Author Interviews, Dengue, Lancet, Vaccine Studies / 29.11.2017

MedicalResearch.com Interview with: Vianney Tricou DPhil Takeda Vaccines Pte Ltd Singapore MedicalResearch.com: What is the background for this study? What are the main findings? Response: Dengue fever is a painful, debilitating mosquito-borne disease caused by any one of the four closely related dengue virus serotypes. Forty percent of the world’s population lives under the threat of dengue, with approximately 390 million infections and 20,000 deaths occurring globally each year. Dengue virus can infect people of all ages and is a leading cause of serious illness among children in some countries in Latin America and Asia. Takeda is developing a dengue vaccine candidate to safely protect children and adults living in, or traveling to, endemic areas against all four dengue virus serotypes, regardless of previous dengue virus exposure.  Takeda’s tetravalent dengue vaccine candidate (TAK-003) is based on a live, attenuated dengue serotype 2 virus, which provides the genetic ‘backbone’ for all four vaccine viruses. Takeda’s ongoing Phase 2 DEN-204 study was designed to assess the safety and immunogenicity of different dose schedules of TAK-003 in approximately 1,800 healthy children and adolescents ages two through 17 years living in dengue-endemic countries in Latin America and Asia. Participants of the DEN-204 trial received either one primary dose of TAK-003, two primary doses of TAK-003 administered three months apart, one primary dose of TAK-003 followed by a booster dose one year later, or a placebo. Eighteen-month interim data showed that that TAK-003 is associated with a reduction in the incidence of dengue in the study participants. Data also showed that TAK-003 induced sustained antibody responses against all four serotypes of dengue virus, regardless of previous dengue exposure and dosing schedule.
Aging, Author Interviews, Heart Disease, Lancet, Social Issues / 26.11.2017

MedicalResearch.com Interview with: [caption id="attachment_38529" align="alignleft" width="70"]Prof Kazem Rahimi FRCP The George Institute for Global Health Oxford Martin School University of Oxford, Oxford Prof. Rahimi[/caption] Prof Kazem Rahimi FRCP The George Institute for Global Health Oxford Martin School University of Oxford, Oxford MedicalResearch.com: What is the background for this study? Response: We decided to investigate this topic because disease incidence data is very important for public health bodies; for example, for the allocation of healthcare resources or for the design and assessment of disease prevention measures. When we reviewed the literature, we found that estimates of heart failure incidence, temporal trends, and association by patient features were scarce. Studies often referred to restricted populations (such as relatively small cohorts that may or may not be representative of the general population), or limited data sources (for example, only including patients hospitalized for their heart failure and not considering those diagnosed by clinicians outside of hospitals). Few studies reported comparable, age-standardized rates, with the result that the rates reported varied considerably across the literature.
Author Interviews, Cost of Health Care, HIV, Lancet / 13.11.2017

MedicalResearch.com Interview with: [caption id="attachment_38292" align="alignleft" width="97"]Dr Valentina Cambiano PhD Institute for Global Health University College London London UK Dr. Cambiano[/caption] Dr Valentina Cambiano PhD Institute for Global Health University College London London UK MedicalResearch.com: What is the background for this study? Response: Pre-Exposure Prophylaxis (PrEP) which involves the use of drugs, which are used to treat HIV, in people without HIV to prevent them from getting is a critical new advance in HIV prevention. It has been shown to reduce the risk of HIV infection by 86% and the benefits heavily out-weigh any concerns. However, introducing this intervention has a cost. When we started working on this study the National Health Services was discussing whether to introduce PrEP and if so for which populations. Unfortunately, at the moment NHS England is not providing Pre-exposure prophylaxis. However, a large study, the PrEP impact trial, funded by the NHS, has just started and this will provide PrEP to 10,000 people.
Author Interviews, Biomarkers, Brain Injury, Lancet / 09.11.2017

MedicalResearch.com Interview with: [caption id="attachment_38107" align="alignleft" width="200"]Prof.dr. J van der Naalt PhD Department of Neurology University Medical Center Groningen Groningen, The Netherlands Prof J van der Naalt[/caption] Prof.dr. J van der Naalt PhD Department of Neurology University Medical Center Groningen Groningen, The Netherlands MedicalResearch.com: What is the background for this study? What are the main findings? Response: Mild traumatic brain injury occurs frequently and is one of the leading cause of morbidity in adults worldwide. It is a major social-economic problem with one in three patients had persistent complaints several months after injury that interfere with resumption of daily activities and work. One of the most important questions concerns the finding that some patients recover without complaints and others do not after sustaining a mild traumatic brain injury. In a follow-up study with more than 1000 participants we found that personality factors are a major factor in the recovery process. In particular coping, that is the way patients adapt to persistent complaints, is important next to emotional distress and impact of the injury. In an add-on study with fMRI we found that in the early phase after injury, the interaction between specific brain networks was temporarily changed. However, when regarding persistent posttraumatic complaints , specific personality characteristics significantly determine long term outcome.
Abuse and Neglect, Circadian Rhythm, Heart Disease, Lancet, Surgical Research / 03.11.2017

