MedicalResearch.com Interview with:
Emily Largent, PhD, JD, RN
Senior Fellow
Leonard Davis Institute of Health EconomicsAssistant Professor, Medical Ethics and Health Policy
Perelman School of MedicineMedicalResearch.com: What is the background for this study? Response: Ending the COVID-19 pandemic through vaccination will require sufficient vaccine uptake. Various means are being considered to promote uptake, including mandatory vaccination. For instance, COVID-19 vaccination might be mandated by states (e.g., as a condition for children to attend public school) or by employers. Given the opposition we’ve seen to masks, to choose just one example, our team wanted to gauge the acceptability of COVID-19 vaccine mandates.
(more…)
MedicalResearch.com Interview with:
Dr. Louis Aronne, MD, FACP
Chief Medical Officer, Intellihealth
Medical Director, Comprehensive Weight Control Center
Weill Cornell Medicine
MedicalResearch.com: What is the background for the study “Effect of an Online Weight Management Program Integrated With Population Health Management on Weight Change: A Randomized Clinical Trial”?Response: More than 70% of U.S. adults have overweight or obesity. Online programs promoting lifestyle change have had some success in helping people achieve and maintain weight loss, but study results have been variable, and these programs have not been widely implemented in primary care. We studied the effectiveness of an online program we have developed (Intellihealth, formerly known as BMIQ) in routine primary care practices, both alone and integrated with population health management (with participants receiving additional support and outreach from nonclinical staff). The study’s objective was to determine whether a combined intervention integrating online weight management with population health management would increase weight loss at 12 months among primary care patients compared with the online program only and usual care.
(more…)
MedicalResearch.com Interview with:
Karin Magnusson PT, PhD
Associate ResearcherLund University and
Norwegian Institute of Public Health
MedicalResearch.com: What is the background for this study? Response: Anterior cruciate ligament (ACL) injury is one of the most common knee injuries, for which very limited data has been presented on the genetic contribution. Based on our knowledge of the role of genetics in the development of ACL-rupture related traits, such as joint hypermobility and knee osteoarthritis, we hypothesized that heritability might play a role also in ACL injury.
Using the Swedish Twin Registry, which is the world's largest twin registry and in this study including more than 88.000 twins, we had unique data to for the first time reliably estimate the heritability for this common knee injury.(more…)
MedicalResearch.com Interview with:
Robert Van Haren, MD, MSPH
College of Medicine
University of CincinnatiMedicalResearch.com: What is the background for this study? Response: The COVID-19 pandemic has impacted all areas of society including the field of oncology. This study evaluated the impact of COVID-19 on lung cancer screening. Screening with low-dose computed tomography (LDCT) scans are important because they reduce lung cancer mortality by at least 20%. Our lung cancer screening program was closed in March 2020 due to COVID 19 and reopened again in June 2020. We cancelled over 800 LDCTs during that time period. (more…)
MedicalResearch.com Interview with:
Joshua Brody MD
Director, Lymphoma Immunotherapy Program
Icahn School of Medicine at Mount Sinai
Hess Center for Science and Medicine
New York, New York 10029
MedicalResearch.com: What is the background for this study? Response: Cancer Immunotherapies target "antigens" on the surface of cells.
-CAR-T cells targets antigens e.g. CD19
-Bispecific antibodies target antigens e.g. CD20
-Anti-PD1 antibodies awaken T cells that target antigens on e.g. MHC-I
Cancer Immunotherapies frequently fail because a small percent of tumor cells simply lack the antigen and cause cancer relapse ('Antigen Escape')
(more…)
MedicalResearch.com Interview with:
Xiaolei Yang
The State Key Laboratory of Nonlinear Mechanics, Institute of Mechanics
School of Engineering Sciences
University of Chinese Academy of Sciences
Beijing, China
MedicalResearch.com: What is the background for this study? What are the main findings?Response: The most important finding of this study is that the transmission of COVID-19 is highly influenced by the airflow and that a slight difference in the airflow can significantly alter the virus spreading pattern in the air. In this study, the change of airflow is caused by a minor difference in the corridor width and the walking speed. However, such a change can also come from other factors, such as the indoor architectural structure, the temperature, the humidity, etc. In many of these cases, the common guideline of 6-feet may not be enough when the influence of airflow is taken into account. Due to this complexity, there is still a gap of knowledge to fill before a safety guideline for different indoor environments can be provided to the public, many research efforts are needed from the fluid mechanics’ aspect.
