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…)
Author Interviews, Infections, OBGYNE, Sexual Health, STD / 13.05.2020

MedicalResearch.com Interview with: Gregory Kaufman, M.D. Senior Vice President Global Clinical and Medical Affairs Specialty at Lupin MedicalResearch.com: What is the background for this study? Would you briefly explain what is meant by trichomoniasis?  How common is this infection? Response: The Phase 3 trial evaluated the effectiveness and safety of a single oral dose of Solosec® (secnidazole) 2g oral granules for the treatment of trichomoniasis in adult women. Top-line results were positive and showed that Solosec was generally well-tolerated. Trichomoniasis is the most common non-viral sexually transmitted infection (STI) in the U.S., and is caused by a protozoan parasite called Trichomonas vaginalis.[i] Trichomoniasis affects 3 to 5 million people in the U.S.,[ii] and is four- to five-times more prevalent in in women, compared to men.[iii]. (more…)
Author Interviews / 13.05.2020

MedicalResearch.com Interview with: Celine Latulipe PhD Associate Professor University of Manitoba MedicalResearch.com: What is the background for this study? What are the main findings? Response: We wanted to find out how many hospitals offer proxy accounts for caregivers of adult patients. Most patient portal systems allow proxy accounts for parents of pediatric patients, so we know the underlying systems support the creation of proxy accountsWhen we were starting this research, the two big healthcare systems where I was located did NOT offer such proxy accounts for caregivers of adult patients, and a staff person at one of those hospitals suggested adult patients share their passwords with their caregiver, if the caregiver needed access to the portal. As a computer scientist, I am well aware of the security and privacy risks associated with password sharing, and I was appalled by this advice. So we did this survey across the US and we found that 45% of the staff contacted in our study gave similar password sharing advice. This is hugely problematic. Caregivers using a patient's password means the caregiver can see everything in the medical record, including things the patient might not want the caregiver to know, such as past diagnoses of stigmatized illnesses, substance abuse or reproductive health decisions. Also, because password re-use is common across systems, a caregiver with a patient's portal password may now have access to the patient's online banking. (more…)
Author Interviews, Dermatology / 13.05.2020

MedicalResearch.com Interview with: Brian S. Kim, MD, MTR, FAAD Associate Professor of Medicine (Dermatology) Co-Director, Center for the Study of Itch and Sensory Disorders Division of Dermatology, Department of Medicine Washington University School of Medicine St. Louis, MO  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Itch is the central and most debilitating symptom of atopic dermatitis. However, surprisingly, measuring itch or quality of life in clinical trials is not often a primary endpoint. Therefore, this study focuses in very detailed fashion on how ruxolitinib cream improves pruritus in a clinically meaningful way and its ultimate impact on quality of life. What patients want to know at the end of the day is how much will this drug change my life?  Not, whether it statistically beat out a placebo group. Indeed, what this study shows is that ruxolitinib cream has a major impact on itch in a meaningful way that is also tied to improvements in quality of life. (more…)
AACR, Author Interviews, Boehringer Ingelheim, Cancer Research / 13.05.2020

