Dr. Chey[/caption]
William D. Chey, M.D., F.A.C.G.
Director, Division of Gastroenterology
Michigan Medicine Gastroenterology Clinic
Ann Arbor, Michigan
MedicalResearch.com: What is the background for this study?
Response: Functional Dyspepsia (FD), which is persistent or recurring upper abdominal pain, burning, or fullness with no known organic cause, is a relatively common and often frustrating condition. The precise causes of this condition are unknown, but problems with mild inflammation, leakiness of the lining of the gut, overactive sensation, and abnormal contractions of the upper digestive tract are thought to play a role in many patients. FD often reoccurs over time and it is an area of high unmet medical need.
Functional Dyspepsia can have a significant impact on quality of life. Currently, off-label medications are used to treat FD, as there is no U.S. Food and Drug Administration (FDA)-approved pharmaceutical product for the condition.
An estimated 62 percent of FD patients suffer from Epigastric Pain Syndrome (EPS, which is epigastric pain or burning), while an estimated 73 percent of FD patients suffer from Postprandial Distress Syndrome (PDS, which is early fullness, pressure and heaviness); 35 percent suffer from both.
In this study, we compared the efficacy of a unique encapsulated formulation of caraway oil and l-Menthol, the primary component in peppermint oil), (COLM-SST) to placebo in patients taking their usual Functional Dyspepsia medications. Caraway oil contains carvone and d-limonene, which have gastroprotective and prokinetic effects; l-Menthol has anti-inflammatory, prokinetic, analgesic and gastroprotective effects.
Prof. Esteva[/caption]
Prof Francisco J Esteva MD PhD
Director of the breast medical oncology program at Perlmutter Cancer Center.
NYU Langone Medical Center
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Trastuzumab is a monoclonal antibody directed against the human epidermal growth factor receptor 2 (HER-2). Trastuzumab therapy has been shown to improve survival in patients with early-stage and metastatic her-2 positive breast cancer.
In this study, we compared the safety and efficacy of the trastuzumab originator (Herceptin) to a trastuzumab biosimilar (CT-P6) in patients with stage I-III HER-2 positive breast cancer receiving neoadjuvant chemotherapy. The study was a randomized phase III trial.
We found the pathological complete response rates were similar in both groups. Both antibodies were safe. Pharmacokinetic studies showed similar plasma concentrations for the trastuzumab originator and the proposed biosimilar.
Dr. Arora[/caption]
Manish Arora, PhD
Associate Professor
Environmental Medicine & Public Health
Icahn School of Medicine at Mount Sinai
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Autism has both genetic and environmental risk factors. Our aim was to study if exposure to toxic metals, such as lead, or disruptions in the uptake of essential nutrient elements such as manganese or zinc would be related to autism risk. Furthermore, we were interested in not only understanding how much exposure had taken place but also which developmental periods were associated with increased susceptibility to autism risk.
Researchers suspect that the risk factors for autism start early in life, even prenatally, but measuring in utero exposures is technically very challenging. We used a newly developed technique that uses lasers to map growth rings in baby teeth (like growth rings in trees) to reconstruct the history of toxic metal and essential nutrient uptake. We applied this technology in samples collected from twins, including twins who were discordant for autism. This allowed us to have some control over genetic factors.
We found that twins with autism had higher levels of lead in their teeth compared to their unaffected twin siblings. They also had lower levels of zinc and manganese. The lower uptake of zinc was restricted to approximately 10 weeks before birth to a few weeks after birth, indicating that as a critical developmental period.
Dr. Smith[/caption]
Gary Smith, MD, DrPH
Director, Center for Injury Research and Policy
Nationwide Children’s Hospital
Columbus, OH
MedicalResearch.com: What is the background for this study?
Response: Lawn mowers continue to be an important source of serious pediatric morbidity in the United States (US) with initial treatment of pediatric lawn mower-related injuries costing about $90 million annually. The long-term physical, psychological, and financial effects of these traumatic injuries can be devastating for those injured and for their families.
This study comprehensively analyzes data over a 25-year period using a nationally representative database to evaluate the epidemiologic characteristics, including mechanism of injury, of lawn mower-related injuries to children in the US. It also provides a discussion of relevant injury prevention strategies.
