Author Interviews, Heart Disease, JAMA, Kidney Disease / 05.12.2015

MedicalResearch.com Interview with: Girish N. Nadkarni, MD, MPH Division of Nephrology, Department of Medicine Icahn School of Medicine at Mount Sinai New York, New York MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Nadkarni: Cardiovascular disease is one of the major causes of morbidity and mortality in patients with kidney disease. Moreover, there is a lack of good quality evidence in kidney disease patients. In addition, previous studies have shown that cardiovascular trials exclude patients with kidney disease. We wanted to analyze all of the clinical trials on acute myocardial infarctions and heart failure in the last decade and see if they continued excluding patients with kidney disease. We discovered that in 371 trials including close to six hundred thousand patients, the majority (57%) excluded patients with kidney disease. A large proportion of the trials excluded patients for non-specific reasons, rather than a prespecified threshold of kidney function and did not report kidney function at baseline. Finally, in trials that did include kidney patients and reported outcomes by kidney function, only 13% showed an interaction or suggestion of harm. (more…)
Author Interviews, Cancer Research, Cleveland Clinic, Heart Disease / 05.12.2015

MedicalResearch.com Interview with: Sadeer G Al-Kindi, MD Fellow, Harrington Heart and Vascular Institute Onco-Cardiology Program, Advanced Heart Failure and Transplant Center, Harrington Heart and Vascular Institute, University Hospitals Case Medical Center Cleveland, OH Medical Research: What is the background for this study? Dr. Al-Kindi: Cardiovascular disease and cancer are the most common causes of death in the United States. They often have the same risk factors (for example, smoking, advancing age, obesity). Many cancers are treated with drugs that can have detrimental effect on the heart thus limiting their use. Some studies have suggested that cardiovascular diseases can worsen outcomes in patients with cancer. The emergence of onco-cardiology programs led to multidisciplinary care of patients with cancer and heart disease. Given this tight relationship between cancers and cardiovascular disease, we hypothesized that heart disease and its risk factors are very common in patients diagnosed with cancer. Medical Research: What are the main findings? Dr. Al-Kindi: Using a very large clinical database of 1/8th of the US population, we identified patients with most common cancers that are treated with cardiotoxic medications and identified the prevalence of cardiovascular diseases. Overall, prevalence was 33% for hematologic malignancies (leukemia and lymphoma), 43% for lung cancers, 17% for breast cancers, 26% for colon cancers, 35% for renal cancers, and 26% for head and neck cancers. Peripheral artery disease, coronary artery disease and cerebrovascular diseases were the most common, followed by heart failure, and carotid artery disease. Despite the high prevalence, only about a half of these patients were on the cardiovascular medicines and half were referred to cardiologists. (more…)
Author Interviews, Genetic Research, Heart Disease, Neurological Disorders, NIH, Science / 05.12.2015

MedicalResearch.com Interview with: Jonathan Kaltman, MD Chief, Heart Development and Structural Diseases Branch Division of Cardiovascular Sciences National Heart, Lung, and Blood Institute Medical Research: What are the main findings? Dr. Kaltman:  Congenital heart disease (CHD) is the most common birth defect but the cause for most defects is unknown.  Surgery and clinical care of patients with congenital heart disease has improved survival but now we are learning that many patients have neurodevelopmental abnormalities, including learning disability and attention/behavioral issues. Medical Research:  What are the main findings?
  • Using exome sequencing we found that patients with  congenital heart disease have a substantial number of de novo mutations.  This finding is especially strong in patients with CHD and another structural birth defect and/or neurodevelopmental abnormalities.
  • Many of the genes identified are known to be expressed in both the heart and the brain, suggesting a single mutation may contribute to both congenital heart disease and neurodevelopmental abnormalities.
(more…)
Author Interviews, Breast Cancer, Brigham & Women's - Harvard, Mental Health Research / 05.12.2015

