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. Brent Richards[/caption]
Brent Richards, MD, MSc
Associate Professor of Medicine
William Dawson Scholar / FRQS Clinical Research Scholar
Departments of Medicine, Human Genetics, Epidemiology and Biostatistics McGill University
Senior Lecturer, King's College London (Honorary)
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Some previous epidemiological studies have suggested that low vitamin D levels are associated with increased rates of asthma, atopic dermatitis—an itchy inflammation of the skin—and elevated levels of IgE, an immune molecule linked to atopic disease (allergies). In our study, we looked at genetic and health data on more than 100,000 individuals from previous large studies to determine whether genetic alterations that are associated with vitamin D levels predispose people to the aforementioned conditions.
We found no statistically significant difference between rates of asthma (including childhood-onset asthma), atopic dermatitis, or IgE levels in people with and without any of the four genetic changes associated with lower levels of 25-hydroxyvitamin D, the form of vitamin D routinely measured in the blood.
Synthetic Biologics, Inc.[/caption]
Sheila Connelly, PhD
Vice President, Research
Synthetic Biologics, Inc.
MedicalResearch.com: What is the background for this study?
Response: Synthetic Biologics, Inc. is focused on the protection and preservation of the gut microbiome which is the diverse collection of microorganisms that live in the intestinal tract. We are learning that the gut microbiome plays a key role in health. Negative changes to the microbiome, called dysbiosis, are linked to disease states including allergies, autism, and obesity, among a rapidly growing list of other conditions. A consequence of using antibiotics is that, in addition to fighting the bacterial infection being treated, they also kill the gut microbiota. The space left in the gut by the dead bacteria allows other surviving bacteria, many times opportunistic pathogens or microbes that are resistant to multiple antibiotics, to overgrow and fill the open niches. Exposure to antibiotics, particularly broad-spectrum antimicrobials, such as penicillins and cephalosporins, is a major risk factor for acquiring a potentially deadly Clostridium difficile infection.
[caption id="attachment_34487" align="alignleft" width="200"]
Dr. Sheila Connelly[/caption]
Another consequence of antibiotic use is the emergence of antibiotic-resistant organisms. Widespread use of antibiotics provides selective pressure for the evolution of lethal, multi-drug resistant pathogens, termed “nightmare bacteria”. The gut microbiome acts as a reservoir of antibiotic resistance that can be triggered, by antibiotic exposure, to acquire and propagate resistance genes.
A way to protect the microbiome and reduce antibiotic resistance is to limit exposure of the gut microbiota to antibiotics. To this end, we developed an antibiotic inactivation strategy using a beta-lactamase enzyme to degrade beta-lactam antibiotics in the GI tract before they can harm the gut microbiome. Beta-lactamases are naturally-occurring bacterial enzymes that confer resistance to beta-lactams, the most widely used broad spectrum antibiotics, and their presence is normally considered an obstacle to efficacious infection control. We took advantage of the highly efficient antibiotic degradation activity of a beta-lactamase and developed SYN-004 (ribaxamase). Ribaxamase is a beta-lactamase engineered to inactivate penicillins and most cephalosporins, formulated for oral delivery, and intended for use with IV beta-lactam antibiotics to degrade the antibiotics in the GI tract to protect the microbiome.
Ribaxamase was demonstrated to significantly reduce the occurrence of C. difficile disease in a recently completed Phase 2b clinical study. The study met its primary endpoint by demonstrating that ribaxamase, when delivered orally with IV ceftriaxone, significantly reduced C. difficile disease in patients treated for a respiratory tract infection. Ribaxamase also resulted in a significant reduction in new colonization by vancomycin-resistant enterococcus (VRE).
For the current study, pig models of antibiotic-mediated gut dysbiosis were established using three classes of beta-lactam antibiotics, a cephalosporin, ceftriaxone, a penicillin, amoxicillin, and a carbapenem, ertapenem. The ceftriaxone model was used to evaluate the protective effect of ribaxamase on the microbiome and the amoxicillin and ertapenem models are intended for evaluation of pipeline products.
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.
MedicalResearch.com Interview with: Dr. Yuan Gao Assistant Investigator at Boston Biomedical MedicalResearch.com: What is the background for this study? What are the main findings? Response: Colorectal cancer (CRC) is the third most commonly diagnosed malignant disease and third most frequent cause of cancer-related death in the United States. Standard treatment for unresectable metastatic CRC...
Dr. Goff[/caption]
Donald C. Goff, MD
Marvin Stern Professor
Vice Chair for Research
Department of Psychiatry
NYU Langone Medical Center
MedicalResearch.com: What is the background for this study?
Response: Since their introduction in the 1950’s antipsychotic drugs have been an integral part of the treatment of schizophrenia. However, over the past decade concerns have been raised about whether these drugs might negatively affect the long-term course of the illness—either by causing supersensitivity of dopamine receptors, which might make patients more prone to psychosis and relapse, or by direct toxic effects on the brain.