(more…)
MedicalResearch.com Interview with:
Kevin Moore, MD
UCL Institute of Liver and Digestive Health
Royal Free Hospital, University College London
MedicalResearch.com: What is hepatorenal syndrome – acute kidney injury (HRS-AKI) and how does terlipressin fit into the treatment landscape?Response: HRS-AKI, also known as hepatorenal syndrome type 1 (HRS-1), is an acute and life-threatening syndrome involving acute kidney failure in people with cirrhosis.[i] HRS-1 can progress to life-threatening renal failure within daysi and has a median survival time of approximately two weeks and greater than 80 percent mortality within three months if left untreated.[ii],[iii]
Terlipressin, a potent vasopressin analogue selective for V1 receptors, is an investigational agent, and its safety and effectiveness have not yet been established by the U.S. Food and Drug Administration. In the U.S., there are currently no approved pharmacologic treatments for HRS-1; however, terlipressin is approved in most other countries, where it has been a standard of care for the last 20 years in the treatment of patients with HRS-1.[iv],[v]
The current standard of care for HRS-1 in the U.S. includes other vasoconstrictors such as midodrine (a drug which can increase blood pressure and potentially improve blood flow into the kidneys) along with concomitant albumin and frequent monitoring, but current data do not support good efficacy.2 Dialysis (a type of renal replacement therapy) is sometimes used in hepatorenal syndrome, but dialysis is not curative and it can be costly.(more…)
MedicalResearch.com Interview with:
Isaac Chua, MD, MPH
Division of General Internal Medicine and Primary Care
Brigham and Women's Hospital
MedicalResearch.com: What is the background for this study? Response: Patient surveys have shown that most people prefer to die at home at the end-of-life. However, during the initial wave of the COVID-19 pandemic, anecdotal evidence from our colleagues and findings from a prior study published in the Journal of the American Geriatrics Society suggested that majority of COVID-19 decedents died in a medical facility. However, less is known about care intensity at the end-of-life according to place of death among patients who died of COVID-19. Therefore, we characterized end-of-life care by place of death among COVID-19 decedents at Mass General Brigham (MGB), the largest health system in Massachusetts.(more…)
MedicalResearch.com Interview with:
Sheela Maru, MD, MPH
Department of Health System Design and Global Health and
Arnhold Institute for Global Health and
Department of Obstetrics, Gynecology and Reproductive Science
Icahn School of Medicine at Mount Sinai
MedicalResearch.com: What is the background for this study?
Response: Universal screening for SARS-CoV-2 infection on Labor and Delivery (L&D) units is a critical strategy to manage patient and health worker safety, especially in a vulnerable high-prevalence community. We describe the results of a SARS-CoV-2 universal screening program at the L&D Unit at Elmhurst Hospital in Queens, NY, a 545-bed public hospital serving a diverse, largely immigrant and low-income patient population and an epicenter of the global pandemic.
(more…)
MedicalResearch.com Interview with:
Nilanjan Chatterjee, PhD
Bloomberg Distinguished Professor
Departments of Biostatistics and Epidemiology
Johns Hopkins Bloomberg School of Public HealthMedicalResearch.com: What is the background for this study?
Response: Calculation of risks or severe COVID-19 disease and mortality for individuals in the general population can help to prioritize prevention efforts, such as early vaccination. We developed a model to estimate risks for COVID-19 mortality for currently uninflected individuals based on sociodemographic factors, pre-existing conditions and local pandemic intensity. The model captures factors associated with both risk of infection and complications after infection.
