Author Interviews, Dermatology, Stem Cells, Surgical Research / 01.06.2020

MedicalResearch.com Interview with: Charles-de-SáM.D., Ph.D. Rio de Janeiro, Brazil MedicalResearch.com: What is the background for this study? Response: Our clinical trial was based on our clinical skin observations in areas submitted to a lipotransfer previously, an ordinary practice in plastic surgery. These clinical observations lead us to investigate what will be the key element played in these findings. Our scientific support investigation addressed the Dardick1and Zuk, P2 studies, that demonstrated fibroblastic-like cells in adipose tissue with regenerative ability. Our clinical trial proposal is to investigate the adipose-derived stem cell (ADSC) role in the photoaged skin. The direct endpoint of the study was to assess the histological benefits provided by the subdermal ADSC injection. Mesenchymal stem cells were obtained from lipoaspirates, expanded in vitro, and introduced into the facial skin of 20 patients submitted after three to four months to a face-lifting surgery. In the retrieved skin, immunocytochemical and ultrastructural analysis quantified elastic matrix components, cathepsin-K, metalloprotease MMP-12, and the macrophage M2 markers: CD68, CD206 and heme-oxygenase-1.An overview of the trial steps is described in the infographic.  (more…)
Author Interviews, JAMA, OBGYNE, Pediatrics / 01.06.2020

MedicalResearch.com Interview with: Katri RäikkönenKatri Räikkönen Professor, Department of Psychology and Logopedics University of Helsinski MedicalResearch.com: What is the background for this study? Response: Maternal antenatal corticosteroid treatment is standard care when there is a risk for preterm delivery. The treatment improves the prognosis of babies born preterm. In high-income countries, antenatal corticosteroid treatment has been in routine use for over 30 years. Recommendations and clinical care guidelines for maternal antenatal corticosteroid treatment differ between continents and countries. In Finland the treatment is currently recommended when the risk for preterm delivery is at 34 gestational weeks or less. In select cases, the treatment is recommended even later in gestation. Corticosteroids accelerate fetal maturation, especially in the lungs, and increase the child’s resilience to the stress that results from being born preterm. However, antenatal corticosteroids not only cross the placenta, but also cross the the blood-brain barrier and may harm fetal brain development. We are not aware of previous population-based studies that would have tested if maternal antenatal corticosteroid treatment would be associated with mental and behavioral disorders in children and we are not either aware of studies that would have tested if any associations would be explained by shared genetic or familial factors. (more…)
Author Interviews, Cost of Health Care, Diabetes / 01.06.2020

MedicalResearch.com Interview with: Amir Meiri, MD MPH Atrius Health/Department of Population Medicine (DPM) | Delivery System Science Fellow HMS and HPHCI, DPM | General Internal Medicine Fellow Atrius Health Kenmore | Urgent Care Physician VA Boston Healthcare | Attending in Internal Medicine and Emergency Medicine  MedicalResearch.com: What is the background for this study? Response: There has been significant media reporting about rising insulin prices and the health impacts of those exorbitant prices. However, it was not clear how these insulin prices may impact out-of-pocket costs among commercially insured patients; though it is clear that those without insurance are affected per previous media reports. Our study examines the difference between insulin manufacturer-set prices and what patients actually pay, the out-of-pocket cost, in the context of the type of insurance patients have. (more…)
Author Interviews, Dermatology, Genetic Research / 01.06.2020

MedicalResearch.com Interview with: Sarah E. Millar, Ph.D. Director, Black Family Stem Cell Institute Professor, Departments of Cell, Developmental and Regenerative Biology and Dermatology Icahn School of Medicine at Mount Sinai New York, NY MedicalResearch.com: What is the background for this study? Response: One of the major roles of the skin is to serve as a protective barrier, both preventing external insults, such as toxins and pathogens, from entering the body, and helping to retain moisture. The mechanisms required for appropriate skin barrier formation remain incompletely understood. Elucidating these processes is important for understanding and developing improved treatments for dermatological diseases in which the skin barrier is dysfunctional, such as eczema and psoriasis. Understanding epigenetic regulators, proteins that modify the structure of genetic material, is an area of scientific interest, as many new drugs target these proteins. Importantly, multiple epigenetic regulators have been shown to be important in skin development. My lab has focused on one group of epigenetic regulators, histone deacetylases (HDACs), because HDAC inhibitors show promise for treating several different cancers and other disorders in which cell proliferation is poorly controlled. We previously showed that HDACs 1 and 2 are required for normal skin development. In the current study, we investigated whether the related protein HDAC3 is also important in establishing the skin barrier.  (more…)
ASCO, Author Interviews, Cancer Research / 30.05.2020