MedicalResearch.com Interview with: Dr. Jamie Stagl, PhD Was a Ph.D. student in Psychology at University of Miami during the research period Currently, a post-doctoral fellow in Psychiatric Oncology Massachusetts General Hospital Cancer Center in Boston Medical Research: What is the background for this study? What are the main findings? Dr. Stagl: This is a newly published finding from a randomized trial funded by the National Cancer Institute that showed that women with breast cancer who received stress management skills early on in their treatment had longer survival and longer time without breast cancer recurrence at eight to 15 years after their initial diagnosis. This secondary analysis is published online and in the November 2015 issue of Breast Cancer Research and Treatment. The study was conducted by senior investigator, Michael Antoni, Ph.D., Survivorship Theme Leader of the Cancer Control research program at Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine and Professor of Psychology and Psychiatry and Behavioral Sciences, and his research team, including lead author Jamie Stagl, Ph.D., currently a postdoctoral fellow at Massachusetts General Hospital Cancer Center in Psychiatric Oncology and Behavioral Sciences. In this trial, women received an intervention called Cognitive-Behavioral Stress Management, which was created by Dr. Michael Antoni at the University of Miami. After surgery for breast cancer, women received 10 weekly, group-based sessions of skills to manage stress based in cognitive-behavioral strategies and relaxation training. Women learned muscle relaxation, mindfulness meditation, and breathing exercises to promote relaxation. Women also learned strategies for altering negative thoughts, worries, and improve coping. Previous studies by Dr. Antoni and his research team have shown that women who received these stress management skills had better psychological adjustment, less distress, and less anxiety through treatment. Dr. Stagl recently published findings showing that these women had less depressive symptoms and better quality of life during survivorship. The current study shows that these women may also benefit from stress management in terms of risk of disease progression and mortality. (more…)
Author Interviews, Breast Cancer, Lancet, Mammograms, Radiology / 05.12.2015

MedicalResearch.com Interview with: Prof Stephen Duffy BSc MSc CStat Professor Of Cancer Screening Wolfson Institute Of Preventive Medicine Queen Mary University of London Medical Research: What is the background for this study? What are the main findings? Prof. Duffy: There is debate on the value of diagnosing and treating ductal carcinoma in situ (DCIS) of the breast, depending mainly on different theories about the risk of progression to invasive breast cancer if DCIS were untreated. No-one asserts that no DCIS is progressive and no-one asserts that all DCIS is progressive. There is, however, a range of opinions on the proportion of progressive disease. We found that those mammography screening units in the UK with higher detection rates of DCIS had lower subsequent rates of invasive cancers in the three years after screening. (more…)
Author Interviews, Beth Israel Deaconess, Brigham & Women's - Harvard, CT Scanning, Gender Differences, Lung Cancer / 04.12.2015

MedicalResearch.com Interview with: Phillip Boiselle, M.D. Staff, Cardiothoracic Imaging Beth Israel Deaconess Medical Center Associate Dean for Academic and Clinical Affairs Professor of Radiology, Harvard Medical School Boston, Mass Medical Research: What is the background for this study? What are the main findings? Dr. Boiselle: Previous studies have shown that women have a greater mortality benefit from lung cancer screening then men, and that this test (CT screening) is more cost-effective for women than men. Our purpose was to determine whether the relative risk of lung cancer for women and men differed depending on the specific type of lung nodule that was discovered at screening. Such differences could potentially help to influence a more personalized approach to patient management in lung cancer screening. (more…)
Abuse and Neglect, Author Interviews, JAMA, OBGYNE / 04.12.2015

MedicalResearch.com Interview with: Alex Haynes, MD, MPH Assistant Professor of Surgery, Harvard Medical School Assistant in Surgery, Massachusetts General Hospital Division of Surgical Oncology Associate Program Director, Safe Surgery, Ariadne Labs Research Associate Harvard School of Public Health and George Molina, MD, MPH Surgical Research Resident Massachusetts General Hospital  Medical Research: What is the background for this study? What are the main findings? Response: We have previously done work looking at the global volume of operations, and in particular the surgical volume at a country level. This work was based on the hypothesis that a certain level of surgical care is necessary for healthy populations. In doing this work, we found that cesarean delivery makes up a large proportion of all operations that happen globally. In the mid-1980’s, based on existing data the World Health Organization made the recommendation that at a country-level, the cesarean delivery rate should not exceed 10 to 15 per 100 live births. We wanted to see if this recommendation was still applicable using current data. In order to answer this question, we used multiple imputation to estimate country-level cesarean delivery rates for all 194 countries in the world in 2012 to investigate the association between country-level cesarean delivery rates and maternal and neonatal mortality. We found that at a population level, as the cesarean delivery rate increased up to about 19 per 100 live births, there was a decrease in country-level maternal and neonatal mortality. However, as country-level cesarean delivery rates rose above this level there were no associated changes in maternal or neonatal mortality. (more…)
Author Interviews, HIV, Immunotherapy, PLoS / 04.12.2015

