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Neurosciences Clinical Trial Opportunities

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Alzheimer’s disease is not normal forgetfulness as we age. Instead, it is a specific form of mental decline. And according to the Alzheimer’s Association it accounts for nearly 80 percent all dementia cases. Natasa Dragicevic, MD, PhD., behavioral neurologist and Alzheimer’s disease specialist with Renown Institute for Neurosciences, weighs in on diagnosing it and the importance of early medical action. How to Diagnose Alzheimer’s Disease In general, the signs of Alzheimer’s disease occur slowly, getting worse over time. For example, forgetfulness is a daily search – for shoes, keys and other misplaced items. Not only is memory affected, but also speech patterns and behavior. There is no single test for Alzheimer’s disease. “Specifically, a neurologist should be the one to diagnose Alzheimer’s disease given differences in presentation,” clarifies Dr. Dragicevic. “And ideally a behavioral neurologist (Alzheimer’s sub-specialist) will be managing the treatment,” she adds. Brain Imaging Diagnosing Alzheimer’s disease involves multiple approaches and medical providers. In short, medical history is reviewed along with a physical exam, lab tests and other diagnostic testing. “A medical workup includes a variety of tests. These include MRI and other brain imaging, as well as neurological and psychological testing. Furthermore, a lumbar puncture is performed to look for markers of the disease,” she states. What Causes Alzheimer’s disease? Although no one knows the cause, researchers think many factors play a role. Uncontrollable risk factors include your genetics and having a family member with the disease. However, the controllable risk factors include: reducing the risk of head injury and keeping your heart healthy. It’s important to realize that high blood pressure, high cholesterol, stroke and diabetes play a role in brain health. Blood loss to the brain causes vascular dementia, leading to long-term blood vessel damage. Symptoms of Alzheimer’s disease Generally speaking, the signs of this disease differ in each person. Yet noticeable behaviors include: • Losing the way to familiar places • Forgetting to pay bills • Trouble finding the right words when talking • Repeating questions • General confusion • Social withdrawal Alzheimer’s Disease – Benefits of Early Diagnosis Equally important, spotting Alzheimer’s disease early allows more time to benefit from medications and possible clinical trials. Likewise, nutrition and exercise changes can be made, increasing blood flow to the body, and perhaps delaying symptoms. Early diagnosis also allows for personal health decisions and quality-of-life conversations to take place.   According to the Alzheimer’s Association, these benefits include: 1. Medical advantage 2. Emotional and social comfort 3. Time to plan ahead 4. Cost savings A Brain Supporting Lifestyle “At the present time, treatment is limited,” explains Dr. Dragicevic. “Usually Alzheimer’s is a progressive ongoing disease – any management at this time is purely symptomatic.” However, she states the following lifestyle changes can help support brain health: • New hobbies such as painting, pottery, music classes or learning a new language • Crosswords, puzzles and playing games, such as Scrabble • Brain challenging mobile apps, such as Luminosity • 30-45 minutes of mild to moderate physical activity per day, such as walking • Eating a Mediterranean diet (primarily plant based foods)

