Yoga May Reduce Disability and Opioid Use In Veterans With Chronic Low Back Pain

MedicalResearch.com Interview with:

Erik Groessl PhD Associate Adjunct Professor Family Medicine and Public Health University of California, San Diego

Dr. Groessl

Erik Groessl PhD
Associate Adjunct Professor
Family Medicine and Public Health
University of California, San Diego

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

Response: Chronic low back pain (cLBP) is prevalent among military veterans, but cLBP treatment options have limited benefits and side effects. This has resulted in efforts to reduce opioid use and embrace nonpharmacological pain treatments.

Yoga has been shown to improve health outcomes and have few side effects in non-veteran community samples.

Our objective was to study the effectiveness and safety of yoga for military veterans with chronic low back pain.  In a study of 150 veterans with cLBP, we found that yoga participants had greater reductions in disability and pain than those receiving usual. Opioid medication use declined among all participants, and no serious side effects occurred.

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Tofacitinib -XELJANZ: Potential New Treatment Option For Moderate To Severe Ulcerative Colitis

MedicalResearch.com Interview with:

William J. Sandborn, MD Professor of Medicine and Adjunct Professor of Surgery Chief, Division of Gastroenterology Vice Chair for Clinical Operations, Department of Medicine Director, UCSD IBD Center University of California San Diego and UC San Diego Health System

Dr. Sandborn

William J. Sandborn, MD
Professor of Medicine and Adjunct Professor of Surgery
Chief, Division of Gastroenterology
Vice Chair for Clinical Operations, Department of Medicine
Director, UCSD IBD Center
University of California San Diego and
UC San Diego Health System

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

Response: There is still a substantial unmet need for new treatments for patients with ulcerative colitis.

A previous Phase II study had suggested that tofacitinib might be effective for short term therapy of ulcerative colitis. The patients in that study for the most part had not failed anti-TNF therapy. Now we report the findings from 3 large Phase III trials, two short term trials and one long term trial, demonstrating that tofacitinib 10 mg twice daily is effective for short term therapy, and that both 5 mg and 10 mg twice daily is effective for long term therapy. We also demonstrated that tofacitinib is effective both in patients who have not failed anti-TNF therapy and patients who have failed anti-TNF therapy.

The study demonstrated induction of clinical remission, clinical response and mucosal healing (flexible sigmoidoscopy improvement) over the short term, and maintenance of clinical remission, clinical response, and mucosal healing over the long term.

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Gene “Decorations” Can Serve as Blood Biomarkers To Detect Cancer

MedicalResearch.com Interview with:

Kun Zhang, PhD Professor UCSD Department of Bioengineering La Jolla, CA 92093-0412

Dr. Kun Zhang

Kun Zhang, PhD
Professor
UCSD Department of Bioengineering
La Jolla, CA 92093-0412

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

Response: We have been interested in a type of chemical modification on the DNA, called CpG methylation, for years. This is like a decoration of DNA molecules that is specific to the cell type or tissue type. We were particularly interested in studying how such decoration spread along the DNA molecules. In this study, we did a very comprehensive search of the entire human genome for various human cell types and tissue types, and found close to 150,000 regions (called MHB in this study) in which adjacent CpG share the same decoration. We then went on to find out how many of such regions are unique to each normal cell/tissue type, and how many are specific to cancers. Then we took some of these highly informative regions as “biomarkers”, and showed that we can detect the absence or presence of cancer, and, in the latter case, where the tumor grow, in a patient’s blood.

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Schizophrenia: SynCav1 As Potential Target To Restore Neuron Function

MedicalResearch.com Interview with:

Brian P. Head, MS, PhD Associate Professor, UCSD Research Scientist, VASDHS Department of Anesthesiology VA San Diego Healthcare System San Diego, CA 92161-9125

Dr. Brian Head

Brian P. Head, MS, PhD
Associate Professor, UCSD
Research Scientist, VASDHS
Department of Anesthesiology
VA San Diego Healthcare System
San Diego, CA 92161-9125

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

Response: DISC1 is a schizophrenia associated gene originally identified in a Scottish family. DISC1 protein is highly expressed in the developing brain and in the dentate gyrus of the adult hippocampus, and is involved in neuritogenesis and neuronal signaling. DISC1 is located in multiple intracellular locations including axons and synapses, and loss of DISC1 function causes deficits in neural development, neuronal proliferation, axonal growth, and cytoskeleton modulation, which are consistent with abnormal neural development in schizophrenia.

SynCav1 means synapsin-driven caveolin construct. Synapsin promoter is neuronal specific which allows us to increase caveolin expression-specifically in neurons. We have previously shown that SynCav1 increases neuronal signaling and dendritic growth and arborization in vitro (Head BP JBC 2011), and when delivered in vivo augments functional neuroplasticity and improves learning and memory in adult and aged mice (Mandyam CD Biol Psych 2015).

Since loss of DISC1 function equates to schizophrenic-like symptoms, then decreased DISC1 expression in Cav-1 KO mice agrees with this premise. Thus, loss of Cav-1 increases their likelihood of developing schizophrenia-like symptoms. Because re-espression of Cav-1 restored DISC1 expression as well as expression of key synaptic proteins, this proof-of-concept findings not only builds upon our previously results demonstrating that Cav-1 is critical for neuronal signaling and functional synaptic plasticity but also strongly links Cav-1 with maintaining normal DISC1 expression levels and potentially attenuating schizophrenia-like symptoms.

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Many Atrial Fibrillation Patients At Risk of Stroke Receive Aspirin Instead of Appropriate Anticoagulation

MedicalResearch.com Interview with:

Jonathan Hsu, MD, MAS, FACC, FAHA, FHRS Assistant Professor Cardiac Electrophysiology, Division of Cardiology University of California, San Diego (UCSD)

Dr. Jonathan Hsu

Jonathan Hsu, MD, MAS, FACC, FAHA, FHRS
Assistant Professor
Cardiac Electrophysiology, Division of Cardiology
University of California, San Diego (UCSD)

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

Response: Atrial fibrillation (AF) is the most common cardiac arrhythmia worldwide and imparts significant stroke risk. In patients with AF determined to be at intermediate to high risk for thromboembolism, anticoagulation with warfarin (a vitamin K antagonist) or the newer non-vitamin K antagonist oral anticoagulants clearly reduces morbidity and mortality compared to aspirin. We sought to evaluate practice patterns of cardiovascular specialists in the United states to determine how often AF patients at risk for stroke are prescribed aspirin over oral anticoagulation, and predictors of this practice.

