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Neurosciences Clinical Trial Opportunities

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Getting the COVID-19 booster is the best way to protect yourself from severe illness or death due to COVID-19, and both the CDC and the FDA have approved booster shots for people ages 18 and older. So, with the holidays right around the corner and infection rates on the rise both in Nevada and nationally, the best thing you can do to prevent the continued spread of this deadly virus is to get boosted today. The Basics: Who: It is recommended that everyone 18 years or older get a COVID-19 booster shot. When: At least 6 months after completing your primary COVID-19 vaccination series. What: Any of the COVID-19 vaccines authorized in the United States. The CDC allows for mix and match dosing for booster shots. How: To make an appointment for your COVID-19 vaccine booster, please visit vaccines.gov today. Appointment Reminders: Don’t forget to bring your CDC vaccination record card to your appointment. Refresh yourself on the potential side effects and remember that these are normal signs your body is building up protection. Commonly Asked Questions: Q: Does anything change if I received the Johnson & Johnson as my first COVID-19 vaccine? A: If you received the Johnson & Johnson COVID-19 vaccine, you are elidable for a booster two months after completing your primary vaccine. Q: Is the formula the same for the boosters as it was for the primary vaccine? A: COVID-19 booster shots are the same formulation as the current COVID-19 vaccines. However, in the case of the Moderna COVID-19 vaccine booster shot, it is half the dose of the vaccine people get for their primary series. Q: Am I still considered “fully vaccinated” if I don’t receive a COVID-19 booster shot. A: Yes, everyone is still considered fully vaccinated two weeks after their second dose in a two-shot series, such as the Pfizer-BioNTech or Moderna vaccines, or two weeks after a single-dose vaccine, such as the J&J/Janssen vaccine. All information courtesy of the Center for Disease Control and Prevention. All information courtesy of the Center for Disease Control and Prevention

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Renown Health has long supported northern Nevada’s LGBTQ+ community Pride events with sponsorship, and we’ve collaborated with local and regional LGBTQ+ organizations as an ally. Renown’s Pride Committee works to deepen and broaden our external and internal efforts around LGBTQ+ community engagement, advocacy, and healthcare issues related to sexual and gender minorities, which is part of the greater Diversity, Equity and Inclusion efforts Renown is undertaking. According to Harvard Chan School, data shows that nearly a sixth of LGBTQ+ adults feel they were discriminated against based on their sexual orientation and gender identity. As a result, this brings to light the important need for education within the healthcare setting. Renown Health is bridging the gap for our LGBTQ+ population, and we know more work needs to take place in order to become an inclusive organization. Below are a few ways we’re working on improving our response to LGBTQ+ needs, and celebrate, respect and honor our diversity by being inclusive. Diversity, Equity and Inclusion The Diversity, Equity and Inclusion subcommittee was formed to heighten the awareness and develop a plan on how to better serve all of our diverse populations, including our LGBTQ+ patients. As the largest healthcare provider in northern Nevada, we knew that we could do a better job. The subcommittee provides us a forum to discuss ideas and develop plans to provide better care to these populations. Updated Medical Records with Preferred Name and Pronouns Of course healthcare is personal. We meet patients at their most vulnerable states. And relating to every person by the correct pronoun shows we respect their gender identity. A new medical records update supports our doctors, nurses and care team in capturing this vital information. We are now able to capture every person’s preferred name, sex and sexual orientation to better care for them. Kathleen Zaski BSN, RN, Manager of Clinical Informatics and IT Applications at Renown explains why this is so important. “Your name and identity are core to who you are as a person, and here at Renown, we aim to take care of you as a whole person and to provide the highest level of quality care to our community – all while ensuring the experience is exceptional and tailored to the individual. In other words, having the patient’s preferred name and pronoun in the medical record is important to validate their identity, and show we care, in an already high stress environment. Specifically, giving our providers easy access to the patients preferred name and pronoun in the medical record, allows them to properly address their health concerns. This also helps the health care provider foster a closer relationship with the patient. Studies have found this actually increases the quality of care by creating a more open and comfortable environment.” Gender Neutral Restrooms Mitch Harper, Senior Program Development Manager at Renown, recognizes there’s still so much more to improve upon in becoming an inclusive organization. “At the end of the day, it’s about creating a safe and welcoming environment for our community and our employees. Access to basic human services shouldn’t be contingent on an individual’s skin color, ethnicity, sex, gender identity, sexual orientation, age, disability, or beliefs. Ensuring that private restrooms are equally available to everyone on our campus is just one way we can provide a more inclusive, caring space for the people we serve.” Updated restroom locations: Roseview Tower: 10 Sierra Tower: 14 Tahoe Tower: 14 Helping to Lead and Influence Change Sean Savoy, Manager of Spiritual Care at Renown "The foundation of spiritual care is compassion – being with people in need by caring, supporting, and showing empathy, and promoting a sense of well-being. Being a member of the LGBTQ+ community informs that deep sense of compassion and empathy in a very special and unique way. Our human value, social validity, the very reality of who and what we are, even our right to exist, love and just be, are often called into question. This, in turn, can cause many of us to question ourselves and wonder about our self-worth. This experience should engender compassion and empathy so that we can better recognize, listen to and meet others’ needs to help them achieve inner peace, explore coping strategies to overcome obstacles during illness or crisis, and even find new balance by re-conceptualizing themselves in the context of health and illness. I have found that the intersectionality of my gay and spiritual selves has been a blessing in my life." Matthew Maloy, Team Lead Applications Specialist at Renown “I am a Team Lead Epic analyst in the IT department that is responsible for clinical based workflows for ED, Trauma, and Critical Care and have worked at Renown for 15 years. Being a part of the LGBTQ+ community influences my daily work by ensuring the Electronic Health Record reflects best practices such as giving clinicians the ability to document a preferred name, and displaying that throughout the medical record for consistency. Having the ability to influence decisions that move our community toward human value for all of us is a priority in my daily work.” Our Mission Renown Health’s mission is to make a genuine difference in the health and well-being of the people and communities we serve, including the LGBTQ+ community. We continue to build relationships to improve care, fostering better health outcomes for ALL of our patients by creating a more inclusive health system.

