Blog Archives - ENCORE Research Group

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ENCORE · Battle of the Abbreviations: NAFLD, NASH, Cirrhosis (not an abbreviation)

Fats are tasty in food, but not particularly good in the bloodstream. They can also be toxic to the liver and cells in general. We have special cells called adipose cells that store fat in our body. These cells have defenses against dangerous fat components called free fatty acids. Free fatty acids are the high-energy parts of fats, the part that gives you energy. Fatty acids are a great way to store energy and can be turned into power for your body, but the high energy content can also be dangerous in the wrong places.

The liver transforms free fatty acids into usable energy. From here, the energy is delivered to cells all over the body. The liver is part of the system that makes sure the body’s energy demands match the available energy. Unfortunately, when too many free fatty acids are delivered to the liver, they can start to build up in the liver tissue and cause damage.

Fatty liver is one of the most common ailments in Western countries. One in every three to four people in the US havw a fatty liver. Excessive alcohol consumption can cause a fatty liver, but most sufferers develop non-alcoholic fatty liver disease (NAFLD). Either way, people have steatosis. Steato- means fat, and -osis indicates a condition, especially an abnormal one. Steatosis of 5-10% is problematic and is the earliest indication that the liver is starting to suffer damage. Many people with fatty liver and no other abnormalities can make a full recovery, usually by stopping whatever is causing the steatosis.

We know that alcohol can directly damage the liver, but how does NAFLD start? The causes are complicated, but some similarities exist. Excess fat released from fat cells, excess fat created by the liver, and excess fats from the diet all find their way into the liver. These are normally not an issue, but all are affected when the body isn’t regulating insulin properly. Insulin lets body parts know when you have food or are starving. When insulin isn’t processed correctly the body thinks it’s starving and tries to compensate – even when there is plenty of food present. In the middle of this the liver suffers.

After a prolonged period of fat accumulation, a patient with NAFLD may develop non-alcoholic steatohepatitis, or NASH. Steato- for fat, hepat- indicating the liver, and -itis which means inflammation. This second leg on the terrible journey develops when fat causes inflammation in the liver. The gut changes and gives the wrong signals to the liver. Cells develop insulin resistance and can’t convert sugars into energy or fats correctly. Free fatty acids cause cell problems and elicit an immune response. Stresses on the liver cause a feedback loop, where inflammation disrupts cell function. The body tries to fix the liver but can’t overcome the massive amount of dangerous fats. Cells in the liver die, and the living cells can be damaged trying to compensate. With NASH, the inflammation is long-lasting, also called chronic.

The liver can regenerate from NAFLD and NASH. It can’t sustain forever, however. When the liver is permanently damaged, the tissue can scar and die. This is a permanent reduction in liver function. We call this scarring Cirrhosis. Cirros- is the Greek word for yellow-brown (the color of a dying liver), and -osis refers to a condition, especially an abnormal one. Cirrhosis has multiple stages and can be asymptomatic but cannot be recovered from without intervention. The current treatment for cirrhosis is a liver transplant.

Though we’ve been talking about the dangers of fats in the bloodstream and liver, it should be noted that the body makes a lot of these fats out of carbohydrates – sugars. A healthy diet without too many sugars and with lots of exercise are the best preventative measures for these conditions. Conditions related to insulin resistance, such as type 2 diabetes and metabolic syndrome can both cause and be caused by these conditions. Also, even though we have presented these as a pathway, note that you can progress from NASH to NAFLD or become symptom-free; it’s not a one-way journey! If you have any of these conditions, talk to your primary care physician to look for solutions. Also, keep an eye out for clinical research trials that may alleviate symptoms or the underlying fat buildup.

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Sources:

Pierantonelli, I., & Svegliati-Baroni, G. (2019). Nonalcoholic fatty liver disease: basic pathogenetic mechanisms in the progression from NAFLD to NASH. Transplantation, 103(1), e1-e13. . https://doi.org/10.1097/TP.0000000000002480

Sanyal, A. J. (2019). Past, present and future perspectives in nonalcoholic fatty liver disease. Nature reviews Gastroenterology & hepatology, 16(6), 377-386.

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ENCORE · How Do We Get NASH?

The liver is an amazing and necessary organ. It can regenerate from a minor injury, break down dangerous chemicals and drugs, and help maintain the proper balance of nutrients, fats, and sugars in the body. It has hundreds of other important roles as well. With all this responsibility, we are in trouble when the liver stops working.

One way the liver stops working is through non-alcoholic steatohepatitis (NASH). Steato- means fat, hepato- indicates the liver, and -itis means inflammation. Steatohepatitis is inflammation of the liver caused by fat accumulation. This is a progressive form of non-alcoholic fatty liver disease – the most common liver disorder in western countries. Progressive means that this disease gets more severe over time.

NASH is a large problem in America, affecting 3-12% of adults. Furthermore, NASH can lead to cirrhosis, where the liver is permanently damaged, and lead to possible liver transplantation. Over a million adults in America have NASH-related cirrhosis.

How do we get NASH? As the name indicates, this is not caused by alcohol. There are many pathways to developing NASH, but the underlying cause may be excess carbs and fatty acids. This can be due to diet or behavior, underlying genetics, or associated syndromes. Some of the syndromes associated with NASH are:

Metabolic syndrome
Obesity
Type 2 diabetes
High blood pressure
Dyslipidemia
Hypothyroidism
Cardiovascular risk
Advanced liver problems

The underlying mechanism of NASH can be very complex. A leading precursor to NASH is insulin resistance, where cells fail to respond to insulin. Conditions that cause or are caused by insulin resistance, such as type II diabetes and metabolic syndrome, may increase your chances of developing NASH. They also may develop or worsen as NASH symptoms get worse.

Insulin resistance causes different types of fats to accumulate in the liver. This makes it very difficult for the liver to process the fats and they ultimately build up in liver cells. These fats, especially ones called nonesterified fatty acids (NFEAs), are very dangerous. They cause damage to liver cells and can also activate cytokines that start the inflammation process.

Eventually, we get NASH, an inflammation cascade in the liver caused by fats. Cytokines start inflammation in the liver. Cell death attracts the immune system, which enters and causes inflammation while trying to help. Liver cells die and are less able to process fats, which leads to a compounding effect. Eventually, we may transition to cirrhosis, where permanent liver scarring and damage occur.

There are few treatments on the market for NASH. As usual, the primary therapy for NASH is a good diet and regular exercise. Medicinal remedies are all in the experimental phases. Potential targets include increasing insulin sensitivity, decreasing fat creation, decreasing circulating fats, breaking fats down, and anti-inflammation treatments.

One way to decrease circulating fats is by expelling them through the digestive system. In the liver, moving fats to the gut is regulated by thyroid hormones. Thyroid hormones activate receptors, which exist all over the body and cause many different effects. Thyroid hormone receptor Beta (THR-β) exists almost exclusively in the liver. Scientists are working to create medicines that activate THR-β and help clear fats from the liver in NASH patients. If you are interested in participating in a research study, contact your local ENCORE Research Group site today!

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Sources:

Noureddin, M., & Sanyal, A. J. (2018). Pathogenesis of NASH: the impact of multiple pathways. Current Hepatology Reports, 17, 350-360.

Parthasarathy, G., Revelo, X., & Malhi, H. (2020). Pathogenesis of nonalcoholic steatohepatitis: an overview. Hepatology communications, 4(4), 478-492. https://doi.org/10.1002/hep4.1479

Pramfalk, C., Pedrelli, M., & Parini, P. (2011). Role of thyroid receptor β in lipid metabolism. Biochimica et Biophysica Acta (BBA)-Molecular Basis of Disease, 1812(8), 929-937. https://doi.org/10.1016/j.bbadis.2010.12.019

Eosinophilic asthma is a type of asthma that is characterized by high levels of eosinophils in the airways. Eosinophils are a type of white blood cell that are involved in the body’s immune response to allergens and other triggers. When eosinophils are activated, they release inflammatory chemicals that can cause damage to the airways, leading to asthma symptoms.

Symptoms of eosinophilic asthma include wheezing, coughing, shortness of breath, and chest tightness. These symptoms may be more severe than those of other types of asthma and may not respond as well to traditional asthma treatments like inhaled corticosteroids.

Diagnosis of eosinophilic asthma involves a blood test to measure eosinophil levels and a sputum test to look for eosinophils in mucus from the lungs. Treatment may involve targeted biologic medications that specifically target eosinophils, such as mepolizumab, reslizumab, and benralizumab. These medications work by reducing the number of eosinophils in the airways, which can help to reduce asthma symptoms and improve lung function.

If you or someone you know has severe asthma, clinical trials may be an option for you. Clinical trials are an important way to test new medications and treatments for asthma and other conditions. They allow researchers to gather important data on the safety and effectiveness of new treatments, and they provide patients with access to cutting-edge therapies that may not be available through traditional channels. By participating in a clinical trial, you can play an important role in advancing medical research and helping to improve the lives of people with eosinophilic asthma and other conditions.

Clinical trials for this condition are currently available at ENCORE Research Group’s Jacksonville Center for Clinical Research, University Blvd. location. To learn more, you can contact us by phone, or sign up on our website. Our knowledgeable staff can guide you through the process and help you determine if a clinical trial is a good option for you.

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Celiac disease is a genetic autoimmune disease that affects the digestive system. It is triggered when a person consumes gluten, which is a protein found in rye, wheat, and barley. When a person with celiac disease eats gluten, their immune system reacts to the protein by attacking the small intestine. The role of the small intestine is to digest food and allow the body to use the nutrients. When the body attacks the small intestine, it damages the lining of the small intestine, resulting in symptoms that include bloating, abdominal pain, and weight loss. Eventually, after the small intestine has suffered damage, it can result in the body’s inability to absorb nutrients, therefore leading to a deficiency of nutrients and health problems.

It is often difficult to tell if children have celiac disease, as the symptoms in children and adults differ.

Symptoms in adults include:

Fatigue
Weight loss
Bloating and gas
Abdominal cramps/pain
Nausea and vomiting
Constipation

Adults can also experience a variety of symptoms unrelated to the digestive system, such as:

Anemia
Loss of bone density
Headaches
Cognitive impairment
Joint pain

Digestive problems are commonly seen in children with celiac disease, rather than in adults with celiac.

Symptoms in children include:

Nausea and vomiting
Diarrhea
Bloating
Constipation
Gas
Weight loss
Anemia
Irritability

Symptoms are often not enough to tell if someone has celiac disease. People are more susceptible to celiac disease if they have some of the risk factors listed below:

Family history of celiac disease and/or dermatitis herpetiformis (itchy skin rash)
Type 1 diabetes
Turner Syndrome or Down Syndrome
Autoimmune thyroid disease
Microscopic colitis
Addison’s disease

Diagnosis of celiac disease is through blood tests that check for certain antibodies and biomarkers.

A serology test detects elevated antibodies which indicate the body is reacting to the gluten protein.
A genetic test detects human leukocyte antigens in order to eliminate the possibility of celiac disease.

Often following these blood tests is an endoscopy/biopsy of the small intestine to evaluate the damage caused by the body’s response to the gluten protein.

Although there is no cure for celiac disease, a change in diet helps to regulate the symptoms of celiac disease. A gluten-free diet often consists of gluten-free foods and vitamin and mineral supplements to regulate the body’s nutrients. Following a gluten-free diet allows the small intestine to heal. Doctors and dietitians can help guide people on their diet and inform them of gluten-free alternatives. This diet is normally life-long in order to prevent symptoms or a flare-up of the small intestine again. Doctors sometimes prescribe steroids as well to help regulate the inflammation of the small intestine.

It is often difficult for people with celiac disease to eat out at restaurants or buy pre-made food from stores as it is tricky to be one hundred percent certain that a food is truly gluten-free. Stickers on foods say “may contain gluten” as a way to protect the manufacturing companies from lawsuits. However, most of the time the food does not contain gluten itself but has a small chance that it could have been cross-contaminated during the production process. This limits food that people with celiac disease feel safe consuming and buying. The FDA has standards that must be met in order for a food to be labeled as “gluten-free”. The final product must contain, at most, 20 mg/kg (20 parts per million) gluten or less. However, this rule does not apply to alcohol which can contain gluten. This amount of gluten (20 ppm) will not result in any side effects in a person with celiac disease, since it is too small of an amount. Another way people can be sure that they are consuming gluten-free foods is to call a restaurant ahead of time and ask if they have a gluten-free menu or serve alternatives for people with gluten intolerance.

Written by: Sofia H. Davila, Clinical Researcher

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Sources:

Mayo Foundation for Medical Education and Research. (2021, August 10). Celiac disease. Mayo Clinic. Retrieved February 17, 2023, from https://www.mayoclinic.org/diseases-conditions/celiac-disease/diagnosis-treatment/drc-20352225

NCI Dictionary of Cancer terms. National Cancer Institute. (n.d.). Retrieved February 17, 2023, from https://www.cancer.gov/publications/dictionaries/cancer-terms/def/small-intestine

U.S. Department of Health and Human Services. (n.d.). Eating, diet, & Nutrition for Celiac Disease. National Institute of Diabetes and Digestive and Kidney Diseases. Retrieved February 20, 2023, from https://www.niddk.nih.gov/health-information/digestive-diseases/celiac-disease/eating-diet-nutrition

Atrial fibrillation (AFib) is a heart rhythm disorder characterized by irregular heartbeats in the heart’s upper chambers, called the atria. In AFib, the electrical signals that regulate the heartbeat become abnormal, causing the heart to beat too fast or slow instead of contracting normally. Atrial fibrillation can have detrimental effects such as stroke, heart failure, and blood clots.

Image Credit: cdc.gov

As a result of the irregular heart beatings, a variety of symptoms can be present such as:

Palpitations (fluttering, pounding, or rapid sensation)
Shortness of breath
Fatigue
Weakness
Dizziness / lightheaded
Chest pain

In some cases, people with AFib may not experience any symptoms, making it difficult for some people to tell whether or not they may have AFib.

Some broader symptoms can include:

Abrupt weight gain
Coughing or wheezing
Fainting
Nausea and appetite loss
Depression

Sometimes even these broader symptoms can not help people determine if they have AFib. The only way for people to know if they have AFib without experiencing any symptoms is to get tested and diagnosed by a doctor. It is strongly recommended that if a person has any of the risk factors below, they get checked, just to be safe, by a doctor.

AFib is often seen in older adults, with risk factors that include:

History of heart disease
High blood pressure
Advancing age
Obesity
Diabetes
Heart failure
Hyperthyroidism
Chronic kidney disease
Smoking or excessive alcohol use

Some treatments are more effective when delivered in the early stages of AFib, which means that a person should not postpone getting checked by a doctor for AFib. However, symptoms and causes of AFib can often differ between men and women. In women, AFib usually is caused by problems with the heart valves. Compared to men, where AFib usually stems from coronary artery disease (CAD). As a result, women with AFib have a greater chance of having a stroke than men with AFib. Women with AFib also are more likely to have heart attacks and congestive heart failure than men with AFib. As a result, treatments for men and women often differ slightly.

Treatment for AFib is typically a medication to control heart rhythm and prevent blood clots. However, in some cases, procedures such as electrical cardioversion, ablation, or implantation of a pacemaker or defibrillator may be necessary. Men with AFib are often placed on non-drug therapies such as pacemakers and catheter ablation. Women with AFib are more likely to have a cardioversion and be prescribed antiarrhythmic medications such as dofetilide. However, typical treatments for both men and women include blood-thinning medications, surgery, and lifestyle changes to manage AFib risk factors.

Written by: Sofia H. Davila, Clinical Researcher

Enrolling Studies

Sources:

Miller, K. (2022, December 27). Atrial fibrillation: The difference between men and women. Healthgrades. Retrieved February 17, 2023, from https://www.healthgrades.com/right-care/atrial-fibrillation/atrial-fibrillation-the-difference-between-men-and-women

Centers for Disease Control and Prevention. (2022, October 14). Atrial fibrillation. Centers for Disease Control and Prevention. Retrieved February 17, 2023, from https://www.cdc.gov/heartdisease/atrial_fibrillation.htm

Our patients are enthusiastic and excited to take part in clinical research. There are a variety of reasons a patient would want to participate in a clinical trial: they join to benefit future generations, to advance medicine, to get medical help and compensation, and to increase diversity. The most frequent reason for joining a clinical study, however, is to help others. Clinical research is the best framework for ensuring the safety and effectiveness of new medications, devices, and procedures. This includes everyone from participants of phase 1 clinical trials to final consumers after FDA approval. But what does the process actually look like for patients?

People hear about us from a wide variety of sources: advertisements, community outreach programs, the internet, and personal referrals from family and friends. Thousands of our patients are referred to us by friends, family, and their own physicians. People’s great experiences with us make them very likely to recommend us to others. Most of our patients are repeat offenders. In fact, over 99% of our patients return for another study.