The model was developed using information from a large UK based cohort study called OpenSAFELY, and was adapted to the US population based on information on mortality rate associated with age and race/ethnicity available through CDC. The model also utilizes information on state level projected death rates from pandemic forecasting models.(more…)
MedicalResearch.com Interview with:
Auriel Willette, PhD
Assistant Professor
Food Science and Human Nutrition
Iowa State University
MedicalResearch.com: What is the background for this study? Response: To date, pharmacology therapies done to slow down or halt Alzheimer's disease have been inconclusive. Lifestyle interventions like changes in diet and activity are also mixed but do show some promise. Dietary clinical trials or self-reported diet have tended to focus on groups of foods such as the Mediterranean or MIND diet. To build from this excellent work, we were curious if we could pinpoint specific foods that were correlated with changes in fluid intelligence over time. Fluid intelligence represents our ability to creatively use existing knowledge, working memory, and other components of "thinking flexibly."
Further, we tested if these patterns of association differed based on genetic risk. In this case, genetic risk was defined as having a family history of Alzheimer's disease or having 1-2 "bad" copies of the Apolipoprotein E (APOE) gene, which is the strongest genetic risk factor for Alzheimer's disease.
(more…)
MedicalResearch.com Interview with:
Andrew W. McHill, PhD
Research Assistant Professor
Oregon Institute of Occupational Health Sciences
Oregon Health & Science University, Portland OR
Portland, OR 97239
MedicalResearch.com: What is the background for this study? Response: It has long been known that there is a home court advantage in sports, whether it be due to the home fans cheering, playing within familiar settings, or travel of the opposing team. However, the contribution of travel to home-court advantage could never be fully teased apart due to all the confounds of the other aspects of playing at home.
In March, the National Basketball Association had to pause their season due to COVID-19 concerns, only to start again several months later with the top 22 teams playing in a “bubble” environment where no teams were required to travel. This created a ‘natural experiment’ wherein we could test the impact of travel on winning and performance before the COVID-19 shutdown with games played in the bubble environment with no travel.
(more…)
MedicalResearch.com Interview with:
Asimanshu Das, Ph.D. student
Brown University School of Engineering
MedicalResearch.com: What is the background for this study? What are the main findings?Response: Driving in a car with ride-share or car-pool is a widely prevalent social interaction. The study aimed to address the airflows inside cars in various window open/closed configurations using computer simulations, and also looking into the possibility of movement of aerosol-type of particles from one occupant to other.
The main findings are that opening windows provides a likely benefit to reduce the potentially pathogenic aerosols inside the cabin. Generally, more windows the better, but at the least it would be advisable to have one rear side window and one frontside window open.
(more…)
MedicalResearch.com Interview with:
William K. Schmidt, Ph.D.
Senior VP Clinical Development
Helixmith Co. Ltd.
MedicalResearch.com:What is the background for this study? How common is diabetic peripheral neuropathy and how does it affect patients?Response: According to the Centers for Disease Control and Prevention (CDC), over 34 million people in the United States have diabetes (about 10% of the U.S. population) and about one in four patients do not know that they have it (https://www.cdc.gov/chronicdisease/resources/publications/factsheets/diabetes-prediabetes.htm). Diabetes can cause significant damage to nerves in the feet, hands, eyes, and other parts of the body.
Diabetic peripheral neuropathy (DPN) is the most common form of nerve damage worldwide; it affects approximately half of the patients with diabetes (Iqbal et al., 2018). In many individuals, severe burning, tingling, “pins and needles,” or cramping pain can occur simultaneously in both feet without external evidence of foot damage. Despite the pain, symptoms may be accompanied by numbness or loss of sensation in the feet. This is called painful diabetic peripheral neuropathy (painful DPN or P-DPN) and may affect up to one-third of the general diabetic population (Yoo et al., 2013). P-DPN may cause increased anxiety and depression, sleep impairment, and difficulties with walking. Up to one-third of P-DPN patients may require the use of a cane, walker, or even a wheelchair due to extreme foot pain. Once P-DPN occurs, it may result in a lifetime of pain and disability.
