In this CME episode, Dr. Andrew Cutler interviews Dr. Vladimir Maletic about novel agents in development for Major Depressive Disorder or MDD. Optional CME/CE Credits and Certificate Instructions: After listening to the podcast, to take the optional posttest and receive CME/CE credit, click: https://nei.global/POD22-MDD. Learning Objectives: After completing this educational activity, you should be better able to: Describe novel mechanisms of action of agents under investigation for the treatment of depression Explain the potential implications of novel rapid-acting and multi-modal agents in optimizing outcomes for patients with unipolar depression Integrate newly available options for depression into clinical practice Accreditation: In support of improving patient care, Neuroscience Education Institute (NEI) is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team. NEI designates this enduring material for a maximum of 1.0 AMA PRA Category 1 Credit ™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. A posttest score of 70% or higher is required to receive CME/CE credit. The content in this activity pertains to pharmacology and is worth 1.0 continuing education hour of pharmacotherapeutics. Credit Types. The following are being offered for this activity: Nurse Practitioner: ANCC contact hours Pharmacy: ACPE application-based contact hours Physician: ACCME AMA PRA Category 1 Credits ™ Physician Assistant: AAPA Category 1 CME credits Psychology: APA CE credits Social Work: ASWB-ACE CE credits Non-Physician Member of the Mental Healthcare Team: Certificate of Participation stating the program is designated for AMA PRA Category 1 Credits ™ Peer Review: The content was peer-reviewed by an MD specializing in psychiatry to ensure the scientific accuracy and medical relevance of information presented and its independence from commercial bias. NEI takes responsibility for the content, quality, and scientific integrity of this CME/CE activity. Disclosures: All individuals in a position to influence or control content are required to disclose any relevant financial relationships. Any potential conflicts of interest were identified and mitigated prior to the activity being planned, developed, or presented. InterviewerAndrew J. Cutler, MD Clinical Associate Professor, Department of Psychiatry, SUNY Upstate Medical University, Syracuse, NY Chief Medical Officer, Neuroscience Education Institute, Carlsbad, CA Consultant/Advisor: AbbVie/Allergan, Acadia, Alfasigma, Biogen, BioXcel, Boehringer Ingelheim, Corium, Intra-Cellular, Ironshore, Janssen, Jazz, Karuna, Lundbeck, Neurocrine, Noven, Otsuka, Relmada, Sage, Sunovion, Supernus, Teva Speakers Bureau: AbbVie/Allergan, Acadia, Alfasigma, BioXcel, Corium, Intra-Cellular, Ironshore, Janssen, Lundbeck, Neurocrine, Noven, Otsuka, Sunovion, Supernus, Teva IntervieweeVladimir Maletic, MD, MS Clinical Professor of Psychiatry, University of South Carolina School of Medicine, Greenville, SC Consultant/Advisor: AbbVie, Alfasigma, Alkermes, Biogen/Sage, Intracellular, Ironshore, Janssen, Lundbeck, Otsuka, Relmada, Sunovion, Supernus, Takeda Speakers Bureau: AbbVie, Alfasigma, Alkermes, Biogen/Sage, Intracellular, Ironshore, Janssen, Lundbeck, Otsuka, Sunovion, Supernus, Takeda Pre-Interview AuthorSabrina K. Bradbury-Segal, PhD Medical Writer, Neuroscience Education Institute, Carlsbad, CA No financial relationships to disclose. The Planning Committee and Peer Reviewer have no financial relationships to disclose. Disclosure of Off-Label Use: This educational activity may include discussion of unlabeled and/or investigational uses of agents that are not currently labeled for such use by the FDA. Please consult the product prescribing information for full disclosure of labeled uses. Cultural Linguistic Competencies and Implicit Bias: A variety of resources addressing cultural and linguistic competency and strategies for understanding and reducing the impact of implicit bias can be found in this handout. Support: This activity is supported by an unrestricted educational grant from Sage Therapeutics, Inc. Released: September 26, 2022 CME/CE credit expires: September 26, 2025
Link to bioRxiv paper: http://biorxiv.org/cgi/content/short/2022.09.23.509254v1?rss=1 Authors: Maitra, M., Mitsuhashi, H., Rahimian, R., Chawla, A., Yang, J., Fiori, L., Davoli, M.-A., Perlman, K., Aouabed, Z., Mash, D. C., Suderman, M., Mechawar, N., Turecki, G., Nagy, C. Abstract: Major depressive disorder (MDD) is a common, heterogenous, and potentially serious psychiatric illness. Diverse brain cell types have been implicated in MDD etiology. Significant sexual differences exist in MDD clinical presentation and outcome, and recent evidence suggests different molecular bases for male and female MDD. We evaluated over 160,000 nuclei from 71 female and male donors, leveraging new and pre-existing single-nucleus RNA-sequencing data from the dorsolateral prefrontal cortex. Cell type specific transcriptome-wide threshold-free MDD-associated gene expression patterns were similar between the sexes, but significant differentially expressed genes (DEGs) diverged. Among 7 broad cell types and 41 clusters evaluated, microglia and parvalbumin interneurons contributed the most DEGs in females, while deep layer excitatory neurons, astrocytes, and oligodendrocyte precursors were the major contributors in males. Further, the Mic1 cluster with 38% of female DEGs and the ExN10_L46 cluster with 53% of male DEGs, stood out in the meta-analysis of both sexes. Copy rights belong to original authors. Visit the link for more info Podcast created by PaperPlayer
Suicidal ideation is something commonly experienced by people in the church, but is either rarely talked about or is met with over-spiritualization, causing more harm than good. I'm joined today with my friend, David Waldy, as we talk about our own experiences with suicide and how our Christian upbringing influenced some of our very negative self-perception. There's a huge stigma around suicide culturally, but even more so within the church. My hope is that this episode will help to dispel som of the sting associated with the topic and provide relief and comfort for those suffering. If you are contemplating harming yourself, please call 988, no matter where you live in the United States. People are waiting to help you. Contact David: http://www.davidwaldy.com/ https://www.tiktok.com/@davidwaldy/ https://www.youtube.com/c/davidwaldy Support the podcast and become a patreon. Produced by Joey Papa Media.
On this episode, I was joined by Bassil Akra, the CEO of AKRA Team. Bassil and I discuss: EU MDR and Implementation Timeframe Notified Bodies, Competent Authorities, MOH's and the EU Commission Article 117 & Drug/Device Combination Products Differences between MDD and MDR for Economic Operators His Favorite Book: EU MDR Dr. Bassil Akra spent the last year supporting medical device, in-vitro diagnostic, combination device companies preparing their strategy for the EU regulations MDR 2017/745 and IVDR 2017/746. Before that, he spent many years as a subject matter expert at the biggest notified body in Europe acting in the various roles and representing locally and globally the notified body association in the various European discussion and guidance documents preparation. Dr. Akra was the Vice President of Strategic Business Development at the Global Medical Health Services of TÜV SÜD Product Service GmbH. He has long experience in leadership, business management, research, development, quality management, and regulatory approval of medical devices, combination devices, and ATMP Products. Dr. Akra played an essential role during the implementation of the medical device regulation in Europe. He was also involved in the drafting of several European guidance documents (e.g. MEDDEV, MDCG, etc.) and International Standard. He spent the last years of his career at TÜV SÜD training and educating the various stakeholders on the EU Legislations (e.g. MDD/AIMDD, MDR and IVDR), supporting their implementation towards achieving the relevant designation ensuring continuity of the healthcare system in the interest of the patient population.