MedicalResearch.com Interview with: Prof David Montaigne MD Faculté de Médecine de Lille H Warembourg Lille, France MedicalResearch.com: What is the background for this study? What are the main findings? Response: It is well known for many decades that cardiovascular diseases exhibit a diurnal variation with for instance higher incidence of myocardial infarction in the early morning as opposed to the evening. Although studies on circadian gene knock-out and mutant mice argue for a biorhythm in myocardial ischemia-reperfusion tolerance, whether a biorhythm in the myocardial tolerance to ischemia, exists in humans was unclear because of conflicting reports in the context of myocardial infarction. We demonstrated for the first time in humans that the myocardial tolerance to ischemia-reperfusion is different along the day, in line with rodent experiments performed in the early 2010s. We demonstrated that this biorhythm is clinically meaningful and that it can be targeted as a cardioprotective strategy. In this topic, Rever-alpha is of specific interest. It belongs at the same time to circadian genes and nuclear receptor families: being a nuclear receptor, it is a feasible pharmacological target, conversely to other circadian genes.
Author Interviews, Cancer Research, Lancet / 30.10.2017

MedicalResearch.com Interview with: [caption id="attachment_37758" align="alignleft" width="110"]Dr Miranda M Fidler, PhD Section of Cancer Surveillance International Agency for Research on Cancer Lyon, France  Dr. Fidler[/caption] Dr Miranda M Fidler, PhD Section of Cancer Surveillance International Agency for Research on Cancer Lyon, France  MedicalResearch.com: What is the background for this study? What are the main findings? Response: The burden of cancer among young adults has been rarely studied in depth. To our knowledge, we describe for the first time the scale and profile of cancer incidence and mortality worldwide among 20-39 year-olds, highlighting major patterns by age, sex, development level, and geographic region. Although cancer is less frequent than that observed at older ages, its impact remains considerable because these individuals have a large proportion of their expected lifespans remaining, contribute substantially to the economy, and play a major role in caring for their families. Worldwide, almost 1 million new cases of cancer and 400 000 cancer-related deaths occurred among young adults aged 20–39 years in 2012. Overall, the most common cancer types in terms of new cases were female breast cancer, cervical cancer, thyroid cancer, leukemia, and colorectal cancer, and the most common types of cancer-related deaths were those due to female breast cancer, liver cancer, leukemia, and cervical cancer. The burden was disproportionately greater among women, with an estimated 633 000 new cancer cases (65% of all new cancer cases in that age group) and 194 000 cancer-related deaths (54% of all cancer-related deaths in that age group) in 2012.
Author Interviews, Gastrointestinal Disease, Global Health, Lancet / 18.10.2017

MedicalResearch.com Interview with: [caption id="attachment_37559" align="alignleft" width="150"]Gilaad Kaplan, MD, MPH, FRCPC Associate Professor  CIHR New Investigator & AI-HS Population Health Investigator Co-Director, Environmental Health Research Group Snyder Institute for Chronic Diseases & Institute of Public Health Departments of Medicine & Community Health Sciences University of Calgary Dr. Kaplan[/caption] Gilaad Kaplan, MD, MPH, FRCPC Associate Professor CIHR New Investigator & AI-HS Population Health Investigator Co-Director, Environmental Health Research Group Snyder Institute for Chronic Diseases & Institute of Public Health Departments of Medicine & Community Health Sciences University of Calgary MedicalResearch.com: What is the background for this study? What are the main findings? Response: The aim of the study was to provide a global perspective on the epidemiology of the inflammatory bowel diseases in the 21st century. During the 20th century IBD was considered a disease of the Western world. At the turn of the 21st century, IBD has become a global disease with accelerating number of cases in the developing world as it transition towards a westernized society.
Author Interviews, Lancet, OBGYNE / 06.10.2017

MedicalResearch.com Interview with: Jonathan Marc Bearak, PhD Senior Research Scientist Guttmacher Institute New York MedicalResearch.com: What is the background for this study? What are the main findings? Response: Although U.S. women who live farther from abortion clinics are less likely to obtain one, no national study has examined inequality in women’s access to abortion and whether inequality in abortion access has increased as the number of abortion clinics have declined. We found that half of women live within 11 miles of an abortion provider. However, 1 in 5 women would need to travel at least 43 miles. We found substantially greater variation within than across states, because even in relatively rural states, women and clinics were concentrated in urban areas. These disparities have persisted since at least 2000.
Author Interviews, Diabetes, Gastrointestinal Disease, Lancet, Mayo Clinic, Weight Research / 29.09.2017

