Tool Helps Chronic Kidney Disease Patients Make Dialysis Decisions

MedicalResearch.com Interview with:
Suma Prakash MD, MSc, FRCPC

Department of Medicine, Division of Nephrology
Case Western Reserve University
MetroHealth Medical Center Cleveland, Ohio

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

Dr. Prakash: Patients with advanced chronic kidney disease are often faced with difficult decisions of having to choose between options to replace their kidney function. Many patients may not be ready to make treatment decisions since most people don’t want to need a chronic medical treatment.

The behavioural stage of change model originally used to help people with smoking cessation has been used to help patients make decisions about self-care with diabetes and undergo cancer screening. It has not been studied in patients with chronic kidney disease. As patients progress through the stages, they are more ready to make decisions. Focusing on better understanding the decision making process from patients’ perspectives allows us as medical professionals to help patients make timely decision about their options.

Continue reading

Gut Bacteria Linked To Heart Failure and Mortality Risk

Professor of Medicine, Cleveland Clinic Lerner College of Medicine at CWRU Director, Cardiomyopathy Program, Kaufman Center for Heart Failure Research Director, Section of Heart Failure and Cardiac Transplantation Medicine Heart and Vascular Institute, Cleveland Clinic Cleveland, OH 44195MedicalResearch.com Interview with:
W. H. Wilson Tang, MD FACC FAHA

Professor of Medicine,
Cleveland Clinic Lerner College of Medicine at CWRU
Director, Cardiomyopathy Program, Kaufman Center for Heart Failure
Research Director, Section of Heart Failure and Cardiac Transplantation Medicine
Heart and Vascular Institute, Cleveland Clinic Cleveland, OH 44195

Medical Research: What are the main findings of the study?

Dr. Tang: A chemical byproduct of gut bacteria-dependent digestion, TMAO (trimethylamine N-oxide), was previously shown to contribute to heart disease development. In this study, blood levels of TMAO for the first time are linked to heart failure development and mortality risk.
Continue reading

Multiple Sclerosis: Generic Copaxone Demonstrates Equivalent Safety and Efficacy

Jeffrey Cohen MD Department of Neurology Cleveland ClinicMedicalResearch.com: Interview with:
Jeffrey A. Cohen, MD
Hazel Prior Hostetler Endowed Chair
Professor, Cleveland Clinic Lerner College of Medicine
Director, Mellen Center for MS Treatment and Research
Neurological Institute
Cleveland Clinic Cleveland, OH  44195

Medical Research: What are the main findings of the study?

Dr. Cohen: The primary objective of the GATE trial was to compare the efficacy and safety of generic glatiramer acetate to the approved form (Copaxone) in relapsing-remitting multiple sclerosis.  The study demonstrated equivalent efficacy of generic glatiramer acetate and Copaxone measured by gadolinium enhancing brain MRI lesions at months 7, 8, and 9 and a number of additional measures of MRI lesion activity.  The study also showed comparable safety (measured by adverse events) and injection site tolerability.

Continue reading

Lung Cancer: Free Fatty Acids as Potential Biomarkers

Daniel I. Sessler, M.D. Michael Cudahy Professor and Chair, Department of Outcomes Research Cleveland Clinic, Cleveland,MedicalResearch.com Interview with:
Daniel I. Sessler, M.D.
Michael Cudahy Professor and Chair, Department of Outcomes Research
Cleveland Clinic, Cleveland, OH


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

Dr. Sessler: Free fatty acids, arachidonic acid and linoleic acid, and their metabolites hydroxyeicosatetraenoic acids (5-HETE, 11-HETE, 12-HETE, and 15-HETE) were 1.8 to 5.7-fold greater in 37 patients with adenocarcinoma versus 111 patients without cancer (all P<0.001). Areas under the receiver operating characteristics (ROC) curve were significantly greater than 0.50 discriminating lung cancer patients and controls for all biomarkers and phospholipids, and ranged between 0.69 and 0.82 (all P<0.001) for lung cancer patients versus controls. Arachidonic acid, linoleic acid, and 15-HETE showed sensitivity and specificity >0.70 at the best cutpoint. Concentrations of free fatty acids and their metabolites were similar in 18 squamous-cell carcinoma patients and 54 non-cancer controls.

Continue reading

Autism: Autistic Brains Create More Information at Rest

Roberto Fernández Galán, PhD Department of Neurosciences, School of Medicine Case Western Reserve University Cleveland, OH, USAMedicalResearch.com Interview with:
Roberto Fernández Galán, PhD
Department of Neurosciences, School of Medicine
Case Western Reserve University
Cleveland, OH, USA
MedicalResearch.com: What are the main findings of the study?

