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Neurosciences Clinical Trial Opportunities

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It seemed like a normal Wednesday, except Kimi Woolsey was feeling really stressed. On Sept. 4, 2019 she was rushing to get ready for an appointment when suddenly, she could not feel her legs. Kimi immediately knew something was wrong and called out to her fiancé, Paul, for help. After seeing a bright light in her right eye, she felt a severe, sharp pain in her head traveling down into her leg. Paul quickly called 911, the EMT’s arrived and her stroke survival journey began. At first the medical team thought she had a complicated migraine, but one of them suspected a stroke. On the way to the hospital Kimi felt numbness and her face drooping, then instantly, no pain. For a moment she thought she was dying, going from pain to numbness and realizing she couldn’t move or speak. Kimi didn’t know she was having another massive stroke in transit. Each year nearly 800,000 people in the U.S. suffer a stroke, or “brain attack” – that’s one every 40 seconds. Of those, about 75% occur in people over age 65. However, at only 45 years old, Kimi is proof that a stroke can happen at any age. Stroke Survival Begins for Kimi Upon arriving at the emergency department of Renown Regional Medical Center the Certified Comprehensive Stroke Center team went into action. Kimi received a brain MRI, then was wheeled into surgery for a thrombectomy (clot removal). She was in the intensive care unit for 11 days. She remembers someone telling her, “Generally people don’t survive this magnitude of stroke.” And a doctor saying, “You are here for a reason.” Kimi’s comeback journey began with the comprehensive care team at Renown Rehabilitation Hospital. “Literally I had the best day of my life that first day there…I was so happy because I couldn’t imagine being in a safer place with people that literally live for you,” she recalls. During her 41 days there, her biggest milestone was being able to get out of bed and walk. For Kimi the support she felt at the rehab hospital was key to her progress, ”I still feel loved and appreciated and they’re rooting for me still and I can feel it.” Although she left the rehab hospital on Oct. 18, 2019, she is still working on improving the left side of her body. Currently Kimi works with therapists in outpatient physical rehabilitation sessions, continuing to see improvement in both her hand and leg. Her advice to those currently in a rehab hospital setting is, “Stay as long as you can to get the most out of it and push, push, push.” Kimi’s Stroke Survival as a Warrior “Having a stroke is not for the faint of heart,” says Kimi. She experienced despair and felt discouraged. Many days she would ask herself, “Why am I here?” Today she proudly calls herself a stroke warrior and refuses to be a victim of her stroke. Alongside her tenacious spirit, Kimi actively helps others on their stroke survival journey. Before her stroke she never dreamed of starting a non-profit foundation. Now, each day you’ll find her texting inspiration to others, offering advice and connecting with other struggling stroke survivors on her Facebook page, Stroke Warrior Recovery Coach. Her goal is to become the person she needed to talk to after her stroke; she currently coaches several stroke survivors. “Stroke survivors need to know that they aren’t alone. Mental support and encouragement are so important for each person’s stroke journey,” Kimi said. Along with the physical changes, Kimi feels the stroke magnified her empathy. “I was always in a hurry in my life. People didn’t go fast enough for me – on the road, at the grocery store, in a line. Now I have more patience with myself and others." Kimi realizes most people cannot wrap their brain around the concept of a stroke. In fact, the brain fog, physical challenges and frustration are hard to explain… unless you’ve experienced them. “You need to find your tribe,” she explains. “I have a passion for helping people through this process.” Most of all, she encourages people to keep going and never stop. After her stroke, Kimi has a greater appreciation for her family, health and life. She is one of the patients featured in the current “Fight The Good Fight” trauma and physical rehab advertising campaign. “I wake up every day and fight,” she asserts. “Each day you have to fight for your recovery and fight for yourself.”

