Dr. Chris Malley[/caption]
Chris Malley PhD
The Stockholm Environment Institute
University of York
MedicalResearch.com: What is the background for this study?
Response: When a baby is born preterm (at less than 37 weeks of gestation, an indicator of premature birth), there is an increased risk of infant death, or long-term physical and neurological disabilities. For example, 965,000 infant deaths in 2013 (35% of all neonatal deaths) have been estimated to be due to preterm birth complications. In 2010, an estimated 14.9 million births were preterm – about 4–5% of the total in some European countries, but up to 15–18% in some African and South Asian countries. The human and economic costs are enormous.
There are many risk factors for preterm birth – from the mother’s age, to illness, to poverty and other social factors. Recent research has suggested that exposure to air pollution could also be a risk factor. Our study quantifies for the first time the global impact of pregnant women's exposure to outdoor fine particulate matter (PM2.5) by combining data about air pollution in different countries with knowledge about how exposure to different levels of air pollution is associated with preterm birth rates.
Dr. Andrew Fenelon[/caption]
Andrew Fenelon PhD
Assistant Professor, Department of Health Services Administration
University of Maryland School of Public Health.
College Park, MD 20742
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Despite the relatively large public investment in housing assistance at the federal level, there have been few nationwide analyses of the impacts of these programs on health and well-being. And as policymakers seek solutions to health disparities that incorporate some of the non-medical determinants of health (such as housing quality), our study can make an important contribution to both health and housing policy.
We use an innovative data linkage program which links individuals in a federal household health survey and administrative housing records from the U.S. Department of Housing and Urban Development (HUD). We examine the health impacts of three HUD housing programs: public housing, housing choice vouchers, and multifamily housing. We find that public housing and multifamily housing lead to an improvement in self-reported health status, and public housing leads to a reduction in serious psychological distress. We do not find health impacts associated with housing choice vouchers.
Dr. Linard Filli[/caption]
Linard Filli, PhD
Gait Research Lab
Department of Neurology
University Hospital Zurich
Zürich
MedicalResearch.com: What is the background for this study?
Response: Gait dysfunction is common in patients with multiple sclerosis (MS) and is perceived as the most restricting of symptoms. Fampridine (4-aminopyridine, dalfampridine), a blocker of voltage-gated potassium channels, is currently the only approved medication for the symptomatic treatment of walking disorders in patients in both the early and late phases of multiple sclerosis.
Dr Sophie Jacqueminet[/caption]
Dr Sophie Jacqueminet
Praticien Hospitalier
Service de Diabétologie
Pole Cardio Métabolisme
Hôpitaux Universitaires
Pitié Salpêtrière - Charles Foix
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: The proportion of women who are overweight or obese is increasing in almost all countries worldwide, and this is being accompanied by an increased risk of developing both type 2 diabetes (T2D) (whether pregnant or not) and gestational diabetes (GDM). While other studies have analysed the links between GDM and adverse outcomes in babies, very large studies that draw on an entire national database, study, are rare.
In our research, all 796,346 deliveries taking place after 22 weeks in France in 2012 were included by extracting data from the hospital discharge database and the national health insurance system. Outcomes were analysed according to the type of diabetes and, in the GDM group, whether or not diabetes was insulin-treated.
The cohort of 796,346 deliveries involved 57,629 (7.24%) mothers with gestational diabetes mellitus. Data linking the mother to the child were available for 705,198 deliveries (88% of the total). The risks of adverse outcomes were two to four times higher for babies of mothers with type 2 diabetes before pregnancy (pregestational diabetes) than for those with GDM. We then adjusted our data, limiting the analysis to deliveries after 28 weeks to ensure all women diagnosed with GDM were included (since diagnosis of GDM in most cases takes place at or after 28 weeks).
Following adjustment, the increased risk of various complications for mothers with gestational diabetes versus mothers without GDM were: preterm birth 30%; Caesarean section 40%; pre-eclampsia/eclampsia 70%; babies born significantly larger than average size (macrosomia) 80%; respiratory distress 10%; birth trauma 30%; and cardiac malformations 30%. While these increased risks combine women with both insulin- and diet-treated GDM, most of the increased risk is found in women with insulin-treated GDM. This is because as stated above, the diabetes is more serious and blood sugar more difficult to control in women who need insulin treatment, resulting in a higher risk of complications than in those women treated with diet only.