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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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Renown Health is one of the country’s first health systems to lift visitor restrictions for patients with COVID-19 and encourage the family to be at the patient’s bedside. Read Darlene and Dave’s story to understand why we’re updating our visitor policy. Dave and Darlene Randolph found joy in exploring antique shops and garage sales to find damaged or discarded vintage pieces. Dave would spend many hours scraping, cleaning, sanding, and refinishing items, transforming them into functional, beautiful pieces of furniture. Every piece in their home rekindles a memory and has a story to tell. On Thanksgiving, when Dave was too ill to gather around their antique dining room table, Darlene called the ambulance. Ailing with COVID-19 for two weeks, Dave had not been improving. When the EMTs reached her home and asked Darlene what underlying conditions he had, she said, “all of them.” David was seriously ill. Hospitalized for COVID-19, their communications options were limited. The only way Darlene could communicate with Dave was on a video call or by telephone. Dave spent 17 days hospitalized at Renown Regional Medical Center in Reno. Darlene spent 17 days waiting by the phone for more information on his condition. Darlene said he had “up days and down days,” but thought he might be home, sitting at their antique dinner table for Christmas. Sadly, Dr. David Randolph lost his battle with COVID-19 on December 13, 2020, and died as he slept in a hospital bed. When Darlene wrote his obituary for the newspaper, she gave thanks to the “tremendous nurses and doctors at Renown Regional Medical Center, for providing his care during a time when the family could not be with him.” Taking Action to Inspire Change Darlene wished she could have been there. Over their 45-year marriage, she had always been there. Darlene said, “I had always been at his bedside, as his advocate, to help communicate and straighten things out.” As a registered dietician, she worked in hospitals, knew the protocol, and knew that Renown had a restricted visitor policy to stop the virus’s spread- to other patients, staff, and their family members. Still, she wished she could have spent more time with him. On Christmas Eve, she sat down and wrote to Renown leadership. “As the wife of a COVID patient who recently passed away in your hospital, I want to express my thanks to you and your staff for the care he received in the last days of his life. I am aware that the nurses and staff are working under dangerous conditions and risking their health and lives by caring for multiple COVID patients. The staff is gracious, concerned, and doing everything they can.” She continued, “I know procedures are changing every hour to try to stay ahead of this dangerous virus, and I am sharing my experiences, hoping they will be helpful when establishing policies that impact families.” Darlene explained that despite receiving assurances that Dave’s nurse or a doctor would call daily, sometimes they would forget. She explains in her letter, “how important it is, in these times when the family cannot visit, and has only infrequent communication and is anxiously waiting at home for information about their loved one, how much it means to get a call from someone caring for him at the hospital. If there is a way you can help assure nurses have time to make calls or assist patients in making calls because it is an important part of patient care.” A Person-Centered Visitor Policy After receiving her letter, Renown leadership called Mrs. David Randolph to thank her, offer his sympathies and ask if Renown could help in any way. Darlene asked if he might reconsider allowing families to visit hospital patients during treatment for COVID-19. As the COVID-19 situation has evolved, the policy has as well. Renown hospitals and medical practices now encourage limited visitors for all patients, including those diagnosed with COVID-19. Renown also has extra safety measures to protect the health of patients, visitors and healthcare employees. Darlene is very pleased that her letter inspired this shift in visitor policies for patients with COVID-19. She says, “I have always tried to think of ways I could help other families. Especially those senior couples where one has been hospitalized and the other is home. My wish is to help others.” Renown Health Visitor Policy Renown Health patients may identify two healthy adult “patient supporters” to accompany them on their hospital stay. For more details, visit our Patient Supporter Guidelines page.

