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News Article | May 10, 2017
Site: www.eurekalert.org

Robert Bush has multiple sclerosis (MS), which sapped his ability to walk five years ago. Joseph McGlynn suffered a stroke that seriously impaired his left side, also five years ago. Using technology designed by Case Western Reserve University and the Advanced Platform Technology and Functional Electrical Stimulation centers at the Louis Stokes Cleveland Veterans Affairs Medical Center, the two men got their feet back under them. Two studies, published in the American Journal of Physical Medicine and Rehabilitation, show that functional electrical stimulation (FES) significantly helped McGlynn and Bush to effectively walk at the medical center. "I went in there and I could barely take two steps," said Bush, 42, who researchers believe is the world's first MS patient to "test-drive" an implanted FES system. The proof-of-feasibility test lasted 90 days. "At the end," said Bush, of Columbus, Ohio, "I was walking down the hallway. To me, it was monumental." A video of him walking with and without the system can be found at: https:/ . McGlynn, 69, of North Royalton, Ohio, could walk with a cane, but not easily. With the technology switched on, he covered far more ground and his pace was twice as fast during his 30-week study. "It's helped with balance and confidence," said McGlynn, who used to tread a lot of stairs maintaining equipment at a steel plant. "I'm confident now that I can walk without stumbling and falling." A video of him walking with and without aid of the system can be found here: https:/ . Nathan Makowski, an investigator at the Cleveland FES Center, created by Case Western Reserve and the Cleveland VA, said that FES technology has been used primarily for therapy in stroke patients in the past. "This, though, is a more long-term assistive system," he said. The researchers hope these studies will lay the foundation for implanted systems that restore some independence to people with MS or who have suffered a stroke. Their numbers are substantial. The National Multiple Sclerosis Society estimates that more than 2.3 million people have the disease worldwide. Surveys have found that 93 percent suffer gait impairment within 10 years of diagnosis and 13 percent report they are unable to walk twice a week. Other research has found that 6 million to 7 million people live with stroke nationally and nearly 30 percent require assistance to walk. "In both cases, there is a disconnect between the brain and muscles," said Stephen Selkirk, MD, a neurologist at the VA's Spinal Cord Injury Division and assistant professor of neurology at Case Western Reserve School of Medicine. "This system replaces the lost connection." The system includes implanted electrodes that tie into nerves that control muscles collectively, called hip and knee flexors and ankle dorsoflexors. In healthy people, the muscles work in seamless coordination each step they take. When Bush or McGlynn walks, he pushes a button on an external controller, which sends signals to a pulse generator, which then sends electrical pulses to the electrodes. The pulses stimulate the nerves, which in turn stimulate the muscles in both of Bush's legs and McGlynn's left leg. "Both guys were taking steps the first time we turned the systems on," said Ron Triolo, a professor of orthopaedics and biomedical engineering at Case Western Reserve and executive director of the Advanced Platform Technology (APT) Center. "When Robert Bush took a step, it wasn't' pretty, but we saw the potential." In each patient, "the pulses are sent in a pattern that is close to how normal muscles work," said Rudi Kobetic, a principal investigator at the Stokes Cleveland VA and APT Center. "We try to time the pattern to stimulation so that it's integrated with their ability. Similar to regular physical therapy, we can see results." Both men gained strength and endurance through repeated use of the systems and fine-tuning by the researchers. Bush went from the two steps to consistently walking more than 30 yards during the trial. In that time, he used a walker to help maintain his balance. "When they turned it on the first time, I was surprised how well it worked," said Bush, who had to give up his construction career due to the disease. "I lifted my knee like I was high-stepping. Once we got it fine-tuned and I got walking, I thought it was amazing. I still think it's amazing." McGlynn's gait became noticeably more symmetrical and energetic, the researchers said. His gait without the system was about 19 yards per minute; with the system, 47 yards per minute. Training with the system improved McGlynn's speed when it was turned off to 23 yards per minute, indicating therapeutic benefit. "Distance is a challenge," he said. Initially, he could walk 83 yards but improved to 1,550 yards--nearly a mile--at the faster gait. "I work up a good sweat and that makes me feel good," he said. Due to his improvements, the research team is developing a system that McGlynn can use at home and outside. "I'll be able to walk for exercise and hopefully be able to walk into church and into a restaurant," McGlynn said. When Bush's trial ended, surgeons removed his implanted electrodes. The researchers are seeking funding to fit him with a permanent FES system in a clinical trial. In the meantime, Bush is now back to using a wheelchair but working to maintain his strength and flexibility, repeatedly standing and sitting while holding onto a rail or standing for long periods of time. "I'm keeping things ready for when they get the green light," he said. Other researchers who contributed to the two studies are the APT Center's Lisa Lombardo, physical therapist; Kevin Foglyano, biomedical engineer; and Gilles Pinault, MD, a surgeon and co-director of the center.


