Prof. Danne[/caption]
Prof. Dr. Thomas Danne
Chief Physician Diabetology, Endocrinology and General Pediatrics and Clinical Researc
Kinder und Junden Krankenhaus
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: The double-blind, placebo controlled, Phase 3 study known as inTandem2 randomized 782 adult patients from 99 sites in the EU and Israel with type 1 diabetes on insulin pump or multiple daily injection therapy who had an A1C level entering the study between 7.0% and 11.0%. The three-arm study evaluated two doses of sotagliflozin, 200mg and 400mg, each taken once daily before the first meal of the day, against placebo. Prior to randomization, insulin was optimized for all patients over a six-week period, with the objective of improving glycemic control using insulin alone. After completion of this optimization period, patients were maintained on optimized insulin and randomized to one of two doses of sotagliflozin or placebo, and their baseline, post-optimization A1C was measured.
The mean baseline A1C levels after the six-week optimization period were 7.8%, 7.7% and 7.7% for patients randomized to the placebo, 200mg and 400mg arms, respectively (A1C was 8.4% across all dose arms prior to insulin optimization).
The primary endpoint of the study was change in A1C from baseline after a 24-week period of treatment. The trial has a double-blind long term extension of 28 weeks, with a total treatment duration of 52 weeks. There were 258 patients in the placebo arm, 261 patients in the 200mg dose arm and 263 patients in the 400mg dose arm. The overall mean placebo-adjusted A1C reduction at week 24 was 0.36% in the 200mg dose arm (p<0.001) and 0.35% in the 400mg dose arm (p<0.001). In response to regulatory input, a secondary endpoint to measure “net clinical benefit” was defined for this study as the proportion of patients at week 24 who achieved the standard of care A1C goal of less than 7.0% without any episode of severe hypoglycemia or DKA. 15% of patients in the placebo arm, 32% in the 200 mg dose arm and 32% in the 400mg dose arm achieved this endpoint (p<0.001 for both treatment arms).
Mackenzie Herzog[/caption]
Mackenzie M. Herzog, MPH
PhD Candidate, Injury Epidemiology
The University of North Carolina at Chapel Hill
MedicalResearch.com: What is the background for this study?
Response: In 1999, a study by Arendt et al. reported that women were more likely to tear their ACL than men while playing the same sport. Since then, numerous studies have investigated this sex difference in ACL injury, and many prevention programs targeting youth athletes have been developed and tested. Although randomized trials have demonstrated the value of injury prevention programs in reducing the risk of ACL injury, the overall impact of these programs has not been examined in the general population. Our study investigated the net impact of research and prevention efforts over nearly 20 years in reducing ACL injuries by assessing time trends of ACL reconstruction, a consequence of ACL injury, among commercially-insured individuals in the United States.
Dr. Reimer[/caption]
Raylene Reimer, PhD, RD
Professor, Faculty of Kinesiology
University of Calgary Department of Biochemistry & Molecular Biology
Cumming School of Medicine Full Scientist
Alberta Children's Hospital Research Institute
MedicalResearch.com: What is the background for this study?
Response: The human gut microbiota is a complex and dynamic population of microorganisms that benefit the human host through a variety of microbial activities (e.g. production of vitamins, immune regulation, utilization of dietary fiber). Despite these benefits however, it is now recognized that disruption of the microbiota (dysbiosis) can upset homeostasis and contribute to diseases such as obesity and type 2 diabetes. Manipulation of the gut microbiota to prevent or treat chronic disease is now an area of intense scientific and clinical interest. Dietary prebiotics, such as inulin and oligofructose, are used selectively by host microorganisms to confer a health benefit. Prebiotics have previously been shown to reduce body fat, improve appetite control and reduce blood glucose in adults with overweight or obesity.
Dr. Kandasamy[/caption]
Jegen Kandasamy MD
Division of Neonatology
Assistant Professor/Director, Rare Disease Program and Congenital Anomalies Program
University of Alabama at Birmingham
Birmingham, Alabama
MedicalResearch.com: What is the background for this study?
Response: Preterm infants, especially those that are born with a birth weight of 750 grams or less, are prone to a lung disease called bronchopulmonary dysplasia (BPD) because the development of lungs in these infants takes place in an environment that has more oxygen than that available in utero. Recently, pulmonary blood vessel growth and function has been hypothesized to play a causal role in the pathogenesis of BPD. Vascular endothelial cell function has been shown to affect hyperoxia-induced lung damage in animal studies. An important source of human vascular endothelial cells is the umbilical cord of newborn infants. These human umbilical venous endothelial cells (HUVEC) have been used to measure endothelial cell function in various diseases but never in diseases related to the newborn infants from whom they were derived.
