Author Interviews, COVID -19 Coronavirus / 27.05.2020

MedicalResearch.com Interview with: Jianfeng Zhou MD, PhD Department of Hematology, Tongji Hospital Tongji Medical College Huazhong University of Science and Technolog Wuhan, Hubei, China MedicalResearch.com: What is the background for this study? Response:  There is accumulating evidence on the key pathophysiological role of cytokines during the severe stage of COVID-19. In the context of lack of vaccine and specific antiviral agents, testing of immunomodulatory agents to reduce excessive or uncontrolled inflammation before it results in irreversible multi-organ dysfunction infection has received increasing research attention. Although several important papers have proposed JAK inhibitors as potential therapeutic targets, the role of JAK inhibitors on COVID-19 patients needs to be clarified quickly, especially in severe COVID-19 patients. (more…)
Author Interviews, Nutrition, Pediatrics, Pediatrics, Weight Research / 26.05.2020

MedicalResearch.com Interview with: Megan H. Pesch, MD, MS, FAAP Assistant Professor C.S. Mott Children’s Hospital University of Michigan MedicalResearch.com: What is the background for this study? Response: Picky eating is common among children and is often both concerning to parents. Healthcare providers may reassure parents that their child will “outgrow” picky eating, however there have been few longitudinal studies examining the trajectories of picky eating in children, as well as associated trends in their growth. In our study we examined the trajectories of picky eating in US children over a 5 year period. We also examined how these picky eating trends were associated with child characteristics, weight status and mother’s feeding behaviors. (more…)
Annals Internal Medicine, Author Interviews, Colon Cancer / 26.05.2020

MedicalResearch.com Interview with: Dr. Nastazja Dagny Pilonis, MD Maria Sklodowska-Curie Memorial Cancer Center Institute of Oncology, Warsaw, Poland MedicalResearch.com: What is the background for this study? Response: Currently recommended 10-year interval between screening colonoscopies is based on the limited evidence. We decided to assess what is the risk of colorectal cancer and colorectal cancer death after singe negative screening colonoscopy. (more…)
Author Interviews, Brigham & Women's - Harvard, Cognitive Issues, Heart Disease, JACC, Lipids / 23.05.2020

MedicalResearch.com Interview with: Robert P. Giugliano, MD, SM Senior Investigator, TIMI Study Group Cardiovascular Medicine Brigham and Women's Hospital Professor of Medicine Harvard Medical School Boston, MA  MedicalResearch.com: What is the background for this study? Response: Some prior studies had suggested that lipid lowering therapies were associated with impaired cognition.  We sought to explore this question in a prospectively designed substudy of the large FOURIER randomized, double-blind clinical trial utilizing patient self-surveys administered the end of the study to determine whether patients themselves noticed any changes in cognition over the duration of the trial. The survey tool was a shortened version of the Everyday Cognition Questionnaire (see attached) that asks patients 23 questions that assess memory and executive function (including subdomains of planning, organization, and divided attention). The questions are in the format of "Compared to the beginning of the study, has there been any change in .....", and are graded as 1=better/no change, 2=questionable/occasionally worse, 3=consistently a little worse, 4=consistently much worse. (more…)
Author Interviews / 22.05.2020

MedicalResearch.com Interview with: Marco Piccininni Research Associate, CONVERGE Universitätsmedizin Institute of Public Health Berlin, Germany MedicalResearch.com: What is the background for this study? Response: The Lombardy region of northern Italy was severely hit by the covid-19 pandemic. However, despite the very high number of confirmed covid-19 deaths in this region, some local investigations suggested that there was a mismatch between the confirmed covid-19 death count and the increase in all-cause deaths. In our study, we decided to further investigate this aspect in the city of Nembro (province of Bergamo), which was one of the first cities to report covid-19 cases, and one of the cities most affected by the pandemic. (more…)
Author Interviews, COVID -19 Coronavirus, Race/Ethnic Diversity / 21.05.2020

MedicalResearch.com Interview with: Charles H. Hennekens, MD, DrPH Sir Richard Doll Professor Senior Academic Advisor FAU, Boca Raton, FL  MedicalResearch.com: What is the background for this study? Response: Blacks and other disadvantaged minorities in the United States have markedly reduced life expectancies compared with their white counterparts.  As is the case with most fatal diseases, coronavirus disease (COVID-19) is already taking a disproportionate toll on blacks and other disadvantaged minorities. (more…)
Author Interviews, Cannabis, Gender Differences / 21.05.2020