When you are interested in an ENCORE Research Group study, our experienced and compassionate recruiters will talk with you. These experts care about your time more than anything else. They will run through a quick checklist to see if you prequalify for a study. If you prequalify, they will schedule an evaluation. They will find a time that works best for you to come in or receive a call with a research coordinator.

Here the compassionate and attentive nature of ENCORE Research Group excels. You will receive forms to fill out your medical history, medications, and contact information. During your appointment, our attentive and detail-oriented staff will review your documents. They will confirm and expand on any medical conditions that may affect your participation. This step makes sure you are always safe and gives our staff personal knowledge to help you during your study. Patient safety is always our number one priority.

After an evaluation, if you choose to participate, you will start the informed consent process. Here you will review the clinical trial process and the plan for your specific study. Research coordinators will explain and review a highly detailed and regulated consent form. This document informs you about the study, potential side effects, the goals and endpoints of the study, your rights, and what to expect. This is a vital step. We will also remind you that you can end participation in the study at any time for any reason. Your voluntary participation does not oblige you to continue at any point.

What happens from here depends on your specific study, but some things will remain constant. Our doctors and medical staff will talk with you. Other patients describe them as professional, friendly, and compassionate. You may receive medication, a placebo, device, or undergo a procedure. This will have been explained in detail during the informed consent process. One big difference between ENCORE Research Group and a normal doctor’s office is the comprehensiveness and amount of follow-up. Our doctors give you their full, undivided attention when you are in their office. They have plenty of time and want to know the intricacies of your medical history. For most studies, our staff will periodically check up on you after you leave. We are also keenly interested in knowing if you experience any new or changing symptoms. This will continue until your study has concluded. Then, if you wish, we will contact you if you qualify for more studies.

This process results in a streamlined, professional, and personal system. You get to help medicine and society, but also experience top-quality, attentive care for a variety of conditions. Join the clinical trial process with ENCORE Research Group and see why nearly all of our patients come back!

By Benton Lowey-Ball, BS Behavioral Neuroscience

Enrolling Studies

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ENCORE · When Good Eosinophils Go Bad

There are many ways to think of the human body. One of my favorites is that the body is like a donut. The inside of the donut is our entire body and everything that makes us what we are. The outside is our skin. The hole in the middle is made of our mouth, throat (esophagus), stomach, and intestines. The body treats the entirety of the digestive tract as the outside world. The intestines act like the skin; keeping most things out of the body and only letting specific molecules through.

This has some important implications. The whole outside of the donut – including the throat and intestines – is covered in epithelial cells. These are tight cells that interact with the outside world. When these cells determine that they are touching something dangerous they signal to get rid of it immediately. This might feel like burning or itching on the skin, and may be something like diarrhea or vomiting in the digestive tract. These may feel crummy to us, but they are very useful in keeping us safe.

The immune system is in charge of identifying and reacting to chemical and biological dangers. These can be harmful bacteria, worms, and things like splinters or some drugs. The immune system kicks into action, trying to kill or remove the dangerous particles without damaging body cells. This is a tricky dance. Antibodies will identify the dangerous particles or creatures and special B or T cells will widely sprinkle alarm particles, calling for reinforcements.

What the body does next is determined by where the danger is found. In the gut – which the body treats as the dangerous outside world – the defenses are strong. One of the biggest guns we have is a cell called an eosinophil. These are very dangerous cells. They contain highly toxic particles and proteins that aggressively dunk in on invaders. They also signal to the intestines to contract and eject the contents. They only exist in specific parts of the body and are normally difficult to activate.

Unfortunately, sometimes our body identifies otherwise safe items as dangerous. This is called allergies, and can be very annoying. Many of us suffer from seasonal allergies, but that doesn’t mean we should glaze over the dangers of allergic reactions. One difficult condition is eosinophilic esophagitis. Eosinophilic means it is caused by the dangerous eosinophil cells. Esophagitis refers to the fact that this happens in the esophagus, the throat. Eosinophils do not normally reside in the throat at all. The throat’s main job is to move food into the stomach, so it doesn’t need to detect danger. When eosinophils mistakenly reside in the throat, however, they can misidentify otherwise safe foods before the stomach gets a chance to digest them. This can result in the eosinophils damaging the throat.

Eosinophilic esophagitis affects four in every thousand people, and can affect people of all ages. Most sufferers were diagnosed as children. In fact, it is one of the most common diagnoses for children who have trouble eating. It is chronic, or long lasting, and symptoms are debilitating. Sufferers experience inflammation of the throat, poor food intake, vomiting, and a poor appetite. Unfortunately there are few treatments available to fix this condition. The most effective has been reducing the diet of patients. This may consist of starting with a very strict diet and reincorporating food slowly to discover triggers. Scientists are actively looking at the underlying causes of why eosinophils are in the throat to begin with. Possible future treatments would likely stop eosinophils in the throat at a cellular or genetic level. The body may be a donut, but that doesn’t mean everything is tasty and fresh. If you are suffering from eosinophilic esophagitis or other conditions, call ENCORE Research Group and ask about studies you may qualify for.

By Benton Lowey-Ball, BS Behavioral Neuroscience

Enrolling Studies

Furuta, G. T., & Katzka, D. A. (2015). Eosinophilic esophagitis. New England Journal of Medicine, 373(17), 1640-1648. https://doi.org/10.1056%2FNEJMra1502863

Janeway Jr, C. A., Travers, P., Walport, M., & Shlomchik, M. J. (2001). Effector mechanisms in allergic reactions. In Immunobiology: The Immune System in Health and Disease. 5th edition. Garland Science. https://www.ncbi.nlm.nih.gov/books/NBK27112/

Rothenberg, M. E. (2004). Eosinophilic gastrointestinal disorders (EGID). Journal of Allergy and Clinical Immunology, 113(1), 11-28. https://doi.org/10.1016/j.jaci.2003.10.047

Zuo, L., & Rothenberg, M. E. (2007). Gastrointestinal eosinophilia. Immunology and allergy clinics of North America, 27(3), 443-455.https://doi.org/10.1016%2Fj.iac.2007.06.002

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ENCORE · You’re Going To Love This Article

In the 1990’s the philosopher Haddaway posed a critical question: What is love? This Valentine’s Day, many of us will experience love and companionship. We like to think of love as an amorphous, idealistic quality, but there are serious biological underpinnings. What is the biology behind love, and is the heart really where love lies (spoiler: maybe?)

We know that the brain directs our physical actions, but for the brain to come up with an idea, it needs input from the outside world. Interestingly, the brain can’t sense anything directly. If someone were to open up your skull and have a poke around, you would undoubtedly have a weird bit of sensation, but you wouldn’t experience the feeling of touch on the brain. We need special sensors (usually located on the skin) to feel things like touch. Indeed, our brain relies on signals coming in from all over the body to tell us about the outside world. Interestingly, we also rely on signals to tell us about the inside world – what we are experiencing. The brain interprets signals from the body, and we can experience that interpretation as an emotion.

As an example: your heart beats automatically all day, every day, at a hopefully regular interval of around once a second. When you see a scary event, such as a wild lion charging you, your brain and body respond in sync. The heart rhythm changes, beating much faster to provide your muscles, sensory organs, brain, etc., extra oxygen in order to move fast. But this effect isn’t strictly rational. After we escape from the lion, we still feel “amped up.” This effect can last for thirty minutes or so, and the reason for the long-lasting effect is complicated. Our autonomic nervous system – the one in charge of things we don’t consciously control – has kicked into action. This pathway acts like cupid, shooting cortisol through our body and activating special nervous system pathways that take a while to cool down. But our brain also looks at the state of our body to interpret our emotional state. If our palms are sweaty, we’re breathing heavily, and our heart is racing, the brain interprets that as being amped up and decides we’re still pretty excited or scared. The brain is in charge of deciphering which emotion we’re feeling, but the body lets us know how strongly we’re feeling that emotion.

This is why we sometimes still feel the need to continue an argument after the other party has conceded. It’s why telling someone to “calm down” doesn’t work – but taking some deep breaths does. Meditation, stretching, exercise, and sleep all affect our emotional state because the brain looks at the condition of the body and tries to figure out how it’s feeling. In addition, a healthy heart that can respond well to changes may increase a person’s emotional regulation. Does it do this with love as well?

According to neuroendocrinology researcher Robert Sapolsky, it does! The science may not be entirely clear, but the easiest way to be certain of this is by looking at the irrationality of love. Love doesn’t make sense, and it’s so strong that we base enormous portions of our life just on this single emotion. Love is the basis of countless pieces of art, works of literature, grand buildings, and justifications for war. When we experience love – that fluttering of the heart, the excitement and elation, the involuntary smile on our face, and the giddiness so high that our mouths stop working and we say embarrassing, cheesy things – it’s the body to blame. Our heart races when we’re in love and the brain sees this as a huge exciting event – because it is. Just seeing the person we love can change our heart rate. Physical touch from a loving partner can help lower our heart rate in response to stressful situations. And the long-term effects of companionship sometimes include a partial synchronization of our heart rhythms.

We can thank our hearts for at least some of what we call love. This Valentine’s day, get your heart racing with a partner or loved one, and keep that heart beating strong!

By Benton Lowey-Ball, BS Behavioral Neuroscience

Enrolling Studies

Ditzen, B., Neumann, I. D., Bodenmann, G., von Dawans, B., Turner, R. A., Ehlert, U., & Heinrichs, M. (2007). Effects of different kinds of couple interaction on cortisol and heart rate responses to stress in women. Psychoneuroendocrinology, 32(5), 565-574. https://doi.org/10.1016/j.psyneuen.2007.03.011

Kandel, E. R., Schwartz, J. H., Jessell, T. M., Siegelbaum, S., Hudspeth, A. J., & Mack, S. (Eds.). (2000). Principles of neural science (Vol. 4, p. 980). New York: McGraw-hill.

Mather, M., & Thayer, J. F. (2018). How heart rate variability affects emotion regulation brain networks. Current opinion in behavioral sciences, 19, 98-104.

Sapolsky, RM. (various works)

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ENCORE · The Long Road Of Cholesterol Research

Cardiovascular disease has remained the number one cause of death worldwide. Multiple clinical trials have revealed that a common and modifiable risk factor for cardiovascular disease is high cholesterol, and if a person lowers their cholesterol, they can lower their risk for heart-related diseases.

Most of us have heard of cholesterol, but what is it? Why is having too much cholesterol a bad thing? How do we get cholesterol in our bodies? What can you do to lower your cholesterol to healthy levels?

Cholesterols are a broad and useful type of fat found in the body. The body needs them to create hormones, essential vitamins (like vitamin D), and other molecules. They float on the surface of our cells, helping to maintain the structure and function of cell barriers. Cholesterols regulate cell activity and act outside of cells. They insulate the neurons in our brain, allowing us to think. In fact, cholesterol is so important to daily function, that every cell in the body can make cholesterol from basic materials, except your eyelashes!

There are times when cholesterol is downright bad. LDL cholesterol and Lipoprotein a [Lp(a)] have some particularly sticky portions that can get stuck to the inside of our bloodstream. We call one of these portions ApoB. Sticky cholesterol obstructs blood flow in the form of plaques. Without help, this leads to atherosclerosis, scarring, and hardening of the arteries. Atherosclerosis further cascades into cardiovascular disease, clots, heart attacks, and stroke. This is very bad. Unfortunately, it is also very common; atherosclerosis in the neck is found in ¼ of people worldwide. Lowering excess cholesterol is a global health concern.

Our liver creates enough cholesterol to supply our bodies. We are also able to absorb cholesterol from our diets and make some in other cells. The most effective methods of reducing cholesterol are lifestyle and diet changes. However, for some people, diet and exercise don’t seem to budge their cholesterol numbers at all. For others, the ability to exercise and dietary restrictions may be limited. This is where medications can step in.

To understand how a medication may reduce LDL and/or Lp(a), we need to learn a bit about how the body makes things from DNA. Genes are bits of DNA that contain the blueprint for a protein. Genes provide the blueprint to messenger RNA (mRNA). The mRNA translates genetic code into proteins. The cells then fold proteins into complicated, machine-like shapes. Proteins interact with molecules and other proteins to create all sorts of things for the body – including cholesterol. Clinical research has been expanding which of these steps we can target for medications.

Statins are the first line treatment for reducing cholesterol. They target hydroxymethylglutaryl coenzyme A (HMG-CoA). HMG-CoA is a protein used to construct cholesterol molecules. Reducing HMG-CoA slows the body’s ability to create cholesterol, lowering cholesterol levels. Statins block the production of the “bad” LDL-C cholesterol and lower levels by as much as 60%. The benefits for statins to reduce cardiovascular events have been proven in multiple clinical trials over a diverse patient population.

Other oral medications, including ezetimibe and bempedoic acid, can be taken with statins. Ezetimibe can lower LDL-C levels by approximately 20% by inhibiting cholesterol absorption in the intestines, making it a useful add-on medication when statins alone are insufficient. Bempedoic acid can lower LDL-C by 15-25% by decreasing cholesterol synthesis in the liver. Because bempedoic acid is converted to an enzyme found only in the liver and not the muscles (like statins), it is often an alternative for patients who have statin-associated muscle myalgias.

Monoclonal antibodies (MoAbs) are a newer class of medication. MoAbs like alirocumab and evolocumab act like signaling molecules. These two stay outside of cells and tell the liver to produce less of the protein PCSK9. Controlling PCSK9 is a newer method of changing a person’s cholesterol profile. PCSK9 controls how much extra LDL cholesterol is absorbed and recycled by cells. MoAb medications affect this by targeting signaling receptors on the outside of the liver.

Even newer medications target the process by which genes get turned on inside the cells. They are called gene silencing therapies because they aim to “silence” the gene’s effects. Antisense oligonucleotides (ASOs) and small interfering RNA (siRNA) stop the liver from producing functional LDL or Lp(a) mRNA molecules. These act at different, very early stages of the cholesterol process. In addition, specialized packaging on the medications deliver them to the liver and not other cells. This can make for very targeted medications that (hopefully) have fewer side effects.

Inclisiran is the first FDA-approved siRNA therapy to lower LDL cholesterol. It is a subcutaneous injection taken twice a year. Imagine going to your physician’s office just twice a year to get your “cholesterol vaccine”!

Even more amazing, gene editing tools such as CRISPR could reduce overexpression of PCSK9 or other genes on a long-term basis. These are still in early phase trials, but the future is looking bright.

Lipoprotein a,or “L-P-little-a”, or Lp(a), is a new target for decreasing the risk of cardiovascular disease. Lp(a) is genetically inherited and increases the risk for both heart disease and stroke because it can promote plaque buildup, blood clots, and inflammation. New gene silencing therapies are in clinical trials right now using both ASO and siRNA technology.

Diet, lifestyle changes, and statins remain the front-line defense against high cholesterol. New medicines may work with or replace these classical defenses. As technologies move through the clinical research apparatus, we may be able to tailor custom combinations of medications for individual patients. ENCORE Research Group has been involved in every step along this path, helping to study medications in every category. Join our team and help pave the way for new medications to help combat high cholesterol!

Enrolling Studies

Sources:

Craig, M., Yarrarapu, S. N. S., & Dimri, M. (2018). Biochemistry, cholesterol. https://www.ncbi.nlm.nih.gov/books/NBK513326/

Fernandez-Prado, R., Perez-Gomez, M. V., & Ortiz, A. (2020). Pelacarsen for lowering lipoprotein (a): implications for patients with chronic kidney disease. Clinical Kidney Journal, 13(5), 753-757. https://doi.org/10.1093%2Fckj%2Fsfaa001

Prati, P., Vanuzzo, D., Casaroli, M., Di Chiara, A., De Biasi, F., Feruglio, G. A., & Touboul, P. J. (1992). Prevalence and determinants of carotid atherosclerosis in a general population. Stroke, 23(12), 1705-1711. https://doi.org/10.1161/01.str.23.12.1705

Tokgözoğlu, L., & Libby, P. (2022). The dawn of a new era of targeted lipid-lowering therapies. European Heart Journal. https://doi.org/10.1093/eurheartj/ehab841

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ENCORE · Understanding And Managing High Triglycerides.mp3

The Role of Apolipoprotein C-III (apoC-III) in Atherosclerosis and Cardiovascular Disease

After we eat a meal, all that energy has to go somewhere. Body cells can use freely floating glucose sugar in the bloodstream, but fats are a bit trickier. Just like oil and water don’t mix, fats have trouble moving through the blood in our veins and arteries. They must be packaged inside special containers called lipoproteins in order to travel where they need to go. For fats that we eat, the fats (called triglycerides) are packaged into ultra-low-density chylomicrons by the digestive system. Our liver also processes and repackages fats. The liver makes very low-density lipoproteins (VLDL) out of triglycerides and ejects them into the bloodstream. VLDLs can then use the bloodstream to travel to fat cells or be converted into other forms of energy storage. The number of triglycerides in the bloodstream at once needs to be well regulated.