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While there used to be three basic treatment options for cancer -- surgery, radiation and chemotherapy, or a combination of the three -- there's a fourth option: clinical trials. Here, a Renown patient shares her successful battle with ovarian cancer, aided by a clinical trial. Shari Flamm's battle with ovarian cancer began in 2011. She was experiencing prolonged bleeding, irregular thyroid levels and anemia and was scheduled to undergo a hysterectomy. Before the surgery, her gynecologist ran routine tests to check for cancer as a precautionary measure. All tests were negative for cancer, expect her CA 125 test. A CA 125 test measures the amount of the protein CA 125 (cancer antigen 125) in the blood. In some cases, a CA 125 test may be used to look for early signs of ovarian cancer in women with a very high risk of the disease. In most laboratories, the normal level is 0 to 35 units/ml. Flamm's CA 125 level was 121. As Flamm can attest, early diagnosis played a key role in her battle with ovarian cancer. September is Gynecologic Cancer and Ovarian Cancer Awareness Month – an important time to learn the signs, symptoms and risk factors of this type of cancer so your doctor can diagnosis the disease as early as possible. Ovarian Cancer: Round One Despite the elevated CA 125 results, her doctor recommended they move forward with the hysterectomy. But when surgery began, doctors discovered a mass. She had stage 4 cancer. The procedure was halted, the mass was biopsied and she was immediately seen by Dr. Peter Lim of the The Center of Hope. Following diagnosis, Flamm underwent surgery with Dr. Lim to remove the cancer, which had spread to part of diaphragm, spleen, colon and other organs. Three months after surgery, Flamm had recovered enough to start six rounds of chemotherapy in her hometown of Carson City. She continued working at a doctor's office during her treatment, and was grateful for Dr. Lim’s ability to co-manage her care so she could stay close to work and family. “To me, chemo was the scariest part because I didn’t like feeling sick,” Flamm says. Thankfully, her body responded well to the treatments and she was back to the things she loved. “I stated working out at the gym, even if it was only for 10 minutes,” she says. She also stayed positive by spending time with her grandchildren, attending a San Jose Sharks hockey game, going for walks and enjoying concerts. Ovarian Cancer: Round Two In November 2014, Flamm had a cancer check-up. That’s when doctors discovered three cancerous tumors. For this round, Flamm choose another treatment option -- clinical trials at Renown Institute for Cancer. Clinical trials are the studies that test whether drugs work, and inform doctors' decisions about how to treat their patients. Flamm participated in a clinical trial that featured oral-targeted therapy stronger than IV chemotherapy. The hope was for the drug to shrink her tumors, however the result was stabilization -- meaning the lumps weren’t growing or spreading. The best part of the clinical trial, Flamm says, was the constant monitoring. Between the CT scans every six weeks, a heart scan every three months and monthly doctor visits, she was confident that if the cancer started growing or spreading, her healthcare team would catch it right away. For Flamm, the benefits of the clinical trial included less hair loss, less fatigue and more time to focus on what’s important in her life -- her family. “I decided I wasn’t going to be that sick grandma on the couch with cancer,” Flamm says. After taking the oral medication for one year, Flamm developed a rash and discontinued treatment due to discomfort. Clinical Trials, Setbacks and Survival In June 2016, two of the three tumors began to grow and had to be surgically removed. Despite the setback, Flamm was determined to maintain a positive outlook. "You have to stay positive because cancer feeds off anger, depression and stress," Flamm says. Flamm was released to go home with clear margins, meaning the tumors were removed and are surrounded by a rim of normal tissue that does not have cancerous cells. Flamm says her outlook on life has changed drastically since her first cancer diagnosis. “Your whole mentality changes when cancer disturbs your life," Flann says. "The things that weren’t important, are now ever so important. I’m a lot calmer now,” Flamm says.

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Excess amounts of sodium doesn’t just increase your risk of a heart attack, it can also increase your risk of a stroke. Unfortunately, avoiding that saltshaker may not be enough. Did you know that the average American consumes 3,400 milligrams of sodium each day? That’s a dangerous number considering that the American Heart Association recommends limiting daily sodium intake to 1,500 milligrams (about half the weight of a penny) to reduce the risk of heart disease and stroke. The problem is not necessarily that you’re putting too much salt on your food, it’s that salt is already in the foods you’re regularly eating. To help keep your sodium intake at a healthy level, make sure you’re aware of “The Salty Six,” six sneaky foods that are surprisingly high in sodium. Breads, Rolls and Tortillas: Although breads and tortillas may not initially appear to be high in sodium, we often consume several servings. Make sure to keep track of your total servings to see how they add up. Deli Meat, Cured Meats and Poultry: It may surprise you that six thin slices of deli meat can add up to more than half of your daily limit, so be mindful when building those sandwiches. Also, do your best to avoid cured meats, which often means the meat has been salted. Substitute uncured, skinless meats instead. Cheese: Salt is an important addition in the cheese-making process, as it prevents bacterial growth. Unfortunately, that added salt can increase your health risks. Limit the amount of cheese you add to meals to keep your sodium content down. Pizza: Take a quick look at the first three items above and it should be no surprise as to why pizza made the list. One slice and you’ve met at least half of your daily limit. Go easy on the cheese and try adding more veggies instead of meat. Canned Soup: One cup of canned soup can be as high as nearly 1,000 milligrams of sodium. When shopping for canned soup it’s important to check the label – not just on sodium content but serving size as well. Always select low-sodium options when possible or cook your own soup at home. Sandwiches and Burgers: A sandwich or burger from your favorite restaurant can contain more than 100 percent of your daily sodium limit. When dining out, it is best to select low-sodium options or eat a half portion to limit the amount of salt. If some of your favorite foods are on this Salty Six list, don’t panic. Although these foods can be high in sodium, it isn’t necessary to cut these foods out of your diet completely. It’s just important to eat them in moderation and be mindful of your daily sodium intake. Look for low-sodium options, use herbs and spices instead of table salt and do your best to stay under the recommended daily limit of 1,500 milligrams.”