MedicalResearch.com Interview with: Dr. Udai Banerji, MD The Institute of Cancer Research and The Royal Marsden MedicalResearch.com: What is the background for this study? Response: Not only have I been working in the RAS mutations oncology world for a while, but I also have prior preclinical experience working with VS-6766 (RAF/MEK inhibitor) and defactinib (FAK inhibitor), the two drugs in the Phase 1 study that was presented at the American Association for Cancer Research (AACR) annual medical meeting on April 27th. It is important to know that there is a great significant medical need for novel treatments for KRAS mutant tumors, which are difficult to treat, aggressive, and quite common across advanced solid tumors, including low-grade serous ovarian cancer (LGSOC), non-small cell lung cancer (NSCLC) and colorectal cancer (CRC), resulting in the need for novel treatments in an area of significant medical need. I felt that early signals in preclinical research warranted a clinical trial; so that, combined with my RAS experience, made pursuing the Phase 1 study a clear fit. A clinical trial setting allowed us to explore RAF and RAS inhibitor combinations in multiple tumor trials, which was our aim. The data presented at AACR convey safety and dose response results from the dose-escalation portion and expansion cohorts from an open-label, investigator-initiated Phase 1 study evaluating the combination of VS-6766 (RAF/MEK inhibitor) and defactinib (FAK inhibitor) therapy in patients with LGSOC and KRAS mutant NSCLC. The introductory data described in the study suggest that a novel intermittent dosing schedule of RAF/MEK and FAK inhibitor combination therapy has promising clinical activity in patients with KRAS mutant LGSOC and KRASG12V mutant NSCLC, including patients formerly treated with a MEK inhibitor. Expansion cohorts remain ongoing.  (more…)
Author Interviews, COVID -19 Coronavirus / 12.05.2020

MedicalResearch.com Interview with: Peter Jüni, MD, FESC Director, Applied Health Research Centre Li Ka Shing Knowledge Institute of St Michael's Hospital Department of Medicine University of Toronto, Ontario  MedicalResearch.com: What is the background for this study? Response: It is unclear whether seasonal changes, school closures or other public health interventions will result in a slowdown of the current coronavirus disease 2019 (COVID-19) pandemic. We studied 144 geopolitical areas around the world with more than 375,000 COVID-19 cases by March 27 to determine whether epidemic growth is globally associated with climate or public health interventions intended to reduce transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). (more…)
Author Interviews / 11.05.2020

MedicalResearch.com Interview with: David Spetzler, M.S., Ph.D., M.B.A. President and Chief Scientific Officer Caris Life Sciences MedicalResearch.com: What is the background for this announcement (WES)? Response: The announcement is about the launch of Caris’ latest molecular profiling test, called MI ExomeTM.  MI Exome a next-generation sequencing-based assay analyzing the whole exome of 22,000 DNA genes.  It is unique in that it will be run on every patient and will deliver unprecedented detail into the genomic characteristics of cancers, which will greatly improve our ability to understand cancer and provide insights needed to help physicians and patients make more informed treatment decisions that improve outcomes. (more…)
Author Interviews, Neurological Disorders, Neurology, Pain Research / 11.05.2020

MedicalResearch.com Interview with: Holly Yancy, DO Headache medicine specialist Banner – University Medicine Neuroscience Institute Phoenix, AZ Dr. Yancy comments on the recent Neurology journal article on the potential impact of yoga on migraine.  MedicalResearch.com: What is the background for this study? How might yoga reduce migraine intensity or frequency?  Response: The authors of this trial have studied the benefits of yoga when added to medical management of episodic migraine. They expand on prior, smaller reports of the potential benefit of yoga and mindfulness to migraine patients with a well-designed study that shows yoga, as an adjunct to preventive medication, can lower the intensity, frequency and impact of migraines. Participants even used less abortive medication. The authors propose multiple potential mechanisms of action, including an increase in parasympathetic / decrease in sympathetic nervous system activity, decreased muscle tension, and stress management. (more…)
Author Interviews, COVID -19 Coronavirus, Emergency Care, Infections, NEJM, Stroke / 09.05.2020

MedicalResearch.com Interview with: Akash Kansagra, MD, MS Assistant Professor of Radiology Neurological Surgery, and Neurology Director, Endovascular Surgical Neuroradiology Co-Director, Stroke and Cerebrovascular Center Washington University and Barnes-Jewish Hospital MedicalResearch.com: What is the background for this study? Response: Over the past five years, medicine has made enormous strides in stroke treatment. The effectiveness of these therapies has been absolutely astounding, and our ability to get patients to hospitals that can provide this life-saving care has also improved dramatically. (more…)
AACR, Author Interviews, Biomarkers, Cancer Research, MD Anderson, Pharmaceutical Companies / 09.05.2020

