Author Interviews, ESMO, Immunotherapy, Melanoma, NEJM / 03.09.2020

MedicalResearch.com Interview with: Reinhard Dummer, Prof. Dr. med. Stv. Klinikdirektor Universitätsspital Zürich, Dermatologische Klinik Zürich MedicalResearch.com: What is the background for this study? Response: Based on molecular biology analysis, a substantial proportion of melanomas are driven by mutations of BRAF resulting in an ongoing growth activating signal. Based on the key role of BRAF several multiple kinase molecules have been developed in order to target this crucial pathway. These medications have shown to improve progression free survival and overall survival in advanced metastatic melanoma. Because there is a tendency for improved outcome in patients with low tumor burden, combined targeted therapy using Dabrafenib and Trametinib have been investigated in the adjuvant (after complete surgical resection) setting in stage III melanoma. And the 5 year data are now available in the New England Journal of Medicine. (more…)
Author Interviews, Cost of Health Care, Genetic Research, Immunotherapy, Melanoma, Surgical Research / 03.09.2020

MedicalResearch.com Interview with: Edmund K Bartlett, M.D. Department of Surgery/Division of Surgical Oncology Memorial Sloan Kettering Cancer Center New York, New York   MedicalResearch.com: What is the background for this study? Response: Indications for adjuvant therapy for resected, high-risk melanoma is a controversial and rapidly-evolving topic in melanoma treatment. Immunotherapy treatments targeting PD-1 have significantly improved survival in advanced-stage disease, but the magnitude of survival benefit in stage III disease--particularly stage IIIA--remains unclear. Recently, 31-GEP (a gene expression profiling assay) has been studied as a risk-stratifying tool to identify patients who are at higher risk for systemic recurrence. Ideally such a tool could identify patients most likely to benefit from immunotherapy treatment in the adjuvant setting (when all visible disease has been removed). (more…)
Alzheimer's - Dementia, Author Interviews, Infections / 01.09.2020

MedicalResearch.com Interview with: Hariom Yadav, PhD Assistant Professor, Molecular Medicine Wake Forest School of Medicine  MedicalResearch.com: What is the background for this study? What are the main findings? Response: As gut microbiota is linked with all kind of known human diseases, however, commonly studied microorganisms are bacteria. Our study is first-of-its kind to discover the role of fungi living in our gut to influence our brain health like Alzheimer’s disease pathology in humans. It also describes that a Mediterranean ketogenic diet can beneficially change fungi and bacteria populations to improve brain health.  (more…)
Accidents & Violence, Author Interviews, Brigham & Women's - Harvard, Emergency Care, JAMA, Surgical Research / 01.09.2020

MedicalResearch.com Interview with: Sarabeth Spitzer, MD Co-Chair of Board, Scrubs Addressing the Firearm Epidemic (SAFE) Department of Surgery, Brigham and Women’s Hospital MedicalResearch.com: What is the background for this study? What are the main findings? Response: Firearm injury is a significant cause of morbidity and mortality in the United States, resulting in almost 40,000 deaths annually in the United States, but very little is known about the epidemiology of nonfatal firearm injuries. Nonfatal firearm injuries can have significant long-term morbidity and are associated with significant cost. We found that there were over 81,000 nonfatal firearm injuries in California over the study period. Over the period, there was a decrease in nonfatal firearm injuries by 38.1%, driven primarily by a decrease in assault injuries.   (more…)
Author Interviews, Autism, Environmental Risks, JAMA, Pediatrics / 31.08.2020

MedicalResearch.com Interview with: Jessica Shoaff, MPH, PhD Postdoctoral Research Fellow and Susan A. Korrick, MD Pulmonary and Critical Care Assistant Professor in the Department of Environmental Health Harvard Medical School · Harvard T. H. Chan School of Public Health Brigham and Women's Hospital Channing Laboratory Boston, MA 02115   MedicalResearch.com: What is the background for this study? What are the main findings? Response: Our study posed the question:  Do teenagers’ exposures to chemicals that are often found in consumer products increase behaviors that are common among individuals diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD)? Our results suggest that teenagers exposed to chemicals often found in consumer products (particularly phthalates) may have increased behaviors that are common among individuals diagnosed with ADHD.  However, we did not study the diagnosis of ADHD (most of our study teens did not have ADHD).  This means our results cannot answer the question of whether these chemical exposures increase the likelihood of being diagnosed with ADHD. Also, in our study design, chemical exposures and ADHD-related behaviors were measured at the same time, so it is not possible to know with certainty whether the chemical exposures altered behavior or behavior altered chemical exposures.  (more…)
Author Interviews / 30.08.2020

