Author Interviews, COVID -19 Coronavirus, Vaccine Studies / 07.04.2020

MedicalResearch.com Interview with: Paul B. McCray, Jr., M.D. Professor of Pediatrics, Microbiology, and Internal Medicine Executive Vice Chair of Pediatrics Associate Director: Center for Gene Therapy Roy J. Carver Chair in Pulmonary Medicine Pappajohn Biomedical Institute Carver College of Medicine University of Iowa, Iowa City, IA  52242 MedicalResearch.com: What is the background for this study? Response: In the face of the COVID-19 pandemic, there is great interest in developing a vaccine that could help protect people from infection with SARS-CoV-2.  Over the last 15 years, my laboratory has helped develop small animal models of the severe coronavirus diseases SARS and MERS to study disease pathogenesis and to test treatments.  In this study, we used a mouse model of the MERS coronavirus to test a vaccine idea in collaboration with Dr. Biao He at the University of Georgia. (more…)
Author Interviews, Baylor College of Medicine Houston, COVID -19 Coronavirus, JAMA, Stanford / 07.04.2020

MedicalResearch.com Interview with: Melissa Bondy, PhD Chair, Department of Epidemiology and Population Health Stanford University  MedicalResearch.com: What is the background for this study? Response: Faculty researchers in Stanford’s Department of Epidemiology & Population Health and collaborators from Baylor College of Medicine and Stanford’s Department of Dermatology developed an online survey aimed at rapidly assessing public concerns about the COVID-19 crisis. This survey, which was posted on 3 social media platforms (Twitter, Facebook, and Nextdoor) on March 14, 2020, collected invaluable data about COVID-19, including symptoms, concerns, and individual actions taken by respondents. Twitter and Facebook posts were sharable to facilitate snowball sampling. The survey was comprised of 21 (multiple-choice, single-choice, numeric, and open-ended) questions, which were designed to collect data concerning respondent demographics and recent cold and flu-like illnesses (if any), as well as information about participants’ concerns and any lifestyle changes that occurred as a result of the COVID-19 crisis. All questions were optional, so response rates were variable.  (more…)
Author Interviews, COVID -19 Coronavirus, Dermatology / 04.04.2020

MedicalResearch.com Interview with: Amit Gefen PhD Professor of Biomedical Engineering The Herbert J. Berman Chair in Vascular Bioengineering Department of Biomedical Engineering, Faculty of Engineering Tel Aviv University, Tel Aviv, Israel MedicalResearch.com: What is the background for this study? Response: Although we are witnessing continuous progress in medical technologies, the design of many of the most commonly used medical devices e.g. oxygen masks or cervical collars has changed very little over a period of decades. Not surprisingly, these devices are also the ones which are frequently associated with device-related pressure ulcers (DRPUs). These DRPUs are frequently a hospital-acquired injury which involves risk of infections (including e.g. sepsis and antibiotic-resistant bacteria), scarring with serious psychological consequences, additional and significant healthcare costs and a basis for liability suits and litigation. The problem is massive in Europe and the US and is most frequently encountered in clinical environments where devices are used intensively, such as in operation theatres, intensive care units and emergency care settings (in both adult and pediatric medicine), but also, in elderly care facilities where patients often have fragile skin. With the current pandemic spread of the coronavirus, facilities worldwide are experiencing a considerable rise in usage of emergency and intensive care equipment, which will very likely considerably escalate the incidence of DRPUs. Early in 2019, a committee of global experts which I have chaired, has met for two days of intensive deliberation in London UK, to start developing the first-ever international consensus document on device-related pressure ulcers . After a rigorous review process by an international review committee of other experts, this consensus report has been published as a Special Edition of the Journal of Wound Care in February 2019 (https://doi.org/10.12968/jowc.2020.29.Sup2a.S1), under the name "Device-related pressure ulcers: SECURE prevention". The publisher has kindly made this publication freely downloadable and thereby accessible and available to anyone, including all professionals who may need guidance in this regard, including clinicians, industry, regulators and academic researches. (more…)
Author Interviews, COVID -19 Coronavirus, Pulmonary Disease / 04.04.2020