MedicalResearch.com Interview with: Andreas Meyerhans, PhD ICREA Research Professor at the University Pompeu Fabra Infection Biology Group Department of Experimental and Health Sciences Universitat Pompeu Fabra Barcelona Spain Medical Research: What is the background for this study? What are the main findings? Dr. Meyerhans: In brief, chronic HIV infections lead to a dampening of HIV-specific killer cells. This phenomenon is named exhaustion and is mediated by inhibitory proteins, such as PD-1, on the cell surface. A consequence of exhaustion is a reduction of the immune control over virus expansion. We have studied the effect of blocking the negative signaling from the inhibitory proteins by means of PD-1/PD-L1 pathway inhibition on effector and regulatory T cells (Treg). We found that one can augment antiviral immune control only when the virus load was well controlled in the HIV-infected individuals i.e. by antiviral drugs. In that case, PD-1/PD-L1 pathway blockage led to an expansion of anti-HIV killer cells over Treg cells. This latter are suppressive white blood cells also subject to the same inhibitory pathway regulation. In contrast, when blood cells from viremic HIV-infected individuals were analyzed, Treg cells expanded efficiently and thus reduced the effector to regulatory T cell ratio that controls HIV. Taken together, our data point to Treg cells as an important component in the outcome of PD-1/PD-L1 pathway inhibitor therapies and suggest a net gain in anti-HIV immune responses only when the HIV loads are well controlled during the administration of these novel compounds. (more…)
Author Interviews, Psychological Science, Sexual Health / 04.12.2015

MedicalResearch.com Interview with: Tess M. Gemberling, M.A. Social Psychology Ph.D. Student Co-Principal Investigator University of Alabama Medical Research: What is the background for this study? Response: Many stereotypes of BDSM (bondage and discipline [B&D], dominance and submission [D/s], sadomasochism [SM],) that can be seen on websites similar to fucked gay xxx, exist; however, research with practitioners suggests these stereotypes are largely unfounded. Preliminary evidence implies BDSM practitioners are psychologically healthy individuals. This study was conducted to further evaluate these results. Medical Research: What are the main findings? Response: Along with other findings, the majority of results indicates practitioners are well functioning. Overall, participants are healthy in the mental, emotional, and interpersonal aspects of their lives. In addition, practitioners are often victims of violence but are not perpetrators of violence. (more…)
Author Interviews, BMC, BMJ, Genetic Research / 03.12.2015

MedicalResearch.com Interview with: Hatem A. Azim MD PhD Breast Cancer Translational Research Laboratory Institut Jules Bordet Université Libre de Bruxelles Brussels, Belgium Medical Research: What is the background for this study? What are the main findings? Dr. Azim: As at breast cancer diagnosis is known to impact prognosis, with young patients having worse outcome. On the other hand, elderly patients are less studies in general and little is known on their tumor characteristics. In this study, we aimed to define the pattern of genomic aberrations in different age groups. This can result in identifying if key potentially targetable genomic alterations are more specific to particular age groups and thus could open the door to design particular studies targeting these aberrations in these age groups. We found that  age is associated with unique biological features at the DNA level, independent of tumor stage, histology and breast cancer molecular subtype. Of particular mention, the higher prevalence of GATA3 mutation in younger patient, a known driver mutation associated with endocrine resistance. In addition, age at diagnosis appears to impact the tumor transcriptome confirming previous observations, but also highlighting novel findings, of particular relevance the higher expression of stem cell related genes in young patients. (more…)
Author Interviews, Karolinski Institute, Lancet, OBGYNE, Weight Research / 03.12.2015

MedicalResearch.com Interview with: Professor Sven Cnattingius Professor in reproductive epidemiology Clinical Epidemiology Unit, Department of Medicine Karolinska University Hospital Karolinska Institutet, Stockholm, Sweden  Medical Research: What is the background for this study? Prof. Cnattingius: Maternal overweight and obesity are associated with increased risks of stillbirth and infant mortality. Weight gain between pregnancies increases risks of other obesity-related complications, including preeclampsia, gestational diabetes, and preterm birth. Weight gain appear to increase these risks especially in women who start off with normal weight. As these complications increases risks of stillbirth and infant mortality, we wanted to study the associations between weight change between successive pregnancies and risks of stillbirth and infant mortality (deaths during the first year of life). Medical Research: What are the main findings? Prof. Cnattingius: The main findings include:
  • Weight gain increases risk of stillbirth in a dose-response manner.
  • In women starting off with normal weight (BMI <25), weight gain  increases risk of infant mortality in a dose-response manner.
  • In women starting off with overweight or obesity (BMI >25), weight loss reduces the risk of neonatal mortality (deaths during the first four weeks of life).
(more…)
Alzheimer's - Dementia, Author Interviews, Nature, UCSF / 03.12.2015