MedicalResearch.com Interview with: Elena B. Hawryluk, MD, PhD Board-certified Dermatologist and Pediatric Dermatologist Assistant Professor of Dermatology Harvard Medical School Faculty Director of Pediatric Dermatology Harvard Combined Dermatology Residency Program. Dr. Hawryluk sees patients at Massachusetts General Hospital and Boston Children’s Hospital, and has a clinical interest in pigmented lesions and melanoma in the pediatric population. Dr. Hawryluk is a member of the Society for Pediatric Dermatology. MedicalResearch.com: What is the background for this study? What are the main findings? Response: Melanoma is exceptionally rare and challenging to diagnose in the pediatric population.  The most important and clearly defined patients with melanoma are those with an aggressive fatal course, so this study was pursued to evaluate fatal presentations to help physicians to recognize those patients at highest risk.  Due to the rarity of fatal pediatric melanoma, in order to study a big enough group, our research team included pediatric dermatologists who collaborated from major institutions across the US and Canada, through the Pediatric Dermatology Research Alliance (PeDRA).  (more…)
Author Interviews, COVID -19 Coronavirus / 29.08.2020

MedicalResearch.com Interview with: Joanne Lemieux, Ph.D. Professor, Director, Membrane Protein Disease Research Group Department of Biochemistry Faculty of Medicine & Dentistry University of Alberta Edmonton AB Canada  MedicalResearch.com: What is the background for this study? Response: Labs at the University of Alberta developed and studied inhibitors directed against the main protease of coronavirus virus back in 2003 during the initial SARS outbreak. These inhibitors were subsequently developed by other labs to treat a fatal form of coromavisus infection in cats. (more…)
Author Interviews, Pediatrics, Vitamin D / 28.08.2020

MedicalResearch.com Interview with: Juan C. Celedón, MD, DrPH, ATSF Niels K. Jerne Professor of Pediatrics Professor of Medicine, Epidemiology and Human Genetics University of Pittsburgh Division Chief, Pulmonary Medicine UPMC Children’s Hospital of Pittsburgh Pittsburgh, PA 15224 MedicalResearch.com: What is the background for this study? Response: Findings from observational studies suggested that vitamin D levels below 30 ng/ml are associated with worse asthma and severe asthma attacks. Based on those results, we conducted a randomized, double-blind, placebo-controlled clinical trial of vitamin D3 supplementation to prevent severe asthma attacks in 192 high-risk children with asthma aged 6 to 16 years who had moderately low vitamin D levels and were taking low-dose inhaled steroids. (more…)
Author Interviews, JAMA, Sexual Health, USPSTF / 28.08.2020

MedicalResearch.com Interview with: Melissa A. Simon, M.D., M.P.H. George H. Gardner Professor of Clinical Gynecology Vice Chair of Clinical Research Department of Obstetrics and Gynecology Professor of Preventive Medicine and Medical Social Sciences Northwestern University Feinberg School of Medicine MedicalResearch.com: What is the background for this study? What are the main findings? Response: Sexually transmitted infections (STIs) are on the rise across the country, with approximately 20 million new cases in the U.S. each year. If untreated, STIs can lead to serious health complications including infertility, AIDS, and cancer. The good news is that effective behavioral counseling has the potential to reduce STI rates by approximately a third. The Task Force continues to recommend behavioral counseling for all sexually active teens and for adults who are at increased risk for STIs. (more…)
Author Interviews / 28.08.2020