MedicalResearch.com Interview with: Cardinale Smith, MD, PhD Associate Professor Medicine, Hematology and Medical Oncology and Geriatrics and Palliative Medicine Icahn School of Medicine at Mount Sinai New York  MedicalResearch.com: What is the background for this study? Response: Cancer patients are often hospitalized with complications from cancer and cancer treatment. Physical decline is common among hospitalized cancer patients and contributes to poorer outcomes including increased length of stay, excess days, readmissions and patient experiences.  Therefore, increased activity and mobilization during hospitalization are essential to prevent functional decline. Whereas previous research has focused on risk factors that limit mobility and interventions for enhancing mobility in well-functioning, community dwelling older adults, there have been limited interventions on the mobility of hospitalized cancer patients. (more…)
ASCO, Author Interviews, Biomarkers, Breast Cancer / 30.05.2020

MedicalResearch.com Interview with: Francois-Clement Bidard, MD PhD Head of Breast Cancer Group, Institut Curie Professor of Med. Oncology, UVSQ/Paris MedicalResearch.com: What is the background for this study? Response: A timely question is how to optimize the endocrine therapy of ER+ HER2- metastatic breast cancers? Aromatase inhibitors (AI) are currently the standard of care in first line, in combination with CDK4/6 inhibitors. Mutations in the estrogen receptor gene (ESR1) can be detected in up to 40% of AI-resistant metastatic breast cancers, but no data was available in the current first line setting (AI combined to CDK4/6 inhibitor). This exploratory study of the first line PADA-1 study reports on the detection rate of ESR1 mutations in cell-free DNA from an “AI-sensitive” population (with no metastatic relapse during adjuvant AI therapy), before the start of therapy (at inclusion). As expected, we found a low prevalence of 3.2% in the general population (N=1,017 patients included). The prevalence of ESR1 mutations among subgroups appeared primarily driven by the type of adjuvant endocrine therapy: patients with prior exposure to adjuvant therapy with AI displayed the highest prevalence of ESR1 mutations (7.1%), followed by patients with no prior adjuvant endocrine therapy (mostly de novo stage IV; ESR1 mutation prevalence: 2.4%). Patients who received adjuvant endocrine therapy with no AI (e.g. tamoxifen only) had the lowest ESR1 mutation prevalence (1.2%). (more…)
ASCO, Author Interviews, Cancer Research, Electronic Records / 30.05.2020

MedicalResearch.com Interview with: Debra A. Patt, MD, PhD, MBA, FASCO Editor-in-chief of the Journal of Clinical Oncology - Clinical Cancer Informatics Medical oncologist at Texas Oncology, and US Oncology Research Breast Cancer Committee member MedicalResearch.com: What is the background for this study? Response: Cancer care is increasing in complexity with differentiation of cancer subtypes, new treatments, and treatment sequences and combinations.  Complying with evidence based therapy has become an increasing challenge.  We see that compliance with guideline based care across the country is highly variable. Our study evaluated an electronic health record based Clinical Decision Support System to facilitate compliance with evidence based guidelines--or pathways--to deliver care to adult patients with cancer. (more…)
Author Interviews, CDC, Dental Research / 30.05.2020