News Article | May 11, 2017
Site: www.biosciencetechnology.com

Robert Bush has multiple sclerosis (MS), which sapped his ability to walk five years ago. Joseph McGlynn suffered a stroke that seriously impaired his left side, also five years ago. Using technology designed by Case Western Reserve University and the Advanced Platform Technology and Functional Electrical Stimulation centers at the Louis Stokes Cleveland Veterans Affairs Medical Center, the two men got their feet back under them. Two studies, published in the American Journal of Physical Medicine and Rehabilitation, show that functional electrical stimulation (FES) significantly helped McGlynn and Bush to effectively walk at the medical center. "I went in there and I could barely take two steps," said Bush, 42, who researchers believe is the world's first MS patient to "test-drive" an implanted FES system. The proof-of-feasibility test lasted 90 days. "At the end," said Bush, of Columbus, Ohio, "I was walking down the hallway. To me, it was monumental." A video of him walking with and without the system can be found here. McGlynn, 69, of North Royalton, Ohio, could walk with a cane, but not easily. With the technology switched on, he covered far more ground and his pace was twice as fast during his 30-week study. "It's helped with balance and confidence," said McGlynn, who used to tread a lot of stairs maintaining equipment at a steel plant. "I'm confident now that I can walk without stumbling and falling." A video of him walking with and without aid of the system can be found here. Nathan Makowski, an investigator at the Cleveland FES Center, created by Case Western Reserve and the Cleveland VA, said that FES technology has been used primarily for therapy in stroke patients in the past. "This, though, is a more long-term assistive system," he said. The researchers hope these studies will lay the foundation for implanted systems that restore some independence to people with MS or who have suffered a stroke. Their numbers are substantial. The National Multiple Sclerosis Society estimates that more than 2.3 million people have the disease worldwide. Surveys have found that 93 percent suffer gait impairment within 10 years of diagnosis and 13 percent report they are unable to walk twice a week. Other research has found that 6 million to 7 million people live with stroke nationally and nearly 30 percent require assistance to walk. "In both cases, there is a disconnect between the brain and muscles," said Stephen Selkirk, MD, a neurologist at the VA's Spinal Cord Injury Division and assistant professor of neurology at Case Western Reserve School of Medicine. "This system replaces the lost connection." The system includes implanted electrodes that tie into nerves that control muscles collectively, called hip and knee flexors and ankle dorsoflexors. In healthy people, the muscles work in seamless coordination each step they take. When Bush or McGlynn walks, he pushes a button on an external controller, which sends signals to a pulse generator, which then sends electrical pulses to the electrodes. The pulses stimulate the nerves, which in turn stimulate the muscles in both of Bush's legs and McGlynn's left leg. "Both guys were taking steps the first time we turned the systems on," said Ron Triolo, a professor of orthopaedics and biomedical engineering at Case Western Reserve and executive director of the Advanced Platform Technology (APT) Center. "When Robert Bush took a step, it wasn't' pretty, but we saw the potential." In each patient, "the pulses are sent in a pattern that is close to how normal muscles work," said Rudi Kobetic, a principal investigator at the Stokes Cleveland VA and APT Center. "We try to time the pattern to stimulation so that it's integrated with their ability. Similar to regular physical therapy, we can see results." Both men gained strength and endurance through repeated use of the systems and fine-tuning by the researchers. Bush went from the two steps to consistently walking more than 30 yards during the trial. In that time, he used a walker to help maintain his balance. "When they turned it on the first time, I was surprised how well it worked," said Bush, who had to give up his construction career due to the disease. "I lifted my knee like I was high-stepping. Once we got it fine-tuned and I got walking, I thought it was amazing. I still think it's amazing." McGlynn's gait became noticeably more symmetrical and energetic, the researchers said. His gait without the system was about 19 yards per minute; with the system, 47 yards per minute. Training with the system improved McGlynn's speed when it was turned off to 23 yards per minute, indicating therapeutic benefit. "Distance is a challenge," he said. Initially, he could walk 83 yards but improved to 1,550 yards--nearly a mile--at the faster gait. "I work up a good sweat and that makes me feel good," he said. Due to his improvements, the research team is developing a system that McGlynn can use at home and outside. "I'll be able to walk for exercise and hopefully be able to walk into church and into a restaurant," McGlynn said. When Bush's trial ended, surgeons removed his implanted electrodes. The researchers are seeking funding to fit him with a permanent FES system in a clinical trial. In the meantime, Bush is now back to using a wheelchair but working to maintain his strength and flexibility, repeatedly standing and sitting while holding onto a rail or standing for long periods of time. "I'm keeping things ready for when they get the green light," he said.