According to the National Institute of Mental Health (NIMH), nearly 20 million Americans each year have a mental illness. These include major depressive disorder (MDD) and dysthymia, both considered forms of clinical depression. While some people experience depression throughout their lives, others develop symptoms later in life, and this is especially true for women who tend to experience depression earlier than men. Because women are nearly twice as likely as men to suffer from depression, they often don't seek treatment due to the belief their symptoms are typical or that they should get over it. We asked a psychologist who has treated women with depression for many years to share some essential facts on this matter. While the exact causes of depression remain unknown, gender distinctions between males and females play a role in why some women develop depression earlier than men. Women are almost twice as likely as men to be diagnosed with depression because of their unique social and hormonal characteristics. What are some early signs of depression in females? The signs of depression are often subtle and complex to recognise in women due to cultural norms and societal expectations. Depression is common in young girls and women because they face challenges such as body image issues, social isolation, or academic stress. Many women don't recognise key signs of depression, making it harder to get timely support. Depression can improve with the proper treatment, including therapy, medication, or both. One noteworthy misbelief about depression is that it's a "normal part of being a woman." This notion may be rooted in the fact that depression commonly affects women. Approximately one in eight American women will develop clinical depression during their lifetime. Moreover, women are almost twice as likely as men to experience symptoms of depression, which may be due to certain societal, hormonal, and biological factors unique to women. Women often face extraordinary challenges, such as dealing with pregnancy or childbirth and balancing work and family responsibilities. These issues contribute to women's anxiety, stress, and depression rates. Women who experience depression also tend to exhibit specific behavioural changes, such as decreased appetite, fatigue, sleep disturbance, psychomotor agitation or retardation, feelings of worthlessness, guilt, diminished ability to concentrate, and suicidal ideation. Here are six things that women living with depression need to know. 1. The key signs aren't always obvious Some symptoms of depression in women are easier to spot — like changes in appetite or sleeping habits, irritability, or feelings of hopelessness. However, your loved ones may brush this off or fail to notice other crucial symptoms. These symptoms include: Anhedonia: This symptom refers to an inability to get enjoyment from activities that previously interested or inspired you. Given that many women toil with feeling exhausted and overworked, this meaningful sign of depression is often confused with burnout or lack of sleep. Diminished interest in sexual activity Drinking extensively: Isolation: Retail therapy: 2. It won't necessarily derail your life completely 3. Depression triggers may relate to your circumstances 4. Depression can set in during certain life stages Prenatal depression Uncomfortable bodily changes, hormonal shifts, and intense planning that come with pregnancy can be overwhelming for expecting mothers — particularly if you Most maternal-mortality statistics exclude suicide and self-harm Postpartum depression (Blues) Perimenopausal depression 5. Changing habits that fuel depression can be difficult to notice 6. Depression is highly treatable Learn more
Link to bioRxiv paper: http://biorxiv.org/cgi/content/short/2022.09.13.507821v1?rss=1 Authors: Doney, E., Dion-Albert, L., Coulombe-Rozon, F., Osbourne, N., Bernatchez, R., Paton, S. E. J., Kaufmann, F. N., Agomma, R. O., Solano, J. L., Gaumond, R., Dudek, K. A., Szyszkowicz, J. K., Signature Consortium,, Lebel, M., Doyen, A., Durand, A., Lavoie-Cardinal, F., Audet, M.-C., Menard, C. Abstract: Major depressive disorder (MDD) is the leading cause of disability worldwide. However, 30-50% of patients are unresponsive to commonly prescribed antidepressants, highlighting untapped causal biological mechanisms. Dysfunction in the microbiota-gut-brain axis, the bidirectional communications between the central nervous system and gastrointestinal tract that are modulated by gut microorganisms, has been implicated in MDD pathogenesis. Exposure to chronic stress disrupts blood-brain barrier integrity, still, little is known about intestinal barrier function in these conditions particularly for the small intestine where most food and drug absorption takes place. Thus, here we investigate how chronic social or variable stress, two mouse models of depression, impact the jejunum (JEJ) intestinal barrier in males and females. Mice were subjected to stress paradigms followed by analysis of gene expression profiles of intestinal barrier-related targets, fecal microbial composition, and blood-based markers. Altered microbial populations as well as changes in gene expression of JEJ tight junctions were observed depending on the type and duration of stress, with sex-specific effects. We took advantage of machine learning to characterize in detail morphological tight junction properties identifying a cluster of ruffled junctions in stressed animals. Junctional ruffling is associated with inflammation, so we evaluated if LPS injection recapitulates stress-induced changes in the JEJ and observed profound sex differences. Finally, LPS-binding protein (LBP), a marker of gut barrier leakiness, was associated with stress vulnerability in mice and translational value was confirmed on blood samples from women with MDD. Our results provide evidence that chronic stress disrupts intestinal barrier homeostasis in conjunction with the manifestation of depressive-like behaviors in a sex-specific manner in mice and possibly, human depression. Copy rights belong to original authors. Visit the link for more info Podcast created by PaperPlayer
Quel est le point commun entre : Top budget, Casino Bio, Reflets de France, la Marque Repère ou encore Monoprix gourmet ? Ce sont toutes des MDD, des marques de distributeurs. Mais c'est quoi exactement une MDD ? Comment sont fabriqués ces produits ? Est-ce que c'est moins bon ? Pourquoi est-ce moins cher ? On répond à toutes vos questions dans le prochain épisode d'Au Rayon Futur, et vous verrez : les MDD ne sont pas des sous-marques ! Hébergé par Acast. Visitez acast.com/privacy pour plus d'informations.
En este episodio estoy con Julian Nuñez, Co-fundador de Yuno, una plataforma para consolidar todos los medios de pago en un solo lugar. Yuno nació en este 2022 y lograron obtener 10 MDD en su ronda pre-semilla!Hablamos de su trayecto pasando del sector público al privado, y después del mundo corporativo al mundo de los startups, nos platica también de su tiempo en Rappi y todos los roles que estuvo en este startup.También hablamos de su proceso para encontrar un problema y una idea para emprender, la importancia de crear una gran cultura desde el inicio, y como evitar el burn out entre los colaboradores.No te pierdas esta gran plática! Donde quiera que estés no olvides dejarnos una reseña Libros mencionados:No Rules Rules - Reed HastingsThe Hard Thing About Hard Things - Ben Horowitz Sobre el invitado:Conecta con Julián en LinkedinYuno | Website Follow Us:NewsletterEscribe una ReseñaEncuesta de AudienciaTikTokInstagramTwitterLinkedinWeb
Dr. Robb Kelly is a renowned Addiction Expert. Born and raised in Manchester, UK, who is eccentric, no holds bar, successful, and places his patients first kind of man. Robb is Meadows Trained in Trauma and holds a double Ph.D. It is necessary for the family to work along with the patient- we uncover the family chaos and dynamics to better resolve addiction. Robb mentors upcoming entrepreneurs because he knows what it takes to run a successful business. Robb has overcome homelessness, alcohol dependency, trauma, PTSD, and MDD and a whirlwind of events to be the "Gordon Ramsay" of the addiction treatment world. Before Robb succumbed to addiction and mental health issues, he played bass guitar at Abbey Studio with Queen, David Bowie, and Elton John. He is an accomplished musician, and the money he made helped him attend Oxford University to pursue a Ph.D. in Psychology. Robb experienced a spiritual awakening on the cold streets of Manchester while homeless and in dire straights. Robb's work ethic is defined by helping the addict step out of their disease and into a solution. He works with everyday people, professionals, and celebrities who want to reach sobriety and live in sustained recovery through evidence-based modalities and a genuine therapeutic alliance. Robb believes in helping marginalized communities because he understands that everyone has different worldviews when addiction is rearing its ugly head. Also, Robb is lecturing at the University of Texas at San Antonio about Addiction and recovery. http://www.RobbKelly.com Sign up for 10% off of Shrink Rap Radio CE credits at the Zur Institute
