Post Exposure Doxycycline in PReP Users May Reduce Risk of Syphilis and Chlamydiae

MedicalResearch.com Interview with:

Professor Jean-Michel Molina MD Head of Department of Infectious Diseases, Hôpital Saint-Louis Paris France 

Prof. Molina

Professor Jean-Michel Molina MD
Head of Department of Infectious Diseases, Hôpital Saint-Louis
Paris France 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: There is a high rate of sexually transmitted infections (STIs) among Pre-exposure prophylaxis users and we wished to assess whether post-exposure prophylaxis (PEP) with doxycycline could reduce the incidence of sexually transmitted infections in this population.

We have found indeed a high rate of STIs most of them (71%) being asymptomatic and warranting therefore systematic testing. Also PEP reduced the incidence of syphilis and chlamydiae infection by 70%, not for gonorrhea due to the high rate of detection in throat swabs without any impact of PEP.

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Tetravalent Vaccine Proves Promising In Protecting Children From Dengue

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.

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Aging Population, Socio-Economic Disparities Linked To Increase in Heart Failure Incidence

MedicalResearch.com Interview with:

Prof Kazem Rahimi FRCP The George Institute for Global Health Oxford Martin School University of Oxford, Oxford

Prof. Rahimi

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.

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HIV PreExposure Prophylaxis -PrEP- For MSM Found To Be Effective and Cost Saving

MedicalResearch.com Interview with:

Dr Valentina Cambiano PhD Institute for Global Health University College London London UK

Dr. Cambiano

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.

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Personality Changes Can Signal Incomplete Recovery After Traumatic Brain Injury

MedicalResearch.com Interview with:

Prof.dr. J van der Naalt PhD Department of Neurology University Medical Center Groningen Groningen, The Netherlands

Prof J van der Naalt

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.

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Matching Time of Day To Patient’s Biorhythm May Improve Surgical Outcomes

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.

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Cancer in Young Adults Disproportionately Affects Women

MedicalResearch.com Interview with:

Dr Miranda M Fidler, PhD Section of Cancer Surveillance International Agency for Research on Cancer Lyon, France 

Dr. Fidler

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.

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With Increasing Westernization, Inflammatory Bowel Disease Becoming a Global Health Issue

MedicalResearch.com Interview with:

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

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.

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Many US Women Face Distance Barriers To Abortion Access

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.

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Liraglutide (SAXENDA) May Lead To Weight Loss By Slowing Stomach Emptying

MedicalResearch.com Interview with:

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

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.

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3-4 Servings Fruits, Vegetables and Legumes Sufficient To Reduce Cardiovascular Mortality

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.

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Diabetes Medication Exenatide Shows Promise In Treating Parkinson’s Disease

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.

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One Time Injection With Spark’s Gene Therapy LUXTURNA Demonstrated Lasting Visual Improvement

MedicalResearch.com Interview with:

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

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.

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Potential Blood Biomarker Predicts Course of Huntington’s Disease

MedicalResearch.com Interview with:

Dr Edward Wild PhD MRC Clinician Scientist Huntington's Disease Centre UCL Institute of Neurology Honorary Consultant Neurologist National Hospital for Neurology & Neurosurgery, London UK

Dr. Wild

Dr Edward Wild PhD
MRC Clinician Scientist
Huntington’s Disease Centre
UCL Institute of Neurology
Honorary Consultant Neurologist
National Hospital for Neurology & Neurosurgery,
London UK

MedicalResearch.com: What is the background for this study?

Response: Having a readily accessible and sensitive biomarker, that is representative of ongoing neuropathology, could facilitate therapeutic development for Huntington’s disease. Neurofilament light (NfL) protein is one of the component that makes up the cytoskeleton of neurons. It is released when neuronal damage or death occurs and can be quantified in blood.

MedicalResearch.com: WWhat are the main findings?

