MedicalResearch.com Interview with: Dr. David Gerber MD
Associate Professor of Internal Medicine
Division of Hematology and Oncology
Harold C. Simmons Cancer Center at UT Southwestern Medical Center
Medical Research: What are the main findings of the study?Dr. Gerber:Fewer than 3% of adult cancer patients in the United States are enrolled in clinical trials. Increasingly numerous and stringent eligibility criteria are a major factor limiting participation in clinical trials. We examined the longstanding and widespread practice of excluding patients with prior cancer from oncology clinical trials. This policy presumably reflects concerns that a prior cancer would interfere with the conduct, outcomes, or interpretation of a clinical trial, although there is no clear evidence supporting that assumption.
We examined more than 50 National Cancer Institute (NCI)-sponsored lung cancer clinical trials. We found that 80% excluded patients with prior cancers. This exclusion criterion was applied broadly, including to more than two-thirds of trials with non-survival endpoints. We then examined national Surveillance Epidemiology and End Results (SEER)-Medicare linked data to estimate the proportion of patients who would be excluded from these trials due to prior cancer. We found that up to 18% of potential patients are excluded for this reason alone. In large phase 3 clinical trials, that corresponds to more than 200 patients.
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For MedicalResearch.comJyrki Virtanen, PhD
Adjunct Professor of Nutritional Epidemiology
University of Eastern Finland
Kuopio, Finland
Medical Research: What are the main findings of the study?Dr. Virtanen: The main finding was that saturated fat intake was not an independent risk factor for Coronary Heart Disease even in a population with relatively high average saturated fat intake, like in this population with middle-aged and older men from Eastern Finland. In other words, intake of carbohydrates in place of saturated fat was not associated with lower risk, not even when the quality of carbohydrates was taken into account. Only when polyunsaturated fat replaced saturated fat in the diet, was the risk of Coronary Heart Disease, especially Coronary Heart Disease mortality, lower. In fact, also replacing trans fat or carbohydrates with polyunsaturated fat was associated with lower risk. The associations were similar with both n-6 and n-3 polyunsaturated fatty acids.
Trans fat intake was not associated with the Coronary Heart Disease risk, but that is most likely explained by the low intake of trans fat in Finland already in mid-1980s.
We also investigated the associations of the fatty acid intake with carotid artery atherosclerosis, and the results were generally similar to the findings with incident Coronary Heart Disease events.
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MedicalResearch.com Interview with: Gary Ulaner, MD, PhD
Assistant Attending Radiologist
Memorial Sloan Kettering Cancer Center
Assistant Professor of Radiology, Weill Cornell Medical School
Chair, Radiology Research Committee
Medical Research: What are the main findings of the study?Dr. Ulaner: FDG PET/CT revealed distant metastases in 17% of asymptomatic stage IIB breast cancer patients below 40 years of age. Although NCCN guidelines recommend against systemic staging in patients with stage II disease, our data suggests that PET/CT might be valuable in younger patients at earlier stages of disease than previously expected.
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MedicalResearch.com Interview with: Dr. Michael Kalloniatis
School of Optometry and Vision Science, UNSW Australia, Sydney, New South Wales, Australia; Centre for Eye Health, Sydney, New South Wales, Australia;
Medical Research: What are the main findings of the study? What was most surprising about the results?Dr. Kalloniatis: Normal mice given a single sildenafil treatment had a transient loss of visual function which recovered in two days. Carrier mice (mice which carry a single copy of a mutation that commonly causes recessive Retintis Pigmentosa) showed a supernormal visual response (a response much larger than the norm) to sildenafil which took two weeks to recover to normal. Carrier mice also showed an increase in an early marker for apoptosis (a protein which suggest cells may be preparing to die) suggesting sildenafil may cause retinal degeneration in these mice.
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MedicalResearch.com Interview with: Nick Lonardo, PharmD
Pharmacy, Clinical Coordinator
Department of Pharmacy Services
Salt Lake City, Utah 84132
Medical Research: What are the main findings of the study?Dr. Lonardo:To our knowledge, this is the first, large, multicenter, retrospective cohort study to show that continuous infusion benzodiazepines are independently associated with increased mortality in mechanically ventilated ICU patients. In addition, benzodiazepines were associated with an increased time of mechanical ventilation and ICU length of stay.