FDA-approved daily oral medications often used to treat P-DPN include Neurontin (gabapentin), Lyrica (pregabalin), Cymbalta (duloxetine), and Nucynta ER (tapentadol). While these “neuropathic pain” medications may dull the pain for some subjects, they produce significant side effects that may be troubling for many patients. Indeed, many patients stop using these pain killers due to lack of effectiveness at doses that they can tolerate (van Nooten et al., 2017) There is also a topical 8% capsaicin patch, but again with limited efficacy. It is well known that the most severely affected patients may require opioid analgesics to control P-DPN (Pesa et al., 2013).
None of the currently used medications have disease-modifying effects. However, our new injectable medication is now in advanced clinical development that has the potential disease-modifying effects lasting months after each treatment, with limited or no side effects for most patients aside from brief injection site discomfort.
(more…)
MedicalResearch.com Interview with:
Joanne L. Blum, MD, PhD, FACP
Texas Oncology and Director
Hereditary Cancer Risk Program
Baylor University Medical Center
MedicalResearch.com: What is the background for this study?Would you briefly describe the POLARIS study?Response: POLARIS is an ongoing prospective, real-world, non-interventional study in patients with HR+/HER2-ABC receiving palboiclib plus endocrine therapy with a targeted enrollment of 1500 patients at 110 sites in the United States and Canada.
MedicalResearch.com: What are the main findings?
Because of the COVID-19 pandemic, approximately one third of the study sites experienced an impact on their responsiveness to correspondence, timely data entry, and subject management.
The geographic location or type (e.g., academic or community) of study site appears associated with whether the site was impacted by COVID-19.
Other study site characteristics were generally similar between sites that reported an impact of COVID-19 and those that were not impacted.
Because of inherent limitations of survey studies, these findings must be interpreted with caution.
MedicalResearch.com Interview with:
David A. Siegel, MD, MPH
Division of Cancer Prevention and Control
US Centers for Disease Control and Prevention
Atlanta, Georgia
MedicalResearch.com: Why is it important to better understand the smoking histories (both current/former and never smokers) among lung cancer patients?Response: Knowledge of smoking status of patients diagnosed with lung cancer can help us understand how to best prevent, detect, and treat lung cancer in the future.
More than 84% of women and 90% of men newly diagnosed with lung cancer had ever smoked cigarettes, and half of patients aged 20 to 64 years newly diagnosed with lung cancer were current cigarette smokers. These findings reinforce the importance of cigarette cessation and lung cancer screening.
1 out of every 8 people diagnosed with lung cancer had never smoked cigarettes, which reiterates the importance of learning more about their risk factors for lung cancer, which could impact prevention and treatment.(more…)
MedicalResearch.com Interview with:
Andrew M. Wilson, MD
Clinical Senior Lecturer in Respiratory Health
University of East Anglia
Norwich and Honorary Consultant Physician in Respiratory Medicine
Norfolk and Norwich University
MedicalResearch.com: What is the background for this study? What are the main findings?Response: Idiopathic pulmonary fibrosis has a poor prognosis and limited treatment options. Clinical trial evidence suggested a survival benefit for people taking co-trimoxazole and microbiological data suggested that infection was implicated in prognosis. However this large multicentre study did not show that co-trimoxazole had an beneficial effect in terms of time to all-cause mortality, hospitalisation or lung transplant in people with moderate and severe idiopathic pulmonary fibrosis
(more…)
MedicalResearch.com Interview with:
Tengteng Wang, PhD, MSPH, MBBS
Postdoctoral Research Fellow
Department of Epidemiology
Harvard T.H. Chan School of Public Health
Channing Division of Network Medicine
Brigham and Women's Hospital
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Type 2 diabetes (T2D) has been associated with poor progression of breast cancer. Moreover, having a breast cancer diagnosis may also increase the risk of developing T2D. Therefore, identifying strategies for T2D prevention among breast cancer survivors may play a key role in improving their survival outcomes. One approach may be through a diabetes risk reduction diet (DRRD), a dietary pattern comprised of 9 components that has been associated with 40% lower T2D risk in a previous Nurses’ Health Study publication.1 However, no studies to date have evaluated the association between adherence to the DRRD (as measured by the DRRD score) and survival outcomes following breast cancer.