Response: We carried out a retrospective cohort analysis of samples from the TRACK-HD study – a multisite longitudinal observational study of HD patients. NfL was quantified in plasma from 298 participants at baseline and follow-up. NfL was significantly higher in HD compared to healthy controls and increased with disease stage. Baseline levels of plasma NfL predicted clinical progression, including cognitive and functional decline, and the rate of global and regional brain atrophy. Premanifest individuals who converted to manifest  Huntington’s disease in the three years of the study had significantly higher levels of plasma NfL at baseline. These associations remained significant after adjustment for the combined interaction of age and CAG, currently the best predictor of age of onset of Huntington’s disease. In a separate cohort, levels of NfL in plasma and CSF were highly correlated.

MedicalResearch.com: What should clinicians and patients take away from your report?

Response: Despite decades of research, no substance in blood has shown any power to predict disease progression of Huntington’s disease. In addition, no substance has been shown to be increased as in premanifest subjects over 10 years from their predicted onset suggesting it may have potential for detecting the earliest signs of HD before overt symptoms manifest.

MedicalResearch.com: What recommendations do you have for future research as a result of this study?

Response: We hope that quantifying NfL will be incorporated into all future observational studies of  Huntington’s disease and potentially retrospectively where blood or CSF samples have been banked. We feel it should also be used in current and future clinical trials as an efficacy marker to assess whether a drug is slowing neuronal damage, at the very least as an exploratory end point. 

MedicalResearch.com: Is there anything else you would like to add?

Response: At the moment we do not have enough information for this blood test to be of clinical relevance and prognosis of a patient. A lot more research needs to be done before it could be use on an individual basis in the clinic.

MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.

Citation: Lauren M Byrne, Filipe B Rodrigues, Kaj Blennow, Alexandra Durr, Blair R Leavitt, Raymund A C Roos, Rachael I Scahill, Sarah J Tabrizi, Henrik Zetterberg, Douglas Langbehn, Edward J Wild. Neurofilament light protein in blood as a potential biomarker of neurodegeneration in Huntington’s disease: a retrospective cohort analysisThe Lancet Neurology, 2017; DOI: 10.1016/S1474-4422(17)30124-2

http://www.thelancet.com/journals/laneur/article/PIIS1474-4422(17)30124-2/fulltext

Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.

 

 

 

Could Vaccine Against Meningococcus Help Protect Against Gonorrhea?

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%.

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Dissolvable Microneedle Patches Can Be Vaccination Game Changer

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.

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Oral Treatment Option for RA Includes Tofacitinib (XELJANZ®) Plus Methotrexate

MedicalResearch.com Interview with:

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

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.

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High Hepatitis C Cure Rate Using Elbasvir plus Grazoprevir In Chronic Kidney Disease

MedicalResearch.com Interview with:

Annette Bruchfeld MD, PhD Senior Consultant Associate Professor Karolinska Institute Dept of Renal Medicine, M99 Karolinska University Hospital Huddinge Stockholm, Sweden

Dr. Bruchfeld

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.

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Adolescents Admitted For Self Harm At Risk For Further Self Harming Behavior

MedicalResearch.com Interview with:

Dr Annie Herbert, PhD Department of Behavioural Science and Health, Institute of Epidemiology and Healthcare University College London London  UK

Dr. Herbert

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.

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Phase I Study Shows IV Gene Therapy May Improve Macular Degeneration

MedicalResearch.com Interview with:

Prof Peter A Campochiaro MD Director, Retinal Cell and Molecular Laboratory Professor of Ophthalmology Johns Hopkins University School of Medicine Baltimore, MD

Dr. Campochiaro

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.

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First Report Of A Therapeutic Vaccine For Gluten Sensitive Celiac Disease

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.

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Xpert HCV Viral Load Test Can Detect Active Hepatitis C Infection From Fingerstick

MedicalResearch.com Interview with:

Jason Grebely PhD Associate Professor Senior Research Fellow (UNSW) Viral Hepatitis Clinical Research Program

Dr. Grebely

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.