MedicalResearch.com Interview with: Aurika Savickaite RN Adult Gerontology Acute Care Nurse Practitioner Bulletproof Coach University of Chicago Medicine MedicalResearch.com: Would you briefly explain what is meant by helmet-based ventilation? How does it work?   Response: For patients in respiratory failure, noninvasive positive pressure ventilation (NIPPV) is usually delivered through a nasal mask or facemask. Many patients develop pain, discomfort – even claustrophobia -- from using NIPPV systems.  The transparent helmet was developed to improve the tolerance of noninvasive ventilation. It allows the patient to see, read, speak and drink without interrupting noninvasive positive-pressure ventilation (NPPV). The helmet has a sealed connection and a soft collar that adheres to the neck which helps prevent the air leaks that are very common with nasal- or face masks.  High positive end-expiratory pressure (PEEP) is vital in treating patients in respiratory failure and thanks to helmets “none to minimum air leak” system, PEEP can be set high (up to 25). NIPPV via a nasal- or full-face mask typically begins to show air leaks when the required pressure exceeds 15-20cm H2O. (more…)
Author Interviews, COVID -19 Coronavirus, Pharmaceutical Companies / 02.04.2020

MedicalResearch.com Interview with: Dr. Larry Schlesinger MD Professor, President and CEO Texas Biomed MedicalResearch.com: What is the background and mission of Texas Biomed? Response: Texas Biomedical Research Institute (Texas Biomed) is a not-for-profit, independent research institute with a strong history of pioneering, biomedical breakthroughs that have contributed to the world of science and human health for nearly 80 years. The Texas Biomed mission is to pioneer and share scientific breakthroughs that protect you, your families and our global community from the threat of infectious diseases. Texas Biomed is capitalizing on its strengths – outstanding collaborative scientists and unique assets and resources. Texas Biomed is home to the nation’s only privately-owned BSL4 facility, five fully outfitted BSL3 facilities with the latest technologies and the Southwest National Primate Research Center (SNPRC). The Institute focuses on a core understanding of the basic biology of infectious diseases, animal model development, and studies to move therapies and vaccines to human clinical trials. The Institute’s independent, nonprofit business model moves science from the bench to clinical trials faster and with less bureaucracy. (more…)
Author Interviews, Columbia, COVID -19 Coronavirus, NYU, Technology / 02.04.2020

MedicalResearch.com Interview with: Professor Anasse Bari PhD Courant Institute of Mathematical Sciences, Computer Science Department, New York University, New York, and Megan Coffee MD PhD Division of Infectious Diseases and Immunology, Department of Medicine New York University, Department of Population and Family Health Mailman School of Public Health Columbia University, New York MedicalResearch.com: What is the background for this study? Coffee and Bari:  This work is led by NYU Grossman School of Medicine and NYU’s Courant Institute of Mathematical Sciences, in partnership with Wenzhou Central Hospital and Cangnan People's Hospital, both in Wenzhou, China. This is a multi-disciplinary team with backgrounds in clinical infectious disease as well as artificial intelligence (AI) and computer science. There is a critical need to better understand COVID-19. Doctors learn from collective and individual clinical experiences. Here, no clinician has years of experience. All are learning as they go, having to make important decisions about clinical management with stretched resources. The goal here is to augment clinical learning with machine learning. In particular, the goal is to allow clinicians to identify early who from the many infected will need close medical attention. Most patients will first develop mild symptoms, yet some 5-8 days later will develop critical illness. It is hard to know who these people are who will need to be admitted and may need to be intubated until they become ill. Knowing this earlier would allow more attention and resources to be spent on those patients with worse prognoses. If there were ever treatments in the future that could be used early in the course of illness, it would be important to identify who would most benefit We present in this study a first step in building an artificial intelligence (AI) framework, with predictive analytics (PA) capabilities applied to real patient data, to provide rapid clinical decision-making support. It is at this point a proof of concept that it could be possible to identify future severity based on initial presentation in COVID-19. (more…)
Author Interviews, COVID -19 Coronavirus / 02.04.2020

MedicalResearch.com Interview with: Hongcui Cao, M.D. State Key Laboratory for the Diagnosis and Treatment of Infectious Diseases National Clinical Research Center for Infectious Diseases The First Affiliated Hospital College of Medicine, Zhejiang University Hangzhou, China MedicalResearch.com: What is the background for this study? Response: The proportion of severe novel coronavirus disease (COVID-19) cases has dropped significantly. Specifically, this number has decreased from 32.4% on January 28 to 21.6% in Wuhan and to 7.2% in other provinces of China on February. Measures such as strengthened medical support and centralized isolation greatly contributed to the improved circumstances, and laid a solid foundation for further enhancing the cure rate and reducing the mortality rate. However, there are still hundreds of severe patients dying every day. It is extremely important to make timely and efficient diagnosis and initiate treatment for severe patients. (more…)
Author Interviews, COVID -19 Coronavirus / 02.04.2020