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MedicalResearch.com Interview with: Joanna Chikwe MD
Associate Professor
Department of Cardiovascular Surgery
Mount Sinai Medical Center and
Natalia N. Egorova, PhD
Department of Health Evidence and Policy,
Icahn School of Medicine at Mount Sinai
New York, New York
Medical Research: What are the main findings of the study?Answer: This is one of the largest studies to date on the long-term outcomes of patients after aortic valve replacement. We found that bioprosthetic valves are as safe as mechanical valves in younger patients (age 50-69) - specifically, long-term death rates and stroke risk were very similar in patients who had either valve type. The main differences lay in the risk of other long-term complications: patients who had bioprosthetic valves were more likely to need repeat surgery in the long-term, whereas patients who had mechanical valves were more likely to experience a major bleeding event.
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MedicalResearch.com Interview with: Elmar A. Joura, MD
Department of Gynaecology and Obstetrics
Medical University of Vienna, Comprehensive Cancer Center
Vienna, Austria
Medical Research: What are the main findings of the study?Dr. Joura: The upcoming ninevalent vaccine has the potential to prevent 85% of the cervical precancers and surgeries such as LEEP (conization)
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MedicalResearch.com Interview with:Patompong Ungprasert, MD
Division of Rheumatology
Mayo Clinic, MN
Medical Research: What are the main findings of the study?Dr. Ungprasert: We find a statistically significant association between NSAIDs (non-steroidal anti-inflammatory drugs) use and VTE (venous thromboembolism).
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MedicalResearch.com Interview Invitation with:Dr. Yann C Klimentidis, PhD
Assistant professor of Epidemiology and Biostatistics
Mel and Enid Zuckerman College of Public Health
University of Arizona Medical Center
Medical Research: What are the main findings of the study?Dr. Klimentidis:The main finding is that the association of physical activity with type-2 diabetes risk is weakest among those who are at high genetic risk for type-2 diabetes. Furthermore, we find that this trend is stronger among women as compared to men, and that it appears to be driven mainly by genetic risk to insulin resistance, as opposed to genetic risk for reduced beta-cell function.
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MedicalResearch.com Interview with: Karin Amrein, MD, MSc
Assistant Professor Department of Internal Medicine
Division of Endocrinology and Metabolism
Medical University of Graz
8036 Graz, Austria
Medical Research: What are the main findings of the study?Dr. Amrein:This is the first large clinical trial on vitamin D in critical care. In a double-blind, randomized, placebo-controlled clinical trial, a population of mixed adult ICU patients with vitamin D deficiency (defined as 25-hydroxyvitamin D [25(OH)D] level ≤ 20ng/ml) was assigned to receive either vitamin D3 or placebo. We used a high loading dose of vitamin D3 followed by monthly maintenance doses of 90,000 IU for a total of 5 months. Because of a substantially increased risk for skeletal complications below 12ng/ml of 25-hydroxyvitamin D, we used this threshold for a predefined subgroup analysis.
Overall, high-dose vitamin D3 compared with placebo did not reduce hospital length of stay (primary endpoint), intensive care unit (ICU) length of stay, hospital mortality, or 6 month-mortality
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MedicalResearch.com Interview with:Ben Metcalf BsC (co-author) on behalf or A/Prof Rana Hinman PhD
Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy,
School of Health Sciences, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Australia
Medical Research: What are the main findings of the study?Dr. Metcalf: This study investigated whether acupuncture is an effective treatment for people aged more than 50 years with chronic knee pain. Participants in our study were randomly assigned to one of four groups; needle acupuncture, laser acupuncture, sham laser acupuncture or no treatment. The people in the treatment groups received acupuncture treatment from a family physician for 12 weeks. Participants were assessed after treatment and again after one year.
There were no significant differences in knee pain or physical function between active and sham laser acupuncture at 12 weeks or at one year. Both needle and laser acupuncture resulted in modest improvements in pain compared with no treatment at 12 weeks that were not maintained at one year. Needle acupuncture improved physical function at 12 weeks compared with no treatment but was not different from sham acupuncture and was not maintained at one year.
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MedicalResearch.com Interview with Megan A. Adams, MD
Gastroenterology Fellow
University of Michigan
Medical Research: What are the main findings of the study?Dr. Adams: Surveys of doctors indicate that their fear of a malpractice lawsuit for missing a diagnosis of esophageal cancer might drive the overuse of tests called upper endoscopies in patients who are at low risk for the cancer. To examine whether this perception of medical liability risk accurately reflects the real likelihood of a malpractice claim, we looked at a national database of malpractice claims, and compared the rate of claims for delay in diagnosis of esophageal cancer in patients without alarm symptoms (weight loss, dysphagia, iron deficiency anemia), with the rate of claims alleging performance of an upper endoscopy without a good reason for performing the procedure.