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Emergency Transfusion of Patients with Unknown Blood Type with Blood Group O Rhesus D Positive Blood

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.

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Intensive Therapy Facilitates Language Recovery in Chronic Aphasia After Stroke

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.

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Vitamin D During Fetal Life and Bone Health in Children at Age 6

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.

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Safety and Immunogenicity of the Tau Vaccine AADvac1 in Patients with Alzheimer’s Disease

MedicalResearch.com Interview with:

Petr Novak, MD, PhD AXON Neuroscience Bratislava, Slovakia

Dr. Petr Novak

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.

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Subtle Differences in Brain Volume Detected On MRI In ADHD

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.

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Money for Medication Improved Adherence To Medications for Psychosis

MedicalResearch.com Interview with:

 Ernst L Noordraven MSc, PhD student Department of Psychiatry Epidemiological and Social Psychiatric Research institute Erasmus University Medical Center Rotterdam Netherlands

Ernst L Noordraven

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).

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Educating Religious Leaders Improves Uptake of Male Circumcision in Tanzania

MedicalResearch.com Interview with:

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

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.
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Vitamin D May Have Protective Role Against Respiratory Infections

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.

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Multiple Treatment Options Now Available for Multiple Sclerosis

MedicalResearch.com Interview with:

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

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.

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Statins Linked to Reduced Risk of Venous Thromboembolism

MedicalResearch.com Interview with:

Setor Kunutsor BSc MD MPhil(cantab) PhD(cantab) Research Fellow/Epidemiologist Musculoskeletal Research Unit University of Bristol School of Clinical Sciences Learning & Research Building (Level 1) Southmead Hospital

Dr. Setor Kunutsor

Setor Kunutsor BSc MD MPhil(cantab) PhD(cantab)
Research Fellow/Epidemiologist
Musculoskeletal Research Unit
University of Bristol
School of Clinical Sciences
Southmead Hospital

MedicalResearch.com: What is the background for this study?

Response: Statins are well established for the prevention of cardiovascular disease and this is based on their ability to lower levels of circulating lipids in the blood. However, statins are also known to have pleotropic effects and these include potential protective effects on multiple disease conditions.

Based on their anti-inflammatory and antithrombotic properties, there have been suggestions that statins may prevent venous thromboembolism (VTE) (which comprises of pulmonary embolism and deep vein thrombosis). The evidence is however uncertain. Several studies utilizing both observational cohort and randomized controlled designs have been conducted to evaluate whether statin therapy or use is associated with a reduction in the incidence of VTE, but the results have been inconclusive. In a recent review that was published in 2012, Rahimi and colleagues pooled the results of several randomized controlled trials (RCTs), but found no significant reduction in the risk of VTE with statin therapy [REF]. Given the publication of new studies since this study was published and the existing uncertain evidence on the effect of statins on VTE, we decided it was time to bring all the evidence together and evaluate if statin therapy really did have a protective effect on the risk of venous thromboembolism.

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Cancer-Related Mortality Low In Men With Benign Prostate Biopsy

MedicalResearch.com Interview with:

Dr. Nina Klemann MD, PhD-student Copenhagen Prostate Cancer Center Copenhagen

Dr. Nina Klemann

Dr. Nina Klemann
MD, PhD-student
Copenhagen Prostate Cancer Center
Copenhagen

MedicalResearch.com: What is the background for this study?

Response: For 30 years, ultrasound-guided biopsies of the prostate have been used in the evaluation of men suspected for prostate cancer. The biopsy needles are employed systematically into the prostate at different sites where prostate cancer is typically present. However, it has been recognized for years, that there is a risk of not hitting the cancer areas, simply by chance. Although cancer diagnosis may be missed in the initial biopsy set by sampling error, it has been a continuous debate whether lethal prostate cancer is missed. Today, we know that prostate cancer is a common finding in men age 50-80, but that the life-time risk of prostate cancer death in this age-group is low. Consequently, we know that there is a considerable risk of diagnosing, and ultimately treating, a disease that will never result in symptoms or death.

