Author Interviews, Imperial College, Stroke, Technology / 06.10.2016

MedicalResearch.com Interview with: Dr Paul Bentley MA MRCP PhD Clinical Senior Lecturer in Clinical Neuroscience Honorary Consultant Neurologist Neurology Dept Imperial College NHS Healthcare Trust Charing Cross Hospital London MedicalResearch.com: What is the background for this study? What are the main findings? Response: gripAble was designed to help people with arm disability practise physiotherapy when a physiotherapist is not available, or in between physiotherapy sessions. We know that the amount of physiotherapy provision in the UK, after stroke or arm injury, is typically below that which is recommended by professional bodies. Furthermore, increasing research suggests that higher-intensity training can boost functional outcomes. The innovation was designed to help people with a range of disabilities including severe paralysis engage with computer games with their weak arm. At the same time its designed to be portable for use at home or in bed, and low-cost. gripAble also enables remote measurement and monitoring of arm function, by setting users a series of calibrated tasks played out on the tablet screen. This way doctors and physiotherapists can assess the needs of a patient, and gain an idea of how well a patient is responding to home physiotherapy. (more…)
Author Interviews, Dermatology, Technology, UCLA / 05.10.2016

MedicalResearch.com Interview with: Dr. Andrea M Armani PhD Fluor Early Career Chair and Associate Professor Mork Family Department of Chemical Engineering and Materials Science University of Southern California, Los Angeles, California MedicalResearch.com: What is the background for this study? Response: The “Internet of Things” (IoT) has seen an explosion in online sensor technologies, including UV sensors and monitors; for example, those from Apple and Samsung. However, they require connectivity and power, and they are integrated into delicate electronic systems that are not compatible with outdoor, athletic activities such as swimming, which is precisely when you should monitor UV exposure. Therefore, somewhat ironically, the technologies developed to meet the demands of the IoT are not ideal for cumulative UV exposure detection. Our goal was to develop a single use patch – like a smart “band-aid” – for the beach to alert users when they had been in the sun for an hour and needed to re-apply sunscreen or get out of the sun altogether. This application required a rugged system that was waterproof, bendable, and compatible with sunscreen. Additionally, the sensor readout needed to be easy to interpret. These requirements influenced our design and material selection. (more…)
Author Interviews, JAMA, Karolinski Institute, Mental Health Research / 05.10.2016

MedicalResearch.com Interview with: Gustaf Brander Department of Clinical Neuroscience Karolinska Institutet MedicalResearch.com: What is the background for this study? Response: Obsessive-compulsive disorder (OCD) is believed to be caused by a complex interaction between genetic and environmental factors. Whereas genetic studies are well underway, the research on environmental factors has been lagging behind. As they explain a significant portion of the variance, are potentially malleable, and are essential for understanding how the genetic component works, this area of research is of great importance. (more…)
Author Interviews, Karolinski Institute, Stem Cells, Tobacco / 05.10.2016

MedicalResearch.com Interview with: Lukasz Antoniewicz MD, PhD candidate Karolinska Institutet Department of Clinical Sciences Danderyd University Hospital Stockholm, Sweden MedicalResearch.com: What is the background for this study? Response: Electronic cigarette sales increase exponentially on a global scale without knowledge about possible negative effects on human health. We performed an exposure study in young healthy volunteers and analyzed blood samples for endothelial progenitor cells and microvesicles. Increase in those markers may reflect vascular injury, inflammation and platelet activation. (more…)
Author Interviews, Health Care Systems, Lancet, Mayo Clinic / 03.10.2016