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Participating in a clinical trial is voluntary and a personal choice. Clinical trials are research studies that involve people and are an important part of patient care. What is a clinical trial?  Clinical trials are research studies that involve people, and they are an important part of patient care. There are several different types of clinical trials; some are designed to understand trends in a disease or identify better ways to diagnose a condition, while others determine if a new treatment is safe and works when treating, improving or preventing a health condition. There are over 400,000 clinical trials currently being conducted in the United States, and even more across the world. This includes health conditions such as heart failure, cancer, Parkinson’s Disease, respiratory conditions like COPD, common infections, cystic fibrosis, and many more. Clinical trials lead the healthcare industry to new discoveries that contribute to reliable and exact care, improving healthcare quality and saving lives. Clinical trials are conducted by a team of researchers, including doctors, pharmacists and clinical research coordinators. These research teams are highly skilled in their specialty areas, often providing traditional patient care and seeing research patients in the same day. These teams are responsible for making sure the clinical trial is completed correctly, and their patients are their top priority. Why should I consider participating in a clinical trial? Participating in a clinical trial is voluntary and a personal choice. There are many reasons why patients decide to get involved in clinical research. While many clinical trials are designed for patients who have a certain health condition, many studies also ask healthy volunteers to contribute in order to compare health outcomes. Clinical trials are also for patients at all different stages of their diagnosis. Depending on the specific study, the patient may receive access to a new cutting-edge treatment before it is widely available. When patients join a clinical trial, the research team becomes a health partner dedicated to their health and well-being. When patients join a clinical trial, they make an informed decision in their healthcare by weighing all available options in addition to routine treatments. Research participants know that they are contributing meaningfully and helping other patients like them. Where can I find more information about clinical trials at Renown Health? Renown Health’s mission is to make a genuine difference in the health and well-being of the communities we serve. Renown’s clinical trial portfolio offers leading care options to patients in northern Nevada, close to home, in a variety of specialties. Contact the Renown Clinical Research Office for more information on clinical trials available to you!

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Michael Millman was all set to move to Reno from the Bay Area when he noticed a pimple-like growth on his forehead, and he decided to get biopsied "just in case." It was July 2020, less than six months into the COVID-19 pandemic, when Michael got the call that the biopsy came back cancerous. He was in shock. Still living in the Bay Area at the time, he immediately scheduled to have the basal cell carcinoma removed in August. After the removal, he thought he was in the clear, but a few months later, Michael noticed that his lymph nodes felt weird, and he even cut himself shaving because of some persistent swelling in the area. Given his recent history of skin cancer, Michael immediately scheduled an appointment with a specialist in the Bay Area. "I met with an ear, nose and throat doctor who suggested a fine needle biopsy of my lymph nodes, tongue and an MRI, both with and without contrast," Michael said. "I remember feeling dreadful and that I couldn't believe this was happening yet again." A Hard Decision Michael's squamous cell carcinoma, determined by the pathology report to be significantly influenced by the HPV virus, had metastasized to his lymph nodes on both sides of his neck, and his doctor said it could be stage four cancer. He remembers feeling like he was in quicksand, unsure if he should follow through with his move to Reno, or stay in the Bay Area for treatment. By now, it was early December 2020, and hospitals in the Bay Area and across the world were at limited capacity due to COVID-19. But, in what Michael describes as a positive twist of fate, the San Francisco ear, nose and throat provider he had seen about his biopsy results mentioned that he knew many providers in the oncology department at Renown, including Abhinand Peddada, MD. The San Francisco provider called Dr. Peddada's office with a referral, and Michael even remembers that Renown called him to hear more about his diagnosis before he even got the chance to call them "To be honest, I was feeling shut out in the Bay Area, and Dr. Peddada said he could help me expedite the treatment process," Michael said. "I finally felt a sense of relief." And so began Michael's 7-week chemoradiation cancer treatment program at Renown.

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There are many misconceptions about clinical research, so we have unpacked a few common myths we hear to help you make an informed decision in your healthcare. Misconception #1: If I join a clinical trial, I’ll just be a guinea pig. Quite the opposite is true! Through honest and respectful conversation, we ensure all participants are informed of the benefits and risks associated with the clinical trial during the informed consent process. Being in a clinical trial is voluntary, and we respect our patients’ decision to join or decline to participate in the clinical trial. You can always change your mind at any time as well. When patients join a clinical trial, they receive an additional team of healthcare professionals, including additional physicians, pharmacists and research coordinators, dedicated to their safety and well-being. This means that clinical trial participants often receive more support than they would in the standard treatment setting. Misconception #2: Clinical trials are too dangerous because they use new treatments that haven’t been tested. We recognize that there are different levels of risk associated with participating in a clinical trial depending on the type of study. However, new treatments are only reviewed through clinical trials after they have gone through extensive testing. New treatments that do not show promising results for safety and potential benefit during laboratory testing do not receive approval to begin clinical trials. Your research team reviews any expected benefits and risks identified from previous studies during the informed consent process, as well as any updates that occur throughout the duration of the clinical trial. The research team stays in close contact with you during the entire process, documenting and treating any side effects that you experience for both your safety and the safety of participants like you. Misconception #3: I don't want to join a trial because I could be wasting my time receiving a placebo. A placebo is a substance that has no therapeutic effect, sometimes called a “sugar pill.” Participants who receive a placebo during a clinical trial are very important, helping researchers definitively determine the specific good and bad effects of the new medication. Many clinical trials that involve a placebo also offer what is called an open label extension or cross-over study. Cross-over studies ensure that anyone taking the placebo can begin receiving the new medication, often for several years. Cross-over studies help clinician researchers understand the long-term effects of a medication while also giving patients free access to novel care for several months and even years.