MedicalResearch.com Interview with: Dr Zhugen Yang Lecturer in Sensor Technology NERC Fellow School of Water, Energy and Environment Cranfield University MedicalResearch.com: What is the background for this study? Response: A recent outbreak of novel coronavirus pneumonia (COVID-19) caused by SARS-CoV-2 infection has spread rapidly around the globe. Some clinical cases have found that some carriers of the virus may be asymptomatic, with no fever, and no, or only slight symptoms of infection. Currently we have a constrained diagnostic testing capacity, Therefore wastewater analysis, also namely wastewater-based epidemiology (WBE), may offer another way to track the spread of the virus that causes the disease and identify the potential infections at the community. Wastewater-based epidemiology approach could provide an effective and rapid way to predict the potential spread of novel coronavirus pneumonia (COVID-19) by picking up on biomarkers in faeces and urine from disease carriers that enter the sewer system. WBE is already recognised as an effective way to trace illicit drugs and obtain information on health, disease, and pathogens  (more…)
Author Interviews, Blood Pressure - Hypertension, COVID -19 Coronavirus / 01.04.2020

MedicalResearch.com Interview with: Fabian Sanchis-Gomar, MD, MSc, PhD Department of Medicine Stanford University Medical Center Stanford, California Department of Physiology, School of Medicine, University of Valencia INCLIVA Biomedical Research Institute Valencia, Spain MedicalResearch.com: What is the background for this study? How does the RAAS system interface with the COVID-19 virus? Response: Angiotensin-converting enzyme (ACE)2 is a functional receptor for coronaviruses, including Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). The exponential growth of contagion by the SARS-CoV-2 all around the world has contributed to raising speculations and concerns about whether two commonly used anti-hypertensive drugs, i.e., ACE inhibitors and angiotensin receptor blockers (ARBs), have positive or negative effects in coronavirus disease 2019 (abbreviated “COVID-19”) patients with arterial hypertension on-going treatment with some of the former drugs. In effect, many professional health organizations have published statements claiming that there is not enough evidence to change the use of ACE-inhibitors or ARBs for the management of raised blood pressure (BP) in the context of avoiding or treating COVID-19 infection. (more…)
Author Interviews, COVID -19 Coronavirus / 31.03.2020

MedicalResearch.com Interview with: Professor Carl Coleman, JD Professor of Law Seton Hall Law School MedicalResearch.com: Do health care workers have an ethical and/or legal obligation to provide treatment during an infectious disease outbreak? Are there exceptions such as pregnancy, if the health care worker is her/himself immunocompromised or have young children at home?   Response: As a legal matter, health care workers can generally be required to fulfill pre-existing employment or contractual obligations during an infectious disease outbreak.  For example, an emergency room nurse who refuses to come to work during a pandemic can be disciplined or fired; a physician who breaches a contractual obligation to provide on-call services during an outbreak can be held liable for damages.  In addition to loss of employment and contractual damages, other potential consequences for failing to honor pre-existing commitments during a pandemic could include professional discipline for patient abandonment and, for physicians with on-call responsibilities in hospital emergency departments, civil fines under the federal Emergency Medical Treatment and Active Labor Act. This does not mean that health care workers are obligated to show up for work during a pandemic regardless of the circumstances.  For example, under the Americans with Disabilities Act, health care workers who are immunocompromised can ask for a "reasonable accommodation," such as the right to work remotely (if possible) or to take leave.  Under the Family and Medical Leave Act, employers with more than 50 employees must give workers up to 12 weeks of unpaid time off to care for a seriously ill immediate family member.  In addition, federal labor laws allow employees to refuse to work under "abnormally dangerous conditions," which might apply in situations where an employer fails to provide necessary protective equipment.  However, assuming protective equipment is available, it is not clear that an outbreak itself would be considered "abnormally dangerous," particularly in fields like emergency medicine, where exposure to contagious disease is always a foreseeable risk. In most states, health care workers without pre-existing employment or contractual obligations cannot be compelled to treat patients during a pandemic.  However, a few states have laws that authorize public health authorities to require health care professionals to work during public health emergencies.  I am not aware of any state that has invoked this authority so far. As for ethical obligations, in 2004, the American Medical Association (AMA) declared that "individual physicians have an obligation to provide urgent medical care during disasters," and that "this ethical obligation holds even in the face of greater than usual risks to their own safety, health or life."  Some academic ethicists have expressed similar views.  Common justifications for this position are that physicians "assumed the risk" of exposure to infectious diseases when they voluntarily committed themselves to the healing professions; that a "social contract" requires physicians to assume risks in exchange for their social status and privileges; and that individuals who are uniquely capable of providing life-saving care have an obligation to do so. However, I am not persuaded that all physicians -- let alone health care workers more generally -- have an ethical obligation to provide treatment when doing so involves significant risk.  A willingness to accept risk is not a condition of obtaining a medical license, nor is it part of the oaths that students commonly take at medical school graduation.  While I agree that physicians have ethical obligations to contribute to society, there are many ways they can fulfill these obligations without assuming personal health risks.  And even assuming that individuals who are in a unique position to provide life-saving care should normally do so, we generally do not expect people to rescue others from danger at significant risk to themselves.  (more…)
Author Interviews, COVID -19 Coronavirus, NEJM / 28.03.2020