MedicalResearch.com Interview with: Colin P. West, MD, PhD, FACP Divisions of General Internal Medicine and Biomedical Statistics and Informatics Departments of Internal Medicine and Health Sciences Research Mayo Clinic MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Physician burnout has reached epidemic levels, as documented in national studies of both physicians in training and practicing physicians demonstrating burnout rates in excess of 50%. Consequences include negative effects on patient care, professionalism, physicians’ own care and safety, and the viability of health-care systems. We conducted a systematic review and meta-analysis to better understand the quality and outcomes of the literature on approaches to prevent and reduce burnout. We identified 2617 articles, of which 15 randomized trials including 716 physicians and 37 cohort studies including 2914 physicians met inclusion criteria. Across interventions, overall burnout rates decreased from 54% to 44%, emotional exhaustion score decreased from 23.82 points to 21.17 points, and depersonalization score decreased from 9.05 to 8.41. High emotional exhaustion rates decreased from 38% to 24% and high depersonalization rates decreased from 38% to 34%. (more…)
Addiction, Author Interviews, Columbia, Opiods / 03.10.2016

MedicalResearch.com Interview with: Silvia S. Martins, MD, PHD Associate Professor of Epidemiology Department of Epidemiology Mailman School Of Public Health Columbia University New York, NY 10032 MedicalResearch.com: What is the background for this study? Response: Given the high probability of nonmedical use among adolescents and young adults, the potential development of prescription opioid use disorder secondary to nonmedical use among youth represents an important and growing public health concern. Still, no study had investigated time trends, specifically if prescription opioid use disorder has increased in the past decade among adolescents, emerging adults and young adults who are nonmedical users of prescription opioids. (more…)
Author Interviews, Brain Cancer - Brain Tumors, Radiation Therapy, Yale / 30.09.2016

MedicalResearch.com Interview with: Nataniel Lester-Coll, MD Chief Resident in Radiation Oncology at Yale New Haven, Connecticut  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Recurrent Glioblastoma Multiforme (GBM) has limited treatment options and the prognosis is poor. Mibefradil diydrochloride was identified using a high-throughput compound screen for DNA double stranded break repair inhibitors. Mibefradil was found to radiosensitize GBM tumor cells in vitro and in vivo. Based on these findings, we sought to determine the maximum tolerated dose of mibefradil and radiation therapy in a Phase I recurrent GBM study. Eligible patients with recurrent  Glioblastoma Multiforme received Mibefradil over a 17 day period, with hypofractionated radiation (600 cGy x 5 fractions). There are 18 patients currently enrolled who have completed treatment. Thus far, there is no clear evidence of radionecrosis. A final dose level of 200 mg/day was reached as the maximum tolerated dose. The drug was very well tolerated at this dose. We saw intriguing evidence of enhanced local control in selected cases. Patients enrolled in a translational substudy who received Mibefradil prior to surgery were found to have adequate levels of Mibefradil in resected brain tumor tissue. (more…)
Author Interviews, Brigham & Women's - Harvard, Depression, JCEM, Menopause, Sleep Disorders / 28.09.2016

MedicalResearch.com Interview with: Hadine Joffe, MD, MSc Associate Professor of Psychiatry, Harvard Medical School Vice Chair for Psychiatry Research Director of Division of Women's Mental Health / Dept of Psychiatry / Brigham and Women’s Hospital Director of Psycho-Oncology Research / Dept of Psychosocial Oncology and Palliative Care /Dana Farber Cancer Institute www.brighamwharp.org MedicalResearch.com: What is the background for this study? Response: We conducted this study to advance our understanding about causes of mood disturbance in the menopause transition that are specifically related to menopause. We used an experimental model to dissect out the contributions of hot flashes and sleep disturbance from contribution of changing levels of estrogen because hot flashes, sleep problems, and estrogen fluctuations co-occur and are difficult to distinguish from one another. Understanding whether hot flashes and/or sleep disturbance are causally related to mood disturbance will help us identify who is at risk for mood changes during the menopause transition. This is incredibly important now that we are finding effective non-hormonal treatments for hot flashes and sleep disruption. (more…)
Author Interviews, C. difficile, Microbiome, Nature, Vanderbilt / 28.09.2016