Dr. Galán: The main finding is that autistic brains create more information at rest than non-autistic brains. This is consistent with the classical view on autism as withdrawal into self. It is also consistent with a recent theory on autism, the “Intense World Theory”, which claims that autism results from hyper-functioning neural circuitry, leading to a state of excessive arousal. From both perspectives, the classical and the IWT, communication and social deficits associated with autism result from having a more intense inner life and a higher level of introspection.
Continue reading

Dabigatran: Comparison Mini-Sentinel Clinical Trials and GI Bleeding

Ilke Sipahi, MD Department of Cardiology Acibadem University Medical School, Istanbul, Turkey Harrington Heart and Vascular Institute, University Hospitals Case Medical Cente  Case Western Reserve University School of Medicine, Cleveland, OhioMedicalResearch.com Interview with:
Ilke Sipahi, MD
Department of Cardiology
Acibadem University Medical School, Istanbul, Turkey
Harrington Heart and Vascular Institute, University Hospitals Case Medical Cente, Case Western Reserve University School of Medicine, Cleveland, Ohio

MedicalResearch.com: Were you surprised at the extreme difference between these 2 analyses?

Answer: I was surprised. However, it is not unusual to find completely
contradictory results in medical studies. I was more surprised at the
fact that FDA paid more attention to it administrative observational
dataset rather than the huge large randomized clinical trials, all
showing excess GI bleeds with dabigatran (Pradaxa). Anyone who is even
slightly familiar with the medical literature knows that randomized trials are the gold standard in medical studies.
Continue reading

Lung Cancer: Breath Test Detection

Dr. Peter Mazzone MD, MPH Pulmonary, Allergy and Critical Care Medicine Cleveland Clinic Main Campus Cleveland, OH 44195MedicalResearch.com Interview with:
Dr. Peter Mazzone MD, MPH
Pulmonary, Allergy and Critical Care Medicine
Cleveland Clinic Main Campus
Cleveland, OH 44195

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

Dr. Mazzone: There were 2 parts to this study:

In the first part we looked at how the breath collection instrument and sensor were performing and made adjustments to both in order to optimize its performance. In the second part we used the improved device and sensor to see if we could accurately separate a sensor signal of our patients with lung cancer from those without lung cancer. We found good separation of lung cancer from non-cancer breath signals, and very good separation of signals of one type of lung cancer from another.

We have concluded that a colorimetric sensor array based breath test is capable of separating those with lung cancer from those without.

We learned about ways that we can enhance the sensor and breath collection instrument, and showed enough promise that this can be an accurate test, that we plan to design a larger study with an improved system in hopes that this will be the final step towards having a clinically useful test.

Citation:

The Analysis of Volatile Organic Compound Profiles in the Breath as a Biomarker of Lung Cancer

Peter Mazzone, MD; Xiaofeng Wang, PhD; Paul Rhodes, PhD; Ray Martino, PhD; Sung Lim, PhD; Mary Beukeman; Meredith Seeley; Humberto Choi, MD; James Jett, MD

Chest. 2013;144(4_MeetingAbstracts):645A. doi:10.1378/chest.1703380

 

 
ADVERTISEMENT

ADVERTISEMENT

URI: Safety and Effectiveness of an Oral CPC Spray

Pranab K. Mukherjee, Ph.D. Assistant Professor Center for Medical Mycology Department of Dermatology University Hospitals Case Medical Center Case Western Reserve University Cleveland, OH 44106-5028MedicalResearch.com Interview with:
Pranab K. Mukherjee, Ph.D.
Assistant Professor
Center for Medical Mycology
Department of Dermatology
University Hospitals Case Medical Center
Case Western Reserve University
Cleveland, OH 44106-5028

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

Answer: We performed a randomized double-blinded placebo-controlled pilot clinical trial to assess the safety, tolerability and effectiveness of a cetylpyridinium chloride (CPC)-based oral spray in the prevention of acute upper respiratory tract infections (URIs).

  • The tested CPC spray (ARMS-I, developed by Arms Pharmaceutical LLC, Cleveland, OH) was safe and exhibited high tolerability and acceptability among study participants
  • The product exhibited a trend to protect against URIs (55% relative reduction compared to the placebo), based on confirmed URIs, post-medication exit interviews, and daily electronic diaries completed by study participants
  • There was statistically significant reduction in frequency of cough and sore throat in the active group
  • The number of days (duration) of cough was significantly reduced in the active group compared to placebo arm
  • URI-associated viruses (influenza, rhinovirus and coronavirus) were detected in three individuals, all in the placebo arm. No virus was detected in the active arm/
  • No drug-related adverse events or oral lesions were observed
  • Previous vaccination status of the study participants did not affect the study outcome.