Link to bioRxiv paper: http://biorxiv.org/cgi/content/short/2022.08.31.505596v1?rss=1 Authors: Haynes, S. E., Seo, H. S., Lacagnina, A., Morel, C., Afzal, M. F., Menigoz, A., Clem, R., Rajan, K., Mayberg, H., Young, L., Han, M.-H. Abstract: Cumulative stress is a major risk factor for developing major depressive disorder (MDD), yet not everyone experiencing chronic stress develops MDD. In those who do not, it is unclear at what point, or by what mechanism, a trajectory of stable resiliency emerges. Utilizing a 10-day repeated social defeat stress model (RSDS) for MDD, we observed that a critical period between 7 and 10 daily defeats marks the phenotypical divergence of resilient from susceptible mice. In response to ongoing stress, corticotropin-releasing factor (CRF) neurons of the oval nucleus of the bed nucleus of the stria terminalis (BNSTov) display a sustained increased firing rate in resilient, but not susceptible mice. This neurophysiological adaptation was self-sustaining, but only after 7 critical stress exposures, indicating that the process of developing resilience is dependent on stress history. Our study reveals a novel process by which individuals might persist in the face of adversity by way of stress-provoked activation, not inhibition of a key CRF limbic region that establishes a pathway to resilience. Copy rights belong to original authors. Visit the link for more info Podcast created by PaperPlayer
In this episode, Greg W. Mattingly, MD, and Vladimir Maletic, MD, have a conversation about the complexities of accurately diagnosing bipolar depression. Bipolar depression can be difficult to differentiate from other psychiatric conditions, such as unipolar depression, depression with mixed features, ADHD, PTSD, and anxiety. This differential is made more challenging in that patients with bipolar depression often have psychiatric comorbidities with overlapping symptomology. Listen as the 2 psychiatrists share their insights on how to act as detectives and weed through clues from current symptoms, past symptoms, and family history to reach an accurate diagnosis. Presenters:Greg W. Mattingly, MDAssociate Clinical Professor PsychiatryWashington University School of MedicineSt Louis, MissouriPresidentSt Charles Psychiatry AssociatesSt Charles, MissouriVladimir Maletic MDClinical ProfessorDepartment of PsychiatryUSC School of MedicineGreenville, South CarolinaThis content is based on a CE/CME program supported by independent educational grants from AbbVie and Intra-Cellular Therapies, Inc.For more programs in this series, visit: https://bit.ly/3TClDqb
In this episode, Ayesha discussed the FDA approval of Axsome Therapeutics' rapid-acting oral treatment Auvelity for the treatment of major depressive disorder (MDD). The approval makes Auvelity the first and only rapid-acting oral medication for depression, and the first and only oral NMDA receptor antagonist approved for MDD. Hear more about the approval, including clinical trial data showing the treatment can take effect in as little as one week, and how it is the first antidepressant approved in over 60 years that has a new mechanism of action.Ayesha shared news about another significant FDA approval for a gene therapy to treat transfusion-dependent beta thalassemia. Bluebird bio was awarded the approval for its gene therapy Zynteglo (beti-cel), which is a one-time treatment for the rare blood disorder. Hear more about the therapy, some of the setbacks bluebird has had to face on the road to its approval and why the treatment has a steep price tag.Read the full articles here:Axsome's Auvelity Wins FDA Approval as First Rapid-Acting Oral Treatment for DepressionBluebird's $2.8M Gene Therapy Zynteglo Wins Landmark FDA Approval for Beta ThalassemiaFor more life science and medical device content, visit the Xtalks Vitals homepage.Follow Us on Social MediaTwitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured
Many people think that when two or more people start a business together, they will automatically get along and have a perfect working relationship. Unfortunately, this is not always the case. Co-founder conflicts can arise for a number of reasons, and if they are not managed correctly, can lead to the downfall of the company. In this episode, I am joined by Jerome McDonagh and Eddy Lee of MDD to discuss how to prevent co-founder conflicts, and how to manage them if they do occur. For more information about MDD, please visit www.mdd.com
Here are the links for everything discussed in Episode 78. Times are also below so feel free to skip around and get to the updates that interest you. (1:10) FDA final rule on OTC hearing aids (1:37) Moderna completes EUA for Omicron-targeting Booster (3:00) Pfizer and BioNTech submit EUA for omicron booster (4:03) FDA updates EUA for Novovax to include adolescents 12 to 17 years of age (5:05) New guidance for Paxlovid drug interactions (6:01) Single use vial of COMIRNATY approved (6:30) Omnipod 5 approved for children ages 2 and older (7:48) Approval of Auvelity for Major Depressive Disorder PAXLOVID Patient Eligibility Screening Checklist Tool for PrescribersCDC website for COVID information - get boosted!FDA monkeypox response websiteConnect with The Rx Daily Dose:Twitter Instagram YouTube Linkedin WebsiteEmail: firstname.lastname@example.orgConnect with Ian Parnigoni PharmD. on social media:Twitter Instagram Linkedin ★ Support this podcast on Patreon ★
Start-ups and tech companies are often lauded for their innovation, but this can make them difficult to value. Traditional valuation methods are based on financial metrics such as earnings and revenue, but these may not be relevant for early-stage businesses. Instead, investors must focus on other indicators such as the team's experience, the market opportunity, and the strength of the product. By taking a closer look at these factors, it is possible to get a more accurate picture of a start-up's potential.I am joined by Jerome McDonagh and Eddy Lee of MDD to take a look at the challenges of valuing startups and tech companies.For more information about MDD, please visit www.mdd.com
Did you know that when looking at the course trajectory of major depressive disorder (MDD) over 6 years, the recovery rate is only 16%? Credit available for this activity expires: [08/12/23] Earn Credit / Learning Objectives & Disclosures: https://www.medscape.org/viewarticle/979072?src=mkm_podcast_addon_979072
Meta reporta pérdidas, Twitter experimenta con Estados y SKY ofrecerá servicios de telefonía través de AT&TPuedes apoyar la realización de este programa con una suscripción. Más información por acáNoticias: -La división de televisión satelital de Grupo Televisa, SKY, ofrecerá servicios de telefonía utilizando la red de AT&T.-Sony está probando nuevas funciones en la beta de actualización para su PlayStation 5, incluyendo la opción de una resolución de 1440p.-Twitter comentó a TechCrunch que está probando la incorporación de estados en los tuits con usuarios selectos-Google anunció que retrasará la eliminación gradual de cookies de terceros en Chrome hasta la segunda mitad de 2024. -Meta reportó un descenso del 1% de sus ingresos trimestrales, reportando la primera caída de la empresa de Mark Zuckerberg desde que cotiza en la bolsaDiscusión: Meta perdió 2,800 MDD con Reality Labs See acast.com/privacy for privacy and opt-out information. Become a member at https://plus.acast.com/s/noticias-de-tecnologia-express.
#RafaelCaroQuintero era uno de los narcotraficantes más buscados por la #DEA, la cual, incluso, ofrecía una #recompensa de 20 MDD por información que llevar a su captura, tras ser liberado en 2013. Hoy, el "Narco de Narcos" fue detenido por autoridades mexicanas y extraditado a Estados Unidos.