MedicalResearch.com Interview with: Eric P Skaar, Ph.D., MPH Director, Division of Molecular Pathogenesis Ernest W. Goodpasture Professor of Pathology Vice Chair for Basic Research, Department of Pathology, Microbiology, and Immunology Vanderbilt University School of Medicine MedicalResearch.com: What is the background for this study? What are the main findings? Response: Nutrient metals are known to be a critical driver of the outcome of host-pathogen interactions, and C. difficile is the most common cause of hospital-acquired infections. C. difficile infection typically occurs following antibiotic-mediated disruption of the healthy microbiome. We were interested in learning how nutrient metals can shape the microbiome and impact the outcome of Clostridium difficile infection. We found that excess zinc alters the structure of the microbiome and increases the severity of C. difficile infection in mice. (more…)
Annals Internal Medicine, Author Interviews, Brigham & Women's - Harvard, Colon Cancer, Geriatrics / 27.09.2016

MedicalResearch.com Interview with: Xabier Garcia-De-Albeniz MD PhD Research Associate Department of Epidemiology Harvard T.H. Chan School of Public Health Mongan Institute for Health Policy Massachusetts General Hospital MedicalResearch.com: What is the background for this study? Response: Randomized controlled trials are considered the gold standard to inform health care delivery. Unfortunately, no randomized controlled trials of screening colonoscopy have been completed. Ongoing trials exclude persons aged 75 or older, and will not have mature results before 2025. However, healthy persons older than 75 may live long enough to benefit from colorectal cancer (CRC) screening. The Medicare program reimburses screening colonoscopy without an upper age limit since the year 2001. We used the extensive experience of Medicare beneficiaries to evaluate the effectiveness and safety of screening colonoscopy. (more…)
Addiction, Author Interviews, Memory, University Texas, Weight Research / 27.09.2016

MedicalResearch.com Interview with: Ursala. H. Winzer-Serhan Ph.D. Associate Professor Department of Neuroscience and Experimental Therapeutics Texas A&M Health Science Center MedicalResearch.com: What is the background for this study? What are the main findings? Response: Nicotine is a plant alkaloid that is naturally occurring in the tobacco plant. Smoking delivers nicotine to the brain where it acts as a stimulant. Tobacco and electronic cigarette smoking delivers many other chemicals to the body, which are harmful and can cause cancer. However, the drug nicotine by itself is relatively benign and poses few health risks for most people. Nicotine acts in the brain on nicotinic receptors, which are ion channels that are widely expressed in the brain. They play an important role in cognitive functions. Research with rodents and in humans has shown that nicotine can enhance learning and memory, and furthermore, can protect neurons during injuries and in the aging brain. With the increasingly older population, it becomes more and more important to delay cognitive decline in the elderly. Right now, there is no drug available that could delay aging of the brain. (more…)
Author Interviews, Baylor College of Medicine Houston, Brain Injury, Depression, JAMA / 26.09.2016

MedicalResearch.com Interview with: Ricardo E. Jorge  MD Professor of Psychiatry and Behavioral Sciences Director Houston Translational Research Center for TBI and Stress Disorders Senior Scientist  Beth K. and Stuart C. Yudofsky Division of Neuropsychiatry Michael E DeBakey VA Medical Center Baylor College of Medicine MedicalResearch.com: What is the background for this study? What are the main findings? Response: Depressive disorders affect between one-third and one-half of patients with traumatic brain injury. Once established, these disorders are difficult to treat and frequently follow a chronic and refractory course. Depression has a deleterious effect on TBI outcomes, particularly affecting the community reintegration of TBI patients. In this randomized clinical trial that included 94 adult patients with TBI, the hazards for developing depression for participants receiving placebo were about 4 times the hazards of participants receiving sertraline treatment. (more…)
Author Interviews, Exercise - Fitness, Karolinski Institute, PLoS / 26.09.2016