In addition, the mitochondria in various cells in our body respond to oxygen toxicity by creating, as well as consuming, reactive oxygen species (ROS) that mediate most of the effects of oxygen-induced damage. Therefore, we designed this study to measure mitochondrial function in vascular endothelial cells obtained from the umbilical cords of prematurely born infants at the time of their birth. We then compared these mitochondrial functional measures between infants who later died or developed BPD versus those who survived without BPD.
Dr. Taveras[/caption]
Elsie M. Taveras, MD, MPH
Ofer and Shelly Nemirovsky MGH Research Scholar
Chief, Division of General Academic Pediatrics, Department of Pediatrics
Mass General Hospital for Children
Professor of Pediatrics, Harvard Medical School
Professor in the Department of Nutrition, Harvard T.H. Chan School of Public Health Boston, MA
MedicalResearch.com: What is the background for this study?
Response: We designed this study to test the effectiveness of two interventions that linked clinical and community approaches in improving childhood body mass index (BMI) and obesity prevalence. Another important question we set out to understand was whether there were outcomes aside from BMI and obesity that mattered most to families of children with obesity.
Dr. Luthar[/caption]
Suniya S. Luthar, Ph.D.
Foundation Professor of Psychology
Arizona State University
Professor Emerita
Columbia University's Teachers College
President-elect, American Psychological Association's Div.7 (Developmental)
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Over the last 20 years, we have found that kids in high achieving schools report higher use of drugs and alcohol than do their counterparts in national normative samples. This particular study was the first in which we followed up samples of high school students through young adulthood, to track levels of substance abuse and addiction.
Our findings showed consistently elevated use of various substances across the years. Of greatest concern were diagnoses of dependence (that is, not just abuse of substances but actual addiction to them); among 26 year olds, rates of these diagnoses were two to three times those in national norms.
Dr. Dunbar[/caption]
Michael S. Dunbar, PhD
Associate Behavioral Scientist
RAND Corporation
MedicalResearch.com: What is the background for this study?
Response: Sexual minority college students suffer from mental health problems like anxiety and depression at higher rates than their heterosexual peers. If they aren’t addressed, these types of issues can have serious negative effects on things like academic achievement, employment, and quality of life –among others. This study analyzed information from a survey about mental health needs and use of mental health services. The survey was completed by over 33,000 students from nine University of California campuses, nine California State University campuses and 15 California community colleges. The results were weighted to help reflect California’s college student population.
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. 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. Herbert[/caption]
Dr Annie Herbert, PhD
Department of Behavioural Science and Health, Institute of Epidemiology and Healthcare
University College London
London UK
MedicalResearch.com: What is the background for this study?
Response: 1 in 25 adolescents (i.e. one in every classroom) will be admitted to hospital as an emergency with injuries related self-harm, drug or alcohol misuse, or violence. Currently, the guidelines for how these adolescents are managed differ greatly depending on the type of injury they come in with (whether through self-harm, drug or alcohol misuse, or violence).
MedicalResearch.com: What are the main findings?
Response: In our study, we found that adolescents admitted with any of these injuries were at an increased risk of suicide and of drug or alcohol related death in the ten years after leaving hospital, compared to other admitted adolescents.While the overall risk is relatively low—for example, 2–3 girls out of 1000 and 7 boys out of 1000 who are admitted as an emergency to hospital with drug or alcohol related injuries die from suicide within 10 years—the rates are 5–6 times higher than among adolescents admitted to hospital following an accident.
Dr. Heere[/caption]
Megan Heere, MD
Assistant Professor of Clinical Pediatrics
Lewis Katz School of Medicine at Temple University
Medical Director
Temple University Hospital Well Baby Nursery
Temple Pediatric Care
Philadelphia, PA 19140
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Bed-sharing, the unsafe practice in which parents sleep in the same bed as their babies, is associated with sleep-related deaths in infants, including sudden infant death syndrome (SIDS) and accidental suffocation and strangulation in bed. No studies have examined the effect of a Finnish-style baby box on infant sleep environment. Face-to-face postpartum education about safe infant sleep, combined with the distribution of a baby box, which is a cardboard bassinet, reduced the rates of bed-sharing during babies' first 8 days of life.