Dr. John Gore[/caption]
Dr. John L. Gore, MD
Associate Professor
Adjunct Associate Professor-Surgery
Department of Urology
University of Washington
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: The rationale for our study derives from the uncertainty that both patients and clinicians confront when trying to make decisions about adjuvant therapy for prostate cancers found to have aggressive pathologic features at the time of radical prostatectomy. There is level 1 evidence in support of adjuvant radiation therapy in this setting, but several factors restrain providers from recommending adjuvant radiation. We found that interjecting a genomic test that predicts the risk of clinical metastases 5 years after surgery impacts the treatment recommended and helps men and clinicians feel more confident in the decision they are making or recommending.
Dr. James Udelson[/caption]
James E. Udelson, MD
Chief, Division of Cardiology
Director, Nuclear Cardiology Laboratory
Professor, Tufts University School of Medicine
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: There are millions of stress tests done every year in the United States and many of them are normal,” said James Udelson, MD, Chief of the Division of Cardiology at Tufts Medical Center and the senior investigator on the study. “We thought that if we could predict the outcome of these tests by using information we already had from the patient before the test, we could potentially save the health care system money and save our patients time and worry.” We were able to get a strong prediction of the possibility of having entirely normal testing and no clinical events such as a heart attack, by developing a risk prediction tool using ten clinical variables that are commonly available to a physician during an evaluation”
Dr. Vashi[/caption]
Neelam A. Vashi, MD
Assistant Professor of Dermatology
Boston University Center of Ethnic Skin and
[caption id="attachment_32217" align="alignleft" width="125"]
Dr.-Maymone[/caption]
Mayra B. C Maymone, MD, DSc
Doctor of Science, Dermatology
Boston University School of Medicine
Boston, MA
MedicalResearch.com: What is the background for this study?
What are the main findings?
Response: Disorders of hyperpigmentation are common in clinical practice and frequently observed in dark-skinned individuals, a subset of the population that reportedly engages less with sunscreen use and other sun-protective behaviors. With the expected shift in US demographics to become a more racially and ethnically diverse population, there is growing interest in finding out more about the sun-protective habits in those with cutaneous hyperpigmentation.
In this cross-sectional study, we found a surprisingly high rate of sunscreen use (67.5%). This is much higher than that observed in the general population and similar to rates observed in individuals with photosensitive disorders and skin cancer. However, the frequency of sunscreen reapplication and other sun-protective measures such as seeking shade and wearing hats were less commonly adopted in our study participants, emphasizing that even in a highly motivated population there is still room for improvement.
Dr. Carla Bann[/caption]
Carla M. Bann, Ph.D.
Division of Statistical and Data Sciences
RTI International
Research Triangle Park, NC
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Several medical advances have been made over the past two decades to improve the care and survival of infants born pre-term. However, approaches to care differ greatly among providers for infants born at the limits of viability (22 to 24 weeks gestation), far earlier than the 40 weeks generally expected for a pregnancy to reach full-term. Little is known about the outcomes of these infants, particularly whether those who survive experience significant neurodevelopmental impairments.
RTI served as the data coordinating center for this research that examined the survival and neurodevelopmental impairment at 18-22 months corrected age of over 4,000 infants born at 22 to 24 weeks gestation during 2000 to 2011 at medical centers participating in a national research network funded by the NIH. In this group of babies, infant survival improved over time from survival rates of 30 percent in 2000-2003 to 36 percent in 2008-2011. The proportion of infants who survived without a neurodevelopmental impairment also increased from 16 percent in 2000-2003 to 20 percent in 2008-2011.
Prof. Ghofrani[/caption]
Prof. Hossein-Ardeschir Ghofrani
University of Giessen and Marburg Lung Center
Giessen, Germany, and
Member of the German Center of Lung Research
and Department of Medicine
Imperial College London
London, UK
MedicalResearch.com: What is the background for this study?
Response: Pulmonary arterial hypertension (PAH) is characterised by increased pulmonary vascular resistance (increased resistance to blood flow in the pulmonary circulation), which can lead to right heart failure and death. Riociguat is the first of a new class of drugs – the soluble guanylate cyclase stimulators. It has been approved for the treatment of PAH based on the impressive efficacy and safety results from two pivotal Phase III studies: PATENT-1 and its long-term extension phase, PATENT-2. PATENT-1 was a 12-week, double-blind, randomized, placebo-controlled trial to evaluate the safety and efficacy of riociguat in patients with PAH. Patients who completed PATENT-1 without ongoing riociguat-related serious adverse events (AEs) could enter PATENT-2, in which they received open-label riociguat. PATENT-1 admitted patients whether they were treatment-naïve or already receiving targeted PAH therapies, such as endothelin receptor antagonists (ERAs) and prostanoids. This current analysis compared the safety and efficacy of riociguat between treatment-naïve and pretreated patients in the PATENT-2 long-term extension study.