MedicalResearch.com Interview with: Maléne Lindholm, PhD Karolinska Institutet Dept. of Physiology & Pharmacology Stockholm Sweden MedicalResearch.com: What is the background for this study? Response: It is well known that exercise training provides marked health benefits and can prevent and treat a broad set of diseases. Therefore, a deeper understanding and characterization of the molecular processes behind training adaptation is essential for human health. This study aimed at exploring the effects of endurance training on the human skeletal muscle transcriptome (activity of all genes) and investigate the possible presence of a muscle memory of training. To do this, the healthy volunteers in this study first trained only one leg, 4 times per week for 3 months. After 9 months of detraining, the subjects then came back and trained both legs in the same way as during the first training period, thus one leg was then previously well-trained and one previously untrained. This meant that each individual was their own control, as both legs have the same genome, experience the same stress, diet etc. Only the training status differed. (more…)
Author Interviews, JAMA, NIH, OBGYNE / 26.09.2016

MedicalResearch.com Interview with: Stefanie N. Hinkle, Ph.D. Staff Scientist | Epidemiology Branch Division of Intramural Population Health Research Eunice Kennedy Shriver National Institute of Child Health and Human Development National Institutes of Health MedicalResearch.com: What is the background for this study? What are the main findings? Response: Thank you for the interest in our research. Nausea and vomiting are very common early in pregnancy and these symptoms can be difficult for women. Before we began this study there was very limited high-quality data on the implications of these difficult symptoms in pregnancy. Our study is unique because we asked women to report their symptoms continuously throughout their pregnancy before they may or may not have gone on to have a loss. We found that among women with 1 or 2 prior pregnancy losses, women who have nausea, and particularly nausea with vomiting, were less likely to have a pregnancy loss. (more…)
Author Interviews, Biomarkers, JAMA, NIH, Parkinson's / 26.09.2016

MedicalResearch.com Interview with: Yong Cheng, PhD, post-doc fellow Section on Cellular Neurobiology Eunice Kennedy Shriver National Institute of Child Health and Human Development National Institutes of Health Bethesda, Maryland MedicalResearch.com: What is the background for this study? Response: Parkinson’s disease is the second most neurodegenerative disease after Alzheimer’s disease. The symptoms of the disease are typically movement related. However, the nonmotor features in PD are increasingly recognized. Evidence suggests that inflammation may play a role in the development of AD, and a substantial number of studies have demonstrated altered levels of peripheral blood inflammatory cytokines in patients with  Parkinson’s disease, but findings have been inconsistent for individual cytokines and between studies. Therefore, we undertook a systematic review of the scientific literature, using a meta-analysis to quantitatively summarize clinical data on blood cytokine levels in patients with PD, compared with healthy controls. (more…)
Author Interviews, Education, Mental Health Research, University of Michigan / 25.09.2016

MedicalResearch.com Interview with: Katherine J. Gold, MD MSW MS Department of Family Medicine Institute for Healthcare Policy and Innovation; Depression Center University of Michigan With co-authors Louise B. Andrew MD JD; Edward B. Goldman JD; Thomas L. Schwenk MD MedicalResearch.com: What is the background for this study? What are the main findings? Response: It is common knowledge that physicians are often hesitant to seek care for mental health concerns. Knowing that female physicians have increased rates of both depression and suicide, we surveyed female physicians who were mothers and who participated in a closed FaceBook group about their mental health, treatment, and opinions about licensing. More than 2100 U.S. physicians responded, representing all specialties and states. Almost half of participants reported that at some point since medical school they had met criteria for a mental illness but didn’t seek treatment. Reasons included feeling like they could get through without help (68%), did not have the time (52%), felt a diagnosis would be embarrassing or shameful (45%), did not want to ever have to report to a medical board or hospital (44%), and were afraid colleagues would find out (39%). Overall, 2/3 identified a stigma-related reason for not seeking help. Almost half reported prior diagnosis or treatment, but just 6% of these women stated they had disclosed this to a state medical board on a licensing application, though states vary on what information they require be disclosed. (more…)
Author Interviews, Breast Cancer, Brigham & Women's - Harvard, Nature, Technology / 23.09.2016