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JAMA Study Looks At Comparable Effectiveness of Four Weight Loss Medications

MedicalResearch.com Interview with:

Siddharth Singh, MD, MS Postdoctoral Fellow, NLM/NIH Clinical Informatics Fellowship Division of Biomedical Informatics Clinical Assistant Professor of Medicine, Division of Gastroenterology, Department of Internal Medicine, University of California San Diego, La Jolla

Dr Siddharth Singh

Siddharth Singh, MD, MS
Postdoctoral Fellow, NLM/NIH Clinical Informatics Fellowship
Division of Biomedical Informatics
Clinical Assistant Professor of Medicine, Division of Gastroenterology, Department of Internal Medicine,
University of California
San Diego, La Jolla

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

Dr. Singh: Over the last 4 years, four new medications have been approved for long-term use for weight loss by the FDA. We sought to evaluate the comparative effectiveness and tolerability of these medications through a systematic review and network meta-analysis. Based on 28 trials in over 29,000 overweight or obese patients, we observed that magnitude of weight loss achieved with these agents is variable, ranging from 2.6kg with orlistat to 8.8kg with phentermine-topiramate. Over 44-75% of patients are estimated to lose at least 5% body weight, and 20-54% may lose more than 10% of body weight; phentermine-topiramate was the most efficacious, whereas lorcaserin was the best tolerated.

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Biomarker Based Chemotherapy Approach Improved Outcomes

MedicalResearch.com Interview with:

Maria Schwaederle PharmD Clinical Research Scientist Center for Personalized Cancer Therapy UCSD Moores Cancer Center La Jolla, CA 92093

Dr. Maria Schwaederle

Maria Schwaederle PharmD
Clinical Research Scientist
Center for Personalized Cancer Therapy
UCSD Moores Cancer Center
La Jolla, CA 92093

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

Dr. Schwaederle: We performed this analysis with experts in the field, including but not limited to Drs Schilsky, Lee, Mendelsohn and Kurzrock, all known for their experience in the area of precision/personalized medicine.
Historically, phase I trials (which are often first in human or highly experimental in other ways) were believed to be examining only toxicity. Our meta-analysis of 13,203 patients shows that in the era of precision medicine, this historical belief needs to be discarded. Second, it is the use of precision medicine that makes this belief outdated.
Indeed, Phase I trials that utilized a biomarker-driven approach that is the essence of precision medicine had a median response rate of about 31%, which is higher than many FDA approved drugs, and this is in spite of the fact that phase I patients are a highly refractory group having failed multiple lines of conventional therapy.

Importantly, however, it was not the use of targeted agents alone that was important. It was the biomarker-based approach where patients are matched to drugs. Without matching, response rates were dismal—about 5%.

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No Apparent Increase in Neuropsychiatric Side Effects From Smoking Cessation Mediations

MedicalResearch.com Interview with:

Robert M. Anthenelli, M.D. Professor and Executive Vice Chair Director, Pacific Treatment and Research Center Department of Psychiatry University of California, San Diego, Health Sciences

Dr. Robert Anthenelli

Robert M. Anthenelli, M.D.
Professor and Executive Vice Chair
Director, Pacific Treatment and Research Center
Department of Psychiatry
University of California, San Diego, Health Sciences 

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

Dr. Anthenelli: Despite growing evidence to the contrary, significant concerns have been raised about the neuropsychiatric safety risk of the smoking cessation medications, varenicline and bupropion. What has been lacking until now among individuals with and without psychiatric disorders is a large, randomized controlled trial that directly compares these medications with placebo and an active comparator (nicotine patch) and that systematically probes for neuropsychiatric adverse events while smokers are trying to quit.

MedicalResearch.com: What are the main findings?

Dr. Anthenelli:

1) Neither varenicline nor bupropion significantly increased incidence of moderate-to-severe neuropsychiatric adverse events relative to placebo or nicotine patch in smokers without or with stable psychiatric disorders.

2) Regardless of treatment condition, smokers with a history of or a current stable psychiatric disorder reported more neuropsychiatric adverse events than their counterparts without such conditions.

3) Varenicline was more effective than placebo, nicotine patch, and bupropion in helping smokers achieve abstinence; bupropion and nicotine patch were more effective than placebo.

4) While quit rates overall were slightly lower in smokers with psychiatric disorders compared with cessation rates in individuals without these conditions, all three medications were more effective than placebo, and their relative efficacy (varenicline > bupropion = nicotine patch > placebo) was the same in this special population of smokers as it was for smokers without mental health disorders.

EAGLES is the first trial to have compared the smoking cessation efficacy of the three, first-line smoking cessation medications in smokers with current or past psychiatric disorders. These results are important because individuals with mental health conditions are disproportionately affected by smoking-related diseases and death.

MedicalResearch.com: What should clinicians and patients take away from your report?

Dr. Anthenelli:

1) In the context of a growing body of studies finding no evidence of a greater incidence of serious neuropsychiatric adverse events in users of varenicline and bupropion compared with nicotine replacement therapy or placebo, it appears these non-nicotine medications can be used safely by psychiatrically stable smokers.

2) Smokers with a history of or current stable psychiatric disorder are more prone to exhibit such events regardless of the medication used and should be monitored during a quit attempt.

3) Varenicline demonstrates superior efficacy to bupropion and nicotine patch, but all three medications are more effective than placebo in smokers with and without stable psychiatric disorders.

MedicalResearch.com: What recommendations do you have for future research as a result of this study?

Dr. Anthenelli: We are looking forward to conducting secondary analyses of the large EAGLES dataset to examine, in finer detail, the safety and efficacy of the three first-line medications in sub-cohorts (e.g., smokers with major depressive disorder, bipolar disorder, and schizophrenia) of the psychiatric cohort. We will also be examining predictors of treatment response to determine whether these vary as a function of a smoker’s psychiatric history.

MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.

Citation:

Neuropsychiatric safety and efficacy of varenicline, bupropion, and nicotine patch in smokers with and without psychiatric disorders (EAGLES): a double-blind, randomised, placebo-controlled clinical trial

Anthenelli, Robert M et al.

The Lancet , Volume 0 , Issue 0 , Published Online: 22 April 2016

DOI: http://dx.doi.org/10.1016/S0140-6736(16)30272-0

Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.