For adults, fasting triglyceride levels should be under 150 mg/dL. This number decreases to below 90 mg/dL for people under 19 years of age. Unfortunately, one in ten adults have high levels, called hypertriglyceridemia. When there are too many triglycerides, they can stick to the inside of the bloodstream. They can create and contribute to hard plaques, a condition called atherosclerosis. These put stress on the cardiovascular system and can lead to atherosclerotic cardiovascular disease (ASCVD). Very high triglycerides above 500 mg/dL is called severe hypertriglyceridemia. This can lead to even more problems, including chylomicronemia, pancreatitis, and death.

What contributes to high triglyceride levels? A lot, actually! A diet that is high in sugars and fats, excessive alcohol consumption, being overweight, and a sedentary lifestyle can contribute. Some conditions, such as diabetes, kidney and liver disease, and thyroid problems increase your chances. Anything that affects liver function is likely to change how the body processes fats and may increase triglycerides. This means some life-saving medications, including several cancer, hypertension, and HIV treatments may increase triglycerides. Some people have high or very high triglycerides – usually in the form of chylomicrons – even without these risk factors. This may be because of our genes.

One of the major genetic culprits for increased triglycerides is a gene called APOC-3. This gene codes for a protein of the same name: Apolipoprotein C-III (apoC-III). You can tell these apart because the gene is uppercase, italicized, and uses a (3), while the protein is mostly lowercase and uses roman numerals (III). The protein apoC-III can lead to some detrimental effects. Normal triglycerides bind to a different protein, apoC-II. This helps them get broken down in the bloodstream. ApoC-III binds to triglycerides in the same place as apoC-II but makes them less able to be processed. These triglycerides build up in the bloodstream and can cause atherosclerosis and ASCVD. Scientists also have evidence that apoC-III makes triglyceride-rich molecules stickier to the arteries. ApoC-III binds to chylomicrons very well, making these fats especially resistant to breaking down.

So why do we have apoC-III anyway? It turns out, not all of us do! Different people have different variations of the APOC-3 gene. Some people have a gene that produces excessive apoC-III protein, and a few have genes that produce none! People with defective APOC-3 genes seem to be just as healthy as everyone else. Maybe healthier, as their levels of triglycerides are very low, even after a fatty meal! Researchers consider a defective APOC-3 gene to be cardioprotective, meaning that it lowers the chances of heart disease.

Are there methods for us to lower the production of apoC-III and our triglyceride-rich chylomicrons? It looks possible. The liver produces more apoC-III in response to high levels of blood sugar and most fats, so lowering these may help. It decreases production of apoC-III when it encounters high levels of insulin or polyunsaturated fats (such as Omega-3 fatty acids). This may be helpful, but is bad news for those with type 2 diabetes. In these patients the bloodstream has extra glucose and lacks insulin.

Treating high triglycerides can be complicated. A diet low in alcohol, carbs, and fats but high in omega-3 fatty acids can help. Exercise and weight loss are often helpful. Doctors may also prescribe fibrates, nicotinic acid (niacin), or statins. Unfortunately, these medications may not work if you have excessive levels of apoC-III and high chylomicrons. A diet that is very low in fats – under 20 grams a day – has been the only option for some patients. New classes of medication may be helpful as well. Antisense oligonucleotides, gene therapy, and custom antibodies can be used to target the production of specific proteins. Antisense oligonucleotides, for instance, bind to APOC-3 mRNA in the cell, preventing it from creating apoC-III proteins. They do this with extreme specificity, targeting only the gene in question. They can also do this only in liver cells by being packaged in a special way. Drugs that target apoC-III production may be able to bring down otherwise stubbornly high triglycerides without too many side effects. A side effect of being on this ENCORE Research Group mailing list is learning about these new medicines and when they may be available for you in a trial!

Enrolling Studies

Sources:

Alves-Bezerra, M., & Cohen, D. E. (2017). Triglyceride metabolism in the liver. Comprehensive Physiology, 8(1), 1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6376873/

Goldberg, R. B., & Chait, A. (2020). A comprehensive update on the chylomicronemia syndrome. Frontiers in endocrinology, 11, 593931. https://doi.org/10.3389/fendo.2020.593931

National Institute of Health, National Heart, Lung, and Blood Institute. (April 7, 2022). High blood triglycerides. U.S. Department of Health and Human Services. https://www.nhlbi.nih.gov/health/high-blood-triglycerides

Rahmany, S., & Jialal, I. (July 18, 2022). Biochemistry, Chylomicron. https://www.ncbi.nlm.nih.gov/books/NBK545157/

Taskinen, M. R., Packard, C. J., & Borén, J. (2019). Emerging evidence that ApoC-III inhibitors provide novel options to reduce the residual CVD. Current atherosclerosis reports, 21(8), 1-10. https://doi.org/10.1007/s11883-019-0791-9

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ENCORE · Sweet Ways To Measure Blood Sugar

In fifth grade, I learned that mitochondria are the powerhouses of the cell. But what’s the fuel? The answer is carbohydrates. Big carbohydrates are broken down by digestion and converted into a couple of simple sugars. The most abundant of these simple sugars in our bodies is glucose.

Glucose is small, simple, and packed with energy. We transport it through our bloodstream to cells in our body. Glucose levels are regulated by the liver and pancreas. Unfortunately, conditions like diabetes can result in the dysregulation of blood glucose levels. Having too much sugar in the blood is very bad over time. It can result in damage to the eyes, kidneys, nerves, and heart. On the flip side, having low blood sugar can get dangerous right away. Glucose is the fuel that powers our cells, without it the brain and other organs can’t function.

We know that glucose is critical to body function. We also know that glucose levels can get out of control. What can we do to make sure glucose levels stay safe? The most important piece of the puzzle is information. Good information on what our blood glucose levels are is critical to know what to do. We get this information by testing our blood glucose levels. There are three major ways of testing blood glucose; chemical redox reactions, color change, and enzyme-based reactions.

Chemical redox reaction testing works because glucose reacts with metals. By measuring how the metals react to blood, we can indirectly measure the amount of glucose. Unfortunately, other chemicals in the blood react to metal as well and can complicate the results. This method is rarely used these days.
The second method is through color change. This method combines blood and a special chemical called o-Toluidine. The o-Toluidine reacts to a specific part of the glucose molecule and changes it to be bright green (normally it is white or colorless). We can measure the color change visually, using test strips or with a digital glucose meter. Color change is cheap and effective, but the o-Toluidine can react to other sugars and give distorted results.
The industry standard for the last few decades has been enzyme-based reactions. A special enzyme, usually glucose oxidase or glucose dehydrogenase reacts with blood. This enzyme is very specific and only reacts to glucose. A result of this reaction is the production of H2O2, hydrogen peroxide. This is easily measured by digital devices. This method is inexpensive and specific, giving good results.

Now we know the chemical methods of measuring glucose, but how do we actually test our glucose level? Three broad testing types exist: oral, self-test, and continuous glucose monitors. These are differentiated mainly by the frequency and invasiveness of the test.

Oral tests are a lengthy and (frankly) pretty gross affair. You fast for several hours, then drink an offensively sweet beverage and wait another hour. Blood is drawn and tested to determine how well your body can break down and clear the glucose from the bloodstream.
Self-tests involve drawing blood and putting it on a strip or in a digital detector. This is quick and can be done many times a day if needed. Unfortunately, repeated pricks can be annoying and you can’t test overnight unless you wake up.
Continuous glucose monitors (CGMs) are worn like a patch and have a tiny sensor that goes just under the skin into the interstitial space and sends results to an external monitor. This tests blood glucose constantly, typically reporting every 1-5 minutes. CGMs can let people know their glucose via a phone app or external device.

As the old saying goes, knowledge is power! With the help of the latest CGM technology, we are able to see information in real-time such as how food, exercise, and stress impact glucose levels. This helps us take immediate action to manage our glucose levels. So, take action to keep your blood glucose in the healthy range with your new knowledge, a good diet, and consistent exercise. Make sure it stays there by monitoring your blood glucose levels regularly. Keep your eyes open to look for new studies looking at ways to monitor your blood glucose and keep your cells powered up!

Enrolling Studies

Sources:

American Diabetes Association (n.d.). Understanding A1C diagnosis. American Diabetes Association. https://diabetes.org/diabetes/a1c/diagnosis

McMILLIN, J. M. (1990). Blood glucose. Clinical Methods: The History, Physical, and Laboratory Examinations. 3rd edition. Chapter 141. https://www.ncbi.nlm.nih.gov/books/NBK248/

Wang, H. C., & Lee, A. R. (2015). Recent developments in blood glucose sensors. Journal of food and drug analysis, 23(2), 191-200. https://doi.org/10.1016/j.jfda.2014.12.001

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ENCORE · Smoking Changes Your Brain

Cardiovascular disease (CVD) is the leading cause of death in the United States. There are several risk factors for cardiovascular disease. This can include things you can’t change, such as sex, age, and genetics. They can also include things you can change. The WHO identifies four big behaviors that can change your risk of developing CVD:

Poor diet
Low exercise
Excessive alcohol consumption
Smoking

These behaviors generally lead to other undesirable indicators of health, including obesity, hypertension, high blood sugar, and increased cholesterol. Clearly, ceasing the behavioral risks is a high priority. Unfortunately, this is often easier said than done.

One of the most difficult habits to quit is smoking. Studies show that those attempting to quit without assistance have an over 90% relapse rate. Several medications exist to help quit smoking, including Bupropion SR (aka Wellbutrin) and Varenicline (aka Chantix). There are also nicotine-based alternatives, including gum, inhalers, lozenges, nasal sprays, and patches. Nicotine rewires the brain as it’s consumed. It releases dopamine, the brain’s reward drug, and rewards us for smoking. Researchers think the frequency of smoking may be partially to blame for the intensity of the addiction. The amount of dopamine released is not particularly high compared with other drugs, but nicotine also causes changes to the striatum. The striatum is part of the reward circuit in the brain. Through a complicated mechanism, nicotine increases the amount of a protein called FosB, which changes the striatum’s sensitivity to dopamine. This is a change at the genetic level which makes the brain more susceptible to further reward signals. Nicotine seems to make normal activities more pleasurable. Unfortunately, as nicotine adjusts the brain’s mechanisms, the brain relies on it to get to a baseline of reward. Upon quitting smoking, the brain finds normal activities less enjoyable.

On its own, nicotine may have negative effects, and in heavy doses it has been shown to be dangerous. The biggest dangers of smoking, however, are likely in the myriad of other chemicals in tobacco and cigarettes. Though nicotine causes changes in the brain, cigarettes cause changes to the fats in your body, further increasing CVD risk. Along with this, cigarettes cause cancer, COPD, diabetes, erectile dysfunction, and immune system changes. Clearly, quitting smoking is critical to health. With the addictive nature of nicotine and the low success rate of quitting cold turkey, assistance may be needed.

The brain gets addicted to nicotine, but we can fight back using behavior. You can actually help yourself “break the cycle” of nicotine addiction by changing your daily routines. For example if the first thing you do in the morning is reach for a cigarette, change your routine to going to the bathroom and brushing your teeth first instead. Behavioral interventions can make a significant difference. Combining behavior changes and counseling with a nicotine replacement or medication can help quit rates approach 30%. Indeed, nicotine replacements are most effective when used with behavioral interventions.

Changing your behavior or routine can have positive impacts on your health. So next time you want to reach for a cigarette, grab your phone instead! Give us a call and discover what clinical trials you can take part in!

Enrolling Studies

Sources:

Bancej, C., O’Loughlin, J., Platt, R. W., Paradis, G., & Gervais, A. (2007). Smoking cessation attempts among adolescent smokers: a systematic review of prevalence studies. Tobacco control, 16(6), e8-e8. https://doi.org/10.1136%2Ftc.2006.018853

Fiore, M. (2008). Treating tobacco use and dependence; 2008 guideline. https://stacks.cdc.gov/view/cdc/6964/cdc_6964_DS1.pdf

Garbin, U., Fratta Pasini, A., Stranieri, C., Cominacini, M., Pasini, A., Manfro, S., … & Cominacini, L. (2009). Cigarette smoking blocks the protective expression of Nrf2/ARE pathway in peripheral mononuclear cells of young heavy smokers favouring inflammation. PloS one, 4(12), e8225. https://doi.org/10.1371/journal.pone.0008225

Koren, M. (Host). (2022, May 22). Nicotine replacement therapies to help stop smoking [Audio podcast episode]. In Medevidence! Truth behind the data. ENCORE Research Group. https://www.buzzsprout.com/1926091/10484183-nicotine-replacement-therapies-to-help-stop-smoking

Messner, B., & Bernhard, D. (2014). Smoking and cardiovascular disease: mechanisms of endothelial dysfunction and early atherogenesis. Arteriosclerosis, thrombosis, and vascular biology, 34(3), 509-515. https://doi.org/10.1161/ATVBAHA.113.300156

NIDA. (2018, September 28). Recent Research Sheds New Light on Why Nicotine is So Addictive. https://nida.nih.gov/about-nida/noras-blog/2018/09/recent-research-sheds-new-light-why-nicotine-so-addictive

US Department of Health and Human Services. (2014). The health consequences of smoking—50 years of progress: a report of the Surgeon General. https://www.ncbi.nlm.nih.gov/books/NBK294320/

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ENCORE · Don’t Drop The Ball On Your New Year’s Resolution

We humans seem to like making a fresh start. Whether it’s the beginning of a semester, a month, or a week, we like having a “clean slate” to make changes. The most widely used of these fresh start times are at the beginning of the year, with a New Year’s Resolution. Over 40% of all Americans make New Year’s resolutions, but much like a firework, we make a bright claim with a loud noise, only for it to burn out quickly as the year goes on. How can we make good resolutions that we are likely to follow, and are there strategies we can use to help us follow through?

Probably the most important piece of a New Year’s Resolution is coming up with a good resolution in the first place! Surveys show that around two-thirds of all resolutions are health-oriented, including eating healthier, exercising, getting in shape, etc. Psychological studies have shown that the wording of your resolution matters. Most resolutions can be broadly lumped into either activation or avoidance goals. Activation goals are those that encourage you to do something: exercise more, eat more greens, etc. Avoidance goals are those that encourage you to not do something: watch less TV, eat less pizza, etc. Several studies have shown that activation goals are significantly more likely to be successful than avoidance goals

Sometimes our end goal is to decrease something: to lose weight, stop smoking, or eat slightly fewer cookies. In order to increase chances of success, it can be helpful to reimagine these goals as activation goals. Instead of losing weight, we can aim to exercise four days a week. Instead of stopping smoking, we can try to chew gum daily. Instead of eating fewer cookies, we can try to do some push-ups instead. When trying to avoid negative things, it can be hard to find rewards and easy to identify failures. By trying to do positive things, we can enjoy the reward of achieving our goal incrementally. Even small changes can help. Instead of “I resolve to eat no cookies this year” we can set the goal as “I resolve to do a push-up instead of eating a cookie every day.” Eventually, we will focus more on the positive action, the push-up, than the negative one, the cookie. This way our brain will spend more time focusing on the things we resolve to do!

When we follow through on a resolution, we are making a behavioral change. These changes are governed by our brain, and mimic changes within it. Some of our most popular resolutions correspond to changes in our reward pathway, called the mesocorticolimbic circuit. This contains several brain structures and is a part of the brain that is hijacked by addictive drugs. Two structures in particular, the nucleus accumbens and striatum, seem to be affected by things like resolutions. Addictive things including sugar decrease these areas’ sensitivity to naturally occurring dopamine. This makes the brain need more and more of those items to find the same level of reward. Lowering sugar, drugs, and alcohol can help restore the dopamine receptors and give your brain a fighting chance. Studies have also shown that exercise increases dopamine sensitivity of the mesocorticolimbic circuit, giving some protection against addictive undesirable behaviors. Other behaviors that we do frequently and repetitively will also make changes to the brain’s pathways, reinforcing the behaviors.

So now we know how to structure our resolutions, and how our brain responds to changes, but what can we do to make sure we don’t give up on our resolutions? The most important change is a lifestyle change. This is true with resolutions, but also with weight loss medications, smoking cessation, etc. Changing the triggers for what you want to avoid makes it easier to do the activities you desire. Even small changes – like sitting in a different chair than your preferred cookie-binge recliner – can make the process easier. Along with this, we want to make sure we have strategies to deal with tempting situations. If work has cookies on Fridays, drinking a lot of water can fill your stomach and help alleviate the temptation. Unexpected situations can also arise. If your mother invites you for afternoon tea and biscuits – only for you to learn that “biscuit” is British for “cookie”- having a plan to politely decline can be very handy. Finally, realize that resolutions aren’t all-or-nothing. If I succumb to chocolatey chip temptation and eat a cookie today, it doesn’t mean I’ve failed at my resolution and should give up. Instead of looking at hiccups as failures, look at them as learning opportunities. These are great opportunities to learn what triggered your lapse and practice a strategy to act positively and avoid this trigger in the future.