Continue reading

Nerve Block after Surgery Reduced Narcotic Usage, Shortened Hospital Stays

MedicalResearch.com Interview with:

Conor P. Delaney, MD MCh PhD FRCSI FACS FASCRS

The Jeffrey L. Ponsky Professor of Surgical Education | Chief, Division of Colorectal Surgery | Vice-Chair, Department of Surgery | Director, CWRU Center for Skills and Simulation | Surgical Director, Digestive Health Institute | University Hospitals Case Medical Center | Case Western Reserve University | 11100 Euclid Avenue Cleveland, OH 44106-5047

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

Answer: Our goal was to see whether the transversus abdominis plane (TAP) block reduced complications and shortened the hospital stay of patients undergoing colorectal operations.  The TAP block is a nerve block injection given at the conclusion of the operation which reduces pain in the operative area.  Results showed that the mean hospital stay dropped to less than 2.5 days after the surgical procedure, significantly lower than the 3.7 days which the University Hospitals Case Medical Center Care pathway had already described for more than 1,000 consecutive patients. In our new study, we employed the TAP block and the Enhanced Recovery Pathway (ERP) on 100 patients.  We found that 27 patients went home the next day and another 35 went home 48 hours after their operations. That is considerably better than the five or six days patients usually stay in the hospital after laparoscopic colorectal procedures, and certainly better than nine days often seen after an open operation.  With a third of patients leaving the day after colorectal resection, we feel these results are significant.
Continue reading

Aortic Dissection Repair: Does the Lunar Cycle Affect Outcomes?

MedicalResearch.com Interview with Dr. Frank Sellke, MD

Chief of cardiothoracic surgery and co-director of the Cardiovascular Institute at Rhode Island, The Miriam and Newport hospitals

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

Dr. Sellke: The main findings of the study are that outcomes of repair of an ascending aortic dissection are improved under a full moon compared to other phases of the moon. This was with regard to both mortality and length of hospital stay. Interestingly, there was no correlation with season of the year.
Continue reading

Analyzing excess mortality from cancer among individuals with mental illness

MedicalResearch.com: eInterview with Siran M. Koroukian, Ph.D.
Population Health and Outcomes Research Core,
Clinical & Translational Science Collaborative
Associate Professor Department of Epidemiology and Biostatistics
School of Medicine Case Western Reserve University
Cleveland, OH 44106-7281

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

Dr. Koroukian: Among individuals who died of cancer, those with mental illness (MI) died an average of 10 years earlier than those without MI.

Overall, there was excess mortality from cancer associated with having mental illness in all the race/sex strata: SMR, 2.16 (95% CI, 1.85-2.50) for black men; 2.63 (2.31-2.98) for black women; 3.89 (3.61-4.19) for nonblack men; and 3.34 (3.13-3.57) for nonblack women.

We note statistically significant higher SMRs for every anatomic cancer site in nonblack men and women and for most cancer sites in black men and women.
Continue reading

Study shows increased prostate cancer risk from vitamin E supplements

Men who took 400 international units (I.U.) of vitamin E daily had more prostate cancers compared to men who took a placebo, according to an updated review of data from the Selenium and Vitamin E Cancer Prevention Trial (SELECT). The findings showed that, per 1,000 men, there were 76 prostate cancers in men who took only vitamin E supplements, vs. 65 in men on placebo over a seven-year period, or 11 more cases of prostate cancer per 1,000 men. This represents a 17 percent increase in prostate cancers relative to those who took a placebo. This difference was statistically significant and therefore is not likely due to chance. The results of this update appeared Oct. 12, 2011, in the Journal of the American Medical Association.

SWOG, an international network of research institutions, carried out SELECT at more than 400 clinical sites in the United States, Puerto Rico, and Canada. SELECT was funded by the National Cancer Institute (NCI) and other institutes that comprise the National Institutes of Health.

“Based on these results and the results of large cardiovascular studies using vitamin E, there is no reason for men in the general population to take the dose of vitamin E used in SELECT as the supplements have shown no benefit and some very real risks,” said Eric Klein, M.D., a study co-chair for SELECT, and a physician at the Cleveland Clinic. “For now, men who were part of SELECT should continue to see their primary care physician or urologist and bring these results to their attention for further consideration.”