Dr. Brian Wong[/caption]
Brian J. F. Wong, MD, PhD
Division of Facial Plastic and Reconstructive Surgery
Department of Otolaryngology–Head and Neck Surgery
Beckman Laser Institute and Medical Clinic
Department of Biomedical Engineering
University of California, Irvine
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Research in facial attractiveness is difficult because of the inherent subjectivity of rating. Most people can look at a face and instinctively tell you whether that face is attractive or not, by subconsciously picking up on biologic cues like fertility, coloration, and proportions.
MedicalResearch.com Interview with: [caption id="attachment_32158" align="alignleft" width="133"] Dr. Won Kyung Song[/caption] Won Kyung Song MD.PhD Assistant Professor, Vitreoretinal service, Department of Ophthalmology CHA Bundang Medical Center CHA University Republic of Korea MedicalResearch.com: What is the background for this study? What are the main findings? Response: The retina is a light-sensitive neural tissue lining the inner surface of...
Dr. Carlos Barcenas[/caption]
Carlos H. Barcenas M.D., M.Sc.
Assistant Professor
Department of Breast Medical Oncology
MD Anderson Cancer Center
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Over the last decade we have realized that we were over-treating many early stage breast cancer patients. In addition to the chemotherapy’s obvious side effects, there are also long term complications for breast cancer survivors. Since 2005, we are using a 21-gene-expression assay that predicts the risk of distant recurrence among early stage breast cancer patients. In 2015, initial results from the international clinical trial, TAILORx, found that women with hormone receptor positive, HER2 and lymph node negative early stage disease that had a low recurrence score (RS) of 0-10 from this assay could have chemotherapy omitted altogether. While these findings changed care for women with a low RS, questions remain regarding the management of women with an intermediate RS, defined by this trial as a RS of 11-25. For our retrospective, single-institution study we identified 1,424 stage I and II breast cancer patients with hormone receptor positive, HER2 and lymph node negative treated between 2005 and 2011 who underwent the 21-gene expression assay. The RS distribution was: 297 (21 percent) scored 0–10; 894 (63 percent) scored 11-25; and 233 (16 percent) scored >25.
Of those groups, 1.7, 15 and 73.4 percent received chemotherapy, respectively. With a median follow up of 58 months, those with a RS of 11-25 had an invasive disease-free survival (IDFS) rate at five years of 92.6 percent, regardless if patients received chemotherapy or not. Among those patients who did not receive chemotherapy, the estimated rates of IDFS and overall survival was 93 percent and 98 percent, respectively, which was comparable to those who did receive chemotherapy.
Dr. Brinda Emu[/caption]
Brinda Emu MD
Assistant Professor of Medicine (Infectious Diseases
Yale University
New Haven, CT
MedicalResearch.com: What is the background for this study?
Response: Ibalizumab is a fully humanized monoclonal antibody that targets the CD4 receptor. This Phase III registrational study enrolled individuals with HIV infection that harbor high levels of multi-drug resistance, with limited treatment options. At IDWeek in October, 2016, data was presented that demonstrated patients experienced a significant decrease in viral load after receiving a single loading dose of ibalizumab 2,000 mg intravenously (IV) in addition to their failing antiretroviral therapies (ART) (or no therapy). Seven days after this loading dose, 83% of patients achieved a ≥ 0.5 log10 decrease from baseline compared with 3% during the seven-day control period .These results were statistically significant (p<0.0001).
At CROI, additional data on the Week 24 results from this study are now presented.
Dr. Kevin Kavanagh[/caption]
Kevin Kavanagh, MD, MS
Board Chairman of Health Watch USA
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: The genesis of our study was a desire to respond to a keynote speech at a major national patient safety conference which seemed to mitigate the problem of preventable hospital mortality in the United States.
Our main finding is that there is credible evidence indicating that the preventable hospital mortality rate is more than 160,000 per year. When one considers the events which were not captured, and that we did not count diagnostic errors or post-discharge presentation of events, this number can be projected to approximate or exceed 200,000.
Dr. Michael Krychman[/caption]
Dr. Krychman is Executive Director, President, and CEO of the Southern California Center for Sexual Health and Survivorship Medicine and Associate Clinical Professor at the University of California, Irvine, Department of Obstetrics and Gynecology. He is a Member of the International Society for the Study of Women’s Sexual Health (ISSWSH), The International Society for Sexual Medicine (ISSM) and a Certified Sexual Counselor by the American Association of Sexuality Educators, Counselors and Therapists (AASECT). He served as a member of the Standards Committee for the International Society for Sexual Medicine during their 2016 International Consensus Meeting.