MedicalResearch.com Interview with: Bin Cao, Yeming Wang, Guohui Fan, Lianghan Shang, Jiuyang Xu, DingyuZhang, Chen Wang on behalf of LOTUS-China Study Group China-Japan Friendship Hospital; Wuhan Jintinyan Hospital; Institute of Respiratory Medicine, Chinese Academy of Medical Science  MedicalResearch.com: What is the background for this study? Response: In the past two months, the outbreak of Coronavirus Disease 2019 (COVID-19) has been spreading rapidly across the world. Science and technology is the most powerful weapon for human to fight against diseases, especially in such a pandemic setting. Seeking for effective antiviral medication is the most critical and urgent among the many scientific tasks in the pandemic. At the most critical moment in the fight against COVID-19, Chinese clinical scientists have stepped forward under extremely difficult research conditions to carry out clinical trials in antiviral treatment including lopinavir–ritonavir and remdesivir, in a swift, decisive and effective manner. These trials have attracted worldwide attention. Recently, the Lopinavir–ritonavir Trial for suppression of SARS-CoV-2 in China (LOTUS-China) has been completed, which, with great clinical significance, can provide strong evidence for the treatment of COVID-19 both in China and around the world. (more…)
Author Interviews, COVID -19 Coronavirus, Lung Cancer / 27.03.2020

MedicalResearch.com Interview with: Dr. Amy C. Moore PhD Director of Science and Research GO2 Foundation for Lung Cancer MedicalResearch.com: What is the mission of the GO2 Foundation for Lung Cancer? Response: GO2 Foundation for Lung Cancer’s mission is to transform survivorship by  saving, extending, and improving the lives of those vulnerable, at risk, and diagnosed with lung cancer. (more…)
Author Interviews, COVID -19 Coronavirus, Duke / 27.03.2020

MedicalResearch.com Interview with: Dr. Rupesh Agrawal, MD Associate Professor Senior Consultant Ophthalmologist Duke-NUS Medical School, Singapore MedicalResearch.com: What is the background for this study? Wasn't Dr Li Wenliang, the Chinese physician who first alerted his community of coronavirus an opthalmologist, with possible exposure to tears from this surgical work with glaucoma patients? Response: Since the start of the pandemic, there have been multiple reports which suggested the transmission of SARS-CoV-2 via ocular fluids. As ophthalmologists, we come into close contact with tears on a daily basis during our clinical examination. Furthermore, many equipment in the clinic like the Goldman tonometer come into direct contact with such ocular fluids, providing a channel for viral transmission. The evidence, as of date, were mainly anecdotal reports included in newspaper articles and media interviews. We wanted to know if the virus can truly be found in tears, so we decided to embark on this study. (more…)
Accidents & Violence, Author Interviews, JAMA, Johns Hopkins, Pediatrics / 07.04.2020