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Vaccines that provide protection against the COVID-19 virus are bringing us closer to the end of this deadly pandemic. Two different COVID-19 vaccines are currently available in the U.S. today: one from Pfizer and the other from Moderna. Kate Ward, PharmD, BCPS, Director of Clinical Pharmacy at Renown Health and Adam Porath, PharmD, Vice President of Pharmacy at Renown, share what you need to know about these vaccines. When two COVID-19 vaccines were approved by the U.S. Food & Drug Administration (FDA) in December 2020, it was cause for celebration. Why? Because according to the CDC, the vaccines are 94 percent or more effective in providing protection against the COVID-19 virus! Many people are seeking information about the new Moderna and Pfizer vaccines. Below, our pharmacy leaders provide answers to some commonly asked questions. How do the COVID-19 Vaccines Work? The Pfizer and Moderna vaccines are both mRNA vaccines that help your immune system develop antibodies against the COVID-19 virus. The vaccines use messenger RNA, or mRNA, to show our bodies’ protein-making cells how to make the spike proteins of the COVID-19 virus. Our immune system reacts to these spike proteins by creating antibodies that can recognize and destroy them. So when a person is exposed to the virus in the future, they will be less likely to get sick. What are the Differences between the Pfizer and Moderna Vaccines? The Pfizer and Moderna COVID-19 vaccines are very similar, with just a few small differences worth noting. The main difference between the two vaccines is when you should receive your follow-up dose. Patients who receive a first dose of Pfizer should receive their second dose about three weeks later. Those who receive a first dose of Moderna should receive their follow-up vaccination roughly four weeks after their first dose. People 18 years and older can receive the Moderna vaccine while people 16 years and older can receive the Pfizer vaccine. Dosage for the Moderna vaccine is 0.5 ml (100 mcg). Dosage for the Pfizer vaccine is 0.3 ml (30 mcg).

