Dr.Paolo Prandoni[/caption]
Paolo Prandoni, M.D., Ph.D. and
Department of Cardiovascular Sciences
Vascular Medicine Unit
University of Padua, Padua
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Dr.Sofia Barbar[/caption]
Sofia Barbar, M.D
Department of Internal and Emergency Medicine
Civic Hospital of Camposampiero
Camposampiero
MedicalResearch.com: WhaWhat are the main findings?
Response: Syncope is defined as a sudden loss of consciousness due to transient global cerebral hypoperfusion characterized by rapid onset, short duration, and spontaneous complete recovery. According to the most recent guidelines, syncope can be classified as neurally-mediated, due to orthostatic hypotension and cardiovascular. Syncope is frequent in general population and represents up to 2% of all attendances in Emergency Department in Europe. The initial approach is unable to identify a plausible cause for syncope in 25-30% of cases and approximately 40% of syncope referred to an Emergency Department is then admitted to the hospital.
Pulmonary embolism (PE) is an obstruction in the pulmonary arteries interfering with both blood circulation and gas exchange and therefore representing a potentially life-threatening event. Clinical features of PE are extremely variable.
Available guidelines on syncope management consider PE as an infrequent cardiovascular cause of syncope. However, the true prevalence of pulmonary embolism in syncope-patients it is actually unknown. Moreover a workup for PE diagnosis in these patients is not suggested in the current guidelines.
Dr. Christopher V. Almario[/caption]
Christopher V. Almario, MD, MSHPM
Assistant Professor of Medicine
Division of Digestive and Liver Diseases, Cedars-Sinai Medical Center
Cedars-Sinai Center for Outcomes Research and Education
Los Angeles, CA
MedicalResearch.com: What is the background for this study?
Response: Recent drug approvals have increased the availability of biologic therapies for inflammatory bowel disease (IBD). However, the growing number of biologics has also made it more difficult for both patients and healthcare providers to navigate treatment options and to ultimately choose the most appropriate therapy.
In this study, we wanted to examine patient decision-making surrounding IBD biologic therapies using conjoint analysis, which is a form of tradeoff analysis that determines how respondents make complex decisions by presenting them with competing product profiles. Here, we quantified the relative importance of 9 biologic therapy attributes (e.g., how the medicine works, how the medicine is received, long-term effectiveness, side-effect profile, etc.) in the decision-making process.
Prof. Jenny Donovan[/caption]
Professor Jenny Donovan
OBE FMedSci NIHR-SI AcSS FFPHM
Director, NIHR CLAHRC West
(National Institute for Health Research Collaboration for
Leadership in Applied Health Research and Care West)
at University Hospitals Bristol NHS Trust
Lewins Mead, Bristol
Professor of Social Medicine
School of Social and Community Medicine
University of Bristol
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: PSA testing identifies many men with prostate cancer, but they do not all benefit from treatment. Surgery, radiation therapy and various programs of active monitoring/surveillance can be given as treatments for fit men with clinically localized prostate cancer. Previous studies have not compared the most commonly used treatments in terms of mortality, disease progression and patient-reported outcomes. In the ProtecT study, we used a comprehensive set of validated measures, completed by the men at baseline (before diagnosis), at six and 12 months and then annually for six years.
The main finding is that each treatment has a particular pattern of side-effects and recovery which needs to be balanced against the findings from the paper reporting the clinical outcomes (Hamdy et al).
Dr. Carolyn Crandall[/caption]
Carolyn J. Crandall, MD, MS, FACP
Professor of Medicine
David Geffen School of Medicine at University of California, Los Angeles
UCLA Medicine/GIM
Los Angeles, California
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Scientists have suspected that genes may contribute to the risk of getting hot flashes and night sweats, but studies so far have been few in number and only focused on small parts of the human gene code (for example, the gene coding for estrogen receptors). No study has ever comprehensively sampled gene variations that span the entire human genome to look for associations between genetic variation and risk of hot flashes and night sweats.
This was the first study of its kind, performed in more than 17.000 postmenopausal women participating in the Women’s Health Initiative Study. We examined 11,078,977 single-nucleotide polymorphisms, or SNPs, which are gene variants, in a genome-wide association study.
Our main results were that 14 gene variants (SNPs) that were significantly associated with increased risk of having hot flashes. All of these variants were located in chromosome 4, in the gene that codes for the tachykinin receptor 3.