Taken together we have solid starting points for our resolutions. Resolve to do positive actions that you want to accomplish. Structure resolutions to be activation based and give yourself opportunities to celebrate success instead of regretting failure. Give yourself the advantage of changing your lifestyle to accommodate and incentivize your resolution. Give yourself a break when you miss a day and learn how to move forward better tomorrow. When we resolve to do things we want to do, we only have to countdown the days until we celebrate another New Year and a successful resolution!

Written by Benton Lowey-Ball, BS Behavioral Neuroscience

Enrolling Studies

Sources:

Larimer, M. E., Palmer, R. S., & Marlatt, G. A. (1999). Relapse prevention. An overview of Marlatt’s cognitive-behavioral model. Alcohol research & health : the journal of the National Institute on Alcohol Abuse and Alcoholism, 23(2), 151–160. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6760427/

Oscarsson, M., Carlbring, P., Andersson, G., & Rozental, A. (2020). A large-scale experiment on New Year’s resolutions: Approach-oriented goals are more successful than avoidance-oriented goals. PLoS One, 15(12), e0234097. https://doi.org/10.1371/journal.pone.0234097

Trifilieff, P., & Martinez, D. (2014). Imaging addiction: D2 receptors and dopamine signaling in the striatum as biomarkers for impulsivity. Neuropharmacology, 76 Pt B(0 0), 498–509. https://doi.org/10.1016/j.neuropharm.2013.06.031

Wimmer, S., Lackner, H. K., Papousek, I., & Paechter, M. (2018). Goal orientations and activation of approach versus avoidance motivation while awaiting an achievement situation in the laboratory. Frontiers in psychology, 9, 1552. https://doi.org/10.3389/fpsyg.2018.01552

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ENCORE · Does Chocolate Really Have Health Benefits

Most of us have heard by now that chocolate is healthy, or that a small amount is healthy, or that you can eat an infinite amount of chocolate and it will be healthy forever. Where do these claims come from, and do they add up?

There is evidence of people consuming chocolate up to 1600 years ago. It is native to the Americas and was said to be the “food of the gods” in mesoamerica. Today we think of chocolate as sweet and delicious and the perfect food, but this was not always the case. Chocolate is thought to have originally been mixed with water and drunk as a bitter, spiced beverage. During the 1500’s chocolate was brought to Europe, where it was considered as exotic as Mars. Healers claimed chocolate healed diseases of the liver and stomach, and that it could help with fever.

By 1631, chocolate had changed. Adding sugar was now typical, and the prescriptions for chocolate had changed as well. Chocolate in this era was used to help gain weight (likely due to sugar), stimulate the brain (likely due to caffeine), and aid in digestion.

Ironically, the same benefits chocolate seemingly presented to chronically underweight pre-industrial people has become a bit of a problem for us. By the mid to late 1800’s there were investigations into the health problems associated with chocolate’s additives – milk and sugar. They found that regularly eating fatty, sugary foods might not be healthy. By the 1900’s chocolate began to be associated with obesity, tooth decay, gum disease, etc. The “dark” chocolate age had begun.

By the early 2000’s, the opinion pendulum on chocolate had begun to swing back. Individual components of chocolate, such as flavanols, methylxanthines (Methyl-zan-theens) and polyphenols were shown to be beneficial to heart function in a lab. Since then there have been claims that chocolate helps everything from cardiovascular problems to metabolic ones and even cancer. It looked like chocolate was on a holiday high in medical opinion.

Unfortunately, these results may have been candy-coated. Research trials haven’t shown as much benefit as in the lab. One sweet spot picked up by newspapers was an observational meta-study which looked at over 300,000 participants. This study looked for an association between chocolate consumption and coronary artery disease (CAD). They found that people who ate chocolate more than once a week (or more than 3½ times a month) had a significantly lower incidence of CAD, heart attack, heart failure, and acute coronary syndrome. It is important to note that this was not an interventional study, and only looked at associations. Additionally, this didn’t take into account the type of chocolate eaten. Finally, this study found that some negative indicators actually rose, likely due to the extra calories from fats and sugars added to chocolates.

The best way to look for health benefits or drawbacks of any medicine is to do an interventional experiment – a clinical trial. This is where you compare groups randomly assigned to take chocolate or a placebo. An examination of 15 such studies where chocolate was the medicine sadly found few benefits. These studies looked for changes in:

Skin condition
Weight / BMI
Blood glucose
Blood pressure
Cholesterol
Cognitive function

When looking at all 15 studies, there was no significant change in any of these indicators. The only significant change across studies was a decrease in triglycerides. This can be helpful, as high triglycerides can be a risk factor for CAD, stroke, and pancreatitis. Overall, however, chocolate doesn’t appear to be the miracle drug it’s been touted as for the last millennium and a half. As we have learned countless times, using randomized clinical (interventional) trials is the best and often only way to discover if medicines have the effects people claim!

Interventional trials are conducted at clinical research organizations such as ours, ENCORE Research Group. We are a premier clinical research organization that has conducted more than 2,500 clinical trials over 25 years and has worldwide recognition for providing patients access to cutting edge medical research.

Written by Benton Lowey-Ball, BS Behavioral Neuroscience

Enrolling Studies

Sources:

Krittanawong, C., Narasimhan, B., Wang, Z., Hahn, J., Virk, H. U. H., Farrell, A. M., … & Tang, W. W. (2021). Association between chocolate consumption and risk of coronary artery disease: a systematic review and meta-analysis. European journal of preventive cardiology, 28(12), e33-e35.https://doi.org/10.1177/2047487320936787

Lippi, D. (2015). Sin and pleasure: the history of chocolate in medicine. Journal of agricultural and food chemistry, 63(45), 9936-9941.

Montagna, M. T., Diella, G., Triggiano, F., Caponio, G. R., Giglio, O. D., Caggiano, G., … & Portincasa, P. (2019). Chocolate,“food of the gods”: History, science, and human health. International Journal of Environmental Research and Public Health, 16(24), 4960. https://doi.org/10.3390/ijerph16244960

Tan, T. Y. C., Lim, X. Y., Yeo, J. H. H., Lee, S. W. H., & Lai, N. M. (2021). The health effects of chocolate and cocoa: A systematic review. Nutrients, 13(9), 2909. https://doi.org/10.3390/nu13092909

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ENCORE · The Science of Gift Giving

With the onset of frosty weather and short days, we can all use a boost. Luckily, giving gifts can produce a “warm glow” to help out. This isn’t just decorative talk, giving gifts has been shown to increase well-being in people across the globe. In study after study, psychologists have found that acts of kindness, such as giving gifts, have positive results on both the receiver and the giver.

In one study, scientists gave children treats while measuring happiness. The children were then asked to give treats to a puppet. These could be their own treats or ones from a researcher’s supply. The data showed the children were happier to give a treat to the puppet than to receive one for themselves and were happiest when they gave their own treat to the puppet. Overall, the cheer of giving seemed maximized when giving away more important gifts.

Why could this be, though? Why would gift giving be beneficial for the person losing something? Could it be that giving a gift clears your already extremely crowded gingerbread house and increases your Feng shui? The real answer is that gift giving is a prosocial behavior. This means that it promotes social acceptance and friendship. This is a positive behavior in social contexts. Prosocial behaviors are seen in several social animals, including apes and dogs.

Scientists have shown that giving gifts can increase synchronization between friends. In two studies, scientists hooked pairs of friends up to brain scanning devices. The friends performed cognitive tasks, then one would give the other a gift (at a random time), and they would perform the task again. The scientists found that accuracy on the tasks increased. In addition, activity increased in the dorsolateral prefrontal cortex (DLPFC). This is part of the brain located beneath the hairline (assuming you have hair). It is associated with decision making and memory, and is also implicated in suppressing selfishness and building relationships. This helps with cognitive tasks, but also with forming and maintaining friendships. Even more interesting, they found that the brain waves of friends were synchronizing! The brainwaves measured in the DLPFC would “sync up” and produce similar patterns after gift giving! Giving a gift doesn’t just increase friendship, it helps you think like your friends too!

The DLPFC isn’t the only section of the brain that’s active when giving. When giving to charity, people’s mesolimbic reward system and subgenual areas activate. The mesolimbic reward system is a general reinforcement pathway in the brain, and also rewards for things like food, sex, and drugs. The subgenual area releases important hormones such as oxytocin (the love hormone) and vasopressin. These make us feel good and increase our social happiness.

So this winter, give gifts to keep yourself warm inside and out. By giving gifts you can increase your own happiness, strengthen bonds with friends, and release dessert-like chemicals in the brain. Also, consider giving the gift of health to others by volunteering for a clinical trial at one of our ENCORE Research Group locations.

By Benton Lowey-Ball, BS Behavioral Neuroscience

Enrolling Studies

Sources:

Aknin, L. B., Barrington-Leigh, C. P., Dunn, E. W., Helliwell, J. F., Burns, J., Biswas-Diener, R., … & Norton, M. I. Prosocial Spending and Well-Being: Cross-Cultural Evidence for a Psychological Universal.https://doi.org/10.1037/a0031578

Aknin, L. B., Hamlin, J. K., & Dunn, E. W. (2012). Giving leads to happiness in young children. PLoS one, 7(6), e39211. https://doi.org/10.1371/journal.pone.0039211

Balconi, M., Fronda, G., & Vanutelli, M. E. (2019). A gift for gratitude and cooperative behavior: brain and cognitive effects. Social cognitive and affective neuroscience, 14(12), 1317-1327. https://doi.org/10.1093/scan/nsaa003

Balconi, M., Fronda, G., & Vanutelli, M. E. (2020). When gratitude and cooperation between friends affect inter-brain connectivity for EEG. BMC neuroscience, 21(1), 1-12.

Curry, O. S., Rowland, L. A., Van Lissa, C. J., Zlotowitz, S., McAlaney, J., & Whitehouse, H. (2018). Happy to help? A systematic review and meta-analysis of the effects of performing acts of kindness on the well-being of the actor. Journal of Experimental Social Psychology, 76, 320-329. https://doi.org/10.1016/j.jesp.2018.02.014

Moll, J., Krueger, F., Zahn, R., Pardini, M., de Oliveira-Souza, R., & Grafman, J. (2006). Human fronto–mesolimbic networks guide decisions about charitable donation. Proceedings of the National Academy of Sciences, 103(42), 15623-15628. https://doi.org/10.1073/pnas.0604475103

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ENCORE · This Article Contains No Fibs About AFib

The familiar wub-dub of the heart accompanies us throughout our lives, providing a gentle beat that keeps us alive. But for some of us, the beat might not be so steady. For 33 million people worldwide, the heartbeat lacks a rhythm at all. It sounds like shoes in a clothes dryer and gets progressively worse. This is called Atrial Fibrillation, or AFib for short. The risks of AFib increase with age, and there is a genetic component as well. Other risk factors include:

Heart failure
Ischemic (low blood flow) heart disease
High blood pressure
Diabetes
Obesity
Sleep Apnea

In order for AFib to occur, doctors believe there needs to be a trigger and a substrate. A trigger, or driver, is the electric signal that travels to the heart and initiates an arrhythmic event. This can be from several areas, but is frequently from one of the big pulmonary veins that carry oxygen to the heart. A substrate is the underlying condition that makes a sustained event possible and could be structural or electrical. Common substrates include the electrical system of the heart, dilation (or stretching) of the atrium, cellular-molecular changes, and/or an increase in disruptive cells called fibroblasts. In general, many or all of these changes would occur, leading to constant AFib.

AFib is very dangerous. Other than a wonky pulse, there are three major complications: heart failure, stroke, and myocardial infarction (a heart attack). Heart failure is when the heart can’t pump enough blood, while stroke and myocardial infarction can be caused by stray blood clots. Heart failure is both a risk and a symptom, which illustrates one way in which AFib is a progressive disease. Through complicated electric and biocellular mechanisms, long term AFib seems to cause more AFib.

Treating AFib has proven difficult. It is effective to treat the underlying risk factors, such as obesity and diabetes, but this is difficult and the actual cause of AFib isn’t always clear. Controlling the rhythm of the heart is also tough and risky, as messing with heart rhythm can easily lead to big problems. Atrial fibrillation ablation is an effective treatment. It is an intensive surgical procedure where doctors scar problem areas to reduce electrical activity. Even with this method, the risk of resurgence is over 30% after 5 years.

Two of the biggest complications of AFib are related to blood clots. Because of this – and the difficulty of other treatments – major pharmaceuticals often target thromboembolisms, or clots. The clotting system itself is very complicated. A simple version is that platelets activate and produce several enzymes. These enzymes make thrombin, which makes a big mesh-like protein called fibrin. This would be a slow process, except that thrombin also activates amplifier enzymes, which makes this process very fast. The fibrin then catches red blood cells and blocks wounds – or blood vessels. When these clots travel to the brain they can cause a stroke. When they restrict blood flow to the heart they can cause a myocardial infarction – a heart attack.

Classic anticoagulants, such as Warfarin (also called Jantoven and Coumadin) work by stopping the clots before they start. These are Vitamin K dependent anticoagulants and can be effective at reducing clots. Unfortunately, they are occasionally too effective. The biggest side effect of Vitamin K dependent anticoagulants is increased bleeding. This can be a serious problem for several patients, including high-risk older patients.

Doctors are investigating new classes of medications which do not depend on vitamin K. These are called Non-vitamin K oral anticoagulants (NOACs) and some target the amplification pathway of clotting instead. There are currently four FDA-approved NOAC drugs on the market; dabigatran (Pradaxa), rivaroxaban (Xarelto), apixaban (Eliquis), and edoxaban (Savaysa). Thrombin and fibrin still get produced and some clotting can occur, but the rapid amplification is shut down. The hope is that this can allow the body to repair trauma and stop external bleeds without building internal clots from AFib. With your help and participation in clinical trials, we can push science without pushing clots.

By Benton Lowey-Ball, BS Behavioral Neuroscience

Enrolling Studies

Sources:

Iwasaki, Y. K., Nishida, K., Kato, T., & Nattel, S. (2011). Atrial fibrillation pathophysiology: implications for management. Circulation, 124(20), 2264-2274. https://doi.org/10.1161/CIRCULATIONAHA.111.019893

Wijesurendra, R. S., & Casadei, B. (2019). Mechanisms of atrial fibrillation. Heart, 105(24), 1860-1867. http://dx.doi.org/10.1136/heartjnl-2018-314267

Vann, M. R. (May 10, 2013) The Sound of an Afib Heartbeat. Everyday Health. https://www.everydayhealth.com/heart-health/sound-of-afib-heartbeat.aspx

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ENCORE · The Difficulties of C.difficile

Clostridioides difficile, C. difficile, or just C. diff is a particularly nasty bacteria that can make us very sick. The bacteria itself has the name difficile because it was difficult to isolate and study when it was first discovered. Forms of the problem bacteria are found all over the environment, but most can’t make us sick. The organism itself doesn’t kill cells like a virus; instead, it can produce toxins that can kill cells in the gut. C. diff has over 800 different strains, but only a few produce dangerous toxins. Overall, C. diff causes dangerous infections in hundreds of thousands of patients each year.

Several people have C. diff inside their gut already, but it doesn’t cause them problems. Other bacteria in our gut can outcompete C. diff and keep it from causing damage. Unfortunately, one of the biggest medical breakthroughs, antibiotics, can destroy these helpful bacteria and allow C. diff to start running amok. In fact, any kind of immunosuppression can increase your risk of developing C. diff, including HIV/AIDS medications and those used after organ transplants. Being above 65 years old is another large risk factor. Close contact with some animals, like pigs, can also pose a risk. The most dangerous forms of C. diff are spread from person to person. This occurs with our most vulnerable populations: those in hospitals and those in elderly care. Due to the innate nature of care, people in hospitals and care homes can be exposed to C. diff unknowingly.

How does C. diff survive in the notoriously clean hospital environment? The bacteria has a special trick up its sleeve; it can become dormant – and almost invincible. C. diff has two life cycle stages, the spore and vegetative stage. While in the spore stage, C. diff is inactive. It doesn’t need to eat or breathe. While in this stage it can survive in the environment, the stomach, through most antibiotics, and through alcohol washes. When a C. diff spore makes it into our gut, however, trouble can begin. It germinates in the duodenum – the part of the intestine connected to the stomach. Here it transforms into the vegetative stage. In the vegetative stage, C. diff is active. It can’t survive the stomach or in oxygen, but thrives in the intestines. Here it grows and reproduces. This is also where some strains produce dangerous toxins.

