Author Interviews, Gastrointestinal Disease / 03.11.2018

MedicalResearch.com Interview with: RedHill BiopharmaDror Ben-Asher Co-Founder, Chairman & CEO RedHill Biopharma Ltd. MedicalResearch.com: Your presentation at United European Gastroenterology Week (UEGW) covered top-line data from your recently completed Phase 3 study of RHB-104 in Crohn’s disease. Can you please briefly remind us of the background for this study and what results you previously announced? Response: Crohn's disease is a devastating gastrointestinal disorder that affects millions of people worldwide. Crohn's is a chronic relapsing disorder that plagues people throughout their lives with a variety of symptoms including severe abdominal pain, diarrhea, bleeding, bowel obstruction, fever and weight loss. The existing treatments for Crohn's disease leave a lot to be desired – they are only partially effective in the long-term control of Crohn's and are associated with serious side effects. In addition, the existing therapies only target treating the symptomatic inflammation associated with Crohn's. We began developing RHB-104 with the MAP hypothesis in mind, a theory that suggests Crohn's is caused by infection by a bacteria, Mycobacterium avium subspecies paratuberculosis (MAP), in susceptible patients. RHB-104 is a patent-protected orally-administered combination of three antibiotics (clarithromycin, clofazimine and rifabutin) in a single oral capsule that has demonstrated its potential to benefit Crohn's patients. When we announced top-line results from the MAP US study, our Phase 3 trial of RHB-104 in patients with moderate to severe Crohn's disease, we showed that RHB-104 demonstrated a significant clinical benefit to patients versus placebo control. Patients treated with RHB-104 showed significant increase in remission at 26-weeks post treatment initiation in addition to being generally safe and well tolerated. (more…)
Addiction, Author Interviews, Neurology / 02.11.2018

MedicalResearch.com Interview with: "Be careful what you wish for #drugs #heroin #addiction #camp #church" by Matthew Kang is licensed under CC BY-ND 2.0Michaël Loureiro, PhD Research Assistant - Group Lüscher Dpt. of Fundamental Neuroscience University of Geneva - Faculty of Medicine MedicalResearch.com: What is the background for this study? What are the main findings? Response: Addiction refers to the repeated and irrepressible urge to consume a drug even in the light of negative consequences. All addictive drugs are initially rewarding and have powerful reinforcing properties, which drive users to use the drug again and again. Within the scientific community, it has been repeatedly argued that for opioids, this initial reinforcing effect does not involve dopamine, and no consensus was emerging. In our study we used some of the most advanced genetic tools to observe that in less than a minute heroin strongly increased the activity of neurons in the midbrain causing a release of dopamine in the striatum, a brain region essential for reward seeking. We further used neuroanatomical tracing methods and found that dopamine neurons activated by heroin were projecting to the very medial region of the ventral striatum. Finally, when we silenced dopamine neurons, heroin lost its reinforcing power, confirming the validity of the dopamine activation hypothesis for opioids. (more…)
Author Interviews, Gastrointestinal Disease, Parkinson's / 01.11.2018

MedicalResearch.com Interview with: Viviane Labrie, Ph.D. Assistant Professor Center for Neurodegenerative Science Van Andel Research Institute Grand Rapids, Michigan MedicalResearch.com: What is the background for this study? Response: Our lab has an interest in the early events and initiation of neurodegenerative diseases. Parkinson’s disease for a long time was thought to be a movement disorder driven by the destruction of dopamine neurons in a specific area of the brain, the substantia nigra. In the last 10 years it has become evident that Parkinson’s disease is not just a movement disorder but hosts a whole range of non-motor systems. One of the most common non-motor symptoms in Parkinson’s patients is issues with the gastrointestinal (GI) tract. GI symptoms often occur early in Parkinson’s disease; for many patients, GI symptoms precede the onset of motor symptoms by as many as 2 decades. Moreover, the GI is not only involved in the early signs of Parkinson’s but has been proposed to be a place in the body where Parkinson’s disease begins. The hallmark pathology of Parkinson’s disease in the brain is Lewy bodies, which contains a clumped form of a protein called alpha-synuclein. There is evidence that Parkinson’s disease pathology, this clumped alpha-synuclein protein, is detectable in the GI tract, even many years before the onset of Parkinson’s motor symptoms. Clumped alpha-synuclein is also capable of traveling across nerve cells. There is evidence that clumped alpha-synuclein can travel up the nerve that connects the GI tract to the brain and enter the brain. This could be disastrous because clumped alpha-synuclein can seed and spread in the brain, which has neurotoxic effects and can eventually lead to Parkinson’s disease. In fact, in the brain of Parkinson’s patients, one of the first places where alpha-synuclein clumps are detected is at the terminal where the gut nerve connects to the brain, and this pathology advances from this point to other brain areas as the disease progresses. This intriguing connection of the GI tract to the early processes of Parkinson’s disease had us interested in trying to understand how the gut could be involved in triggering Parkinson’s. But the GI tract is a very big place, and we first asked ourselves, where should we look to better understand GI involvement in Parkinson’s disease? (more…)
Author Interviews, CDC, Hospital Acquired / 01.11.2018