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PET Scanning Highlights Link Between Stress and Heart Disease

MedicalResearch.com Interview with:

Dr Ahmed Tawakol MD Massachusetts General Hospital and Harvard Medical Schoo

Dr Ahmed Tawakol

Dr Ahmed Tawakol MD
Co-Director, Cardiac MR PET CT Program
Massachusetts General Hospital and
Harvard Medical School 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: While the link between stress and heart disease has long been established, the mechanism mediating that risk hasn’t been clearly understood. Animal studies showed that stress activates bone marrow to produce white blood cells, leading to arterial inflammation.  This study suggests an analogous path exists in humans. Moreover, this study identifies, for the first time in animal models or humans, the region of the brain (the amygdala) that links stress to the risk of heart attack and stroke.

The paper reports on two complementary studies.

The first analyzed imaging and medical records data from almost 300 individuals who had PET/CT brain imaging, primarily for cancer screening, using a radiopharmaceutical called FDG that both measures the activity of areas within the brain and reflects inflammation within arteries.  All participants in that study had no active cancer or cardiovascular disease at the time of imaging and each had information in their medical records on at least three additional clinical visits after imaging.

The second study enrolled 13 individuals with a history of post-traumatic stress disorder, who were evaluated for their current levels of perceived stress and received FDG-PET scanning to measure both amygdala activity and arterial inflammation.

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Gastric Bypass Surgery Improves Quality of Life For Obese Teenagers, But Complications Not Rare

MedicalResearch.com Interview with:
Dr Thomas H. Inge MD

University of Colorado Denver School of Medicine
Aurora, CO 80045

MedicalResearch.com: What is the background for this study?

Response: Gastric bypass surgery helps severely obese teenagers lose weight and keep it off, according to the first long term follow up studies of teenagers who had undergone the procedure 5-12 years earlier. However, the studies show some patients will need further surgery to deal with complications or may develop vitamin deficiencies later in life, according to two studies published in The Lancet Diabetes & Endocrinology.
Severe obesity is classified as having a BMI of 40 or over (around 100 pounds overweight) and affects around 4.6 million children and teenagers in the USA. It causes ill health, poor quality of life and cuts life expectancy.

The studies are the first to look at long-term effects of gastric bypass surgery in teenagers. Until now, it has been unclear how successful the surgery is in the long-term and whether it can lead to complications. Thousands of teenagers are offered surgical treatment each year.

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Gastric Bypass Surgery Found Safe and Effective in Adolescent Severe Obesity

MedicalResearch.com Interview with:
Dr Torsten Olbers PhD

Department of Gastrosurgical Research
Institute of Clinical Sciences
University of Gothenburg, Sahlgrenska University Hospital
Gothenburg Sweden 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The background to study was the lack of effective treatments for adolescents with severe obesity and the observation that many adults undergoing gastric bypass regret that they didn’t´t do it earlier.

The medical indication is to hopefully prevent development of diseases and organ damage due to cardiovascular risk factors and to enable them to have normalised psychosocial development (education, relation etc).

In fact most of the adolescents undergoing surgery had parents having undergone surgery.

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Living Near Major Roads Associated With Increased Dementia Risk

MedicalResearch.com Interview with:

Hong Chen, PhD Scientist, Environmental Health Assessment Public Health Ontario | Santé publique Ontario Assistant Professor, Dalla Lana School of Public Health, University of Toronto Adjunct Scientist, Institute for Clinical Evaluative Sciences (ICES) Toronto, ON

Dr. Hong Chen

Hong Chen, PhD
Scientist, Environmental Health Assessment
Public Health Ontario | Santé publique Ontario
Assistant Professor, Dalla Lana School of Public Health
University of Toronto
Adjunct Scientist, Institute for Clinical Evaluative Sciences
Toronto, ON

MedicalResearch.com: What is the background for this study?