Dr. Richard Frye[/caption]
Richard Eugene Frye MD
Child Neurologist and Director of Autism Research
Arkansas Children's Hospital Research Institute
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: The study is a 12-week double-blind placebo-control clinical trial of folinic acid on improve core and associated symptoms of autism. We found that children that received folinic acid demonstrated significantly more improvement in verbal communication and behavior as compared to those children that received the placebo. In addition we found that a specific blood biomarker called the folate receptor alpha autoantibody predict response to the treatment.
Dr. Shirish Gadgeel[/caption]
Shirish Gadgeel, MD
Leader of the Thoracic Oncology Multidisciplinary team
Professor at Karmanos Cancer Institute
Detroit
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: LUX-Lung 7 is the first global, head-to-head trial comparing second- and first-generation EGFR-directed therapies (afatinib and gefitinib respectively) for patients with EGFR mutation-positiveNon-Small Cell Lung Cancer NSCLC who received no prior treatment. The Phase IIb trial included 319 patients with advanced stage NSCLC harboring common EGFR mutations (del19 or L858R). The trial's co-primary endpoints were progression-free survival (PFS) by independent review, time to treatment failure and overall survival (OS); and the secondary endpoints included ORR, disease control rate, tumor shrinkage, patient-reported outcomes and safety.
Prof. Kavita Vedhara[/caption]
Kavita Vedhara FAcSS
Professor of Health Psychology
Division of Primary Care
School of Medicine
University Park,Nottingham
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: There has been a longstanding interest in the role of the hormone cortisol in fertility, because of its potential to affect the functioning of the biological systems that influence both conception and pregnancy.
This interest has extended to IVF, with researchers exploring the relationship between levels of the hormone and pregnancy since the advent of the treatment in the late 1970s.
However, a recent review showed that the relationship between cortisol and pregnancy in IVF was unclear. A number of reasons were highlighted for this, including that all of the studies to date had relied on short-term measures of the hormone measured in blood, saliva, urine and sometimes follicular fluid. Such measures can only capture hormone levels over a matter of minutes and hours. Such ‘snapshots’ are unable to give us an accurate picture of the levels of hormone over longer periods of time. This is important because any clinically relevant effects of cortisol on fertility are only likely to occur in the context of long-term changes in the hormone.
In recent years it has become possible to measure long-term levels of cortisol in hair. Cortisol is deposited in the hair shaft and because human hair grows, on average, 1cm per month, a 3cm sample of hair closest to the scalp can tell us about levels of cortisol in the previous 3 months.
We used the development of this technique to examine whether long term levels of cortisol (as measured in hair), or short term levels of cortisol (as measured in saliva) could predict whether or not women going through IVF would become pregnant. If you are trying to obtain a perfect cortisol balance, I use this product that helps to do just that.
Prof. Ivan Martin[/caption]
Professor Ivan Martin, PhD
Department of Surgery and Department of Biomedicine
University Hospital Basel
University of Basel
Basel, Switzerland
MedicalResearch.com: What is the background for this study and new use of autologous nasal chondrocytes?
Response: We previously demonstrated that nasal chondrocytes, harvested from the nasal septum, have a larger and more reproducible capacity to form new cartilage than articular chondrocytes, harvested from the knee joint. We further established that the cartilage tissue generated by nasal chondrocytes can respond to physical forces (mechanical loads) similar to articular cartilage and has the ‘plasticity’ to adapt to a joint environment, since it efficiently integrated with surrounding articular cartilage when implanted in goat joints. This was the rationale for using nasal chondrocytes for articular cartilage repair.
Dr. Samira Anderson[/caption]
Samira Anderson, AuD., Ph.D.
Assistant Professor
Department of Hearing and Speech Sciences
Faculty, Program in Neuroscience and Cognitive Sciences
Faculty, Maryland Language Science Center
Director, The Hearing Brain Lab
www.hearingbrainlab.umd.edu
University of Maryland – College Park
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: It is known that older adults ability to understand speech in background noise is enhanced by factors other than hearing. Older adults draw on cognitive resources to improve their understanding of what is said more so than do younger adults. Specifically, they can use the context of the conversation to fill in the gaps of what they might have missed due to background noise. They also benefit when the distracting noise or talker is speaking in a language that is unintelligible to them. So someone who speaks English will understand the conversation better when the distracting talker is speaking a language other than English. If the background talker is speaking a different language, then that background talker is easier to ignore.
In this study we were motivated to find out what is happening in the brain when older and younger adults are listening to a story spoken in English and ignoring a background talker who is speaking either in English or in Dutch. We found that overall the neural responses of older adults were degraded by noise to a greater extent than in younger adults, despite that fact that they had normal hearing. However, the neural response in older adults improved when the background talker was speaking Dutch compared to English, and this same improvement was not seen in younger adults. The older adults also reported that it was easier for them to focus on the English talker when the background talker was speaking Dutch, but the young adults said it didn't make any difference.