MedicalResearch.com Interview with: Natalie Artzi PhD principal research scientist MIT's Institute for Medical Engineering and Science and Assistant professor of medicine Brigham and Women's Hospital With co-authors: Avital Gilam, João Conde, Daphna Weissglas-Volkov, Nuria Oliva, Eitan Friedman, Noam Shomron MedicalResearch.com: What is the background for this study? What are the main findings? Response: Metastases are the primary cause for mortality in breast cancer, the most common cancer in women regardless of ethnicity. Recent studies show that germline sequence variants, such as single-nucleotide polymorphisms (SNPs) in miRNA-binding sites, can disrupt the downregulation by miRNAs, with a profound effect on gene expression levels and consequentially on the phenotype, including increased risk for cancer. In the current study, we aimed to determine the potential effect of SNPs within miRNA-binding sites on metastatic breast cancer progression and their potential use as suppression targets to prevent metastasis. Our collaborators at Tel-Aviv Universityin a research led by Dr. Noam Shomron found that the SNP, rs1071738, located in a target site for miR-96 and miR-182 on the 3’-UTR of the PALLD gene, encodes the Palladin actin-associated protein, which is a documented player in breast cancer motility. In vitro experiments revealed a functional downregulation of Palladin levels by miR-96 and miR-182, which subsequently reduces migration and invasion abilities of breast cancer cells. My lab then showed in an in vivo experiment that the use of nanoparticles embedded in a hydrogel scaffold as a miRNA delivery vehicle enables an efficient and specific delivery of miR-96/miR-182 directly to breast tumours, which results in marked reduction of breast cancer metastasis. We then proceeded to study the effect of combination therapy in which we will use a chemotherapy drug to shrink the primary tumor and the miRNAs to prevent metastasis. The intercalation of a chemotherapy drug, cisplatin, to the miR-conjugated nanoparticles further improved the effect, leading to significant reduction in both primary tumour growth and metastasis. Our study highlights the therapeutic potential of miRNAs, and specifically miR-96 and miR-182, and support the importance of Palladin regulation in breast cancer metastasis. (more…)
Author Interviews, Epilepsy, JAMA, Mayo Clinic, Neurological Disorders / 23.09.2016

MedicalResearch.com Interview with: Brian Nils Lundstrom, MD, PhD Department of Neurology Mayo Clinic Rochester, Minnesota MedicalResearch.com: What is the background for this study? What are the main findings? Response: About as many people have drug-resistant focal epilepsy as have multiple sclerosis, and treatment options are limited. This study describes an alternative treatment option that has proven very helpful for the majority of participants. Electrical stimulation is delivered continuously via implanted electrodes to the region of brain where seizures start. The electrical stimulation decreases the seizure-related discharges from the brain, and for about 40% of patients their disabling seizures were completely stopped. (more…)
Author Interviews, Memory, Scripps / 23.09.2016

MedicalResearch.com Interview with: Ron L. Davis, PhD Professor and Chair Department of Neuroscience Florida campus of The Scripps Research Institute MedicalResearch.com: What is the background for this study? What are the main findings? Response: While calcium’s importance for our bones and teeth is well known, its role in neurons—in particular, its effects on processes such as learning and memory—has been less well defined. Our new study, published in the journal Cell Reports, offers new insights how calcium in mitochondria—the powerhouse of all cells—can impact the development of the brain and adult cognition. Specifically, we show in fruit flies, a widely used model system, that blocking a channel that brings calcium to the mitochondria called “mitochondrial calcium uniporter” causes memory impairment but does not alter learning capacity. That surprised us – we thought they wouldn’t be able to learn at all. This is important because defects in the same calcium channel function have been shown to be associated with intellectual disability in humans. (more…)
Author Interviews, Breast Cancer, Cancer, Genetic Research, UT Southwestern / 23.09.2016