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More Muscle in Lean Women Linked To Lower Diabetes Risk

MedicalResearch.com Interview with:

Britta Larsen, Ph.D. Assistant Professor Family Medicine & Public Health University of California, San Diego Medical Teaching Facility La Jolla, CA 92093-0628

Dr. Britta Larsen

Britta Larsen, Ph.D.
Assistant Professor
Family Medicine & Public Health
University of California, San Diego
Medical Teaching Facility
La Jolla, CA 92093-0628 

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

Dr. Larsen: We know that muscle is important for metabolic processes, but there has been very little research on the role muscle may play in the development of metabolic diseases like type 2 diabetes. While excess fat can increase the risk of metabolic disease, there are people who are normal weight who still develop diabetes, and it’s possible that this could be due to low muscle mass. Our main findings were that, in normal weight women, women with more abdominal, thigh, and overall muscle were less likely to develop diabetes over a 13-year period. 
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Shorter Overnight Fast May Increase Risk of Breast Cancer Recurrence

MedicalResearch.com Interview with:

Ruth E. Patterson, PhD Professor, Department of Family Medicine and Public Health Associate Director, Population Sciences Program Leader, Cancer Prevention Moores Cancer Center UC San Diego La Jolla, CA

Dr. Ruth Patterson

Ruth E. Patterson, PhD
Professor, Department of Family Medicine and Public Health
Associate Director, Population Sciences
Program Leader, Cancer Prevention
Moores Cancer Center
UC San Diego
La Jolla, CA

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

Dr. Patterson: Our research team was intrigued with studies in mice showing that even when eating a high-fat diet, mice who were subjected to a 16-hour fasting regimen during the sleep phase were protected against abnormal glucose metabolism, inflammation and weight gain; all of which are associated with poor cancer outcomes.

We had access to a study conducted in breast cancer survivors called the Women’s Healthy Eating and Living Study (WHEL).  Participants in this study completed food records, which give the time of eating meals and snacks.  We used the food records to estimate the average nightly fasting interval in 2413 breast cancer survivors.  Overall, we found that women who had a nightly fasting interval of less than 13 hours had a 36% increased risk of breast cancer recurrence and a nonsignificant increase in mortality.  We also found that women with a short nightly fast had poorer glucoregulation and worse sleep, both of which might explain the link to breast cancer.

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Intracoronary Gene Transfer Improved Ejection Fraction in Heart Failure

MedicalResearch.com Interview with:

H Kirk Hammond, MD Professor of Medicine (Cardiology) University of California San Diego Veterans Affairs San Diego Healthcare System San Diego, CA 92161

Dr. H. Kirk Hammond

H Kirk Hammond, MD
Professor of Medicine (Cardiology)
University of California San Diego
Veterans Affairs San Diego Healthcare System
San Diego, CA 92161 

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

Dr. Hammond: Heart failure affects >28 million patients worldwide and is the only cardiovascular disease that is increasing in prevalence. Despite steady improvement in drug therapy for heart failure, recent hospitalization rates and mortality have changed little. New therapies are needed. Adenylyl cyclase type 6 (AC6), is a protein that catalyzes the conversion of ATP to cAMP and is an important determinant of heart function. The amount and function of AC6 are reduced in failing hearts, and preclinical studies have shown benefits of increased cardiac AC6 content on the heart. The aim of the trial was to determine safety and heart function gene transfer of AC6, achieved by intracoronary delivery of an inactivated virus carrying the gene for AC6 (Ad5hAC6) in patients with symptomatic heart failure and reduced ejection fraction. Our hypothesis was that AC6 gene transfer would safely increase function of the failing hearts of patients with heart failure.

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Dual and Concordant Vaginal and Oral HPV Infections in Women

MedicalResearch.com Interview with:

Ryan K. Orosco, MD Division of Head and Neck Surgery Department of Surgery University of California, San Diego

Dr. Ryan Orosco

Ryan K. Orosco, MD
Division of Head and Neck Surgery
Department of Surgery
University of California, San Diego

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

Dr. Orosco: Our group at UC San Diego is interested in HPV as it relates to diseases of the head and neck.  HPV is a well-publicized cause of cervical cancer, and awareness about its link to throat (oropharynx) cancer is rapidly increasing.

Less well-known, is the relationship between HPV and benign (non-cancerous) diseases such as genital warts and papilloma of the throat.  As we strive to understand how to best care for patients with HPV-related disorders, it is important to understand the entire process of disease progression, which begins with HPV infection. Our group wanted to explore the relationship between HPV infection in the two most commonly infected body sites: oral and vaginal.

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Children Can Maintain Healthy Weight By Eating Slowly

Geert W. Schmid-Schonbein, Ph.D. Distinguished Professor and Chairman Department of Bioengineering Adjunct Professor in Medicine University of California San Diego

Prof. Schmid-Schonbein

MedicalResearch.com Interview with:
Geert W. Schmid-Schonbein, Ph.D.
Distinguished Professor and Chairman
Department of Bioengineering
Adjunct Professor in Medicine
University of California San Diego

Medical Research: What is the background for this study? What are the main findings?

Dr. Schmid-Schonbein: Most approaches to control/reduce body weight focus on reducing food quantity, improving quality and promoting daily activity. These approaches, effective in the short term, only yield modest weight control. Weight management strategies recommended in the past have not significantly diminished the current trend towards childhood and adolescence obesity.

We developed and tested an alternative approach to control weight gain in healthy individuals to reduce the risk for development of obesity and diabetes complications. The essence is to:

Eat deliberately slow AND stop eating when you feel no longer hungry”.

The approach avoids any form of special diet, uses no drugs, can be adopted for a lifetime and used in any ethnic environment. Children in a Mexican School in Durango were instructed by a pediatrician to learn to eat deliberately slow and to stop eating when the satiety reflex sets in, i.e. the moment when the feeling of hunger has disappeared.

They were instructed to:

  • quench the thirst at the beginning of a meal with water,
  • use a portable 30 second hourglass sand timer,
  • take a bite only when the sand timer was turned, and
  • stop eating when they were no longer hungry (as compared to feeling of fullness), and
  • limit food consumption after the point of satiety.

Over a one-year period, children not using the hourglass excessively increased their body-mass index, while in contrast children using the hourglass grew normally their body-mass index. Body surface area and waist hip ratio followed the same trend. The study shows feasibility of regulating food intake by education that is directed at developing slow eating habits and cessation of eating at satiety. A combination of behavioral training and focused eating monitoring may constitute a weight control method that may serve a life-time and can be promoted for children and adolescents at moderate costs, on a national basis.

