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, Biomarkers, Gastrointestinal Disease / 28.03.2020

MedicalResearch.com Interview with: Jean-Frederic Colombel MD The Henry D Janowitz Division of Gastroenterology Icahn School of Medicine at Mount Sina New York, NY 10029, USA MedicalResearch.com: What is the background for this study? Response: The goals of therapy in Crohn’s disease have shifted from mere control of symptoms also called clinical remission towards combination of clinical and endoscopic remission also called deep remission which is now considered as the new therapeutic “target”. However it has yet to be proven that targeting deep remission instead of clinical remission is able to stop the progression of Crohn’s disease towards bowel damage, complications and hospitalizations. This study is a post-hoc analysis of the CALM trial that was published in The Lancet in 2018 where newly diagnosed patients were randomized to escalate therapy based on symptoms only (control arm) or based on a combination of symptoms and two biomarkers namely C-reactive protein in blood and calprotectin in stools (tight control arm). (more…)
Author Interviews, JAMA, Ophthalmology, Rheumatology / 15.12.2019

MedicalResearch.com Interview with: Robert Ritch, MD, FACS, FARVO Shelley and Steven Einhorn Distinguished Chair Professor of Ophthalmology, Surgeon Director Emeritus Chief, Glaucoma Services Emeritus The New York Eye and Ear Infirmary of Mount Sinai New York, NY 10003 Founder, Medical Director and Chairman, Scientific Advisory Board The Glaucoma Foundation  MedicalResearch.com: What is the background for this study? Response: Nailfold capillaroscopy (NFC), long used in rheumatology is a new approach to investigation of glaucoma. Posterior to the nailbed and just anterior to the proximal nailfold is the cuticle, which has no structural elements visible to the naked eye. NFC is a non-invasive imaging modality that provides a highly magnified view of the capillaries at the nailfold of digits. It has also been used in ophthalmology to show morphological changes at the nailfold capillaries of POAG and XFG/XFS patients, helping to confirm the systemic nature of these diseases. With nailfold capillaroscopy, an extensive array of capillaries can be seen greatly enlarged on a monitor screen. Capillary loops can be imaged, stored, recorded with videoscopy, and blood flow actively imaged and measured.. The first series of papers on glaucoma were written by Prof Josef Flammer’s group at the turn of the 21st century, looking at vasospasm, blood flow in normal-tension and high-tension glaucoma, and relating ocular blood flow alterations to systemic vascular regulation and relating laser Doppler flowmetry to NFC. Studies from Korea later associated nailbed hemorrhages and loss of nailbed capillaries to the presence of optic disc hemorrhages and investigated correlation of of heart rate variability with visual field defects and nailfold capillaroscopy. Studies by our group began with the publication in 2015 of a paper by Pasquale et al (Nailfold Capillary Abnormalities in Primary Open-Angle Glaucoma: A Multisite Study. IOVS;56:7021) using NFC video microscopy, associating dilated capillaries, avascular zones, and hemorrhages with primary open-angle glaucoma. Successive manuscripts and presentations at conferences have indicated differences between capillary loop patterns in high-tension and normal-tension POAG and exfoliation syndrome/exfoliation glaucoma. Our goal in this paper was to compare nailfold peripheral blood flow in XFG, which had not previously been compared to control subjects using NFC. We explored the peripheral blood flow at the nailfold of patients with high-tension glaucoma, normal-tension glaucoma, exfoliation glaucoma (XFG) and compared it to control subjects further evaluate the possible differences between these glaucoma entities. We examined the morphology and extent of nailfold capillary loops, vascular tortuosity, blood flow, and nailfold hemorrhages. (more…)
Author Interviews, Biomarkers, Hematology, Transplantation / 09.12.2019