MedicalResearch.com Interview with: Roshni Rao, M.D Breast Surgery University of Texas Southwestern MedicalResearch.com: What is the background for this study? What are the main findings? Response: Triple negative breast cancer (TNBC) is characterized by not having estrogen, progesterone, or Her2Neu receptors. Although a less common type, it is aggressive, and leads to a disproportionate number of deaths from breast cancer. TNBC is more common in young, African American women, but can be found in other ethnic groups as well. This study performed mitochondrial DNA (mtDNA) analysis, to evaluate for patient genetic ancestry, in 92 patients with TNBC. In regards to self-identified ethnicity, there were 31 African-Americans, 31 Whites, and 30 Hispanics. Utilizing mtDNA, 13% of patients had discordance between self identified ethnicity and mtDNA analysis. Discordance was highest in the Hispanic group. The Hispanic patients were also much younger at initial age of diagnosis, and less likely to have a family history of breast cancer. Ancestry from Nigeria, Cameroon, or Sierre Leone were most common in the African-Americans with triple negative breast cancer. (more…)
Author Interviews, Case Western, Genetic Research / 22.09.2016

MedicalResearch.com Interview with: Carlos E. Crespo-Hernández PhD Associate Professor and Co-director of the Center for Chemical Dynamics Department of Chemistry Case Western Reserve University Cleveland, Ohio MedicalResearch.com: What is the background for this study? What are the main findings? Response: Two new letters of DNA have recently been successfully incorporated and replicated by a modified strain of E. coli, thus generating the world’s first semi-synthetic organism with an expanded genetic alphabet. With the expansion of the genetic alphabet, the question arises as to whether the incorporation of unnatural DNA base pairs into cells can adversely affect the integrity of the genetic code and the viability of the cells upon exposure to sunlight or even conventional laboratory lighting. Natural DNA is susceptible to damage by ultraviolet light, but this damage is largely repaired by enzymatic repair mechanisms in living cells. Our recent study has found that the two new, unnatural DNA bases—d5SICS and dNaM—are able to efficiently absorb near-visible light, which is abundant in sunlight and standard fluorescent lighting. Not only that, but upon absorbing near-visible light these unnatural bases produce up to 100 times more reactive species than the most reactive natural DNA base. A line of skin cancer cells incorporating one of these unnatural DNA bases was used to investigate these effects on living cells. Following exposure to a low dose of near-visible light, we observed an increase in the generation of reactive oxygen species within cells containing the unnatural DNA base and a significant decrease in cell survival. (more…)
Author Interviews, Baylor College of Medicine Houston, Biomarkers, Weight Research / 22.09.2016

MedicalResearch.com Interview with: Makoto Fukuda Ph.D. Assistant Professor Children's Nutrition Research Center Department of Pediatrics Baylor College of Medicine Houston, Texas 77030 MedicalResearch.com: What is the background for this study? What are the main findings? Response: A hallmark characteristic of obesity is diminished actions of metabolic hormones that are critically required to maintain whole body energy balance and glucose homeostasis. Leptin is a crucial and powerful hormone that keeps body weight normal. It was hoped that leptin might be a “magic bullet” that could cure obesity. Shortly after the discovery, however, obese individuals were found to have little or no response to exogenously administered leptin, a state of “leptin resistance”. These observations created a central question to be addressed in the field, which would help our understanding of the core of pathophysiology of obesity. While we and other groups previously demonstrated that Epac, a signaling molecule known as a GTP/GDP exchange factor directly activated by cAMP, is involved in cellular leptin resistance, the role of brain Epac signaling in the whole body metabolism has not yet established. We approached this question by using brain-specific knockout mice of Rap1, a direct activator of Epac. As expected from previous results, mice with brain-specific deficiency of Rap1 failed to develop leptin resistance even when they were challenged with a hypercaloric diet. What impressed us most in this study was that Rap1 in the brain plays a key role in the whole body metabolic control, beyond its role in controlling leptin sensitivity. Loss of brain Rap1 protects mice from diet-induced obesity and disordered glucose balance, whereas these knockout mice maintained a similar body weight to that of control mice on a normal regular diet. Further, pharmacological inhibition of this pathway reversed leptin resistance and reduced the body weight of dietary obese mice. At the cellular level, we found an unexpected link between Rap1 and endoplasmic reticulum (ER) stress that has emerged as a causative contributor to the development of leptin resistance. (more…)
Author Interviews, Diabetes, Diabetologia, NIH, OBGYNE / 21.09.2016