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Primary Care Continuity Reduced Emergency Department Use and Hospitalizations

Nadereh Pourat, PhD Professor, Department of Health Policy and Management, UCLA Fielding School of Public Health Adjunct Professor, UCLA School of Dentistry Director of Research, UCLA Center for Health Policy ResearchMedicalResearch.com Interview with:
Nadereh Pourat, PhD

Professor, Department of Health Policy and Management, UCLA Fielding School of Public Health
Adjunct Professor, UCLA School of Dentistry
Director of Research, UCLA Center for Health Policy Research

Medical Research: What is the background for this study? What are the main findings?

Dr. Pourat: We have succeeded to insure most of the uninsured population in the U.S., but now have to figure out how to reduce costs while improving health. We had the opportunity to examine the role of continuity with a primary care provider, which is one of the pathways that looked promising in improving health and reducing costs. We were evaluating a major demonstration program in California called the Health Care Coverage Initiative (HCCI) and one of the participating counties implemented a policy to increase adherence by only paying for visits if patients went to their assigned providers. We examined what happened to patients who always or sometimes adhered to their provider versus those who never adhered. We found that adherence or continuity reduced emergency department use and hospitalizations. This would lead to savings because of the high costs of these services.

Medical Research: What should clinicians and patients take away from your report?

Dr. Pourat: The study shows that both patients and clinicians would benefit from continuity with the primary care provider. Clinicians can actually make a difference in helping patients: they can teach patients about self-care and help them manage their conditions better. Patients would benefit from following through with treatment plans and experience less medical error and duplication of services which are potentially harmful. Continuity fosters rapport and trust between patients and providers and can be beneficial to both.

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Risk Score May Help Identify MSM Most In Need Of HIV Prevention Resources

MedicalResearch.com Interview with:
Dr. Martin Hoenigl
Center for AIDS Research
University of California, San Diego

Medical Research: What is the background for this study? What are the main findings?

Dr. Hoenigl: Although men who have sex with men (MSM) represent a dominant risk group for human immunodeficiency Virus, the risk of HIV infection within this population is not uniform. Characterizing and identifying the MSM at greatest risk for incident HIV infection might permit more focused delivery of both prevention resources and selection of appropriate interventions, such as intensive counseling, regular HIV screening with methods that detect acute infection (ie, nucleic acid amplification test), and antiretroviral preexposure prophylaxis (PrEP).

By using data collected at a single HIV testing encounter from 8326 unique MSM were analyzed, including 200 with AEH (2.4%), we were able to create the San Diego Early Test (SDET) risk score. The SDET score consist of four risk behavior variables which were significantly associated with an AEH diagnosis (ie, incident infection) in multivariable: condomless receptive anal intercourse (CRAI) with an HIV-positive MSM (3 points), the combination of CRAI plus 5 or more male partners (3 points), 10 or more male partners (2 points), and diagnosis of bacterial sexually transmitted infection (2 points), all as reported for the prior 12 months. The SDET risk score is deployed as a freely available tool at http://sdet.ucsd.edu.

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Increased Time Watching TV Linked To Childhood Obesity

Mark D. DeBoer, MD, MSc, MCR Associate Professor of Pediatrics Division of Pediatric Endocrinology, University of VirMedicalResearch.com Interview with:
Mark D. DeBoer, MD, MSc, MCR
Associate Professor of Pediatrics
Division of Pediatric Endocrinology, University of Virginia

Medical Research: What is the background for this study? What are the main findings?

Dr. DeBoer: The American Academy of Pediatrics recommends that children watch no more than 2 hours of TV daily. We wanted to see if children watching shorter amounts of TV were more likely to have higher weight status. We found that children in kindergarten who watched 1-2 hours a day were more than 40% more likely to be overweight and obese and gained more unhealthy weight over the next year.

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Cancer Risk Elevated In Patients With Hepatitis C

Lisa M. Nyberg, MD, MPH Transplant Hepatologist Director, Hepatology Research Kaiser Permanente, Garfield Specialty Center San Diego, CA  92111MedicalResearch.com Interview with:
Lisa M. Nyberg, MD, MPH
Transplant Hepatologist
Director, Hepatology Research
Kaiser Permanente, Garfield Specialty Center
San Diego, CA  92111

Medical Research: What is the background for this study? What are the main findings?

Dr. Nyberg: The overall cancer rates were higher in patients with Hepatitis C (HCV) vs those without HCV. Of note, though, the HCV cohort had higher rates of alcohol abuse, tobacco use, cirrhosis and diabetes mellitus (DM). However, even after stratification for the variables alcohol abuse, tobacco use, body mass index (BMI) and DM; the increased cancer rates remained significant for total cancer sites, liver cancer and NHL.

Note that this study does not establish a cause and effect relationship between Hepatitis C and cancer. A strength of this study is that it is an evaluation of a large patient population (n=35,712 with HCV and 5,297,191 without HCV). Limitations of the study are those inherent in epidemiological studies using large databases. For example, confounders may not be accurately recorded in automated databases (smoking and alcohol abuse may be under-recorded).

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Selective Estrogen Receptor Degrader May Help Patients With Resistant ER+ Breast Cancer

Presented by Dr. Maura N. Dickler MD Associate member of the Breast Medicine Service at Memorial Sloan Kettering Cancer Center and Weill Medical College of Cornell University in New YorMedicalResearch.com Interview with:
Presented by Dr. Maura N. Dickler MD
Associate member of the Breast Medicine Service at
Memorial Sloan Kettering Cancer Center and
Weill Medical College of Cornell University in New York

Medical Research: What is the background for this study?

This year, breast cancer will claim the lives of nearly 40,000 women in the United States, and up to half of these women will have a disease that is driven by the estrogen receptor.