MedicalResearch.com Interview with: "Hospital Room" by Kyle Taylor is licensed under CC BY 2.0Dr. Shelley Magill, MD Medical Officer and CDC lead for the hospital HAI (hospital acquired infections) and antimicrobial use prevalence survey MedicalResearch.com: What is the background for this study? Response: The prevalence survey effort began in 2009. The goal was to obtain a snapshot of all healthcare-associated infections affecting hospital patients, not limited to those commonly reported to the National Healthcare Safety Network. We conducted our first full-scale hospital prevalence survey in 2011, in collaboration with the Emerging Infections Program, a network of 10 state health departments and academic and other partners. Data from that survey showed that about four percent of patients had a healthcare-associated infection—or, on any given day, about 1 in 25 patients. We repeated the survey in a similar group of hospitals in 2015 to see whether changes had occurred. (more…)
Author Interviews, BMJ, Pediatrics, Weight Research / 01.11.2018

MedicalResearch.com Interview with: "babies (365-222)" by Robert Couse-Baker is licensed under CC BY 2.0Dr. Christopher M Stark Department of Pediatrics William Beaumont Army Medical Center El Paso, Texas Department of Pediatrics Walter Reed National Military Medical Center Bethesda, Maryland MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Rates of pediatric obesity have increased over the past decade, which has led researchers to search for modifiable risk factors that may explain this increase. Recent studies have identified an association between native gut bacteria alterations and the development of obesity. Several population-based studies have evaluated whether or not there is an association between antibiotic exposure and the development of obesity, with mixed results. No studies have previously evaluated if acid suppressing medications are associated with developing obesity. We found that young children prescribed antibiotics, acid suppressants, and combinations of these medications in the first two years of life are more likely to develop obesity after two years of age. Our study represents the largest study to evaluate pediatric antibiotic prescriptions and obesity risk, with nearly ten times as many patients as the next largest study. (more…)
Author Interviews, Autism, JAMA, OBGYNE / 01.11.2018

MedicalResearch.com Interview with: Magdalena Janecka PhD Department of Psychiatry Icahn School of Medicine at Mount Sinai MedicalResearch.com: What is the background for this study? Response: Our paper explored the association between maternal use of medication during pregnancy and the rates of autism in a large cohort from Israel. This followed on from a number of earlier studies reporting that the use of certain medications - for example antidepressants - during pregnancy is associated with higher rates of autism in children. However, rather than test the effects of any particular drug, or a set of drugs aggregated based on maternal condition, our large dataset allowed us to group all medications prescribed to pregnant women based on their drug target, and in the subsequent analyses focus on over 50 groups that included drugs with neurotransmitter-relevant targets - for example agonists and antagonists of their receptors. (more…)
Author Interviews, Occupational Health, Rheumatology / 01.11.2018