Response: Over the past several decades, there is unequivocal evidence that living close to major roadways may lead to various adverse health outcomes, such as cardio-respiratory related mortality and mortality. In the past decade, concern is growing that exposures associated with traffic such as air pollution and noise may also have an adverse impact on brain health. Several experimental studies show that air pollutants and diesel exhaust induce oxidative stress and neuroinflammation, activate microglia (which act as the first and main form of immune defense in the central nervous system), and stimulate neural antibodies. There are also a small number of epidemiological studies linking traffic-related noise and air pollution to cognitive decline and increased incidence of Parkinson’s disease and Alzheimer’s disease.

Studies also showed that living near roads was associated with reduced white matter hyperintensity volume and cognition, but its effect on the incidence of dementia, Parkinson’s disease, and multiple sclerosis is unknown. Given hundreds of millions of people worldwide live close to major roads, we conducted this population-based cohort study to investigate the association between residential proximity to major roadways and the incidence of these three neurological diseases in Ontario, Canada.

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Infections in Infancy, Not Antibiotics Associated With Childhood Obesity

MedicalResearch.com Interview with:

De-Kun Li, MD, PhD Senior Research Scientist Division of Research Kaiser Foundation Research Institute Kaiser Permanente Oakland, CA 94612

Dr. De-Kun Li,

De-Kun Li, MD, PhD
Senior Research Scientist
Division of Research
Kaiser Foundation Research Institute
Kaiser Permanente
Oakland, CA 94612

MedicalResearch.com: What is the background for this study?

Response: The composition of gut microbia (microbiome) has emerged as a key contributor to human disease risk. The external influence on the composition of microbiome in early childhood, especially in infancy, has been linked to increased risk of childhood obesity. Several studies have examined use of antibiotics in infancy and reported an association between use of antibiotics and increased risk of childhood obesity. This has caused a great uncertainty among both pediatricians and parents regarding treatment of infant infections. However, the previous studies failed to separate the effect of underlying infections for which antibiotics were used from the effect of the antibiotics itself. The contribution of our study was to examine the effects of infections and antibiotic use separately.

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Incidence, Risk factors and Prevention of Hepatitis C Reinfection

MedicalResearch.com Interview with:
Naveed Zafar Janjua, MBBS, MSc, DrPH
Senior Scientist, Clinical Prevention Services
BC Centre for Disease Control
Clinical Associate Professor, School of Population and Public Health
University of British Columbia

MedicalResearch.com: What is the background for this study?

Response: Hepatitis C is a viral infection that affects the liver. About quarter of people infected with hepatitis C clear their infection spontaneously rest develop chronic infection. Left untreated, hepatitis C could results in scarring of liver (liver cirrhosis), liver cancer or death. New anti-viral drugs are highly effective in curing hepatitis C, about than 95 per cent of those treated can be cured. However, people who engage in high risk activities such as people who inject drugs (PWID) remain at risk of reinfection. As the cost of treatment is very high, re-infection is a concern among physicians and policy makers in Canada and around the world.

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Vandetanib Had Antitumor Activity In RET-rearranged NSC Lung Cancer

MedicalResearch.com Interview with:
Dr Kiyotaka Yoh

Department of Thoracic Oncology
National Cancer Center Hospital East
Kashiwa, Japan

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: LURET is multicenter, single-arm, phase II study to evaluate the efficacy and safety of vandetanib as RET inhibitor in patients with advanced RET-rearranged non-small-cell lung cancer (NSCLC). In 2012, RET rearrangements were identified as rare oncogenic alterations for NSCLC.