To address these concerns, we convened a panel of international experts to review the evidence supporting these concerns, including findings from clinical studies, brain imaging studies, post-mortem examination of the brains of people treated with these drugs, and studies in which these drugs were administered to animals.
Dr. Kempen[/caption]
John H Kempen, MD, PhD
Protocol Chair, MUST Trial Follow-up Study; Vice Chair, MUST Research Group
Director of Epidemiology for Ophthalmology, Massachusetts Eye and Ear
Harvard Medical School
Editor-in-Chief, Ophthalmic Epidemiology
President, Sight for Souls
MedicalResearch.com: What is the background for this study?
Response: Uveitis is about the fifth leading cause of blindness in the united states. Among types of uveitis, intermediate, posterior and panuveitis are the leading causes of blindness. Before 2005, systemic therapy with corticosteroids—supplemented when indicated with immunosuppressive drugs (most of the time)—was the primary treatment recommended for these conditions. With approval of the fluocinolone acetonide implant in 2005 for intermediate, posterior and panuveitis, it became unclear which of the alternative treatment approaches should be the treatment of choice.
The multicenter uveitis steroid treatment (must) trial was initiated in 2005 to directly compare the alternative treatments. Systemic therapy was administered using high dose prednisone followed by tapering of corticosteroids to maintenance doses of 10 mg/day or less (generally 7.5 mg/day or less) or to zero; this was supplemented by immunosuppressive corticosteroid-sparing drugs in 88% of participants. Implant therapy was done by initial quieting of the anterior chamber of the eye with topical, injected or systemic corticosteroids followed by surgical implant placement within 28 days (first eye) and 56 days (second eye if it was indicated). After this, systemic corticosteroids and immunosuppressive drugs were tapered off.
Dr. Razaz[/caption]
Neda Razaz, PhD, MPH
Postdoctoral Fellow
Reproductive Epidemiology Unit
Karolinska Institutet
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Multiple births of twins and triplets – and the associated health risks – have increased in many high-income countries, with a respective two-fold and three-fold increase in recent decades.
In Canada, triplet births or higher have increased from 52.2 per 100 000 live births to 83.5 between 1991 and 2009, mainly because of an increase in fertility treatments for older women of child-bearing age. In this study we found that among twin and triplet pregnancies that were reduced to singleton or twin pregnancies, there was a substantial reduction in complications such as preterm birth and very preterm birth. Although rates of death and serious illness were not lower among all multifetal pregnancies that were reduced, pregnancies that resulted from fertility treatments did show a significant reduction in rates of death or serious illness following fetal reduction.
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. Grace H. Lo[/caption]
Grace H. Lo MD MSc
Department of Medicine, Baylor College of Medicine
Medical Care Line and Research Care Line, Houston VA HSR&D Center for Innovations in Quality, Effectiveness and Safety
Michael E. DeBakey Medical Center, Houston, TX
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Osteoarthritis is the most common form of arthritis. Many people who have signs of osteoarthritis on x-rays do not necessarily complain of pain. Presently, there are no known strategies for preventing the development of pain in this group of people.
This study suggests that if these people have noisy knees (otherwise known as “crepitus”), they are at higher risk for developing pain within the next year compared to the people who do not have noisy knees. Future studies that target people who have x-ray signs of osteoarthritis, who do not complain of pain, but do report noisy knees, hold the promise of identifying interventions that can prevent knee pain.
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.
Prof. Chandola[/caption]
Tarani Chandola
Professor of Medical Sociology
Social Statistics Disciplinary Area of the School of Social Sciences
University of Manchester
MedicalResearch.com: What is the background for this study?
Response: We (the authors) were particularly interested in examining evidence for the common perception that people at the top of the occupational hierarchy are the most stressed. And also what happens to people’s stress levels when they retire. We had assumed that people with poorer quality work to have decreased levels of stress when they retired. There have been other studies on this topic before, but none that have used salivary cortisol to measure physiological stress responses. We analysed changes in people’s stress levels before and after retirement, in a follow up study of over 1,000 older workers in the British civil service. Stress levels were measured by taking salivary cortisol samples across the day, from awakening until bedtime.
Dr. Gershoni[/caption]
Moran Gershoni PhD
Senior intern, Molecular Genetics
Weizmann Institute of Science
Ben Gurion University
Rehovot Area, Israel
MedicalResearch.com: What is the background for this study?