MedicalResearch.com Interview with: Dr. W. Benjamin Nowell, Ph.D. Director of Patient-Centered Research CreakyJoints, study co-author Co-principal investigator of ArthritisPower MedicalResearch.com: What is the background for this study? What are the main findings? Response: Rheumatoid Arthritis (RA) can diminish patients’ work productivity and increase the risk of long-term disability, economic insecurity and worsening health, but limited research informs these issues. The purpose of our study was to examine associations between patients’ RA disease activity and their productivity and workplace support, using real-world data from the ArthritisPower research registry. Our study looked at a sample of participants with RA who had a history of or current treatment with non-biologic and/or biologic disease-modifying antirheumatic drugs (DMARD) (n=296). Among the study sample, 74 percent had high disease activity (HDA) as determined by RAPID3 (>12), a common measure of disease activity in RA.
  • High disease activity was associated with lower education (p<0.001) and higher likelihood of disability (9%, p<0.001) compared to those without high disease activity.
    • Patients with HDA missed more days of work than non-HDA patients (mean: 6.1 vs 3.8 days, respectively; p=0.03), but non-HDA participants reported more days off due to medical appointments (2.6 vs 1.2 days, respectively) while HDA patients missed more days due to RA treatment side effects (mean: 0.5 vs 0.1 days, respectively).
  • Based on scores from the Work Productivity and Activity Impairment (WPAI) questionnaire, RA seems to affect work productivity to a greater extent in participants with HDA than without (WPAI scores 5.3 and 3.3, respectively; p<0.001). Participants who were not currently employed reported having more physically demanding tasks (e.g. heavy load lifting) and less workplace flexibility (e.g. working from home) in their most recent paid position than currently employed participants.
  • However, in a multivariate regression analysis, we found that participants who could request changes in work start and stop times on a daily basis were 2.9 (95% CI: 1.53, 5.46) times more likely to be unemployed (adjusting for age, disease activity, and satisfaction with social participation) than those unable to make this request (p<0.0001).
About ArthritisPower: Created by CreakyJoints and supported by a multiyear, multimillion dollar investment by the Patient-Centered Outcomes Research Institute (PCORI), ArthritisPower is the first-ever patient-centered research registry for joint, bone, and inflammatory skin conditions. The free ArthritisPower mobile and desktop application allows patients to track and share their symptoms and treatments while also participating in voluntary research studies in a secure and accessible manner. ArthritisPower Patient Governors serve as gatekeepers for researchers who seek access to registry data or solicit the community to participate in unique, voluntary studies. To learn more and join ArthritisPower, visit www.ArthritisPower.org.  (more…)
AHA Journals, Author Interviews, Blood Pressure - Hypertension, Heart Disease, UT Southwestern / 31.10.2018

MedicalResearch.com Interview with: Wanpen Vongpatanasin, M.D. Professor of Medicine Norman & Audrey Kaplan Chair in Hypertension Fredric L. Coe Professorship in Nephrolithiasis and Mineral Metabolism Research Director, Hypertension Section, Cardiology Division, UT Southwestern Medical Center Dallas, TX 75390-8586 Dr. Wanpen Vongpatanasin, M.D. Professor of Medicine Program Director, Hypertension Fellowship Program UT Southwestern Medical Center in Dallas MedicalResearch.com: What is the background for this study? What are the main findings? Response: The new US hypertension guideline places a greater emphasis on out-of-office blood pressure measurement, and maintains that a clinic BP of 130/80 mm Hg is equivalent to the same reading for home BP monitoring or daytime ambulatory BP monitoring. That is based, however, on data from non-US cohorts, primarily from Japanese cohorts and some European populations. None has been studied in the US population until now. To find out, we analyzed large multi-ethnic studies of primarily young and middle-aged adults in Dallas, Texas, and Durham, N.C., that compared home blood pressure to clinic measurements, using the regression correlation (i.e. regression approach). To confirm the findings, we use another approach called “outcome approach” by determining risks of stroke, MI, and death associated with a clinic systolic blood pressure reading of 130 mmHg from the 3,132 participants in the Dallas study during an 11-year follow up. Then, we determined the home blood pressure levels that carried the same heart disease risk and stroke risk as the clinic systolic 130 mm Hg reading. We found that the level of home blood pressure of 130/80 mm Hg actually best correlates with blood pressure taken at the doctor’s office of 130/80 mmHg. This is true for whites, blacks and Hispanic patients in both treated and untreated population.  (more…)
Asthma, Author Interviews, FDA, Regeneron / 31.10.2018