MedicalResearch.com Interview with: Elsa Suberbielle, DVM, PhD Research Scientist Gladstone Institute of Neurological Diseases San Francisco, CA 94158 Medical Research: What is the background for this study? Dr. Suberbielle: BRCA1 is a key protein involved in DNA repair, and mutations that impair its function increase the risk for breast and ovarian cancer. Research into DNA repair mechanisms in dividing cells recently was recently rewarded by the Nobel Prize in Chemistry. In such cells, BRCA1 helps repair a type of DNA damage known as double-strand breaks that can occur when cells are injured. In neurons, though, such breaks can occur even under normal circumstances, for example, after increased brain activity, as shown by the team of Gladstone scientists in an earlier study. The researchers speculated that in brain cells, cycles of DNA damage and repair facilitate learning and memory, whereas an imbalance between damage and repair disrupts these functions. Medical Research: What are the main findings? Dr. Suberbielle In a new study published in Nature Communications, Researchers from the Gladstone Institutes demonstrates that Alzheimer’s disease is associated with a depletion of BRCA1 in neurons and that BRCA1 depletion can cause cognitive deficits. The researchers experimentally reduced BRCA1 levels in the neurons of mice. Reduction of the DNA repair factor led to an accumulation of DNA damage and to neuronal shrinkage. It also caused learning and memory deficits. Because Alzheimer’s disease is associated with similar neuronal and cognitive problems, the scientists wondered whether they might be mediated by depletion of BRCA1. They therefore analyzed neuronal BRCA1 levels in post-mortem brains of Alzheimer’s patients. Compared with non-demented controls, neuronal BRCA1 levels in the patients were reduced by 65-75%. To determine the causes of this depletion, the investigators treated neurons grown in cell culture with amyloid-beta proteins, which accumulate in Alzheimer brains. These proteins depleted BRCA1 in the cultured neurons, suggesting that they may be an important cause of the faulty DNA repair seen in Alzheimer brains. Further supporting this conclusion, the researchers demonstrated that accumulation of amyloid-beta in the brains of mice also reduced neuronal BRCA1 levels. They are now testing whether increasing BRCA1 levels in these mouse models can prevent or reverse neurodegeneration and memory problems. (more…)
Author Interviews, CDC, Gender Differences, HIV / 03.12.2015

MedicalResearch.com Interview with: Dr. Andrew Auld MD, MSc Medical Epidemiologist Division of Global HIV & TB CDC MedicalResearch: What is the background for this study? Dr. Auld: Equitable access to antiretroviral therapy for men and women living with HIV is a principle endorsed by most countries and funding bodies, including the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR). This analysis, including more than 765,000 adult patients starting antiretroviral therapy in 12 countries (10 African countries, Haiti, and Vietnam), is the most up-to-date and comprehensive assessment of differences in HIV treatment access among men and women with HIV in developing countries. MedicalResearch: What are the main findings? Dr. Auld: Investigators showed that in all 10 African countries and Haiti, women with HIV were far more likely to be on treatment than men. In these 11 countries, women were 23%–83% more likely to access antiretroviral therapy than men with HIV. In addition, in six African countries and Haiti, gender imbalance in HIV treatment access appears to be getting worse over time. (more…)
Author Interviews, Blood Pressure - Hypertension, Coffee / 03.12.2015

MedicalResearch.com Interview with: Wenji Li, MMed, PhD Postdoc Associate Department of Pharmaceutics Ernest Mario School of Pharmacy Rutgers, The State University of New Jersey Medical Research: What is the background for this study? What are the main findings? Dr. Li: Hypertension is a vital risk factor for many serious disorders. Male and age ≥40 years were found to be highly associated with more severe hypertension. In Singapore, the prevalence of hypertension increased markedly from age 40 years onwards. Tea, a popular beverage in Chinese people, has been approved to possess many beneficial pharmacological effects including antihypertension. However, no clinical studies on the correlation between tea drinking and its effect on lowering blood pressure among Singaporeans have been conducted. To find out the potential link, we are the first to investigate the correlation of hypertension and consumption of tea, health supplements, living habits and socio-demographic factors among Singaporean Chinese residents. By the large scale cross-sectional epidemiology study (N = 1184), we found the prevalence of hypertension among the whole investigated population was 49.73% and the prevalence increased to 66.47% in the sub-population aged ⩾60 years. High risk of hypertension was associated with age ⩾60 years, obesity, family history of hypertension, diabetes history, hyperlipidemia history, male and coffee intake. In contrast, drinking green tea at least 150 ml per week was associated with lower hypertension risk. Drinking combination of green tea and British tea was associated with higher reduction in the risk of hypertension. This study suggests that consumption of tea, especially green tea and British tea, is beneficial for lowering the risk of hypertension while the consumption of coffee may have the opposite effect.  (more…)
Author Interviews, Breast Cancer, Depression, JNCI, Kaiser Permanente / 03.12.2015