MedicalResearch.com Interview with: [caption id="attachment_37242" align="alignleft" width="125"]Prof Michael Camilleri, MD Gastroenterologist, Professor of Medicine, Pharmacology and Physiology at Mayo Clinic Clinical Enteric Neuroscience Translational and Epidemiological Research (CENTER) Mayo Clinic, Rochester, MN Prof. Camilleri[/caption] Prof Michael Camilleri, MD Gastroenterologist, Professor of Medicine, Pharmacology and Physiology at Mayo Clinic Clinical Enteric Neuroscience Translational and Epidemiological Research (CENTER) Mayo Clinic, Rochester, MN MedicalResearch.com: What is the background for this study? What are the main findings? Response: Liraglutide is approved for treatment of obesity; the precise mechanisms for the beneficial weight loss are unclear. We are interested to learn whether it is possible to identify people who are more likely to benefit from this treatment.
Author Interviews, Heart Disease, Lancet, Nutrition / 30.08.2017

MedicalResearch.com Interview with: Ms Victoria Miller Population Health Research Institute DBCVS Research Institut McMaster University, Hamilton, ON Canada MedicalResearch.com: What is the background for this study? What are the main findings? Response: PURE study is prospective urban rural epidemiology study that included aged 35 to 70 years from 26 low-income, middle-income, and high-income countries on 5 continents. Data were collected at the community, household, and individual levels. Standardized questionnaires were used to collect information about demographic factors, socio-economic status (education, income, and employment), lifestyle (smoking, physical activity, and alcohol intake), health history and medication use. Standardized case-report forms were used to record data on major cardiovascular events and mortality during follow-up, which were adjudicated centrally in each country by trained physicians using standard definitions. Participants’ habitual food intake was recorded using country-specific (or region specific in India) validated food frequency questionnaires (FFQs) at baseline. The median follow up is 7.4 years and we are aiming for follow up people at least for 15 years. During 7.4 years of follow up more than 6000 CVD and 7000 mortality recorded. Higher fruit, vegetable and legume intake is associated with a lower risk of cardiovascular, non-cardiovascular and total mortality. Our findings show the lowest risk of death in those who consume three to four servings (equivalent to 375-500 grams per day) of fruits, vegetables and legumes per day, with little additional benefit for intake beyond that range. When examined separately, fruit intake is associated with lower risk of cardiovascular, non-cardiovascular and total mortality, while legume intake is inversely associated with non-cardiovascular and total mortality. For vegetables, raw vegetable intake is more strongly associated with lower risk of total mortality compared to cooked vegetable intake.
Author Interviews, Diabetes, Lancet, Parkinson's / 08.08.2017

MedicalResearch.com Interview with: Dr Dilan Athauda MRCP Sobell Department of Motor Neuroscience and Movement Disorders UCL Institute of Neurology & The National Hospital for Neurology and Neurosurgery London MedicalResearch.com: What is the background for this study? Response: Exenatide is a synthetic version of a naturally occurring protein - exendin-4 - that was originally discovered by Dr John Eng in the early 1990’s in the saliva of the Gila Monster, a venomous lizard native to the Southwestern United states. He and his team were looking for bio-active peptides in insect and lizard venom that could be useful for people with Type 2 diabetes. They discovered that exendin-4 was extremely similar to a human hormone called Glucagon-like peptide-1 (GLP-1).  In humans, GLP-1 is secreted after you eat a meal to stimulate insulin secretion (and inhibit glucagon production) of which the end result is a lowering of blood sugar. Unfortunately human GLP-1 is rapidly broken down by a circulating enzyme called dipeptidyl peptidase IV (DPP-IV) and its effects only last minutes. Importantly, it was discovered that exendin-4 is naturally resistant to the actions of this enzyme, meaning it’s effects on blood sugar control lasts much longer in the body.  These properties made it very attractive to people trying to treat people with Type 2 diabetes and following many successful randomised controlled trials of patients with Type 2 diabetes in 2005, exenatide was approved for use as a treatment.  During this time, work led by Nigel Greig’s group at the NIA showed that first evidence that exendin-4 had neuroprotective properties, and could protect neurons from a variety of stresses and could also improve growth and rescue degenerating cells. Over the next few years, various groups used exendin-4 in a variety of animal toxin models of Parkinson’s disease and showed that exendin-4 could halt the progression of Parkinsonism and prevent cell death in these models through beneficial effects on inflammation, mitochondrial function and cell survival. Based on this encouraging pre-clinical data, Professor Foltynie supervised the first small, “open-label”, human trial of exenatide in patients with Parkinson’s disease.  The team found that patients treated with exenatide for 1 year (in addition to their usual medication) had less decline in their motor symptoms when assessed without their medication compared to the control group (just on their usual medication) and this advantage over the control group was still present 1 year after stopping the exenatide injections.  However, this trial was open-label – patients knew they were getting a (potentially beneficial) experimental therapy and so we couldn’t exclude the fact that placebo effects were explaining some of the results we saw. As a result of the potentially beneficial results seen in this small open label trial we carried out a double-blind, placebo controlled trial.
Author Interviews, Genetic Research, Lancet, Ophthalmology / 17.07.2017

