Author Interviews, COVID -19 Coronavirus, Lancet / 02.06.2020

MedicalResearch.com Interview with: Holger Schünemann, MD, PhD, FRCPC Professor of Clinical Epidemiology and of Medicine Co-Director, WHO Collaborating Centre for Infectious Diseases, Research Methods and Recommendations Director, Cochrane Canada and McMaster GRADE Centre Department of Health Research Methods, Evidence, and Impact Canada  MedicalResearch.com: What is the background for this study? Response: Many countries and regions have issued conflicting advice about physical distancing to reduce transmission of COVID-19, based on limited information. In addition, the questions of whether masks and eye coverings might reduce transmission of COVID-19 in the general population, and what the optimum use of masks in healthcare settings is, have been debated during the pandemic. (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…)
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, Brigham & Women's - Harvard, Clots - Coagulation, Diabetes, Heart Disease, Lancet / 08.09.2019

MedicalResearch.com Interview with: Deepak L. Bhatt, MD, MPH, FACC, FAHA, FSCAI, FESC Professor of Medicine, Harvard Medical School Executive Director of Interventional Cardiovascular Programs, Brigham and Women’s Hospital Heart & Vascular Center MedicalResearch.com: What is the background for this study? Response: Dual antiplatelet therapy (DAPT) is known to improve outcomes in patients with acute coronary syndromes (ACS), prior myocardial infarction (MI), or recent coronary stenting. What was unknown is whether patients with diabetes and stable coronary artery disease – a group generally believed to be at high ischemic risk – would benefit from initiation of long-term DAPT with low-dose aspirin plus ticagrelor versus low-dose aspirin (plus placebo). This is what THEMIS was designed to test, with THEMIS-PCI designed prospectively to examine those patients specifically who had a history of previous percutaneous coronary intervention (PCI). (more…)
Author Interviews, Brigham & Women's - Harvard, Global Health, Infections, Lancet, Pediatrics / 21.08.2019

MedicalResearch.com Interview with: Tori Cowger, MPH Ph.D Student | Population Health Sciences Department of Epidemiology Harvard T.H. Chan School of Public Health  MedicalResearch.com: What is the background for this study? Response: Globally, approximately one million cases of tuberculosis disease (TB) and 233,000 TB-related deaths occurred among children aged younger than 15 years during 2018. TB in children and adolescents is clinically and epidemiologically heterogeneous, making diagnosis, care, and prevention challenging. Understanding this heterogeneity can inform TB care and prevention efforts, and efforts to eliminate disparities in TB incidence and mortality in these groups. In this study, we describe the epidemiology of TB among children and adolescents in the United States, and report TB incidence rates for US territories and freely associated states and by parental country of birth, which have not been previously described. (more…)
Author Interviews, Heart Disease, Lancet, Mayo Clinic, Technology / 02.08.2019

MedicalResearch.com Interview with: Paul Friedman, M.D. Professor of Medicine Norman Blane & Billie Jean Harty Chair Mayo Clinic Department of Cardiovascular Medicine Honoring Robert L. Frye, M.D. MedicalResearch.com: What is the background for this study? Response: Atrial fibrillation is an irregular heart rhythm that is often intermittent and asymptomatic.  It is estimated to affect 2.7–6.1 million people in the United States, and is associated with increased risk of stroke, heart failure and mortality. It is difficult to detect and often goes undiagnosed. After an unexplained stroke, it is important to accurately detect atrial fibrillation so that patients with it are given anticoagulation treatment to reduce the risk of recurring stroke, and other patients (who may be harmed by this treatment) are not. Currently, detection in this situation requires monitoring for weeks to years, sometimes with an implanted device, potentially leaving patients at risk of recurrent stroke as current methods do not always accurately detect atrial fibrillation, or take too long. We hypothesized that we could train a neural network to identify the subtle findings present in a standard 12-lead electrocardiogram (ECG) acquired during normal sinus rhythm that are due to structural changes associated with a history of (or impending) atrial fibrillation.   Such an AI enhanced ECG (AI ECG) would be inexpensive, widely available, noninvasive, performed in 10 seconds, and immensely useful following embolic stroke of unknown source to guide therapy. To test this hypothesis, we trained, validated, and tested a deep convolutional neural network using a large cohort of patients from the Mayo Clinic Digital Data Vault. (more…)
Author Interviews, Lancet, Neurology, Surgical Research / 05.07.2019

