Panitumumab (Vectibix) For Primary HER2-Negative Inflammatory Breast Cancer

MedicalResearch.com Interview with:

Naoto Tada Ueno, M.D., Ph.D., F.A.C.P. Executive Director, Morgan Welch Inflammatory Breast Cancer Research Program and Clinic Section Chief, Section of Translational Breast Cancer Research, Department of Breast Medical Oncology Division of Cancer Medicine The University of Texas MD Anderson Cancer Center Houston, TXNaoto Tada Ueno, M.D., Ph.D., F.A.C.P.
Executive Director, Morgan Welch Inflammatory Breast Cancer Research Program and Clinic
Section Chief, Section of Translational Breast Cancer Research, Department of Breast Medical Oncology
Division of Cancer Medicine
The University of Texas MD Anderson Cancer Center
Houston, TX

 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The best outcome of inflammatory breast cancer (IBC) is dependent on achieving a pathological completed response after neoadjuvant chemotherapy for primary inflammatory breast cancer, which is the most aggressive type of breast cancer.

We have conducted extensive preclinical work, which showed that EGFR is a potential therapeutic targets of IBC.

Based on this preclinical data, we have conducted a phase II study to determine the pathological complete response rate of panitumumab plus neoadjuvant chemotherapy for HER2 negative primary inflammatory breast cancer.  Continue reading

Allergic Rhinitis Can Impair Adolescent Sleep and School Performance

MedicalResearch.com Interview with:

Michael S. Blaiss, MD, FACAAI Executive Medical Director American College of Allergy, Asthma & Immunology Arlington Heights, IL 60005

Dr. Blaiss

Michael S. Blaiss, MD, FACAAI
Executive Medical Director
American College of Allergy, Asthma & Immunology
Arlington Heights, IL 60005

MedicalResearch.com: Is this research important? Why or why not?

Response: There has not been a comprehensive review of how allergic rhinitis impacts the adolescent population. Most studies put adolescents in with children and yet we know that how disease affects adolescents may be dramatically different than children. Adolescents is a difficult enough time with a chronic condition

MedicalResearch.com: What is the key take-home message?

Response: The symptoms associated with nasal and eye allergies can be different in adolescents compared with adults and children and lead to poor quality of life and impair learning in school. Adolescents with AR/ARC may experience difficulties falling asleep, night waking, and snoring, and generally have poorer sleep. Therefore health care providers need to aggressively control the adolescent’s allergic rhinitis.  Continue reading

Early Clinical Trials of AMO-02 Show Promise in Congenital and Childhood Myotonic Dystrophy Type 1

MedicalResearch.com Interview with:

Joseph Horrigan MD, Pediatric neuropsychiatrist

Dr. Horrigan

Dr. Joseph Horrigan MD
Pediatric neuropsychiatrist

Chief medical officer

 


MedicalResearch.com: What is the background for this study? Would you briefly explain what is meant by myotonic dystrophy? What are the manifestations of this disease?

Response: This was the first pharmaceutical intervention study conducted in adolescents and adults with congenital and juvenile onset DM1. Myotonic dystrophy type 1 (DM1) is a disorder that impacts multiple body systems following a trinucleotide expansion repeat of the DMPK gene on chromosome 19. Children with Congenital DM1 present at birth with respiratory insufficiency, talipes equinovarus (clubfoot), feeding difficulties and hypotonia. There is a risk mortality rate in the first year of life. As children grow, they are at risk for intellectual impairment, autistic features, gastrointestinal symptoms, motor delay and a variety of muscle-based symptoms.

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Full-Term Infant Deaths in US Remain High, Many From Suffocation

MedicalResearch.com Interview with:

Neha Bairoliya, Ph.D. Harvard Center for Population and Development Studies Cambridge, MA 02138

Dr. Bairoliya

Neha Bairoliya, Ph.D.
Harvard Center for Population and Development Studies
Cambridge, MA 02138

MedicalResearch.com: What is the background for this study? What are the main findings? 

Response: While the high prevalence of preterm births and its impact on infant mortality in the US have been widely acknowledged, recent data suggest that even full-term births in the US face substantially higher mortality risks compared to European countries with low infant mortality rates.

In this paper, we use the most recent birth records in the US to more closely analyze the primary causes underlying mortality rates among full-term births. We show that infants born full-term in the US face 50%-200% higher risks of infant mortality compared to leading European countries.