MedicalResearch.com Interview with: RegeneronNeil Graham,  M.B.B.S., M.D., M.P.H VP of Immunology & Inflammation Regeneron MedicalResearch.com: What is the background for this announcement?  Response: Patients with moderate-to-severe asthma often have uncontrolled, persistent symptoms despite standard-of-care therapy that may make them suitable for treatment with a biologic therapy. They live with coughing, wheezing and difficulty breathing, and are at risk of severe asthma attacks that may require emergency room visits or hospitalizations. [i],[ii] Oral corticosteroids can provide relief for severe, short-term symptoms. However, their chronic use is limited to the most severe patients due to the potential for serious side effects. [iii],[iv] A particular type of inflammation contributes to the cause of uncontrolled symptoms in multiple inflammatory diseases such as asthma and atopic dermatitis.[v] Dupixent is a medicine that inhibits the overactive signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13), two key proteins that contribute to this type of inflammation. This inhibits cytokine-induced inflammatory responses, including the release of proinflammatory cytokines, chemokines, nitric oxide, and IgE; however, the mechanism of action of Dupixent in asthma has not been definitively established. (more…)
Author Interviews, Cognitive Issues, Critical Care - Intensive Care - ICUs, NEJM, Vanderbilt / 31.10.2018

MedicalResearch.com Interview with: Brenda Truman Pun, DNP, RN Program Clinical Manager Vanderbilt University Medical Center MedicalResearch.com: What is the background for this study? Response: Delirium is a serious problem in Intensive Care Units around the world. Approximately 80% of mechanically ventilated patients develop delirium, acute confusion, while in the ICU. Once thought to be a benign side effect of the ICU environment, research now shows that delirium is linked to a myriad of negative outcomes for patients which include longer ICU and Hospital stays, prolonged time on the ventilator, increased cost, long-term cognitive impairment and even mortality. For a half a century clinicians have been using haloperidol, an typical antipsychotic, to treat delirium in the ICU. However, there has never been evidence to support the use of haloperidol or its pharmacologic cousins, the atypical antipsychotics, to treat delirium. These drugs have serious side effects that include heart arrhythmias, muscle spasms, restlessness and are associated with increased mortality when given for prolonged periods in the outpatient settings leading to a black box warning for their use in this setting. The MIND-USA study was a double blind placebo controlled trial which evaluated the efficacy and safety of antipsychotics (i.e., haloperidol and ziprasidone) in the treatment delirium in adult ICU patients.   (more…)
Author Interviews, Heart Disease, Surgical Research / 31.10.2018

MedicalResearch.com Interview with: Akram Elgendy MD Division of Cardiovascular Medicine University of Florida   MedicalResearch.com: What is the background for this study? Response: Recent clinical trials have demonstrated that percutaneous patent foramen ovale closure is associated with lower risk of stroke recurrence in cryptogenic stroke patients. However, new-onset atrial fibrillation (AF) has been reported as a safety concern. To better understand the risk of new-onset AF, we performed a meta-analysis of PFO closure trials in patients with cryptogenic stroke and migraine. (more…)
Author Interviews, Brain Injury, Heart Disease, JAMA, Neurology / 31.10.2018

MedicalResearch.com Interview with: Marion Moseby-Knappe, MD Neurologist and Researcher Center for Cardiac Arrest at Lund University and Skane University Hospital Lund, Sweden MedicalResearch.com: What is the background for this study? What are the main findings? Response: Our research focuses on improving methods for examining unconscious patients treated on intensive care units after cardiac arrest. If a patient does not wake up within the first days after cardiac arrest, physicians need to evaluate how likely it is that the patient will awaken at all and to which extent there is brain injury. According to European and American guidelines, decisions on further medical treatment of cardiac arrest patients should always be based on a combination of examinations and not only one single method. Various methods are combined when assessing the patient such as examining different neurologic reflexes, head scans (computed tomography or magnetic resonance imaging), other specialist examinations (electroencephalogram or somatosensory evoked potentials) or blood markers. Our research focuses on patients included in the largest cardiac arrest trial to date, the Targeted Temperature Management after Out-of-Hospital Cardiac Arrest (TTM) Trial. (more…)
Author Interviews, Cost of Health Care, JAMA, Kidney Disease / 31.10.2018

MedicalResearch.com Interview with: "Plugged into dialysis" by Dan is licensed under CC BY 2.0Amal Trivedi, MD, MPH Associate Professor of Health Services, Policy and Practice Associate Professor of Medicine Brown University MedicalResearch.com: What is the background for this study? What are the main findings? Response: The Affordable Care Act Medicaid expansion gave states the option to expand coverage to low-income adults. Prior research has reported that these expansions have been associated with increased coverage, improved access to care, and in some studies better self-rated health. To date the impact of Medicaid expansion on mortality rates, particularly for persons with serious chronic illness, remains unknown. Our study found an association between Medicaid expansion and lower death rates for patients with end-stage renal disease in the first year after initiating dialysis.  Specifically, we found an absolute reduction in 1-year mortality in expansion states of -0.6 percentage points, which represents a 9% relative reduction in 1-year mortality.      (more…)
Author Interviews, Pharmacology, Schizophrenia / 31.10.2018