MedicalResearch.com Interview with: Johnathon P. Ehsani, PhD Assistant Professor Johns Hopkins School of Public Health MedicalResearch.com: What is the background for this study? Response: Car crashes are the leading cause of death and disability for young people. So, what can parents do during the learner stage of licensing to reduce their teenagers’ crash risk during independent driving? The learner stage is a brief window of opportunity to influence the safety of their teenager. This is when teenagers are required to practice driving under the supervision of a licensed adult – typically mom or dad. Once teenagers get their license to start driving on their own, their crash risk increases - but parents have fewer chances to intervene at that point.  (more…)
Author Interviews, COVID -19 Coronavirus, Infections, Pediatrics / 07.04.2020

genentech MedicalResearch.com: What are the applicable pediatric and post-exposure indications? Response: We recently announced that the U.S. FDA has accepted a New Drug Application (NDA) as well as two supplemental New Drug Applications (sNDA) for Xofluza® (baloxavir marboxil). The FDA accepted an NDA for a new formulation of Xofluza as one-dose granules for oral suspension (2 mg/mL), potentially offering a more convenient option for children and those who have difficulty swallowing. In addition, the application seeks approval of Xofluza for the treatment of acute uncomplicated influenza in otherwise healthy children aged one to less than 12 years of age who have been symptomatic for no more than 48 hours. The FDA also accepted an sNDA for post-exposure prophylaxis of influenza in people one year of age and older for both the oral suspension and currently-available tablet formulation. (more…)
Author Interviews, Endocrinology, Ophthalmology, Thyroid Disease / 06.04.2020

MedicalResearch.com Interview with: Dr. Raymond Douglas MD PhD Board Certified Oculoplastic Surgeon Beverly Hills, CA  MedicalResearch.com: What is the background for this study? Would you briefly explain what is meant by proptosis?  How does teprotumumab work? Response: This study provides pooled efficacy data from the Phase 2 and 3 clinical trials of teprotumumab showing that the recently FDA-approved medicine effectively reduces proptosis, also known as eye bulging, in patients with Thyroid Eye Disease (TED) regardless of age, gender and smoking status. Proptosis is one of the most debilitating symptoms of TED, especially given the accompanying pain, vision impairment and emotional distress. Teprotumumab is a fully human monoclonal antibody and a targeted inhibitor of the IGF-1 receptor. In patients with Thyroid Eye Disease, the IGF-1 receptor is overexpressed on orbital tissues and when activated, causes inflammation and enlargement of ocular muscles, expansion of orbital tissue and fat and forward displacement of the eye, resulting in eye bulging. The proteins in teprotumumab target and bind to the IGF-1 receptor and inhibit its function, thereby reducing inflammation, preventing tissue expansion behind the eye, and preventing muscle and fat tissue remodeling. Based on this mechanism of action, it is believed that teprotumumab addresses the underlying biology of the disease.  (more…)
Author Interviews, COVID -19 Coronavirus / 03.04.2020

MedicalResearch.com Interview with: Prof. Amitai Ziv, MD, MHA Deputy Director of Sheba Medical Center Founder and Director, The Israel Center for Medical Simulation MedicalResearch.com: Would you briefly describe the mission/history of Sheba Medical Center? Response: Born together with Israel in 1948, Sheba Medical Center, Tel HaShomer is the largest and most comprehensive medical center in the Middle East. Sheba is the only medical center in Israel that combines an acute care hospital and a rehabilitation hospital on one campus, and it is at the forefront of medical treatments, patient care, research and education. As a university teaching hospital affiliated with the Sackler School of Medicine at Tel-Aviv University, it welcomes people from all over the world indiscriminately. For the past two years (2019 and 2020), Newsweek Magazine has named Sheba one of the top ten hospitals in the world. MSR, the Israel Center for Medical Simulation at Sheba Medical Center, is the country’s only national multi-modality, interdisciplinary simulation center. Through MSR’s training courses, which can include sophisticated robotics, surgical simulators and role-playing actors, healthcare providers effectively improve their clinical and communication skills, creating a safer, more ethical, patient-centered culture of treatment. (more…)
Author Interviews, Dermatology, Technology / 03.04.2020