Wright J.T.,Case Western Reserve University | Williamson J.D.,Sticht Center on Aging | Whelton P.K.,Tulane University | Snyder J.K.,U.S. National Institutes of Health | And 12 more authors.
New England Journal of Medicine | Year: 2015

BACKGROUND The most appropriate targets for systolic blood pressure to reduce cardiovascular morbidity and mortality among persons without diabetes remain uncertain. METHODS We randomly assigned 9361 persons with a systolic blood pressure of 130 mm Hg or higher and an increased cardiovascular risk, but without diabetes, to a systolic blood-pressure target of less than 120 mm Hg (intensive treatment) or a target of less than 140 mm Hg (standard treatment). The primary composite outcome was myocardial infarction, other acute coronary syndromes, stroke, heart failure, or death from cardiovascular causes. RESULTS At 1 year, the mean systolic blood pressure was 121.4 mm Hg in the intensivetreatment group and 136.2 mm Hg in the standard-treatment group. The intervention was stopped early after a median follow-up of 3.26 years owing to a significantly lower rate of the primary composite outcome in the intensive-treatment group than in the standard-treatment group (1.65% per year vs. 2.19% per year; hazard ratio with intensive treatment, 0.75; 95% confidence interval [CI], 0.64 to 0.89; P<0.001). All-cause mortality was also significantly lower in the intensivetreatment group (hazard ratio, 0.73; 95% CI, 0.60 to 0.90; P = 0.003). Rates of serious adverse events of hypotension, syncope, electrolyte abnormalities, and acute kidney injury or failure, but not of injurious falls, were higher in the intensivetreatment group than in the standard-treatment group. CONCLUSIONS Among patients at high risk for cardiovascular events but without diabetes, targeting a systolic blood pressure of less than 120 mm Hg, as compared with less than 140 mm Hg, resulted in lower rates of fatal and nonfatal major cardiovascular events and death from any cause, although significantly higher rates of some adverse events were observed in the intensive-treatment group. © 2015 Massachusetts Medical Society.