MedicalResearch.com Interview with: Jelena Kunovac, M.D., M.S. Founder and Chief Executive Chief Medical Officer Altea Research Las Vegas, Nevada MedicalResearch.com: What is the background for this study? Response: We conducted the study to confirm that the addition of samidorphan to olanzapine does not have an effect on the antipsychotic efficacy of olanzapine in subjects with an acute exacerbation of schizophrenia. (more…)
Accidents & Violence, Author Interviews, JAMA / 31.10.2018

MedicalResearch.com Interview with: "Halloween Parade 2014" by GoToVan is licensed under CC BY 2.0Dr. John A. Staples, MD Clinical Assistant Professor University of British Columbia MedicalResearch.com: What is the background for this study? What are the main findings? Response: At this time last year, my co-author Candace Yip and I noticed an impressive number of advertisements for Halloween-themed parties at bars taped to lamp-posts. We wondered if the combination of dark costumes, dark evenings, alcohol and trick-or-treaters made the streets more dangerous for pedestrians. To see if our hunch was correct, we examined 42 years of data on all fatal vehicle crashes in the United States between 1975 and 2016. We compared the number of pedestrian fatalities between 5 p.m. and midnight on Halloween with the number during the same hours on control days one week earlier and one week later. We found that 14 pedestrian deaths occurred on the average Halloween, while only 10 pedestrian deaths occurred on the average control evening. This corresponded to a 43% increase in the relative risk of pedestrian fatality on Halloween. Among children aged 4 to 8 years of age, the risk of death was ten times higher on Halloween evening compared to control evenings. Risks were highest around 6pm, which is prime trick-or-treating time. Absolute risks were small and declined throughout the four decades of the study, but the relative risk increase on Halloween persisted throughout the entire study interval.  (more…)
Author Interviews, Flu - Influenza, Genentech / 30.10.2018

MedicalResearch.com Interview with: Mark D. Eisner, MD, MPH Vice PresidentProduct Development Immunology, Infectious Disease and Ophthalmology Genentech Dr. Eisner discusses the announcement that the FDA has approved XOFLUZA™ (baloxavir marboxil) for the treatment of acute, uncomplicated influenza. MedicalResearch.com: What is the background for this announcement? Response: Each year, an estimated 3-11 percent of the U.S. population gets the flu, and it can be very serious, resulting in hospitalization or even death. Since 2010, the Centers for Disease Control and Prevention (CDC) estimates that the flu has resulted annually in 9.2 to 35.6 million illnesses, 140,000 to 900,000 hospitalizations and 12,000 to 80,000 deaths. The severity of last year’s flu season underscores the need for new medical options beyond currently available antivirals. XOFLUZA was granted Priority Review in June 2018 based on results from the Phase III CAPSTONE-1 study of a single dose of XOFLUZA compared with placebo or oseltamivir 75 mg, twice daily for five days, in otherwise healthy people with the flu, as well as results from a placebo-controlled Phase II study in otherwise healthy people with the flu. (more…)
Author Interviews, Cost of Health Care, JAMA / 30.10.2018

MedicalResearch.com Interview with: Samir C. Grover MD, MEd, FRCPC Division of Gastroenterology Program Director Division of Gastroenterology Education Program University of Toronto MedicalResearch.com: What is the background for this study? What are the main findings? Response: We know that physician-industry interactions are commonplace. Because of this, there has been a movement to make the presence of these relationships more transparent. For clinical practice guidelines, this is especially important as these documents are meant to be objectively created, evidence based, and intended to guide clinical practice. The standard in the US come from the National Academy of Medicine report, "Clinical Practice Guidelines We Can Trust", which suggests that guideline chairs should be free of conflicts of interest, less than half of the guideline committee should have conflicts, and that guideline panel members should declare conflicts transparently. Other studies, however, have shown that some guidelines don't adhere to this advice and have committee members who don't disclose all conflicts. We thought to look at this topic among medications that generate the most revenue, hypothesizing that undeclared conflicts would be especially prevalent in this setting. We found that, among 18 guidelines from 10 high revenue medications written by 160 authors, more than (57%) had a financial conflict of interest, meaning they received payments from pharmaceutical companies that make or market medications recommended in that guideline. About a quarter of authors also received, and didn't disclose payments from one of these companies. Almost all the guidelines did not adhere to National Academy of Medicine standards. (more…)
Accidents & Violence, Author Interviews, JAMA, Johns Hopkins, Surgical Research / 30.10.2018