MedicalResearch.com Interview with: Jung-Im Na, MD PhD Associate Professor, Department of Dermatology Seoul National University Bundang Hospital Korea  MedicalResearch.com: What is the background for this study? Would you briefly explain what is meant by a convolutional neural network? Response: When a very young child looks at a picture, she can easily identify cats and dogs, however, even the most advanced computers had struggled at this task until recently. Computers began to “see” with the recent advancement of Deep Learning techniques. Deep Learning is a machine learning technique that teaches computers to learn from raw data. Most deep learning methods use artificial neural network architectures, imitating human brain, and convolutional neural networks (CNN) is a particular type of deep learning architecture, imitating the visual cortex. CNN is especially powerful for recognizing images. CNN exploit the information contained in image datasets to automatically learn features and patterns. (more…)
Author Interviews, Heart Disease, Lipids / 02.04.2020

MedicalResearch.com Interview with: Nathan D. Wong, PhD, FACC, FAHA, FNLA Professor and Director Heart Disease Prevention Program Division of Cardiology, University of California, Irvine MedicalResearch.com: What is the background for this study? Response: Many higher risk persons, despite guideline-recommended therapy such as statins, still suffer from cardiovascular disease events. There are few therapies available to reduce this persistent risk. The REDUCE-IT trial led by Brigham and Women’s Hospital in Boston researchers originally published in November of 2018 was landmark in showing for the first time a highly purified, stable, prescription fish oil product, icosapent ethyl (an EPA only compound marketed as Vascepa®) if given to high risk persons with either cardiovascular disease or diabetes and two or more risk factors who were on statin therapy and had elevated triglyceride levels, achieved an unprecedented 25 percent reduction in the risk of time to first cardiovascular disease events. Given that many persons often experience multiple cardiovascular events, a follow-up analysis showed that TOTAL cardiovascular events were reduced by 30 percent.  (more…)
Author Interviews, Heart Disease, Lipids / 01.04.2020

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? How does Evinacumab differ from the three drugs used in triple therapy for this severe form of hypercholesterolemia? Response:      Despite available lipid lowering therapies, the vast majority of patients with homozygous familial hypercholesterolemia are unable to achieve desirable LDL-cholesterol levels and remain at high risk for premature atherosclerotic cardiovascular disease. Unlike statins and PCSK9-inhibitors which act mainly by upregulating LDL receptor activity on the cell surface, evinacumab, a monoclonal antibody inhibitor of ANGPTL3, acts independent of the LDL receptor. (more…)
Author Interviews, Cost of Health Care, JAMA, Opiods / 01.04.2020

MedicalResearch.com Interview with: Aparna Soni PhD, Assistant Professor Department of Public Administration and Policy School of Public Affairs American University Washington, DC MedicalResearch.com: What is the background for this study? Response: The United States is in the midst of an opioid epidemic. Opioids are responsible for nearly 50,000 deaths per year and present a substantial financial burden on hospitals. The rate of opioids-related hospital events has tripled since 2005. We are particularly concerned about rising hospitalizations because they may stem from a lack of access to treatment for individuals with opioid use disorder. Medication-assisted treatment is effective in treating opioid use disorder but can be unaffordable for people without health insurance. (more…)
AstraZeneca, Author Interviews, Diabetes, Heart Disease, JAMA / 01.04.2020

MedicalResearch.com Interview with: John J. V. McMurray,  MD FRCP FESC FACC FAHA FRSE FMedSci British Heart Foundation Cardiovascular Research Centre University of Glasgow Glasgow, United Kingdom  Kieran F Docherty DAPA-HF investigator British Heart Foundation Cardiovascular Research Centre, University of Glasgow     MedicalResearch.com: What is the background for this study? Response: DAPA-HF was a double-blind randomized controlled trial comparing dapagliflozin 10 mg once daily with placebo in 4744 patients with heart failure and reduced ejection fraction (HFrEF). The primary outcome was a composite of time to occurrence of a worsening heart failure event (principally heart failure hospitalization) or cardiovascular death, whichever came first. Dapagliflozin reduced the primary outcome by 26% and reduced the risk of each of heart failure hospitalization and cardiovascular death individually, as well as overall mortality. Patient symptoms were also improved. The aim of the present report was to examine the effect of dapagliflozin separately in patients with and without type 2 diabetes at baseline (45/55% split in the trial). The reason for this was that dapagliflozin was originally introduced as a glucose-lowering medication for the treatment of type 2 diabetes. We find that dapagliflozin was equally beneficial in patients with and without diabetes and was as well tolerated in patients without diabetes as in those with diabetes. More remarkably, among the patients without diabetes, dapagliflozin was as effective in participants with a completely normal glycated haemoglobin (HbA1c) as in those with prediabetes. In patients with a normal HbA1c, dapagliflozin did not lead to any reduction in HbA1c, but did improve clinical outcomes.  (more…)
Author Interviews, Heart Disease, NEJM, Stanford / 31.03.2020