The two main drivers of these high relative risks are increased risk of mortality due to congenital malformations, which patients cannot really do much about other than ensuring adequate screening during pregnancy, and high risk of sudden unexpected deaths in infancy, which should largely be preventable through appropriate sleeping arrangements. While we do not have data on actual sleeping arrangements from our study, other data sources suggest that a substantial number of babies continue to sleep on their tummy; we also found a shockingly large number of babies dying from suffocation, which suggests that parents either use covers that are not safe, or let children sleep in their own beds.

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Do We Have Free Will? Neuroscientists Aren’t Sure

MedicalResearch.com Interview with:

Veljko Dubljević, Ph.D., D.Phil. Assistant Professor of Philosophy, Department of Philosophy and Religious Studies, and  Science Technology and Society Program, North Carolina State University Raleigh, NC 27607 

Dr. Veljko Dubljević

Veljko Dubljević, Ph.D., D.Phil.
Assistant Professor of Philosophy,
Department of Philosophy and Religious Studies, and
Science Technology and Society Program,
North Carolina State University
Raleigh, NC 27607 

MedicalResearch.com: What is the background for this study?

Response: There is considerable controversy about the interpretation of data of the neuroscientific studies done by Benjamin Libet. On the one hand, Libet claimed that his work disproves certain metaphysical conceptions of free will (Libertarianism), whereas it does not disprove others (e.g., Compatibilism). In a nutshell, the reason for these claims is that Libet found preparatory brain activity (Readiness Potentials or RPs) some 500ms before the conscious decision to act was felt by study participants. That seemed to exclude the possibility that mental causation was taking place. At the same time, the onset of movement left a time-window for a ‘veto-decision’. This led Libet to conclude that there is no ‘free will’, but that there is a ‘free won’t’.

On the other hand, there were many criticisms of the study – methodological or substantive. Most notably, Patrick Haggard argued that it is not RPs that are correlates of a decision to act, but Lateralized Readiness Potentials (LRPs). Haggard agreed with many critics of Libet in that RPs could be connected to a range of other phenomena, and that preparatory brain activity that is most important for a decision to act already has to be ‘lateralized’. Namely, the decision to move the left or right arm is critical in this regard, and will lead to RP being focused in one or the other hemisphere, thus making LRPs the point of interest for any conscious decision to act. All in all, Haggard claimed to have replicated Libet’s major findings, with the caveat that timing of LRPs excludes the time-frame for a ‘veto-decision’. This Haggard claimed makes the evidence more in line with the metaphysical doctrine of ‘hard determinism’, which excludes agency and responsibility.

Many other neuroscientists followed Libet’s (and Haggard’s) lead and these experiment became part of ‘lore’ in neuroscience education – many other labs performed similar experiments and claimed to basically replicate the findings.

Our study was the first to review all available evidence.

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Investigational Imaging Test Can Help Determine Success or Failure of Bone Marrow Transplant

MedicalResearch.com Interview with:

Kirsten Williams, M.D. Blood and marrow transplant specialist Children’s National Health System

Dr. Williams

Kirsten Williams, M.D.
Blood and marrow transplant specialist
Children’s National Health System 

MedicalResearch.com: What is the background for this study? What are the main findings? 

Response: This study addressed a life-threatening complication of bone marrow transplantation called bone marrow failure. Bone marrow transplantation has provided a cure for patients with aggressive leukemias or acquired or genetic marrow dysfunction. The process of bone marrow transplantation involves giving chemotherapy and/or radiation, which removes the diseased blood cells from the bone marrow. After this, new bone marrow stem cells are infused from a healthy individual. They travel to the bone marrow and start the slow process of remaking the blood system. Because these new cells start from infancy, it takes upwards of four to five weeks for new mature healthy cells to emerge into the blood, where they can be identified. Historically, there has been no timely way to determine if the new cells have successfully repopulated unless they can be seen in the blood compartment. This condition of bone marrow failure is life-threatening, because patients don’t have white blood cells to protect them from infection. Once bone marrow failure is diagnosed, a second new set of stem cells are infused, often after more chemotherapy is given. However, for many individuals this re-transplantation is too late, because severe infections can be fatal while waiting cells to recover.