MedicalResearch.com Interview with: David S Hong, M.D MD Anderson Department of Investigational Cancer Therapeutics Division of Cancer Medicine University of Texas MedicalResearch.com: What is the background for this study? Response: Larotrectinib is a first-in-class, CNS active, oral TRK inhibitor exclusively designed to treat tumors with an NTRK gene fusion and does not have secondary targets. In previous presentations and published in The Lancet Oncology, larotrectinib demonstrated robust tumor-agnostic efficacy in an integrated dataset of 159 adult and pediatric patients with TRK fusion cancer across three clinical trials (Feb 2019 data cut-off date). In these studies, the objective response rate (ORR), according to investigator assessment, was 79% (95% confidence interval [CI], 72 – 85%), with a complete response rate of 16%. In this analysis presented at AACR 2020, we sought to evaluate the outcomes in patients from the integrated data set based on different baseline characteristics, including prior lines of therapy and Eastern Cooperative Oncology Group (ECOG) performance status. ECOG measures how the disease impacts a patient. ECOG describes a patient’s level of functioning with a numbering scale (0-5) so physicians can uniformly describe a patient’s ability to care for themselves, daily activity and physical activity (selfcare, walking, working, etc). (more…)
AACR, Author Interviews, Bayer, Cancer Research / 08.05.2020

MedicalResearch.com Interview with: David S Hong, M.D Department of Investigational Cancer Therapeutics Division of Cancer Medicine MD Anderson, University of Texas MedicalResearch.com: What is the background for this study? Response: Larotrectinib is a first-in-class, CNS active, oral TRK inhibitor exclusively designed to treat tumors with an NTRK gene fusion and does not have secondary targets. In previous presentations and published in The Lancet Oncology, larotrectinib demonstrated tumor-agnostic efficacy in an integrated dataset of 159 adult and pediatric patients with TRK fusion cancer across three clinical trials (Feb 2019 data cut-off date). In these studies, the objective response rate (ORR), according to investigator assessment, was 79% (95% confidence interval [CI], 72 – 85%), with a complete response rate of 16%. A variety of NTRK genes have been identified in various tumor types including fusions and non-fusions (e.g., amplifications, rearrangements, deletions, slice variants). In the analysis presented at AACR 2020, we sought to evaluate this pooled data to determine the efficacy of larotrectinib in patients with non-fusion alterations in NTRK genes.  (more…)
Author Interviews, COVID -19 Coronavirus, Infections, Pulmonary Disease / 08.05.2020

MedicalResearch.com Interview with: Jehan Alladina MD Massachusetts General Hospital Pulmonary and Critical Care Medicine Boston, Massachusetts MedicalResearch.com: What is the background for this study? Response: During the pandemic, clinicians around the world have shared anecdotal experiences to help inform care of patients with COVID-19. However, these anecdotes and observations, without careful analysis, can bias clinicians; many clinicians have even recommended experimental therapies based on this information alone. To that end, the goal of our study was to rigorously examine the respiratory failure experienced by critically ill patients with COVID-19 and understand their response to the standards of care for respiratory failure. (more…)
Author Interviews, COVID -19 Coronavirus, Lancet, Rheumatology / 08.05.2020

MedicalResearch.com Interview with: Dr. Giulio Cavalli MD PhD & Prof. Lorenzo Dagna MD FACP Ospedale San Raffaele and Vita-Salute San Raffaele University Milan, Italy     MedicalResearch.com: What is the background for this study? Response: Upon encountering pathogens, our immune system produces pro-inflammatory mediators, called cytokines. Cytokines activate cells from the immune system. In most people, production of cytokines is an appropriate and protective response to infection. However, some individuals develop excessive and detrimental inflammatory responses, which are even more harmful than the pathogen itself to the host organism. We hypothesized that some patients with COVID-19 might develop excessive and detrimental inflammation, and that treatment with anti-inflammatory agents might be beneficial in this population. Anakinra is an inhibitor of the pro-inflammatory molecule interleukin 1 (IL-1). It was originally marketed for the treatment of rheumatoid arthritis, but is now mostly used to treat a variety of pediatric inflammatory diseases. (more…)
Author Interviews, Breast Cancer, Cancer Research, Genetic Research, JAMA / 08.05.2020