Among 17 eligible patients included in primary analysis, the objective response rate was 53% (95% CI 28–77), which met the primary endpoint. At the data cutoff, median progression-free survival was 4.7 months (95% CI 2.8–8.5). Overall, vandetanib was tolerated, with an adverse event profile similar to those seen in previous large population studies of vandetanib in patients with unselected NSCLC.

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Study Supports Mesh Surgery for Incontinence But Not for Bowel or Bladder Prolapse

MedicalResearch.com Interview with:
Dr Rachael Wood PhD

Consultant in Public Health Medicine – women and children’s health
NHS National Services Scotland
Information Services Division
Edinburgh

MedicalResearch.com: What is the background for this study?

Response: Mesh surgery for female stress urinary incontinence and pelvic organ prolapse is currently controversial.

Mesh surgery was introduced to overcome recognised limitations of traditional, non-mesh, surgery for these conditions, in particular extensive surgery and long hospital stays for incontinence and high failure/recurrence rates for prolapse. Mesh surgery may therefore offer additional benefits over traditional surgery. Mesh surgery may also carry additional risks however, with patient advocacy groups highlighting cases of severe, long term, mesh-related complications in some women who have undergone mesh surgery.

We therefore used routinely available, population based hospital discharge records from Scotland to identify women having mesh and non-mesh procedures for incontinence and prolapse. We then followed the women up for up to 5 years to assess how often they were readmitted for complications or further incontinence or prolapse surgery.

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Photodynamic Therapy May Be Useful In Some Low-Risk Prostate Cancer

MedicalResearch.com Interview with:
Prof Mark Emberton
UCL Faculty of Medical Sciences
London

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The key driver was a desire to come up with a treatment for men with localised prostate cancer that was better tolerated that the traditional options. The intervention is a combination of padeliporphin, a short acting photosensitiser which was developed by Drs Shertz and Salomon at the Weismann Institute. This is activated by a laser inserted into the prostate.

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Genetic Predisposition To Schizophrenia Associated With Childhood Impairments

MedicalResearch.com Interview with:
Dr Lucy Riglin

Division of Psychological Medicine and Clinical Neurosciences
MRC Centre for Neuropsychiatric Genetics and Genomics
Cardiff University School of Medicine
Cardiff UK

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Schizophrenia is a mental disorder that usually occurs after puberty. However, previous research suggests that individuals who go on to develop schizophrenia often presented cognitive, social, behavioural, and emotional impairments in childhood.

Our study found that, in a general population sample, genetic risk for schizophrenia was associated with these childhood impairments as early as age 4 years.

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Study Finds No Clear Benefit of Mesh For Prolapse Surgery

MedicalResearch.com Interview with:

Prof. Cathryn Glazener PhD Health Services Research Unit University of Aberdeen Aberdeen,UK

Prof. Cathryn Glazener

Prof. Cathryn Glazener PhD
Health Services Research Unit
University of Aberdeen
Aberdeen,UK

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Prolapse is a condition that affects up to half of all women after childbirth. Women notice a bulge or discomfort in their vaginas due to pressure from the bladder, bowel or womb moving downwards. Women who have surgery for their prolapse have a 3 in 10 chance of needing at least one more operation, so the success rate is not great. Gynaecologists hoped that by reinforcing their repairs the success rate would get better.

PROSPECT was a pragmatic, multicentre randomised controlled trial conducted in 35 centres across the UK. Women undergoing their first operation for prolapse were randomised to having a standard repair of the front or back wall of the vagina, or a repair reinforced by synthetic non-absorbable mesh, or a biological graft.
We found that, in contrast to previous research, women were just as likely to be cured after standard surgery rather than reinforced repairs. They were just as likely to have other symptoms such as bladder or sexual problems, and other adverse effects such as infection, bleeding or pain.

However, about 1 in 10 of the women who had mesh did have mesh exposure when a small portion of the mesh becomes visible through the vaginal wall. Although many women did not have symptoms, about half of those women needed a small operation to remove or bury the exposed mesh.