We were the first group to use a new imaging test to understand how the newly infused bone marrow cells develop inside the patient. We have recently published a way to detect the new bone marrow cell growth as early as five days after the cells are given. We used an investigational nuclear medicine test to reveal this early cell growth, which could be detected weeks before the cells appear in the blood. This radiology test is safe, does not cause any problems and is not invasive. It is called FLT (18F-fluorothymidine) and the contrast is taken up by dividing hematopoietic stem cells. The patients could even see the growth of their new cells inside the bone marrow (which they very much enjoyed while waiting to see recovery of the cells in their blood). We could use the brightness of the image (called SUV) to determine approximately how many weeks remained before the cells were visible in the blood.

Finally, we actually could see where the new cells went after they were infused, tracking their settling in various organs and bones. Through this, we could see that cells did not travel directly to all of the bones right away as was previously thought, but rather first went to the liver and spleen, then to the mid-spine (thorax), then to the remainder of the spine and breastplate, and finally to the arms and legs. This pattern of bone marrow development is seen in healthy developing fetuses. In this case, it occurs in a similar pattern in adults undergoing bone marrow transplant.

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Tick Bites Plus Blood Type Predispose to Red Meat Allergy

MedicalResearch.com Interview with:

Brestoff-Parker

Dr. Brestoff-Parker

Jonathan R. Brestoff-Parker, MD, PhD
PSTP Resident, Clinical Pathology
Department of Pathology & Immunology
Washington University School of Medicine

MedicalResearch.com: What is the background for this study? What are the main findings? 

Response: Red meat allergy is a recently recognized food allergy in which people experience a delayed allergic response about 3-6 hours after eating red meats that contain the allergen alpha-gal.

Red meat allergy is thought to be caused by tick bites which expose humans to alpha-gal, however other factors that contribute to disease risk are not well described. Alpha-gal looks a lot like the B antigen, which is one of the factors that determines blood type. So we wondered whether people with blood types B or AB are protected from getting red meat allergy. We were amazed when we found that patients who make the B antigen (blood types B or AB) are 5 times less likely to have red meat allergy than patients who do not make the B antigen (blood types O or A).  Continue reading

Atopic Dermatitis: IF Used At All, Systemic Steroids Should Be Short Term Bridge To Other Therapies

MedicalResearch.com Interview with:

Dr. Jonathan L. Silverberg MD PhD MPH Assistant Professor in Dermatology Medical Social Sciences and Preventive Medicine Northwestern University, Chicago, Illinois

Dr. Jonathan Silverberg

Dr. Jonathan L. Silverberg MD PhD MPH
Assistant Professor in Dermatology
Medical Social Sciences and Preventive Medicine
Northwestern University, Chicago, Illinois

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Systemic corticosteroids are commonly used as systemic treatments for atopic dermatitis. However, few studies assessed the efficacy and safety of systemic corticosteroids in atopic dermatitis. This systematic review sought to summarize the available evidence for their use in atopic dermatitis.

Overall, 52 reviews and 12 studies were included in this systematic review. Most studies suffered from small sample size, low quality. In one of the only randomized-controlled trials performed, systemic corticosteroids were less effective than cyclosporine and led to more rebound flares. There were numerous safety and tolerability concerns with both short and long-term treatment with systemic corticosteroids. One study found that even short-term use of systemic corticosteroids was associated with increased sepsis, venous thromboembolism and fractures.

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Married Head/Neck Cancer Patients Less Likely To Smoke, More Likely To Live Longer

MedicalResearch.com Interview with:

Nosayaba Osazuwa-Peters, BDS, MPH, CHES Instructor, Department of Otolaryngology-Head and Neck Surgery Saint Louis University School of Medicine Member, Saint Louis University Cancer Center St Louis, Missouri

Nosayaba Osazuwa-Peters

Nosayaba Osazuwa-Peters, BDS, MPH, CHES
Instructor, Department of Otolaryngology-Head and Neck Surgery
Saint Louis University School of Medicine
Member, Saint Louis University Cancer Center
St Louis, Missouri 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Several studies have shown that there is an adverse effect of smoking on head and neck cancer survival; however, there are studies that show no effect between smoking and head and neck cancer. We wanted to investigate this problem using a single institution’s cancer dataset. Additionally, we wanted to understand the role of marital status in the smoking behavior of head and neck cancer patients, and to understand if smoking played any role in head and neck cancer survival.

Our study confirmed that head and neck cancer patients who were smokers at the time of diagnosis had lower survival rates than nonsmokers. We also found that married head and neck cancer patients were less likely to be smokers and more likely to survive longer than those unmarried.

