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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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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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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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As the holiday season draws near, we find more reasons to celebrate with loved ones. At Renown Health, we are kicking off the celebrations early this November with American Diabetes Month. Approximately 37 million Americans, including 270,000 Nevadans, have been diagnosed with diabetes with as many as 95% of those diagnosed living with type 2 diabetes mellitus (T2DM). What is Type 2 Diabetes? Type 2 diabetes is a chronic health condition that occurs because your body is not using insulin (a hormone made by the pancreas to help cells use the food we eat for energy) as well as it should, resulting in high blood sugar levels. It is important to obtain a diagnosis for T2DM and ensure it is well-controlled to prevent serious health complications. Those with diabetes are at higher risk for blindness, kidney failure, heart disease, stroke and amputation. Tips for Supporting Your Health with Type 2 Diabetes Know Your Blood Sugar Levels: Work with your healthcare provider to establish target blood sugar levels, and make sure to monitor your levels regularly as advised by your healthcare provider to prevent or delay health complications associated with T2DM. Focus on Your Plate: Eating foods such as fruits and vegetables, lean meats or plant-based proteins, healthy fats and whole grains supports diabetes management. If choosing healthy foods is difficult due to your busy schedule, cost or simply because you aren’t sure where to start, talk with your healthcare provider who may refer you to a registered dietitian. Registered dietitian nutritionists are certified nutrition specialists who can provide education and practical tips for eating to support your T2DM diagnosis with visits covered by many insurance plans. Prioritize Staying Active: Engaging in regular exercise is good for everyone, especially those living with T2DM. Exercise helps your cells become more sensitive to insulin and therefore supports healthy blood sugar levels. Always check with your healthcare provider prior to beginning a new exercise plan. Support Stress Reduction: Stress is unavoidable but can be managed through regular exercise, getting enough quality sleep (7-8 uninterrupted hours per night) and practicing meditation and other mindfulness techniques. Plan Ahead for Holiday Gatherings: There’s still room for celebration while focusing on blood sugar management. Consider bringing a healthy dish to your gathering, focus on filling your plate with vegetable sides and eating those first and incorporate a family walk after dinner. If traveling, pack nutritious snacks that support your health and keep you full. Lastly, enjoy the special dishes and desserts this season has to offer in single-serving portions.

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Clinical research provides agency for our patients navigating a scary diagnosis, and the field has never been stronger in northern Nevada. This strength is thanks in part to the Affiliate Clinical Research Office (ACRO) formed by the 2021 affiliation between Renown Health and the University of Nevada, Reno School of Medicine. Since its creation, the ACRO team has been busy ensuring that community members have access to the latest care options and exceptional experiences as participants in both research and their healthcare. Here are just a few things that set this office apart from the rest. 1. A focus on engagement In 2022, the ARCO team focused on promoting a research culture with patients, clinicians, residents and students by intentionally engaging with healthcare providers, department administrators, internal research team members and leadership. They educated the community with learning materials that emphasized the importance of doing research. This team also worked with front-line staff to raise awareness and excitement about the clinical research options available for Renown Health patients. 2. Meaningful partnerships The most impactful partnership to date is between Renown Health and UNR Med. By identifying opportunities and leveraging resources across institutions, we have maximized our impact and built a solid and sustainable foundation. This gives the people of northern Nevada greater access to new interventions or novel treatments. This team is also investing in the community and national partnerships to provide training opportunities for our research staff and learning opportunities for our medical students. 3. Novel treatments across many disease areas Our research study offerings must reflect the healthcare needs of our community and the expertise of practicing clinicians. The department has over 80 active studies in neurology, pulmonology, oncology, cardiology, pediatrics and disease prevention. The ARCRO team strives to expand care opportunities to allow our community members to stay close to home when seeking care. This year, they will continue exploring our community's unmet healthcare needs by bringing new treatment options to the greater Reno area.