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The University of Nevada, Reno School of Medicine (UNR Med) and Renown Health affiliated in June of 2021. First Integrated Health System The University of Nevada, Reno School of Medicine (UNR Med) and Renown Health affiliated in June of 2021. This agreement established Nevada’s first integrated health system with missions in education, patient care, and clinical research. While there was extensive media coverage regarding the historic partnership in general, there is less information regarding the important impact to the community. In terms of clinical research, the potential benefits are endless. The School of Medicine has a very successful program in molecular bio sciences. That means they have a plethora of brilliant minds working on the smallest components of life related to body systems and disease. With the affiliation, there is a distinct opportunity to bridge some of these important findings happening on campus and translate them into care protocols for the patients seen in the community. Making connections between the cellular basics to the physical manifestations of conditions is a key opportunity of the affiliation. Additionally, cooperative funding models for projects that fit in the translational research bucket are available to these researchers. Renown and UNR Med are poised to provide potentially cutting-edge treatments with bench to bedside research. Expanding Clinical Trials Perhaps the most important outcome of the affiliation is access to novel treatments via clinical trials. In the coming years, Renown and UNR Med will work to expand their clinical trial portfolio in an effort to provide a clinical trial option for many diseases in addition to standard of care. This endeavor will allow patients to make an informed choice about their healthcare. With novel treatments available right here in Reno, people won’t have to travel to other research institutions for similar care. This eases a tremendous potential burden on patients and families alike navigating complex illnesses like cancer. The affiliation is exciting and provides many opportunities for clinicians (present and future) and the community. Renown's Clinical Research Office is thrilled to be a part of this historic time and are enthusiastic to communicate our successes and opportunities to the community. We sincerely look forward to contributing to the vision of “a healthy Nevada.”

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Renown Health, the region's leading cardiology care provider, is offering a clinical trial for eligible patients struggling to control their high blood pressure. Nearly half of adults (119.9 million) in the United States have hypertension, or blood pressure that is higher than normal. Hypertension can put you at risk of other life-threatening disease, such as a heart attack or stroke. There are methods that cardiologists use to manage high blood pressure, but only 1 in 4 adults with hypertension (27.0 million) have their blood pressure under control.* Some patients with high blood pressure experience resistant hypertension, which does not respond well to multiple antihypertensive medications given at the same time. This means that there are many important opportunities for healthcare professionals to explore new ways to treat hypertension.  At Renown Health, we lead the region in cardiology care with our technological expertise and patient-centered approach. That is why our cardiology team is partnering with the Renown Research Office to offer the RADIANCE Continued Access Protocol (RADIENCE CAP) clinical trial to eligible patients. RADIANCE CAP is a non-randomized study designed to allow for continued access to ultrasound renal denervation therapy via the Paradise System, and to allow for the on-going collection of safety and effectiveness data in patients with uncontrolled hypertension despite the prescription of antihypertensive medications. The body’s complex communication system between the brain, heart and kidneys can sometimes become overactive, increasing your blood pressure through messages in the nervous system. Renal denervation is a minimally-invasive procedure which reduces activity from the nerves in your kidneys to lower blood pressure.  This is the third in a series of renal denervation clinical trials Renown Health has offered to patients with resistant hypertension over the last several years, with over 40 local participants.  “All the participants that I have had the pleasure to work with on these studies are very excited and grateful to have this option for helping control their blood pressure” states Lisa English, Lead Clinical Research Coordinator for Cardiology studies at Renown Health. “I love getting to know each one of them and helping on their healthcare journey. We have an amazing team of providers and staff at Renown that go out of their way to make patients experiences positive and the studies successful.” Dr. Michael Bloch, Cardiologist and Principal Investigator for the RADIANCE CAP study at Renown Health’s Institute for Heart and Vascular Health adds, “Despite lifestyle modifications like diet and exercise and the widespread availability of effective and well-tolerated medications, approximately 50% of all people with hypertension have inadequate blood pressure control putting them at risk for stroke, heart failure and kidney disease. As a one-time durable procedure, renal denervation with the Paradise endovascular system from ReCor Medical, Inc. may help millions of patients improve their blood pressure control without necessarily needing to increase their medications.” Our teams of expert providers and researchers are here to support you on your healthcare journey. Talk to your provider about the RADIANCE CAP clinical trial at your next appointment to see if participation may be right for you.

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