MedicalResearch.com Interview with: Dr. Natasha van Zyl, MBChB (Cape Town), FRACS FRACS Plastic and Reconstructive Surgeon Melbourne, Australia  MedicalResearch.com: What is the background for this study? What are the main findings? Response: The estimated global incidence of spinal cord injury (SCI) from all causes is 40 to 80 new cases per million population per year which means that every year between 250 000 to 500 000 people worldwide suffer SCI (1)(chap 2 p 17). In Australia the age standardised, annual incident rate of persisting traumatic SCI for Australian residents aged 15 years and above is 11.8 cases per million.(2) Just over 50% of all spinal cord injuries  in Australia occur at the cervical level resulting in tetraplegia. (2) Cervical spinal cord injury is a devastating, life-changing injury impacting almost every aspect of a person’s work, family and social life. Although compared to many other health conditions it has a relatively low incidence, it is certainly a high cost health condition, with the lifetime cost per tetraplegia incident case estimated to be AU$9.5 million.(3) For those living with tetraplegia improvement in hand function is their highest ranked goal.(4) As such, reconstruction of upper extremity function in cervical spinal cord injury is a crucial component of the surgical rehabilitation of people with mid/low cervical spinal cord injury as it has the capacity to restore critical functions such as elbow extension, wrist extension, grasp, key pinch and release. Traditionally these functions have been reconstructed using tendon transfers, which move a functioning muscle to a new insertion site to recreate the function of a paralysed muscle.(5) (more…)
Asthma, Author Interviews, Environmental Risks, Lancet, Pediatrics / 12.04.2019

MedicalResearch.com Interview with: Ploy Pattanun Achakulwisut, PhD Postdoctoral Scientist in Climate change, Air pollution, and Public Health Milken Institute School of Public Health (Anenberg Group The George Washington University, D.C  MedicalResearch.com: What is the background for this study? Response: Dozens of epidemiological studies have found positive and generally statistically significant associations between long-term exposure to traffic-related air pollution (TRAP) and asthma development in children. The evidence is most robust for nitrogen dioxide (NO2), a major component of and commonly used surrogate for the complex TRAP mixture. Recent reviews conducted by the US Environmental Protection Agency and Health Canada concluded that there is “likely a causal relationship” between long-term NO2 exposure and pediatric asthma development. Using NO2 as a proxy for TRAP, our study provides the first global estimate of the number of new asthma cases among children that are attributable to traffic pollution, using fine spatial-scale global datasets that can resolve within-city and near-roadway NO2 exposures. (more…)
Allergies, Author Interviews, Immunotherapy, Lancet / 02.04.2019

MedicalResearch.com Interview with: Arnon Elizur MD Director, The Institute of Allergy, Immunology & Pediatric Pulmonology Yitzhak Shamir Medical Center Zerifin, Israel MedicalResearch.com: What is the background for this study?   Response: Tree nuts are among the most common food allergies and are a major cause of fatal and near fatal reactions. Patients with tree nut allergy are often allergic to several nuts, further increasing the risk of accidental exposures, dietary limitations, and the emotional burden and anxiety in affected patients. In the past 10 years, oral immunotherapy (OIT) has shown promise as a treatment modality for milk, egg and peanut allergies. However, limited data exists on oral immunotherapy for tree nuts and the treatment is complicated by the high prevalence of co-allergy to several nuts. (more…)
Author Interviews, Biomarkers, Lancet, OBGYNE, Pediatrics / 01.04.2019