The database contained 278,220 claims filed against physicians in 1985-2012. The incidence of reported medical liability claims for failure to screen for esophageal cancer in patients without alarm features was quite low (19 claims in 11 years, 4 paid). In contrast, there were 17 claims in 28 years for complications of upper endoscopies with questionable indication (8 paid).
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MedicalResearch.com Interview with:Lior Yankelson, MD PhD
Tel Aviv Medical CenterMedicalResearch: What are the main findings of the study?Dr. Yankelson:The main findings of the study are that new onset atrial fibrillation after TAVI does not confer a significant risk for mortality , and confers somewhat increased risk for stroke. The latter issue is expected to become less significant with new technological advancements coming into the market, such as lower profile devices and emboli protection both mechanical and pharmaceutical. The more significant and alarming finding is that patients with atrial fibrillation have more than 4 fold risk for death at 1 year post TAVI compared to patients without afib. This is very significant and raises questions regarding the benefit for the procedure in these patients.
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MedicalResearch.com Interview with:
Dr. Emma Taylor MD
UCLA Division of Dermatology and Department of Medicine
David Geffen School of Medicine
Los Angeles, CA,
Medical...
MedicalResearch.com Interview with: Marwan Badri MBChB, MRCP
Cardiovascular disease fellow
Lankenau Medical Center
Wynnewood Pa
Medical Research : What is the background for this study?Dr. Badri: Recent years witnessed increased emphasis of the role of clinical guidelines in cardiovascular care. Physicians are encouraged to practice within the framework of major society guidelines to deliver better, more cost-effective patient care. It is therefore vital that the recommendations in these guidelines are applicable to most of the patient population. Since some clinical trials have been shown in the past to unfavorably exclude women, racial minorities and elderly patients, we conducted this study to see if the clinical trials used to form the American College of Cardiology/American Heart Association adequately represent these patient groups.
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MedicalResearch.com Interview with:Keren Lehavot, PhD
Research Clinical Psychologist
VA Puget Sound Health Care System
Assistant Professor
Department of Psychiatry & Behavioral Sciences
University of Washington
Medical Research: What are the main findings of the study?Dr. Lehavot:Alcohol misuse is a significant public health concern among women living in the U.S. Women who have served in the military are a unique population who report relatively high rates of hazardous drinking, and those who identify as lesbian or bisexual (LB) may be at especially high risk for alcohol misuse. While previous research suggests that lesbian or bisexual veterans report higher rates of alcohol misuse than their heterosexual counterparts, mediators that might explain this disparity have not been identified. To that end, we examined the role of civilian and military traumas and mental health symptoms (i.e., depression, post-traumatic stress disorder) in explaining disparities in alcohol misuse between sexual minority and heterosexual women veterans across the U.S. Women veterans were recruited using the Internet to participate in an online, anonymous, national survey.
Findings indicated that lesbian or bisexual veterans scored significantly higher on an alcohol misuse measure than heterosexual women veterans. LB veterans also reported higher rates of childhood trauma, physical victimization in adulthood both during the military and as a civilian, and mental health symptoms, partly accounting for their higher rates of alcohol misuse.
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MedicalResearch.com Interview with:Kelly R. Reveles, PharmD, PhD
The University of Texas College of Pharmacy
Medical Research: What are the main findings of the study?Dr. Reveles: Our study utilized data from the Centers for Disease Control and Prevention’s National Hospital Discharge Surveys. Patients were selected for this study if they were at least 18 years of age and had an International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) code for Clostridium difficile infection (CDI) (ICD-9-CM code 008.45). We found that Clostridium difficile infection incidence increased from 4.5 CDI discharges/1,000 total discharges in 2001 to 8.2 CDI discharges/1,000 total discharges in 2010. Mortality varied over the study period with peak mortality occurring in 2003 (8.7%) and the lowest rate occurring in 2009 (5.6%). Median hospital length of stay (LOS) was 8 days and remained stable over the study period. In summary, the incidence of Clostridium difficile infection in U.S. hospitals nearly doubled from 2001 to 2010, with little evidence of recent decline. Additionally, there does not appear to be a significant decline in mortality or hospital LOS among patients with Clostridium difficile infection.