MedicalResearch.com Interview with: “Me holding USP gun” by Nghị Trần is licensed under CC BY 2.0Faiz Gani, PhD Postdoctoral research fellow Department of Surgery Johns Hopkins University School of Medicine MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Firearm related injuries are a leading cause of injury and death in the United States, yet, due to combination of factors, limited data exist that evaluate these injuries, particularly among younger patients (patients younger than 18 years). The objective of this study was to describe emergency department utilization for firearm related injuries and to quantitate the financial burden associated with these injuries. In our study of over 75,000 emergency department visits, we observed that each year, over 8,300 children and adolescents present to the emergency department for the treatment / management of a gunshot injury. Within this sub-population of patients, we observed that these injuries are most frequent among patients aged 15-17 years and while these injuries decreased over time initially, were observed to increase again towards the end of the time period studied. In addition to describing the clinical burden of these injuries, we also sought to describe the financial burden associated with these injuries. For patients discharged from the emergency department, the average (median) charge associated with their care was $2,445, while for patients admitted as inpatients for further care, the average (median) charge was $44,966. Collectively these injuries resulted in $2.5 billion in emergency department and hospital charges over the time period studied. This translates to an annual financial burden of approximately $270 million. (more…)
Anesthesiology, Author Interviews, Opiods, Pain Research, Surgical Research / 29.10.2018

MedicalResearch.com Interview with: "Surgery" by Army Medicine is licensed under CC BY 2.0Dr. Nirmal B. Shah Anesthesia Resident PGY-IV (CA-III) Thomas Jefferson University Hospital MedicalResearch.com: What is the background for this study? What are the main findings?  Response: With the ongoing opioid epidemic, we believe it is important to understand patients’ perceptions of pain medications and pain control after surgery. We believe patients’ expectations and perceptions regarding perioperative pain medications has not been well understood. We were hoping to understand patients’ knowledge, concerns, and biases of pain medication along with information to optimize acute pain management. The goal of this survey study was to understand patient expectations regarding pain medications including opioids and non- opioids.  In the United States, over 100 million surgical procedures are performed every year. Nearly 80% of these patients will experience post-operative pain. Adequate treatment of post-operative pain has been shown to improve clinical and economic outcomes, thus there has been an increased effort towards improving post-operative pain control. Through our research, we demonstrated that patients expect to experience postoperative pain after a surgical procedure and expect to be prescribed a pain medication. Patients believe that opioid medications will be most effective in treating postoperative pain compared to non-opioid medications, which could be contributing to the opioid epidemic. 503 patients presenting for elective surgery at Thomas Jefferson University Hospital in Philadelphia, PA were sampled during this survey. 76% of patients expected to be prescribed an opioid pain medication at discharge, 47% of patients expected to be prescribed acetaminophen (Tylenol) pain medication at discharge, while 30% of patients expected to be prescribed an NSAID (Motrin) pain medication at discharge. 94% of patients expecting to receive an opioid pain medication believe it would be effective in controlling their post-operative pain. This difference was not observed in patients expecting prescriptions for non-opioid pain medications. Overall, patients expect to experience pain after surgery and be prescribed analgesics they perceived to be most effective, opioids. (more…)
Author Interviews, Biomarkers, Infections, JAMA, Stanford / 29.10.2018