The toxins of C. diff can produce a host of issues. The toxins can degrade and kill intestinal cells and cause inflammation of the intestines. Major symptoms are diarrhea, inflammation of the gut, and tissue necrosis (cell death). Other symptoms can include:

Fever
Tenderness and pain in the stomach
Loss of appetite and nausea
A severely dilated colon (toxic megacolon)
Sepsis (severe infection response)
Death

So what can be done to fight C. diff? The first line of defense is the simplest: wash your hands! Prevention is the strongest barrier: avoid close contact with people who have an active infection and wash clothes and linens regularly. A medical professional (who should be wearing gloves!) can monitor any antibiotics an infected person is currently taking and might suggest probiotics. Some specific antibiotics target C. diff, including Metronidazole, Vancomycin, and Fidaxomicin. These may have unpleasant side effects, but can be effective. Treatments available include fecal microbiota transplantation (FMT), antitoxins, new antibiotics, and injectable antibodies. Additionally, prophylactics that can help protect the gut and vaccines against the dangerous toxins are in development. Keep an eye out, and with your participation in clinical trials, we can help protect those at the highest risk from C. diff!

By Benton Lowey-Ball, BS Behavioral Neuroscience

Enrolling Studies

Sources:

Dayananda, P., & Wilcox, M. H. (2019). A review of mixed strain Clostridium difficile colonization and infection. Frontiers in microbiology, 10, 692.https://doi.org/10.3389/fmicb.2019.00692

Smits, W. K., Lyras, D., Lacy, D. B., Wilcox, M. H., & Kuijper, E. J. (2016). Clostridium difficile infection. Nature reviews Disease primers, 2(1), 1-20. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5453186/

U.S. Department of Health & Human Services/Centers for Disease Control and Prevention (September 7, 2022). What is C. diff https://www.cdc.gov/cdiff/what-is.html

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ENCORE · Heart Failure, Don’t Miss the Signs

When EMTs arrive on the scene of an emergency, they have to remember their ABCs. These are Airway, Breathing, and Circulation. The absolute top priority for any patient is to ensure they have an open airway to breathe, that air is entering the lungs, and that the heart is pumping blood to the brain and other organs. This is also the most important thing our body does in daily life as well. We can go weeks without food, days without water, hours without ice cream, and minutes without oxygen.

In order to get oxygen from the lungs to our brain and organs, we rely on one of the most remarkable organs in our body: the heart. The heart pumps automatically, nonstop, 24/7, from womb to grave. It consists of four chambers, two on top, and two on the bottom. Each heartbeat pulls blood into the top two chambers and pumps it out of the bottom two. The bottom two are more muscular and do the heavy lifting. Unfortunately, the heart can deteriorate and lead to heart failure.

Heart failure is a condition where the heart can’t pump well enough to deliver oxygen to the organs effectively. The heart is still pumping, but organs are not receiving enough oxygen to function. This is not good. Heart failure affects over six million Americans and ten times as many people worldwide. Risk factors for heart failure include:

Heart disease, including Coronary Artery Disease
High Blood pressure
Tobacco
Excessive alcohol
Poor diet
Lack of exercise
Obesity
Diabetes

Heart failure has several signs and symptoms. Some of the most consistent are edema and shortness of breath. Edema is fluid trapped in the body’s tissues and most often pools in the lower extremities and the abdomen. Shortness of breath is due to the heart failing to deliver enough oxygen. This is particularly prevalent when trying to do activities or when lying down. Shortness of breath can keep patients from exercising or sleeping, which only exacerbates problems. Patients who have limited exercise in their routine may not be aware of progressive difficulty, masking this important symptom.

Other symptoms can be broad and nonspecific. They include:

Sudden weight gain
Persistent coughing or wheezing
Lightheadedness and fainting
Depression
Nausea and loss of appetite
Irregular heartbeat, high pulse, and palpitations
Fatigue

If you have heart failure and find yourself experiencing several of these conditions simultaneously, especially with edema and shortness of breath, we urge you to contact your physician immediately. Additionally, you may want to keep track of your level of fatigue because this symptom increases as the heart failure progresses. The excellent news is that new and exciting monitoring devices are currently being developed to help patients manage their heart failure and determine if their condition is deteriorating.

Check out clinical research options available to you with ENCORE Research Group on our enrolling studies page.

By Benton Lowey-Ball, BS Behavioral Neuroscience

Enrolling Studies

Sources:

Albert, N., Trochelman, K., Li, J., & Lin, S. (2010). Signs and symptoms of heart failure: are you asking the right questions?. American Journal of Critical Care, 19(5), 443-452. https://doi.org/ajcc2009314

Groenewegen, A., Rutten, F. H., Mosterd, A., & Hoes, A. W. (2020). Epidemiology of heart failure. European journal of heart failure, 22(8), 1342-1356. https://doi.org/10.1002/ejhf.1858

U.S. Department of Health & Human Services/Centers for Disease Control and Prevention (October 14, 2022). Heart failure https://www.cdc.gov/heartdisease/heart_failure.htm

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ENCORE · Tryptophan and Turkey, Turning the Tables on Thanksgiving Tiredness

We all know how Thanksgiving works. A giant meal with a giant turkey followed by tasty desserts. Then, after the meal, sleepiness sets in. But why? We usually blame the turkey and the tryptophan in the protein. But I’m a vegetarian, and I still get the post-thanksgiving snoozies. So, what is tryptophan, and does it make us tired, or is there something else to blame? This article contains a cornucopia of information to help answer these questions.

Tryptophan is an essential amino acid. Amino acids are the building blocks of proteins and are baked into many of the body’s needs. Being an “essential” amino acid means that we can’t create our own tryptophan and must instead gather it from the foods we gobble up. We need some tryptophan in our diet because it is used to create some critical molecules our body uses.

Two of these important molecules are the neurotransmitter serotonin and the hormone melatonin. These are critical little molecules derived from tryptophan and – interestingly, both interact with our sleep cycle. Serotonin acts on parts of the brain involved with learning, pain, social behavior, and sleep, among many others. Melatonin is like turkey dressing; it’s harvested further from serotonin and can increase sleepiness. Neither of these gets produced in large quantities after eating turkey, however. The large amount of other amino acids found in turkey protein keep tryptophan from making a pilgrimage to the brain after a meal because the amino acids compete for rides on the path to our brain.

So then, why do we feel tired after a big Thanksgiving meal? Well, one reason might be linking carbs (sugars) to tryptophan. Some carbohydrates can increase the ability of tryptophan to cross into the brain and get serotonin and melatonin cooking. Additionally, heavy carbohydrate intake has been associated with higher levels of tiredness and lower levels of alertness. This can be attributed to the rise in blood sugar from the heavy carbohydrates which is followed by release of insulin to lower the blood sugar. The lower blood sugar causes you to feel tired. So too much dessert might be resulting in a blood sugar crash after the meal.

In fact, too much of everything may be making you tired. When we eat large meals, the body activates the parasympathetic nervous system. This is also known as the “rest and digest” pathway, and does exactly what it sounds like. After a large meal, the body focuses on relaxation and digestion. This can cause extra blood flow into the stomach and can make you less alert and awake.

Turkey may get too much blame for our tiredness. As my sweet tooth will attest, the desserts may be a bigger culprit. So, this Thanksgiving, feel free to gather the family to feast (and nap) as you please, but squash the blame on the turkey!

Written by: Benton Lowey-Ball, BS Behavioral Neuroscience

Enrolling Studies

Sources:

Ballantyne, C. (2007). Does Turkey Make You Sleepy? Scientific American. https://www.scientificamerican.com/article/fact-or-fiction-does-turkey-make-you-sleepy/

Høst, U., Kelbaek, H., Rasmusen, H., Court-Payen, M., Christensen, N. J., Pedersen-Bjergaard, U., & Lorenzen, T. (1996). Haemodynamic effects of eating: the role of meal composition. Clinical Science, 90(4), 269-276.

Mantantzis, K., Schlaghecken, F., Sünram-Lea, S. I., & Maylor, E. A. (2019). Sugar rush or sugar crash? A meta-analysis of carbohydrate effects on mood. Neuroscience & Biobehavioral Reviews, 101, 45-67.

Vreeman, R. C., & Carroll, A. E. (2007). Medical myths. Bmj, 335(7633), 1288-1289.

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ENCORE · Experience The Hawthorne Effect

Several of my friends hate flossing their teeth. They go months without flossing, which I think is pretty gross. But then an odd thing happens. About a week before their dental appointment, these same friends will start flossing. By the time they reach their appointment, they have unusually clean gums (though dentists can see through this fairly well, I’m told). On a different tone, some family members have a condition called White Coat Syndrome. When they go to the doctor’s office, their nervousness causes a spike in blood pressure or heart rate, giving deceptively high readings. What’s going on? Can psychological effects like these be used to our advantage?

The Hawthorne Effect is a term used to describe a very beneficial effect seen in clinical trials. This is named after a productivity study in Hawthorne Works, a Western Electric factory in the 1920s and 30s. The study was attempting to discover a link between the amount of light and productivity of workers. When increasing the amount of light, productivity increased. Strangely, when lowering the amount of light, productivity also increased! Researchers attributed the increase in productivity to the workers simply being observed. In research, we tend to see increased positive results for patients simply because we are observing them in a study.

Hawthorne Works

Let’s analyze a 2014 sleep study. Researchers measured 195 patients’ amount and quality of sleep at night. 81 days later, before any medical intervention, researchers measured the patients again. They found that patients slept an average of 30 minutes longer per night and had an increased quality of sleep. This was before any medication or intervention! The change was attributed to the Hawthorne Effect.

Patients at ENCORE Research Group comment on the excellent quality of care they receive during clinical trials. Instead of seeing a doctor for a few minutes once a year, patients see doctors and medical staff for much longer and are encouraged or required to call and report changes in health. Quality of care is increased and makes for a pleasant and healthful patient experience. Patients in clinical trials may also experience more observation time from medical professionals due to the attention to detail that clinical trials require for data integrity in studies.

Finally, patients are found to have better adherence to medication requirements while undergoing clinical trials. The increased emphasis on accuracy and adherence results in better patient outcomes, even when they are part of a placebo or standard-of-care group.

In clinical trials, we see these benefits and must account for them. Randomization of patients helps spread the effect. Everyone sees increased baseline results on average; we are interested to find out if those receiving investigational treatment do even better. Join a clinical trial today and experience the Hawthorne Effect for yourself… and floss your teeth!

Written by Benton Lowey-Ball, BS Behavioral Neuroscience

Enrolling Studies

Sources:

Benedetti, F., Carlino, E., & Piedimonte, A. (2016). Increasing uncertainty in CNS clinical trials: the role of placebo, nocebo, and Hawthorne effects. Lancet Neurol, 15, 736-47. http://dx.doi.org/10.1016/S1474-4422(16)00066-1

Cizza, G., Piaggi, P., Rother, K. I., Csako, G., & Sleep Extension Study Group. (2014). Hawthorne effect with transient behavioral and biochemical changes in a randomized controlled sleep extension trial of chronically short-sleeping obese adults: implications for the design and interpretation of clinical studies. PLoS One, 9(8), e104176. https://doi.org/10.1371/journal.pone.0104176

ENCORE Research Group. (2020, October 14). Hawthorne effect.[Video]. Youtube. https://www.youtube.com/watch?v=1DH7jwqFlyw

Mayo, E. (1993). The human problems of an industrial civilization. The Macmillan Company.

McCarney, R., Warner, J., Iliffe, S., Van Haselen, R., Griffin, M., & Fisher, P. (2007). The Hawthorne Effect: a randomised, controlled trial. BMC medical research methodology, 7(1), 1-8. https://doi.org/10.1186/1471-2288-7-30

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ENCORE · Cirrhosis: When the Liver Fails, the Brain Suffers

The liver is critical to maintain body function. Unfortunately, millions of Americans suffer from liver disease. When the liver suffers prolonged damage, scarring can form. This scarring, called cirrhosis, is debilitating and reduces liver function. Cirrhosis is sometimes called end stage liver disease, and is irreversible. On its own, cirrhosis can be painful and cause suffering, but is frequently made worse through complications. One of these is encephalopathy.

Encephalopathy is a broad term used to describe several diseases and disorders. The unifying concept is that these diseases change the brain’s structure or function. When the cause of this change is through cirrhosis, the condition is called hepatic encephalopathy. This is the condition caused by cirrhosis of the liver, and can be horrible. It comes with a high mortality rate, over 25%, and affects over 30% of people with cirrhosis.

The full mechanism of how hepatic encephalopathy works isn’t fully known. The most likely candidate for hepatic encephalopathy is a buildup of ammonia in the bloodstream. Ammonia is a common waste product for many cells. A damaged liver has trouble filtering ammonia from the blood. The ammonia accumulates in the blood where it can travel to the brain and cause confusion and disorientation at first. Additionally, liver damage can result in reduced muscle mass and immunosuppression. Muscles can remove excess ammonia from the blood, but may become damaged without a functional liver and be unable to help. A reduced immune system can lead to a buildup of harmful bacteria that produce excess ammonia. These combine to create excess toxic levels of ammonia in the bloodstream that make their way to the brain.

The brain is normally protected from toxins in the blood through the blood brain barrier. Astrocytes are special cells in the brain that surround blood vessels and help filter the blood, letting only specific nutrients and particles through. Excess ammonia in the blood appears to damage astrocytes, with wide ranging effects on the brain. When the blood-brain barrier is reduced, toxins can enter the brain. This can lead to damage in neurotransmission, meaning the brain cannot function effectively. There is also an increased chance of infection in the brain and alterations to brain metabolism.

This is a devastating compilation which can drastically reduce quality of life. In the early stages of hepatic encephalopathy, people may experience a general slowing of the brain. This is noticeable in attention, some motor response, and other vague areas. As the encephalopathy progresses, people experience more severe symptoms. Changes in personality have been reported, such as irritability and impulsivity. They may angrily buy m&ms in the checkout line. It also slows the brain and reduces its ability to function. People may become disoriented, experience distortions of time and space, become excessively sleepy, and descend into a coma. Clearly this condition needs medical attention!

Luckily, hepatic encephalopathy can be reversible in many patients! The most important short-term treatment is to get rid of excess blood ammonia. The current standard of care is lactulose, a chemical that binds to ammonia and expels it rectally. This helps in the short term, and can also be recommended to help reduce recurrence. Though effective, lactulose is a laxative and can cause bloating, cramping, and other undesirable side effects. Because of this, many patients don’t like using this drug long term. Since the immune system is suppressed with cirrhosis, antibiotics may help as well. In fact, antibiotics may be helpful in preventing hepatic encephalopathy in the first place by eliminating harmful, ammonia producing bacteria before they can produce too much ammonia. Used with or without probiotics and drugs that help restore normal brain chemistry, we may be able to lower the burden of hepatic encephalopathy for those who suffer.

Written by Benton Lowey-Ball, BS Behavioral Neuroscience

Enrolling Studies

Sources:

Bustamante, J., Rimola, A., Ventura, P. J., Navasa, M., Cirera, I., Reggiardo, V., & Rodés, J. (1999). Prognostic significance of hepatic encephalopathy in patients with cirrhosis. Journal of hepatology, 30(5), 890-895. https://doi.org/10.1016/s0168-8278(99)80144-5

Ferenci, P. (2017). Hepatic encephalopathy. Gastroenterology report, 5(2), 138-147. https://doi.org/10.1093/gastro/gox013

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ENCORE · Dependent vs Independent Variables, How to Tell the Difference

In science and medicine we measure if and how well things work using measurements. This idea may sound simple, but it’s often a challenge to find out exactly what to measure – and how. We typically measure things that can change – things that can vary. We call these things variables. Variables can be broadly split into two major categories: dependent and independent. Either type of variable can change, the difference is what changes them.

Independent variables are changed by researchers, particularly in clinical (patient) research. This variable in a medical research study is what we are testing. The changes to an independent variable may include dose, length, and method of drug delivery. We evaluate independent variables that may change outcomes of the people in a study – but sometimes they do not. In order to understand the effect of medicines, researchers test the medicine against a control. The control could be a placebo (something that has no effect) or a standard of care (the current normal medicine).

Dependent variables are what we expect to change during a trial. In a clinical research, we may expect changes in blood pressure, cholesterol levels, disease symptoms, mortality, and other categories. In a well designed study, we assess changes in the dependent variables related to changes in the independent variables. There is always the chance that the dependent variables are changed by other things, however. A patient might take a new blood pressure medicine but retire from their job. The reduced stress could decrease their blood pressure even if the medicine did not.

Because of individual changes in people’s circumstances, researchers use statistics to find trends. If your blood pressure medicine was only studied on the one person above, you might have erroneous results. Instead clinical trials have dozens, hundreds, or even thousands of participants. With large populations these little differences get figured out. One person might retire, but another might get fired, having an opposite effect. Altogether, statistical analysis can help discover if any changes in the dependent variable are due to the effects of the independent ones.

Chart 1. Each amount of Rosuvastatin on the left corresponds to an amount of LDL on the right. The dependent variable (LDL levels) change in proportion to the amount of independent variable (rosuvastatin) taken by the patient.