MedicalResearch.com Interview with: Francesca Filbey, PhD Associate Provost and Professor of Cognition and Neuroscience Bert Moore Chair The University of Texas at Dallas MedicalResearch.com: What is the background for this study? Response:  Studies have reported differences in how males and females respond to cannabis and how they develop problems related to cannabis use.  We sought to determine whether craving may underlie this difference in male and female cannabis users. (more…)
Author Interviews, OBGYNE, Pediatrics / 21.05.2020

MedicalResearch.com Interview with: Yanmin Zhu, M.S., Ph.D. Postdoctoral Research Fellow Division of Pharmacoepidemiology and Pharmacoeconomics Brigham and Women's Hospital and Harvard Medical School  MedicalResearch.com: What is the background for this study? Response: Animal studies and case reports suggest a potential teratogenic effect associated with the use of high doses of fluconazole during pregnancy. The malformations reported in case reports have a distinct phenotype, including femoral bowing, thin ribs, cleft palate, and abnormal craniofacial ossification. A few controlled studies have examined the risk of congenital malformations associated with the use of fluconazole during the first trimester, but findings are inconsistent. (more…)
AHA Journals, Author Interviews, COVID -19 Coronavirus, NYU / 21.05.2020

MedicalResearch.com Interview with: Shadi Yaghi, MD Assistant Professor Department of Neurology at NYU Grossman School of Medicine Director, Clinical Vascular Neurology Research, NYU Langone Health Director, Vascular Neurology, NYU Langone Hospital-Brooklyn  MedicalResearch.com: What is the background for this study? Response: Our aim was to determine the characteristics of imaging proven ischemic stroke in the setting of COVID-19 infection and compare them to those of ischemic stroke but without COVID-19 infection. (more…)
Author Interviews, Cancer Research, Melanoma, Nature / 21.05.2020

MedicalResearch.com Interview with: Dr. Kelly Brooks PhD Research Officer QIMR Berghofer Medical Research Institute     MedicalResearch.com: What is the background for this study? Response: There are approximately 175 new cases a year for melanomas inside the eye called uveal melanomas. These cancers spread to other sites of the body in about half of patients. Uveal melanomas are very different to skin melanomas and so far no effective treatment have been approved to treat uveal melanoma once it has spread. We sequenced uveal melanoma tumours from over 100 different patients to look at what mutations are responsible for tumour growth and development.  (more…)
Author Interviews, Dermatology / 21.05.2020

MedicalResearch.com Interview with: Dr. Melanie D. Palm, MD, MBA Board-certified dermatologist and cosmetic surgeon San Diego, CA Clinical investigator in the Restylane Kysse phase 3 Galaderma trial Dr. Palm discusses the recent announcement that the FDA has approved Restylane® Kysse for lip augmentation and the correction of upper perioral rhytids (wrinkles)  in adults over the age of 21.   MedicalResearch.com: What is the background for this announcement?
    • Restylane® Kysse has been approved and used in Europe and Canada for several years. It is now the first FDA-approved hyaluronic acid (HA) lip filler in the U.S. formulated with XpresHAn Technology™ (pronounced ex-'spre-shan’) for smooth, natural-looking results.
    • It is FDA-approved for use not only in the lip but for improvement of upper lip lines.
    • Restylane Kysse is the third product (following Restylane Defyne and Restylane Refyne) in the Restylane family of fillers to use XpresHAn Technology™ which allows for a gel that integrates into the skin for natural expression in motion
(more…)
Author Interviews, Gender Differences, JAMA, Surgical Research, University of Pittsburgh / 21.05.2020

MedicalResearch.com Interview with: Sara P. Myers, M.D., Ph.D. University of Pittsburgh School of Medicine  MedicalResearch.com: What is the background for this study? Response: Compared to other fields, medicine, and especially academic surgery and its subspecialties, trail with respect to gender diversity. Considering that these fields were traditionally male-dominated, two issues that may present ongoing challenges to the retention and promotion of women are pro-male bias and negative stereotypes about women. Training specific to pursuing a surgical career begins in residency, so it is important to understand how these issues affect motivation and achievement during this formative period. In our study we first evaluated the association between pro-male bias and research-related career engagement using a survey methodology, and then looked at whether evoking negative stereotypes about women was associated with reduced performance on a simulated technical skill assessment called the Fundamentals of Laparoscopic Surgery (FLS) assessment.  (more…)
Author Interviews, Cancer Research, COVID -19 Coronavirus / 19.05.2020