MedicalResearch.com Interview with: Robert Fisher, MD, PhD Professor of Oncological Sciences Icahn School of Medicine at Mount Sinai Member of The Tisch Cancer Institute MedicalResearch.com: What is the background for this study? Response: Gene transcription by RNA polymerase II underlies cellular identity, and cell fate decisions such as proliferation or death, and is regulated by enzymes that add phosphates (kinases) or remove them (phosphatases) from components of the transcription machinery. Here we define two kinase-phosphatase switches that regulate different steps of the transcription cycle in human cancer cells.  We raised antibodies specific for different phosphorylated states of a key elongation factor, Spt5, and used genomic analyses such as chromatin immunoprecipitation and sequencing (ChIP-seq) to monitor when these phosphorylations were added and removed, and by which kinases and phosphatases, respectively, as RNA polymerase II traversed genes in human cancer cells. (more…)
Author Interviews, Geriatrics, Hearing Loss, JAMA / 28.08.2020

MedicalResearch.com Interview with: Cameron C. Wick, MD Assistant Professor, Otology/Neurotology Washington University School of Medicine St. Louis, MO MedicalResearch.com: What do you see as the primary message of your findings for the general public? Response:  Older adults not satisfied with their hearing aids achieved clinically meaningful improvement in both hearing and quality of life with a cochlear implant compared to an optimized bilateral hearing aid condition. MedicalResearch.com: Do you see your findings as changing the way older adults with hearing loss are managed? Response:   Yes and partially because this study is unique in its design and the outcomes that were measured. Specifically  the study is a prospective, multicenter clinical trial conducted at 13 locations across the United States. All patients were setup with a 30-day optimized hearing aid experience before cochlear implantation (context: sometimes hearing aids are not appropriately optimized so baseline testing may not reflect the "best" that hearing aids can do). This study assesses both hearing data as well as quality of life data before and 6-months after cochlear implantation. After implantation patients were tested in both the unilateral (cochlear implant alone) and bimodal (cochlear implant plus hearing aid in the opposite ear) conditions.  My paper is a subanalysis of adults 65 years and older (range 65 - 91 years) enrolled in the clinical trial. The principal investigator of the clinical trial is Dr. Craig Buchman. Dr. Buchman and myself are at Washington University in St. Louis which was the lead center for the clinical trial. The findings of the study are meaningful because they demonstrate clear superiority of cochlear implants over hearing aids in many key areas, such as understanding speech, hearing in background noise, and ability to communicate. Hearing loss, which becomes more prevalent as we age, can negatively impact communication leading to social isolation, depression, frustration, and possibly cognitive decline. This study highlights that if patients are not satisfied with their hearing aid performance then they should be referred to a center that can evaluate for cochlear implantation. Cochlear implant indications have evolved considerably since they were first FDA approved in 1984. This study emphasizes that patients do not have to be profoundly deaf to experience significant hearing and social benefits from cochlear implants. Also, it demonstrates that cochlear implant surgery is well tolerated even as adults age and acquire other health ailments.  (more…)
Author Interviews, COVID -19 Coronavirus, Medical Imaging / 27.08.2020

MedicalResearch.com Interview with: Bruce G. Haffty, MD FACR FASTRO FASCO Associate Vice Chancellor Cancer Programs Rutgers Biomedical and Health Sciences Professor and Chair, Dept. Radiation Oncology Rutgers Robert Wood Johnson and New Jersey Medical Schools Rutgers Cancer Institute of New Jersey MedicalResearch.com: What is the background for this study? : What are the main findings? Response: That at peak times of COVID in NJ, in a tertiary care hospital with lots of COVID patients, where cancer patients still need to get treated, there was no evidence of surface COVID contamination, which should be reassuring to patients requiring radiation treatment in a busy hospital with a high in patient population of COVID patients. It should be noted that patients and staff were routinely mask wearing, observing social distancing and routinely hand washing as well as screening patients as they came in to the department with temperature checks and questions regarding symptoms. (more…)
Author Interviews, COVID -19 Coronavirus, Inflammation / 27.08.2020