MedicalResearch.com Interview with: Hrishikesh Srinagesh MD The Tisch Cancer Institute at Mount Sinai MedicalResearch.com: What is the background for this study? Response: Graft-versus-host disease (GVHD) is the leading cause of non-relapse mortality (NRM) after allogeneic hematopoietic cell transplantation (HCT). Acute GVHD occurs in approximately 50% of HCT patients and targets the skin, liver, and gastrointestinal tract primarily. The change in clinical symptoms (e.g. reduction in volume of diarrhea) is used as the primary endpoint in most trials of acute GVHD treatment, but more accurate metrics are needed to predict long-term survival. Over the past decade, the Mount Sinai Acute GVHD International Consortium (MAGIC) has studied two biomarkers important in GVHD pathogenesis: suppressor of tumorigenesis 2 (ST2) and regenerating islet-derived 3 alpha (REG3). These proteins are shed into the bloodstream when the gastrointestinal tract is damaged during GVHD, the most lethal form of acute GVHD. The concentrations of ST2 and REG3 can be used generate an individual’s estimated probability of 6 month NRM known as the MAGIC Algorithm Probability (MAP). Our study evaluated whether the MAP measured at the start of GVHD treatment and four weeks later could predict long-term survival and we compared the MAP to clinical response after four weeks, the gold standard of response.  (more…)
Author Interviews, Ophthalmology / 14.10.2019

MedicalResearch.com Interview with: Sumayya Ahmad, MD Assistant Professor of Ophthalmology Icahn School of Medicine at Mount Sinai MedicalResearch.com: What is the background for this study? Response: The cornea is usually curved like a basketball or a globe. Roughly all of the edges are about equal distant from the center. With this shape, light enters the eye normally and the image is not distorted.  However, not all eyes are shaped that way. About 30% of eyes have  astigmatism, in which the cornea is shaped like a football, or elongated in one axis. If the longest diameter is up and down, we call that with the rule astigmatism, and if it is to the side, we call that against-the rule astigmatism. A lot of studies have been devoted to astigmatism over the years, but nobody has looked at it from a population perspective in the United States and tried to figure out the relationships it may have. Most studies are from one center or other country's databases, but not ours. The National Health and Nutrition Examination Survey, or NHANES, is a survey composed in the United States each year that looks at a representative sample of people from across the country. It's a great way to study the relationship between the environment and people. We tried to look at demographic factors (like age, gender, race) and ocular factors related to against and with the rule astigmatism. (more…)
Author Interviews, Heart Disease, JAMA, Stem Cells / 26.03.2019

MedicalResearch.com Interview with: Annetine C. Gelijns, PhD Professor and System Chair Population Health Science and Policy Icahn School of Medicine at Mount Sinai Alan J Moskowitz, MD Professor of Population Health Science and Policy Icahn School of Medicine at Mount Sinai MedicalResearch.com: What is the background for this study? Where do these mesenchymal cells come from?  Response: Implantable LVADs significantly improve the survival and quality of life of advanced heart failure patients. However, these devices are associated with substantial adverse events, including infection and thromboembolic events. Moreover, whereas these devices improve myocardial function, few patients recover sufficient function to be explanted from their LVAD. These observations have focused attention on stem cells as a possible adjunctive therapy to further augment cardiac recovery. Mesenchymal precursor cells (MPCs), which are obtained from healthy donors and culture-expanded, have been shown in animal and early human studies to improve cardiac function. Using temporary weaning as a signal of cardiac recovery, we conducted an exploratory trial in the Cardiothoracic Surgical Trials Network (CTSN), which found that MPCs increased the probability of temporary weaning from full LVAD support compared to sham-control patients. Therefore, this signal of efficacy led the CTSN to design our current follow-up trial evaluating the efficacy and safety of a higher dose of MPCs in LVAD patients. (more…)
Author Interviews, Endocrinology, Gender Differences, Hormone Therapy / 26.03.2019