In this prospective cohort study among 8,320 breast cancer survivors, we found that greater adherence to the diabetes risk reduction diet after diagnosis was associated with a statistically significant 31% lower risk of overall mortality. Reduced breast cancer-specific mortality was also observed, which was more pronounced (20% lower risk) among those who improved adherence after diagnosis compared to women with consistently low DRRD adherence before and after diagnosis. (more…)
MedicalResearch.com Interview with:
Nicholas S. Reed, AuD
Assistant Professor | Department of Epidemiology
Core Faculty | Cochlear Center for Hearing and Public Health
Johns Hopkins University Bloomberg School of Public Health
MedicalResearch.com: What is the background for this study?
Response: It is known that hearing aid ownership is relatively low in the United States at less than 20% of adults with hearing loss owning and using hearing aids. However, many national estimates of hearing aid ownership are based on data that is over 10 years old. Our team was interested in trying to understand whether ownership in hearing aids had changed over time. We used data from 2011 to 2018 in a nationally representative (United States) observational cohort (The National Health and Aging Trends Study) of Medicare Beneficiaries aged 70 years and older to estimate the change in hearing aid ownership.
In our analysis, the proportion of Medicare beneficiaries 70 years and older who reported owning and using their hearing aids increased 23.3% from 2011 to 2018. However, this growth in ownership was not equal across all older adults. For example, while White males saw a 28.7% increase in hearing aid ownership, Black females saw only a 5.8% increase over the same 8-year period. Moreover, adults living at less than 100% federal poverty level actually saw an overall 13.0% decrease in hearing aid ownership while those living at more than 200% federal poverty line saw an overall 30.6% increase. (more…)
MedicalResearch.com Interview with:
Ed Breitschwerdt, DVM, DACVIM
The Melanie S. Steele Distinguished Professorship in Medicine
Professor, Internal Medicine
NC State College of Veterinary Medicine
MedicalResearch.com: What is the background for this study? Response: Bartonella species represent a medically underappreciated group of vector-transmitted bacteria that are increasingly implicated in a spectrum of animal and human diseases. Most recently, our research group has focused on the potential role of these bacteria as a cause or co-factor in patients with neuropsychiatric symptoms. This focus is based upon prior case reports and case series generated by our research group and others.
(more…)
MedicalResearch.com Interview with:
Steven Pipe, MD
Professor of Pediatrics and Pathology
Laurence A. Boxer Research Professor of Pediatrics and Communicable Diseases
Pediatric Medical Director, Hemophilia and Coagulation Disorders Program
Director, Special Coagulation Laboratory
University of Michigan
MedicalResearch.com: What is the background for this study?Response: Hemophilia B is an inherited bleeding disorder where patients are missing clotting factor IX (9), a critical blood clotting protein.Patients with a severe deficiency are at risk for traumatic and spontaneous bleeds – primarily into joints.Repeated bleeding into joints causes more than acute pain and swelling but also leads to inflammatory and degenerative changes in joints that eventually leads to severe debilitating arthritis that can be crippling.To try to prevent this, patients as young as infants are placed on regular infusions of clotting factor IX concentrates.The relatively short half-life of factor IX means patients must infuse on average once to twice a week.These can only be delivered intravenously – parents and then patients themselves have to learn this.Prophylaxis must be continued lifelong to try to prevent bleeding events and protect joint health over the lifespan.This is a tremendous burden on the patient and their caregivers.Even with regular prophylaxis, joint bleeds may still occur and arthropathy may still ensue.This is because the blood levels often reach critically low levels prior to the next infusion.Gene therapy aims to deliver a functional copy of the factor IX gene such that the patient’s own liver will make a continuous supply of factor IX that is delivered to the bloodstream.At steady state with levels close to or within the normal range, patients would no longer be subject to bleeding events and would not require prophylaxis any longer.We hope that such a one-time treatment would produced durable, “functionally curative” levels of factor IX.(more…)
MedicalResearch.com Interview with:
Martin J. Bergee
Professor and Associate Dean for Academic Affairs
School of Music
University of Kansas
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: The idea that listening, participating, or achieving in music makes you better at another subject, say, math, science, or reading, has been around for a while. Indeed, there’s a relationship between achievement in music and achievement in other content areas. But I’ve always assumed that the relationship was spurious, that is, driven my any number of such background influences as urbanicity, ethnicity, SES, level of parent education, the type of school one attends, and so forth. Essentially, I set out to demonstrate once and for all that with these background influences accounted for statistically, the relationship is considerably attenuated. Much to my surprise, however, music achievement’s relationships with reading and math achievement remained quite strong.