Morgan R.L.,Centers for Disease Control and Prevention | Baack B.,Centers for Disease Control and Prevention | Smith B.D.,Centers for Disease Control and Prevention | Yartel A.,Centers for Disease Control and Prevention | And 2 more authors.
Annals of Internal Medicine | Year: 2013

Background: Hepatitis C virus (HCV) is a leading cause of hepatocellular carcinoma (HCC). In the United States, this form of cancer occurs in approximately 15 000 persons annually. A systematic review of the evidence is needed to assess the benefits of treatment of HCV-infected persons on development of HCC. Purpose: To systematically review observational studies to determine the association between response to HCV therapy and development of HCC among persons at any stage of fibrosis and those with advanced liver disease. Data Sources: MEDLINE, EMBASE, CINAHL, the Cochrane Library, Web of Science, and the Database of Abstracts of Reviews and Effectiveness from inception through February 2012. Study Selection: English-language observational studies that compared therapy-derived sustained virologic response (SVR) with no response to therapy among HCV-infected persons, targeted an adult population, and had an average follow-up of at least 2 years. Data Extraction: Two investigators independently extracted data into uniform relative risk measures. The Grading of Recommendations Assessment, Development and Evaluation framework was used to determine the quality of the evidence. Data Synthesis: Thirty studies fulfilled the inclusion criteria, and 18 provided adjusted effect estimates that were used to calculate pooled relative risks. Among HCV-infected persons, SVR was associated with reduced risk for HCC (relative risk for all persons, 0.24 [95% CI, 0.18 to 0.31], moderate-quality evidence; advanced liver disease hazard ratio, 0.23 [CI, 0.16 to 0.35], moderate-quality evidence). Limitation: In the meta-analyses, some variables could not be controlled for because of the observational design of the included studies. Conclusion: Sustained virologic response after treatment among HCV-infected persons at any stage of fibrosis is associated with reduced HCC. The evidence was determined to be of moderate quality.


Roncone D.P.,Louis Stokes Cleveland Veterans Affairs Medical Center
Optometry | Year: 2011

Background: Keratoectasia is a rare but well-known complication after laser-assisted in situ keratomileusis (LASIK). Patients with this condition can have high and irregular astigmatism. When the treatment of the high astigmatic correction cannot be accomplished surgically or when the keratoectasia patient rejects surgical enhancement, optical correction with devices such as soft or rigid gas-permeable contact lenses may be pursued. In fact, toric soft contact lenses are a good first option for fitting postoperative keratoectasia patients. Case report: A 58-year-old white male presented for an examination with a complaint of decreased distance vision in the right eye (OD) after having traditional LASIK for myopia with astigmatism in both eyes (OU) in 1999 and limbal relaxing incision enhancement OD in 2003. Refraction showed high mixed astigmatism OD (+1.75 -5.75×075). Slit lamp examination found irregularity of the cornea, evidenced by an inferior cone with pigmented Fleischer ring OD. Video keratometry had keratometry readings of 43.50 at 160, 39.87 at 070, elevated shape measure (0.40), elevated corneal irregularity measure (3.96), an inferior cone on the elevation map, and asymmetric bowtie with elongation inferonasally on the axial map, which confirmed the diagnosis of postoperative keratoectasia. Because new surgical treatments at that time for corneal ectasia were in their infancy and not approved by the U.S. Food and Drug Administration, the patient opted for a trial toric soft contact lens fitting, which improved his corrected distance visual acuity to 20/25. Conclusion: This case report confirms that toric soft contact lenses are a good first choice in fitting patients with high and irregular astigmatism from postoperative LASIK corneal ectasia. It also confirms that excellent vision and comfort with toric soft contact lenses is possible in these patients. © 2011.


Donskey C.J.,Louis Stokes Cleveland Veterans Affairs Medical Center | Kundrapu S.,Case Western Reserve University | Deshpande A.,Cleveland Clinic
Infectious Disease Clinics of North America | Year: 2015

Asymptomatic carriage of toxigenic strains of Clostridium difficile is common in health care facilities and the community. However, infection control efforts have traditionally focused almost entirely on symptomatic patients. There is now growing concern that asymptomatic carriers may be an underappreciated source of transmission. This article provides an overview of the pathogenesis and epidemiology of C difficile colonization, reviews the evidence that asymptomatic carriers shed spores and contribute to transmission, and examines practical issues related to prevention of transmission from carriers. © 2015.