MedicalResearch.com Interview with: Reina Haque, PhD, MPH Research scientist Department of Research & Evaluation Kaiser Permanente Southern California Pasadena Calif Medical Research: What is the background for this study? What are the main findings? Dr. Haque: Tamoxifen is a commonly prescribed generic drug taken by women with breast cancer to reduce their chances of developing a recurrence. Tamoxifen is recommended for five years, but has notable side effects, including hot flashes, night sweats and depression. Since hormone replacement therapy is not recommended to alleviate these symptoms in breast-cancer survivors, antidepressants have been increasingly prescribed for relief. Almost half of the 2.4 million breast-cancer survivors in the U.S. take antidepressants. However, previous studies have suggested that antidepressants reduce tamoxifen's effectiveness in lowering subsequent breast-cancer risk. This study was conducted to determine whether taking tamoxifen and antidepressants (in particular, paroxetine) concomitantly is associated with an increased risk of recurrence or contralateral breast cancer. (more…)
ASCO, Author Interviews, Immunotherapy, Ovarian Cancer / 02.12.2015

MedicalResearch.com Interview with: Junzo Hamanishi  M.D., Ph.D. Department of Gynecology and Obstetrics, Kyoto University Graduate School of Medicine Assistant Professor Kyoto Japan Medical Research: What is the background for this study? Dr. Hamanishi: More than 70% of patients with advanced ovarian cancer who achieve remission ultimately relapse and there are few effective treatments for these patients. Because the development of new treatment strategies for these patients is urgently required, we have focused on and studied the potential of cancer cells to escape from host immunity with PD-1/PD-L1 immunosuppressive signal in the tumor microenvironment to find new treatment strategies to overcome this phenomenon, collaborating with Professor Honjo who discovered PD-1 since 2006. Therefore, we conducted a phase II clinical trial in 20 platinum-resistant, recurrent ovarian cancer patients to evaluate the safety and anti-tumor efficacy of anti-PD-1 antibody (nivolumab) with 2 cohort at a dose of 1 or 3 mg/kg (constituting two 10-patient cohorts). Medical Research: What are the main findings? Dr. Hamanishi: This study is the first investigator-initiated phase II clinical trial testing the safety and efficacy of nivolumab against platinum-resistant ovarian cancer. In the 20 patients in whom responses could be evaluated, the best overall response was 15%, including two patients with a durable complete response (3mg/kg cohort). The disease control rate in all 20 patients was 45%. The median progression-free survival was 3.5 months, with a median overall survival of 20.0 months. Especially in the 3 mg/kg cohort, two patients achieved a complete response, and disease stabilized in another two patients. The objective response rate in 3mg/kg cohort cohort was 20% and disease was controlled in 40% of the higher-dose group. In the four patients who demonstrated an antitumor response, responses were durable and evident. Grade 3 or 4 treatment-related adverse events (AE) occurred in eight out of 20 patients or 40% overall. However, the frequency of AEs were not different in 2 cohorts. (more…)
Author Interviews, Infections, Nature / 02.12.2015

MedicalResearch.com Interview with: Professor Søren Riis Paludan DMSc, PhD Department of Biomedicine Aarhus University Denmark Medical Research: What is the background for this study? What are the main findings? Prof. Paluden: We were interested in understanding the first immune reactions that occur when an organism meets an infectious agent (virus or bacteria). The main finding is that we have identified an immune reaction that is activated as the microbe disturbed the mucus layer at mucosal surfaces. This is an immune reaction occuring earlier than what has been thought previously, and may represent a mechanism that enables the organism to fight most microbes that we meet without mounting strong immune responses. This is important, since strong immune reactions - in addition to contributing to elimination of microbes - also have negative effects such as fever, etc. (more…)
Author Interviews, Cognitive Issues, Exercise - Fitness, JAMA, Lifestyle & Health / 02.12.2015

MedicalResearch.com Interview with: Tina Hoang MSPH Staff Research Associate Northern California Institute for Research and Education, Veterans Affairs Medical Center Dr. Kristine Yaffe MD Professor of Psychiatry, Neurology, and Epidemiology University of California San Francisco, CA  94121 Medical Research: What is the background for this study? What are the main findings? Response: We assessed physical activity and TV watching in young adults over 25 years to see if there was an association with cognitive function in middle age.  Most previous studies have only considered this association in older adults. We found that both low physical activity and high TV watching over time were associated with worse cognitive function. (more…)
Author Interviews, Breast Cancer, Journal Clinical Oncology, MRI, Yale / 02.12.2015