Episode 52. There are many more types of depressive disorders than typical major depressive disorder (MDD) that was discussed in the previous episode. All of them have the potential to be serious and debilitating. This episodes covers subtypes of MDD like seasonal depression (seasonal affective disorder), atypical depression, substance-induced MDD, and MDD with psychotic features. Other depressive disorders talked about include persistent depressive disorder (dysthymia), minor depressive disorder, postpartum depression, and adjustment disorder. Visit First Line's website where you can submit questions and feedback as well as view blog posts: https://poddcaststudios.wixsite.com/firstlinepodcast This episode is sponsored by TrueLearn. TrueLearn special discount codes: For $10 off Shelf/COMAT, use code firstline-shelf For $15 off COMLEX subscriptions, use code firstline-comlex For $35 off USMLE subscriptions, use code firstline-usmle Use this link to easily find First Line on different platforms and social media platforms: linktr.ee/FirstLinePodcast First Line is now available on Spotify & Anchor, Apple Podcasts, Google Podcasts, Overcast, Stitcher, Amazon Music & Audible, iHeartRadio, Vurbl, Breaker, Castbox, PocketCasts, Castro, Player Fm, Pod Bean, Reason, Vurbl, and TuneIn. First Line is on Instagram @firstlinepodcast and on Facebook www.facebook.com/firstlinepodcast Content on First Line is for educational and informational purposes only and should not be taken as medical advice. Please see your primary care physician (DO or MD) for any medical concerns you have. All ideas expressed are individual ideas of the host and do not represent any organizations the host is linked to. --- This episode is sponsored by · Anchor: The easiest way to make a podcast. https://anchor.fm/app --- Send in a voice message: https://anchor.fm/firstline/message Support this podcast: https://anchor.fm/firstline/support
In this episode, I am joined by Dr.Robb Kelly. He shares with us his challenging journey with addiction and how he came out the other side. Dr.Robb believes anyone can change their circumstance and that you can have the amazing life you dream of. Shifting your mindset to believing you can do it and that anything is possible is the first step. Taking one day at a time, change can be possible. Listen in to Dr. Robbs's words of wisdom and the knowledge that you are worth it and can get out of the hole you're in. About our guest: Robb has overcome homelessness, alcohol dependency, trauma, PTSD, MDD, and a whirlwind of events to be the "Gordon Ramsay" of the addiction treatment world. Before Robb succumbed to addiction and mental health issues, he played bass guitar at Abbey Studio with Queen, David Bowie, and Elton John. He is an accomplished musician, and the money he made helped him attend Oxford University to pursue a Ph.D. in Psychology. Robb experienced a spiritual awakening on the cold streets of Manchester while homeless and in dire straights. Robb's work ethic is defined by helping the addict step out of their disease and into a solution. He works with everyday people, professionals, and celebrities who want to reach sobriety and live in sustained recovery through evidence-based modalities and a genuine therapeutic alliance. Robb believes in helping marginalized communities because he understands that everyone has different worldviews when addiction is rearing its ugly head. Learn more about Dr. Kelly, including his incredible book “Daddy, Daddy Please Stop Drinking” here: https://robbkelly.com/ (https://robbkelly.com/) www.facebook.com/drrobbkelly twitter.com/RobbKellyGroup linkedin.com/in/dr-robb-kelly-07718133 https://www.instagram.com/robbkellyrecoverygroup/ (https://www.instagram.com/robbkellyrecoverygroup/) Thanks for listening! It means so much to us! If you would like to continue the conversation with us, head on over to https://www.instagram.com/annamaydonova/ (Instagram) or/and http://facebook.com/anna.maydonova.58 (Facebook) for more healing, stories, and magic. Subscribe to the podcast This journey is impossible to do on your own, so make sure to like and subscribe so we can help more people like you! Share the podcast If you have someone in your life, who is struggling to overcome their trauma, this is something you can give them that truly can change the course of their life forever. Leave us a review We appreciate every bit of feedback to make this a value-adding part of your day. Ratings and reviews from our listeners not only help us improve, but also help others find us in their podcast app. If you have a minute, an honest review on iTunes goes a long way! Thank You!! Do you have some feedback or questions about this episode? Leave a note in the comment section below!
Episode 51. In the first episode of Season 2, I am discussing what everyone needs to know about major depressive disorder (MDD) including risk factors, how it is diagnosed, and how it is treated. Visit First Line's website where you can submit questions and feedback as well as view blog posts: https://poddcaststudios.wixsite.com/firstlinepodcast This episode is sponsored by TrueLearn. TrueLearn special discount codes: For $10 off Shelf/COMAT, use code firstline-shelf For $15 off COMLEX subscriptions, use code firstline-comlex For $35 off USMLE subscriptions, use code firstline-usmle Use this link to easily find First Line on different platforms and social media platforms: linktr.ee/FirstLinePodcast First Line is now available on Spotify & Anchor, Apple Podcasts, Google Podcasts, Overcast, Stitcher, Amazon Music & Audible, iHeartRadio, Vurbl, Breaker, Castbox, PocketCasts, Castro, Player Fm, Pod Bean, Reason, Vurbl, and TuneIn. First Line is on Instagram @firstlinepodcast and on Facebook www.facebook.com/firstlinepodcast Content on First Line is for educational and informational purposes only and should not be taken as medical advice. Please see your primary care physician (DO or MD) for any medical concerns you have. All ideas expressed are individual ideas of the host and do not represent any organizations the host is linked to. --- This episode is sponsored by · Anchor: The easiest way to make a podcast. https://anchor.fm/app --- Send in a voice message: https://anchor.fm/firstline/message Support this podcast: https://anchor.fm/firstline/support
Videos: 1.Tucker Carlson Tonight – Friday, June 17 (12:30) 2. America's wars: The invented reason and the real reason (2:12) 3. William Mandel Denounces HUAC: “This Collection of Judases” 4. NATO is a paper army (7:01) 5. What It's Like Living in California Now (8:37) Pistachios may lower vascular response to stress in type 2 diabetes Penn State University, June 17, 2022 Among people with type 2 diabetes, eating pistachios may reduce the body's response to the stresses of everyday life, according to Penn State researchers. “In adults with diabetes, two servings of pistachios per day lowered vascular constriction during stress and improved neural control of the heart,” said Sheila G. West, professor of biobehavioral health and nutritional sciences. “Although nuts are high in fat, they contain good fats, fiber, potassium and antioxidants. Given the high risk of heart disease in people with diabetes, nuts are an important component of a heart healthy diet in this population.” West and her colleagues investigated the effects of pistachios on responses to standardized stress tasks in patients with well-controlled Type 2 diabetes who were otherwise healthy. They used a randomized, crossover study design in which all meals were provided. Each of the diets contained the same number of calories. After two weeks on the typical American diet — containing 36 percent fat and 12 percent saturated fats — participants were randomized to one of two test diets. During the four-week test diets, participants ate only food supplied by the study. The researchers reported the results of this study in a recent issue of the Journal of the American Heart Association. “We found that systolic blood pressure during sleep was particularly affected by pistachios,” she said. “Average sleep blood pressure was reduced by about 4 points and this would be expected to lower workload on the heart.” The researchers found that the pistachio diet lowered vascular constriction during stress. When arteries are dilated, the load on the heart is reduced. The physical challenge involved immersing one hand into icy water for two minutes. Study finds curcumin, the main polyphenol in turmeric, as effective as Prozac in treating depression Government Medical College (India), June 6, 2022 A recent study published in Phytotherapy Research shows that curcumin, the main polyphenol in turmeric, is as at least as effective as fluoxetine (Prozac) in treating depression. Not only can it help ease symptoms of depression, but it does so safely, without the potential to cause suicidal thoughts, weight gain