MedicalResearch.com Interview with: Catalin S. Buhimschi MD, MMS, MBA Professor of Obstetrics and Gynecology Division of Maternal Fetal Medicine Director of Obstetrics Department of Obstetrics and Gynecology Chicago, IL, 60612 MedicalResearch.com: What is the background for this study? What are the main findings? Response: In 2008, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal–Fetal Medicine Units Network published the results of a randomized controlled trial of magnesium sulfate for the prevention of cerebral palsy (CP). The results of this trial suggested that fetal exposure to magnesium sulfate before anticipated early preterm delivery did not reduce the combined risk of moderate to severe cerebral palsy or death, although the rate of cerebral palsy was reduced among survivors. As such, the search for a biomarker or a therapeutic solution to prevent CP had to continue. We are grateful to the NICHD for giving us access to the umbilical cord blood samples retrieved at the time of birth for the infants enrolled, who were also followed for 2 years postnatally. We discovered that fetus’s ability to switch-on haptoglobin (Hp) expression in response to inflammation was associated with reduction of intra-ventricular hemorrhage (IVH) and/or death, and cerebral palsy and/or death. Fetuses unable to mount such a response in-utero had an increased risk of adverse outcomes. (more…)
Author Interviews, Lancet, OBGYNE, Pediatrics, Weight Research / 28.03.2019

MedicalResearch.com Interview with: Liv Guro Engen Hanem, PhD Candidate Department of Clinical and Molecular Medicine Norwegian University of Science and Technology MedicalResearch.com: What is the background for this study?   Response: The antidiabetic drug metformin is increasingly used in pregnancy: to treat gestational diabetes and type 2 diabetes, and to prevent pregnancy complications related to polycystic ovary syndrome (PCOS) and obesity. Metformin passes the placenta, and the fetus is thus exposed to the drug. Although no teratogenicity has been reported, metformin might have long-term effects on offspring health. This study is a follow-up of cardiometabolic risk factors of 141 5- to 10-year-old children born in the PregMet study. This study was a double-blind, randomized controlled trial (RCT) designed to test the hypothesis that metformin given throughout pregnancy reduces the prevalence of pregnancy complications that are associated with the common endocrine disorder PCOS. Pregnant women with PCOS were randomized to receive metformin or placebo throughout pregnancy.  (more…)
Author Interviews, Brigham & Women's - Harvard, Ebola, Global Health, Lancet / 28.03.2019

MedicalResearch.com Interview with: Patrick Vinck, PhD Research Director, Harvard Humanitarian Initiative Assistant Professor, Global Health and Population T.H. Chan Harvard School of Public Health; Emergency Medicine Harvard Medical School Lead Investigator, Brigham & Women's Hospital  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: The second worst epidemic of Ebola on record is currently unfolding in the eastern part of the Democratic Republic of the Congo. Whether or not safe practices are implemented to prevent the spread of the epidemic is influenced by the behavior of individuals at-risk of contracting the Ebola Virus Disease (EVD) - Will they follow the recommendations of health professionals? Will they report suspected cases and deaths? Will they seek treatment from health professionals? Will they accept vaccines and adopt preventive behaviors? We find that belief in misinformation about Ebola is widespread and trust in authorities is generally low, likely as a result of decades of violence and poor governance and, more recently, the politicization of the Ebola response. Our analysis shows that trust and (mis-)information influence adherence to risk avoidance behavior and acceptance of vaccination. (more…)
Author Interviews, Cancer Research, Global Health, Lancet, Weight Research / 04.02.2019