MedicalResearch.com Interview with: [caption id="attachment_35971" align="alignleft" width="133"]Stephen R. Russell, MD Dina J Schrage Professor of Macular Degeneration Research Service Director, Vitreoretinal Diseases and Surgery Professor of Ophthalmology and Visual Sciences The University of Iowa Dr. Russell[/caption] Stephen R. Russell, MD Dina J Schrage Professor of Macular Degeneration Research Service Director, Vitreoretinal Diseases and Surgery Professor of Ophthalmology and Visual Sciences The University of Iowa MedicalResearch.com: What is the background for this study? What are the main findings? Response: This study examines the efficacy (and safety) of treating children and adults with a form of retinitis pigmentosa known as RPE65-associated Lebers congenital amaurosis, with an adeno-associated viral vector(AAV) delivered RPE65 construct.  Building on successful phase 1/2b trials from multiple centers, the AAV-hRPE65v2 agent now designated as voretigene neparvovec, contains a highly optimized enhancing sequence and promoter. The main findings were an improvement on a multiple light level mobility test (MLMT) and multiple additional supportive secondary endpoints which included improvements in full-field light sensitivity, Goldmann visual field, and others.
Author Interviews, Infections, Lancet, STD, Vaccine Studies / 11.07.2017

MedicalResearch.com Interview with: Helen Petousis-Harris. BSc, PhD Senior Lecturer, Dept General Practice and Primary Health Care Academic Head, Immunisation Research and Vaccinology Immunisation Advisory Centre School of Population Health, Faculty of Medical and Health Sciences University of Auckland MedicalResearch.com: What is the background for this study? What are the main findings? Response: Early thinking came from two quarters. One, the observation that the NZ OMV vaccine appeared broadly protective – beyond the clone it was based on and two, the observation of graphs depicting annual number of cases from both Cuba and NZ. There is nothing to suggest other types of meningococcal vaccine have had any effect on gonorrhoea so we are interested in the OMV vaccines. This led to the hypothesis that as these two Neisseria species are related the meningococcal OMV in the form of a vaccine may offer some kind of cross protection. To explore this possibility we conducted a case-control study that compared the vaccination status of cases (gonorrhoea) and controls (Clamydia). We found that the cases with gonorrhoea were less likely to be vaccinated than the controls and after we controlled for confounders – ethnicity, SE deprivation, age we found a vaccine effectiveness of 31%.
Author Interviews, Emory, Flu - Influenza, Lancet, Technology, Vaccine Studies / 28.06.2017

MedicalResearch.com Interview with: Dr Nadine G Rouphael MD Associate Professor of Medicine, Emory University Director of the VTEU and HIPC networks at the Hope Clinic of the Emory Vaccine Center Decatur GA 30030, USA MedicalResearch.com: What is the background for this new technology and study? What are the main findings? Response: Different groups including a group of researchers at Georgia Tech have been working on the microneedle technology for more than 20 years. The dissolvable microneedle patches are already used in several cosmetic products and drugs. However, vaccination with microneedle patches has been studied mostly in animals. Our phase 1 trial published this week in The Lancet showed that vaccination with the microneedle patches was safe, with no related serious adverse events reported. Local skin reactions to the patches were mostly mild itching and faint redness that lasted two to three days. No new chronic medical illnesses or influenza-like illnesses were reported with either the patch or the injection groups. Antibody responses generated by the vaccine, as measured through analysis of blood samples, were similar in the groups vaccinated using patches and those receiving intramuscular injection, and these immune responses were still present after six months. When asked after immunization, more than 70 percent of patch recipients reported they would prefer patch vaccination over injection or intranasal vaccination for future vaccinations.
Author Interviews, Lancet, Rheumatology, UT Southwestern / 20.06.2017

MedicalResearch.com Interview with: [caption id="attachment_35455" align="alignleft" width="150"]Roy Fleischmann, MD MACR Medical Director Metroplex Clinical Research Center Clinical Professor of Medicine University of Texas Southwestern Medical Center Dallas, TX 75231 Dr. Fleischmann[/caption] Roy Fleischmann, MD MACR Medical Director Metroplex Clinical Research Center Clinical Professor of Medicine University of Texas Southwestern Medical Center Dallas, TX 75231 MedicalResearch.com: What is the background for this study? What are the main findings? Response: In the phase 3 studies of tofacitinib, it was noted that the clinical responses to tofacitinib monotherapy were higher than the responses to tofaciotinib plus MTX and that tofacitinib plus methotrexate had numerically higher clinical responses compared to adalimumab plus methotrexate. This study was a non-inferiority design which compared tofacitinib monotherapy to tofacitinib + MTX and to adalimumab +MTX and tofacitinib monotherapy to tofacitinib +MTX in MTX incomplete responders. It was found that tofacitinib + MTX is non-inferior to adalimumab + MTX (and vice versa) and neither was superior to the other. The results of tofacitinib to either combination was non-conclusive showing neither non-inferiority or inferiority, but suggesting that either combination will be effective in more patients in a group of patients.
Author Interviews, Hepatitis - Liver Disease, Kidney Disease, Lancet, Merck / 01.06.2017