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Improved DNA Analysis Reduces False Positive Prenatal DNA Testing For Trisomy Conditions

MedicalResearch.com Interview with:

Professor Sir Nicholas Wald FRCP FRS Professor of Preventive Medicine Wolfson Institute of Preventive Medicine Barts and The London School of Medicine and Dentistry Queen Mary University of London London

Prof. Wald

Professor Sir Nicholas Wald FRCP FRS
Professor of Preventive Medicine
Wolfson Institute of Preventive Medicine
Barts and The London School of Medicine and Dentistry
Queen Mary University of London
London

MedicalResearch.com: What is the background for this study?

Response: Prenatal screening for Down’s syndrome (trisomy 21), Edwards syndrome (trisomy 18) and Patau syndrome (trisomy 13) by maternal plasma DNA analysis has an improved screening performance compared with conventional screening but is too expensive to be performed routinely and has a technical failure rate.

The aim of the study was to take advantage of the improved screening performance of the DNA analysis in conjunction with the existing methods thereby providing a seamless testing interface between the “old” and the “new” methods that would detect a larger proportion of affected pregnancies with a much lower false-positive rate, at a much reduced cost compared with universal DNA testing and with no failed tests. The novel approach was to conduct a conventional screening test using a screening cut-off level that identifies about 10% of women with the highest risks of having an affected pregnancy (much higher than in conventional screening) and then to perform a DNA test using a portion of the original blood sample collected for the conventional test. Progressing to the DNA test was automatic for these high risk women without their having to be recalled for counseling and a fresh blood sample (ie as a reflex response hence the term “reflex DNA screening”).

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Matching Time of Day To Patient’s Biorhythm May Improve Surgical Outcomes

MedicalResearch.com Interview with:
Prof David Montaigne MD

Faculté de Médecine de Lille H Warembourg
Lille, France

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: It is well known for many decades that cardiovascular diseases exhibit a diurnal variation with for instance higher incidence of myocardial infarction in the early morning as opposed to the evening. Although studies on circadian gene knock-out and mutant mice argue for a biorhythm in myocardial ischemia-reperfusion tolerance, whether a biorhythm in the myocardial tolerance to ischemia, exists in humans was unclear because of conflicting reports in the context of myocardial infarction.

We demonstrated for the first time in humans that the myocardial tolerance to ischemia-reperfusion is different along the day, in line with rodent experiments performed in the early 2010s.

We demonstrated that this biorhythm is clinically meaningful and that it can be targeted as a cardioprotective strategy.

In this topic, Rever-alpha is of specific interest. It belongs at the same time to circadian genes and nuclear receptor families: being a nuclear receptor, it is a feasible pharmacological target, conversely to other circadian genes.

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Personalizing Human-Robot Interactions Can Facilitate Rehabilitation

MedicalResearch.com Interview with:

Ben-Gurion University of the Negev student researcher Shir Kashi interacts with robotic arm as part of her research in personalizing human-robot interactions to develop an interactive movement protocol for rehabilitation.

Ben-Gurion University of the Negev student researcher Shir Kashi interacts with robotic arm as part of her research in personalizing human-robot interactions to develop an interactive movement protocol for rehabilitation.

Shelly Levy-Tzedek, PhD
Head of the Cognition, Aging and Rehabilitation Lab
Faculty of Health Sciences, Dept. of Physical Therapy
& The Zlotowski Center for Neuroscience
The Ben Gurion University

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Following brain injury, patients who need to practice their physical therapy exercises at home. Many don’t practice enough or at all at home, and so we are designing robot companions to encourage them to practice and to track their progress. This study is a first step towards this goal. Here, we studied how people played a leader-follower mirror game with a robotic arm, where a person and robot took turns following each other’s joint movements patterns. When the robotic arm was leading, it performed movements that were either sharp, like dribbling a ball, or smooth, like tracing a circle.

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Regular Use of Artificial Sweeteners May Worsen Blood Glucose Control

MedicalResearch.com Interview with:

Dr. Richard L. Young PhD Associate Professor Adelaide Medical School The University of Adelaide Group Leader, Intestinal Nutrient Sensing Group Centre for Nutrition & Gastrointestinal Diseases South Australian Health & Medical Research Institute North Terrace, Adelaide | SA 

Dr. Young

Dr. Richard L. Young PhD
Associate Professor Adelaide Medical School
The University of Adelaide
Group Leader, Intestinal Nutrient Sensing Group
Centre for Nutrition & Gastrointestinal Diseases
South Australian Health & Medical Research Institute
North Terrace, Adelaide | SA

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: This study was a clinical trial in healthy subjects dosed a sweetener combination (sucralose and acesulfame-K) at a  dose to equal 1.5 L of artificial sweetened drink per day. This was given in capsules to dissolve in the proximal intestine (3 capsules per day, 2 weeks) and was a randomised, placebo-controlled double-blind study.