MedicalResearch.com Interview with: Shiyi Wang, MD, PhD Assistant Professor of Epidemiology (Chronic Diseases) Yale School of Public Health Medical Research: What is the background for this study? Dr. Wang: As magnetic resonance imaging (MRI) of the breast has become part of medical care, there is increasing concern that this highly sensitive test might identify health problems that otherwise would not have had an impact on the patient – so called “overdiagnosis”. However, even if MRI use leads to overdiagnosis, the main “theoretical” benefit of early detection by MRI is to prevent future advanced diseases, the prognosis of which is deleterious. A systematic literature review found that, compared to mammography and/or ultrasound, MRI had a 4.1% incremental contralateral breast cancer (breast cancer in the opposite breast) detection rate. At this point, the impact of MRI on long-term contralateral breast cancer outcomes remains unclear.  Medical Research: What are the main findings? Dr. Wang: Analyzing the Surveillance, Epidemiology, and End Results-Medicare dataset, we compared two groups of women who had breast cancer (one group receiving an MRI, and the other not) in terms of stage-specific contralateral breast cancer occurrences. We found that after five years, the MRI group had a higher detection rate of cancer in the opposite breast than the non-MRI group (7.2 % vs. 4.0%). Specifically, MRI use approximately doubles the detection rate of early stage contralateral breast cancer, but does not decrease the incidence of advanced stage contralateral breast cancer occurrences after a 5-year follow-up. Our results indicate that nearly half of additional breast cancers detected by the preoperative MRI were overdiagnosed, which means that many of these occult cancers not detected by MRI would not have become clinically evident over the subsequent 5 years. There was no evidence that MRI use was benefiting women because the rate of advanced cancer was similar in the MRI and the non-MRI groups. (more…)
Author Interviews, HIV, NEJM, Sexual Health / 02.12.2015

MedicalResearch.com Interview with: Dr Jean-Michel Molina Department of Infectious Diseases Saint-Louis Hospital and University of Paris Diderot Paris France MedicalResearch: What is the background for this study? What are the main findings? Dr. Molina: Men who have sex with men (MSM) are disproportionately affected by HIV worldwide and represent the today in Europe the largest group in which new HIV infections are diagnosed with no decrease over the last 8 years. The first study assessing preexposure prophylaxis (PrEP) efficacy among MSM was published in 2010 (the Iprex study) which reported for the first time a 44% reduced incidence of HIV in those randomized to receive daily tenofovir/emtricitabine  TDF/FTC (one pill per day) as compared to placebo. Adherence to a daily pill regimen was found to be challenging however since only half of the participants (according to drug detection in blood) were taking their daily regimen. Post-hoc analyses suggested that among those with drugs detectable in plasma, PrEP efficacy could be as high as 92%. However, long term adherence to a daily regimen represents the Achille’s heel of daily PrEP, as shown later in other large PrEP trials among women in Africa (VOICE and Fem-PrEP). Based on data from animal models we wished to assess whether PrEP with TDF/FTC taken on demand, at the time of sexual activity, could improve adherence, thereby efficacy and also improve safety and cost. In this randomized double blind placebo controlled trial, on demand PrEP with TDF/FTC reduced the incidence of HIV by 86% in the intent to treat analysis as compared to placebo, and the only 2 participants who became infected in the TDF/FTC arm after more than a year of follow-up, had discontinued the use of PrEP months before infection. The ANRS Ipergay study reports therefore a very high efficacy of PrEP, similar to that also reported in another PrEP study carried out in the UK among MSM with daily TDF/FTC (PROUD), which results were disclosed at the same time. Both studies have increased awareness about the real potential of PrEP and have had a strong impact on WHO and European guidelines. (more…)
Author Interviews, JAMA, Lung Cancer, Radiation Therapy / 02.12.2015

MedicalResearch.com Interview with: Benjamin Movsas, MD Chairman of Radiation Oncology Henry Ford Hospital Detroit, Michigan  Medical Research: What is the background for this study? What are the main findings? Dr. Movsas: The background is that a recent randomized lung cancer trial (RTOG 0617) showed a lower (rather than a higher) survival among the patients who received a higher dose of radiation (RT).  This unexpected finding was puzzling as there were few differences in toxicity between the radiation dose arms noted by health care providers. The main finding of the quality of life (QOL) analysis was that there was indeed a large difference in QOL as reported by the patients themselves (with lower QOL on the high RT dose arm at 3 months).  Moreover, while this study was not randomized for RT technique, about half of the patients received intensity modulated RT (IMRT), a more sophisticated approach than the alternative (3D conformal RT), which can better protect normal tissues.  Despite the fact that patients with larger tumors received IMRT, their self reported QOL one year later was significantly better (ie, much less decline in QOL) relative to patients who received 3D conformal RT.  Finally, higher QOL at baseline significantly predicated for better survival. (more…)
Author Interviews, Brain Injury, Mayo Clinic, Neurological Disorders / 02.12.2015