Dr David Lynch[/caption]
Dr David Lynch MB, MRCPI
Leonard Wolfson Clinical Fellow
UCL Institute of Neurology
Queen Square, London
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: In 2011 it was discovered that mutations in a gene called CSF1R cause a rare syndrome of early onset dementia often accompanied by movement disorders, spasticity and seizures, which is named adult onset leukoencephalopathy with axonal spheroids (ALSP). The hallmarks of ALSP are a characteristic appearance on MRI imaging and findings in brain pathological specimens - axonal swellings or 'spheroids'. We manage a multidisciplinary group with expertise in leukoencephalopathies and have previously identified patients with mutations in CSF1R. However, we also found patients with a syndrome typical of ALSP who did not carry mutations in CSF1R.
In this study, we showed that some of these patients carry recessive mutations in a different gene, AARS2. This included a patient with characteristic axonal spheroids in brain tissue and typical ALSP clinical and imaging features.
Dr.Joseph A. Ladapo[/caption]
Joseph A. Ladapo, MD, PhD
Division of General Internal Medicine and Health Services Research
David Geffen School of Medicine
UCLA
Los Angeles, CA 90024
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Four million adults in the U.S. undergo stress testing or coronary computed tomographic angiography (CTA) each year because of suspected coronary disease. These patients are high risk for adverse cardiovascular events, but they are often not treated with the right medications after testing. Little is known about how CTA or stress testing affect physician and patient decisions about cardiovascular medications and preventive lifestyle choices like exercise and weight loss. Using data from patients in the PROMISE trial (PROspective Multicenter Imaging Study for Evaluation of chest pain), we found that patients who underwent CTA for suspected coronary artery disease were more likely to start a statin and aspirin and more likely to eat better and lose weight.
Dr. Ying Kong[/caption]
Ying Kong Ph.D.
Assistant Professor
University of Tennessee Health Science Center
Department of Microbiology, Immunology, and Biochemistry
Memphis, TN 38163
MedicalResearch.com: What is the background for this study?
Response: Tuberculosis (TB) is a public health concern worldwide, with high morbidity and mortality. The causative agent of TB, M. tuberculosis, grows very slowly in culture. For research of TB, we need to quantitate bacterial numbers in order to evaluate drug and vaccine efficacy or to identify bacterial genes that are critical for survival in hosts or causing disease.
M. tuberculosis divides every ~20 hours, which is much slower than other bacteria such as E. coli and Salmonella typhimurium, which divide every 20 minutes. Conventionally, quantitation of M. tuberculosis needs to spread M. tuberculosis on agar plates and wait for four weeks to obtain visible colonies, and then to count colony forming units. For the fast-growing bacteria, it takes only 18 hours to obtain visible colonies on agar plates. We and other groups have developed fluorescent protein labeled M. tuberculosis strains in order to quantitate M. tuberculosis in real time by measuring fluorescence. In this way, we are able to estimate bacterial number right after fluorescence measurement, which only takes a few minutes. However, this technology is not a diagnostic tool for clinical use, because the M. tuberculosis strains that we used were recombinant strains transformed with fluorescent protein genes. Another imaging technology that we have developed, REF, is for diagnosis purpose, which has been described in details in our other papers (Xie H, et al. Rapid point-of-care detection of the tuberculosis pathogen using a BlaC-specific fluorogenic probe. Nat Chem. 2012 Oct;4(10):802-9. Cheng Y, et al. Fluorogenic probes with substitutions at the 2 and 7 positions of cephalosporin are highly BlaC-specific for rapid Mycobacterium tuberculosis detection. Angew Chem Int Ed Engl. 2014 Aug 25;53(35):9360-4.).
Dr. Hugh S. Taylor[/caption]
Hugh S. Taylor, MD
Anita O'Keeffe Young Professor of Obstetrics, Gynecology, and Reproductive Sciences and Professor of Molecular, Cellular, and Developmental Biology; Chair of Obstetrics
Gynecology, and Reproductive Sciences, Yale School of Medicine
Chief of Obstetrics and Gynecology
Yale-New Haven Hospital
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: The abstract presented at ASRM featured results from two replicate pivotal Phase 3 clinical trials evaluating the efficacy and safety of Elagolix in premenopausal women who suffer from endometriosis. Elagolix is an investigational, orally administered, gonadotropin-releasing hormone (GnRH) receptor antagonist that blocks endogenous GnRH signaling by binding competitively to GnRH receptors in the pituitary gland. Administration results in rapid, reversible, dose-dependent inhibition of luteinizing hormone and follicle-stimulating hormone secretion, leading to reduced ovarian production of the sex hormones, estradiol and progesterone, while on therapy.
