASA failure. Dr. James Addington is reading our e-Pearl of the week about hypoglycorrhachia. In the next part of the podcast Dr. Andy Southerland interviews Dr. Seemant Chaturvedi about a brief review of new oral anticoagulant (Dabigatran), reference clinical trial, indication and dosing. The participants had nothing to disclose except Drs. Cote, Addington, Southerland and Chaturvedi.Dr. Cote served on the scientific advisory board for Bayer Schering Pharma, Bristol-Myers Squibb, Boehringer Ingelheim, Pfizer Inc; serves on the scientific advisory board for DSMB for National Institute of Health (Point Study), Steering committee for the National Institute of Health (SPS3 study); is a consultant for Otsuka Pharmaceutical Co., Ltd.; received speaker honoraria from Boehringer Ingelheim, Merck Serono, Sanofi-aventis.Dr. Addington serves on the editorial team for the Neurology® Resident and Fellow Section. Dr. Southerland serves as Podcast Deputy Editor for Neurology®; serves as Clinical Research Advisor for Totier Technologies, Inc.Dr. Chaturvedi serves as an editorial board member for Neurology®, Stroke; serves as contributing editor NEJM Journal Watch Neurology; serves as executive committee member for ACT I study; is a consultant for Genetech, Inc., Boehringer Ingelheim, Abbott Vascular, Thorhill research, WL Gore, Bristol-Myers Squibb; receives research support from Daichi Sankyo, AstraZeneca, Pfizer Inc, NIH; received compensation for expert witness testimony.
1) Exposure to stroke belt on incident stroke and 2) Topic of the month: Stroke trials. This podcast for the Neurology Journal begins and closes with Dr. Robert Gross, Editor-in-Chief, briefly discussing highlighted articles from the print issue of Neurology. In the second segment Dr. Andy Southerland interviews Dr. Virginia Howard about her paper on exposure to the stroke belt on incident stroke in adulthood. Dr. Adam Numis is reading our e-Pearl of the week about Neuro-Behcet's disease. In the next part of the podcast Dr. Brett Kissela focuses his interview with Dr. Chelsea Kidwell about the MR Rescue trial. The participants had nothing to disclose except Drs Howard, Numis, Kissela and Kidwell.Dr. Howard serves on DSMB for NIH-NIDA; is a consultant for NIH review committees and receives research support from the NIH.Dr. Numis serves on the editorial team for the Neurology® Resident and Fellow Section. Dr. Kissela serves on scientific advisory board for Allergan, Inc.; has received funding for travel and speaker honoraria from Allergan, Inc.; has received research support from the NIH, will receive compensation from Reata Pharmaceuticals, Inc. for serving on the Event Adjudication Committee for the BEACON study, which they are sponsoring. and provides medico-legal reviews.Dr. Kidwell serves as an editorial board member of Stroke, Neurocritical Care Journal, Journal of Neuroimaging and Stroke Research and Treatment; and receives research support from Baxter and NIH.
1) Anterior disconnection syndrome and 2) Topic of the month: AAN Plenary Sessions. This podcast for the Neurology Journal begins and closes with Dr. Robert Gross, Editor-in-Chief, briefly discussing highlighted articles from the print issue of Neurology. In the second segment Dr. Jeff Waugh interviews Drs. Ana Pereira and Alvardo Pascual-Leone about their paper on the anterior disconnection syndrome. Dr. Jennifer Fugate is reading our e-Pearl of the week about normal pressure hydrocephalus. In the next part of the podcast Dr. Alberto Espay interviews Dr. Richard Bedlack about his plenary session on contemporary clinical issues. The participants had nothing to disclose except Drs. Waugh, Pascual-Leone, Fugate, Espay and Bedlack.Dr. Waugh serves as an editorial board member of the Journal of Pediatric Biochemistry.Dr. Pascual-Leone serves on the scientific advisory board for Nexstim, NeoSync, Starlab, Neuronix, Allied minds and NovaVision, inc.; serves as an Associate Editor for European Journal of Neuroscience and Frontiers in Neuroscience; is listed as co-inventor in several patents related to real-time integration of TMS with EEG and functional imaging; receives research support from Nexstim, Neuronix, NIH, The Michael J. Fox Foundation, Berenson-Allen Foundation and RJG Family Foundation.Dr. Fugate serves on the editorial team for the Neurology® Resident and Fellow Section. Dr. Espay is supported by the K23 career development award (NIMH, 1K23MH092735); has received grant support from CleveMed/Great Lakes Neurotechnologies, Davis Phinney Foundation, and Michael J Fox Foundation; personal compensation as a consultant/scientific advisory board member for Solvay Pharmaceuticals, Inc., Abbott, Chelsea Therapeutics, TEVA Pharmaceutical Industries Ltd, Impax Pharmaceuticals, Solstice Neurosciences, and Eli Lilly and Company; and honoraria from Novartis, the American Academy of Neurology, and the Movement Disorders Society. He serves as Assistant Editor of Movement Disorders and on the editorial boards of The European Neurological Journal and Frontiers in Movement Disorders.Dr. Bedlack serves on the scientific advisory board DSMB for the ceftriaxone ALS trial; serves on the speakers' bureau of Pfizer Inc, Eli Lilly and Company, Athena Diagnostics and Avanir Pharmaceuticals; is a consultant for Avanir Pharmaceuticals, Sanofi-aventis, Athena Diagnostics and UCB; receives research support from UCB, Biogen, Cytokinetics, Neuraltis and NIH. His clinic is sponsored by the ALS Association; and he is also involved in conducting clinical trials.
Dr Roma Chilengi, Head of Clinical Trials at the Kenya Medical Research Institute (KEMRI)/Wellcome Trust Research Programme in Kilifi, Kenya discusses clinical trial data safety monitoring boards (DSMBs). This introduction starts with a definition of a DSMB and discusses their roles and when they are required. DSMS constitutions, charters and considerations for under developed settings are also discussed.
Dr Roma Chilengi, Head of Clinical Trials at the Kenya Medical Research Institute (KEMRI)/Wellcome Trust Research Programme in Kilifi, Kenya discusses clinical trial data safety monitoring boards (DSMBs). This introduction starts with a definition of a DSMB and discusses their roles and when they are required. DSMS constitutions, charters and considerations for under developed settings are also discussed.
© 2020-2025 Ivy Podcast Discovery LLC