MedicalResearch.com Interview with: Kevin Bieniek B.Sc. Biology and Psychology Neuroscience researcher Mayo Clinic’s campus in Florida.  Medical Research: What is the background for this study? What are the main findings? Response:  Chronic traumatic encephalopathy (CTE) is a progressive neurodegenerative disorder linked to repetitive traumatic brain injury often sustained through contact sports and military blast exposure.  While CTE was first described in boxers in the 1920s, to date many descriptions of CTE have been made in high-profile professional athletes, but the frequency of Chronic traumatic encephalopathy pathology in athletes with more modest contact sports participation is unknown.  For this study, researchers at the Mayo Clinic in Jacksonville, FL examined the Mayo Clinic Brain Bank, one of the largest brain banks of neurodegenerative diseases.  In searching through medical records of over 1,700 patients, 66 individuals with clinically-documented contact sports participation were identified.  Of these 66 former athletes, 21 or 32% had pathologic changes in their brains consistent with CTE.  By comparison, none of 198 control individuals that did not have contact sports documentation in their medical records (including 66 women) had CTE pathology.  These results have been recently published in the December issue of the journal Acta Neuropathologica <<hyperlink: http://www.springer.com/medicine/pathology/journal/401. (more…)
Author Interviews, Exercise - Fitness, Orthopedics / 01.12.2015

MedicalResearch.com Interview with: Uwe Schütz, M.D. Radiologist and specialist in orthopedics and trauma surgery Department of Diagnostic and Interventional Radiology University Hospital of Ulm Germany Medical Research: What is the background for this study? What are the main findings? Dr. Schütz: In this study, which is a small part of the Trans Europe Foot Race (TEFR) TEFR-project, we investigated the question, what happens to the joints, in detail to the joint cartilage of the lower extremities, when running 4500 km without any day rest for nearly 10 weeks. Is there really a risk for developing an arthrosis when doing this, like some researches and many physicians postulate? Well, what we find when accompanying 44 ultra-athletes with a modern 1.5Tesla MRI mounted on a custom made 38tonnes truck trailer day by day over 64 days on their way throughout whole Europe is, that the joint cartilage is initially altered by this running burden: It shows signals of cartilage matrix degradation beneath the first 1000 to 1500 km of running. But then the situation changes. When further running occurs, then the cartilage shows the ability to partially regenerate under ongoing running burden. This is a pretty new and astonishing finding, first time measured and observed in human joint in vivo. But knowledge of Scandinavian animal studies show the same behavior in dog cartilage. (more…)
Author Interviews, JAMA, University of Michigan / 01.12.2015

MedicalResearch.com Interview with: Mark D. Peterson, Ph.D., M.S. University of Michigan, Medicine Department of Physical Medicine and Rehabilitation Ann Arbor, MI  Medical Research: What is the background for this study? What are the main findings? Dr. Peterson: Cerebral palsy (CP) is a neurodevelopmental condition caused by a disturbance to the developing fetal or infant brain. While the incidence of CP has remained stable in recent years, the mortality rate of children with Cerebral palsy has declined, suggesting that adults with Cerebral palsy represent a growing population whose healthcare needs are poorly understood.  More than half of children with Cerebral palsy are independently mobile at 8 years of age; however, a large proportion lose mobility in adulthood. These declines are attributed to pain, fatigue, and muscle weakness, and result in chronic inactivity and accelerated aging. Despite this, there have been virtually no specific surveillance efforts or even epidemiologic studies to examine the prevalence of lifestyle-related chronic diseases in adults with Cerebral palsy. Therefore, the purpose of this study was to examine estimates of chronic conditions in a large, U.S. population-representative sample of adults with CP (n=1,015 fromthe Medical Expenditure Panel Survey (MEPS) (2002-2010). We demonstrated that adults with cerebral palsy had significantly greater estimates of chronic diseases, including diabetes, asthma, hypertension and other heart conditions, stroke, emphysema, joint pain, and arthritis as compared with adults without Cerebral palsy. (more…)
Asthma, Author Interviews, JAMA, OBGYNE, Pediatrics / 01.12.2015

MedicalResearch.com Interview with: Dr Mairead Black MBChB, MRCOG, MSc Research Fellow, Wellcome Trust Clinical Lecturer, Obstetrics and Gynaecology School of Medicine and Dentistry, Division of Applied Health Sciences University of Aberdeen Aberdeen Maternity Hospital, Cornhill Road Aberdeen AB25 2ZD  Medical Research: What is the background for this study? Dr. Black: The current thinking is, if a baby is exposed to labour, then it is also exposed to ‘good bacteria’ that mothers pass on during the birth, and they are also exposed to a degree of natural stress at the time of birth that might make them more resistant to developing future illnesses. The World Health Organisation formerly recommended that no more than 15 percent of deliveries should be C-sections. However rates in some countries have soared – China and Brazil have rates in excess of 50%, whilst in the UK the figure is 26% with almost half of these being planned in advance. The main purpose of this study was to explore whether health outcomes in children up to very early adulthood differ according to how they are delivered and whether avoiding labour entirely, i.e. via a planned C-section, could put children at a disadvantage compared to those delivered vaginally or by emergency C-section, where most will have been exposed to labour. The study analysed data from over 300,000 births between 1993 and 2007 across Scotland, using routinely collected data from seven linked databases. (more…)
Author Interviews, Hepatitis - Liver Disease, Nature / 01.12.2015