Dr. Anita Soni[/caption]
Anita Soni, PhD, MBA
Survey Analyst/Statistician
Agency for Healthcare Research and Quality
MedicalResearch.com: What is the background for this study?
Response: This statistical brief uses the data from the Medical Expenditure Panel Survey (MEPS), which collects a broad range of data related to the health care of the U.S. civilian noninstitutionalized population including health insurance coverage, the number and types of health care events and the sources of payment and payment amounts for those events. The survey also gathers information on which medical conditions are associated with the reported health care events. Condition-specific health care expenditure information derived from MEPS data is useful for policy makers in determining where to focus health policies to improve the quality and efficiency of the health care system from the perspective of disease treatment and management.
This Statistical Brief presents data regarding medical expenditures for nine conditions for which an estimated 10 percent or more of the U.S. civilian noninstitutionalized population (individuals age 18 and older) received health care in 2013.
Dr. Schram[/caption]
Miranda T. Schram PhD
Associate professor
Department of Medicine
Maastrich
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Late-life depression, also called vascular depression, is highly prevalent, recurrent and difficult to treat. Anti-depressants only relieve symptoms in about 50% of the patients. So we urgently need new treatment targets for this disease.
In this study we found that microvascular dysfunction, irrespective if you measure this by biomarkers in the blood or in the brain, is associated with an increased risk for depression. Moreover, we found evidence from longitudinal studies that microvascular dysfunction, at least of the brain, may actually be a cause of depression. To investigate this, we undertook a meta-analyses of data from over 40,000 individuals of whom over 9,000 had a depression.
Dr. Mahmoudi[/caption]
Elham Mahmoudi, PhD, MS
Section of Plastic Surgery, University of Michigan Medical School
Ann Arbor, Michigan
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: About one-third of all women diagnosed with breast cancer undergo mastectomy. In recent years, owing to advancements in screening and treatment, life expectancy after being diagnosed with breast cancer has increased. Research has shown that for patients who undergo mastectomy, breast reconstruction offers many psychological benefits such as improved self-esteem, reduced sexual dysfunction, decreased anxiety, and overall improvement in quality of life. After the passage of the Women’s Health and Cancer Rights Act in 1998, the coverage of post-mastectomy breast reconstruction (PBR) by any type of health insurance became mandatory. However, there are large and widening racial and ethnic disparities in PBR, with White women having a higher rate of PBR than women from other racial and ethnic groups.
In 2011, the State of New York enacted a law mandating that surgeons advise their patients undergoing mastectomy about available breast reconstruction options, insurance coverage, and referral to a plastic surgeon. We evaluated the effect of this law on racial/ethnic disparities in immediate PBR.
Our results did not show any effect on the overall rate of immediate post-mastectomy breast reconstruction or on disparities between white and African-American women; however, we found that White-Hispanic and White-other racial/ethnic group disparities in immediate PBR were reduced by 9 and 13 percentage points, respectively. This is a substantial reduction in disparity within only a year after the passage of the law, which demonstrates the importance of physician-patient communication.
Dr. Jean-François Cailhier[/caption]
Jean-François Cailhier, M.D., Ph.D., FRCP(c)
Professeur Agrégé de Clinique/ Associate Professor
Département de Médecine, Faculté de Médecine
Université de Montreal
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Milk Fat Globule Epidermal Growth Factor-8 (MFG-E8) is released by apoptotic cells and activated cells in the skin. Its effect on endothelial cells and pericytes was previously reported to accelerate wound healing.
In our wound healing model, we demonstrated that MFG-E8 was important to reprogram skin macrophages into pro-repair cells. Moreover, we demonstrated that administration of exogenous MFG-E8 was able to accelerate wound healing in WT and MFG-E8 KO mice by generating M2 macrophages. Furthermore, to highlight to importance of MFG-E8 on macrophage reprogramming, adoptive transfer of MFG-E8-treated macrophages also promoted wound healing. These pro-repair effects seem to be dependent on the production of a crucial fibroblast growth factor, basic Fibroblast Growth Factor (bFGF), by macrophages which promoted fibroblast migration and proliferation.
Dr. Bruchfeld[/caption]
Annette Bruchfeld MD, PhD Senior Consultant
Associate Professor
Karolinska Institute
Dept of Renal Medicine, M99
Karolinska University Hospital Huddinge
Stockholm, Sweden
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: In patients with stage 4–5 chronic kidney disease(CKD), hepatitis C virus (HCV) infection can accelerate the decline in kidney function, impair health-related quality of life (HRQOL), and decrease survival chances of both patients and grafts in transplantation recipients.