MedicalResearch.com Interview with: [caption id="attachment_35005" align="alignleft" width="112"]Annette Bruchfeld MD, PhD Senior Consultant Associate Professor Karolinska Institute Dept of Renal Medicine, M99 Karolinska University Hospital Huddinge Stockholm, Sweden Dr. Bruchfeld[/caption] Annette Bruchfeld MD, PhD Senior Consultant Associate Professor Karolinska Institute Dept of Renal Medicine, M99 Karolinska University Hospital Huddinge Stockholm, Sweden MedicalResearch.com: What is the background for this study? What are the main findings? Response: In patients with stage 4–5 chronic kidney disease(CKD), hepatitis C virus (HCV) infection can accelerate the decline in kidney function, impair health-related quality of life (HRQOL), and decrease survival chances of both patients and grafts in transplantation recipients. In this study additional data from patients with stage 4–5 chronic kidney disease undergoing treatment for HCV infection in the C-SURFER study, including HRQOL and resistance analyses was presented not previously reported for this patient population with gwnotype 1 infection. The final virological analysis of this study indicated a high cure rate with sustained virological response at 12 weeks after the end of treatment (SVR12) in more than 98% of all treated patients. Even in patients with resistance-associated substitutions (RASs) the SVR was high in 11 (84·6%) of 13 patients genotype 1a infection.
Author Interviews, Lancet, Mental Health Research, Pediatrics / 26.05.2017

MedicalResearch.com Interview with: [caption id="attachment_34863" align="alignleft" width="200"]Dr Annie Herbert, PhD Department of Behavioural Science and Health, Institute of Epidemiology and Healthcare University College London London  UK Dr. Herbert[/caption] Dr Annie Herbert, PhD Department of Behavioural Science and Health, Institute of Epidemiology and Healthcare University College London London  UK  MedicalResearch.com: What is the background for this study? Response: 1 in 25 adolescents (i.e. one in every classroom) will be admitted to hospital as an emergency with injuries related self-harm, drug or alcohol misuse, or violence. Currently, the guidelines for how these adolescents are managed differ greatly depending on the type of injury they come in with (whether through self-harm, drug or alcohol misuse, or violence). MedicalResearch.com: What are the main findings? Response: In our study, we found that adolescents admitted with any of these injuries were at an increased risk of suicide and of drug or alcohol related death in the ten years after leaving hospital, compared to other admitted adolescents.While the overall risk is relatively low—for example, 2–3 girls out of 1000 and 7 boys out of 1000 who are admitted as an emergency to hospital with drug or alcohol related injuries die from suicide within 10 years—the rates are 5–6 times higher than among adolescents admitted to hospital following an accident.
Author Interviews, Lancet, Macular Degeneration, Ophthalmology / 18.05.2017

MedicalResearch.com Interview with: [caption id="attachment_34685" align="alignleft" width="101"]Prof Peter A Campochiaro MD Director, Retinal Cell and Molecular Laboratory Professor of Ophthalmology Johns Hopkins University School of Medicine Baltimore, MD Dr. Campochiaro[/caption] Prof Peter A Campochiaro MD Director, Retinal Cell and Molecular Laboratory Professor of Ophthalmology Johns Hopkins University School of Medicine Baltimore, MD MedicalResearch.com: What is the background for this study? What are the main findings? Response: Patients with wet age-related macular degeneration (AMD) have increased levels of vascular endothelial growth factor (VEGF) in their eyes resulting in growth of abnormal blood vessels that leak fluid into the retina and reduce vision. The current treatment is to inject proteins that block VEGF which initially provides a very good effect, but repeated injections are needed. Patients sometimes are unable to keep up the frequency of visits and injections needed to keep the disease quiet and over time there is often gradual loss of vision. The aim of this study was to test a new approach through which a viral vector is injected into the eye resulting in production of a protein that block VEGF in the eye reducing the need for repeated injections. These are the major findings: 1) Intravitreous injection of an AAV2 vector expressing a protein that blocks vascular endothelial growth factor (VEGF) was safe and well-tolerated. (2) 5 of 10 patients injected with the highest dose (2 × 10¹⁰ vector genomes) had measurable levels of the therapeutic protein in samples removed from the front of the eye- all of these patients had no or very low levels of anti-AAV2 serum antibodies and 4 of the 5 patients who did not show expression had high anti-AAV2 serum antibodies (3) Eleven patients had fluid in or under the retina before vector injection and 6 of them showed substantial reduction of the fluid which is the desired outcome.
Author Interviews, Gastrointestinal Disease, Lancet, Vaccine Studies / 13.05.2017