Dr. Jatana[/caption]
Kris Jatana, MD FAAP
Pediatric Otolaryngologist
Nationwide Children’s Hospital
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: This study looked at a 21-year period – 1990 through 2010 – and focused on children younger than 18 years of age treated in U.S. hospital emergency departments for cotton tip applicator-related ear injuries. About 263,000 children were injured during the study period, which comes out to approximately 1000 injuries seen in emergency departments every month or 34 per day.
The majority of injuries occurred when cotton tip applicators were used to clean a child’s ear canal (73%), and most of those injuries occurred when a child was using a cotton tip applicator on their own (77%), or their parent was using the device (16%) to clean the ear canal. About two out of every three patients were younger than 8 years of age, and patients aged 0-3 years accounted for 40% of all injuries.
Surprisingly, the highest rate of injury was in children 0-3 years old. The most common injuries were foreign body sensation (30%), perforated ear drum (25%) and soft tissue injury (23%).
Dr. Monika Goyal[/caption]
Monika Goyal, M.D., M.S.C.E.
Assistant Professor of Pediatrics & Emergency Medicine
Director of Research, Division of Emergency Medicine and Attending Physician
Children’s National Health System
The George Washington University
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: As pediatric emergency clinicians, unfortunately, many of us have cared for a number of children who have been victims of gun violence. We wanted to investigate whether gun laws may make a difference in the rates of firearm-related morbidity and mortality in children. We specifically were interested in emergency department visits because they relate directly to the care we provide to pediatric patients.
Our main findings from our five-year study were that children are affected by gun violence nationally and, specifically, we saw regional differences in emergency department visits made by children who were victims of firearm violence.
Overall, firearm-related visits by patients 21 and younger to emergency departments remained consistent over time at a rate of 65 per every 100,000 visits until 2013, when they decreased slightly to 51 per 100,000 visits.
We also found that regions with more strict gun laws had lower rates of emergency department visits by children for gun violence compared with those regions with less stringent laws. We used the Brady Score, which looks at various state gun laws and assigns a score, to measure strictness. Then, based on state-level scores, we created regional composite scores.
Dr. Hicks[/caption]
Steven Daniel Hicks, MD, PhD
Assistant Professor, Division of Academic General Pediatrics
College of Medicine
Penn State Health
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: There are about 3 million concussions in the US each year and the majority occur in children. Parents of children with concussions commonly cite length of recovery as a major concern, but pediatricians have no objective or accurate tests for addressing this concern.
Our research group previously identified small regulatory molecules called microRNAs that were altered in both the spinal fluid and saliva in children with traumatic brain injuries. In this study we investigated whether those microRNAs could predict duration of concussion symptoms. In 52 children with concussion we found a set of microRNAs that predict whether concussion symptoms would last beyond one month with over 80% accuracy. This was significantly more accurate than survey based tools such as the sports concussion assessment tool or a modified concussion clinical risk score. Interestingly, the microRNAs with predictive accuracy targeted pathways involved in brain repair and showed correlations with specific concussion symptoms.
Dr. Niinistö[/caption]
Sari Niinistö, PhD
Senior Researcher,
Public Health Solutions, Nutrition Unit
National Institute for Health and Welfare
Helsinki, Finland
MedicalResearch.com: What is the background for this study?
Response: Previous prospective studies have observed protective association between fish-derived fat and type 1 diabetes related autoimmunity in older children. Also some other fatty acids have been associated with the risk for type 1 diabetes associated autoimmunity. We wanted to study very young children, because type 1 diabetes associated autoimmunity often begins early, already in infancy. Therefore, we investigated whether serum fatty acid levels during infancy or the main dietary sources of fatty acids (breast milk and infant formula) were related to the development of autoimmunity responses among children at increased genetic risk of developing type 1 diabetes.
Dr. Signes-Pastor[/caption]
Dr. Antonio J. Signes-Pastor, PhD
Institute for Global Food Security
Queen’s University Belfast
Belfast, Northern Ireland, United Kingdom,
Department of Epidemiology, Geisel School of Medicine
Dartmouth College Lebanon, NH
MedicalResearch.com: What is the background for this study?
Response: Inorganic arsenic is a human carcinogen, which has also been associated with several adverse health effects including neurological, cardiovascular, respiratory, and metabolic outcomes. Early life exposure is of particular concern since it may adversely impact on lifetime health outcomes. If low inorganic arsenic drinking water is available the main source of exposure is the diet, especially rice and rice-based products, which are widely used during weaning and to feed infants and young children. In order to reduce exposure, the EU has recently regulated (1st January 2016) the inorganic arsenic maximum level of 0.1 mg/kg for rice products addressed to infants and young children. This level is also under consideration by the US FDA.