  • Although medicines have been approved for the treatment of hormone receptor-positive breast cancer for decades, more treatment options are needed.
  • Resistance to endocrine therapies causes morbidity and mortality for women with metastatic estrogen receptor-positive (ER+) breast cancer as many patients relapse or develop resistance to available hormonal agents via estrogen-dependent and estrogen-independent mechanisms.
  • Dual-acting investigational Selective Estrogen Receptor Degrader (SERDs) could potentially lead to a new treatment option for people with hormone receptor-positive breast cancer and may help overcome resistance to current anti-hormonal medicines.
  • GDC-0810 is a dual-acting investigational next-generation oral SERD that works in a number of ways to prevent estrogen fueling tumor growth. It is not only designed to target the estrogen receptor (ER) as an antagonist, but also to cause degradation of the ER protein. In preclinical studies, GDC-0810 was shown to induce tumor regressions in both tamoxifen sensitive and tamoxifen resistant tumor models in vivo.

Medical Research: What are the main findings?

  • Clinical data from the dose-escalation portion of a Phase I/IIa study evaluating GDC-0810 appears to have an acceptable safety profile with encouraging anti-tumor activity in postmenopausal women with advanced breast cancer positive for the estrogen receptor (ER), all of whom were previously treated with standard endocrine therapy.
  • Promising anti-tumor activity was observed in 38% of patients on study for six months or longer. At all doses tested, there was robust engagement of the estrogen receptor by GDC-0810 as demonstrated by fluoroestradiol (FES) PET scans.  Overall, the most common adverse events of any grade related to GDC-0810 were diarrhea, nausea and fatigue.

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Prolonging Duration Of Nightly Fast May Reduce Breast Cancer Risk

Catherine Marinac Doctoral Candidate UC San Diego/San Diego State University Joint-Doctoral Program in Public Health La Jolla, CA 92093MedicalResearch.com Interview with:
Catherine Marinac

Doctoral Candidate
UC San Diego/San Diego State University
Joint-Doctoral Program in Public Health
La Jolla, CA 92093

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

Response: The dietary advice for cancer prevention usually focuses on limiting consumption of red meat, alcohol, and refined grains, and increasing consumption of plant foods. However, new evidence suggests that other fundamental aspects of diet, such when and how often people eat, can also play a role in cancer risk. For example, research in mice suggests that decreasing the number of hours we eat during the day, and increasing the length of time we fast overnight can improve metabolic parameters and reduce risk of developing a number of chronic diseases including cancer.

Similar to the data from animal models, we found that women who fasted for longer periods of time overnight had significantly better control over blood glucose concentrations – and these effects were independent of how much women ate. This finding is relevant to cancer research because people who have poor glucose control are significantly more likely to develop certain types of cancer. It is hypothesized that high concentrations of circulating glucose may fuel cancer growth and progression.
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Sleep Disturbance in Glaucoma Patients Due To Retinal Ganglion Cell Death

MedicalResearch.com Interview with: Carolina P B Gracitelli, M.D. Ophthalmology - PhD Candidate/ Research Fellow University of California San Diego - Hamilton Glaucoma Center  Medical Research: What is the background for this study? What are the main findings?  Dr. Gracitelli:  Of all the diseases that can lead to blindness, glaucoma is one of the most important diseases; it affects more than 70 million people worldwide, of whom approximately 10 % are bilaterally blind. Different studies have reported that the damage caused by glaucomatous disease lead to retinal ganglion cell (RGC) loss and consequently loss of intrinsically photosensitive retinal ganglion cells (ipRGCs), which is a subtype of RGC. This subpopulation of RGC is clearly related with non-image-forming visual function such as photic synchronization of circadian rhythms  and the pupillary light reflex. However, the true impact of glaucoma on sleep quality, sleep disturbance or circadian rhythm was until nowadays controversial. The main clinical finding of our study was that glaucoma leads to RGC death, including ipRGC death. These cells are connected to several non-image-forming functions, including circadian photoentrainment and pupillary reflexes. Therefore, the image-forming and non-image-forming visual systems are associated with glaucoma. Circadian function has not been well investigated in clinical daily practice, but it can interfere with the quality of life of these patients. Concerns about sleep disturbances in glaucoma patients should be incorporated into clinical evaluations.   Medical Research: What should clinicians and patients take away from your report? Dr. Gracitelli:  Our data support the concept that glaucoma is associated with a loss of ipRGCs that mediate the pupillary light response, particularly to the sustained component of the blue flash with a luminance of 250 cd/m2. Additionally, glaucoma patients had significant sleep disturbances that were inversely correlated with a measure of ipRGC function, the pupillary light reflex. These results suggest that the loss of ipRGCs in glaucoma may also lead to sleep disturbances. Both non-visual functions of ipRGCs are correlated, indicating that attention should be paid to the non-image forming visual functions in glaucoma patients.   Medical Research: What recommendations do you have for future research as a result of this study?  Dr. Gracitelli:  Sleep disorders is a complex system, therefore, some conclusions in this study should be carefully evaluated. Further studies with larger cohorts could also help to elucidate the association between the pupillary reflex and the polysomnography parameters. And longitudinal studies can better explain the associations between sleep disorders and glaucoma progression.  In addition, we know that there are several types of ipRGCs and they have specific functions (pupillary reflex or circadian rhythms), therefore, evaluations would also need to include a more thorough assessment to understand better the specific role of ipRGCs in sleep disturbances. However, it is true that these ipRGCs functions are impaired in glaucoma, affecting the quality of life of these patients.   Citation:   Intrinsically Photosensitive Retinal Ganglion Cell Activity Is Associated with Decreased Sleep Quality in Patients with Glaucoma  Gracitelli, Carolina P.B. et al. Ophthalmology Published Online: April 06, 2015 DOI: http://dx.doi.org/10.1016/j.ophtha.2015.02.030MedicalResearch.com Interview with:
Carolina P B Gracitelli, M.D.
Ophthalmology – PhD Candidate/ Research Fellow
University of California San Diego – Hamilton Glaucoma Center

Medical Research: What is the background for this study? What are the main findings?

Dr. Gracitelli: Of all the diseases that can lead to blindness, glaucoma is one of the most important diseases; it affects more than 70 million people worldwide, of whom approximately 10 % are bilaterally blind. Different studies have reported that the damage caused by glaucomatous disease lead to retinal ganglion cell (RGC) loss and consequently loss of intrinsically photosensitive retinal ganglion cells (ipRGCs), which is a subtype of retinal ganglion cell. This subpopulation of RGC is clearly related with non-image-forming visual function such as photic synchronization of circadian rhythms and the pupillary light reflex. However, the true impact of glaucoma on sleep quality, sleep disturbance or circadian rhythm was until nowadays controversial.