MedicalResearch.com Interview with: Anurag K. Singh MD Professor of Oncology Director of Radiation Research Leader, Cell Stress and Biophysical Therapy Program Associate Dean Graduate Medical Education, Research Roswell Park Comprehensive Cancer Center Buffalo NY 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 with high recurrence scores (RS) have RS of 26-30. Optimal adjuvant systemic therapy in this subgroup remains unclear, and national guideline currently recommends 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, Colon Cancer, Gastrointestinal Disease, Infections / 08.05.2020

MedicalResearch.com Interview with: Ulrik Stenz Justesen, MD, DMSc Senior consultant at Department of Clinical Microbiology Odense University Hospital Denmark  MedicalResearch.com: What is the background for this study? Response: Anaerobic bacteria are bacteria that do not require oxygen for energy production, and live in various environments including the human gut, where they usually do not cause infections directly. Previous studies have reported an association between bacteria from the Bovis group streptococci, Clostridium septicum and colorectal cancer (CRC). Recently associations between different Bacteroides species., Fusobacterium nucleatum and CRC have also been reported. We aimed to investigate this further in a large-scale study.  (more…)
Author Interviews, COVID -19 Coronavirus / 08.05.2020

MedicalResearch.com Interview with: Anirban Basu, Ph.D. Stergachis Family Endowed Director and Professor The Comparative Health Outcomes, Policy, and Economics (CHOICE) Institute University of Washington, Seattle MedicalResearch.com: What is the background for this study? What are the main findings? Response: The infection fatality ratio (IFR) of Covid19 infections is a key parameter to model the future burden of this pandemic. Case fatality rates at any point in time provide a biased estimate of IFR because of the undercounting in both the reported number of covid deaths (numerator) and the reported number of Covid19 cases (denominator). Instead, this study looked at the temporality or time trend of the CFRs within specific counties in the US (where data were deemed to be mature) to understand the underlying IFRs that these trends allude to. It estimates county-specific IFR to range from 0.5% to 3.6%, with a population average for the US at 1.3% (95% CCI: 0.6% - 2.1%).  (more…)
Author Interviews, Dermatology, Melanoma / 08.05.2020

MedicalResearch.com Interview with: Neelam A. Vashi, MD Associate Professor of Dermatology Director, Boston University Center for Ethnic Skin Director, Cosmetic and Laser Center Boston University School of Medicine and Daniela P.Sanchez BS Boston Medical Center Boston, MA 02118 MedicalResearch.com: What is the background for this study? Response: Although melanoma most commonly affects Caucasians, Hispanics are disproportionately affected by greater morbidity and mortality rates when diagnosed. Poor prognosis in Hispanic patients is likely multifactorial, and may be secondary to lack of knowledge or misconceptions about melanoma risk, atypical presentation, impaired access to care, and language barriers, ultimately resulting in a delay in diagnosis. (more…)
Author Interviews / 07.05.2020

Hemp-derived cannabidiol (CBD), or hemp extract, has been gaining in popularity in recent years. As long as CBD extract is produced using hemp plants, not marijuana, and contains less than 0.3% THC, it's considered legal in all 50 states. Some states enforce restrictions on buyers, but federally, general consumers who want to use CBD are in the clear.

Unfortunately, while the social stigma surrounding hemp extract has largely been eradicated in general populations, the athletic community hasn't fully embraced the benefits of CBD and some competitive fields still have strict regulations in place governing its use. Read on to find out what amateur, college, and professional athletes need to know.