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Peripheral IV Lines Linked To Lower Risk of Blood Clots After Transfusion

MedicalResearch.com Interview with:
Mary A.M. Rogers, PhD, MS

Research Associate Professor
Research Director, Patient Safety Enhancement Program
Department of Internal Medicine
University of Michigan
Ann Arbor, MI

MedicalResearch.com: What is the background for this study?

Response: Peripherally inserted central catheters (PICCs) are commonly used for vascular access in hospitalized patients. Previous studies have shown that PICCs of larger gauge (diameter) increase the risk of developing venous thromboembolism (blood clots in the deep veins that sometimes travel to the lung). Red blood cell transfusion is also known to increase the risk of venous thromboembolism. Because PICCs are often used to transfuse blood, we designed a study to investigate whether the method of transfusion delivery influences the risk of developing venous thromboembolism.

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New Protocol To Allow Rapid Steroid Reduction After Kidney Transplantation

MedicalResearch.com Interview with:
Prof. Dr. med. Christian Hugo
Head, Division of Nephrology
Medical Clinic III
Universitätsklinikum Carl Gustav Carus
an der Technischen Universität Dresden
Dresden

MedicalResearch.com: What is the background for this study?

Response: At the end of 2007, the harmony trial was designed predominantly based on the one year results of the ELITE-Symphony trial, demonstrating that low dose tacrolimus, mycophenolate mofetile, and steroids together with monoclonal interleukin-2-receptor (CD 25 antigen) antibody induction therapy has superior efficacy in renal transplant patients compared to all other regimens (low or normal dose cyclosporine or sirolimus) tested. While these advantages of the low dose tacrolimus protocol were so convincing to become the new gold standard of immunosuppressive therapy within the next few years (see KDIGO guide lines for renal transplantation in 2009), the low dose tacrolimus treatment arm also demonstrated increased incidence rates regarding post-transplantation diabetes mellitus (PTDM, at that time called new onset of diabetes after transplantation – NODAT) compared to the low cyclosporine treatment arm. Previous studies had also demonstrated a detrimental association between NODAT and cardiovascular events and mortality, the leading cause of death in renal transplant recipients. Corticosteroid-free or rapid withdrawal regimens were relatively encouraging regarding influencing NODAT rates but only at the price of an increased rate of T cell mediated acute rejections.

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Short Interventions By Primary Care Physicians Can Help Patients Lose Weight

MedicalResearch.com Interview with:

Paul Aveyard PhD MRCP FRCGP FFPH Professor of Behavioural Medicine Nuffield Department of Primary Care Health Sciences University of Oxford Radcliffe Primary Care Building Radcliffe Observatory Quarter Oxford

Prof. Paul Aveyard

Paul Aveyard PhD MRCP FRCGP FFPH
Professor of Behavioural Medicine
Nuffield Department of Primary Care Health Sciences
University of Oxford
Radcliffe Primary Care Building
Radcliffe Observatory Quarter
Oxford

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: We know that opportunistic brief interventions by physicians can be effective, but there is no evidence that they are so for obesity. Physicians worry that broaching this topic will be offensive, time-consuming, and ineffective. We needed a randomised trial to assess whether physicians’ fears were justified, or in fact brief interventions could be as effective for patients who are overweight as they are for smoking or problem drinking and that’s what we did.