and even changes in blood pressure and heart rate that can lead to shock and death — some of the many side effects which have been linked to Prozac. The study, conducted by researchers from the Department of Pharmacology at the Government Medical College in Bhavnagar, India, assessed groups of people who took curcumin capsules and Prozac, either individually or combined. Twenty people took 500 mg curcumin capsules twice daily, 20 took 20 mg of Prozac daily, and the remaining 20 people took a combination of the two. The Hamilton Depression Rating Scale, a questionnaire designed to gauge the severity of a person's depression level, was given to assess any changes in mood among the individuals who participated in this study. The findings showed that curcumin worked just as well as Prozac, acting as the “first clinical evidence that curcumin may be used as an effective and safe modality for treatment in patients with MDD without concurrent suicidal ideation or other psychotic disorders.” (1, 3) MDD stands for “Major Depressive Disorder.” Monkeys that eat omega-3 rich diet show more developed brain networks University of Oregon, June 13, 2022 Study gives new insight into similarity of complex brain networks in monkeys, humans Monkeys that ate a diet rich in omega-3 fatty acids had brains with highly connected and well organized neural networks — in some ways akin to the neural networks in healthy humans — while monkeys that ate a diet deficient in the fatty acids had much more limited brain networking, according to an Oregon Health & Science University study. The study, published in the Journal of Neuroscience, provides further evidence for the importance of omega-3 fatty acids in healthy brain development. It also represents the first time scientists have been able to use functional brain imaging in live animals to see the large-scale interaction of multiple brain networks in a monkey. These patterns are remarkably similar to the networks found in humans using the same imaging techniques. The study measured a kind of omega-3 fatty acid called docosahexaenoic acid, or DHA, which is a primary component of the human brain and important in development of the brain and vision. The study found that the monkeys that had the high-DHA diet had strong connectivity of early visual pathways in their brains. It also found that monkeys with the high-DHA diet showed greater connections within various brain networks similar to the human brain — including networks for higher-level processing and cognition ‘Mini-strokes' lead to PTSD and other psychiatric disorder University of Erlangen-Nuremberg, Germany June 15, 2022 Transient ischemic attacks are commonly referred to as “mini-strokes,” but this does not make them any less serious than major strokes. In fact, a recent study has found that around 30% of patients who have transient ischemic attacks go on to develop the symptoms of post-traumatic stress disorder (PTSD). Transient ischemic attacks (TIAs) occur when the flow of blood to the brain is disrupted temporarily, often by blood clots or other debris. They differ from major strokes in that the flow of blood is only blocked for a relatively short time – usually no more than 5 minutes. Despite only disrupting blood flow temporarily, TIAs serve as warning signs for future major strokes. They indicate that there is a partially blocked artery or a clot source in the heart. The Centers for Disease Control and Prevention (CDC) report that between 10-15% of people with TIA will experience a major stroke within 3 months. “We found 1 in 3 TIA patients develop PTSD,” says study author Kathrin Utz from the University of Erlangen-Nuremberg, Germany. “PTSD, which is perhaps better known as a problem found in survivors of war zones and natural disasters, can develop when a person experiences a frightening event that poses a serious threat.” The researchers found that about 30% of the TIA patients reported symptoms of PTSD and 14% showed signs of a significantly reduced mental quality of life. Around 6.5% of the participants also had a reduced physical quality of life. TIA patients who showed signs of PTSD were also more likely to show signs of depression, anxiety and a lower overall quality of life than those who did not. Exercise linked to brain cell growth and improved memory University of Jyvaskyla (Finland), June 14, 2022 New research out of the University of Jyvaskyla in Finland has shown that exercise helps with preserving brain cells and preventing loss of memory, cognitive issues and general memory problems. In the Finnish study, aerobic activity in particular was found to support healthier brain cells and prevent memory problems better than other exercise types studied, including weight lifting and high-intensity interval training (HIIT). While weight lifting and HIIT have better fat burning properties, moderate aerobic exercise seems to cultivate healthier brain cells and protect against loss of memory. For the study, University of Jyvaskyla researchers put groups of rats on three different workout programs to determine their effects on memory and overall brain health. Weight lifting, running and high-intensity interval training were the three types studied. The training regimens created were made to model approximately what the typical human might do in a workout program. The running group used a treadmill much as humans do, and the weight lifting group climbed a ladder with little weights attached to their tails. The HIIT group alternated short durations of sprinting and jogging. By study's end, while all of the rats showed general fitness gains, the weight lifting group and the HIIT group showed no signs of neurogenesis, or new brain cell growth. By contrast, the running group demonstrated growth in brain cells as well as a reduction in the loss of memory and memory problems. Organic food consumers have a 21% lower risk of pre-eclampsia Norwegian Institute of Public Health, June 15, 2022 Pregnant women may be able to lower their risk of a potentially deadly complication known as pre-eclampsia by more than 20 percent simply by eating more organic vegetables, according to a study conducted by researchers from the National Institute for Consumer Research and the Norwegian Institute of Public Health, and published in BMJ Open. “The result is intriguing and supports that diet during pregnancy can influence the risk of pre-eclampsia,” researcher Hanne Torjusen, PhD, said. Pre-eclampsia is a complication of late pregnancy characterized by high blood pressure and protein in the urine. The cause of the condition is not known, although it has been linked to a variety of risk factors including some of the same risk factors as cardiovascular disease. Mild cases may resolve without problems, but severe cases may progress into a life-threatening condition that can only be alleviated through premature delivery of the baby. The new study is the first to show a connection between organic food consumption and lower pre-eclampsia risk.
🔥 Fernando Quesada Arroyo, socio de Cortés Quesada Abogados, habla de la intención de la SENER para que grandes consumidores que utilizan gas importado lo compren sólo a CFE o a Pemex. 👨⚖️ Carlos Véjar, Abogado de Comercio y Arbitraje Nacional e Internacional de Holland & Knight, nos explica que en el 2021, México escaló al quinto sitio con el mayor número de disputas de inversión privada en arbitrajes internacionales. 👨🏫 Carlos Lau, co fundador y director general de Kurios, nos habla del levantamiento de capital por $2.3 MDD, para que Edtech llegue a México e impulsar lo digital. Manuel Sescosse, presidente de la Asociación de la Tauromaquia Mexicana, comenta que la Segunda Sala de la Corte determinó que los gobiernos de los estados no pueden emitir una declaratoria para catalogar a las corridas de toros como patrimonio cultural inmaterial.
En el nuevo episodio del podcast Libre Como El Viento hablamos de: Movimiento Ciudadano trabaja para quitar del poder a Morena. Denuncian por violación a jurídico de Tijuana. Jaime Bonilla compró condominio de 3.9 MDD. Violencia se recrudece en BC: 110 homicidios en 15 días. Más detalles, en la edición impresa del Semanario ZETA y en www.zetatijuana.com