MedicalResearch.com Interview with: Leslie Williams, BS, RN, MBA</strong> Director, Founder, President and Chief Executive Officer <strong>Dr Robert P Anderson MBChB BMedSc PhD FRACP</strong> Chief Scientific Officer ImmusanT Cambridge, MALeslie Williams, BS, RN, MBA Director, Founder, President and Chief Executive Officer and Dr Robert P Anderson MBChB BMedSc PhD FRACP Chief Scientific Officer ImmusanT, Cambridge, MA MedicalResearch.com: What is the background for this study? Response: The 2 Phase 1 trials were randomized, double-blind, placebo-controlled, multi-center studies evaluating the safety, tolerability, and relevant bioactivity of Nexvax2 in HLA-DQ2.5+ patients with celiac disease. In one study, patients received three fixed doses of Nexvax2 or placebo once per week over a three-week period. In the other study, patients received 16 fixed doses of Nexvax2 or placebo twice per week over an eight-week period. Both studies evaluated a range of fixed, intradermal dose administrations in a series of ascending dose cohorts, which included a crossover, double-blind, placebo-controlled oral gluten challenge in the screening and post-treatment periods. The primary outcome measures were the number and percentage of adverse events in the treatment period.
Author Interviews, Biomarkers, Hepatitis - Liver Disease, Lancet, Merck / 25.04.2017

MedicalResearch.com Interview with: [caption id="attachment_34147" align="alignleft" width="200"]Jason Grebely PhD Associate Professor Senior Research Fellow (UNSW) Viral Hepatitis Clinical Research Program Dr. Grebely[/caption] Jason Grebely PhD Associate Professor Senior Research Fellow (UNSW) Viral Hepatitis Clinical Research Program MedicalResearch.com: What is the background for this study? What are the main findings? Response: Globally, testing and diagnosis of hepatitis C virus infection remain low. Although point of care tests for HCV infection exist, but many of these tests only measure HCV antibodies (previous exposure), not HCV RNA (active infection). Given that 25% of individuals spontaneously clear HCV infection, efforts to enhance diagnosis of chronic HCV infection and improve the HCV care cascade requires enhanced uptake of HCV RNA testing. We conducted the first evaluation of the Xpert HCV Viral Load test (manufactured by Cepheid) - a point-of-care hepatitis C virus test that can detect active infection - from a finger-stick sample of blood. We established that there is good sensitivity and specificity of the Xpert HCV Viral Load point-of-care test using blood samples collected by finger-stick in participants attending drug health and homelessness services in Australia.
Author Interviews, Hematology, Lancet / 09.04.2017

MedicalResearch.com Interview with: Dr. med. Kathleen Selleng, OÄ, QB Hämotherapie Universitätsmedizin Greifswald Institut für Immunologie und Transfusionsmedizin, Abt. Transfusionsmedizin Sauerbruchstraße Greifswald Deutschland MedicalResearch.com: What is the background for this study? What are the main findings? Response: Red blood cell concentrates (RBCs) of blood group O RhD negative are frequently used as universal blood for emergency transfusions in patients with unknown blood type. This leads to an over-proportional use of these red blood cell concentrates and regular shortages of O RhD negative RBCs. Due to these shortages, patients with known RhD negative blood type sometimes have to be transfused with RhD positive RBCs. The present study shows that the overall risk to induce an anti-D by transfusing all emergency patients with unknown blood type with O RhD positive RBCs is in the range of 3 to 6%, while this risk is much higher (20-30%) in RhD negative patients which have to be transfused with RhD positive RBCs due to RhD negative RBC shortages.
Author Interviews, Lancet, Stroke / 07.03.2017

MedicalResearch.com Interview with: Caterina Breitenstein, PhD Department of General Neurology, University of Muenster, Germany Annette Baumgärtner, PhD Faculty of Health and Social Sciences, Fresenius University of Applied Sciences, Hamburg, Germany MedicalResearch.com : What is the background for this study? What are the main findings? Response: For a long time, it has been assumed that language recovery is limited to the first months after the initial stroke. During the past two decades, however, several clinical studies and systematic reviews have challenged this dogma by demonstrating functional gains in stroke survivors during the chronic post-stroke stage (at least 6 months post the initial stroke) whenever speech and language therapy (SLT) intensity was sufficiently high (i.e., at least 5 h/week for several weeks). These studies, however, lacked the methodological quality required for evidence-based interventions (for criteria, please refer to http://www.cebm.net/ocebm-levels-of-evidence). Until now, this lack in evidence severely hampers stroke survivors’ access to language rehabilitation services . The present multicenter randomized controlled healthcare trial FCET2EC (acronym stands for "From Controlled Experimental Trial to=2 Everyday Communication) is the first study worldwide to compare three weeks of intensive SLT provided under routine clinical conditions to an equally long period of no (or low intensity) SLT. After 3 weeks of intensive individualized therapy, the 156 stroke survivors with chronic aphasia verbally expressed themselves more effectively in daily-life communicative situations, like changing a doctor’s appointment by a telephone call. Additionally, patients and their significant other rated their communication-related quality of life as significantly improved. Last but not least, therapy effects remained stable over a follow-up period of six months after the intensive intervention.
Author Interviews, Endocrinology, Lancet, OBGYNE, Pediatrics, Vitamin D / 07.03.2017