MedicalResearch.com Interview with: Hyuna Sung, PHD Principal Scientist, Surveillance Research American Cancer Society, Inc. 250 Williams St. Atlanta, GA 30303  MedicalResearch.com: What is the background for this study? Response: This project was motivated by our previous finding on the rise of colorectal cancer among young adults before age 55. Changes in cancer trends among young age group have significant implications because the newly introduced carcinogenic agents are likely to affect trends among young people before they affect those among older people. Owing to this relationship, cancer trends among young people can be often considered as a bellwether for future disease burden. Given the dramatic increase of the obesity prevalence during 3-4 decades in the US, we wanted to expand the colorectal cancer finding to the more comprehensive list of cancers and explain them in the context of obesity epidemic. (more…)
Author Interviews, Global Health, Health Care Systems, Lancet, Pediatrics / 29.01.2019

MedicalResearch.com Interview with: "By @plumavioleta "Atardecer en #caracas... #avebolivar # ccs #venezuela." via @PhotoRepost_app" by Pedro Fanega is licensed under CC BY 2.0. To view a copy of this license, visit: https://creativecommons.org/licenses/by/2.0Ms Jenny García, PhD candidate Institut National d’Études Démographiques INED Institut de Démographie de l'université Paris 1 Panthéon Sorbonne IDUP Paris, France Prof Gerardo Correa, MSc Instituto de Investigaciones Económicas y Sociales IIES Universidad Católica Andrés Bello UCAB Caracas, Venezuela Prof Brenda Rousset, PhD Departamento de Estadística, Escuela de Sociología (FaCES) Universidad Central de Venezuela UCV Caracas, Venezuela MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Venezuela, as many countries in Latin America, showed substantial improvements in infant mortality rates during the last 60 years. However, the decreasing pattern might be reversing. Recent socioeconomic and political events have led to a collapse in living standards, along with a breakdown of the health system. At the same time, a strict secrecy policy has ruled public institutions, and since 2013 the Venezuelan government stopped publishing mortality statistics. This study attempts to fill this gap and estimate infant mortality using hospital and census data after 2013. The main finding is that infant mortality rates in Venezuela may have stopped decreasing and started increasing in 2009 – around the time funding for the Venezuelan health system started to be substantially reduced. By 2016, the infant mortality rate was 21.1 deaths per 1000 live births, which is 1.4 times the rate in 2008 (15.0 deaths per 1000 live births), and equivalent to the rate recorded in the late 1990s, meaning 18 years of progress may have been lost.  (more…)
Aging, Author Interviews, Geriatrics, Lancet, Nutrition, UC Davis, Weight Research / 15.01.2019

MedicalResearch.com Interview with: Valter Longo, PhD Edna M. Jones Professor of Gerontology Professor of Biological Sciences Leonard Davis School of Gerontology Director of the USC Longevity Institute USC MedicalResearch.com: What is the background for this study? What are the main findings? Response: The use of a low calorie diet that mimics fasting for 4 days twice a month starting at middle age can extend lifespan and rejuvenate mice. In humans a similar diet once a month causes improvements in cholesterol, blood pressure , inflammation, fasting glucose etc consistent with rejuvenation (more…)
Author Interviews, Depression, Hip Fractures, Lancet / 06.12.2018

MedicalResearch.com Interview with: Prof. Gillian Mead Chair of Stroke and Elderly Care Medicine Prof. Martin Dennis Chair of Stroke Medicine Centre for Clinical Brain Sciences The University of Edinburgh   MedicalResearch.com: What is the background for this study? Response: We are both practicing stroke physicians as well as clinical trialists. Therefore our interest in this area was triggered by the exciting results of the FLAME trial in 2011. This appeared to indicate that fluoxetine might boost the recovery of stroke patients. Potentially this was very important given the increasing numbers of people having disability due to stroke, and the fact that fluoxetine is inexpensive and could be introduced very easily into clinical practice. We were further encouraged by the large numbers of small RCTs we identified when we carried out a Cochrane systematic review on the topic. These trials provided more evidence of potential benefit but there was evidence that trials of greater quality showed less benefit, and benefits were greater in patients who were depressed. We felt there was a need for more evidence derived from much larger numbers of patients. (more…)
Author Interviews, Lancet, Mental Health Research, PTSD / 16.11.2018