Sweetener treatment increased glucose absorption (assessed by serum 3-O-methy glucose), increased glycemic responses to duodenal glucose infusion and decreased GLP-1 responses.

These data show that intake of these sweeteners in healthy subjects may increase glycemic responses, and are the first to document an effect of these sweeteners to increase glucose absorption in humans.

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Phase III Study of Stivarga (Regorafenib) For Progressed Hepatocellular Carcinoma

MedicalResearch.com Interview with:

Dr. Jordi Bruix, MD Professor of Medicine University of Barcelona Director of the Barcelona Clinic Liver Cancer (BCLC) Group Liver Unit Hospital Clinic of Barcelona

Dr. Bruix

Dr. Jordi Bruix, MD
Professor of Medicine
University of Barcelona
Director of the Barcelona Clinic Liver Cancer (BCLC) Group Liver Unit
Hospital Clinic of Barcelona

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The RESORCE Phase III pivotal trial is an international, multicenter, placebo-controlled trial which investigated the efficacy of Stivarga (regorafenib) in adults with Child-Pugh A and Barcelona Clinic Liver Cancer Stage Category B or C hepatocellular carcinoma (HCC) who had documented disease progression following first-line treatment with Nexavar (sorafenib).

Trial participants were administered a daily oral 160mg dose (three weeks on/ one week off) of regorafenib plus best supportive care (BSC), or placebo plus BSC.

Results from the trial demonstrated that participants treated with regorafenib experienced a statistically significant and clinically meaningful improvement in the study’s primary endpoint—overall survival (OS). Participants treated with regorafenib demonstrated a median overall survival of 10.6 months vs. 7.8 months with placebo.

At ASCO 2017, an exploratory analysis evaluated the impact of baseline alpha-fetoprotein (AFP) and c-Met as predictors of poor prognosis in patients enrolled in the RESORCE trial (Abstract #4078).

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How Well Do Personal Sound Amplifiers Compare To Conventional Hearing Aides?

MedicalResearch.com Interview with:

Nicholas S. Reed, AuD Instructor | Department of Otolaryngology-Head/Neck Surgery PhD Candidate  | Graduate Training Program in Clinical Investigation Center on Aging and Health Johns Hopkins University School of Medicine Johns Hopkins University Bloomberg School of Public Health

Dr. Nicholas Reed

Nicholas S. Reed, AuD
Instructor | Department of Otolaryngology-Head/Neck Surgery
PhD Candidate  | Graduate Training Program in Clinical Investigation
Center on Aging and Health
Johns Hopkins University School of Medicine
Johns Hopkins University Bloomberg School of Public Health

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Hearing Aids are medical devices regulated by the FDA which must be purchased through a licensed individual while personal sound amplification products (PSAPs) are essentially unregulated devices some of which can manipulate and increase sound similar to a hearing aid but cannot market themselves are devices for hearing loss. PSAPs can be purchased online or in the back of a store and are generally less expensive than hearing aids.

We aimed to explore a select group of PSAPs to see if they helped someone with mild to moderate hearing loss improve speech understanding (i.e. ability to repeat back sentences) in the presence of mild background noise (think a lunch crowd at a restaurant) as well as a hearing aid. We selected four PSAP devices that were technologically strong (i.e. meet many standards a hearing aid might be asked to meet) and one PSAP that was technologically fairly poor (i.e. lots of sound distortion) after an in-house electroacoustic analysis of devices. Our hearing aid was selected because it was a popular choice at a university audiology clinic. Forty-two people completed the speech testing unaided (i.e. with no device) and then with each of the five PSAPs and one hearing aid (order of devices was randomized).

We looked at improvement with the devices from unaided. We found that some PSAPs help people understand speech about as well as a hearing aid in this controlled environment while one PSAP actually hindered participants’ ability to understand speech due to sound distortion – imagine how difficult it can be when listening on a poor cell phone signal.

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