Other variables exist in a study. The most concerning of these variables is known as a confounding variable. This is a variable that can undermine the study at a fundamental level. A confounding variable can be introduced by researchers and might include things like placing all overweight patients in the 10 mg group and all underweight people in the placebo group. ENCORE Research Group (and any legitimate clinical research group) avoids confounding variables and bias by randomizing patients. Patients are randomized through an impartial method (usually a computer program) which will randomly place patients into any of the test groups. By randomizing patients, we can avoid the most concerning confounding variables and make sure we are studying what we intend to!

To learn more about the clinical trial process, call our Recruitment Team at (904) 730-0166.

Written by Benton Lowey-Ball, BS Behavioral Neuroscience

Enrolling Studies

Sources:

Schweiger, C. (2003). Clinical trials with rosuvastatin: efficacy and safety of its use. Italian Heart Journal: Official Journal of the Italian Federation of Cardiology, 4, 33S-46S. https://pubmed.ncbi.nlm.nih.gov/14983745/

Stewart, P. A. (1978). Independent and dependent variables of acid-base control. Respiration physiology, 33(1), 9-26. https://www.nlm.nih.gov/nichsr/stats_tutorial/section2/mod4_variables.html

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ENCORE · The “Spanish Flu” of 1918

A pandemic spread around the planet in the first quarter of the century. Not this century, however, but the last. The 1918 Flu Pandemic was the largest and deadliest outbreak of disease since the bubonic plague in the 1300s. The first official reported case was in Kansas in 1918. This gives the disease its proper name, the 1918 Influenza Pandemic. A much more common name, however, is the Spanish Flu.

The name Spanish Flu is an unfair name. Spain lost around a quarter million people to the 1918 Influenza. This is less than half as many as the USA, and fewer than Afghanistan, Mexico, Russia, Italy, and Japan. On top of that, India lost somewhere above 18 million people, and China between four and nine million. The big difference in losses was due to Spain being neutral during World War I. Because of this, they weren’t shy about publishing accurate data. Spain was the first country to publicly disclose that the pandemic was real, and other countries underreported or lied about numbers for years. This may strike some as familiar; during the COVID-19 pandemic, several national and local governments around the world tried to downplay the severity of COVID for political gain.

But what is influenza? Influenza, known as the flu, is very similar to COVID-19 in many ways. It is a viral infection, and its primary symptoms are cough, fever, joint pain, headache, body aches, and others. However, more serious complications such as pneumonia, liver damage, or brain problems can be triggered by influenza. It spreads through the air and can survive in water. Soap, changes in pH, and heat can destroy the influenza virus. The most dangerous part of influenza is how variable it is.

The influenza virus has several subtypes, and each of these mutates constantly. This makes it hard for the immune system to detect and fight new forms of the virus. It also means the specific symptoms of infections can change. In the 1918 influenza pandemic, the strain of influenza was particularly deadly for young, healthy people. This resulted in a lot of excess deaths compared to other strains.

The 1918 Influenza Pandemic was made much worse because of World War I. The war resulted in overcrowded barracks, troops stuffed in ships, and people crowding in shelters. Additionally, it spread wide and far as governments deployed troops around the world. A lack of accurate reporting and proactive measures certainly didn’t help. The biggest difference between then and now was medicine.

1918 was over a hundred years ago, but in the realm of medicine, it may as well have been much longer. Viruses were only discovered around 20 years prior, and there were no effective ways to fight them. There were no antiviral medications. For patients that developed pneumonia, there were no ventilators and no antibiotics. On top of this, there was no influenza vaccine.

The “Spanish flu” of 1918 helped refocus medical attention around pandemics – particularly influenza. In the early 1930s new vaccines were being developed from chicken eggs, and less than ten years later, the first experimental influenza vaccines were developed. Today, our yearly flu shots come from a direct line of response from the 1918 influenza pandemic. A century later, we have come a long way with medical advances, and since we know the influenza virus mutates regularly, the best way to help continue the fight against it is to participate in a clinical trial for the latest flu vaccines.

Written by Benton Lowey-Ball, BS Behavioral Neuroscience

Enrolling Studies

Sources:

Hayden, F. G., & Palese, P. (2009). Influenza virus. Clinical virology, 943-976.

Jester, B., Uyeki, T. M., Jernigan, D. B., & Tumpey, T. M. (2019). Historical and clinical aspects of the 1918 H1N1 pandemic in the United States. Virology, 527, 32-37.

Johnson, N. P., & Mueller, J. (2002). Updating the accounts: global mortality of the 1918-1920″ Spanish” influenza pandemic. Bulletin of the History of Medicine, 105-115.

Knobler, S. L., Mack, A., Mahmoud, A., & Lemon, S. M. (2005). The threat of pandemic influenza: are we ready? workshop summary.

Mayer, J. (29 January 2019). “The Origin Of The Name ‘Spanish Flu’”. Science Friday. Retrieved 30 July 2021. https://www.sciencefriday.com/articles/the-origin-of-the-spanish-flu/

CDC, National Center for Immunization and Respiratory Diseases. (September 28, 2022). Similarities and Differences between Flu and COVID-19. https://www.cdc.gov/flu/symptoms/flu-vs-covid19.htm

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ENCORE · Insulin Resistance: The Dark Side of Diabetes

How does the body use energy? After we eat, most food is broken down into parts that cells can use for energy. The bloodstream carries these pieces through the bloodstream to our cells, which let them in and convert food to energy. In some cases, the cells don’t let food particles in. In these cases, the problem may be diabetes.

Cells need to separate their insides from the environment around them. Cells only let in specific molecules at specific times. Insulin is the molecule that tells cells to let in sugars in the form of glucose. It is produced by the pancreas and is released when the pancreas detects high levels of sugars in the blood. In some cases, such as with obesity, fatty acids can disrupt how cells absorb and use sugar in the blood. When this happens, cells are less sensitive to insulin and absorb less blood sugar per unit of insulin in the blood. Since blood sugar stays high, the pancreas produces more and more insulin, which has less and less effect. Cells can’t respond to all the excess insulin and are increasingly resistant to its effects.

Insulin is also the hormone the pancreas uses to communicate with the liver about blood sugar. When the liver detects insulin it converts blood glucose into glycogen, a short term storage molecule. When high levels of insulin persist, the liver sends extra energy to fat cells.

After long periods of insulin resistance, the pancreas itself stops working properly. Pancreatic cells become damaged and unable to produce insulin. This is called Type 2 Diabetes (T2D). With T2Ds, blood sugar stays high, insulin stops being produced, any produced insulin is less effective, and cells stop metabolizing properly. On top of this, the body gains excess weight which can stress the pancreas further. Other symptoms include cardiovascular disease, nerve dysfunction in the extremities (called neuropathy), and increased chance of death.

Diabetes is very common in the United States. Tens of millions of Americans have T2D. Type 1 diabetes is an autoimmune disorder which results in pancreatic damage. Type 2 diabetes is an insulin resistance disorder and can have a slow onset. Major risk factors are obesity and lack of exercise. These should be the first steps to managing T2D as well.

When a healthy diet and exercise aren’t enough to manage healthy blood sugars, or aren’t an option, several key medications exist to help with type 2 diabetes:

Insulin: By injecting insulin with meals, the effects of a compromised pancreas can be reduced. Synthetic insulin, such as glargine, is in wide use.
Glucagon-like peptide-1 receptor agonists (GLP-1 RA): These stimulate the pancreas and coerce it into properly releasing the correct amounts of insulin. It slows some pancreatic cells and helps restore the pancreas-liver communication lines. One generic name for GLP-1 RA drugs is semaglutide, often branded as Ozempic and Rybelsus. A benefit of these drugs is that a common side effect is weight loss, one of the drivers of type 2 diabetes.
Metformin: Originally inspired by the French Lilac plant, metformin lowers blood sugar levels by acting on the liver, bloodstream, intestinal tract, and even the gut microbiome! The complex action on different areas of the body results in overall lower blood sugar levels.
SGLT2 Inhibitors: These act on the kidneys, changing the threshold of reabsorption of sugar so they excrete more than usual removing blood sugar through the urine.

Altogether, there are several medications which may be helpful for controlling type 2 diabetes. Discovering how these medications interact, lowering side effects, and finding treatments that are easy and straightforward is key. If you have type 2 diabetes, look for enrolling studies soon and improve your diet and exercise if possible!

Written by Benton Lowey-Ball, BS Behavioral Neuroscience

Enrolling Studies

Sources:

Berg, J. M., Tymoczko, J. L., & Stryer, L. (2012). Biochemistry (7th Ed., pp 798-803). New York: W. H. Freeman and Company

DeFronzo, R. A., Ferrannini, E., Groop, L., Henry, R. R., Herman, W. H., Holst, J. J., … & Weiss, R. (2015). Type 2 diabetes mellitus. Nature reviews Disease primers, 1(1), 1-22. https://www.nature.com/articles/nrdp201519

Olokoba, A. B., Obateru, O. A., & Olokoba, L. B. (2012). Type 2 diabetes mellitus: a review of current trends. Oman medical journal, 27(4), 269. http://doi.org/10.5001/omj.2012.68

Rena, G., Hardie, D. G., & Pearson, E. R. (2017). The mechanisms of action of metformin. Diabetologia, 60(9), 1577-1585. https://doi.org/10.1007%2Fs00125-017-4342-z

U.S. Department of Health & Human Services/Centers for Disease Control and Prevention (August 10, 2021). Insulin Resistance and Diabetes https://www.cdc.gov/diabetes/basics/insulin-resistance.html

U.S. Department of Health & Human Services/Centers for Disease Control and Prevention (December 16, 2021). Type 2 Diabetes https://www.cdc.gov/diabetes/basics/type2.html

Witters, L. A. (2001). The blooming of the French lilac. The Journal of clinical investigation, 108(8), 1105-1107.https://doi.org/10.1172%2FJCI14178

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ENCORE · Tau: A Little Protein With Big Effects

Methods used to diagnose Alzheimer’s disease are changing. In the past, the only definitive way to diagnose Alzheimer’s disease was after death, by an autopsy, which is not exactly helpful for treatment. The autopsy would reveal both amyloid plaques and tau tangles in the brain; these are hallmarks that characterize Alzheimer’s disease. Thankfully, science has drastically improved over the years. We currently have spinal fluid tests that look for these two key biomarkers and imaging tests that show changes in the brain.

A recent example of other evolving diagnosis methods is COVID-19. Early in the pandemic, when there were no COVID-19 tests, the only way to know if someone might have the virus was to check for a fever. Nowadays, we look for biomarkers – such as with a rapid antigen test – which can detect antigens to the virus even in asymptomatic people.

We now understand that a person can be suffering from the progressive nature of Alzheimer’s even if they do not yet show signs of cognitive impairment. Without biomarker testing, most patients’ first symptoms are memory loss, including long and short-term. Alzheimer’s is usually associated with increased age because the biological underpinnings of the disease accumulate over time. Diagnosis can be made by using something called the ATN framework. This framework describes the two major proteins involved, amyloid plaques and tau tangles, and the associated neurodegeneration – changes in the brain structure.

Let’s discuss the AT part of ATN: the two protein accumulations called amyloid plaques and tau tangles. It is no coincidence that these are also the biomarkers sought by scientists and doctors when diagnosing Alzheimer’s. Amyloid plaques are bundles of protein that build up outside of cells in the brain. They disrupt how cells connect and communicate with each other. Tau tangles are proteins found inside the neurons. In a healthy neuron, tau proteins help stabilize the microtubule that transfers nutrients. In Alzheimer’s patients, the tau proteins become corrupted and tangled, blocking the neuron’s transport system. This leads to cell death. As more cells die and neural network connections break down, areas in the brain begin to shrink. In the late stages of Alzheimer’s disease, there is widespread loss of brain volume.

The N of ATN is neurodegeneration which is the deterioration of neurons causing specific structural changes to the brain. A structural MRI and a radioactive PET scan are two classic methods of determining neurodegeneration. These are effective as staging tools, discovering how far along the disease has progressed. They are effective but can be expensive and time-consuming.

The good news is that researchers are currently working on blood tests that will hopefully be able to detect tau biomarkers quickly and easily. A blood test should be easy, cheap, and relatively simple. With luck, these early biomarker findings will also help drive the effectiveness of clinical therapies, paving the way for better Alzheimer’s treatments in the years to come.

By Benton Lowey-Ball, BS Behavioral Neuroscience

Enrolling Studies

Sources:

Kandel, E. R., Schwartz, J. H., Jessell, T. M., Siegelbaum, S., Hudspeth, A. J., & Mack, S. (Eds.). (2000). Principles of neural science (Vol. 4, pp. 1149-1159). New York: McGraw-hill.

Largent, E. A., Wexler, A., & Karlawish, J. (2021). The Future Is P-Tau—Anticipating Direct-to-Consumer Alzheimer Disease Blood Tests. JAMA neurology, 78(4), 379-380. https://doi.org/10.1001/jamaneurol.2020.4835

Ossenkoppele, R., Reimand, J., Smith, R., Leuzy, A., Strandberg, O., Palmqvist, S., … & Hansson, O. (2021). Tau PET correlates with different Alzheimer’s disease‐related features compared to CSF and plasma p‐tau biomarkers. EMBO molecular medicine, 13(8), e14398. https://doi.org/10.15252/emmm.202114398

Peterson, R. C. [UCI MIND] (2019, April 3). Diagnosis of Alzheimer’s disease in the era of biomarkers – Ronald C. Petersen, MD, PhD [Video]. Youtube. https://www.youtube.com/watch?v=KtS5xynes2M

What Happens to the Brain in Alzheimer’s Disease? (2017, May 16) National Institute on Aging. https://www.nia.nih.gov/health/what-happens-brain-alzheimers-disease

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ENCORE · Good Kidneys Gone Bad: Renal Impairment

Imagine if your plumbing stopped up. Not your toilets, but your sink and shower. How would you get rid of the dirt and junk off your skin? How would you make sure you stay clean? Our kidneys ask this question every day. The blood in our body travels around and around, including the critical filtration stage of the kidneys. The kidneys act as a big two-way filter. Impurities and excess minerals or water are extracted from the blood, and necessary minerals or water are added as needed. The kidneys keep the ingredients of blood at healthy levels. Finally, kidneys get rid of waste products and extra water by producing urine. When this goes wrong, your blood can’t function properly and waste products can build up.

When dealing with the kidneys, you may see three terms thrown about. The origin of “kidney” is unknown, but likely English. “Renal” is the Latin word for kidneys, and the prefix “nephro-” is Greek in origin. If you see any of these terms you can bet we’re dealing with the kidneys. With this in mind, when the kidneys fail to perform their job, we call it renal insufficiency.

There are two major divisions in how the kidneys fail, based on the amount of time.

Acute kidney injury (AKI) has a sudden onset. It may affect 100,000 people a year in the United States, with a higher proportion of sufferers being Black or African American than White.
Chronic kidney disease (CKD) is the long term degradation of the kidneys. It is harder to measure, as the kidneys do a pretty good job compensating: until they don’t. It is estimated that around 2 million Americans may be suffering from CKD, with the majority being men.

There are several possible causes of renal impairment. The vast majority of causes are “upstream,” meaning something affects the blood before it gets to the kidneys.

In acute cases, this can be hypotension – not enough fluid, some drugs, such as NSAIDs, or organ failure. When there isn’t enough fluid in the bloodstream, the kidneys compensate by releasing more water, which can deplete the kidney’s reserves and cause failure.

In chronic kidney disease, the most frequent cause is diabetes, especially type 2. Prolonged hypertension, and vascular diseases can also be the culprit. With chronic cases, the kidneys will do their best to compensate – constantly filtering out excess blood sugar, for instance. Over time, the excess sugar damages the blood vessels in the kidneys. Some parts of the kidneys may fail and the remaining portions get stressed and eventually decompensate. This is when the kidney fails as an organ.

Other possible causes of renal impairment are contained in the kidneys and “downstream” blockages. The kidneys themselve can be the victim of disease or injury, possibly due to long term upstream stress. The ability of the kidney to release urine can also -in rare cases – be disrupted.

Regardless of the cause, renal impairment is very dangerous. The kidneys are responsible for keeping blood healthy. A failure of the renal system can result in a need for dialysis or transplant. Dialysis is when external technology filters blood and maintains levels. This is uncomfortable, cumbersome, and expensive.

Fixing renal impairment can be a tall order. The most important step is usually treating the underlying cause. Since the kidneys filter several drugs out of the bloodstream, stopping or replacing them may be key. Fluids may need to be replaced in acute cases, and lifestyle changes may be needed in chronic ones. Maintaining healthy blood sugar levels can be key if the root cause is diabetes. For heavily progressed chronic renal impairment, dialysis or transplant may be the only options.

Transplant and dialysis are not fun, so we should try to avoid renal impairment before it starts. Many of the tactics to keep your kidneys healthy are the same to keep the rest of your body healthy. Exercise, not overindulging on sugar, and keeping your diet under control can help. Additionally, maintaining a healthy blood pressure is vital. Finally, lowering or cutting out tobacco and alcohol can help keep your kidneys healthy. When it comes to filtering your blood, give your kidneys every advantage you can!