MedicalResearch.com Interview with: Sacha Gnjatic, PhD Associate Director of the Human Immune Monitoring Center Associate Professor of Medicine, Oncological Sciences and Pathology Icahn School of Medicine at Mount Sinai Member of the Precision Immunology Institute and The Tisch Cancer Institute Mount Sinai MedicalResearch.com: What is the background for this study? Would you explain what is meant by cytokine/cytokines? Response: COVID-19 is a disease where inflammation is suspected to play a large role in pathogenicity, possibly more so than the tissue damage created by the virus alone. Cytokines are small soluble proteins that are produced by both immune cells and cells from tissues, and many play a role in signaling such inflammation, to alert of tissue damage or infection. Among these cytokines, interleukin-6 (IL-6), IL-8, IL-1beta, and Tumor Necrosis Factor alpha (TNF-a) have been well established as important markers of pathogenic inflammation. Drugs that counteract these cytokines are routinely use in various inflammatory disease, from rheumatoid arthritis to plaque psoriasis and Crohn’s disease. When the initial wave of SARS-CoV-2 infection hit our hospitals in New York, we therefore wondered whether these cytokines were associated with COVID-19 disease severity and outcome, and hoped that a rapid test to detect them in blood could be useful to make clinical decisions about treatment. We were able to analyze a very large number of patient samples (>1400) in a period of one month, and confirmed our findings in a second smaller cohort. (more…)
Author Interviews, Heart Disease, Lipids, PAD, Women's Heart Health / 27.08.2020

MedicalResearch.com Interview with: First Author: Dhruv Mahtta, DO, MBA Cardiovascular Disease Fellow Baylor College of Medicine Houston, TX Senior & Corresponding Author Dr. Virani Salim S. Virani, MD, PhD, FACC, FAHA, FASPC Professor, Section of Cardiovascular Research Director, Cardiology Fellowship Training Program Baylor College of Medicine Staff Cardiologist, Michael E. DeBakey Veterans Affairs Medical Center Co-Director, VA Advanced Fellowship in Health Services Research & Development at the Michael E. DeBakey VA Medical Center, Houston, TX Investigator, Health Policy, Quality and Informatics Program Michael E. DeBakey Veterans Affairs Medical Center HSR&D Center of Innovation Houston, TX @virani_md MedicalResearch.com: What is the background for this study? What are the main findings? What do you think accounts for the gender differences? Response: We know that women with ischemic heart disease (IHD) have lower prescription rates for statin and high-intensity statin therapy. In this study, we assessed whether the same trends hold true for women with other forms of atherosclerotic cardiovascular disease (ASCVD) i.e. women with peripheral artery disease (PAD) or ischemic cerebrovascular disease (ICVD). Maximally tolerated statin therapy is a Class-I indication in patients with clinical ASCVD which includes PAD and ICVD. We also assessed statin adherence among men and women with PAD and ICVD. Lastly, we performed exploratory analyses to assess whether statin therapy, statin intensity, and statin adherence in women with PAD and ICVD were associated with cardiovascular outcomes and/or mortality.  (more…)
Author Interviews, COVID -19 Coronavirus, Gastrointestinal Disease / 27.08.2020

MedicalResearch.com Interview with: Dr. Arvind J. Trindade, MD Director of Endoscopy Long Island Jewish Medical Center Associate professor at Feinstein Institutes for Medical Research Division of Gastroenterology, Zucker School of Medicine Hofstra/Northwell, Northwell Health System New Hyde Park, NY MedicalResearch.com: What is the background for this study? Response: Although most patients with COVID-19 present with respiratory symptoms, gastrointestinal (GI) symptoms have also been reported in up to 25% of patients. Some case reports have shown acute pancreatitis as the initial presentation in patients with COVID-19, however the literature supporting this is limited. Our study aimed to report the point prevalence, risk factors, and outcomes of hospitalized patients with COVID-19 presenting with acute pancreatitis in a large health system and to compare outcomes of pancreatitis in patients without COVID-19. (more…)
Author Interviews, Brigham & Women's - Harvard, Gastrointestinal Disease, Technology / 27.08.2020