MedicalResearch.com Interview with: Sanford Nidich, Ed.D. Director, Center for Social-Emotional Health Maharishi University of Management Research Institute Fairfield, Iowa MedicalResearch.com: What is the background for this study? What are the main findings? Response: Posttraumatic stress disorder (PTSD) is a complex and difficult-to-treat disorder, affecting 10-20% of veterans across eras. Previous research raised the question of whether a non-trauma focused treatment can be as effective as trauma exposure therapy in reducing PTSD symptoms. The overall objective of the study was to compare Transcendental Meditation (TM), a non-trauma focused practice, to prolonged exposure (PE) in a non-inferiority clinical trial, and to compare both to a PTSD health education control group. Transcendental Meditation was found to be as effective as PE in reducing PTSD symptoms severity from baseline to three-month posttest. In standard superiority comparisons, significant reductions in PTSD symptoms were found for TM vs. HE, and PE vs. HE. Percentages of participants with clinically significant improvement, as measured by the Clinician-Administered PTSD Scale (CAPS) interview (≥10 point reduction), were TM=61%, PE=42%, and HE=32%  (more…)
Author Interviews, Global Health, Hospital Acquired, Infections, Lancet / 07.11.2018

MedicalResearch.com Interview with: "Antibiotics" by Michael Mortensen is licensed under CC BY-SA 2.0Dr Alessandro Cassini MD Epidemiologist, European Centre for Disease Prevention and Control Solna, Sweden MedicalResearch.com: What is the background for this study? Response: We published an ECDC study estimating attributable deaths and disability-adjusted life-years caused by infections with antibiotic-resistant bacteria in the European Union and the European Economic Area (EU/EEA). This study is based on 2015 data from the European Antimicrobial Resistance Surveillance Network (EARS-Net). The study was developed by experts at ECDC and the Burden of AMR Collaborative Group, and published in The Lancet Infectious Diseases. (more…)
Author Interviews, Infections, Lancet, Urinary Tract Infections / 27.10.2018

MedicalResearch.com Interview with: https://www.shionogi.com/Simon Portsmouth, MD Senior Medical Director Shionogi Inc. MedicalResearch.com: What is the background for this study? What are the main findings? Response: Antibiotics for multidrug resistant  Gram-negative infections are desperately needed. Cefiderocol is the first siderophore antibiotic to reach patients. Siderophore antibiotics bind to free iron and use the bacterial active iron transport channels to cross the outer membrane of Gram-negative bacteria. Laboratory studies have shown that cefiderocol is active against multi-drug resistant Gram-negative bacteria, often where no other antibiotics are active. It is able to overcome most types of antibiotic resistance due to its active transport into cells and stability against all carbapenemases. The need for antibiotics for carbapenem resistant Gram-negative infections is described as a critical need by the WHO. This trial was the first in humans with serious infections and demonstrated excellent efficacy in a complicated patient population where almost ¼ were over 75 years of age. Additionally cefiderocol did not appear to have any safety problems, and was well tolerated. (more…)
Author Interviews, Brain Injury, CT Scanning, Emergency Care, Lancet, Technology / 16.10.2018

MedicalResearch.com Interview with: Qure-ai.jpgSasank Chilamkurthy AI Scientist, Qure.ai MedicalResearch.com: What is the background for this study? Response: Head CT scan is one of the most commonly used imaging protocols besides chest x-ray. They are used for patients with symptoms suggesting stroke, rise in intracranial pressure or head trauma. These manifest in findings like intracranial haemorrhage, midline shift or fracture. Scans with these critical findings need to be read immediately. But radiologists evaluate the scans on first-come-first-serve basis or based on stat/routine markers set by clinicians. If the scans with critical findings are somehow pushed to the top of radiologists’ work list, it could substantially decrease time to diagnosis and therefore decrease mortality and morbidity associated with stroke/head trauma. (more…)
Author Interviews, Diabetes, Gluten, Lancet, OBGYNE, Pediatrics / 21.09.2018