MedicalResearch.com Interview with: Joshua Safer, MD, Executive Director Center for Transgender Medicine and Surgery Mount Sinai Health System Senior Faculty, Medicine, Endocrinology, Diabetes and Bone Disease Icahn School of Medicine at Mount Sinai MedicalResearch.com: What is the background for this study? What are the main findings? Response: The standard trans feminizing hormone regimen includes estrogen both to suppress testosterone and so that the individual has sufficient circulating sex hormone in the body for good bone health. After orchiectomy, there is no need to suppress testosterone because the levels are very low and it is common to cut the estrogen dose in half.  Cis women with premature ovarian failure often take about 2 mg of estradiol daily so that dose has seemed reasonable for trans women without testes.  However, when my co-author Sira Korpaisarn and I checked estradiol levels and gonadotropins (pituitary hormones, LH and FSH) as a guide to dosing, we found that based on that testing, trans women may require higher doses of estrogens than the 2 mg that we expected. (more…)
Author Interviews, Endocrinology, Genetic Research / 24.03.2019

MedicalResearch.com Interview with: Emily J. Gallagher, MD Assistant Professor of Medicine Endocrinology, Diabetes and Bone Disease Icahn School of Medicine at Mount Sinai  MedicalResearch.com: What is the background for this study? Response: Multiple Endocrine Neoplasia Syndrome Type 2 (MEN2) is an inherited endocrine disorder characterized by the development of pheochromocytoma, medullary thyroid carcinoma (MTC) and parathyroid tumors. It occurs due to activating missense variants in the RET gene. The estimated prevalence of MEN2 is 1 per 30,000 in the general population. Through a collaboration between The Center for Genomic Health, the Charles Bronfman Institute for Personalized Medicine, and the Division of Endocrinology at Mount Sinai, our aim was to investigate the prevalence and clinical manifestations of pathogenic RET variants in the multi-ethnic BioMe Biobank. The BioMe Biobank is an electronic health record-linked biobank with exome sequencing data available for more than 30,000 patients recruited across The Mount Sinai Health System. (more…)
Author Interviews, Erectile Dysfunction, Heart Disease / 20.03.2019

MedicalResearch.com Interview with: Jagat Narula, MD, PhD Philip J. and Harriet L. Goodhart Professor of Medicine (Cardiology) Associate Dean for Global Health Director of the Cardiovascular Imaging Program Mount Sinai Medical Center MedicalResearch.com: What is the background for this study? What are the main findings? Response: Atherosclerosis has been linked to causing erectile dysfunction (ED) in the majority of patients with this cardiovascular condition, but researchers have not had the means of demonstrating atherosclerosis in penile arteries until now.  This unique study uses advanced imaging to detect how strong the association actually is.  For the first time, researchers have used advanced imaging of penile arteries to show a link between atherosclerosis and erectile dysfunction (ED). (more…)
Author Interviews, Heart Disease, JACC, Technology / 20.03.2019

MedicalResearch.com Interview with: Annapoorna Kini, MD Zena and Michael A Wiener Professor of Medicine Director of the Cardiac Catheterization Laboratory Mount Sinai Heart at Mount Sinai Hospital MedicalResearch.com: What is the background for this study?  
  • Expanding indication and use of Transcatheter aortic valve replacement (TAVR) poses a unique problem of coronary access after valve implantation.
  • Troubleshooting tools and techniques have been published but are not available at the fingertips of the user at all the times.
  • We tried to address this unique problem with an innovative educational mobile application (app) called "TAVRcathAID".
(more…)
Accidents & Violence, Author Interviews, Heart Disease, Inflammation, JACC, Lipids / 18.03.2019

MedicalResearch.com Interview with: Dr. George Dangas MD PhD Professor of Medicine, Cardiology Mount Sinai Health System MedicalResearch.com: What is the background for this study? Response: Widespread use of statins targeted to decrease levels of low density lipoprotein cholesterol (LDL-C) below 70mg/dL are recommended by guidelines. However, residual cholesterol risk may only be one part of the residual risk equation. Indeed, Biological inflammation has long been known as a pathophysiological mechanism of atherosclerosis and the recent CANTOS trial opened new therapeutic perspective by demonstrating that inflammation modulation via selective interleukin-1β inhibition could result in improved diagnosis in patients with coronary artery disease. However, the prevalence and impact of a residual inflammatory biological syndrome in patients with controlled cholesterol risk is unclear. (more…)
Author Interviews, Opiods, Orthopedics / 18.03.2019