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MedicalResearch.com Interview with: Associate Professor Dafna MeromPh.D
Physical Activity and Health
University of Western Sydney
Penrith NSW Australia
Medical Research: What are the main findings of the study?Dr. Merom:In a cohort of 1667 older Australian men (mean age 76.8 years) data on incident falls were collected every four months by telephone interview. We compared the rate of falling over 48 months of follow-up of men who participated in golf, Calisthenics, lawn balls, aerobic machines and swimming. We found that only swimming was associated with 33% reduction in falls occurrence. We also found that swimmers performed better on balance tests in our baseline measurements. In particular on the postural stability test and for those whose leisure activity was only swimming, apart from walking and other lifestyle activities.
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MedicalResearch.com Interview with:Georgina Long BSc PhD MBBS FRACP
Associate Professor of Melanoma Biology and Translational Research
Melanoma Institute Australia and the University of SydneyMedical Research: Could you provide some background on this project? Why did you decide to do this research project? What prior work led up to this latest paper?Dr. Long: Pre-clinically, we had data that showed that the combination of BRAF inhibitor + MEK inhibitor
Decreased skin proliferative toxicity seen with BRAF inhibitors alone (seen as hyperproliferative lesions in rats)
and delayed the emergence of resistance I.e. The tumours in the mice reduced in size more, and stayed reduced for longer.We then confirmed this concept in a randomised phase 2 study, although it was not powered for a definitive progression free survival (PFS_ difference like a phase 3 trial is, we saw a strong difference in response rate and in PFS, yet there were only 54 patients per arm.
MedicalResearch.com Interview wth:Mei-Ju Ko, MD, PhD
Department of Dermatology, Taipei City Hospital
Department of Dermatology, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan.
Medical Research: What are the main findings of the study?Dr. Ko: In this study, not only did we find that serum levels of interleukin (IL)-31 were significantly higher in hemodialysis patients with pruritus symptoms, but we also demonstrated a positive exposure-response relationship between IL-31 levels and visual analog scale (VAS) scores of pruritus intensity. We also noted an inverse correlation between the severity of pruritus and the dialysis dose assessed by Kt/V.
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MedicalResearch.com Interview with:Philip Gorelick, M.D., M.P.H, F.A.C.P.
Medical Director of the Hauenstein Neuroscience Center
Saint Mary’s Health Care, Grand Rapids, MI;
Professor, Translational Science and Molecular Medicine
Michigan State University College of Human Medicine;
Board member of the National Stroke Association
and
Judy Lenane, R.N., M.H.A.
Chief Clinical Officer of iRhythm Technologies, Inc.
Medical Research: What is atrial fibrillation and how common a problem is it among US adults?Dr. Gorelick: Nearly 3 million people in the US suffer from Atrial Fibrillation or “Afib,” an abnormal heart rhythm that causes the heart to beat rapidly and irregularly. While Afib can occur at any age, the incidence increases with age and the number of cases is expected to increase significantly in the coming years as the population ages. Approximately 5 percent of people 65 years and older and one in every 10 people over 80 years of age have Afib. It is more common in those with high blood pressure, heart disease or lung disease. (more…)
MedicalResearch.com Interview with: Jorge F. Saucedo MD
Allstate Foundation, Judson B. Branch Chair of Cardiology
Head, Division of Cardiology
Co-Director Cardiovascular Institute
NorthShore University HealthSystem
Clinical Professor of Medicine
University of Chicago Pritzker School of Medicine
Talla A. Rousan, MD
Oklahoma City, OK.
First author of study.
Medical Research: What are the main findings of the study?Answer: It was found that patients with diabetes mellitus (DM) presenting with acute myocardial infarction (AMI) have a higher in-hospital mortality rate compared to patients without DM. Patients with insulin-requiring diabetes mellitus presenting with non-ST-segment elevation myocardial infarction had higher in-hospital mortality rate than patients with non-insulin requiring diabetes mellitus.(more…)
MedicalResearch.com Interview with:Giuseppe Curigliano M.D. Ph.D.
Medico Direttore, Director
Divisione Sviluppo Nuovi Farmaci per Terapie Innovative
Early Drug Development for Innovative Therapies Division
Via Ripamonti, Milano
Medical Research: What are the main findings of the study?Dr. Curigliano:In the CLEOPATRA study, 808 patients from 25 countries with HER2-positive metastatic breast cancer were randomised to receive first-line placebo/trastuzumab/docetaxel or pertuzumab/trastuzumab/docetaxel. Randomisation was stratified by geographic region and neo/adjuvant chemotherapy.