Dr. Varma[/caption]
Rohit Varma, MD, MPH
Executive Director - USC Roski Eye Institute and
Dean of the Keck School of Medicine of USC
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Visual impairment in early childhood has profound impact on a child’s development. It can significantly impair development of visual, motor, and cognitive function1-3 and lead to adverse psychosocial consequences. There has been a lack of accurate data characterizing the current and expected numbers of visual impairment cases among preschool children in the United States from 2015 to 2060.
The number of preschool children with visual impairment is projected to increase by 26% in 2060. And 69% of these visual impairment will result from simple uncorrected refractive error such hyperopia and myopia, which can be prevented or treated by low-cost refractive correction.
Dr. Tove Fall[/caption]
Tove Fall, PhD
Department of Medical Sciences
Molecular Epidemiology and Science for Life Laboratory, Uppsala University
Uppsala, Sweden
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Type 1 diabetes is a severe chronic disease in children. There are few established risk factors, but it has been hypothesized that factors related to reduction of microbial exposure in childhood may increase the risk. We have previously shown that children in dog-owning families are at lower risk for asthma, and we now wanted to investigate the relationship of dog ownership and diabetes. We did this by studying the whole Swedish child population with record linkage across registers of health and dog ownership. We could not find evidence for an association of dog ownership and type 1 diabetes in the general population.
Prof. Pell[/caption]
Professor Jill Pell MD
Director of Institute (Institute of Health and Wellbeing)
Associate (School of Medicine, Dentistry and Nursing)
University of Glasgow
MedicalResearch.com: What is the background for this study?
Response: The novelty of our study lies in its scale and scope. In terms of scope, it reported on six educational outcomes and three health outcomes in the same group of children.
In terms of scale, it is the first study of a whole country to compare educational outcomes of children with treated ADHD with their unaffected peers and is more than 20 times larger than previous studies on similar educational outcomes. The only previous countrywide study on health outcomes, included only children with very severe ADHD who were in psychiatric hospitals.
Dr. Miller[/caption]
Robin Lin Miller, Ph.D.
Professor, Ecological-Community Psychology
Co-Director, MA in Program Evaluation
Chair, Graduate Program in Ecological-Community Psychology
Michigan State University
East Lansing, MI 48824
MedicalResearch.com: What is the background for this study?
Response: We wanted to identify promising strategies for providing access to HIV-testing for gay and bisexual male youth. We were especially interested in testing strategies to reach gay and bisexual male youth of color, as they bear a disproportionate burden of the HIV epidemic and are the least likely to be aware of their HIV status. We also wanted to explore approaches to successfully link these youth with HIV-negative test results to diverse HIV prevention services, including pre-exposure prophylaxis, when warranted.
Although some argue that the ideal place to test adolescents and young adults is via emergency rooms and in routine medical care visits, we found that we were able test many more youth with previously undiagnosed HIV-infection through intensive, targeted community outreach efforts. We also tested a much higher proportion of young men of color through targeted outreach.
Dr. Raines[/caption]
Deborah A. Raines PhD, EdS, RN, ANEF
School of Nursing
University at Buffalo
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: This research grew from my experience as a neonatal nurse. I have worked with many families preparing to take their baby home and have seen the anxiety they experience wondering if they will be able to take care of their baby’s medical needs at home.
Parents are usually most anxious about emergency situations that may occur. Majority of these parents are able to state what they should do, but have never experienced the actual situation with their baby. This study was designed to see if a simulation experience would fill this gap in parents’ preparation for the discharge of their baby from the NICU. This study had parents participated in a customized simulation to have them experience the care needed by their baby at home following discharge from the NICU.
The findings revealed that parents reported a nearly 30 percent increase in confidence in their abilities to care for their baby after participating in the simulation.
Dr. Yong Yu[/caption]
Dr. Yongfu Yu, PhD
Department of Clinical Epidemiology
Aarhus University Hospital
Aarhus, Denmark
MedicalResearch.com: What is the background for this study?
Response: Bereavement by the death of a close relative is ranked as one of the most severe life events and it is likely to cause psychological stress regardless of coping mechanisms. An increased risk of mortality and adverse health outcomes has been observed among the bereaved spouses, parents, and children. It is estimated that nearly 8% of individuals in the US experienced a sibling death in childhood but much less is known about its health consequences. Sibling relationship tends to be the longest and the most intimate in family thus the death of a sibling can be a devastating life event, especially when this event happens at early ages. However, to our knowledge, no study has investigated the effects of sibling death in childhood on subsequent mortality in bereaved siblings with a long follow-up time.