MedicalResearch.com Interview with: Knud Josefsen, senior researcher Bartholin Institute, Rigshospitalet, Copenhagen K, Denmark MedicalResearch.com: What is the background for this study? What are the main findings? Response: In a large population of pregnant women, we found that the risk of the offspring being diagnosed with type 1 diabetes before the age of 15.6 years (the follow up period) was doubled in the group of women ingesting the highest amounts of gluten (20-66 g/day) versus the group of women ingesting the lowest amounts of gluten (0-7 g/day). For every additional 10 grams of gluten ingested, the risk for type 1 diabetes in the child increased by a factor of 1.31. It the sense that it was a hypothesis that we specifically tested, we were not surprised. We had seen in animal experiments that a gluten-free diet during pregnancy protected the offspring from diabetes, and we wanted to see if we could prove the same pattern in humans. There could be many reasons why we would not be able to show the association, even if it was there (sample size, low quality data, covariates we could not correct for and so on), but we were off course pleasantly surprised that we found the association that we were looking for, in particular because it is quite robust (more…)
Author Interviews, Diabetes, Heart Disease, Lancet / 12.08.2018

MedicalResearch.com Interview with: Dr Araz Rawshani, PhD Department of Molecular and Clinical Medicine Institute of Medicine University of Gothenburg Gothenburg, Sweden MedicalResearch.com: What is the background for this study?  Response: Patients with type 2 diabetes have 2 to 4 times greater risk for death and cardiovascular events compared to the general population. There are several randomized trails that encourage a range of interventions that target traditional and modifiable risk factors, such as elevated levels for glycated hemoglobin, blood pressure and low-density lipoprotein cholesterol to reduce the risk for complications of type 2 diabetes. However, there are few randomized trails that have investigated the effects of multifactorial risk factor intervention in reducing the risk for death and cardiovascular events, as compared to patients that are treated with usual care. We set out to investigate the extent to which the excess risk associated with type 2 diabetes may be mitigated or potentially eliminated by means of evidence-based treatment and multifactorial risk factor modification. In addition, we estimated the relative importance between various risk factors and the incremental risk of death and cardiovascular events associated with diabetes. Furthermore, we investigated the association between glycated hemoglobin, systolic blood pressure and low-density lipoprotein cholesterol (LDL-C) within evidence based target ranges and the abovementioned outcomes. (more…)
Author Interviews, Eli Lilly, Lancet, Pharmacology, Rheumatology, UCLA / 26.07.2018

MedicalResearch.com Interview with: Daniel J. Wallace M.D., FACP, MACR Associate Director, Rheumatology Fellowship Program Board of Governors, Cedars-Sinai Medical Center Professor of Medicine, Cedars-Sinai Medical Center David Geffen School of Medicine Center at UCLA In affiliation with Attune Health Beverly Hills, Ca 90211 MedicalResearch.com: What is the background for this study? What are the main findings?   Response: This is the first positive study of systemic lupus erythematosus (SLE) using baricitinib,  a small oral molecule that blocks the JAK system. The human kinome consists of 500 genes and helps regulate cell surface receptor interaction. While agents that inhibit certain pathways are approved for rheumatoid arthritis and certain malignancies, this is the first study of its kind in SLE. (more…)
Author Interviews, Cancer Research, Lancet / 10.07.2018