By Benton Lowey-Ball, BS Behavioral Neuroscience

Enrolling Studies

Adapted from:

Bindroo, S., & Rodriguez, Q. BS; Challa, HJ Renal Failure. (February 24, 2022). StatPearls; StatPearls Publishing: Treasure Island, FL, USA. https://www.ncbi.nlm.nih.gov/books/NBK519012/

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ENCORE · With a Reduced Ejection Fraction, Oxygen Is Going Nowhere Fast

Heart failure is quite frankly, a terrifying sounding condition. It is severe, but not as immediately drastic as it sounds. Put simply, heart failure is when the heart fails to pump as much blood as the body will need long-term. The heart works like a balloon, filling with blood and contracting to pump it out. Ejection fraction is a term used to describe the amount of blood pumped out compared with the total the heart can hold. In a normal heart, 50-70% of blood is ejected with each heartbeat. When this amount falls below 40%, a person has a reduced Ejection Fraction (the rEF of HFrEF). This is a serious condition.

The heart pumps blood to every cell in the body. This is how cells receive oxygen and nutrients, and how they get rid of waste products. Without enough blood, cells suffocate. Oxygen isn’t reaching cells and the brain interprets this as being short of breath. Common symptoms of HFrEF include:

Fatigue
Difficulty breathing, especially when lying down or sleeping
Inability to exercise
Ankle swelling

Inside the body, doctors can also look for diagnostic markers. These may include structural changes to the heart and increased natriuretic peptides. Natriuretic peptides are hormones that regulate the amount of salt and water in the blood. They act as vasodilators, opening blood vessels which can be helpful in compensating for heart failure. The body attempts to compensate for the loss of oxygen and nutrients in the blood in many ways, but long term the body has trouble sustaining with heart failure.

Who is at risk of developing HFrEF? Unfortunately, it is more prevalent in the United States than almost anywhere else, affecting 6.5 million Americans each year. Risk factors include age, being male, obesity, and smoking. Additionally, other medical conditions increase your risk of developing Heart Failure with reduced Ejection Fraction. Previous heart attacks, coronary heart disease, diabetes, and hypertension are some associated conditions. All told, HFrEF leads to around a million hospitalizations every year, and being hospitalized for HFrEF comes with a low 5-year survival rate.

What can be done? There are several methods of dealing with a reduced ejection fraction. Some methods treat symptoms, such as diuretics, and others can help reduce mortality, such as beta-blockers. There are several other medications and even some implantable devices that can help with HFrEF. These can help improve your ejection fraction or health outcomes but are not yet a silver bullet. New medications with increased outcomes and fewer side effects are entering clinical trials and may help with the underlying condition. To learn more about current heart failure research options, call our office today.

Written by Benton Lowey-Ball, BS Behavioral Neuroscience

Enrolling Studies

Bloom, M. W., Greenberg, B., Jaarsma, T., Januzzi, J. L., Lam, C. S., Maggioni, A. P., … & Butler, J. (2017). Heart failure with reduced ejection fraction. Nature reviews Disease primers, 3(1), 1-19. https://www.nature.com/articles/nrdp201758

Martinez-Rumayor, A., Richards, A. M., Burnett, J. C., & Januzzi Jr, J. L. (2008). Biology of the natriuretic peptides. The American journal of cardiology, 101(3), S3-S8. https://doi.org/10.1016/j.amjcard.2007.11.012

Murphy, S. P., Ibrahim, N. E., & Januzzi, J. L. (2020). Heart failure with reduced ejection fraction: a review. Jama, 324(5), 488-504. https://doi.org/10.1001/jama.2020.10262

Diet-and-Exercise-May-Not-Be-Able-to-Help-With-This-Inherited-Cardiovascular-Risk-Factor.jpg

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ENCORE · Diet And Exercise May Not Be Able To Help With This Inherited Cardiovascular Risk Factor

If someone in your family had a heart attack or stroke before the age of 60, you could be at risk and might want to have your blood tested for this little-known hereditary risk factor, Lp(a). Cardiovascular disease remains the leading cause of death in the United States, even during the COVID-19 pandemic. Determining and reducing the risk factors for cardiovascular disease is critical.

Lipoprotein(a), also called Lp(a), pronounced “LP Little a” is a particularly dangerous culprit. Its levels are controlled by a single gene, and a single genetic variation in this gene is enough to drastically change Lp(a) levels. Unfortunately, since it is genetically determined, diet, exercise, and lifestyle have little or no effect on Lp(a) levels. High Lp(a) can contribute to several cardiovascular conditions. These include a two to three times increase in the risk of developing:

Coronary heart disease
Peripheral heart disease
Aortic valve stenosis
Ischemic stroke

Lp(a) has been referred to as the evil twin of the more familiar LDL (bad) cholesterol and is a triple threat because it is:

Pro-atherogenic: higher risk fatty deposits in the walls of arteries
Pro-thrombotic: promotes blood clots
Pro-inflammatory: inflammation is an important risk of cardiovascular disease

There are two methods of measuring Lp(a). The most common method of measuring Lp(a) is by mass, in mg/dL. Measuring how many individual particles, regardless of size, is another method and is measured in nmol/L. It is important to know which method was used when understanding your numbers. If you have never had your Lp(a) level checked, we offer Lp(a) testing to our ENCORE community for those who pre-qualify (call for details).

Currently, there are no approved therapies to lower Lp(a) levels and reduce one’s risk. However, three exciting therapies are currently being studied in clinical trials at ENCORE Research Group sites across Florida. The good news is that because of clinical research and your involvement, we have new treatments for elevated Lp(a) on the horizon!

Written by Benton Lowey-Ball, BS Behavioral Neuroscience

Enrolling Studies

Sources:

Kamstrup, P. R. (2021). Lipoprotein (a) and cardiovascular disease. Clinical chemistry, 67(1), 154-166. https://doi.org/10.1093/clinchem/hvaa247

Miksenas, H., Januzzi, J. L., & Natarajan, P. (2021). Lipoprotein (a) and cardiovascular diseases. JAMA, 326(4), 352-353. doi:10.1001/jama.2021.3632

Health.harvard.edu

Amgenscience.com

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ENCORE · Why You Should Consider Getting A Fibroscan

Fatty liver disease is incredibly prevalent in the United States. Some estimates place the number of Americans with non-alcoholic fatty liver at over 30%, that’s around 100 million people in this country! Liver diseases are deadly serious; the liver is a critical organ and without it we cannot survive. The biggest problem with all liver diseases is that they frequently progress without symptoms. Because of this, the disease may progress to a dangerous or irreversible stage before it is even detected. Clearly, early, and routine testing for people at risk is critical.

We can’t see the liver from the outside, so the only way to learn about how it is doing is by looking at it. We can look through the skin using technology or under a microscope using a biopsy.

A biopsy – looking at a section of the liver under the microscope – is the “gold standard” of liver diagnostic techniques. This has drawbacks, however. Patients typically need to dedicate half a day to the procedure, and there can be rare complications. A biopsy is an invasive procedure requiring a piece of the liver be taken and examined. It is a critical piece of the liver diagnosis pie but is not a routine procedure to be done without cause.

Imagining techniques can be very effective in diagnosing a fatty liver. Some techniques, such as a CAT scan and ultrasound, can’t diagnose the amount of scarring on the liver but can give an indication that there is fat present. CAT scans use x-rays, but imaging is otherwise safe. An ultrasound is fast and non-invasive. It is an excellent first step that many doctors use when they suspect a fatty liver. Magnetic Resonance Imaging (MRI) is the next best diagnostic procedure to a liver biopsy. With an MRI, doctors can clearly see the state of the liver. They are expensive, however. This again means they are an excellent tool for those who are known to have fatty liver but may not be an option for all patients to use regularly.

Ultrasonic elastography is a different technique. It is commonly called Fibroscan, after the manufacturer of the diagnostic tool. Fibroscan uses sound waves to gently shake the liver and measure how it responds. The liver will stretch slightly. In a healthy liver, the tissue stretches more, but hard scar tissue is less elastic. The fibroscan can interpret the difference and determine how much fat and scar tissue is present. The test is very similar to an ultrasound; it is painless, fast, and safe. The fibroscan does not replace other imaging techniques but is cheap and effective at determining the stage of fatty liver present. Unlike other techniques, a Fibroscan can be done routinely for anyone who is at risk of having fatty liver.

Fibroscans are very popular around the world, including in Europe, Asia, South America, and Canada. It is a cheap procedure with little reimbursement for practitioners, which unfortunately prevents widespread use in the USA. Risk factors for non-alcoholic fatty liver include being overweight or obese, being prediabetic or having diabetes, and eating a high-fat diet. If you are concerned about fatty liver, talk to your primary care physician and/or contact ENCORE Research Group for a complimentary Fibroscan.

Written by Benton Lowey-Ball, BS Behavioral Neuroscience

Enrolling Studies

Afdhal, N. H. (2012). Fibroscan (transient elastography) for the measurement of liver fibrosis. Gastroenterology & hepatology, 8(9), 605.

Koren, M. (Host). (2022, July 20). Common fibroscan technology questions [Audio podcast episode]. In Medevidence! Truth behind the data. ENCORE Research Group. https://encoredocs.com/medevidence/

Koren, M. (Host). (2022, July 13). You cannot live without your liver [Audio podcast episode]. In Medevidence! Truth behind the data. ENCORE Research Group. https://encoredocs.com/medevidence

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ENCORE · Metabolic Syndrome – When Fat Fights Back

Metabolic syndrome is a cluster of conditions which have been slowly rising in people in the United States. It is also known as insulin resistance syndrome.

It is currently defined as three of the following conditions:

Excess fat around the waist
High plasma glucose concentration
High blood pressure
High triglycerides
Low levels of good cholesterol or HDL

Having one of these conditions does not mean that you have metabolic syndrome. Having three or more of these conditions will result in a diagnosis of metabolic syndrome and will increase your risk of health complications. If left untreated, metabolic syndrome can lead to heart disease, Type 2 diabetes, and stroke.

Metabolic syndrome is incredibly prevalent – affecting over one-third of Americans. Hispanic adults are at the highest risk. Among non-Hispanic adults, white men and black women are at higher risk than other groups. Other risk factors include lifestyle, age, family history, and use of some medications. Similar conditions may increase the chances of getting metabolic syndrome. These include being overweight or obese, immune system and sleep problems, and PCOS. Unfortunately, these risk factors overlap with the symptoms. This implies that metabolic syndrome may spiral and get worse over time.

The exact mechanism of metabolic syndrome is unknown, but scientists have an idea of what is to blame. It may be insulin resistance, dysfunctional fat cells, inflammation, and oxidative stress. Insulin resistance causes the cells to store sugars instead of using them. This makes cells (and people) tired and increases fat. Fat cells may become overactive and grow so large that they die, prompting an immune response. The immune system may cause inflammation and plaque build ups in the bloodstream. Inflammation can further cause skin problems and long-term damage.

While it sounds like this is all the fault of insulin resistance, it is not that clear cut. There may be many pathways into metabolic syndrome. Inflammation can be caused directly through a dysfunctional molecule responsible for fighting tumors. The liver has an important role in guiding the insulin response of the body. Obesity can cause oxidative stress that damages fat cells. Several other processes can interrupt these systems. Additionally, each symptom can increase the risk of developing others.

So what can we do about metabolic syndrome? There are no approved medications to cure the underlying condition. For medical solutions, doctors may prescribe symptomatic treatments. These treat the parts of metabolic syndrome that we can diagnose: high triglycerides, cholesterol, and hypertension.

Currently, our best way to fight metabolic syndrome is through diet and exercise. This may seem overwhelming to some people and making solid changes takes time. Instead of exercise, many need to think of movement. Movement can look like walking in the neighborhood, gardening, housecleaning, or anything that gets you moving, gets your heart rate up and is something you enjoy.

Changes in other lifestyle choices may include consuming less sugar and sugary drinks, cutting out smoking and drinking, and getting regular sleep! Lack of appropriate sleep can increase your appetite for high-calorie foods due to hormonal changes. There are two hormones that make you hungry or full. Ghrelin is the hormone that increases your appetite and makes you crave food. Leptin is the hormone that makes you feel full with little appetite. These hormones can become unbalanced with lack of sleep, leading to negative changes in appetite.

There is no silver bullet for everyone, but it’s a good start to take steps towards healthier lifestyle changes.

Written by Benton Lowey-Ball, BS Behavioral Neuroscience

Enrolling Studies

References:

McCracken, E., Monaghan, M., & Sreenivasan, S. (2018). Pathophysiology of the metabolic syndrome. Clinics in dermatology, 36(1), 14-20. https://doi.org/10.1016/j.clindermatol.2017.09.004

Moore, J. X., Chaudhary, N., & Akinyemiju, T. (2017). Peer reviewed: Metabolic syndrome prevalence by race/ethnicity and sex in the United States, National Health and Nutrition Examination Survey, 1988–2012. Preventing chronic disease, 14.

Zimmet, P., Alberti, K. G. M. M., Stern, N., Bilu, C., El‐Osta, A., Einat, H., & Kronfeld‐Schor, N. (2019). The Circadian Syndrome: is the Metabolic Syndrome and much more!. Journal of internal medicine, 286(2), 181-191. https://onlinelibrary.wiley.com/doi/full/10.1111/joim.12924

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ENCORE · Vaccine Types: A Short History

With flu season on the horizon, reviewing the vaccine pathway and how we got to where is worthwhile. We have an amazing and complex immune system. It has several specialized cells, but detection is the first line of an immune response. Detecting a harmful organism that has invaded the body can be surprisingly tricky. This is because cells have to chemically discover specific proteins or sugars on the outside of pathogens. These proteins or sugars can (and do) mutate in quickly-replicating pathogens. Luckily, our immune system can learn the danger of closely-related pathogens.

Vaccines have a long and storied history. From the first records of vaccines in China hundreds of years ago to the first inoculation against smallpox (using cowpox) to today’s cutting-edge mRNA vaccines, the technology is constantly improving. Here are some of the major ways vaccines are made:

Use a weak virus

The cowpox-smallpox vaccine was an example of a live, whole-pathogen vaccine. This is a type of vaccine where doctors inject small amounts of live viruses into the body. The body responds and becomes inoculated against large doses of the virus in the wild. In the 1950’s live-attenuated vaccines became available. In these, the virus is weakened in a lab so it does not cause serious disease in people. This type of vaccine provides a strong and long-lasting response. Examples of live attenuated vaccines include measles, mumps, and rubella vaccine (MMR), smallpox, chickenpox, and yellow fever.

Use a dead pathogen

There are other methods to mitigate the problems of live viruses. An inactivated vaccine uses dead virus or bacteria. This makes the vaccine much safer and comes with fewer side effects, but is less effective. The current yearly flu vaccines are inactivated vaccines. Some manufacturers use hen’s eggs to grow the vaccine before inactivation. The resulting vaccine can contain very small amounts of egg protein as a result. The CDC still recommends those with egg allergies get the flu vaccine.

Use part of a virus or bacteria

Subunit vaccines are pieces of a pathogen – generally protein or sugar pieces. These aren’t whole viruses and have fewer side effects as a result. Additionally, these subunits may be able to grant protection against many forms of a pathogen. The Hepatitis B vaccine is an example of a protein subunit vaccine.

Target a dangerous product

Toxoid vaccines such as DPT can help lessen the damage of infection because some bacteria do their damage by releasing dangerous toxins instead of attacking cells. Toxoid vaccines train the body to recognize these toxins as dangerous. Diphtheria and tetanus vaccines are examples of toxoid vaccines.

Get the body to do the work

Nucleic acid vaccines are a new and different approach that has many benefits. Instead of using a weakened or inactivated pathogen to trigger our immune system, nucleic acid vaccines employ the body to make the vaccines in house. DNA, mRNA, and vector virus vaccines use genetic code created in a laboratory; there is no virus needed to develop the vaccine. Messenger RNA (mRNA) vaccines are the best known and use mRNA, a blueprint for creating specific proteins. When injected into the body, they provide the instructions for our body to produce antigens (proteins) that trigger an immune response. The T-cell and antibody response that follows can fight the disease. This can provide long-lasting, stable, relatively low symptom responses. The real benefit, however, is the time it takes to develop a new vaccine is drastically reduced. This was evident with COVID-19, when researchers created a brand-new vaccine in less than a year. Equally important was distributing it to hundreds of millions of people one year after. A typical vaccine takes 10-15 years to develop – and even longer to scale production.

New studies are coming to compare the effectiveness of mRNA-based vaccines to inactivated vaccines for viruses and diseases beyond covid. Keep a lookout to join this new and developing vaccine research.