TELL EVERYONE - New mom chat - Kali's article and twitter - https://www.insider.com/my-child-diagnosed-rare-genetic-condition-syngap1-2022-6 - https://twitter.com/WorthKali - Tavillas: https://syngap.fund/susan (6/22/15) CHECK OUT THIS CONFERENCE: https://syngap.fund/treat DRUG CO NEWS - Anglemans and Ionis! https://www.prnewswire.com/news-releases/ionis-treatment-for-angelman-syndrome-receives-orphan-drug-and-rare-pediatric-disease-designations-from-us-fda-301566169.html - Praxis update: At the end, scroll down. CIITIZEN - Webinar was awesome https://syngap.fund/virginie - Sign up! https://www.ciitizen.com/syngap1/ PROBABLY GENETIC IS WORKING! - Assessment: syngap.fund/maybe - https://symptom-checker.probablygenetic.com/syngap/ - Webinar: https://syngap.fund/PG - Sponsored testing with Mahzi! https://mahzi.com/ REMEMBER NOT TO MISS - June 2022 https://mailchi.mp/syngapresearchfund.org/june22 - Sign up for the EF Panel: https://bit.ly/efmen FUNDRAISERS - MDBR: Join us and secure $30k matching funds https://syngap.fund/SRFMDBR22 - MICE: Help us Make 2! https://syngap.fund/2mice EVENTS - June 25 in DFW - Join us for a family meeting and hear from Dr. Perry. Link soon. - September 12-14 in San Diego - #GlobalGenes Meeting. Link soon. - October 8 in NJ - Caren Leib Gala https://www.syngapresearchfund.org/get-involved/fundraising/caren-leib-gala - October 8 in SC - Scramble for SYNGAP https://www.syngapresearchfund.org/get-involved/fundraising/scramble-for-syngap - November 12 in GA - Sparks of Hope Gala https://syngap.fund/soiree - December 1 in TN - Syngap Science Meeting - https://syngap.fund/treat This is a podcast: subscribe to and rate this 10 minute #podcast #SYNGAP10 here https://www.syngapresearchfund.org/syngap10-podcast Apple podcasts: https://podcasts.apple.com/us/podcast/syngap10-weekly-10-minute-updates-on-syngap1-video/id1560389818 Episode 64 of #Syngap10 - June 14, 2022 #F78A1 #Syngap #epilepsy #autism #intellectualdisability #id #anxiety #raredisease #epilepsyawareness #autismawareness #rarediseaseresearch #SynGAPResearchFund #CareAboutRare #PatientAdvocacy #GCchat #Neurology #GlobalCollaboration #EpilepsyFoundation #Praxis #ProbablyGenetic #Mahzi Copy from letter from Praxis: Monday morning, June 6th, we published an 8K filing announcing news involving multiple programs at Praxis Precision Medicines. One of these announcements pertained to the FDA's clinical hold on our recent IND filing for PRAX-222 in SCN2A, so we wanted to share further context for it. On May 25, 2022, the Company received a communication from the U.S. Food and Drug Administration (the “FDA”) providing additional information on the clinical hold placed on the Company's Investigational New Drug application (the “IND”) for the study of PRAX-222, an antisense oligonucleotide, for the treatment of patients with SCN2A gain-of-function mutations. The communication indicated that our IND could be cleared once we submit additional documentation related to the preclinical non-human primate toxicology study that supports the proposed starting dose in the clinical study. We're requesting a Type A meeting with the FDA to confirm the study design and further clarify the requirements for dose escalation beyond the starting dose. This surely will leave our SCN2A community with questions about the timing of our path forward. While the protocol and the discussions being held with the FDA remain confidential, we will do our best to maintain transparency and responsiveness throughout the process. We continue to be fully committed to advancing PRAX-222 to clinical study. We also want to restate that this news is specific to PRAX-222, without impact on our PRAX-562 program for SCN2A, SCN8A and TSC. In Monday's press release, we reiterated our focus on driving toward proof of concept for PRAX-562. We'll provide further updates on PRAX-562 as we approach major milestones on this path. In addition, our other programs in PCDH19 and SYNGAP1 remain on-track. Beyond epilepsy, Monday's 8K filing announced significant news pertaining to our Aria study of PRAX-114 in Major Depressive Disorder (MDD). It is with great regret that we announce the failure of the Aria Study, a study to determine the efficacy of a GABBA PAM extrasynaptic preference medicine to achieve fast-acting, lasting reduction of symptoms of MDD. After reviewing the data and our operational controls and observing failure to achieve our primary endpoint, we determined that PRAX-114 was indeed safe but not efficacious, and no further research and development of PRAX-114 is warranted. This conclusion has a negative impact on the study of PRAX-114 to treat Post-Traumatic Stress Disorder and Essential Tremor. This is a difficult decision for the Praxis team; but our commitment and capacity to researching and developing genetic insight-based treatments for people living with disorders of the CNS is in no way diminished.
Can we use ketamine as a maintenance treatment for MDD? In this episode, Dr. Phelps discusses CANMAT's recommendations for the use of ketamine for MDD. Faculty: Jim Phelps, M.D. Host: Jessica Diaz, M.D. Learn more about Premium Membership here Earn 0.5 CMEs: Quick Take Vol. 35 The Canadian Network for Mood and Anxiety Treatments (CANMAT) Task Force Recommendations for the Use of Racemic Ketamine in Adults With Major Depressive Disorder
Mestá a obce zvažujú zvyšovanie daní - - - Poslanci dali zelenú nájomným bytom - - - Rozvedení rodičia by sa mohli na podmienkach starostlivosti o dieťa dohodnúť aj bez súdu - - - Novým komisárom pre deti sa stal Jozef Mikloško - - - Slovensko odchádza z MS v hokeji bez medaily - - - Kapitán slovenských futbalistov Marek Hamšík ukončil reprezentačnú kariéru - - - Hviezda Repete Dušan Grúň oslávil 80-tku - - - O pár dní bude MDD
Thank you Yuri Anderson, OMS III for developing this podcast! Thank you Carl "I wish I had a nickname" Ketcham, OMS III for joining us. This podcast has high yield information at the onset for both GAD and MDD. The podcast then moves to a description of terms that is likely very helpful before tackling a review of the literature supporting the use of Mindfulness Based Techniques. Lastly, we tackle where this therapy may be going in the future (Elon?). We enjoyed our discussion and hope you find it as interesting as we did! Thank you Jordan Turner for creating the perfect bumper music!
Depression, or what is termed medically as major depressive disorder (MDD), is so incredibly multi-faceted that there isn't just one path to healing for everyone who has it. And yes, you can heal from depression. There is a small genetic role ~ about 1/3rd of it in some twin studies, but the other 2/3rds is largely environmental, situational, biological, generational, nutritional, spiritual, emotional, metabolic, immune, and so much more. I talk a little about my experience healing from depression, as a physician, and what it all meant for me. And then I discuss some of the lesser known therapies (outside of the standard of care of anti-depressants and therapy) that have been studied for major depressive disorder, including acupuncture, hypnosis, aromatherapy, light therapy, saffron, and st. john's wort. Shownotes HERE -------------------------------------------------------------- Our Brain Health Integrative Guide is gone, to make room for a FREE Integrative Wellness Course Module on "How To Aromatherapy for Women's Wellness". All for Free. My presentation and handout on how to become your own aromatherapist for some of the most common conditions that we have to deal with as women! The science behind aromatherapy, precautions, and how to make your own topical, diffusion, sprays, bath salt blends! Worth $100! All for FREE. For a very limited time, so get it today at www.healthispowher.com. Link Below: You can sign up here! ---------------------------------------------------------------- We hope you enjoy the episode and if you do, please SUBSCRIBE, RATE, and REVIEW So you can help us increase our reach to help more women awaken their best selves, have more energy, and live the life they dreamed of while healing and recovering from any pain and health issues! ---------------------------------------------------------------- Be on the lookout for the foundational coaching masterclasses this coming new year! And for those of you ready to heal from a chronic condition, we will have your advanced master coaching program coming soon for Menopause, PCOS, Endometriosis, Pelvic Pain, Hormone Regulation, Autoimmune Disease, Chronic Fatigue, Fibromyalgia, and More! We will be launching one of these come 2022, so be on the lookout or email us at email@example.com to get on the list! ---------------------------------------------------------------- DISCLAIMER Anna Esparham, M.D.is a medical doctor, but she is not your doctor, and she is not offering medical advice on this podcast. If you are in need of professional advice or medical care, you must seek out the services of your own doctor or health care professional. The opinions of podcast guests are not necessarily those of Dr. Esparham, MD and Health Is PowHer, LLC and do not represent her or the company. This podcast provides information only, and does not provide any financial, legal, medical or psychological services or advice. None of the content on this podcast prevents, cures or treats any mental or medical condition. You are responsible for your own physical, mental and emotional well-being, decisions, choices, actions and results. Health Is PowHer, LLC disclaims any liability for your reliance on any opinions or advice contained in this podcast.