Response: The background for this study is the question why "bad" is common? More specifically, we asked why the prevalence of some unfitted traits, like diseases and infertility, is sometimes much higher than intuitively expected? Several years ago we hypothesized that, at least in some of the cases, the relatively high prevalence of a morbid phenotype is directly arises from the fact that humans are composed of two ‘kinds’, men and women. This is since men and women share nearly the same genome but differently utilize some of it. Thus, the very same genetic code might affect men and women in a different and even in an antagonist manner. Therefore, disease-cause mutations in one sex can be neutral, or even beneficial, to the other sex. This allows such mutations to be sustained and propagated to relative high population frequencies.
Dr. Sandhya Manohar[/caption]
Sandhya Manohar, MBBS, Nephrology Fellow
Project mentor: Sandra M. Herrmann, MD
Department of Nephrology and Hypertension
Mayo Clinic, Rochester, MN
MedicalResearch.com: What is the background for this study?
Response: In the last few decades advances in the field of industrialization and technology has turned our world into a 24-7 work zone. Many organizations have turned to a shift system to keep up with the demands of the new world. The consequent changes to our circadian rhythm have resulted in dramatic effects to our body’s physiology. Reports have been surfacing of higher rates of diabetes, obesity, and even cancer in this shift work population.
The risk of hypertension though was controversial and so we set out to review this in our meta-analysis.
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. Agarwal[/caption]
Nayan Agarwal MD
Intervention Cardiology Fellow,
University of Florida,
Gainesville, FL
MedicalResearch.com: What is the background for this study?
Response: Long term anticoagulation is indicated in patients with mechanical heart valves, prior thromboembolic events, atrial fibrillation etc, to prevent recurrent thrombo-embolic episodes. About 20-30% of these patients also have concomitant ischemic heart disease requiring percutaneous coronary intervention (PCI).
Post PCI, patients require treatment with dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor (clopidogrel, prasugrel, ticagrelor) to prevent stent thrombosis. Thus, these patients may end up needing triple antithrombotic therapy with oral anticoagulant (OAC) and DAPT, which increases the bleeding risk.
Both American College of Cardiology(ACC) and European Society of Cardiology (ESC), currently recommend triple therapy in these patients. Recently new evidence has emerged that such patients can be managed with dual therapy of a single antiplatelet (SAPT) and OAC. Hence, we decided to do a systematic review of these studies to evaluate safety and efficacy of dual therapy of SAPT and OAC against triple therapy of DAPT and OAC.
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. Kragholm[/caption]
Kristian Kragholm, MD, PhD
Departments of Cardiology and Epidemiology/Biostatistics,
Aalborg University Hospital,
Aalborg, DK
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: It is well known that early help from bystanders including cardiopulmonary resuscitation (CPR) before arrival of the emergency medical services can increase chances of 30-day survival by three to four times compared to situations where no bystander resuscitation was initiated.
The main and novel finding of our study is that bystander interventions, in addition to increasing survival, also lowers the risk of damage to the brain and nursing home admission in 30-day survivors during the first year following out-of-hospital cardiac arrest.
Dr. Vianney Tricou[/caption]
Dr Vianney Tricou DPhil
Takeda Vaccines
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 four closely related dengue virus serotypes, and persons living in dengue endemic regions may be affected by dengue more than once in their lifetime. Some individuals with dengue fever are hospitalized and may need intensive therapy to prevent shock and death, and severe dengue is a leading cause of hospitalization and death among children and adults in some Asian and Latin American countries. About half of the world’s population lives under the threat of dengue and the disease has a significant medical and economic impact in the tropical and subtropical regions of the world where dengue is endemic.
Takeda is committed to improving global public health and to developing a life-saving dengue vaccine candidate for people around the world. Takeda’s tetravalent dengue vaccine candidate (TAK-003) is based on a live-attenuated dengue serotype 2 virus (DENV-2), which provides the genetic ‘backbone’ for all four attenuated dengue virus serotypes present in the vaccine. Takeda’s Phase 1 and Phase 2 clinical study program includes 8 studies to date that assess the safety and/or immunogenicity of this candidate, before moving into Phase 3.
Takeda’s ongoing Phase 2 DEN-204 study is designed to assess the safety and immunogenicity of one- and two-dose schedules of TAK-003 in 1,794 healthy children and adolescents ages two through 17 years living in dengue-endemic countries in Latin America and Asia.
As published in The Lancet Infectious Diseases in March 2017, an interim analysis of DEN-204 data indicated that TAK-003 elicited antibody responses to all four dengue serotypes in the population studied, regardless of whether they had previous dengue exposure.
A second TDV dose improved antibody responses against DENV-3 and DENV-4 in children who were seronegative before vaccination. In this study, the safety profile was consistent with that observed in earlier Phase 1 and 2 studies.
Dr. Beohar[/caption]
Nirat Beohar, MD
Vice-Chief of Cardiology
Director Cardiac Catheterization Laboratory
Director Structural Heart Disease Program
Director Interventional Cardiology Fellowship program
Cardiac Catheterization Laboratory
Columbia University Division of Cardiology,
Mount Sinai Medical Center
Miami Beach, Miami, FL 33140
MedicalResearch.com: What is the background for this study?