MedicalResearch.com: What is the background for this technology and study? What are the main findings?
Response: Viveve Medical, Inc. is a women's health and wellness company committed to advancing new solutions to improve women's overall well-being and quality of life. The internationally patented Viveve® technology and the GENEVEVE™ treatment, incorporates clinically-proven, cryogen-cooled monopolar radiofrequency (CMRF) energy to uniformly deliver non-ablative, deep penetrating volumetric heat into the submucosal layer of the vaginal introitus (opening) while gently cooling surface tissue to generate robust neocollagenesis. One 30-minute in-office session tightens and restores the tissue around the vaginal introitus addressing the common medical condition of vaginal laxity and can improve a woman’s sexual function.
VIVEVE I is a landmark study. Results of the VIVEVE I clinical study, "Effect of Single-Treatment, Surface-Cooled Radiofrequency Therapy on Vaginal Laxity and Female Sexual Function: The VIVEVE I Randomized Controlled Trial," were recently published in the February 2017 issue of the Journal of Sexual Medicine (JSM) under the Female Sexual Function category. Some of my high-level thoughts to reiterate from this study are:
It is the first-ever large, randomized, sham-controlled study to demonstrate the safety and efficacy of energy-based procedures in gynecological applications, including vaginal laxity, which is a significant medical condition affecting millions of women worldwide that may lead to a reduction in sexual function.
The primary endpoint of the VIVEVE I study was a comparison of the proportion of women reporting no vaginal laxity in the treatment group versus the sham group at 6 months post-treatment.
Subjects receiving the active treatment were three times more likely to report no vaginal laxity at six months versus the sham group (p-value = 0.006).
Statistically significant and sustained improvement in sexual function (baseline FSFI total score ≤26.5) after a single treatment, with an adjusted mean difference in the active group vs sham group of 3.2 at 6 months (p-value = 0.009). "Placebo Effect" in the sham group did not rise above dysfunctional (FSFI ≤26.5) and diminished at 6 months.
Statistically significant improvement in sexual function was achieved in 93% of subjects in the active group vs the sham group in two individual key domains of FSFI (p-value = 0.007).
Bottom line: Geneveve is a safe effective treatment that can be performed as an outpatient in one 30-minute visit to improve sexual function as it has been affected by vaginal laxity.
Dr. Corrine Voils,[/caption]
Corrine I. Voils, PhD
Research Career Scientist, William S Middleton Veterans Memorial Hospital
Visiting Professor of Surgery, University of Wisconsin-Madison
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Weight loss interventions can help people lose weight, but most people tend to regain weight after a weight loss period. There is a need to identify effective strategies to help people maintain weight loss. We found that an intervention focused on maintenance behavioral skills that was delivered primarily by telephone reduced weight regain compared to usual care over 56 weeks.
Margaret Rosenzweig[/caption]
Margaret Q. Rosenzweig PhD, CRNP-C, AOCNP, FAAN
Acute and Tertiary Care Department
University of Pittsburgh School of Nursing
MedicalResearch.com: What is the background for this study?
Response: A significant survival disparity still exists between African American and non-Hispanic white women diagnosed with breast cancer. There is evidence that symptom incidence, associated distress, and overall cancer-related distress may be unexplored, important contributing factors. The current study was a secondary, exploratory aim from the Attitudes, Communication, Treatment, and Support (ACTS) Intervention to Reduce Breast Cancer Treatment Disparity study, which is a randomized controlled trial of a psychoeducational intervention to encourage acceptance and adherence to chemotherapy compared with usual care for African American women with breast cancer. The purpose of the current study was to:
1) describe and compare the number of chemotherapy-related symptoms and associated distress among AA women with breast cancer over the course of chemotherapy at 3 time points (at baseline before initiating chemotherapy, midpoint, and at the completion of chemotherapy); and
2) to describe the relationship between the number of chemotherapy-related symptoms and overall cancer distress compared with the ability to receive at least 85% of the prescribed chemotherapy within the prescribed timeframe.
Dr. Rachel Wuerstlein[/caption]
Dr. med. Rachel Würstlein
Senior Specialist
Clinic and Polyclinic for Obstetrics and Gynecology
Klinikum der Ludwig-Maximilians-Universität München • Campus Innenstadt
Munich
MedicalResearch.com: What is the background for this study?