The data demonstrated dose-dependent superiority in reducing daily menstrual and non-menstrual pelvic pain associated with endometriosis compared to placebo. At month three and month six, patients treated with Elagolix reported statistically significant reductions in scores for menstrual pain (dysmenorrhea) and non-menstrual pelvic pain associated with endometriosis as measured by the Daily Assessment of Endometriosis Pain scale. The safety profile of Elagolix was consistent across both Phase 3 trials and also consistent with prior Elagolix studies.
Dr. Corey Pelletier[/caption]
Corey Pelletier PhD
Director, Health Economics & Outcomes Research
Celgene Corporation
Summit, NJ
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: In a phase III clinical trial, ABRAXANE demonstrated significant improvement in ORR vs paclitaxel in patients with metastatic breast cancer. Celgene initiated this study because limited data exist on the comparative effectiveness of ABRAXANE vs paclitaxel for patients with metastatic breast cancer, including HR+/HER2- and triple negative (TN) metastatic breast cancer (MBC), in a real-world setting. This study used a U.S. based electronic medical record (EMR) dataset to evaluate the real-world comparative effectiveness of second-line ABRAXANE vs paclitaxel in patients with MBC and included patients with HR+/HER2- or TN MBC. This study also assessed adverse events and use of supportive care in this patient population.
The median time to treatment discontinuation (TTD) for ABRAXANE vs paclitaxel was 4.50 vs 2.83 months (adjusted P<0.0001*) in all patients. Patients with HR+/HER2- or TN MBC had similar TTD. The median time to next treatment (TTNT) in all patients was 5.9 vs 4.2 months (adjusted P=0.2140*) for ABRAXANE vs paclitaxel, respectively. Patients receiving ABRAXANE had less fatigue, neuropathy, and anemia compared to patients receiving paclitaxel. Patients treated with ABRAXANE also used less antiemetics, and had fewer treatments for hydration or allergic reaction compared to those treated with paclitaxel. Patients treated with paclitaxel used less GCSF and had fewer treatments for bone loss compared to those treated with ABRAXANE.
*TTD and TTNT were adjusted for age, number of metastases, targeted agent use, adjunctive chemotherapy, HER2 status, TN status, and CCI score without age.
Dr. Eric A. Secemsky[/caption]
Eric A. Secemsky, MD MSc
Interventional Cardiology Fellow
Massachusetts General Hospital
Harvard Medical School
Fellow, Smith Center for Outcomes Research in Cardiology
Beth Israel Deaconess Medical Center
MedicalResearch.com: What is the background for this study?
Response: Use of oral anticoagulant (OAC) therapy prior to coronary stenting is a significant predictor of post-procedural bleeding events. Previous studies have estimated that the frequency of chronic OAC use among patients undergoing percutaneous coronary intervention (PCI) is between 3% to 7%. Yet many of these analyses examined select patient populations, such as those admitted with acute myocardial infarction or atrial fibrillation, and preceded the market approval of non-vitamin K antagonist oral anticoagulants (NOACs). As such, the contemporary prevalence of OAC use among all-comers undergoing PCI, as well as associated risks of adverse events, are currently unknown.
Therefore, we used PCI data from a large, integrated healthcare system to determine current use of oral anticoagulant use among all-comers undergoing coronary stenting and the related short- and long-term risks of therapy.
Andrew Reynolds[/caption]
Andrew Reynolds
Department of Human NutritionUniversity
Otago Dunedin New Zealand
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Current guidelines for people with type 2 diabetes are to undertake activities such as walking for at least 150 minutes a week, or 30 minutes a day. When to walk in the day is not specified. We thought it reasonable that walking after meals would improve blood sugars more so than a walk where the timing was unspecified.
Our randomised controlled trial considered exactly this, a prescription to walk as per the guideline of 30 minutes a day and a prescription to walk for 10 minutes after each meal. Our participants were free-living, but wore accelerometers to record their movement, and continuous glucose monitoring systems to observe their blood glucose levels. We found that post-meal blood sugar levels dropped 12 per cent on average when the participants followed the walking after meals advice compared to walking at any time of the day. Most of this effect came from the highly significant 22 per cent reduction in blood sugar when walking after evening meals, which were the most carbohydrate heavy, and were followed by the most sedentary time.