MedicalResearch.com Interview with: Paul Lyon DPhil, MRCS Academic Clinical Fellow in Radiology Oxford University Hospitals NHS Foundation Trust Oxford, UK MedicalResearch.com: What is the background for this study? What are the main findings? Response: Delivering therapeutic doses of systemic chemotherapy to solid tumours, whilst ensuring side effects remain tolerable, has a presented a long-standing and unsolved challenge in oncology. With the advent of smart nanomedicines for clinical use, such as Lyso-Thermosensitive Liposomal Doxorubicin (LTLD, ThermoDox®, Celsion, USA), which has been formulated to release its doxorubicin content at 2.5°C above body temperature, there is now opportunity for targeted tumour therapy in combination with therapeutic devices. Much like a magnifying glass can focus energy from the sun to burn a hole in paper, ultrasound can be focused deep within the body to induce therapeutic effects in tumours, including ablation, hyperthermia and other bioeffects. Since its inception in the 1940s, focused (or therapeutic) ultrasound has evolved and is now FDA-approved for a variety of indications including ablation of several tumour types, virtue of being safe, non-invasive and non-ionising. Building on decades of preclinical research efforts worldwide, the TARDOX study is the first clinical trial to attempt triggered drug delivery to a target tumour non-invasively using an external focused ultrasound device. This phase 1 study which ran between March 2015-March 2017 in Oxford, UK, treated 10 patients with inoperable primary or secondary liver tumours which were either stable or refractory to previous chemotherapies. In each patient, a single intervention under general anaesthetic was performed during which a selected liver tumour was targeted and gently heated with focused ultrasound following an intravenous infusion of LTLD. Biopsies were used to determine the quantity of intratumoral doxorubicin before and after the ultrasound exposure.  (more…)
Author Interviews, Beth Israel Deaconess, HIV, Lancet, Vaccine Studies / 08.07.2018

MedicalResearch.com Interview with: Dan Barouch, M.D., Ph.D. Professor of Medicine Harvard Medical School Ragon Institute of MGH, MIT, and Harvard Director, Center for Virology and Vaccine Research Beth Israel Deaconess Medical Center Boston, MA 02215 MedicalResearch.com: What is the background for this study? What are the main findings? Response: This study demonstrates that the mosaic Ad26/Env HIV vaccine candidate induced robust and comparable immune responses in humans and monkeys. Moreover, the vaccine provided 67% protection against viral challenge in monkeys.    (more…)
Asthma, AstraZeneca, Author Interviews, Immunotherapy, Lancet, Pulmonary Disease / 27.06.2018

MedicalResearch.com Interview with: Reynold A. Panettieri, Jr., M.D. Professor of Medicine, Robert Wood Johnson Medical School Vice Chancellor, Clinical & Translational Science Director, Rutgers Institute for Translational Medicine & Science Emeritus Professor of Medicine, University of Pennsylvania Child Health Institute of New Jersey Rutgers, The State University of New Jersey New Brunswick, NJ  08901 MedicalResearch.com: What is the background for this study? Response: Severe asthma is characterized by Type 2 inflammation manifested by increases in IL-13, IL-4 and Il-5 levels in the airways that promotes airway hyperresponsiveness and in part irreversible airway obstruction.  These clinical manifestations profoundly increase asthma morbidity and mortality. To address an unmet therapeutic need, Tralokinumab was developed as a monoclonal antibody targeting soluble IL-13 with the goal of improving lung function and patient reported outcomes while decreasing annual exacerbation rates.  Stratus 1 and 2 represent two identical randomized, double-blind, placebo-controlled, phase 3 clinical trials in severe asthma.  These international trials enrolled approximately 2000 subjects with severe asthma and examined whether Tralokinumab decreased annualized exacerbation rates (AER) as compared with placebo (primary outcome). (more…)
Author Interviews, Diabetes, Heart Disease, Lancet, Metabolic Syndrome, Weight Research / 01.06.2018