Response: Gene expression profiles provide important information on the risk of recurrence, and subtyping in HR+ HER2- early breast cancer, in addition to conventional clinicopathological factors. The PRIMe study was performed by the West German Study Group (WSG) and prospectively investigated the impact of the gene expression tests MammaPrint, a 70-Gene Breast Cancer Recurrence Assay, and the corresponding 80-Gene Molecular Subtyping Assay, BluePrint, on adjuvant chemotherapy decisions for early-stage breast cancer patients.
To do this, a risk assessment (chemotherapy followed by endocrine therapy, versus endocrine therapy alone) for distant metastasis was performed in 452 patients from 27 study centers using conventional clinicopathological factors such as tumour size and grade first, then compared to the results of the gene expression tests MammaPrint and BluePrint. Doctors and patients then reviewed the results and made a decision on the optimal treatment plan, namely in deciding whether or not patients would benefit from, and should therefore be treated with adjuvant chemotherapy.
Olga Khavjou[/caption]
Olga Khavjou
RTI International
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Cardiovascular disease (CVD) is the leading cause of death in the United States and is one of the costliest chronic diseases. As the population ages, CVD costs are expected to increase substantially. To improve cardiovascular health and control health care costs, we must understand future prevalence and costs of CVD.
In 2015, 41.5% (more than 100 million people) of the U.S population was estimated to have some form of CVD. By 2035, the number of people with CVD is projected to increase to over 130 million people, representing a 30% increase in the number of people with CVD over the next 20 years. Between 2015 and 2035, real total direct medical costs of CVD are projected to more than double from $318 billion to $749 billion and real indirect costs (due to productivity losses) are projected to increase from $237 billion to $368 billion. Total costs (medical and indirect) are projected to more than double from $555 billion in 2015 to $1.1 trillion in 2035.
Pedro González Muniesa
Director of International Relations of Human Nutrition and Dietetics
Universidad de Navarra
Nutrition Research Center / Dpt. Nutrition, Food Science and Physiology
School of Pharmacy / University of Navarra
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Several other studies have reported lower incidence rates of conditions linked to MetS such as obesity (Díaz-Gutiérrez et al.,2016; Voss et al., 2013; Woolcott et al., 2014), heart disease (Ezzati et al., 2012; Faeh et al., 2016), hypertension (Norboo et al., 2015) or type 2 diabetes (Woolcott et al., 2014) on subjects living at high altitudes.
To our knowledge this is the first study that has found a protective effect on living at a higher altitude against metabolic syndrome, and it is one of the very few that has found this effect at a median altitude of less than 600 meters.
Dr. Julie Nangia[/caption]
Julie Rani Nangia, M.D.
Assistant Professor
Breast Center - Clinic
Baylor College of Medicine
Houston, TX, US
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: This study was fueled by the feedback from women undergoing chemotherapy treatment for breast cancer. One of the most distressing side effects of their treatment is hair loss. It robs them of their anonymity and, for many, their femininity. Scalp cooling therapy has been available for a few years in the UK, but has faced obstacles in FDA clearance in the states. The makers of the scalp cooling device used in this study, Paxman Coolers Ltd., have a personal connection to breast cancer, as the company founder’s wife passed away from the disease.
This was the first randomized scalp cooling study, and it shows that the Paxman Hair Loss Prevention System is an effective therapy for reducing chemotherapy-induced alopecia. The results show a 50% increase in hair preservation of grade 0 or 1, meaning use of a scarf or wig is not necessary, in patients who received the scalp cooling therapy as opposed to those who did not.
Dr. Gavin Oudit[/caption]
Gavin Y Oudit, MD, PhD, FRCPC
Associate Professor, Department of Medicine, University of Alberta
Clinician-Scientist
Mazankowski Alberta Heart Institute
Canada Research Chair in Heart Failure
Division of Cardiology
Edmonton, Alberta
Heart specialist Gavin Oudit and his research team discovered a molecule — angiotensin converting enzyme 2 (ACE2)—that works to restore balance to the pathways responsible for chronic and acute heart failure, including in hearts from patients with advanced heart failure who underwent heart transplants.
In developing the new drug, Oudit and his team discovered to an extent not seen before how the renin-angiotensin system (RAS), which regulates the body’s sodium balance, fluid volume, and blood pressure, is at play in both acute and chronic heart failure. In collaboration with Dr. Oudit, recombinant human ACE2 was made by Apeiron Biologics, purchased by GlaxoSmithKline, and has recently completed phase II clinical trial.