MedicalResearch.com Interview with: Paolo A. Ascierto, MD Melanoma. Cancer Immunotherapy and Development Therapeutics Unit Istituto Nazionale Tumori IRCCS Fondazione "G. Pascale" Napoli - Italy  MedicalResearch.com: What is the background for this study? What are the main findings? Response: As we know, in Covid-19 pneumonia, especially in its complication “acute respiratory distress syndrome (ARDS)”, a key role is played by the immune system. We know that when we treat a tumor with immunotherapy, it could give side effects because the stimulated immune system produces a series of substances to destroy the tumor. Sometimes, the immune system can also give side effects related to a hypersecretion of some cytokines, such as IL 6, the target of tocilizumab. This condition is called cytokine storm, or better, cytokine release syndrome (CRS).Oncologists use tocilizumab in the management of CRS that can occur following the use of bispecific antibodies, or recently, the use of CAR-T cell therapy, where such drug is approved for CRS treatment.  (more…)
Author Interviews, Cancer Research, Lancet, Nature / 19.05.2020

MedicalResearch.com Interview with: Matthew Galsky, MD Icahn School of Medicine at Mount Sinai New York, NY MedicalResearch.com: What is the background for this study? Response: Standard first-line treatment for metastatic urothelial (bladder) cancer has been platinum-based chemotherapy for decades. In 2016, atezolizumab, an immunotherapy that inhibits PD-L1, received accelerated approval by the FDA for the treatment of metastatic urothelial cancer for patients progressing despite prior platinum-based chemotherapy and this was followed by approvals for 4 additional PD-1 or PD-L1 inhibitors in this setting over the next couple years. With this first new drug class approved, representing the first new drugs approved for metastatic urothelial cancer for decades, logical question arose (a) should we combine these drugs with platinum-based chemotherapy in the first-line metastatic treatment setting and (b) is there a role to replace first-line chemotherapy with atezolizumab monotherapy. The IMvigor 130 trial was designed to address these questions. The trial enrolled 1213 patients who were randomized to treatment with (a) atezolizumab plus platinum-based chemotherapy, (b) placebo + platinum-based chemotherapy, or (c) atezolizumab monotherapy. The trial employed a hierarchical analysis plan such that comparisons between arms for certain endpoints could only be formally tested if other the preceding comparisons demonstrated a significant improvement.  (more…)
ASCO, Author Interviews, Cancer Research / 19.05.2020

MedicalResearch.com Interview with: Dr. Jesus G. Berdeja, MD Director of Myeloma Research Sarah Cannon Nashville, TN MedicalResearch.com: What is the background for this study? Response: Despite many advances in the treatment of multiple myeloma in recent years, the majority of patients will progress through all available therapies and ultimately succumb to their disease.  Thus there is still a high unmet medical need. The Phase 1b/2 CARTITUDE-1 study evaluates the safety and efficacy of JNJ-4528, an investigational BCMA-directed CAR-T therapy, in the treatment of patients with relapsed or refractory multiple myeloma. Participants in this study have already tried approved therapies, and had received a median of five prior treatment regimens and their median overall survival is less than 12 months.  (more…)
Author Interviews, JAMA, Orthopedics, Race/Ethnic Diversity, Surgical Research / 19.05.2020

MedicalResearch.com Interview with: Alyson Cavanaugh, PT, PhD Joint Doctoral Program in Epidemiology University of California, San Diego/ San Diego State University MedicalResearch.com: What is the background for this study? Response: More than 700,000 total knee replacements are performed annually in the United States, but there is a racial disparity in outcomes after the surgery. If the knee replacement procedure is considered a highly effective treatment, why don't black women present with the same outcomes as whites? Physical function when going into surgery has a large impact on the potential functional outcomes after surgery. Our hypothesis was that black women were presenting to surgery with poorer physical function, which was contributing to poorer functional outcomes after surgery. (more…)
Author Interviews, JAMA, STD / 19.05.2020