Stephen F. Wendolowski[/caption]
Stephen F. Wendolowski
Research Assistant
Pediatric Orthopaedics
Cohen Children’s Medical Center
New Hyde Park, NY, 11040
MedicalResearch.com: What is LEAN?
Response: LEAN is a management principle that supports the concept of continuous improvement through small incremental changes to not only improve efficiency, but also quality. Particularly, we took interest in the 5S’s – Sort, Simplify, Sweep, Standardize, and Self-Discipline. We felt that Sort, Simplify, and Standardize were the most relevant to surgery.
Dr. Alan Menter[/caption]
Dr. Alan Menter MD
Texas Dermatology Associates
MedicalResearch.com: What is the background for this study?
Response: Psoriasis on the palms and soles of the feet—also known as palmoplantar psoriasis of which there are 2 variants, plaque type or pustular, —can significantly affect a person’s quality of life and is often difficult-to-treat with available treatments. Researchers in this study set out to determine the efficacy and safety of Taltz (ixekizumab) through 60 weeks among patients with moderate-to-severe plaque psoriasis with significant palmoplantar involvement. Plaque psoriasis is the most common form of psoriasis appearing as raised, red patches covered with a silvery white buildup of dead skin cells which are often painful or itchy. This study was an analysis of UNCOVER-3, a Phase 3, multicenter, double-blind, placebo-controlled trial.
In the first 12 weeks of this study, patients were randomized to receive placebo, etanercept (50 mg, twice-weekly) or 80 mg of Taltz every two weeks or every four weeks, following an initial starting dose of 160 mg. At 12 weeks, all patients received open-label Taltz every four weeks through 60 weeks.
Dr. Melanie Royce[/caption]
Melanie Royce, MD, PhD
Professor of Medicine
University of New Mexico School of Medicine
Director of the Breast Multidisciplinary Clinic and Program
UNM Cancer Center.
Albuquerque, NM
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: BOLERO-4 is an open label, single-arm, Phase II study that evaluates the combination of everolimus plus letrozole as a first-line treatment for hormone receptor (HR)-positive/HER2-negative advanced breast cancer patients, as well as the use of everolimus plus exemestane beyond initial progression.
Results of the Phase II BOLERO-4 clinical trial, presented as an oral presentation at the 2016 European Society for Medical Oncology (ESMO) annual meeting, show preliminary evidence that everolimus in combination with letrozole is effective in treating women with HR-positive/HER2-negative advanced breast cancer in the first-line setting. With follow up of 17.5 months, the median progression-free survival (PFS) is not yet reached. At six months, 83.6% (95% CI: 77.3-88.2%) of women taking everolimus plus letrozole in the first-line setting were without disease progression, and 71.4% (95% CI: 64.0%-77.5%) did not have disease progression at twelve months.
Safety findings from BOLERO-4 are consistent with previous studies of everolimus in advanced breast cancer, with the most common adverse events being stomatitis (67.8%), weight loss (42.6%) and diarrhea (36.1%). These adverse events were mostly grade 1 or 2 in severity1.
Dr Nicholas Kirkby[/caption]
Dr Nicholas Kirkby
BHF Intermediate Fellow | Vascular Biology
National Heart & Lung Institute | Imperial College London
London
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: We know drugs like ibuprofen, called ‘non-steroidal anti-inflammatory drugs’ cause an increase in the risk of heart attacks. These side effects cause very real concerns for the many millions of people who rely on them. They are also the reason why there are no new drugs in this class and why they have been withdrawn (2011) for use as a preventative treatment for colon cancer. Previous research from our group suggests that L-arginine supplements may prevent the cardiovascular side effects caused by these drugs. Our findings here suggest that a particular formulations of ibuprofen, called ibuprofen arginate, which is already available in many parts of the world, can act like an L-arginine supplement and that this could potentially protect the cardiovascular system.
Dr. Luis E. Rohde[/caption]
Luis E. Rohde, MD, ScD
Postgraduate Program in Health Science: Cardiology and Cardiovascular Sciences, Medical School, Federal University of Rio Grande do Sul,
Cardiovascular Division, Hospital de Clínicas de Porto Alegre
MedicalResearch.com: What is the background for this study?
Response: Caffeine-rich beverages have been implicated as a common cause of several cardiac-related symptoms, such as palpitations, tachycardia, or irregular heartbeats.
Because of this “intuitive” assumption, counseling to reduce or avoid caffeine consumption is still widely recommended in clinical practice by most physicians for patients with any heart disease.