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With front-line workers receiving the first COVID-19 vaccinations, many of us are feeling hope, but also worry. As a result, we are joining with the Ad Council, the COVID Collaborative, HHS, CDC and NIAID (along with top health and medical organizations) to address your vaccine concerns and questions. Will the vaccine be available to everyone in Nevada? The Nevada Department of Health and Human Services (DHHS) is collaborating with health systems about the use of initially available, limited supplies of COVID-19 vaccines. They will provide guidance on the prioritization order of who will receive the vaccine. This will be based on available quantities, high-risk locations of work and certain other risk factors, and recommendations and guidance for public health agencies. The CDC has provided guidance to initially focus on the following groups: Healthcare personnel likely to be exposed to or treat people with COVID-19, nursing home residents and others in institutional settings; People at risk for severe illness from COVID-19 due to underlying medical conditions; People 65 years of age and older; Other essential workers. I worry the vaccine has been rushed The U.S. national vaccine safety system ensures that all vaccines are as safe as possible, and because vaccines are given to millions of healthy people to prevent serious diseases, they’re held to very high safety standards. COVID-19 vaccines are undergoing a rigorous development process that includes vaccinating tens of thousands of people who participate in a study to generate the needed clinical data. These clinical trials generate scientific data for the FDA to determine the safety and efficacy of each vaccine. It’s worth noting that the clinical studies to establish the safety and efficacy of the Covid-19 vaccines were as big and thorough as recent studies for other licensed vaccines (for example, the shingles vaccine). I'm concerned about the vaccine's side effects The most common side effects are very similar to those seen with most vaccines, such as: sore arms, fevers, and tiredness within 72 hours after the vaccine. These side effects usually mean that the vaccine is generating an immune response, indicating it is working. Short-term side effects observed in the leading COVID-19 vaccine trials include: Injection site pain and redness Fatigue Muscle aches and pains Joint pain Headache I’m afraid I’ll get COVID-19 from the vaccine None of the authorized and recommended COVID-19 vaccines, or COVID-19 vaccines currently in development in the United States, contain the live virus that causes COVID-19. This means that a COVID-19 vaccine cannot make you sick with COVID-19. Can children receive the COVID-19 vaccine? Not at the moment. In early clinical trials for various COVID-19 vaccines, only non-pregnant adults at least 18 years of age participated. However, clinical trials continue to expand those recruited to participate. The groups recommended to receive the vaccines could change in the future. As of now, it is recommended that children do not receive the vaccine. More information will be available from the vaccine manufacturers. I do not believe vaccines are effective Both this disease and the vaccine are new. We don’t know how long protection lasts for those who get infected or those who are vaccinated. What we do know is that COVID-19 has caused very serious illness and death for a lot of people. If you get COVID-19, you also risk giving it to loved ones who may get very sick. Getting a COVID-19 vaccine is a safer choice. The FDA is responsible for making sure that, just like any other medications, any FDA-authorized or approved COVID-19 vaccines are safe and they work. The EUA (Emergency Use Authorization) will not be provided if the FDA feels that the vaccine is unsafe. I can't get vaccines to due to a medical condition Adults of any age with certain underlying medical conditions are at increased risk for severe illness from the virus that causes COVID-19. mRNA COVID-19 vaccines may be administered to people with underlying medical conditions provided they have not had a severe allergic reaction to any of the ingredients in the vaccine. The following information aims to help people in the groups listed below make an informed decision about receiving the mRNA COVID-19 vaccine. It is extremely important to speak with your doctor regarding your specific medical condition, and always follow their strict advice regarding the COVID-19 vaccine, or any other vaccines. Sources: Renown COVID-19 Ad Council COVID Collaborative U.S. Department of Health & Human Services Centers for Disease Control and Prevention National Institute of Allergy and Infectious Disease

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Renown Health is closely following the national outbreak of the monkeypox virus and urging healthcare providers to be alert for patients with illnesses associated with a rash. In working with the Washoe County Health District (WCHD), Renown is closely monitoring the spread of monkeypox in the community and looking to prevent and reduce the spread of monkeypox. To help to ease worries, we consulted with Paul De Leon, Infection Preventionist at Renown Health. What Exactly is Monkeypox? Monkeypox is a rare viral illness caused by the monkeypox virus — the same family of viruses that causes Smallpox. Although symptoms are similar to Smallpox, monkeypox symptoms are milder and rarely fatal. However, it's important to mention that this virus can be more severe for these susceptible groups: Immunocompromised Pregnant women A fetus or newborn baby Women who are breastfeeding Young children Those with severe skin diseases such as eczema How is Monkeypox Transmitted? The monkeypox virus is not easily transmitted but occurs through sustained person to person close contact with an infected individual. Monkeypox can also be transmitted through direct contact with infectious rash, scabs, or body fluids. Monkeypox can also be spread through prolonged intimate physical contact, such as kissing, cuddling or sex. Lastly, monkeypox can be spread through contaminated linens or bedding. Transmission through respiratory secretions is uncommon but has been reported after prolonged face-to-face contact with symptomatic individuals. In addition, pregnant women can spread the virus to their fetuses through the placenta. Monkeypox Testing If you think you have monkeypox, contact your primary care physician or other medical providers to obtain testing. Notify the provider ahead of time before entering the physical office. Signs & Symptoms This current outbreak of West African monkeypox does not have the typical presentation of classic monkeypox. Symptoms usually appear one to three weeks after infection and include: Pimple-like rash or blisters on the face, inside the mouth, and on other areas of the body, like the hands, feet, chest, genitals, or anus. The rash will go through serval stages, including scabs, before healing and may be painful or itchy. Other symptoms of monkeypox can include: Fever Headache Muscle aches and backache Swollen lymph nodes Chills Exhaustion Respiratory symptoms such as sore throat, nasal congestion, or cough Symptoms of monkeypox may occur before or after a rash with some individuals only report experience a rash. Individuals with monkeypox are infectious once symptoms begin and remain infectious until lesions form scabs, scabs fall off, and a fresh layer of skin forms. The illness typically lasts 2-4 weeks.

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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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