MedicalResearch.com Interview with: Barbara Van Der Pol, PhD, MPH President, American STD Association President-Elect, International Society fo STD Research Professor of Medicine & Public Health Director, STD Diagnostics Lab Director, UAB STD Clinical Research Organization University of Alabama at Birmingham Birmingham, AL  35294 MedicalResearch.com: What is the background for this study? Response: For many decades, public health programs focused on control and prevention of sexually transmitted infections (STI) have relied on lab based tests that required a 1-day to 1-week wait for test results.  Efforts to shorten the duration of infection lead to treating at the time of the clinic visit based on the association between certain clinical signs or symptoms and the likelihood of infection. Unfortunately, more than ½ of infected persons do not have signs or symptoms so they receive no treatment until test results are available. Thus, a test that could be performed at the clinical site with a limited wait time would improve the accuracy of treatment and shorten the duration of infection. Such a strategy will hopefully reduce the number of return clinic visits, the possibility of transmission, and the potential for consequences of untreated infection such as infertility.  (more…)
Author Interviews, Cost of Health Care, JAMA / 19.05.2020

MedicalResearch.com Interview with: James D. Chambers, PhD, MPharm, MSc Associate Professor of Medicine Tufts Medical Center Institute for Clinical Research and Health Policy Studies MedicalResearch.com: What is the background for this study? Response: We know that biosimilars have not had the same uptake in the US as they have had elsewhere. We know that this is in part due to reference product manufacturer tactics to delay biosimilar market entry and patent disputes. In this study we examined whether lack of preferred coverage by commercial health insurers may also play a role. (more…)
Author Interviews, Cost of Health Care, JAMA, Primary Care / 19.05.2020

MedicalResearch.com Interview with: Sara Martin, MD, MSc Santa Rosa Family Medicine Residency Program Santa Rosa, California MedicalResearch.com: What is the background for this study? Response: To improve access to comprehensive primary care, we need to understand how much is being spent on primary care. Until recently, the United States lacked any data-based estimate of primary care expenditure.  This study utilizes Medical Expenditure Panel Survey (MEPS)data from 2002 – 2016 to estimate the percentage of healthcare expenditures that was spent on primary care. Most discussions around health care expenditure in the U.S. focus on the fact that we spend more than any other country and do not have the corresponding outcomes to match that investment.  This paper focuses the conversation around the distribution of the expenditure. (more…)
Author Interviews, JAMA, Pediatrics, Social Issues, Technology / 18.05.2020

MedicalResearch.com Interview with: Pooja S. Tandon, MD, MPH Center for Child Health, Behavior and Development Seattle Children's Research Institute MedicalResearch.com: What is the background for this study? Response: Cell phone use is common among middle and high school students, yet we do not have an understanding of school cell phone policies and practices in the U.S. We conducted a survey of public schools serving grades 6-12. The survey sent to over 1,100 school principals, representing a national sample of schools across the U.S., asked questions about the presence of a cell phone policy for students and staff and restrictions on phone use. Additional questions addressed consequences of policy violation, the use of cell phones for curricular activities and principals’ attitudes toward cell phone policies. (more…)
Author Interviews, Cannabis, CDC, JAMA, Pediatrics, Tobacco Research / 18.05.2020

MedicalResearch.com Interview with: Susan Hocevar Adkins, MD Lead Author, Senior Medical Officer, and Commander United States Public Health Service CDC MedicalResearch.com: What is the background for this study? Response: Since August 2019, the Centers for Disease Control and Prevention (CDC), the US Food and Drug Administration (FDA), and state, local, and territorial health departments have been investigating a national outbreak of e-cigarette, or vaping, product use-associated lung injury (EVALI). Although clinical presentation and outcomes of EVALI patients generally have been reported, data on adolescent patients are more limited. This article fills this gap by using data from national EVALI surveillance at CDC to examine demographic, substance use, and clinical characteristics of adolescent EVALI patients relative to young adult and adult EVALI patients. (more…)
Author Interviews, Infections, OBGYNE / 16.05.2020