(more…)
MedicalResearch.com Interview with:
Sitara Weerakoon, MPH (she/her)PhD Candidate | Epidemiology & Biostatistics
Graduate Research Assistant
Center for Pediatric Population Health
UTHealth
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Measures to control the spread of COVID-19 included stay-at-home mandates and business lockdown policies which resulted in many facing a loss of income or employment and more time spent isolated at home. Life stressors (like job loss and social isolation) have been shown to be associated with increased drinking at unhealthy levels. Those with a history of mental health problems may be even more at risk.
We aimed to see if binge drinking (5 or more drinks [male] or 4 or more drinks [female] in one session) and levels of alcohol consumption among binge drinkers were impacted by these pandemic-related factors. We found that increased time spent at home (in weeks) was associated with a 19% increase in the odds of binge drinking and binge drinkers with a previous diagnosis of depression and current depression symptoms (during the early months of the pandemic) had a 237% greater odds of drinking more alcohol (vs drinking the same amount) compared to those with no history and current symptoms of depression.
(more…)
MedicalResearch.com Interview with:Prof. Martin Scholz
Heinrich-Heine-University
Düsseldorf, Germany
MedicalResearch.com: What is the background for this study?
Response: Primary care physicians should have options available to effectively treat newly diagnosed COVID-19 patients in the outpatient setting to avoid severe COVID-19 progression, hospitalizations, and mortality. Already since the beginning of the pandemic different early treatment options were evaluated. My co-authors, Dr. Zelenko, Dr. Derwand, and myself were keen to confirm retrospectively the observed evidence for beneficial early treatment effects of an already applied triple therapy in combination with a risk stratification approach. The defined risk stratification allowed to differentiate between patients at low and high risk for disease progression and guided treatment decisions.
(more…)
MedicalResearch.com Interview with:
William Wood, MD
Associate Professor of Medicine, Division of Hematology
UNC School of Medicine
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: In the earliest days of the COVID-19 pandemic, there were concerns that individuals with cancer, and especially those with hematologic malignancies, could be at higher risk for adverse outcomes following COVID-19 infection than the general population. For this reason the ASH Research Collaborative developed a voluntary data collection registry in which providers or sites caring for patients with hematologic malignancies and COVID-19 infection provided de-identified data via an online data collection platform.