MedicalResearch.com Interview with: Nathalie Eckel, MSc German Diabetes Center Düsseldorf, Germany  MedicalResearch.com: What is the background for this study?  Response: Obesity is associated with metabolic disorders such as diabetes, high blood pressure and hypercholesterolemia, and with a higher risk of cardiovacular disease compared to normal weight. However, there is also the phenomenon of the so-called "metabolically healthy obesity" and "metabolically unhealthy normal-weight". So far it has been unclear how metabolic risk factors change over time in metabolically healthy people depending on body weight and what cardiovascular disease risk results from this. (more…)
Author Interviews, Circadian Rhythm, Lancet, Mental Health Research / 16.05.2018

MedicalResearch.com Interview with: Laura Lyall MA; MSc; PhD Research Associate Institute of Health and Wellbeing University of Glasgow MedicalResearch.com: What is the background for this study? Response: Previous studies have suggested a link between disturbed circadian rhythms and depression and bipolar disorder. These studies have however usually used small samples, subjective measures of circadian disruption, or have not accounted for potential confounding factors like sociodemographic and lifestyle characteristics. The UK Biobank cohort has accelerometry (activity monitor) data as well as mental health, lifestyle, BMI and sociodemographic data for over 91,000 individuals, and means we can address this question using objective measures of circadian rhythmicity on a large scale. We derived a measure of relative amplitude from the UK Biobank’s accelerometry data, which was recorded for 7 days between 2013-2014 from around 100,000 participants. Relative amplitude reflects the distinction, in terms of activity levels, between an individual’s most active 10 hours and least active 5 hours, in an average day. If an individual is inactive during the day, or has disturbed sleep at night, the will show low relative amplitude, consistent with disturbed circadian rest-activity patterns. (more…)
Author Interviews, Lancet, Neurological Disorders, Neurology / 23.03.2018

MedicalResearch.com Interview with: David Birnkrant, MD Professor of Pediatrics, Case Western Reserve University School of Medicine Director of Pediatric Pulmonology & Student Education, MetroHealth Medical Center MedicalResearch.com: What is the background for this study? What are the main findings? Response: This study updates guidance on all aspects of the multi-disciplinary care of patients with Duchenne muscular dystrophy (DMD). The project was funded by the CDC’s National Center on Birth Defects and Developmental Disabilities and the results were recently published as three articles in The Lancet Neurology. The project was guided by a 25-member steering committee. Eleven expert committees worked over a period of three years to develop guidelines based on the RAND/UCLA appropriateness method, in which assessments and interventions were evaluated for appropriateness and necessity. The recommendations update those originally published in 2010. Duchenne muscular dystrophy is transmitted by X-linked recessive inheritance and thus affects primarily boys and men. Patients affected by DMD do not produce functional dystrophin protein, resulting in progressive weakness of skeletal, respiratory, and heart muscles, causing a shortened life span. Teens and young men may require surgery for curvature of the spine, a ventilator device to assist breathing, and a feeding tube to help ensure adequate nutrition. The approach of the various subspecialties involved in DMD management has evolved, with more anticipatory assessment and therapy, identifying and addressing predictable medical complications as early as possible for optimal patient outcomes. With this kind of multi-disciplinary care, people with DMD now live into their 30s and beyond. Along with the emergence of new genetic and molecular therapies, the recognition that people with DMD are living longer was one of the main motivations behind the need for these updated care considerations. Patients with DMD, their families and their advocacy organizations are driving a new emphasis on optimizing quality of life, not just prolongation of survival. Thus, there was a need to address issues related to transitions of care from childhood to adulthood, coordination of care across subspecialties, and other topics related to education, vocation, independence, personal relationships, emotional health, and intimacy. The updated care considerations thus include eleven topic areas, eight of which were part of the 2010 guidelines. These are: (1) diagnosis, (2) neuromuscular management, (3) rehabilitation management, (4) gastrointestinal and nutritional management, (5) respiratory management, (6) cardiac management, (7) orthopedic and surgical management, and (8) psychosocial management. Three topics are new: (9) primary care and emergency management, (10) endocrine management (including growth, puberty, adrenal insufficiency, and bone health), and (11) transitions of care across the lifespan. (more…)