MedicalResearch.com Interview with: Cuilin Zhang MD, PhD Senior Investigator NICHD, National Institutes of Health  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Pregnant women are at high risk of developing depressive symptoms; at least 10% US women suffering from depression during pregnancy. Gestational diabetes is a common pregnancy complication, affecting 4-7% of pregnancies in the U.S..  Gestational diabetes has  adverse health implications on both women and their children.   Depression and glucose intolerance commonly co-occur among non-pregnant individuals; however, the temporal relationship between gestational diabetes and depression during pregnancy and the postpartum period is less understood. (more…)
Author Interviews, Columbia, NEJM, Orthopedics, Osteoporosis / 21.09.2016

MedicalResearch.com Interview with: Felicia Cosman, M.D. Medical Director of the Clinical Research Center Helen Hayes Hospital Professor of Medicine Columbia University College of Physician and Surgeons New York Editor-in-Chief, Osteoporosis International MedicalResearch.com: What is the background for this study? What are the main findings? Response: Amgen and UCB presented detailed data from the Phase 3 FRAME study in an oral session at ASBMR 2016, and the data were also published in the New England Journal of Medicine. Additionally, the FRAME abstract has been awarded the 2016 ASBMR Most Outstanding Clinical Abstract Award. The FRAME data show significant reductions in both new vertebral and clinical fractures in postmenopausal women with osteoporosis. Patients receiving a monthly subcutaneous 210 mg dose of romosozumab experienced a statistically significant 73 percent reduction in the relative risk of a vertebral (spine) fracture through 12 months, the co-primary endpoint, compared to those receiving placebo (fracture incidence 0.5 percent vs. 1.8 percent, respectively [p<0.001]). By six months, new vertebral fractures occurred in 14 romosozumab and 26 placebo patients; between six to 12 months, fractures occurred in two versus 33 additional patients in each group, respectively. Patients receiving romosozumab experienced a statistically significant 36 percent reduction in the relative risk of a clinical fracture, a secondary endpoint, through 12 months compared to those receiving placebo (fracture incidence 1.6 percent vs. 2.5 percent, respectively [p=0.008]). In patients who received romosozumab in year one, fracture risk reduction continued through month 24 after both groups transitioned to denosumab treatment through the second year of the study: there was a statistically significant 75 percent reduction in the risk of vertebral fracture at month 24 (the other co-primary endpoint) in patients who received romosozumab followed by denosumab vs. placebo followed by denosumab (fracture incidence 0.6 percent vs. 2.5 percent, respectively [p<0.001]). Clinical fractures encompass all symptomatic fractures (both non-vertebral and painful vertebral fractures; all clinical fractures assessed in the FRAME study were symptomatic fragility fractures. A 33 percent reduction in relative risk of clinical fracture was observed through 24 months after patients transitioned from romosozumab to denosumab compared to patients transitioning from placebo to denosumab (nominal p=0.002, adjusted p=0.096). (more…)
Author Interviews, Baylor College of Medicine Houston, Brain Injury, Depression, JAMA / 21.09.2016

MedicalResearch.com Interview with: Ricardo E. Jorge MD Professor of Psychiatry and Behavioral Sciences Director Houston Translational Research Center for TBI and Stress Disorders Senior Scientist Beth K. and Stuart C. Yudofsky Division of Neuropsychiatry Michael E DeBakey VA Medical Center Baylor College of Medicine MedicalResearch.com: What is the background for this study? What are the main findings? Response: Depressive disorders affect between one-third and one-half of patients with traumatic brain injury (TBI). Once established, these disorders are difficult to treat and frequently follow a chronic and refractory course. Depression has a deleterious effect on TBI outcomes, particularly affecting the community reintegration of TBI patients. In this randomized clinical trial that included 94 adult patients with TBI, the hazards for developing depression for participants receiving placebo were about 4 times the hazards of participants receiving sertraline treatment. (more…)
Author Interviews, Diabetes, JAMA, Mayo Clinic, Outcomes & Safety / 21.09.2016