We believe that our findings – that 20% of patients with blood cancers who had COVID-19 infection died, including 33% of those who required hospital or ICU level-care – indicate that patients with blood cancers are a medically vulnerable group when it comes to COVID-19. The risk of dying was highest in patients who were older, had more severe infection, opted to forego more intensive treatment, and/or had poorer prognosis before their COVID-19 infection, as determined by their treating clinicians
(more…)
MedicalResearch.com Interview with:
Jonathan Silverberg, MD, PHD, MPH
Associate Professor
Director of Clinical Research
Director of Patch Testing
George Washington University School of Medicine and Health Sciences
Washington, DC
MedicalResearch.com: What is the background for this studyResponse: Chronic hand eczema was previously shown to be associated with higher rates of allergic contact dermatitis. Yet, little is known about recent trends in North America with respect to the clinical presentation and allergen profile in chronic hand eczema. This study sought to determine the clinical characteristics and etiologies of hand eczema in a large North American cohort of adults referred for patch testing. The patients in the study were patch tested using the North American Contact Dermatitis Group’s allergen screening series. (more…)
MedicalResearch.com Interview with:
Dr. Corina Dutcus MD
Vice President of Clinical Research
Oncology Business Group
Eisai
MedicalResearch.com: What is the background for this study? Would you briefly explain how lenvatinib works? Is it used for any other malignancies, ex. thyroid cancer?Response: LENVIMA (lenvatinib), discovered and developed by Eisai, is an orally available multiple receptor tyrosine kinase inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4). LENVIMA inhibits other kinases that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression in addition to their normal cellular functions, including fibroblast growth factor (FGF) receptors FGFR1-4, the platelet derived growth factor receptor alpha (PDGFRα), KIT, and RET.
LENVIMA is approved in combination with everolimus for the treatment of patients with advanced renal cell carcinoma (RCC) following one prior anti-angiogenic therapy. The approved starting dose for LENVIMA is 18 mg daily. The objective of Study 218, a randomized, open-label, Phase 2 trial, was to assess whether the lower starting dose of LENVIMA (14 mg daily) in combination with everolimus (5 mg daily) would provide similar efficacy with an improved safety profile compared to the FDA-approved starting dose of LENVIMA (18 mg daily) plus everolimus (5 mg daily) in patients with advanced renal cell carcinoma (RCC) following prior treatment with an antiangiogenic therapy.
In the US, LENVIMA is also indicated for:
the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (RAI-refractory DTC);
for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC);
and in combination with pembrolizumab, for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy, and are not candidates for curative surgery or radiation. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial.
MedicalResearch.com Interview with:
Jeremy M. Gernand, PhD, CSP, CRE
Associate Professor
Environmental Health and Safety Engineering
Department of Energy and Mineral EngineeringMedicalResearch.com: What is the background for this study?
Response: Given concern in the public about exposure to nanoparticles in cosmetics, we decided to investigate the exposure potential for inhaling nanoparticles during the application of aerosol mineral-based sunscreens that are typically marketed as safer for children. We choose three commercially available sunscreens to test in the lab in a manner intended to capture the amount of inhaled particles that would typically occur during application of sunscreen to the mid-point of one’s own arm.(more…)
MedicalResearch.com Interview with:
Lianne Soller, PhD
Allergy Research Manager
BC Children’s Hospital Allergy Clinic
Vancouver, BC, Canada
MedicalResearch.com: What is the background for this study?
Response: Peanut oral immunotherapy (also known as OIT) has been studied for many years in clinical trials and has been found to be safe and effective in preschoolers. However, we know that clinical trials do not always reflect what happens in the real world.
We wanted to see study whether peanut OIT would work as well in the real world. This is a follow up of our preschool peanut OIT safety study published in April 2019 which noted only 0.4% severe reactions and 4% epinephrine use during build-up.
(more…)
MedicalResearch.com Interview with:
Gbenga Ogedegbe, MD, MPH
Dr. Adolph & Margaret Berger Professor of Population Health
Director, Division of Health & Behavior
Director Center for Healthful Behavior Change
Department of Population Health
NYU Langone Health
NYU School of Medicine
MedicalResearch.com: What is the background for this study? Response: The background for the study is the disproportionately higher rates of COVID-19 hospitalizations and deaths in Blacks and Hispanics compared to Whites in major cities across the country. We asked two questions: 1) are there racial/ethnic differences in COVID-19 outcomes (likelihood of testing positive, hospitalizations, severe illness, and deaths) among patients who receive care at NYU Langone Health? If there are differences, are they explained by comorbidity and neighborhood characteristics (poverty, educational status, employment, housing, proportion of Blacks and Hispanics in communities)?
(more…)
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