#31 “When Rach overcame cockfight! ” This week on your favorite podcast, we continue on our quest to track down Mitch Evans! Rachel's latest semi celeb DM slide. Even though she can't have him just yet, Carl got her the closest to mitch she's got so far. The incredible & wild Sophie Nathan joins us once again to share a tale of the time she went to London and found herself a Wimbledon competing tennis player. This story could only happen to our beloved Soph-Nath. The next part is a real treat. Whether or not you've ever wondered what Rachel's first shag fresh out of the bonds of marriage was like, you're getting the story this week, thanks to the amazing yarn spinning of our mate & regular on MDD, Bex. Loving what you are hearing? Follow us on socials! Instagram: instagram.com/marrieddivorcedanddating/ Rachel's Instagram: instagram.com/rachelohdear/ Carl's Instagram: instagram.com/carlpthompson/ Sophie Nathans instagram: instagram.com/sophie_nathan Bex's Instagram: instagram.com/bexdewhurst/ Wanna email us a story, we know you've got one? firstname.lastname@example.org Intro Music: Neill Fraser - Married Divorced & Dating Theme instagram.com/neillfraser/
What are the regulatory pathways used in the United States versus the European Union (EU)? Dealing with regulators can be challenging and emotionally draining. Win in the U.S. and EU marketplace by delegating all things regulatory to a grief counselor. In this episode of the Global Medical Device Podcast, Jon Speer and Etienne Nichols talk to Michelle Lott, Founder and Principal of leanRAQA. Also, she served a four-year term on the FDA's Device Good Manufacturing Practice Advisory Committee (DGMPAC).Michelle is on a mission to help smaller companies with regulatory strategy, planning, submissions, audit preparation and remediation, due diligence, quality systems, and compliance.Some of the highlights of this episode include:Why new clients work with Michelle: It's easy to find a competent regulatory person, but how many are you going to enjoy working with and able to make you laugh when you really feel like crying?Even with the adoption of EU MDR, people are still in denial when it comes to those with certificates that expire in May 2024 and think they still have time to get certificates reissued.Several small companies, as well as large corporations, are choosing to not go to market or withdraw products in the EU because of the lack of value and revenue.The cost, clinical data, and limited number of notified bodies are some of the biggest challenges for those in the EU versus U.S. market.Companies should perform a market analysis to determine if their revenue model will support year-over-year costs and third-party fees to stay in the EU market.The impact to quality in the European healthcare system could turn the U.S. into a destination for medical tourism. It could happen if an analysis is not done by the government or competent authority.A quality management system (QMS) has to have an ISO 13485 certification in the EU. The U.S. doesn't require a QMS until a product is put into commercialization and meets performances, standards, and expectations.According to Michelle, the five stages of regulatory grief are denial, anger, bargaining, depression, and acceptance.Memorable quotes from Michelle Lott:“If you don't have a relationship with a notified body yet, you're already almost too late. You just can't make any commitments to or marketing plans for the EU right now, in terms of timing.”“The first thing is to do that market analysis, and then, if they decide that Europe is still something that they want to do, second, you need to get in line with a notified body.”“There's no such thing as grandfathering underneath the EU.”“There were 18,000 certificates issued under MDD, and only one percent of those have made it all the way through MDR.”“To properly prepare technical documentation, it is truly a cross-functional effort and it's going to require a lot of very in-depth expertise.”Links:Michelle Lott on LinkedInRegulatory + Quality Assurance (leanRAQA)leanRAQA - Free GuidesRAQA Today PodcastFDA - Device Good Manufacturing Practice Advisory Committee (DGMPAC)European Union - Medical Device Regulation (EU MDR)ISO 13485FDA - Quality Management System Regulation (QMSR)True Quality 2022The Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru AcademyGreenlight GuruGlobal Medical Device Podcast Email
Regulatory landscape is growing increasingly complex with new European Union Medical Device Regulations and In Vitro Diagnostic Regulations. In fact, research from MedTech Europe predicts that as many as 76% of products will be withdrawn from the market as a result and the complexity isn't limited to just our friends in Europe. The US, Australia, Canada, China, and many more countries are adapting their regulatory approach. The only thing that doesn't change is change itself - applies both in life and regulatory. Today we're going deeper into how to modernize regulatory affairs, specifically for medtech. James Gianoutsos is the Founder & President of RimSys - a regulatory information management platform that centralizes regulatory activities in the cloud. From product documentation to streamlined submissions to monitoring market status, RimSys can save RA teams hours and hours. Any life sciences founder listening in can learn from James's experience jumping into entrepreneurship from his career in Quality/Regulatory and how to get to market faster utilizing digital technologies. Enjoy!About James GiantoutsosJames Gianoutsos is a quality assurance and regulatory affairs professional who has a diverse background in the medical device, pharmaceutical and biologics industries. James' professional experience includes the design, premarket approval, clinical trials, manufacturing, distribution and post-market surveillance of drug products and class I, II, and III devices. It also includes products in a variety of clinical applications including infant jaundice management, neonatal respiratory care, infant incubation, sleep therapy, management of respiratory insufficiency, surgical adhesive for internal use, surgical sealant for prevention of gastrointestinal leaks, and bone healing accelerants. James has extensive experience in establishing and maintaining quality management systems in accordance with FDA, ISO, cGMP, MDD, CMDCAS requirements and standards and has helped develop and submit multiple regulatory filings including Premarket Approvals (PMA), 510(k)s, Design Dossiers, Technical Files and INDs. James holds a Bachelor of Science in operations management as well as a Master of Business Administration (MBA) with a concentration in operations management and strategy from the University of Pittsburgh – Katz Graduate School of Business.About RimsysRimsys was founded in 2017 by regulatory affairs professionals who asked the simple question: “Isn't there a better way to do this?” Like all RA teams, they spent hours looking for information, manually managed global product registrations, and struggled to keep up with changing regulations and standards. The Rimsys Platform is designed specifically to help medtech companies address these challenges, and confidently establish global regulatory compliance.Show noteshttps://www.rimsys.io/Rimsys Series A postJames Giantoutsos LinkedInQualio WebsitePrevious episodes: https://www.qualio.com/from-lab-to-launch-podcastApply to be on the show: https://forms.gle/uUH2YtCFxJHrVGeL8Music by keldez
PMCF is something that was existing before with MDD 93/42/EC but this is more in focus now with the new EU MDR 2017/745. In this episode, I have invited Matthias Fink from TÜV SÜD to help us understand some of the mistakes we are making in the creation of our PMCF. He will tell us what to do and how to distinguish between the different PMCF types. Who is Matthias Fink? Board-certified orthopedic and trauma surgeon with 17 years of experience in orthopedic, trauma, and reconstructive surgery and extensive training in cardiovascular and thoracic surgery. Working for TÜV SÜD Product Service in Germany since 2016 as a Clinical Reviewer in the Clinical Centre of Excellence before joining TÜV SÜD America in 2017. Senior Clinical Expert Orthopedic Surgery for the Clinical Centre of Excellence and the Team Manager of the Clinical Focus Team North America. Presenter at national and international conferences and workshops on the clinical requirements and the implementation of the EU MDR. Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… Links Matthias Fink LinkedIn Page: https://www.linkedin.com/in/matthias-fink-47a3b227/ MDCG PMCF plan 2020-7: https://ec.europa.eu/health/document/download/a5cdb303-c782-4010-8723-7d389af678f7_en MDCG PMCF report 2020-8: https://ec.europa.eu/health/document/download/11121036-696a-4589-a311-c5525bd84df3_en TÜV SÜD Medical and Health Care LinkedIn Page: https://www.linkedin.com/showcase/tuvsud-medicaldevices/ Application page for MDR services: https://www.tuvsud.com/en/industries/healthcare-and-medical-devices/medical-devices-and-ivd/medical-device-market-approval-and-certification/medical-device-regulation/mdr-request-for-service-registration Information on the clinical data requirements under the MDR: https://www.tuvsud.com/en/industries/healthcare-and-medical-devices/medical-devices-and-ivd/clinical-services/clinical-data-for-medical-devices A search engine of the TÜV SÜD resource center with webinars and published white papers: https://www.tuvsud.com/en-us/resource-centre Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice
This week: The end of the public health emergency is nearing; Federal agencies hit with EHR outage. Plus: Akili's video game-like intervention improved users' cognitive functioning.Links to the stories:HHS is giving clear signals of wind down of public health emergencyEHR outage takes down federal Cerner systemsAkili Interactive's DTx improves cognitive function in adults with MDD
El quaterback del equipo de Las Vegas firmó una extensión por 121 MDD. El panorama del Draft en 2022 ¿falta talento en la posición de pasador? Los desafortunados comentarios de Cam Newton ¿alguién estaría dispuesto a firmarlo después de este nuevo episiodio?