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Stroke is unfortunately common, with 1 in 5 American women experiencing it each year. When it comes to a stroke the phrase “time is brain” speaks to the urgency of getting rapid care. In fact, a woman may lose nearly 2 million neurons per minute of oxygen loss to the brain. The Renown Health Comprehensive Stroke Center experts share the importance of timely treatment and how stroke symptoms can differ in women. Women and Stroke – Surprising Symptoms  Each year stroke affects more women than men. Even more concerning, women are less likely to recover from a stroke. The following non-traditional, less common, warning signs can be common in women: Hiccups with chest pain Sudden disorientation, drowsiness, confusion or a general altered mental status Nausea or vomiting A sudden headache that feels like the ‘worst headache of your life’ Unusual chest pain (especially with hiccups) Body numbness or weakness, such as an arm or leg suddenly ‘falling asleep’ Fainting or loss of consciousness Stroke Diagnosis The first step is neuroimaging by CT scan. This allows for rapid identification of any bleed, and also assists in determining candidacy for the early clot busting medication. MRI brain imaging is much higher resolution, and can better determine the core stroke size, assisting in prognosis and recovery. Since strokes have several different origins, an inpatient workup is essential to determine the underlying cause. Whether the stroke is secondary to plaque in the large vessels, clots being thrown in the setting of atrial fibrillation (an abnormal heart rhythm), or small vessel disease from years of uncontrolled vascular risk factors (high blood pressure, smoking, high cholesterol, diabetes), determining the cause is essential to implementing a management plan to reduce risk for further strokes. Quick Treatment for Stroke is Key Early recognition of stroke symptoms and seeking prompt attention is paramount. There are interventions that can be instituted to minimize the stroke and increase likelihood of recovery, but only if a patient presents to the hospital early. A clot busting medication, called tPA, can be given to patients with stroke if given within 4-5 hours from time of onset. Renown Regional Health Center is designated as a Comprehensive Stroke Center, the highest level of stroke certification available. To earn the designation of comprehensive stroke center, a hospital has to meet stringent requirements, including biannual on-site evaluations. This includes care for ischemic stroke patients (lack of blood flow), hemorrhagic stroke patients (bleeds), and determining the underlying cause to guide secondary stroke management prevention. Stroke Symptoms Remember “B.E.F.A.S.T.” to recognize the symptoms of a stroke below: B – Balance Being off balance or dizzy, is common. E – Eyes An eyesight change such as blurring or double vision may occur. F – Face droop One side of the face, or lip, droops A – Arm weakness Does one arm drift down? S – Speech Talking may slur or sound strange. T – Time Time to call 911. Call an ambulance immediately if you or anyone else, experiences any of these symptoms.

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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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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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Did you know an estimated 1.9 million neurons and 14 billion synapses are lost per minute during a stroke? That’s why every second counts. Anyone can have a stroke, but your chances increase if you have certain risk factors. That’s why the best way to protect yourself or your loved ones from a stroke is to know the risks and how to manage them. You can make changes to your lifestyle to lower your risk of stroke by asking yourself the following questions: 1. Is my blood pressure normal? High blood pressure is the leading cause of stroke and the most important controllable risk factor. If you’ve had a stroke, lowering your blood pressure can help prevent future strokes. 2. Can I quit smoking? Smoking damages blood vessels, clogs arteries and raises blood pressure — doubling your risk of stroke. If you want to reduce your risk of stroke and heart attack, quitting smoking is the first step — and Renown can help you with this. Learn more: Renown Health Quit Tobacco Program. 3. Do I make time to exercise 30 minutes a day? Many studies link consistent exercise habits with lower stroke risk. Also, being overweight contributes to high cholesterol, high blood pressure, heart disease and diabetes, all increasing your stroke risk. You don’t need to run a marathon — just commit to making time to move each day. 4. Do I regularly eat processed food and sugar? Eating less cholesterol and fat, especially saturated and trans fats, may reduce the fatty deposits (plaque) in your arteries. Also, eating five or more servings of fruits and vegetables per day may reduce your stroke risk. If you are diabetic, follow recommendations to get your diabetes under control.

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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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