MedicalResearch.com Interview with: Paul Cagle, Jr. MD Assistant Professor of Orthopedic Surgery Icahn School of Medicine at Mount Sinai MedicalResearch.com: What is the background for this study? What are the main findings ie What are some of the significant comorbidities?  Response: In this study our goal was to better understand what medical issues (medical comorbidities) can cause trouble or issue for patients with a proximal humerus fracture (shoulder fracture).  To tackle this issue we used a large national sample of patients and sorted our the different medical issues the patients had. We found that patients with increased medical issues had longer hospital stays and higher use of opioid medications (pain medications). (more…)
Author Interviews / 18.03.2019

MedicalResearch.com Interview with: Darwin Chen, MD Assistant Professor of Orthopedic Surgery Icahn School of Medicine at Mount Sinai MedicalResearch.com: What is the background for this study? What are the main findings? Response: Periprosthetic joint infection unfortunately remains a leading cause of total knee arthroplasty failure. One method of mitigating the risk of PJI is to use antibiotic loaded bone cement in a prophylactic fashion. While the use of antibiotic cement makes inherent sense, the decision is not as simple as it seems. There are potential side effects such as renal damage, antibiotic hypersensitivity, and antibiotic resistance. Antibiotics decrease the mechanical strength of cement fixation, which may impact component loosening. Additionally, antibiotic cement is significantly more expensive than standard cement, driving up cost. Currently there is no consensus on if antibiotic cement truly reduces infection risk and there are many conflicting studies. The purpose of our study is the use a large national database to evaluate real world utilization patterns of antibiotic cement, and assess outcomes, complications, and cost associated with antibiotic cement usage. Our hypothesis was that antibiotic cement is associated with a decreased risk of infection and no increased risk of systemic complications.  (more…)
Author Interviews, Opiods, Orthopedics, Surgical Research / 18.03.2019

MedicalResearch.com Interview with: Dr. Alexis Colvin, MD Associate Professor of Orthopedic Surgery Icahn School of Medicine at Mount Sinai  MedicalResearch.com: What is the background for this study? Response: 40% of all opioid overdose deaths involve a prescription opioid and orthopaedic surgeons are the 3rd highest prescribers of opioids.  Set guidelines for post surgery opioid prescriptions have not been established.  Arthroscopic knee meniscectomy is one of the most common orthopaedic procedures.  The purpose of this study was to determine how many opioids were being prescribed  among a group of six sports fellowship trained orthopaedic surgeons versus how many patients were actually using. (more…)
Author Interviews, Dermatology, Surgical Research / 05.03.2019

MedicalResearch.com Interview with: Hooman Khorasani, M.D. Cosmetic Surgeon & Mohs Skin Cancer Surgeon Icahn School of Medicine at Mt. Sinai MedicalResearch.com: What is the background for this study? Response: Lipomas are tumors composed of mature fat cells located just beneath the skin surface. They are the most common soft tissue tumor and are estimated to occur in 1% of the population. These benign tumors are more common in overweight individuals, diabetics, patients with elevated serum cholesterol, and those suffering from familial multiple lipomatosis. Most of these tumors are treated for cosmetic reasons; however, large lipomas can also cause significant functional impairment. Traditional treatment includes surgical removal and / or liposuction. Deoxycholic acid is a member of the bile acid family that assists in the breakdown of fat. We investigated the use of deoxycholic acid injections to reduce the size of large lipomas prior to surgical removal. (more…)
Author Interviews, Autism, Cognitive Issues, JAMA / 04.01.2019

MedicalResearch.com Interview with: Tjasa Velikonja, PhD Department of Psychiatry The Seaver Autism Center for Research and Treatment Icahn School of Medicine at Mount Sinai New York, New York MedicalResearch.com: What is the background for this study? What are the main findings? Response: Autism is a lifelong condition, and challenges associated with autism persist from childhood into adulthood. Despite this, research and treatment have been largely dedicated to children. Because of that, we had very little understanding of what areas – what cognitive domains - are most severely impacted in adults with autism. Importantly, the lack of such information also limits treatment development in this area. What is known already is that adults with autism display deficits in social cognition (which refers to the role that cognitive processes play in our social interactions). Although our meta-analysis supported these theories, it also highlighted several other challenges in cognitive processing, such as deficits in processing speed and verbal learning and memory. And these impairments were observed in adults with autism without an overall intellectual disability. (more…)
Author Interviews, Health Care Systems, Ophthalmology / 07.11.2018