MedicalResearch.com Interview with: Giovanni Traverso, MB, BChir, PhD Gastroenterologist and biomedical engineer Division of Gastroenterology at BWH Instructor of medicine at Harvard Medical School MedicalResearch.com: What is the background for this study? Response: We began working on this project with the goal to develop liquid drug formulations that could offer an easier-to-swallow alternative to capsules, especially for children. We started to think about whether we could develop liquid formulations that could form a synthetic epithelial lining that could then be used for drug delivery, making it easier for the patient to receive the medication by providing drugs in extended release formats. We discovered that an enzyme called catalase could help assemble molecules of dopamine into the polymer (poly-dopamine). These polymers have muco-adhesion properties, which means that after polymerization, the polymer can attach to the tissue very strongly. Also, catalase is found throughout the digestive tract, with especially high levels in the upper region of the small intestine. This is the first example, to the best of our knowledge, of small intestinal targeting system enabled through in-situ tissue-enzyme-catalyzed polymerization. The coating lasts up to 24 hours, after which it is shed and excreted based on experiments we conducted in pigs. (more…)
Author Interviews, Lipids, Regeneron / 26.08.2020

MedicalResearch.com Interview with: Professor F. J. Raal, FRCP, FCP(SA), Cert Endo, MMED, PhD Director, Carbohydrate & Lipid Metabolism Research Unit Professor & Head, Division of Endocrinology & Metabolism, Faculty of Health Sciences, University of the Witwatersrand  MedicalResearch.com: What is the background for this study? Response: The objective of this randomized phase 3 study was to evaluate the efficacy and safety of evinacumab in adult patients with homozygous familial hypercholesterolemia (HoFH), a condition that remains very difficult to treat. The primary endpoint was reduction of low-density lipoprotein cholesterol (LDL-C) from baseline with evinacumab compared to placebo at 24 weeks.  MedicalResearch.com: Would you briefly explain what is meant by homozygous familial hypercholesterolemia? How many individuals may be affected by this disorder? Response: HoFH, or homozygous familial hypercholesterolemia, is the most serious and more rare form of familial hypercholesterolemia (FH).  It is estimated that as many as 1 in 300,000 people worldwide and approximately 1,300 people in the U.S. are affected by HoFH. A person who has HoFH has inherited two FH genes, one from each parent. They therefore have LDL-C levels that are elevated 4-fold or greater from birth and are at high risk for premature atherosclerotic disease and cardiac events which can occur in childhood. While current treatment guidelines recommend early and intensive LDL-C lowering, people with HoFH tend to be less responsive (or unresponsive) to standard lipid-lowering therapies, including high-intensity statins and PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitors and often require lipid apheresis. (more…)
Author Interviews, COVID -19 Coronavirus, NYU, Rheumatology / 26.08.2020

MedicalResearch.com Interview with: Dr. Fernandez-RuizRuth Fernandez-Ruiz, MD Post-Doctoral Fellow Department of Rheumatology NYU Langone Heath  MedicalResearch.com: What is the background for this study? Response: Patients with systemic lupus erythematosus (SLE) represent a unique population in considering risk for COVID-19 with biologic, genetic, demographic, clinical and treatment issues at play. By the nature of their chronic inflammatory autoimmune condition, the presence of comorbidities, and regular use of immunosuppressants, these individuals would traditionally be considered at high risk of contracting SARS-CoV-2 and possibly having worse outcomes from the viral infection. However, it might be speculated that inherently elevated type I Interferon, characteristic of the majority of patients with SLE, confers a protective effect as a first line anti-viral defense. Additionally, hydroxychloroquine, which was suggested as a potential therapeutic agent for COVID-19 early on, is used in most patients with SLE. Accordingly, we initiated this study to provide critical data needed to address the frequency and severity of COVID-19 in patients with SLE. (more…)
Author Interviews, Coffee, OBGYNE / 25.08.2020