MedicalResearch.com Interview with: Audry H. Garcia PhD Scientist Department of Epidemiology Erasmus MC, University Medical Center Rotterdam Rotterdam, the Netherlands  MedicalResearch.com: What is the background for this study? Response: Fetal bone mineralisation requires an adequate transfer of calcium to the fetus by the end of the pregnancy. Considering that vitamin D is required to maintain normal blood concentrations of calcium, adequate 25-hydroxyvitamin D (25[OH]D) concentrations in pregnant women seem to be crucial for bone development of the offspring. Maternal vitamin D deficiency during pregnancy has been associated with abnormal early skeletal growth in offspring and might be a risk factor for decreased bone mass in later life. Several studies have linked vitamin D deficiency in fetal life to congenital rickets, craniotabes, wide skull sutures and osteomalacia. However, the evidence of long-lasting effects of maternal vitamin D deficiency during pregnancy on offspring’s skeletal development is scarce and inconsistent, and has led to contradictory recommendations on vitamin D supplementation during pregnancy.
Alzheimer's - Dementia, Author Interviews, Lancet, Vaccine Studies / 01.03.2017

MedicalResearch.com Interview with: [caption id="attachment_32529" align="alignleft" width="200"]Petr Novak, MD, PhD AXON Neuroscience Bratislava, Slovakia Dr. Petr Novak[/caption] Petr Novak, MD, PhD AXON Neuroscience Bratislava, Slovakia MedicalResearch.com: What is the background for this study? Response: Alzheimer’s disease is a complex, multifactorial disorder, with many-faceted neuropathology. A hallmark finding is the co-existence of neurofibrillary pathology (such as neurofibrillary tangles) composed of tau protein, and amyloid-β pathology (plaques) [1]. Neurofibrillary pathology is closely correlated with cognitive impairment in Alzheimer’s disease [2], while support for the role amyloid in the disease pathogenesis comes from the ability of certain mutations to induce AD in an autosomal-dominant fashion [3]. The field has explored various anti-amyloid therapies to great extent, and continues to do so with undiminished effort [4]; meanwhile, there is a noticeable paucity of investigated therapies aimed at neurofibrillary tau protein pathology, despite the ability of tau protein dysfunction to cause a multitude of neurodegenerative disorders, collectively named “tauopathies” [5]. AADvac1 is the first tau-targeted immunotherapy investigated in humans [6], a pioneering effort to target the component of AD neuropathology that is proximal to neuronal damage and cognitive loss, and thus to halt or slow the progression of Alzheimer’s disease.
ADHD, Author Interviews, Lancet, MRI, Neurological Disorders / 01.03.2017

MedicalResearch.com Interview with: M. (Martine) Hoogman PhD. Postdoc and PI of ENIGMA-ADHD Radboud universitair medisch centrum Department of Human Genetics Nijmegen, The Netherlands MedicalResearch.com: What is the background for this study? What are the main findings? Response: There are many neuro-imaging studies aimed at investigating structural brain changes related to ADHD, but the results are often inconclusive. There are two main reasons for this: 1) the small sample size of the studies and 2) the heterogeneous methods used. We tried to address these issues by forming an international collaboration to provide a sample size sufficient to detect even small effects in volume differences. And in addition, we analyzed all the raw scans again using homogenized methods. There are data of more than 1700 patients (aged 4-63 years of age) and more than 1500 healthy controls in our dataset, coming from 23 sites around the world. We studied the possible volume differences between cases and controls of 7 subcortical regions and intracranial volume by performing mega- and meta-analysis.
Author Interviews, Compliance, Lancet, Mental Health Research, Schizophrenia / 27.02.2017