MedicalResearch.com Interview with: "Mycobacterium tuberculosis Bacteria, the Cause of TB" by NIAID is licensed under CC BY 2.0Purvesh Khatri, Ph.D. Associate Professor Stanford Institute for Immunity, Transplantation and Infection (ITI) Stanford Center for Biomedical Informatics Research (BMIR) Department of Medicine Stanford University Stanford, CA 94305 MedicalResearch.com: What is the background for this study? What are the main findings? Response: We have previously described a 3-gene signature for distinguishing patients with active tuberculosis (ATB) from those with other diseases, latent mycobacterium tuberculosis (LTB) infection, and healthy controls (Sweeney et al. Lancet Respir Med 2016). The current study in JAMA Network Open is a follow up study to validate the 3-gene signature in 3 additional independent cohorts that were prospectively collected. Using these 3 cohorts we have now showed that the 3-gene signature (1) can identify patients with LTB that will progress to ATB about 6 months prior to diagnosis of active tuberculosis. (2) can identify patients with ATB in active screening, and (3) can identify patients with ATB at diagnosis that have higher likelihood of persistent lung inflammation due to subclinical ATB at the end of treatment.  (more…)
Aging, Author Interviews, Geriatrics, Social Issues / 29.10.2018

MedicalResearch.com Interview with: "Elderly woman speaks about Water Supply and Sanitation program in Nepal" by World Bank Photo Collection is licensed under CC BY-NC-ND 2.0Dr Sharon Leitch | MBChB, DCH, PGDipGP, FRNZCGP General Practitioner, Clinical Research Training Fellow Department of General Practice and Rural Health University of Otago New Zealand MedicalResearch.com: What is the background for this study? Response: Loneliness is associated with poor health, reduced quality of life, and increased mortality. Loneliness typically worsens with age. We were curious to learn what the prevalence of loneliness was among older New Zealanders, if there were age-specific associations with loneliness, whether there were any associations between demographic and psychosocial variables and loneliness, and we also wanted to compare centenarians (100 years or older) with elderly people (aged 65-99 years). Centenarians are a particularly interesting group to study because they are a model of successful ageing. The international Resident Assessment Instrument-Home Care (interRAI-HC) assessment has been mandatory in New Zealand for anyone undergoing assessment for publically funded support services or residential care since 2012, providing us with a comprehensive data set. We conducted a retrospective, observational, cross-sectional review of the interRAI-HC data from over 70,000 people living in the community who had their first assessment during the study period (January 2013-November 2017). We analysed eight items from the interRAI-HC data set to describe the population and evaluate the core psychosocial components of aging; age, gender, ethnicity, marital status, living arrangements, family support, depression and loneliness. (more…)
Author Interviews, Kidney Disease, Mineral Metabolism, Pharmacology / 29.10.2018

MedicalResearch.com Interview with: Dr Mattias Ivarsson PhD CEO, Inositec, co-author of data MedicalResearch.com: What is the background for this study? Response: When control of factors in the blood that regulate mineral balance in the body is lost, the subsequent build-up of calcium deposits in the arterial walls and cardiac valves lead to an increase in cardiac events, particularly in patients with chronic kidney disease or diabetes, as well as all-cause mortality. There is a significant unmet need for therapeutic agents capable of reducing pathological mineral accumulation regardless of their root cause. To date, there is no approved therapy for treating calcification-dependent cardiovascular disease.  (more…)
Author Interviews, Cannabis, Kidney Disease / 29.10.2018

MedicalResearch.com Interview with: "Big bags of medical #marijuana on Cannabis Culture News LIVE - watch now on www.pot.tv" by Cannabis Culture is licensed under CC BY 2.0Praveen Kumar Potukuchi, B.Pharm, MS The University of Tennessee Health Science Center MedicalResearch.com: What is the background for this study? Response: Several case reports have indicated that synthetic cannabinoid use is associated with acute kidney injury (AKI). However, it is unclear whether similar adverse effects could occur with medicinal or recreational cannabis use. Previous research has shown that the use of medical marijuana /cannabis for an average of two weeks resulted in no serious adverse effects and no incidence of AKI. However, there are no studies which investigated the effects of marijuana/cannabis use on the incidence of AKI in patients with advanced CKD. (more…)
Author Interviews, Pediatrics / 28.10.2018

MedicalResearch.com Interview with: Michael Snape, Ph.D. Chief executive officer Chief scientific officer AMO Pharma  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: This is a further analysis of the Phase II Proof of Concept study that was described in March.  We have extended the findings from that study by performing further analyses of the data obtained and also commencing an analysis of the relationship between the levels of AMO-02 involved and the clinical response seen. The main finding is a confirmation that our previously reported conclusions are supported.  The concordant trend analysis revealed a clear dose-response relationship that favored the 1000 mg over 400 mg dose for four of the 10 response variables differed in favor of 1000 mg over 400 mg dose on key clinician and caregiver measures, autism scores and grip strength.  (more…)
Author Interviews, Biomarkers, Cancer Research, Prostate Cancer / 28.10.2018