Response: Nirat Beohar MD, Director of the Cardiovascular Catheterization Laboratory and Vice-Chief of Cardiology at the Columbia University Division of Cardiology at the Mount Sinai Medical Center and co-authors report the effect of trans-catheter aortic valve replacement (TAVR) on subsequent renal function and outcomes in high-risk and inoperable patients presenting with baseline renal dysfunction (eGFR < 60 ml/min/1.73 m2). This was a sub-study of patients undergoing TAVR in the PARTNER 1 trial and continued access registry that was conducted in 25 centers in the United States and Canada.
Dr. Sandborn[/caption]
William J. Sandborn, MD
Professor of Medicine and Adjunct Professor of Surgery
Chief, Division of Gastroenterology
Vice Chair for Clinical Operations, Department of Medicine
Director, UCSD IBD Center
University of California San Diego and
UC San Diego Health System
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: There is still a substantial unmet need for new treatments for patients with ulcerative colitis.
A previous Phase II study had suggested that tofacitinib might be effective for short term therapy of ulcerative colitis. The patients in that study for the most part had not failed anti-TNF therapy. Now we report the findings from 3 large Phase III trials, two short term trials and one long term trial, demonstrating that tofacitinib 10 mg twice daily is effective for short term therapy, and that both 5 mg and 10 mg twice daily is effective for long term therapy. We also demonstrated that tofacitinib is effective both in patients who have not failed anti-TNF therapy and patients who have failed anti-TNF therapy.
The study demonstrated induction of clinical remission, clinical response and mucosal healing (flexible sigmoidoscopy improvement) over the short term, and maintenance of clinical remission, clinical response, and mucosal healing over the long term.
Dr. Harri Hemilae[/caption]
Harri Hemilä, MD, PhD
Department of Public Health
University of Helsinki
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Some zinc lozenges intended for treating the common cold have contained zinc acetate and some others have contained zinc gluconate. There have been proposals that zinc acetate might be more optimal salt for lozenges than zinc gluconate.
Therefore I compared the randomized trials that have used zinc acetate with zinc gluconate to see if there is difference between the lozenges. Although the average effect in 3 studies with zinc acetate lozenges was greater (40%) than the average effect in 4 studies with zinc gluconate lozenges (28%), that difference was explained by random variation.
I also analyzed the dose dependency of the effect and found that 2 studies that used 192 and 207 mg per day elemental zinc did not find greater benefit than 5 studies that used 80 to 92 mg per day zinc. The overall average effect of zinc lozenges was 33% reduction in common cold duration and that effect seems to be reached with doses less than 100 mg per day.
Megan Monsanto[/caption]
Megan M. Monsanto, B.S.
Joint Doctoral Student
Department of Cell and Molecular Biology
San Diego State University &
University of California San Diego
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: In the field of cardiovascular research there is ongoing debate regarding the optimal cell population(s) to use for the treatment of patients with heart failure. A major reason being, the lack of understanding of the actions and synergism between distinct myocardial-derived stem cell populations. This prompted our group to establish a protocol to isolate multiple stem cell populations from a single human myocardial tissue sample that will allow for the discovery of new insights at the cellular level, with the ultimate goal being to achieve true myocardial regeneration upon injection back into the patient.
Dr. Haffty[/caption]
Bruce G. Haffty, MD
Professor and Chair, Department of Radiation Oncology
Rutgers Cancer Institute of New Jersey
Rutgers Robert Wood Johnson Medical School and
Rutgers New Jersey Medical School
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Shorter courses of radiation for patients treated by lumpectomy are now commonly employed. For patients receiving radiation to the chest wall and lymph nodes after mastectomy, the standard 5 to 6 week course is used and shorter courses have not been adopted.
We initiated this trial of a shorter course of radiation to the chest wall and lymph nodes after mastectomy to test its feasibility, safety and outcome.
Dr. Cannon[/caption]
Ronald Cannon, Ph.D.
Staff scientist at NIH’s National Institute of Environmental Health Sciences
MedicalResearch.com: What is the background for this study?
Response: The protein pump, P-glycoprotein, is a major obstacle to the delivery of therapeutic drugs across the blood-brain barrier and into the central nervous system (CNS). During the last 10 years, our laboratory has studied the regulation of P-glycoprotein with the hope of treating CNS diseases.
MedicalResearch.com: What are the main findings?
Response: Our most recent finding shows that the antidepressant, amitriptyline, suppresses P-glycoprotein pump activity. The discovery is significant because P-glycoprotein restricts most CNS targeted drugs from entering the brain. If fully translatable to human patients, suppression of P-glycoprotein could allow higher levels of CNS therapeutic drugs to reach their intended target.