The SELECT study began in 2001 and included over 35,000 men. It was started because earlier research had suggested that selenium or vitamin E might reduce the risk of developing prostate cancer. However, based on an independent safety monitoring review in autumn 2008, participants were told to stop taking their study supplements because it had become clear that the trial would never produce the 25 percent reduction in prostate cancer the study was designed to show with the use of these supplements. In 2010, the study sites were closed and over half of the participants consented to have their health monitored via mail questionnaires. Now, because of this latest finding, researchers are encouraging all participants to consider taking part in long-term study follow-up so investigators can continue to track outcomes.

SELECT was undertaken to substantiate earlier, separate findings from studies in which prostate cancer risk was not the primary outcome. A 1998 study of male smokers in Finland who took 50 I.U. of vitamin E daily to prevent lung cancer, showed 32 percent fewer prostate cancers in men who took the supplement. A 1996 study of men and women with a history of skin cancer who took selenium for prevention of disease recurrence showed that men who took the supplement had 52 percent fewer prostate cancers than men who did not take the supplement.

Based on these and other findings, men were recruited to participate in SELECT. They were randomly assigned to take one of four sets of supplements or placebos, with more than 8,000 men in each group. One group took both selenium and vitamin E; one took selenium and a placebo that looked similar to vitamin E; one took vitamin E and a placebo that looked similar to selenium; and the final group received placebos of both supplements. Men who took selenium alone or vitamin E and selenium together were also more likely to develop prostate cancer than men who took a placebo, but those increases were small and possibly due to chance.

“SELECT has definitively shown a lack of benefit from vitamin E and selenium supplements in the prevention of prostate cancer and has shown there is the potential for harm,” said Lori Minasian, M.D., study co-author and acting director of NCI’s Division of Cancer Prevention. “Nevertheless, this type of research has been critically important to understanding the potential benefits and risks from supplements.”

SELECT researchers are now measuring the amount of vitamin E, selenium, and other nutrients in the blood of participants when they joined the trial, to see if the effect of the supplements depended upon this baseline level of micronutrient. Other researchers are looking at single nucleotide polymorphisms, which are DNA changes known as SNPs, to see if a change in one or more genes could affect cancer risk or perhaps increase a man’s risk of developing prostate cancer while taking vitamin E.

The participant samples come from the study biorepository of blood and toe nail clippings which, when coupled with the extensive clinical information on participants, is a vital resource for further study. “SWOG is soliciting proposals from researchers nationwide to use the SELECT biorepository to help answer the biological question of why vitamin E increased risk instead of decreasing it,” said Laurence Baker, D.O., study co-author and chairman of SWOG. “There are many more questions raised by these study results than we have answers for, and thus the need for further investigation.”

Except for skin cancer, prostate cancer is the most common type of cancer in men in the United States. The current lifetime risk of prostate cancer for American men is 16 percent. In 2011, there will be an estimated 240,890 new cases of prostate cancer and 33,720 deaths from this disease in the United States.

Reference: EA Klein, IM Thompson, CM Tangen, JJ Crowley, MS Lucia, PJ Goodman, L Minasian, LG Ford, HL Parnes, JM Gaziano, DD Karp, MM Lieber, PJ Walther, L Klotz, JK Parsons, JL Chin, A Darke, SM Lippman, GE Goodman, FL Meyskens, and LH Baker. Vitamin E and the Risk of Prostate Cancer: Results of The Selenium and Vitamin E Cancer Prevention Trial (SELECT). JAMA. October 12, 2011. 306(14) 1549-1556.

Tyk2 protein potential new Breast Cancer Therapy Target

New Rochelle, NY, October 5, 2011 — A possible new target for breast cancer therapy comes from the discovery that the Tyk2 protein helps suppress the growth and metastasis of breast tumors, as reported in Journal of Interferon & Cytokine Research, a peer-reviewed journal published by Mary Ann Liebert, Inc.

Qifang Zhang and Andrew Larner, Virginia Commonwealth University (Richmond, VA), and colleagues from VCU, Temple University School of Medicine (Philadelphia, PA), Jagiellonian University (Krakow, Poland), and Miyazaki University (Japan), present data demonstrating that mice lacking Tyk2 tyrosine kinase that are injected with breast cancer cells exhibit enhanced breast tumor growth and metastasis compared to mice with normal Tyk2 protein expression.

The authors conclude that altered Tyk2 expression affects the ability of the animals’ immune systems to respond to the tumor challenge. They present the evidence in the article entitled, “The Role of Tyk2 in Regulation of Breast Cancer Growth,” and they describe the role of Tyk2 in immunity-related biochemical signaling pathways.

“This study suggests that boosting Tyk2 activity may be beneficial for arresting breast tumor growth,” says Ganes C. Sen, PhD, Chairman, Department of Molecular Genetics, Cleveland Clinic Foundation and Co-Editor-in-Chief of Journal of Interferon & Cytokine Research.