MedicalResearch.com Interview with: Davide Pellacani Ph.D. Postdoctoral Fellow, Eaves' Lab Terry Fox Laboratory, BC Cancer Research Centre Vancouver, BC MedicalResearch.com: What is the background for this study? What are the main findings? Response: Prostate cancer is characterized by frequent DNA methylation changes compared to normal tissue. Nevertheless, understanding which of those changes lead to the acquisition of malignant proprieties is complicated by the predominance of cells with luminal features in prostate cancers. In this study we generated DNA methylation maps of two distinct cell populations found within prostate cancer samples (called basal and luminal) and their normal counterparts. These datasets clearly showed that many of the common DNA methylation changes found in prostate cancer are present in luminal cells from both cancer and normal tissues. These changes are not necessarily cancer-specific, and are likely due to the bias associated with analyzing tissues in bulk, where most cancer cells have luminal-like features. We used these datasets to derive two cancer-specific and phenotype-independent DNA methylation signatures: one specific to prostate cancer luminal cells, and one composed of changes measured in both luminal and basal cancer cells. We then validated the potential clinical utility of these signatures by testing their ability to distinguish prostate cancer from normal samples, and tumours that have already escaped the prostate from those that have not, using the publicly available dataset from The Cancer Genome Atlas. (more…)
Accidents & Violence, Author Interviews, Cannabis / 28.10.2018

MedicalResearch.com Interview with: Prof. Mark A. R. Kleiman PhD Affiliated Faculty, NYU Wagner; Professor of Public Policy NYU Marron Institute of Urban Management MedicalResearch.com: What is the background for this study? What are the main findings?  Response: As state after state legalizes the sale of cannabis, the question of cannabis-impaired driving is getting more attention. There is evidence that the practice has become more common, both because cannabis use - and especially heavy, frequent use - has increased and because a distressingly large fraction of cannabis users believe, falsely, that stoned driving is safe. The natural response to the problem is to treat cannabis on a par with alcohol: fairly severe criminal penalties for impaired driving, with impairment defined by a specific level of the drug in the body. The paper argues that this would be a mistake, for four independent reasons: - While cannabis makes driving riskier, it does so by about a factor of two, with no strongly observed dependency on dosage. Alcohol, by contrast, has a steep dose-effect curve. At the legal limit of 0.08% blood alcohol content by weight, the relative risk of drunk driving is at least eight; at 0.15%, which is fairly common, the relative risk has been estimated at 30-50. So there is no justification for punishing stoned driving as severely as we punish drunk driving. - The lack of evidence of a strong dose-effect relationship suggests that a legal standard based on the content of cannabinoids in blood may not be appropriate. - Even if a blood standard were valid, the lack of a breath test would make enforcing that standard nearly impossible as a practical matter. - The long and unpredictable course of cannabis metabolism means that frequent users will be at risk of failing a drug test even when they are neither subjectively intoxicated nor objectively impaired. Worse, they would have no way of judging in advance whether or not driving would be legal. The result would be a re-criminalization of cannabis use through the back door.  (more…)
Author Interviews, Weight Research / 27.10.2018

MedicalResearch.com Interview with: Dr. Kaitlin Wade PhD Research Associate and Early Career Researcher Representative Integrative Epidemiology Unit (IEU) Bristol Medical School (Population Health Sciences) Faculty of Health Sciences University of Bristol  MedicalResearch.com: What is the background for this study? Response: Whilst severe obesity increases the risk of death in the population, there are conflicting results in the literature with some papers suggesting a protective effect of being overweight. Many observational studies also report a J-shaped association between body mass index – a measure of weight accounting for a person’s height – and mortality, where individuals who are underweight also have an increased risk of mortality compared to those within the ‘normal’ range. Such controversial findings are not without limitation, as bias by age, ill-health and other lifestyle factors are likely. One method to overcome the limitations of observational studies – Mendelian randomization – uses genetic variation in a person’s DNA to help understand the causal relationships between risk factors and health outcomes to provide a more accurate estimate of relationships by removing confounding factors (such as smoking, income and physical activity) and reverse causation (where people lose weight due to ill-health), which can explain conflicting findings in previous studies. Until now, no study has used such a genetic-based approach to explore the link between body mass index and mortality. (more…)