MedicalResearch.com Interview with: SCYNEXIS IncMarco Taglietti, M.D. President and Chief Executive Officer SCYNEXIS Inc Dr. Taglietti discusses SCYNEXIS’ announcement of positive results from its second Phase 3 study investigating the safety and efficacy of oral ibrexafungerp as a treatment for vaginal yeast infection.  MedicalResearch.com: What is the background for this study? Response:  The VANISH-306 study is one of two Phase 3 randomized, double-blind, placebo-controlled, multi-center studies designed to demonstrate the superiority of oral ibrexafungerp to placebo as a treatment of vaginal yeast infections, also known as vulvovaginal candidiasis. Ibrexafungerp is a novel oral/intraveneous broad-spectrum antifungal in late stage development for multiple indications, from the treatment and prevention of vaginal yeast infections to life-threatening invasive fungal infections in the hospital setting. The VANISH-306 study was conducted in 42 centers in the US and EU and enrolled 449 patients. Patients were randomized to oral ibrexafungerp (two doses of 300mg taken 12 hours apart for one day) or placebo in a 2:1 ratio The primary endpoints included clinical cure rate, defined as the complete resolution of all signs and symptoms at the test-of-cure visit (Day-10) and secondary endpoints included mycological eradication and change in signs and symptoms scores compared to baseline at both day 10 and follow-up visit (Day-25). The VANISH-306 study reported positive topline data which showed that 63.3% of ibrexafungerp-treated patients saw a complete resolution of signs and symptoms 10 days following a single day dose of ibrexafungerp. The first study in the VANISH program was VANISH-303, a US-based study, had an identical design to the VANISH-306 study. The VANISH-303 study reported positive topline data in November 2019 which showed that 50.5% of ibrexafungerp-treated patients saw a complete resolution of signs and symptoms 10 days following a single day dose of ibrexafungerp. Both VANISH studies showed a highly significant statistical difference in the primary and secondary efficacy endpoints. The product was well tolerated. (more…)
Author Interviews, JAMA, Surgical Research, Weight Research / 16.05.2020

MedicalResearch.com Interview with: Wei Bao, MD, PhD Assistant Professor Department of Epidemiology, College of Public Health, University of Iowa, Iowa City, IA 52242 and Dr. Yangbo Sun, PhD (Former postdoc research scholar at University of Iowa) Tenure-track Assistant Professor The University of Tennessee Health Science Center.   MedicalResearch.com: What is the background for this study? Response: Obesity is a rising epidemic in the United States and worldwide. Bariatric surgery has been shown to be the most effective and durable treatment for clinically morbid obesity which is difficult to reverse through traditional approaches such as lifestyle intervention. There has been long-standing uncertainty and debate regarding the value of pre-operative weight loss as a requirement for bariatric surgery. Meanwhile, one of the major indicators for surgery outcomes is 30-day mortality after surgery, which is especially important for bariatric surgery because the vast majority of the patients undergoing bariatric surgery are voluntary and if the surgery were not performed, they are not supposed to die in short term. So far, the association of pre-operative weight loss with 30-day mortality after bariatric surgery remains unclear. Therefore, in this study, we examined the associations of pre-operative BMI and weight loss with 30-day mortality following bariatric surgery using a large database among ~500,000 patients who underwent bariatric surgery in the United States and Canada. (more…)
Author Interviews, Diabetes, Genetic Research, Pancreatic / 15.05.2020

MedicalResearch.com Interview with: Dr. Núria Malats, MD PhD, Head of the Genetic and Molecular Epidemiology Group Spanish National Cancer Research Centre (CNIO)  MedicalResearch.com: What is the background for this study? Response: The high mortality of pancreatic cancer is a consequence of late diagnosis because of the absence of symptoms in the earliest stages, and defining risk populations is therefore crucial to be able to carry out diagnostic tests that reveal the presence of the tumour as early as possible. Diabetes and pancreatic cancer are connected because the pancreas secretes insulin; in diabetic people, this does not occur in a normal way. It is estimated that around 50% of patients with pancreatic cancer presents diabetes. But it is an outstanding challenge for researchers to figure out which is the cause and which is the consequence.  To conduct the study, the team used data from more than 3,500 persons from PanGenEU, a large European study involving centres from six countries, including Spain, and led by Malats, to analyse the relationship between multiple risk factors and pancreatic cancer. (more…)
Author Interviews, Cancer Research, COVID -19 Coronavirus / 14.05.2020