Iacopetti C.L.,Case Western Reserve University | Packer C.D.,Louis Stokes Cleveland Veterans Affairs Medical Center
Clinical Medicine and Research | Year: 2014

Cannabis is the most widely used illicit drug in the United States, with lifetime prevalence of use estimated at 42% to 46%. The antiemetic properties of cannabis are well-known by the medical community and the general public; however, less well-recognized is the paradoxical potential for certain chronic users to develop hyperemesis. We describe in this case a patient with prior extensive work-up for nausea and vomiting and previous diagnosis of cyclic vomiting syndrome who presented with characteristic features of cannabinoid hyperemesis syndrome. We review the current literature for this condition and highlight potential mechanisms for its pathogenesis. © 2014 Marshfield Clinic.


Jain M.K.,Case Western Reserve University | Sangwung P.,Case Western Reserve University | Hamik A.,Case Western Reserve University | Hamik A.,Louis Stokes Cleveland Veterans Affairs Medical Center
Arteriosclerosis, Thrombosis, and Vascular Biology | Year: 2014

This invited review summarizes work presented in the Russell Ross lecture delivered at the 2012 proceedings of the American Heart Association. We begin with a brief overview of the structural, cellular, and molecular biology of Krüppel-like factors. We then focus on discoveries during the past decade, implicating Krüppel-like factors as key determinants of vascular cell function in atherosclerotic vascular disease. © 2013 American Heart Association, Inc.


Chee C.E.,Case Western Reserve University | Chee C.E.,Louis Stokes Cleveland Veterans Affairs Medical Center | Meropol N.J.,Case Western Reserve University
Oncologist | Year: 2014

The decision regarding adjuvant therapy for patients with stage II colon cancer remains a challenge. In contrast to stage III colon cancer, for which compelling clinical data support the use of adjuvant chemotherapy, the clinical benefit of systemic therapy in unselected patients with stage II disease is modest at best. Risk stratification based on clinicopathologic features and DNA mismatch repair status is commonly used in adjuvant therapy decisions, but these factors do not have a desired level of precision in identifying patients at high risk. Recently, gene expression platforms have been developed to further define risk and to assist in therapeutic decision making for patients with stage II disease. This review describes those platforms that are furthest along in clinical development, in an effort to place their potential clinical application in context. © AlphaMed Press 2014.


Naylor M.D.,University of Pennsylvania | Aiken L.H.,University of Pennsylvania | Kurtzman E.T.,George Washington University | Olds D.M.,Louis Stokes Cleveland Veterans Affairs Medical Center | Hirschman K.B.,University of Pennsylvania
Health Affairs | Year: 2011

Under the Affordable Care Act of 2010, a variety of transitional care programs and services have been established to improve quality and reduce costs. These programs help hospitalized patients with complex chronic conditions-often the most vulnerable-transfer in a safe and timely manner from one level of care to another or from one type of care setting to another. We conducted a systematic review of the research literature and summarized twenty-one randomized clinical trials of transitional care interventions targeting chronically ill adults. We identified nine interventions that demonstrated positive effects on measures related to hospital readmissions-a key focus of health reform. Most of the interventions led to reductions in readmissions through at least thirty days after discharge. Many of the successful interventions shared similar features, such as assigning a nurse as the clinical manager or leader of care and including in-person home visits to discharged patients. Based on these findings, we recommend several strategies to guide the implementation of transitional care under the Affordable Care Act, such as encouraging the adoption of the most effective interventions through such programs as the Community-Based Care Transitions Program and Medicare shared savings and payment bundling experiments. © 2011 by Project HOPE - The People-to-People Health Foundation, Inc.

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