The main clinical finding of our study was that glaucoma leads to retinal ganglion cell death, including ipRGC death. These cells are connected to several non-image-forming functions, including circadian photoentrainment and pupillary reflexes. Therefore, the image-forming and non-image-forming visual systems are associated with glaucoma. Circadian function has not been well investigated in clinical daily practice, but it can interfere with the quality of life of these patients. Concerns about sleep disturbances in glaucoma patients should be incorporated into clinical evaluations.

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More Asians and Hispanics Developing Non-Melanoma Skin Cancer

MedicalResearch.com Interview with:
Arisa Ortiz, MD, FAAD Assistant Clinical Professor
Director, Laser and Cosmetic Dermatology
Senior author: Brian Jiang, MD and
First author Tiffany Loh, BS
Department of Dermatology UC San Diego

Medical Research: What is the background for this study? What are the main findings?

Response: Non-melanoma skin cancers (NMSCs) are the most common type of malignancy in the United States, affecting an estimated 3.5 million people each year. Previous perception has remained that skin cancer risk in Hispanics and Asians is lower than that of Caucasians. However, despite historically lower rates of skin cancer, in recent years, the incidence of skin cancer in these groups has reportedly been increasing in the United States. As Hispanics and Asians constitute two of the most rapidly expanding ethnic groups in the US, the rise in NMSCs in these populations is particularly concerning.

The finding from our study were as follows: Hispanic patients were significantly younger than Caucasians and Asians (p=0.003, 0.023 respectively). The majority of Non-melanoma skin cancers in Caucasians occurred in men, while this gender ratio was reversed for both Hispanics and Asians. There were significantly more cases of Non-melanoma skin cancers occurring in the “central face” area in Hispanics. Race was not a significant predictor for specific NMSC type (BCC or SCC).

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Both Stenting and Bypass Surgery Reasonable For 2+ Blocked Coronary Arteries

Sripal Bangalore, MD, MHA, FACC, FAHA, FSCAI, Director of Research, Cardiac Catheterization Laboratory, Director, Cardiovascular Outcomes Group, The Leon H. Charney Division of Cardiology, Associate Professor of Medicine, New York University School of Medicine, New York, NY 10016.MedicalResearch.com Interview with:
Sripal Bangalore, MD, MHA, FACC, FAHA, FSCAI
Director of Research, Cardiac Catheterization Laboratory,
Director, Cardiovascular Outcomes Group,
Associate Professor of Medicine,
New York University School of Medicine,
New York, NY 10016

Medical Research: What is the background for this study? What are the main findings?

Dr. Bangalore: Prior studies have shown a mortality benefit of bypass surgery over stenting. But these studies compared bypass surgery with older generation stents which are no longer used. We used data from the New York state registry of patients who underwent stenting or bypass surgery for 2 or more blockages of coronary arteries. With data from over 18,000 patients we found that there was no difference between stenting and bypass surgery for long term mortality. In addition we found that both procedures have trade offs. Bypass surgery has upfront risk of death and stroke whereas PCI has long term risk of needing a repeat procedure. In addition, in patients who underwent incomplete revascularization, there was increase in myocardial infarction with PCI.

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Despite High Risk Of Stroke, Some Atrial Fibrillation Patients Not Adequately Anticoagulated

Jonathan L. Halperin, M.D. The Robert and Harriet Heilbrunn Professor of Medicine Mount Sinai School of MedicineMedicalResearch.com Interview with:
Jonathan L. Halperin, M.D.

The Robert and Harriet Heilbrunn Professor of Medicine
Mount Sinai School of Medicine

Dr. Halperin is a member of the Steering Committee for the GLORIA-AF program and a consultant to Boehringer Ingelheim, which sponsored this research.

Medical Research: What is the background for this study? What are the main findings?

Dr. Halperin: The two analyses come from the GLORIA-AF Registry Program, a global, prospective, observational study supported by Boehringer Ingelheim, which is designed to characterize the population of newly diagnosed patients with non-valvular atrial fibrillation (NVAF) at risk for stroke, and to study patterns, predictors and outcomes of different treatment regimens for stroke risk reduction in non-valvular atrial fibrillation patients. The data is based on treatment trends in 3,415 patients who entered the registry from November 2011 to February 2014 in North America. All patients had a recent diagnosis of NVAF, and 86.2 percent had a CHA2DS2-VASc score of 2 or higher.

Results from the first analysis demonstrated that patients with the paroxysmal (occasional) form of non-valvular atrial fibrillation and at a high risk for stroke (CHA2DS2-VASc score of 2 or higher) were given an anticoagulant medication less often than those with persistent or permanent forms of NVAF, and a CHA2DS2-VASc score of 2 or higher. This pattern runs counter to NVAF guidelines calling for patients to receive oral anticoagulant therapy based on their risk of stroke, rather than the type of atrial fibrillation.

In the second analysis, researchers found that despite high stroke risk, a considerable number of patients receive only aspirin or no medication.

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Pre-Hospital Delay Influences Sex Differences in Acute Coronary Care

MedicalResearch.com Interview with:
Raffaele Bugiardini, M.D.
Professor of Cardiology
University of Bologna

Medical Research: What is the background for this study? What are the main findings?

Dr. Bugiardini: Our analysis differs from previous reports of outcomes following STEMI because prior studies have not looked at sex differences in outcomes adjusted for time from symptom onset to hospital presentation and subsequent utilization of cardiac revascularization procedures, and rates of revascularization are typically significantly lower in women compared with men

Our study is the first to look at the relationship between delays and outcomes. Continue reading

Dark Chocolate May Improve Exercise Capacity and Metabolic Parameters

Pam R. Taub, MD, FACC Assistant  Professor of Medicine UC San Diego Health System Division of Cardiology Encinitas, CA 92024MedicalResearch.com Interview with:
Pam R. Taub, MD, FACC
Assistant  Professor of Medicine
UC San Diego Health System
Division of Cardiology Encinitas, CA 92024

Medical Research: What is the background for this study?

Dr. Taub: Epidemiological studies indicate that the consumption of modest amounts of dark chocolate (DC), which contains the natural cacao flavanol (-)-epicatechin (Epi,) is associated with reductions in the incidence of cardiovascular diseases (CVD). The health benefits of dark chocolate have been attributed to Epi. Clinical studies using cocoa and/or DC in normal volunteers or subjects with CVD have reported improvements in peripheral and coronary vascular endothelial function, blood pressure, lipids, insulin resistance, and inflammatory markers. The mechanism underlying these improvements is thought to be due to increased nitric oxide levels and improved endothelial function. We have also shown that capacity of Epi to favorable impact mitochondria under normal and disease states.