MedicalResearch.com Interview with: Victor M. Montori, MD MSc Knowledge and Evaluation Research Unit in Endocrinology Mayo Clinic, Rochester, Minnesota MedicalResearch.com: What is the background for this study? Response: Hypoglycemia can acutely disrupt patients’ lives through symptoms ranging from bothersome to life-threatening; worsen quality of life; and hinder medication adherence and glycemic control. Hypoglycemia is now known to increase risk of mortality, cognitive impairment, and cardiovascular events. In order to improve the quality of diabetes care, healthcare organizations use publicly reported performance measures for quality measurement and improvement, and pay-for-performance initiatives. The degree to which existing performance measures are aligned with guidelines, particularly in regard to hypoglycemia avoidance, is uncertain. (more…)
Author Interviews, Autism, Biomarkers, JAMA, NIH, Pediatrics / 21.09.2016

MedicalResearch.com Interview with: Dr. Yong Cheng, PhD Postdoctoral Fellow NIH MedicalResearch.com: What is the background for this study? Response: Autism spectrum disorder (ASD) is a group of neurodevelopmental disorders which affect about 1 in 68 children in the United States, according to data from the Centers for Disease Control and Prevention. Brain-derived neurotrophic factor (BDNF) is an important moderator in neurodevelopment and neuroplasticity, and studies have suggested the involvement of BDNF in ASD. Although some clinical studies show abnormal expression of BDNF in children with ASD, findings have been inconsistent. Therefore, we undertook a systematic review of the scientific literature, using a meta-analysis to quantitatively summarize clinical data on blood BDNF levels in children with ASD, compared with healthy peers. (more…)
Author Interviews, JCEM, Microbiome, Pediatrics, Weight Research, Yale / 21.09.2016

MedicalResearch.com Interview with: Nicola Santoro, MD, PhD Associate Research Scientist in Pediatrics (Endocrinology) Yale University MedicalResearch.com: What is the background for this study? What are the main findings? Response: The study start from previous observations showing an association between the gut microbiota and obesity. Similarly to what previously described in adults and in children, we found an association between the gut microbiota and obesity. We took a step further and also observed that the gut flora is associated to body fat partitioning (amount of fat in the abdomen). Moreover, we observed that the effect of microbiota could be mediated by the short chain fatty acids a product of gut flora. (more…)
Author Interviews, NYU, Transplantation / 20.09.2016

MedicalResearch.com Interview with: Ariane K. Lewis, MD Division of Neurocritical Care Departments of Neurology and Neurosurgery NYU Langone Medical Center MedicalResearch.com: What is the background for this study? What are the main findings? Response: Death by neurologic criteria (DNC, also known as brain death) is widely accepted by physicians, lawyers, and ethicists as being equivalent to cardiopulmonary death. Declaration of DNC is based on strict criteria written by the American Academy of Neurology in 1995 that require: • Identification of a definitive etiology for catastrophic brain injury; • Confirmation that prerequisite conditions are met (normal blood pressure and temperature, exclusion of complicating factors such as medications or laboratory abnormalities that could impact the exam); and • Demonstration that a patient is comatose, lacks brainstem reflexes, and is incapable of breathing spontaneously. If a portion of the examination cannot be performed, an ancillary test such as an electroencephalogram or angiogram is used to confirm lack of brain activity or blood flow to the brain. If a patient is pronounced dead by neurologic criteria, organ support is discontinued unless organ donation is planned. An independent representative from an organ donation team approaches families to discuss donation, and if families agree to donation, organs are given to patients on the 120,000 person waitlist in the United States based upon need. (more…)