CBD for Amateur Athletes

Amateur athletes don't have to worry about the restrictions put in place by regulatory bodies. They are free to take advantage of CBD's non-psychoactive therapeutic benefits, which include reduced joint pain and inflammation and improved muscle recovery after strenuous workouts. Guardian Athletic has more information about the benefits of cannabidiol for athletes looking to reduce recovery time and improve performance on their website.

Those who plan to engage in collegiate athletics or try out for semi-pro or professional sports teams should be aware that CBD can show up on a blood test for several days after consumption. They should also note that some hemp extracts contain up to 0.3% THC. This extremely low concentration is unlikely to produce a positive test result for marijuana, but it's still better to buy CBD from a reputable supplier that uses lab testing to ensure 0% THC concentrations.

(more…)
Asthma, AstraZeneca, Author Interviews / 06.05.2020

MedicalResearch.com Interview with: Ubaldo Martin MD VP Clinical Respiratory RIA Late Stage Development AstraZeneca MedicalResearch.com: What is the background for this study? Response: BORA was an extension study evaluating the long-term safety and specific aspects of efficacy in patients who had previously been in the benralizumab pivotal studies.  After the patients completed the pivotal studies (Calima, Sirocco and Zonda), they were eligible to join BORA which followed adults for an additional year and adolescent for an additional 2 years.  All patients receive one of two dosages of benralizumab.  The abstract reports the outcomes of adolescents in the BORA study who were followed for approximately 3 years in total. (more…)
Author Interviews, Gastrointestinal Disease / 06.05.2020

MedicalResearch.com Interview with: Gregory S. Sayuk, MD, MPH John T. Milliken Department of Medicine Division of Gastroenterology Associate Professor of Medicine and Psychiatry Associate Director, Fellowship Training Program Washington University School of Medicine MedicalResearch.com: What is the background for this study? Response: The primary objective of this analysis, “Plecanatide for Patients with Chronic Idiopathic Constipation and Irritable Bowel Syndrome‒Constipation: Analysis of Abdominal Pain from Four Randomized Phase 3 Clinical Trials,” was to determine the impact of plecanatide on abdominal pain in patients with chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C), in addition to comparing efficacy results in patient populations with minimal to mild pain versus moderate to severe pain at baseline. This was a post hoc analysis of data from the four large, phase 3 plecanatide pivotal trials in CIC and IBS-C. (more…)
Author Interviews, Brigham & Women's - Harvard, Nature, Weight Research / 05.05.2020

MedicalResearch.com Interview with: Ronald Kahn, MD Chief Academic Officer, Joslin Diabetes Center Mary K. Iacocca Professor of Medicine Harvard Medical School MedicalResearch.com: What is the background for this study? What are the main findings? Response: Adipose tissue is a heterogeneous organ and composed of several cell types, including mature adipocytes, preadipocytes, stem cells, endothelial cells, and various blood cells. Different adipose depots have distinct physiological functions associated with their anatomical location and cell composition. For example, accumulation of intra-abdominal (visceral) white adipose tissue is associated with insulin resistance and metabolic syndrome, whereas accumulation of subcutaneous adipose tissue is not metabolically detrimental and may be even associated with increased insulin sensitivity. Determining the mechanisms for these phenotypic differences could lead to development of novel therapies for diabetes, obesity, and their associated morbidities. A central challenging question in research of metabolic disease is whether disease risk for diabetes and metabolic syndrome is driven by a subset of fat cells that may interact with environmental stresses in disease pathogenesis in a way different from other fat cells. Indeed, previous studies from the Kahn lab have shown different fat cells in a single depot from the mouse may exhibit developmental heterogeneity. In this new study, we attempted to address this question for human white fat using a synergistic application of several methodologies: 1) single cell transcriptional profiling of human white fat during differentiation, 2) analysis of individual clones of white fat cells taken from humans at surgery, 3) novel computer based network analysis and 4) integration of the gene signatures across experimental models. Single-cell RNA sequencing is an ideal technique to profile gene expression of heterogeneous cell populations obtained from a single tissue, including fat tissue. (more…)