We previously conducted pilot study in five patients with heart failure and type II diabetes, and showed that in skeletal muscle (SkM) biopsies there is a severe reduction in mitochondrial volume and cristae, as well as, in structural/functional proteins. After treatment with Epi rich dark chocolate , there was a significant recovery of SkM mitochondrial cristae, structural/functional proteins (e.g. mitofilin), as well as in regulators of mitochondrial biogenesis. However, no studies have examined the capacity of Epi rich dark chocolate to enhance exercise capacity in normal subjects and assess its impact on mitochondrial and oxidative control systems.

Medical Research: What are the main findings?

Dr. Taub: Seventeen subjects were randomized to placebo (n=8) or DC groups (n=9) and consumed 2 squares of chocolate (20 g, provided by Hershey) for 3 months.

We showed in the chocolate group subjects had improved levels of HDL cholesterol and enhanced exercise capacity that is linked to the stimulation of SkM metabolic control endpoints which enhance mitochondrial function.

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MAPT locus on Chromosome 17 Links Parkinson’s and Alzheimer’s Diseases

Dr. Rahul S. Desikan MD, PhD Department of Radiologoy University of California, San Diego School of MedicineMedicalResearch.com Interview with:
Dr. Rahul S. Desikan MD, PhD
Department of Radiologoy
University of California, San Diego School of Medicine

Medical Research: What is the background for this study? What are the main findings?

Dr. Desikan: The MAPT gene encodes the tau protein, which plays an integral role in Alzheimer’s disease (AD) neurodegeneration. Though a number of studies have investigated this issue, the role of the MAPT gene in Alzheimer’s disease is still unclear. In contrast, a number of studies have found a robust association between MAPT and increased risk for other ‘tauopathies’ like Parkinson’s disease (PD). In our study, rather than evaluating all possible genetic loci, we only assessed shared genetic variants between Alzheimer’s disease and PD. By using this type of approach, we were able to increase our statistical power for gene discovery in Alzheimer’s disease.

We found genetic overlap between Alzheimer’s disease and Parkinson’s disease at a locus on chromosome 17 within the MAPT region. Our findings demonstrate that this MAPT associated locus increases risk for Alzheimer’s disease, correlates with gene expression of MAPT and is associated with brain atrophy of the entorhinal cortex and hippocampus on longitudinal MRI scans.

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Study Addresses Factors Prolonging ED Visits For Psychiatric Patients

Michael Wilson, MD, PhD, FAAEM Attending Physician, UCSD Department of Emergency Medicine Director, Department of Emergency Medicine Behavioral Emergencies Research (DEMBER) lab UC San Diego Health SystemMedicalResearch.com Interview with:
Michael Wilson, MD, PhD, FAAEM
Attending Physician, UCSD Department of Emergency Medicine
Director, Department of Emergency Medicine Behavioral Emergencies Research (DEMBER) lab UC San Diego Health System

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

Dr. Wilson: Emergency departments (EDs) nationwide are crowded. Although psychiatric patients do not make up the largest proportion of repeat visitors to the emergency department, psychiatric patients stay longer in the ED than almost any other type of patient. So, it’s really important to find out things about these patients that may predict longer stays.

In this study, we looked at patients on involuntary mental health holds. The reasoning is simple: patients on involuntary mental health holds aren’t free to leave the ED. So, the only thing that should really matter is how quickly an Emergency department can release them from the involuntary hold. Surprisingly, though, this wasn’t the only thing that correlated with longer stays.

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Study Links Red Meat To Inflammation and Tumor Formation

MedicalResearch.com Interview with:
Annie Samraj and  Ajit Varki MDDr. Annie Samraj MD
Postdoc Fellow
Varki Lab and

Ajit VAjit Varki MD Distinguished Professor of Medicine and Cellular & Molecular Medicine Co-Director, Center for Academic Research and Training in Anthropogeny (CARTA) Co-Director, Glycobiology Research and Training Center (GRTC)  University of California, San Diego, 9500 Gilman Drive, La Jolla, CA 92093-0687.arki MD
Distinguished Professor of Medicine and Cellular & Molecular Medicine , Co-Director, Center for Academic Research and Training in Anthropogeny, Co-Director, Glycobiology Research and Training Center
University of California, San Diego, La Jolla, CA

Medical Research: What is the background for this study? What are the main findings?

Dr. Varki: For the past decade, there has been increasing evidence that people who consume red meat (beef, pork, lamb) are at a higher risk for certain kinds of cancers. Although red meat is a high quality source of protein, iron and vitamins, too much consumption may be harmful to humans. While there are other hypotheses under consideration, we focused on a non-human sugar molecule called Neu5Gc in red meat that could explain the link to cancer risk.

We extensively studied various foods and concluded that red meat (particularly beef) is rich in Neu5Gc. In contrast poultry, fish steaks and hen eggs have little or no Neu5Gc. From previous studies, we knew that animal-derived Neu5Gc could be incorporated into human tissues. In this study, we hypothesized that eating red meat could lead to inflammation if the body’s immune system targets the foreign Neu5Gc. Chronic inflammation is also known to instigate or promote tumor progression.

To test this hypothesis, we used mice engineered to be similar to humans in that they lacked Neu5Gc, and also produced antibodies against it. When these mice were fed Neu5Gc, they developed systemic inflammation. Tumor formation increased fivefold and Neu5Gc accumulated in the tumors, proving the hypothesis. None of the various control groups of mice showed this effect.

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HIV+ Adults May Have Poorer Hearing

dr-peter-torre Dr. Peter Torre III PhD Associate Professor, Audiology Director, Recreational Noise Exposure and Hearing Lab San Diego State UniversityMedicalResearch.com Interview with:
Dr. Peter Torre III PhD
Associate Professor, Audiology
Director, Recreational Noise Exposure and Hearing Lab
San Diego State University


Medical Research: What is the background for this study? What are the main findings?

Dr. Torre: The primary purpose of our study was to evaluate hearing sensitivity in HIV+ and HIV- adults. And subsequently, in HIV+ adults only, to examine whether HIV disease variables or treatment was associated with hearing sensitivity.