MedicalResearch.com Interview with: AVM BiotechologyTheresa A. Deisher, Ph.D Founder and CEO Chariman of Board AVM Biotechnology Dr. Deisher discusses AVM Biotechnology’s plan to study the immune stimulator AVM0703, developed for it’s anti-tumor effects,  as a potential agent to combat COVID-19.  MedicalResearch.com: What is the background for this study? What is AVM0703 currently being studied to treat?   Response: Our lead small molecule, AVM0703, is a novel, patent-pending repurposed formulation of an active pharmaceutical ingredient that has been U.S. Food and Drug Administration (FDA)-approved since 1961. AVM0703 works by supercharging and mobilizing immune cells, including a novel natural killer T-cell (NKT), novel cytotoxic T lymphocytes and a CD11b very high dendritic cell, which invade and destroy tumors more effectively than untreated immune cells. AVM Biotechnology has received clinical trial approval from the FDA to begin Phase I/II trials to characterize the safety, tolerability, pharmacokinetics, and antitumor activity of AVM0703 administered as a single intravenous infusion to pediatric and adult patients (≥12 years old) with terminal, no-option lymphoid malignancies. In addition, we are planning to study AVM0703 in Phase I/II trials in patients with severe or life-threatening COVID-19 infection. The proposed study is a randomized, double-blind, placebo-controlled, single-ascending dose study of AVM0703 administered as a single intravenous infusion. The study’s objective is to evaluate the safety and efficacy of AVM0703 in patients with COVID-19, as well as assess pharmacokinetics and dosing, including the maximum tolerated dose and the recommended Phase II dose. We hope to begin recruiting patients next month (June 2020). (more…)
Author Interviews, Cancer Research, Genetic Research, JAMA / 14.05.2020

MedicalResearch.com Interview with:
  • Sung Jun Ma, MD, resident physician in Radiation Medicine at Roswell Park Comprehensive Cancer Center (first author)
  • Oluwadamilola T. Oladeru, MD, a resident physician at Massachusetts General Hospital Cancer Center
MedicalResearch.com: What is the background for this study? Response: More than 40% of women with hormone receptor-positive, HER2-negative early-stage breast cancer have high recurrence scores (RS) of 26-30. Optimal adjuvant systemic therapy in this subgroup remains unclear, and national guidelines currently recommend either chemoendocrine therapy or endocrine therapy alone. In addition, the difference in overall survival of a patient with a RS 26-30 versus RS >30 is unclear. (more…)
Author Interviews, Brigham & Women's - Harvard, Cost of Health Care, Heart Disease, Race/Ethnic Diversity, Statins / 14.05.2020

MedicalResearch.com Interview with: Dr. Ankur Pandya, PhD Assistant Professor of Health Decision Science Department of Health Policy and Management Harvard T.H. Chan School of Public Health MedicalResearch.com: What is the background for this study? Response: The 2013 ACC-AHA cholesterol treatment guidelines greatly expanded statin medication eligibility for individuals between the ages of 40-75 years without known cardiovascular disease, and there was some concern that African Americans at "intermediate risk" per those guidelines could be (arguably) overtreated with statins. The 2018 ACC-AHA guidelines included coronary artery calcium assessment for individuals at intermediate cardiovascular disease risk; those with a "zero" calcium score and no other risk factors would now change the eligibility (from indicated statin to not indicated). (more…)
Author Interviews, Brigham & Women's - Harvard, Gender Differences, Genetic Research, Nature / 13.05.2020

MedicalResearch.com Interview with: Nolan Kamitaki PhD Harvard Medical School MedicalResearch.com: What is the background for this study? Response: Previous work from our lab found that the strongest common genetic association to schizophrenia is driven in part by copy number variation of the C4 genes.  Given that lupus and Sjogren's syndrome, two autoimmune disorders, have association patterns that span the same region of the human genome, we wondered if part of the signal for these diseases may also arise from variation of C4 given that both have hypocomplementemia as a characterizing trait.   The other main finding is that these associations appear to be sex-biased, where the protection from each additional copy of the C4 gene was greater in men than in women.  When we went back to the data used in the previous study from our lab association C4 variation to schizophrenia, we found that the effect was stronger in men there as well.  Although the expression of C4 at the RNA level does not appear to differ between men and women, we saw that men had more C4 protein in both cerebrospinal fluid and blood plasma, suggesting that this may explain the greater genetic association in men. (more…)