MedicalResearch.com Interview with: [caption id="attachment_32460" align="alignleft" width="180"] Ernst L Noordraven MSc, PhD student Department of Psychiatry Epidemiological and Social Psychiatric Research institute Erasmus University Medical Center Rotterdam Netherlands Ernst L Noordraven[/caption] Ernst L Noordraven MSc, PhD student Department of Psychiatry Epidemiological and Social Psychiatric Research institute Erasmus University Medical Center Rotterdam Netherlands MedicalResearch.com: What is the background for this study? What are the main findings? Response: Provision of financial incentives is a promising intervention for improving adherence in patients taking antipsychotic medication. We aimed to assess the effectiveness of this intervention for improving adherence to antipsychotic depot medication in patients with psychotic disorders, irrespective of their previous compliance. Our 12-month randomized controlled trial showed that financial incentives improved adherence to antipsychotic depot medications in patients with psychotic disorders, regardless of their level of compliance at study entrance. Patients received either treatment as usual plus a financial reward for each depot of medication received (€30 per month if fully compliant; intervention group) or treatment as usual alone (control group). Based on the use of depot registrations from 155 patients (92%), the adjusted difference in adherence was 14·9% (95% CI 8·9–20·9%; p<0·0001) in favour of the intervention group. Our study is also the first to demonstrate that the effects on medication adherence persist after monetary rewards are discontinued, for at least a 6-month follow-up period (adjusted difference 6·5%, 95% CI 2·0–10·9; p=0·047).
Author Interviews, Global Health, HIV, Lancet / 19.02.2017

MedicalResearch.com Interview with: [caption id="attachment_32187" align="alignleft" width="132"]Jennifer A. Downs, M.D., Ph.D. Assistant Professor of Medicine and Microbiology & Immunology Department of Medicine Weill Cornell Medicine Center for Global Health New York, NY 10065 Dr. Jennifer Downs[/caption] Jennifer A. Downs, M.D., Ph.D. Assistant Professor of Medicine and Microbiology & Immunology Department of Medicine Weill Cornell Medicine Center for Global Health New York, NY 10065 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Between 2002 and 2006, three large randomized controlled trials in sub-Saharan Africa demonstrated that male circumcision reduces new HIV infections in men by approximately 60%. Based on these findings, the World Health Organization recommended male circumcision as an HIV prevention strategy in countries with high levels of HIV and a low prevalence of male circumcision. This led to prioritization of 14 countries in Eastern and Southern Africa for massive scale-up of male circumcision beginning in 2011. In many of these countries, the uptake of male circumcision was lower than expected. In northwest Tanzania, where we work, there are a number of barriers to male circumcision. Some of these barriers are cultural, tribal, economic, and religious. We conducted focus group interviews in 2012 that showed that many Christian church leaders and church attenders in our region in Tanzania had major concerns about whether male circumcision was compatible with their religious beliefs. This led us to hypothesize that the uptake of male circumcision could be increased when religious leaders were taught about male circumcision, with the goal that they would then be equipped to discuss this issue with their congregations.
Author Interviews, Infections, Lancet, Vitamin D / 14.02.2017

MedicalResearch.com Interview with: Dr. Adrian R Martineau B Med Sci DTM&H MRCP PhD Clinical Professor of Respiratory Infection and Immunity Centre for Primary Care and Public Health. Blizard Institute, Barts and The London School of Medicine and Dentistry Queen Mary, University of London MedicalResearch.com: What is the background for this study? Response: In addition to its well-known effects on bone, Vitamin D has also been shown to boost immune responses to viruses and bacteria that cause respiratory infections in lab experiments. In order to see whether these effects translate into a health benefit, a total of 25 clinical trials of vitamin D supplementation to prevent various respiratory infections have been carried out in around 11,000 people living in 14 different countries over the last decade. These trials have yielded conflicting results: in some, vitamin D reduced the risk of infections, but in others it did not. The reason why vitamin D ‘worked’ in some trials, but not in others, has been the subject of much debate. In order to answer this question, we assembled an international consortium of investigators and compiled the raw data from every trial into a single database containing information from 10,933 people in total. This allowed us to run sub-group analyses to determine whether particular groups of people benefit more from vitamin D supplementation than others.
Author Interviews, Lancet, Multiple Sclerosis, Neurological Disorders, Pharmacology / 12.02.2017

MedicalResearch.com Interview with: [caption id="attachment_31938" align="alignleft" width="147"]Tomas Kalincik, MD, PhD, PGCertBiostat Neurologist and Senior Research Fellow Melbourne Brain Centre | Department of Medicine | University of Melbourne Department of Neurology | Royal Melbourne Hospital Melbourne | Victoria | Australia Dr. Tomas Kalincik[/caption] Tomas Kalincik, MD, PhD, PGCertBiostat Neurologist and Senior Research Fellow Melbourne Brain Centre | Department of Medicine | University of Melbourne Department of Neurology | Royal Melbourne Hospital Melbourne | Victoria | Australia MedicalResearch.com: What is the background for this study? What are the main findings? Response: Multiple sclerosis is a disease predominantly of young adults, with the peak of incidence in the 3rd and 4th decades. It is the most common cause of neurological disability in young adults. Only in Australia, 23,000 people are living with MS, with MS representing an annual cost of almost 1 billion $AU to the Australian society. It is a disease that presents with broad range of neurological symptoms and signs, which are typically temporary (these are called relapses) that with time can lead to permanent neurological disability. While there is currently no cure for MS, with appropriate therapy, its symptoms can be controlled and the disability progression slowed down.