Robb has overcome homelessness, alcohol dependency, trauma, PTSD, and MDD and a whirlwind of events to become an expert in the addiction treatment world. Before Dr. Kelly succumbed to addiction and mental health issues, he played bass guitar at Abbey Studio with Queen, David Bowie, and Elton John. He is an accomplished musician, and the money he made helped him attend Oxford University to pursue a Ph.D. in Psychology. He experienced a spiritual awakening on the cold streets of Manchester while homeless and in dire straights. To learn more about Dr. Kelly and his work, visit https://robbkelly.com/
Major Depressive Disorder is a relatively common mood disorder that can impact the way a person thinks, feels, and behaves. Learn about the symptoms and frequency that characterize MDD and what treatments are available. Jared K. O'Garro-Moore, Ph.D., is an Assistant Professor in Medical Psychology (in Psychiatry) at Columbia University Irving Medical Center. Dr. O'Garro-Moore specializes in the treatment of adults with mood and anxiety disorders as well as personality disorders. Integrating his advanced training in Cognitive Behavioral Therapy (CBT), Dialectical Behavioral Therapy (DBT), and Acceptance and Commitment Therapy (ACT), Dr. O'Garro-Moore is able to tailor his treatment to fit each individual's needs. If you enjoy this podcast, be sure to follow or subscribe wherever you are listening, and share You Ask, We Answer with your colleagues and friends. You can also subscribe to our YouTube Channel here, where we have an animated video with Dr. O'Garro-Moore on this topic: https://www.youtube.com/c/PsychHub. You Ask, We Answer is a co-production from Psych Hub and Columbia University Department of Psychiatry, and brought to you by HCA Healthcare. This show is for educational purposes only. Visit https://psychhub.com to dig deeper and access the world's most comprehensive platform for behavioral health education. Follow us on Social Media Twitter: https://twitter.com/PsychHub Instagram: https://www.instagram.com/psychhubeducation YouTube: https://www.youtube.com/c/PsychHub
El especialista en temas financieros, Eduardo Torreblanca, en entrevista con Manuel López San Martín habló sobre las remesas que suman 7 mil 840.8 MDD en el primero bimestre de 2022, una cifra récord, de acuerdo con Banxico.
Can you detect when a patient with MDD has reached a breaking point? Credit available for this activity expires: 3/24/2023 Earn Credit / Learning Objectives & Disclosures: https://www.medscape.org/viewarticle/970613?src=mkm_podcast_addon_970613
Since MDR is live we get from surprises to surprises. And we wanted in this episode to share with you some lessons learned regarding Clinical Evaluation. You maybe noticed that between MDD and MDR the audit style for CER is different. Even if the requirements are mostly the same. So today we'll try to guide you to be on the safe side with Cesare Magri from Be-on-Clinical. Who is Cesare Magri? Cesare has a mixed Background: Physics and Neuroscience, PhD in Informatics. He worked as a biostatistician at Max Planck in Tübingen and started working with medical devices and clinical evaluations in 2013. Recently he founded be-on-Clinical together with Stefan Bolleininger in 2020. Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses... Links Cesare Magri Linkedin: https://www.linkedin.com/in/cesare-magri-92465345/ Be-on-Quality: https://www.be-on-quality.com/en/about-en/ Clinical Evaluation Template Pack: https://school.easymedicaldevice.com/product/clinical_pack/ Podcast Episode - Create Intended Purpose: https://podcast.easymedicaldevice.com/65/ Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice
Why should community leaders focus on mental health as an important economic issue? According to a study published by PharmacoEconomics, latest estimates show that the incremental economic burden of adults with major depressive disorders (MDD) was $326 billion in 2018, 38 percent higher than in 2010. On this week's CDI Podcast, we explore why supporting mental health should be a crucial piece of every leader's community and economic development plans.
In this episode, we talk about depression. Some of the things we cover: Signs and symptoms to be aware of and when to reach out for help The stigma of depression vs. other mental health struggles How common depression can be March is Self-Harm Awareness Month and what self-harm means What is Dysthymia and Manic Depressive disorder (MDD) and the differences Surprising facts about suicidal ideation https://suicidepreventionlifeline.org We would love to connect with you! If you listen to this podcast, please hit the subscribe button so that you never miss an episode and share this podcast with your community and friends. Tag us so we can give a shout out and if you really enjoyed this episode, feel free to share the love and leave a review. The podcast officially has its own handle and page! Connect with us here: https://www.instagram.com/hillaryandchristina/ Check out Christina's website at: https://www.christinaennabe.com/. And as always, stay well!
Hey everyone! I've got my Psychiatric/Mental Health Nurse Practitioner hat on this episode and am putting my Yale degree to use by breaking down the clinical symptoms of Major Depressive Disorder (5:47). It delights me that we are taking mental health more seriously as a generation, and it's important to be equipped with the right language and information so listeners like you all are able to properly identify when you may need to seek help. Also a warning that there is a brief discussion of suicidal ideation in this episode (22:25) as it can be a symptom of MDD. A list of episode timestamps are below: Symptoms (13:13) Statistics (28:00) Comorbidities (34:10) Family History (37:11) Depressive Subtypes (39:37) If any questions arise about this topic that you'd like to ask me personally, feel free to reach out via my contact info below. Despite the heavier nature of this episode's content, I hope it is impactful. Please follow/subscribe, share and recommend to those you feel it may help. If you have been having suicidal thoughts, the National Suicide Hotline is accessible 24/7 at 1-800-273-8255. Literature references for the episode: Diagnostic and Statistical Manual for Psychiatric Disorders (V) ; Synopsis of Psychiatry Contact email: email@example.com Follow me on social: Twitter: @uzoamakachinelo Instagram: @bibliotherapy_pod
Go online to PeerView.com/TTU860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. In this activity, an expert in psychiatry discusses the evidence for the use of GABA-modulating neuroactive steroids for major depressive disorder. Upon completion of this CE activity, participants will be able to: Summarize the evidence supporting a role for GABAergic dysfunction and altered neuroactive steroid signaling in major depressive disorder (MDD), Recognize the burden of MDD and the impact of delayed or suboptimal treatment on patient outcomes, Evaluate recent safety and efficacy data related to emerging treatment options for MDD, recognizing potential implications for the future treatment landscape.
On this episode of Chase The Vase Podcast, I sit with Dr. Robb Kelly and we discuss real recovery. He shares his story and road to recovery. Dr. Robb has overcome homelessness, alcohol dependency, trauma, PTSD, and MDD and a whirlwind of events in his life. Before Robb succumbed to addiction and mental health issues, he played bass guitar at Abbey Studio with Queen, David Bowie, and Elton John. He is an accomplished musician, and the money he made helped him attend Oxford University to pursue a Ph.D. in Psychology. Robb experienced a spiritual awakening on the cold streets of Manchester while homeless and in dire straights. I guarantee, that this episode will provide you with tangible tools to begin your recovery! I invite you listen to this episode and take the challenge Dr. Robb issues. What do you have to lose, your addiction? After listening to this episode, check out the www.striplingwarriorchallenge.com for more details on where to begin your recovery! --- Support this podcast: https://anchor.fm/brock-m-bevell/support
Stigma. It can be the difference between getting well and avoiding the help you need, especially when we're talking about mental health. Even though the awareness of mental health needs are increasingly common, we still see people delay seeking treatment due to stigma: feelings of shame and disgrace that lead to concerns about being treated differently. In this episode, our LISTEN WELL host Dr. Mo Alsuwaidan is tackling stigma with renowned psychiatrist and president of the WPA, Dr. Afzal Javed, and Ms. Anita Abu Bakar, president of MIASA – the Mental Illness Awareness and Support Association in Malaysia. Mental Illness Awareness & Support Association: https://miasa.org.my/Virtual Event: The pandemic's toll on mental health - https://www.statnews.com/2021/02/25/virtual-event-the-pandemics-toll-on-mental-health/Article: Reducing the stigma of mental health disorders with a focus on low-and middle-income countries- https://www.sciencedirect.com/science/article/pii/S1876201821000575