MedicalResearch.com Interview with: Professor Jack E. James, PhD Reykjavík University Reykjavík Iceland  MedicalResearch.com: What prompted this study?  Response: Chronic exposure to any chemical during pregnancy is cause for concern. There should be no exception simply because that chemical, caffeine, happens to be widely consumed. Caffeine is a habit-forming substance of no nutritional value. If anything, its widespread consumption suggests that it should be given special attention. Concern is heightened by what is known about the effects of caffeine on the human body, where it affects neural processes in the brain, including networks that control respiration and heart function. When consumed during pregnancy, caffeine readily crosses the placenta, exposing the fetus to the drug. Notably, the fetus is largely physically incapable of metabolising caffeine – that ability develops during the first year of life. Pregnancy studies have shown that caffeine can interfere with fetal heart function and oxygenation.  (more…)
Author Interviews, CDC, COVID -19 Coronavirus, Heart Disease / 25.08.2020

MedicalResearch.com Interview with: Eric J. Chow, MD, MS, MPH Epidemic Intelligence Service Officer (completed in 2020); Influenza Division. Centers for Disease Control and Prevention  MedicalResearch.com: What is the background for this study? What are the main findings?
  • Both heart disease and influenza epidemics cause substantial morbidity and mortality every year. In some seasons, influenza virus infections alone contribute up to 810,000 hospitalizations and 61,000 deaths. There is increasing evidence that there is overlap between infections, specifically influenza, and heart disease. In our study, we sought to describe the frequency and risk factors for acute cardiac events in patients who are hospitalized with influenza.
  • In over 80,000 adults hospitalized with influenza over 8 seasons (2010-2018), almost 12% were diagnosed with acute cardiac events, with acute heart failure and acute ischemic heart disease being the most common.
  • Among patients hospitalized with influenza who experienced acute cardiac events, almost one-third were admitted to the intensive care unit and 7% died while hospitalized.
  • Our study also reaffirmed that people who are older, smoke tobacco or have underlying cardiovascular disease, diabetes and kidney disease are at increased risk for the most common acute cardiac events, acute heart failure and acute ischemic heart disease.
  • Although vaccinated persons had a lower risk of acute ischemic heart disease and acute heart failure, this study was not designed to specifically assess vaccine effectiveness.  However, this and other studies support the importance of influenza vaccines for people with underlying heart conditions. 
(more…)
Author Interviews, Environmental Risks, JAMA, Pediatrics / 24.08.2020

MedicalResearch.com Interview with: Kaleab Baye PhD Center for Food Science and Nutrition Addis Ababa University MedicalResearch.com: What is the background for this study? Response: Reducing child stunting is one of the most important objectives of the Sustainable development goals (SDGs) and the World Health Assembly (WHA). Progress is routinely measured using anthropometric indices such as height-for-age z score that compare child height to the World Health Organization (WHO) growth standards. Such comparisons rely on the assumption that children living in ideal home environment that promotes adequate growth have the same growth potential, irrespective of their genetic make-up. This assumption was confirmed by the Multicenter Growth Reference Study (MGRS), which was the origin of the development of the growth standards. However, the MGRS excluded sites above 1500 m above sea level (asl); hence, it remains unclear whether the widely adopted WHO growth standards are applicable to populations above the 1500 m asl threshold. This study investigated the association between altitude and linear growth faltering and evaluated whether the prescriptive WHO growth standards can apply to children residing at higher altitudes. (more…)
Author Interviews, COVID -19 Coronavirus, Weight Research / 24.08.2020

MedicalResearch.com Interview with: Lisa Pawloski PhD Associate Dean for International Programs Professor of Anthropology College of Arts and Sciences The University of Alabama Tuscaloosa, AL 35487 MedicalResearch.com: What is the background for this study? What are the main findings? Response: This exploratory research uses the currently available data on COVID-19 cases and mortality, along with estimates of the morbidly obese populations in the United States by county to examine the association between morbid obesity and deaths from COVID-19 and to identify potential coincident spatial clusters of morbid obesity and COVID-19 deaths. Results indicate statistically significant positive correlation between population adjusted COVID-19 deaths and cases and the estimated population with a BMI>=40. Clustering analyses show there is a predominant similarity in the distribution of COVID-19 deaths and obesity. Our findings suggest it is critical to include an awareness of obesity when developing infectious disease control measures and point to a greater need to focus resources towards obesity education and policy initiatives.  (more…)
Author Interviews, COVID -19 Coronavirus / 24.08.2020