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There are nearly 1 million adults living with MS in the United States alone. For comparison, that is roughly the entire population of the Reno/Sparks and Las Vegas areas combined. MS is a neurological autoimmune condition which means that the immune system of patients with MS attacks the body’s myelin, a protective substance that covers your nerves. When this happens, the unprotected nerves can be damaged. Patients with MS may experience many different symptoms ranging from mild to severe, such as mobility and vision problems, fatigue and difficulty thinking. MS is usually diagnosed between the ages of 20-50, but late onset MS can occur in patients over 50 years old. While there is no cure for MS, there are effective treatments that can help reduce the burden of patients’ symptoms and create a positive quality of life. At Renown Health, we have joined the fight against MS through a partnership between advanced neurology programs and providers and our research office. We are proud to offer newly diagnosed MS patients the opportunity to choose between standard care treatment options or participating in an open label clinical trial, the AGNOS study. This study is assessing the impact of a new medication, ofatumumab, as the first disease modifying therapy participants receive for managing relapsing remitting MS, the most common form of MS.

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Did you know that the Renown Research Office has partnered with the University of Nevada, Reno School of Medicine Clinical Research Office to form the Integrated Clinical Research Office? This means we are able to provide more clinical research opportunities and expertise to our northern Nevada community than ever before. Over the past two years, we have significantly expanded our clinical trial offerings from 35 to 101 studies to meet the healthcare needs of our community members and keep care options local. Currently, we offer clinical research as a care opportunity in areas such as cardiology, pulmonology, endocrinology, oncology, pediatrics, neurology and immunizations. What is Clinical Research? Clinical research is simply medical research that involves human volunteers (participants). Research studies have to be reviewed and approved by ethics committees to ensure that the questions researchers want to answer are appropriate and that research participants are protected throughout the study. Often when we talk about clinical research, we are referring to a clinical trial. Clinical trials are a type of clinical research study that places research participants into groups to study the safety and effectiveness of new medications and devices on a specific health outcome. Clinical trials follow rigorous standards and must pass four phases of testing, where each phase works progressively to understand the correct dosing and effects in larger and more diverse groups of people. Why is Clinical Research Important? Did you know that all medications, diagnostic tests and medical devices prescribed and used today by physicians and health practitioners were once tested in clinical trials? Clinical research advances medical care by helping us understand how to prevent disease and to provide new and better treatments for a wide range of health conditions. At Renown Health, we know the importance of offering the latest opportunities in healthcare, especially when standard of care options have been exhausted. What Are Some Considerations for Participating in Clinical Research? Research volunteers are often drawn to participating in studies because they are interested in accessing the latest health care treatments and/or they want to contribute to scientific discovery. If you are interested in becoming a research volunteer, you should first make sure you fully understand what the study and researcher is asking you to do and consider whether you are comfortable with the study activities and commitments to time and travel such as for required study appointments. Remember, participating in a research study is completely voluntary. That means you choose whether to participate, and you can choose to stop participating in a research study at any time, for any reason. Where Can I Find More Information About Clinical Research? There are many resources you can access if you have questions or want to learn more about clinical research. Your healthcare provider can assist you in your healthcare journey by discussing care options and exploring if participating in a clinical trial may be right for you. The Nevada Division of Public and Behavioral Health recently launched their Clinical Trials Info for Nevadans webpage which provides information on finding clinical trials in Nevada, understanding the importance of diversity in clinical trials, and linked resources to learn more about clinical trials. The U.S. Department of Health and Human Services Office for Human Research Protections provides informational videos, questions to ask researchers prior to participating and information on regulations in place to protect research participants. Finally, at the Renown Research Office, we are always here to support your clinical research journey and can be reached at Renown-CRD@renown.org or 775-982-3646. At Renown Health, our goal is to make it easy for patients to access clinical research as a care opportunity where patients can access a variety of standard care treatment options for their health condition or choose to participate in a clinical trial. For more information about clinical trial opportunities available to you or to ask any questions, contact the Renown Research Office at Renown-CRD@renown.org or 775-982-3646.

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