In this study additional data from patients with stage 4–5 chronic kidney disease undergoing treatment for HCV infection in the C-SURFER study, including HRQOL and resistance analyses was presented not previously reported for this patient population with gwnotype 1 infection.
The final virological analysis of this study indicated a high cure rate with sustained virological response at 12 weeks after the end of treatment (SVR12) in more than 98% of all treated patients. Even in patients with resistance-associated substitutions (RASs) the SVR was high in 11 (84·6%) of 13 patients genotype 1a infection.
Dr. Jalali[/caption]
Professor Rakesh Jalali, MD
Professor of Radiation Oncology
President, Indian Society of Neuro-Oncology
Tata Memorial
Parel, Mumbai India
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Randomized controlled trials to test the efficacy of radiotherapy techniques are challenging to perform. High-precision conformal techniques such as stereotactic radiosurgery/radiotherapy, intensity modulated radiotherapy (IMRT) and particle therapy, etc have been incorporated into routine clinical practice including for brain tumors without always being supported by level-1 evidence.
We therefore conducted a prospective, randomized, controlled trial of stereotactic conformal radiotherapy compared to conventional radiotherapy in young patients with residual/progressive bening and low grade brain tumors requiring radiotherapy for optimal disease control.
Dr. Clarke[/caption]
Dr. Gerard Clarke PhD
APC Microbiome Institute
Department of Psychiatry and Neurobehavioural Science
University College Cork, Cork, Ireland
MedicalResearch.com: What is the background for this study?
Response: Over the last decade or so, we and others have shown that the gut microbiome exerts a broad influence on the central nervous system, reflected in a range of abnormal behaviours and altered brain function in germ-free animals. These germ-free animals grow up in a sterile bubble and allow us to see what aspects of brain and behaviour could be under the influence of the microorganisms in our gastrointestinal tract.
One of the most consistent findings to emerge relates to anxiety-like behaviours.
MedicalResearch.com Interview with: Dr Christopher Michael Cook MBBS Bsc(Hons) MRCP MRC Clinical Research Fellow NHLI, Cardiovascular Medicine, Imperial College London MedicalResearch.com: What is the background for this study? Response: FFR-CT is a novel non-invasive technique for estimating the functional significance of a coronary stenosis from CT coronary angiography images. A number of meta-analyses already exist for determining the...
Dr. Sonawane[/caption]
Kalyani B. Sonawane, PhD
Assistant Professor/ PhD Program Director
Department of Health Services Research, Management and Policy
College of Public Health and Health Professions
University of Florida
Gainesville, FL 32610
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Almost one-third of Americans have high blood pressure. Of those patients who are prescribed medication to control their blood pressure, about 30 percent have problems with side effects and nearly 50 percent will not have their blood pressure controlled within the first year of taking medication. In such scenarios, physicians have the option to either add a medication, such as fixed-dose combination, to the patient’s regimen or gradually increase a patient’s dose of their current drug to achieve blood pressure control; and gradually decrease the dose of their current drug or switch to a different drug to resolve side effects. Using healthcare claims data, we compared the economic impact of these alternative treatment modification strategies.
Dr. Kan Cao[/caption]
Kan Cao PhD
Associate professor of cell biology and molecular genetics
University of Maryland
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: In 2015, our group demonstrated a surprising positive effect of methylene blue in treating fibroblast cells from progeria patients, a severe premature aging disease. Interestingly, we also noticed a beneficial effect of methylene blue in protecting normal skin cells.
In this study, we followed the initial observation, compared methylene blue with other popular antioxidants, and conducted further analysis of the effects of methylene blue in 3d reconstructed skin.
The take home message is that we believe methylene blue has a great anti-aging potential. As it is also super safe, we suggest it a potent ingredient for skin care products.
Cora Bernard[/caption]
Cora Bernard, MS, PhD candidate
Pre-doctoral Student in Management Science and Enginnering
Affiliate, Center for Health Policy and the Center for Primary Care and Outcomes Research
Stanford Health Policy
MedicalResearch.com: What is the background for this study?