At ESMO 2014 the CLEOPATRA researchers reported results of a final prespecified OS analysis (February 2014). This overall survival (OS) analysis was planned when ≥385 deaths were reported. The log-rank test, stratified by prior treatment status and geographic region, was used to compare OS between arms, applying the threshold of p ≤ 0.0456. Subgroup analyses of OS were performed for stratification factors and other key baseline characteristics.At median follow-up of 50 months (range 0 to 70 months), the statistically significant improvement in OS in favour of pertuzumab/trastuzumab/docetaxel arm was maintained (HR = 0.68, p = 0.0002). Median OS was 40.8 months in the placebo arm and 56.5 months in the pertuzumab arm, with difference of 15.7 months. The PFS in pertuzumab arm was 18.7 vs 12.4 months in placebo arm, HR 0.68 (p < 0.0001).
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MedicalResearch.com Interview with:
Eric Macy, MS, MS
Allergy & Immunology
Kaiser Permanente Medical Group-Allergy
Medical Research: What are the main findings of the study?Dr. Macy:
Cephalosporins are currently widely and relatively safely used in individuals with a history of a penicillin "allergy" in their medical record.
Cephalosporin associated anaphylaxis is very rare, even in individuals with a history of penicillin "allergy".
Cephalosporin associated serious cutaneous adverse reactions are extremely rare.
Cephalosporin associated Clostridium difficile and serious nephropathy are relatively common.
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MedicalResearch.com Interview Invitation with: Dr. Iffat Rahman Ph.D.
Unit of Nutritional Epidemiology, Institute of Environmental Medicine, Karolinska Institutet, Box 210, 17177 Stockholm, Sweden
Medical Research: What are the main findings of the study?Dr. Rahman: Our study suggests that moderate to high level of physical activity could protect against heart failure in women.
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MedicalResearch.com Interview with:Professor Usha Menon, Evangelia-Ourania FourkalaPhD
and Matthew Burrell PhD
Gynaecological Cancer Research Centre, Women's Cancer, UCL EGA
Institute for Women's Health, University College London, UK
Medical Research: What are the main findings of the study?Response: Our study has shown that skirt size is a good proxy for central obesity. Each unit increase in UK skirt size every ten years between the age of 20 and 60 was associated with a 33% increase in postmenopausal breast cancer in our cohort.
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MedicalResearch.com Interview with:Prof. Dr. med. Alain Nordmann
Innere Medizin FMH
Basel, Switzerland
Medical Research: What are the main findings of the study?Dr. Nordmann: Based on available randomised controlled trials, garlic preparations seem to lower blood pressure in individuals with hypertension in the short term. However, the quality of the studies and the lack of long-term data preclude the routine use of garlic preparations to lower blood pressure in individuals qualifying for antihypertensive drug therapy.
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MedicalResearch.com Interview with:Katharina Mayer MD
Deutsches Herzzentrum München,
Technische Universität München,
Munich, Germany
Medical Research: What are the main findings of the study?
Dr. Mayer:Patients whose platelets do not respond well to aspirin carry a higher risk of death or stent thrombosis. Platelet response to aspirin is an independent predictor of ischemic events in patients undergoing percutaneous coronary interventions (PCI).
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MedicalResearch.com: Interview with: Dr. Aaron P. Thrift PhD
Public Health Sciences Division
Fred Hutchinson Cancer Research Center
Seattle, WA.
Medical Research: What are the main findings of the study?Dr. Thrift: We conclude that height is inversely associated with risk of esophageal adenocarcinoma, both in men and women. The association is not due to confounding from known risk factors or bias.
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MedicalResearch.com Interview with: Stewart Agras, M.D.
Professor of Psychiatry Emeritus
Stanford University School of Medicine
MedicalResearch: What was the study about?
Dr. Agras: Family-based treatment (FBT) has been shown to be more effective than individual psychotherapy for the treatment of adolescent anorexia nervosa. This treatment focuses on helping the family to re-feed their child. The question posed in this study was whether Family-based treatment would have any advantages over Systemic family therapy (SyFT) focusing on family interactions that may affect the maintenance of the disorder. The participants were 164 adolescents with anorexia nervosa and their families – one of the largest studies of its type.
(more…)
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