MedicalResearch.com Interview with: Nathan Radcliffe, MD Senior Faculty, Ophthalmology Glaucoma and Cataract surgeon Mount Sinai Health System MedicalResearch.com: What is the background for this study? Response: Glaucoma is a leading cause of blindness and the mainstay of therapy is to lower the intraocular pressure (IOP) with topical eye drops. Up to 40% of patients may require more than one eye drop to control the disease, and yet taking more than one eye drop bottle can result in higher costs, more eye irritation, worse therapeutic compliance, and possibly worse outcomes, be sure to consult your eye surgeon before increasing any eye treatment to ensure it won't do any further damage to the eye. Compounded therapies (not FDA approved, but made at the physician’s request by a compounding pharmacy) can be created to contain multiple glaucoma therapies in one bottle. We sought to determine if a compounded solution containing three or four drops in one bottle could control glaucoma as well as three or four separate bottles (standard of care) in patients requiring three or four eye drop bottles to control glaucoma. We performed a multi-center, randomized, observer-masked, parallel-group study comparing a compounded therapy containing latanoprost 0.05%, dorzolamide hydrochloride 2%, timolol maleate 0.5%, brimonidine tartrate 0.2% with 0.01% BAK to standard three or four bottle regaimins. We measured IOP and corneal staining (a sign of preservative toxicity), as well as other safety measures at week one, month one, two and three. (more…)
Author Interviews, Autism, JAMA, OBGYNE / 01.11.2018

MedicalResearch.com Interview with: Magdalena Janecka PhD Department of Psychiatry Icahn School of Medicine at Mount Sinai MedicalResearch.com: What is the background for this study? Response: Our paper explored the association between maternal use of medication during pregnancy and the rates of autism in a large cohort from Israel. This followed on from a number of earlier studies reporting that the use of certain medications - for example antidepressants - during pregnancy is associated with higher rates of autism in children. However, rather than test the effects of any particular drug, or a set of drugs aggregated based on maternal condition, our large dataset allowed us to group all medications prescribed to pregnant women based on their drug target, and in the subsequent analyses focus on over 50 groups that included drugs with neurotransmitter-relevant targets - for example agonists and antagonists of their receptors. (more…)
Author Interviews, Dermatology, Environmental Risks / 15.10.2018

MedicalResearch.com Interview with: Dr. Janet Prystowsky, MD Dr. Prystowsky is a leading board-certified dermatologist in New York City.   In addition to her private practice, Dr. Prystowsky is a senior attending physician at Mount Sinai Roosevelt/St. Luke’s Medical Center. http://www.janetprystowskymd.com/ MedicalResearch.com: When does sun damage to the skin start?  Is there such a thing as a 'safe tan'?  Who is most susceptible to photoaging?  What parts of the body are more likely to show signs of sun damage?  Response: Sun damage will increase a person’s risk of premature aging and skin cancer.  Although tanning does function to help protect your skin from excessive ultraviolet radiation tanning is still a form of sun damage.  Also, people with very fair skin may not tan at all; only burn.  They are the most susceptible to sun damage. Certain medical conditions (e.g., Lupus), medications, cosmetics, and food can make your more reactive (photosensitive) to sunlight. "Sunburn" by Kelly Sue DeConnick is licensed under CC BY-SA 2.0Sunburns are caused by UV damage from sun rays, almost entirely due to UVB rays. UVA rays are weaker for burning but can contribute to blistering sunburns as well. For example, If you get lime peel rubbed on your skin while you are in the sun, you could get a bad burn.  UVA can also cause significant skin damage that can result in premature wrinkling, brown spots, and skin cancer. That's why you'll see dermatologists pushing for broad-spectrum sunscreens as opposed to sunscreens that just protect against UVB rays.  (more…)