Response: The US opioid epidemic is leading to an increase in the US drug-injecting population, which also increases the risks of HIV transmission. It is critical to public health that the US invests in a coherent and cost-effective suite of HIV prevention programs. In our model-based analysis, we considered programs that have the potential both to prevent HIV and to improve long-term health outcomes for people who inject drugs. Specifically, we evaluated opioid agonist therapy, which reduces the frequency of injection; needle and syringe exchange programs, which reduce the frequency of injecting equipment sharing; enhanced HIV screening and antiretroviral therapy programs, which virally suppress individuals and decrease downstream transmission; and oral HIV pre-exposure prophylaxis (PrEP), which is taken by an uninfected individual and lowers the risk of infection.
Dr. Kharbanda[/caption]
Dr. Elyse Olshen Kharbanda, MD MPH
HealthPartners Institute
Minneapolis, MN
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Pregnant women who get the flu are at an increased risk for severe illness. To protect pregnant women, the Advisory Committee on Immunization Practices recommends women receive inactivated influenza vaccine (IIV) during any trimester of their pregnancy.
This study used data from the Vaccine Safety Datalink to evaluate if there was an increased risk for selected major structural birth defects for infants whose mothers received IIV in the first trimester of pregnancy versus infants who were unexposed to IIV. Among over 425,000 live births, including 52,856 whose mothers received IIV during first trimester, we evaluated risks for major structural birth defects. In this large observational study, we did not observe increased risks for major structural birth defects in offspring following first trimester maternal inactivated influenza vaccine exposure.
Dr. Phipatanakul[/caption]
Wanda Phipatanakul, MD, MS
Associate Professor of Pediatrics
Harvard Medical School
Director, Asthma Clinical Research Center
Boston Children's Hospital
Asthma, Allergy and Immunology
Boston, MA 02115
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Observational studies have limitations in their ability to examine disparities in asthma, as these studies have relied on self-reported measures of medication use, asthma diagnosis, severity, outcomes, and access to care.
Using data collected from a randomized controlled trial, we found that subjects with lower income had a significantly higher number of asthma treatment failures and asthma exacerbations, independent of race, BMI, education, perceived stress, baseline lung function, hospitalizations, inhaled corticosteroid adherence, inhaled corticosteroid dose, environmental allergen sensitization, and second-hand smoke exposure.
Dr. Lisonkova[/caption]
MedicalResearch.com Interview with:
Sarka Lisonkova, MD, PhD
Assistant Professor,
Department of Obstetrics and Gynaecology,
University of British Columbia.
Children’s and Women’s Health Centre
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Adverse fetal and infant outcomes associated with maternal age were known and our study confirms that the risk of fetal and neonatal death and severe neonatal morbidity increases among mothers over 30 years. We also knew that older mothers are more likely to have hypertension, diabetes, and other chronic diseases, and they are more likely to develop gestational diabetes, hypertension during pregnancy, and preeclampsia. These complications may put the fetus or newborn at risk, but are generally not considered to be potentially life threatening to the mother. Our study adds new information on the rates of severe maternal morbidities that have a high case-fatality rate, lead to organ damage, or have serious health implications such as hysterectomy. Our study also adds the information on the rates of any severe adverse birth outcome - for baby or mom - in the association with maternal age, which is important for counseling. Women usually want to know ‘what are the chances that anything bad happens’.
Deborah Evans[/caption]
Deborah Evans, MA, MSW, LCSW
Manager, Social Work Services
DaVita Kidney Care
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: For patients with end-stage renal disease (ESRD) receiving dialysis, receipt of a transplant offers the best possible long-term treatment option. However, the process of becoming qualified to receive a transplant involves many steps, beginning with the patient’s statement of interest.
In this study, we sought to characterize transplant interest among patients in a large dialysis organization in the U.S. and to explore reasons identified by the patients for lack of interest in transplant when applicable.
As of November 2016, of the 182,906 patients with available transplant status information in the LDO database, 58,057 (31.7%) expressed that they were not interested in transplant. Among patients not interested in transplant, the most frequently identified reasons for lack of interest were:
Dr. Smith[/caption]
Gary Smith, MD, DrPH
Director, Center for Injury Research and Policy
Nationwide Children’s Hospital
Columbus, OH
MedicalResearch.com: What is the background for this study?