MedicalResearch.com Interview with: Marcia L. Parker, DMD Division of Oral Health National Center for Chronic Disease Prevention and Health Promotion CDC MedicalResearch.com: What is the background for this study? Response: This report reviewed three measures of tooth loss among adults over 50 years old with selected chronic conditions. The report analyzed data from the 2011–2016 cycles of the National Health and Nutrition Examination Survey (NHANES) to compare the rates of total tooth loss, severe tooth loss (less than 8 teeth), and lacking functional dentition (less than 20 teeth) among people with and without selected chronic conditions. (more…)
Author Interviews, Blood Clots, Clots - Coagulation, COVID -19 Coronavirus, JAMA / 29.05.2020

MedicalResearch.com Interview with: Dr Tristan Morichau-Beauchant, MD. Intensive Care Unit Centre Cardiologique du Nord Saint-Denis, France MedicalResearch.com: What is the background for this study? Response: During the spread of the COVID-19 epidemic in France, early reports on severe patients stated a highly increased inflammatory response associated with procoagulant changes in coagulation pathways and high D-Dimer levels. Preliminary reports from the intensive care community signaled frequent events of deep vein thrombosis (DVT) among this population. We decided to perform prospectively a venous ultrasonogram of the inferior limbs for all patients with severe COVID-19 pneumonia at admission in our ICU.  All patients had acute respiratory distress syndrome according to the Berlin definition an required mechanical ventilation. Considering the high prevalence of venous thrombosis at admission we repeated a venous ultrasonography after 48 hours if the first exam was normal. All patients received standard anticoagulant prophylaxis since hospital admission. (more…)
ASCO, Author Interviews, Cancer Research, Leukemia, UC Davis / 28.05.2020

MedicalResearch.com Interview with: Brian A. Jonas, M.D., Ph.D. UC Davis Health System MedicalResearch.com: What is the background for this study? At this year’s American Society of Clinical Oncology (ASCO) and European Hematology Association (EHA) virtual meetings, we presented data on the rapidity and likelihood of response to venetoclax treatments, and its associated characteristics, in older patients with newly diagnosed acute myeloid leukemia (AML). We evaluated data from two clinical trials of venetoclax in combination with azacitidine, or decitabine (M14-358), or low-dose cytarabine (LDAC) (M14-387) in this patient population. (more…)
Author Interviews, COVID -19 Coronavirus, JAMA / 28.05.2020

MedicalResearch.com Interview with: Soumya Sen PhD McKnight Presidential Fellow Mary & Jim Lawrence Fellow of Carlson School Director of Research, MIS Research Center Associate Professor, Information & Decision Sciences Carlson School of Management University of Minnesota, Minneapolis, MN MedicalResearch.com: What is the background for this study? Response: As the Covid-19 pandemic unfolded across the United States, one of the greatest barriers to understanding the extent of the problem was the lack of reliable and consistent data. Some of the metrics being reported, such as case count and death, are insufficient for hospital capacity planning. Case count is a conservative estimate of the actual number of infected individuals in the absence of community-wide serologic testing, while death count is a lagging metric and insufficient for proactive hospital capacity planning. A more valuable metric for assessing the effects of public health interventions on the health care infrastructure is hospitalizations. Therefore, the Medical Industry Leadership Institute (MILI) and the Management Information Systems Research Center (MISRC) at the Carlson School of Management launched the COVID-19 hospitalization tracking project in March to consistently track and report daily hospitalizations from all reporting states. Tracking daily hospitalization data is a major step forward in quantifying the current impact on local hospital systems, modeling and  forecasting future utilization needs, and tracking the rate of change in the disease severity. It is also useful for understanding the role of health policy interventions in slowing or reducing the impact of the pandemic. (more…)
Author Interviews, Cancer Research, JAMA, Yale / 28.05.2020

MedicalResearch.com Interview with: Daniel J. Boffa, MD Associate Professor of Thoracic Surgery Yale School of Medicine MedicalResearch.com: What is the background for this study? Response: The study examined networks that formed around hospitals that had been previously ranked in the top-50 by US News and World Report.  These top-ranked hospitals have shared their brand with hospitals in their network, which leads some people to believe that the care is the same at top-ranked hospitals and their affiliate hospitals.  We wanted to determine if outcomes after complex surgical procedures were truly the same at affiliate hospitals and top-ranked hospitals.  (more…)
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…)