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Early Parent-Focused Interventions Improved Communication Skills in Autistic Children

MedicalResearch.com Interview with:

Prof. Tony Charman Chair in Clinical Child Psychology King's College London, Institute of Psychiatry, Psychology & Neuroscience (IoPPN) Department of Psychology PO77, Henry Wellcome Building De Crespigny Park Denmark Hill London

Prof. Tony Charman

Prof. Tony Charman
Chair in Clinical Child Psychology
King’s College London, Institute of Psychiatry, Psychology & Neuroscience (IoPPN)
Department of Psychology
PO77, Henry Wellcome Building
De Crespigny Park
Denmark Hill London

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The study is a follow-up of a treatment trial on which we have previous reported. In the original Preschool Autism Communication Trial (PACT), 152 children aged 2-4 with autism were randomised to receive the 12 month early intervention or treatment as usual. The type of early intervention used in this study focuses specifically on working with parents. Through watching videos of themselves interacting with their child and receiving feedback from therapists, parents are able to enhance their awareness and response to their child’s unusual patterns of communication; they become better able to understand their child and communicate back appropriately in a focused way. Parents take part in 12 therapy sessions over 6 months, followed by monthly support sessions for the next 6 months. In addition, parents agree to do 20-30 minutes per day of planned communication and play activities with the child.

The study published today is the follow-up analysis of the same children approximately 6 years after the end of treatment. The main findings are that children who had received the PACT intervention aged 2-4 had less severe overall symptoms six years later, compared to children who only received ’treatment as usual’ (TAU) with improved social communication and reduced repetitive behaviours, although no changes were seen in other areas such as language or anxiety. These findings on an international recognised and blind rated observational measure of autism symptoms were accompanied by improvements in children’s communication with their parents for the intervention group, but no differences in the language scores of children. Additionally, parents in the intervention group reported improvements in peer relationships, social communication and repetitive behaviours. However, there was no significant difference between the two groups on measures of child anxiety, challenging behaviours (eg, conduct/oppositional disorder) or depression.

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Stem Cells From Nose Used To Repair Knee Cartilage

MedicalResearch.com Interview with:

Professor Ivan Martin, PhD Department of Surgery and Department of Biomedicine University Hospital Basel University of Basel, Basel, Switzerland

Prof. Ivan Martin

Professor Ivan Martin, PhD
Department of Surgery and Department of Biomedicine
University Hospital Basel
University of Basel
Basel, Switzerland

MedicalResearch.com: What is the background for this study and new use of autologous nasal chondrocytes?

Response: We previously demonstrated that nasal chondrocytes, harvested from the nasal septum, have a larger and more reproducible capacity to form new cartilage than articular chondrocytes, harvested from the knee joint. We further established that the cartilage tissue generated by nasal chondrocytes can respond to physical forces (mechanical loads) similar to articular cartilage and has the ‘plasticity’ to adapt to a joint environment, since it efficiently integrated with surrounding articular cartilage when implanted in goat joints. This was the rationale for using nasal chondrocytes for articular cartilage repair.

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Cost Analysis of Exposure to Endocrine-Disrupting Chemicals in US

MedicalResearch.com Interview with:
Teresa Attina, MD, PhD
Research Scientist
NYU Langone School of Medicine
Department of Pediatrics
New York, NY 10016

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Endocrine-disrupting chemicals (EDCs) have been recently documented to contribute substantially to disease and dysfunction in the European Union (EU), with an annual estimated cost of €163 billion, corresponding to 1.28% of EU Gross Domestic Product. Our current study documents even greater annual costs in the US, $340 billion, corresponding to 2.33% of US GDP. These findings speak to the large health and economic benefits to regulating EDCs, which should be weighed against the cost of safer alternatives.

The different costs between the EU and the US are due to different exposure levels to EDCs, and policy predicts exposure. US costs are higher mainly because of the widespread use of brominated flame retardants in furniture, whereas Europe restricted its use in 2008. Americans have much higher levels, such that the average American has a serum level of these chemicals that would be in the top 5% of Europeans. As a result, children born to pregnant women have lower IQs, such that more children suffer from intellectual disability.

On the other hand, in Americans, levels of certain pesticides in foods are much lower due to the Food Quality Protection Act, which requires additional safety thresholds to protect pregnant women and children from exposure. The costs of pesticide exposures in the US were much lower ($12.6 billion) compared to Europe ($121 billion) because fewer children suffer loss of IQ as a result.

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