MedicalResearch.com Interview with: Dr. Ajit Ahlawat (en.) Scientific staff (Post-Doc), Department Experimental Aerosol & Cloud Microphysics Leibniz Institute for Tropospheric Research (TROPOS) MedicalResearch.com: What is the background for this study?   Response: World Health Organization (WHO) has recently acknowledged that novel coronavirus (COVID-19) can be transmitted via aerosols after an appeal from 239 scientists from 32 countries including the chemist Prof. Hartmut Herrmann from our institute i.e. TROPOS. In order to contain the spread via the aerosol particles floating in the air, the researchers recommend not only continuing to wear masks but also, and above all, good indoor ventilation. In aerosol research, it has been long known that air humidity plays a major role i.e. either at high humidity, more water adheres to the particles and so they can grow faster or at low humidity, evaporation occurs and particle will lose its water content. So, we were curious about what types of studies have already been conducted on this topic and how indoor relative humidity (RH) will influence SARS-CoV-2 airborne transmission in indoor environments. (more…)
Author Interviews, COVID -19 Coronavirus, Pediatrics / 22.08.2020

MedicalResearch.com Interview with: Lael Yonker, MD Pediatric Pulmonology Director, MGH Cystic Fibrosis Center Principal Investigator, Pediatric COVID biorepository Mucosal Immunology and Biology Research Center Massachusetts General Hospital MedicalResearch.com: What is the background for this study? What are the main findings? Response: Children were initially felt to be spared from the COVID-19 pandemic. Here, we show that children can become sick from SARS-CoV-2 infection, and even if the initial illness is mild, some go on to develop a severe inflammatory illness after the initial illness. We also show that children can carry very high levels of virus early in the course of infection, suggesting they may play a larger role in spreading the virus than previously thought. (more…)
AstraZeneca, Author Interviews, Pulmonary Disease / 22.08.2020

MedicalResearch.com Interview with: Frank Trudo, MD MBA Vice President, US Medical Affairs Respiratory & Immunology AstraZeneca  MedicalResearch.com: What is the background for this study? Response: ETHOS was a randomized, double-blinded, multi-center, parallel-group, 52-week trial to assess the efficacy and safety of PT010 in symptomatic patients with moderate to very severe COPD and a history of exacerbation(s) in the previous year. A subset of patients participated in the 4-hour pulmonary function test (PFT) sub-study, with the following primary endpoints: change from baseline in morning pre-dose trough FEV1 at Week 24 at (both doses of budesonide/glycopyrrolate/formoterol fumarate MDI versus glycopyrrolate/formoterol fumarate MDI), and FEV1 area under the curve from 0-4 hours at Week 24 (both doses of budesonide/glycopyrrolate/formoterol fumarate MDI vs budesonide/formoterol fumarate MDI).  (more…)
Asthma, AstraZeneca, Author Interviews / 22.08.2020

MedicalResearch.com Interview with: Frank Trudo, MD MBA Vice President, US Medical Affairs Respiratory & Immunology AstraZeneca     MedicalResearch.com: What is the background for this study?
  • Multiple pathways drive asthma. T2 inflammation-driven asthma is present in many patients with severe asthma and is typically characterized by elevated levels of T2 inflammatory biomarkers, including blood eosinophils, serum IgE and fractional exhaled nitric oxide.
    • Some patients with severe asthma do not present with increased T2 inflammation. However, currently available biologic therapies only target T2-driven inflammation.
  • The PATHWAY trial evaluated the efficacy and safety of three dose regimens of tezepelumab versus placebo as an add-on therapy in patients with a history of asthma exacerbations and uncontrolled asthma despite receiving inhaled corticosteroids/long-acting beta2-agonists with or without oral corticosteroids and additional asthma controllers. Overall, the trial showed tezepelumab significantly reduced annualized asthma exacerbation rates of 71%.
  • This post-hoc analysis presented virtually at ATS evaluated the effect of Tezepelumab treatment on asthma exacerbation rates on a seasonal and weekly basis.
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Author Interviews, Heart Disease, JAMA, Lipids / 21.08.2020