The main findings were that HIV+ adult had poorer hearing for both the lower and higher frequencies compared with HIV- adults, although we did not find any significant associations between HIV variables and treatment variables with hearing loss.
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Hospital Readmissions May Not Be A Good Quality Indicator

MedicalResearch.com Interview with:
Ralitza P. Parina, MPH,
Senior medical student
John Rose, MD MPH
Department of Surgery at University of California San Diego

Medical Research: What is the background for this study? What are the main findings?

Response: This study looked at the association between hospital 30-day readmission rates and 30-day mortality rates. While readmission rates are coming into increasing focus with CMS reimbursement cuts for hospitals with higher than expected rates, they remain a poorly studied metric of quality. High readmission rates have been unequivocally tied to increased costs, but it remains unclear whether they actually represent poor quality of care and worse outcomes for patients. We chose to compare readmission rates as a quality metric to the well-established “gold standard” of mortality.

We found that 85% of hospitals did not show a correlation between readmission and mortality, i.e. their rates were not both high or both low. Furthermore, among hospitals that were outliers in at least one of the measures, almost a third were in the category of low or normal readmission rates with higher than expected mortality.

The implications are twofold: first, readmission and mortality rates are not strongly correlated.
Second, focusing on readmission rates as an outcome will miss a large number of poorly performing hospitals with higher than expected mortality rates but low or expected readmissions.

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Surgical Quality Enhanced By Electronics Records Data

MedicalResearch.com Interview with:
Jamie Anderson MD MPH
Department of Surgery
University of California, San Diego

Medical Research: What is the background for this study? What are the main findings?

Dr. Anderson: Risk adjustment is an important component of outcomes and quality analysis in surgical healthcare. To compare two hospitals fairly, you must take into account the “risk profile” of their patients. For example, a hospital operating on predominately very sick patients with multiple co-morbidities would be expected to have different outcomes to a hospital operating on relatively healthier patients with fewer co-morbidities. Somewhat counter-intuitively, it is possible that a hospital with a 10% mortality rate may be better than a hospital with 5% mortality rate when you adjust for the risk of the patient population.

Currently, the “gold standard” database to evaluate surgical outcomes is the American College of Surgeons National Surgical Quality Improvement Program (NSQIP), which includes a number of variables on each patient to perform risk adjustment. However, collecting these variables is costly and time consuming. There is also concern that risk adjusted benchmarking systems can be “gamed” because they include data elements that require subjective interpretation by hospital personnel.

With the widespread adoption of electronic health records, the aim of this study was to determine whether a number of objective data elements already used for patient care could perform as well as a traditional, full risk adjustment model that includes other provider-assessed and provider-recorded data elements.

We tested this hypothesis with an analysis of the NSQIP database from 2005-2010, comparing models that adjusted for all 66 pre-operative risk variables captured by NSQIP to models that only included 25 objective variables. These results suggest that rigorous risk adjusted surgical quality assessment can be performed relying solely on objective variables already captured in electronic health records.

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Pulmonary Embolism: Urine Fibrinopeptide B As Screening Tool

MedicalResearch.com Interview withTimothy Fernandes, M.D., M.P.H. University of California, San Diego - La Jolla, CA
Timothy Fernandes, M.D., M.P.H.

University of California, San Diego
La Jolla, CA


MedicalResearch: What are the main findings of this study?

Dr. Fernandes: The fibrinopeptides are cleaved off of fibrinogen by thrombin during the generation of a new clot. These small molecules are excreted into the urine and we have developed a urine assay to measure the level of FPB. We examined the performance of urine FPB as a screening test for acute pulmonary embolism, blood clots that travel to the lungs.

The study group consisted of 344 patients: 61 (18%) with pulmonary embolism and 283 (83%) without. At a threshold of 2.5 ng/ml, urine FPB demonstrated sensitivity of 75.4% (95% CI: 62.4-85.2%), specificity of 28.9% (95% CI: 23.8-34.7%), and negative likelihood ratio of 0.18 (0.11-0.29), weighted by prevalence in the sample population. However, the thresholds of 5 ng/ml and 7.5 ng/ml had sensitivities of only 55.7% (95% CI: 42.5-68.2%), and 42.6% (30.3-55.9%), respectively.

The urine fibrinopeptide B assay at a cut-off of 2.5 ng/ml had a sensitivity of 75.4% for detecting pulmonary embolism. For diagnosis of PE, this sensitivity is comparable to previously published values for the first generation plasma latex and whole blood D-dimer assays (not as well and the D dimer ELISA assay).
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Gulf War Illness May Be Due to Mitochondrial Damage from Toxin Exposures

Beatrice A. Golomb MD, PhD Professor of Medicine Family and Preventive Medicine University of California, San DiegoMedicalResearch.com Interview with:
Beatrice A. Golomb MD, PhD
Professor of Medicine
Family and Preventive Medicine
University of California, San Diego


MedicalResearch.com: What are the main findings of the study?

Dr. Golomb: The main finding is that veterans with Gulf War illness have bioenergetic defects — dysfunction of mitochondria, the energy producing elements of cells — that is evident in comparing affected veterans to matched healthy controls.

An estimated 1/4 to 1/3 of the ~700,000 US veterans from the 1990-1 Gulf War developed chronic multisymptom health problems that entail fatigue, cognitive and other CNS problems, muscle pain, weakness and exercise intolerance, with high rates of gastrointestinal (especially diarrhea) and neurological problems, and other symptoms – as well as autonomic dysfunction. Evidence suggests these problems have not abated with time. Veterans from other nations that have conducted epidemiological studies, including the UK, Canada, and Australia, also show elevated rates of problems.

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Autism: New Evidence that Brain Changes Begin in Pregnancy

MedicalResearch.com Interview with:
Dr. Erik Courchesne PhD
Professor, Department of Neurosciences
UC San Diego School of Medicine

MedicalResearch.com: What are the main findings of the study?

Dr. Courchesne: “Building a baby’s brain during pregnancy involves creating a cortex that contains six layers,” Courchesne said. “We discovered focal patches of disrupted development of these cortical layers in the majority of children with autism.” The authors created the first three-dimensional model visualizing brain locations where patches of cortex had failed to develop the normal cell-layering pattern.

The study found that in the brains of children with autism key genetic markers were absent in brain cells in multiple layers. “This defect,” Courchesne said, “indicates that the crucial early developmental step of creating six distinct layers with specific types of brain cells – something that begins in prenatal life – had been disrupted.”  The study gives clear and direct new evidence that autism begins during pregnancy.

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