MedicalResearch.com Interview with: David J. Maron, MD, FACC, FAHA Clinical Professor of Medicine Chief, Stanford Prevention Research Center Director, Preventive Cardiology Stanford University School of Medicine  MedicalResearch.com: What is the background for this study? Response: Among patients with stable coronary disease and moderate or severe ischemia, whether clinical outcomes are better in those who receive an invasive intervention plus medical therapy than in those who receive medical therapy alone is uncertain. The goals of treating patients with stable coronary disease are to reduce their risk of death and ischemic events and to improve their quality of life. All patients with coronary disease should be treated with guideline-based medical therapy (GBMT) to achieve these objectives. Before the widespread availability of drug-eluting stents, strategy trials that tested the incremental effect of revascularization added to medical therapy did not show a reduction in the incidence of death or myocardial infarction. In one trial, fractional flow reserve–guided percutaneous coronary intervention (PCI) with drug-eluting stents, added to medical therapy, decreased the incidence of urgent revascularization but not the incidence of death from any cause or myocardial infarction at a mean of 7 months, whereas the 5-year follow-up showed marginal evidence of a decrease in the incidence of myocardial infarction. (more…)
Author Interviews, Diabetes, Kidney Disease, OBGYNE, Race/Ethnic Diversity / 30.03.2020

MedicalResearch.com Interview with: Silvi Shah, MD, MS, FACP, FNKF, FASN Assistant Professor Division of Nephrology University of Cincinnati Cincinnati, OH-45267 MedicalResearch.com: What is the background for this study? Response: The study identified 42,190,790 pregnancy related hospitalizations between Jan. 1, 2006 and Dec. 31, 2015, using data from the from the Nationwide Inpatient Sample. (more…)
Alzheimer's - Dementia, Author Interviews, Cognitive Issues / 28.03.2020

MedicalResearch.com Interview with: Joanne Ryan, PhD Senior Research Fellow, ASPREE From the School of Public Health and Preventive Medicine Monash University Melbourne, Australia MedicalResearch.com: What is the background for this study? Response: Aspirin is a commonly used drug known to reduce inflammation, and prevent blood clotting (antiplatelet) - which is why it is commonly used in secondary prevention in individuals with established cardiovascular disease. Inflammation is thought to be a central mechanism in Alzheimer's disease, implicated in the neuropathological cascade leading to the development of dementia and other forms of dementia. Cardiovascular risk factors and stroke are both associated with cognitive decline and an increased risk of dementia. This formed the basis of the hypothesis that aspirin could be beneficial in helping to reduce cognitive decline and the occurrence of Alzheimer's Disease. (more…)
Author Interviews, Biomarkers, Gastrointestinal Disease / 28.03.2020

MedicalResearch.com Interview with: Jean-Frederic Colombel MD The Henry D Janowitz Division of Gastroenterology Icahn School of Medicine at Mount Sina New York, NY 10029, USA MedicalResearch.com: What is the background for this study? Response: The goals of therapy in Crohn’s disease have shifted from mere control of symptoms also called clinical remission towards combination of clinical and endoscopic remission also called deep remission which is now considered as the new therapeutic “target”. However it has yet to be proven that targeting deep remission instead of clinical remission is able to stop the progression of Crohn’s disease towards bowel damage, complications and hospitalizations. This study is a post-hoc analysis of the CALM trial that was published in The Lancet in 2018 where newly diagnosed patients were randomized to escalate therapy based on symptoms only (control arm) or based on a combination of symptoms and two biomarkers namely C-reactive protein in blood and calprotectin in stools (tight control arm). (more…)
Author Interviews, Mental Health Research, Pediatrics / 26.03.2020

MedicalResearch.com Interview with: Jillian Hardin, Ph.D. Developmental Psychophysiology Lab Florida Atlantic University MedicalResearch.com: What is the background for this study? Response: Most Kangaroo Care (KC) research examines the procedure’s positive physiological and psychological developmental effects on preterm infants as these infants are separated from their mothers before the end of gestation. However, the aim of our study was to determine whether kangaroo care parent-training and implementation with non-vulnerable, full-term infants provided developmental neurophysiological benefits.  (more…)