Response: Golf is enjoyed worldwide as a leisure activity and competitive sport. While golf is viewed as a low-risk sport, acute traumatic and overuse injuries do occur. Previous studies have generally focused on the clinical aspects of golf-related injuries. Few studies examine injuries that occurred during practice at home or school, or due to conditions or hazards on a golf course.
Dr. Loebel[/caption]
Antony Loebel, M.D.
Executive Vice President and Chief Medical Officer
Sunovion, Head of Global Clinical Development
Sumitomo Dainippon Pharma Group
MedicalResearch.com: What is the background for this study? What are the main findings?
In the six-week, randomized, double-blind, placebo-controlled study, 347 children and adolescents (10 to 17 years of age) with bipolar depression received once-daily LATUDA flexibly dosed (20-80 mg/day) or placebo.The Phase 3 clinical study met its primary endpoint, showing statistically significant and clinically meaningful improvement in symptoms compared to placebo. LATUDA was generally well tolerated, with minimal effects on weight and metabolic parameters.
The primary efficacy endpoint was change from baseline to week 6 on the Children Depression Rating Scale, Revised (CDRS-R) total score. LATUDA was associated with statistically significant and clinically meaningful improvement in bipolar depression symptoms compared to placebo, based on CDRS-R total score (-21.0 vs. -15.3; effect size = 0.45; p<0.0001) and CGI-BP-S score for depression (-1.49 vs. -1.05; effect size = 0.44; p<0.001).
LATUDA also demonstrated statistically significant improvement on secondary efficacy endpoints.
The most common treatment-emergent adverse events reported for LATUDA compared to placebo were nausea (16% vs. 5.8%), somnolence (9.1% vs. 4.7%), weight gain (6.9% vs. 1.7%), vomiting (6.3% vs. 3.5%), dizziness (5.7% vs. 4.7%) and insomnia (5.1% vs. 2.3%). LATUDA was associated with no increases in fasting glucose or lipids, and minimal increase in mean weight vs. placebo (+0.74 kg vs. +0.44 kg).
Dr. Eliza Miller[/caption]
Eliza Miller, M.D.
Vascular neurology fellow
New York-Presbyterian Hospital/Columbia University Medical Center
New York City
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Preeclampsia is a common disorder that causes high blood pressure during pregnancy. It affects about 1 in 20 pregnant women. Women with preeclampsia are at higher risk for stroke during pregnancy and post-partum, but it’s very difficult to predict who is going to have a stroke. Our study looked at a large dataset of billing data from New York State, and compared women who had preeclampsia and strokes to women who had preeclampsia but did not have a stroke.
We found that preeclamptic women with urinary tract infections, bleeding or clotting disorders, or preexisting high blood pressure were at higher risk of having strokes during pregnancy or postpartum.
Dr. Jinhui Zhao[/caption]
Dr. Jinhui Zhao PhD
Scientist, Centre for Addictions Research of BC
University of Victoria
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: There are now many studies questioning the validity of the theory that moderate alcohol consumption protects against heart disease. We provided an up to date and comprehensive review of the evidence from ‘cohort’ studies i.e. those that assess health risk behaviours of people then follow them up for a number of years to see what characteristics predict death from a particular condition. We wished to test the theory that the appearance of health benefits in relation to heart disease is due to biases that accumulate and become more severe when cohorts are recruited at older ages (e.g. over 55 years). We found evidence to support this hypothesis. Moderate drinkers recruited before 55 years of age did not show any evidence of reduced risk of heart disease even when followed up into old age. Moderate drinkers from the older cohorts, however, did appear to have significant benefits – a finding we attribute to selection biases that accumulate across the life-course.
Several published meta-analyses showed inconsistent findings about how alcohol consumption affects the risk of coronary heart disease (CHD). Most systematic reviews find associations between low-volume alcohol consumption and reduced CHD risk, while some also find increased CHD risk for higher levels of consumption (Maclure 1993, Corrao, Rubbiati et al. 2000, Corrao, Bagnardi et al. 2004, Ronksley, Brien et al. 2011, Roerecke and Rehm 2012). More recent evidence has accumulated to suggest that the case for cardio-protection may be less straightforward. The association of alcohol consumption with CHD may be confounded or modified by other factors such as age and sex and / or biased by those factors which have not been investigated or controlled for in these previously published studies.