MedicalResearch.com Interview with: First Author Dhruv Mahtta, DO, MBA Cardiovascular Disease Fellow Baylor College of Medicine Houston, TX Senior & Corresponding Author Salim S. Virani, MD, PhD, FACC, FAHA, FASPC Professor, Section of Cardiovascular Research Director, Cardiology Fellowship Training Program Baylor College of Medicine Staff Cardiologist, Michael E. DeBakey Veterans Affairs Medical Center Co-Director, VA Advanced Fellowship in Health Services Research & Development Michael E. DeBakey VA Medical Center, Houston, TX MedicalResearch.com: What is the background for this study? Response: The incidence of atherosclerotic cardiovascular disease among young patients has been on the rise. These patients with premature and extremely premature atherosclerotic cardiovascular disease experience similar rates of mortality compared to older adults. Additionally, these young patients have a greater accrued rate of life-time morbidity. Therefore, secondary prevention measures such as use of guideline concordant statin therapy and aspirin therapy are paramount in this population.  (more…)
Accidents & Violence, Author Interviews, Race/Ethnic Diversity / 21.08.2020

MedicalResearch.com Interview with: Ashwini Sehgal, MD Professor, Department of Medicine, School of Medicine Professor, Department of Bioethics, School of Medicine Professor, Department of Population and Quantitative Health Sciences, School of Medicine Director and Duncan Neuhauser Professor of Community Health Improvement, Center for Reducing Health Disparities, Case Western School of Medicine  MedicalResearch.com: What is the background for this study? Response: News media and politicians frequently discuss the high toll of deaths from firearms and drug overdoses. They usually mention the numbers of deaths, citing figures like 40,000 firearm deaths last year, or death rates such as 20 overdose deaths per 100,000 population. But for most people, it's hard to grasp the real meaning of both the large absolute numbers and the small annual rates.  So in a new study published in the American Journal of Medicine, I used official death certificate data to calculate the chance that an American child will die from a gunshot or a drug overdose over the course of a lifetime. (more…)
Author Interviews, Brigham & Women's - Harvard, COVID -19 Coronavirus, JAMA, Social Issues / 21.08.2020

MedicalResearch.com Interview with: Monik Carmen Jimenez, Sc.D Assistant Professor of Medicine Brigham and Women's Hospital MedicalResearch.com: What is the background for this study? Response: We wanted to get a comprehensive picture of the epidemiology of COVID-19 in carceral facilities that included jails and was not restricted solely to prisons. We utilized publicly available data collected in Massachusetts, pursuant to a court order. These data included prison and jail systems and were used to calculate rates of confirmed cases of COVID-19 and testing rates among incarcerated individuals. We were also able to compare those to changes in the population size within each system. (more…)
Author Interviews, Biomarkers, Cancer Research / 20.08.2020

MedicalResearch.com Interview with: Dr. Alexey Aleshin, M.D., MBA Senior Medical Director Natera MedicalResearch.com: What is the background for this study? Response: Checkpoint inhibitor-based immunotherapies (ICI)  have changed the management of a range of cancers of diverse histologies. While these therapies are well tolerated and efficacious, only a minority (<20%) of patients respond to treatment or derive durable clinical benefit from them, highlighting the need for a pan-cancer biomarker that can predict response prior to, or shortly after, treatment initiation. With immune checkpoint inhibitors (ICIs) rapidly becoming a cornerstone of cancer therapy, early determination of response to ICI treatment can optimize patient benefit and minimize the risk of toxicities, while potentially reducing unnecessary treatment and costs to patients and payers. Additionally, due to the nature of immune checkpoint inhibition, atypical patterns of response have emerged. For instance, tumor pseudoprogression — a transient increase in tumor size due to the infiltration of immune cells, followed by delayed shrinkage — has been reported in as much as 10% of patients receiving ICI therapy. Distinguishing pseudoprogression from true progression is clinically important to avoid premature discontinuation of a treatment that may have future benefit, or delay the initiation of an alternative line of therapy. However, they are hard to differentiate using current imaging techniques. Our study published in Nature Cancer earlier this month, demonstrates that bespoke circulating tumor DNA (ctDNA) testing may be a valuable tool that sheds light on both of these issues. (more…)