MedicalResearch.com Interview with: Prof. Yaakov Nahmias PhD Director of the Alexander Grass Center for Bioengineering Hebrew University of Jerusalem Medical Research: What is the background for this study? Prof. Nahmias: The liver has a limitless capacity of the human liver to regenerate from even a massive loss of mass. However, the intrinsic capacity of liver cells to proliferate is lost when cells are removed from the body. Medical Research: What are the main findings? Prof. Nahmias: We found that a weak expression of Human Papilloma Virus (HPV) proteins released hepatocytes from cell-cycle arrest and permitted the cells to multiply in response to Oncostatin M (OSM) an immune cytokine recently found to be involved in liver regeneration. While previous efforts caused hepatocytes to multiply without control, converting hepatocytes  into tumor cells with little metabolic ability, we selected colonies that only multiply in response to OSM. Activation with OSM triggered cell growth with a doubling time of 40 hours. Removal of OSM caused  growth to stop, allowing the cells to regain a high level of metabolic activity within 4 days. We produced hepatocytes from ethnically diverse individuals. Importantly, the growing hepatocytes  showed a similar toxicology response to normal human hepatocytes across 23 different drugs. (more…)
Author Interviews, OBGYNE, Race/Ethnic Diversity / 30.11.2015

Medical research.com Interview with: Rada K. Dagher, Ph.D. Assistant Professor University of Maryland School of Public Health Department of Health Services Administration College Park, MD 20742 MedicalResearch: What is the background for this study? Dr. Dagher: In the United States, 51% of all pregnancies are unintended, and these happen disproportionately among racial and ethnic minorities. For example, in 2008, rates of unintended pregnancies were 69% among African American women, 56% among Hispanic women, and 40% among White women. Our study utilized 2006-2010 data from a nationally representative dataset, the National Survey of Family Growth, to investigate the reasons behind these racial/ethnic disparities. MedicalResearch: What are the main findings of this study? Dr. Dagher: The main findings of this study are as follows. Age and marital status differences explained both racial and ethnic disparities, where being single and younger than 20 years old at the time of conception contributed to the differences in unintended pregnancy between African American and White women, and between Hispanic and White women. However, there were also unique factors explaining the differences in unintended pregnancy between African Americans and Whites (respondent’s mother’s age at first birth, income, and insurance status) and the differences between Hispanics and Whites (U.S. born status and educational level). These findings provide support for culturally-tailored public health interventions that target at-risk groups of women such as younger, unmarried, lower income, lower educated, non-U.S. born women and those with public insurance, in order to reduce racial/ethnic disparities in unintended pregnancy. MedicalResearch: What should clinicians and patients take away from your report? Dr. Dagher: Our findings suggest that interventions to reduce racial and ethnic differences in unintended pregnancy should take into account multiple factors at multiple levels of influence. For example, at the policy level, the Affordable Care Act has mandated that health plans cover women’s preventative health care, including contraceptives, without cost sharing. Thus, primary care providers could educate their patients about these new policy provisions and encourage them to take advantage of them, especially patients at higher risk of unintended pregnancy such as women who are younger than 20, unmarried, non-U.S. born, have lower income, and those with public insurance. (more…)
Author Interviews, JAMA, Prostate Cancer, Radiation Therapy / 30.11.2015

MedicalResearch.com Interview with: Prof Nicholas James STAMPEDE Trial Chief Investigator Director of the Cancer Research Centre Warwick Medical School University of Warwick Coventry and Professor of Clinical Oncology Cancer Centre, Queen Elizabeth Hospital Birmingham Medical Research: What is the background for this study? What are the main findings? Dr. James: The STAMPEDE trial is a multi-arm, multi-stage trials platform testing a range of different therapies in addition to standard of care (SOC) for men commencing long term androgen deprivation therapy (ADT) for newly diagnosed locally advanced or metastatic prostate cancer. These data from the control arm form part of a pair of publications detailing outcomes in the control arm of STAMPEDE and help to make sense of the forthcoming paper on the randomised comparisons currently in press at the Lancet. (more…)