Written by Benton Lowey-Ball, BS Behavioral Neuroscience

Enrolling Studies

References:

NIH, National Institute of Allergy and Infectious Diseases. (2021). Flu vaccine and people with egg allergies. https://www.cdc.gov/flu/prevent/egg-allergies.htm

NIH, National Institute of Allergy and Infectious Diseases. (2019). Vaccine types. https://www.niaid.nih.gov/research/vaccine-types

Greenwood, B. (2014). The contribution of vaccination to global health: past, present and future. Philosophical Transactions of the Royal Society B: Biological Sciences, 369(1645), 20130433.

Boylston, A. (2012). The origins of inoculation. Journal of the Royal Society of Medicine, 105(7), 309-313.

Whats-Being-Done-to-Increase-Clinical-Trial-Diversity.jpg

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ENCORE · What’s Being Done to Increase Clinical Trial Diversity?

Earlier this year, a bipartisan bill was introduced in the US congress to increase diversity in clinical research trials. The DEPICT act, as it’s called, has many major changes to how clinical trials would be conducted. These changes would affect sponsors, the government, and clinical research sites. Sponsors are the companies which develop new drugs and devices in clinical trials.

The bill would require new demographic analyses for drug and device trials by sponsors. Demographic data includes age, sex, race, and ethnicity. Sponsors would investigate the rates of a disease among demographic groups before starting a trial. They would then devise a diversity action plan. This ensures the clinical trial includes a representative sample of the affected population. Let’s say a drug targeted lung cancer, for example. The sponsor would have to find out who has increased chances of getting lung cancer. If they found that Black Americans were at higher risk, they would make a plan to ensure this group was included in any research trials. Plans could include community outreach, specific site selection, and diversity training.

A key aspect of the bill is discovering how to best reach diverse communities. Research sponsors would need to submit annual reports. These would outline how successful their studies were at reaching the demographic goals. If they failed to meet goals, they would give possible reasons they did not. The Food and Drug Administration (FDA) would compile and analyze the reports. The FDA would issue public reports on diversity and enrollment targets. They would also publish justifications for failure to meet targets and recommendations to solve this. Additionally, the National Institute of Health (NIH) would provide outreach. For sponsors, they would issue best practices for increasing diversity. They would engage with minorities to bring awareness of clinical research trials. They would also help local organizations inform their community about research trials.

The final piece of the bill is increasing access. The bill would enhance clinical research infrastructure in underserved communities. The bill provides grants to expand clinical research facilities. These would be in rural areas, on Indian tribal lands, and in federally recognized underserved communities. The grants would help facilities conduct research trials in these areas.

Altogether, this bill addresses the shortcomings of clinical trials in diverse communities. It closes the gap between who suffers from medical conditions and who participates in clinical research trials. It helps find out which methods increase clinical trial diversity. It also helps expand access to clinical trials in underserved communities. There is still a long way to go before this bill makes it to the voting floor, but it’s a good step.

Written by: Benton Lowey-Ball, B.S. Behavioral Neuroscience

Enrolling Studies

Source:

Text – H.R.6584 – 117th Congress (2021-2022): DEPICT Act. (2022, February 3). https://www.congress.gov/bill/117th-congress/house-bill/6584/text

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ENCORE · The Fight Against Hypertension

Hypertension is one of the most prevalent conditions on the planet. Scientists estimate that it affects 30-45% of adults, somewhere over a billion people! Hypertension is the chronic elevation of blood pressure. The CDC defines it as above 130 mmHg systolic or above 80 mmHg diastolic. For short periods of time, elevated blood pressure can be useful – for exercise, say. People can have high blood pressure for years without symptoms. For long periods of time, however, hypertension is deadly serious. Unfortunately, living with high blood pressure can lead to a host of problems. Hypertension can lead to heart attack and stroke, and damage to the heart, brain, kidneys, and even eyes!

Everyone is at risk of high blood pressure. In America, men have a higher likelihood of hypertension. There are also differences in ethnicity and race, non-Hispanic Black or African American adults are at the highest risk. Unfortunately, even the lowest risk categories still have around a 40% prevalence of high blood pressure. Clearly this is a large issue in America and around the world.

The big culprit behind hypertension is the Renin–angiotensin–aldosterone system (RAAS). RAAS is a critical system for maintaining blood pressure. It regulates two primary factors: the amount of blood and how constricted blood vessels are. It does this through the kidney, liver, and adrenal gland (just above the kidneys). In response to body signals, the kidneys release an enzyme to the liver. In response, the liver produces the hormone angiotensin I. Another enzyme, angiotensin-converting enzyme (ACE) converts this to angiotensin II, which goes to work.

Angiotensin II has wide-ranging effects to increase sodium and water retention. It also causes blood vessels to constrict. Angiotensin II is very short-lived, only lasting 1-2 minutes. One of its many effects is to get the adrenal gland to produce aldosterone. Aldosterone has similar effects as angiotensin II, but instead of a few minutes, it takes hours or days to take effect. The end result is that two major hormones – one fast-acting and one slow-acting – cause high blood pressure.

There are many medications available to fight hypertension. Most of these, such as diuretics or beta-blockers, have wide-ranging side effects. This is because they are system-wide, indiscriminate actors on the body. Beta-blockers, for instance, slow the heart. This is helpful in lowering blood pressure but obviously leads to other effects on the body. RAAS-acting specific medications may be more helpful in combating hypertension with minimal side effects. ACE inhibitors, for instance, stop the fast-acting angiotensin II from having its effect on the body. This targeted approach to hypertension can lead to fewer side effects in some patients. Unfortunately, by acting on only the fast-acting portion of RAAS, they must be taken daily. Even worse, a few missed doses can have longer-term effects on blood pressure. Luckily, researchers are investigating other targeted methods of reducing the effect of RAAS, and blood pressure! Keep an eye out for a clinical research study to help investigate this exciting part of the fight against hypertension.

Written by: Benton Lowey-Ball, B.S. Behavioral Neuroscience

Enrolling Studies

Sources

Fountain, J. H., & Lappin, S. L. (2017). Physiology, renin angiotensin system.

National Center for Chronic Disease Prevention and Health Promotion, Division for Heart Disease and Stroke Prevention. (September 27, 2027). Facts about hypertension. U.S. Department of Health and Human Services. https://www.cdc.gov/bloodpressure/facts.htm

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ENCORE · Celiac Article – The Symptoms Of Celiac Can Be Hard To Digest

Celiac disease is one of the major health issues on our planet, affecting around 1% of the population (that’s about 80 million people!). Celiac disease is more likely to occur in females. Though onset can occur at any age, it is most likely to be discovered around age two or during young adulthood.

Celiac disease is commonly known as gluten intolerance and is classically characterized by its gastrointestinal symptoms including diarrhea, loss of appetite, weight loss, and other digestive issues. Additionally, there are other symptoms that are unrelated to the digestive system. These include anemia, bone density issues, neurological symptoms, skin rash, and more. Together these make for a severe detriment in the quality of life of most celiac sufferers.

Like most autoimmune disorders, the leading symptoms come from the body’s immune system overreacting and causing damage. Celiac disease is unusual in that the reason for the immune response is gluten, which we eat. Gluten is a structural protein found in wheat, rye, barley, spelt, and kamut. Gluten isn’t fully digestible, and some intact protein pieces make it through the stomach into the intestines. In celiac patients, the protein pieces cross the intestinal lining and are mistaken for dangerous particles or microorganisms. This can trick the immune system into action, causing inflammation and damage.

The number of people with celiac disease has been growing significantly. Five times as many people had the condition in 2000, compared with 1975. Scientists are still unsure why the disease has been growing worldwide. Better clinical testing, a spread of high gluten Mediterranean diets, and new varieties of grain are leading theories. Scientists have been able to discover much of the underlying mechanism of how celiac disease occurs, thankfully. It is genetic, and the key player appears to be HLA-DQ2 or HLA-DQ8 antigens which mistake gluten for danger. The presence of HLA-DQ2/DQ8 isn’t enough to guarantee celiac disease, but it is required. Additional contributors are thought to be other genes, environmental factors, and gut microbiota. Regardless, 95% of celiac patients have one of these dangerous antigens.

Currently, the only treatment for celiac is a strict gluten-free diet. This can be difficult to maintain, and even with a gluten-free diet, some patients continue to have symptoms. Additionally, contaminants can be unknowingly present in food and even low amounts of gluten can cause a resurgence of symptoms. Scientists are looking for new ways to combat this disease and participating in clinical trials is the best way that you can help move celiac disease medicine forward.

Written by: Benton Lowey-Ball, B.S. Behavioral Neuroscience

Enrolling Studies

Source:

Caio, G., Volta, U., Sapone, A., Leffler, D. A., De Giorgio, R., Catassi, C., & Fasano, A. (2019). Celiac disease: a comprehensive current review. BMC medicine, 17(1), 1-20.

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ENCORE · Good Medicine Is Only Half The Picture

My buddy recently bought an e-bike on the internet. It has an enormous battery, goes pretty fast, and is salt air resistant – an important feature at the beach. It’s the perfect bike. Or at least it would be, except it is still on a dock in China, waiting for a cargo ship to deliver it. The bike is no good if it can’t get to where it needs to be. The same is true of drugs: a drug is only as good as its delivery system.

Usually, the “buyer” of a drug is a cell somewhere in the body. Sometimes they are in specific areas, and sometimes they’re all over the place. Regardless, getting the drug to the target cells has always been a challenge. Our main delivery routes currently are swallowing, inhalation, skin absorption, and injection. Each has different uses, benefits, and drawbacks, but the route isn’t enough. Ingested medicines, for example, need to survive the harsh stomach acid but still be absorbable by the intestines. Injected medications are cleared by the liver at high speeds, reducing the effectiveness of a drug. Effective drug delivery means getting medicine to the right place at the right time, intact.

One of the best-known developments in medications has been the use of mRNA in COVID vaccines. Actually getting the delicate molecules inside cells for an immune response was one of the unsung heroes of this vaccine. Scientists implemented lipid nanoparticles to get the job done. This was no easy challenge. Lipid nanoparticles are teeny packages of fat that protect the mRNA vaccine until it can get into target cells. They are small and strong to enter cells without disintegrating in the bloodstream. The development of lipid nanoparticles was just in time for the COVID pandemic and has shown to be very effective. The drawbacks are that they must be produced perfectly every time for billions of doses and must be kept extremely cold, at least currently.

A much less widespread development has been the creation of microneedles. These are already in use for cosmeceutical applications. Microneedles are generally smaller than one or two millimeters and don’t puncture the skin all the way to the blood layer. This allows for simpler delivery and at-home administration of some medicines. Microneedles can also be coated with a dry version of medicines, allowing for shelf-stable drug delivery. This could be particularly helpful in areas with inadequate infrastructure and a lack of medical personnel.

Researchers are developing many other new and exciting delivery methods. Targeted organ delivery is the practice of delivering medicine to specific organs. One example is coating a medicine in a urine-resistant coating for injection into the bladder. Cellular delivery uses living cells to carry medication to the target site. These living cells may be red blood cells or beneficial cyanobacteria. Attaching medicine to red blood cells can help drugs resist the powerful cleanup mechanism of the liver. This may allow for lower doses to have bigger effects. Attaching to beneficial spirulina platensis cyanobacteria may help medicines cross the stomach intact and deliver medicine straight to the intestines. This can allow for targeted organ delivery or for longer release of medicines. Finally, some scientists are experimenting with physically squeezing cells. This opens temporary pores for direct drug delivery. Such a system could enable scientists to deliver medicine to billions of cells per minute.

All these exciting new delivery systems will have a big impact. Medicines of the future may be delivered in lower doses and with fewer side effects. We can also expect new uses for old medicines, as they will be able to be used in new ways and able to target new organs. Several of our clinical trials at Encore Research Group use these new methods. It’s an exciting time to help be on the cutting edge of what new medicine delivery will look like in the future. With luck, these new delivery methods will open new doors for medicines to help save lives and heal conditions. With even more luck, my buddy might get his bike by the end of the year.

Written by: Benton Lowey-Ball, B.S. Behavioral Neuroscience

Enrolling Studies

Sources:

May, M. (2022). Why drug delivery is the key to new medicines. Nature Medicine, 28(6), 1100-1102.

National Institute of Health, National Institute of Biomedical Imaging and Bioengineering. (October, 2016). Drug delivery systems. U.S. Department of Health and Human Services. https://www.nibib.nih.gov/science-education/science-topics/drug-delivery-systems-getting-drugs-their-targets-controlled-manner

Your-Phone-May-Be-Able-to-Hear-Congestive-Heart-Failure.jpg

Heart disease is the leading cause of death in the United States. Though there are several types of heart disease, one of the main ways the heart actually dies is through congestive heart failure, when the heart fails to pump effectively. Ineffective pumping causes blood and other fluids to build up throughout the body. Eventually, the fluid buildup may keep the heart from functioning at all, a condition called acute decompensated heart failure. This is an emergency condition, and without rapid medical treatment quickly leads to death. Fortunately, with early intervention, several patients can recover – at least temporarily. Clearly, one of the keys to saving people is early intervention.

The vocal cords and lungs may be affected by congestive heart failure. As these fill with fluid, there are changes in how the voice sounds. These changes are difficult for people to hear, but technology might be able to help out. One type of technology looking to tackle the topic is a deep neural network called HearO.

Deep neural networks are a subset of artificial intelligence. These systems learn how to make predictions from examples. The HearO system, made by the company Cardio Medical, analyzed the voices of people with congestive heart failure. The system learned by comparing people’s voices while they were “wet” (fluid-filled while in the hospital) and “dry” (after hospital treatment and discharge). Using this, the system learned to detect voice differences in the severity of the condition.

The HearO system has now been packaged as a smartphone app. Patients talk into the app every day and it compares their voice to itself. It scans for changes that indicate a fluid build-up (and danger!). The hope is that HearO will help detect changes in the voice before acute decompensated heart failure occurs. Clinical trials are currently underway to test the HearO’s effectiveness and some of our ENCORE Research Group sites are enrolling for this.

Written by: Benton Lowey-Ball, B.S. Behavioral Neuroscience

Enrolling Studies

Sources:

Amir, O., Abraham, W. T., Azzam, Z. S., Berger, G., Anker, S. D., Pinney, S. P., … & Edelman, E. R. (2022). Remote speech analysis in the evaluation of hospitalized patients with acute decompensated heart failure. Heart Failure, 10(1), 41-49.

Brooks, M. (2015, December 15). Smartphone app could give voice to congestion in heart failure. Medscape. https://www.cordio-med.com/wp-content/uploads/2021/12/smartphone-app-could-give-voice-to-congestionin-heart-failure.pdf

Tomov, N. S., & Tomov, S. (2018). On deep neural networks for detecting heart disease. arXiv preprint arXiv:1808.07168.

We’ve all heard enough about COVID-19, but it’s worth remembering that other viruses still try to get cozy in our respiratory system. One virus that is very prevalent in the United States is Respiratory Syncytial (“sin-sish-ul”) Virus, or RSV for short. It’s so widespread that the CDC states that nearly all children will get RSV before their second birthday. The oldest (above 65) and youngest (under 5) populations are most at risk of complications. Those most in danger are premature children, those with compromised immune systems, and those with underlying heart or lung diseases. All told, RSV accounts for around 177,000 hospitalizations of seniors (65+) and 58,000 children (under 5) each year.

RSV is easily transmissible. It passes from person to person through coughs, sneezes, or indirect means, like touching a doorknob and then your face. Most patients experience mild, cold-like symptoms. These include runny nose, fever, cough, sneezing, etc. Symptoms usually come in stages over a couple of weeks. Very young children and those at higher risk may experience more severe symptoms. In children under six, RSV might present as irritation, decreased activity, and breathing difficulty, which can be severe – and very scary! In adults over 65, severe symptoms can include a worsening of asthma or COPD, pneumonia, and the development of Congestive Heart Failure – a fluid buildup in the heart that prevents it from pumping effectively.

Much like the flu, RSV is seasonal. In most of the United States, the season is from September to February. The Florida Department of Health notes that Florida has a longer season than the rest of the nation. Here, the season for RSV is from August through April. The CDC has found that all across the south the year-round RSV cases increased. 2021 saw an unexpected surge of RSV over the summer. This is in part because the same tactics used to stem COVID-19 also protect against RSV. These protective measures include wearing masks, washing hands and surfaces, and social distancing. As these restrictions were lessened, cases of RSV rose to unprecedented summer levels.

Unfortunately, there is no cure for RSV. As it’s a virus, antibiotics are ineffective. Most patients will recover naturally. For others, best practices are treating symptoms by managing fever, pain, fluid intake, and any complications. For children and infants at severe risk, monthly Palivizumab injections may be available. Unfortunately, there are no publicly available vaccines for adults at increased risk. There are vaccines currently being researched that are going through clinical trials. With your help, we can find an effective RSV vaccine and help protect those at risk.

Written by: Benton Lowey-Ball, B.S. Behavioral Neuroscience

Enrolling Studies

Sources:

Centers for Disease Control and Prevention. (2019). Respiratory Syncytial Virus Infection (RSV). Atlanta, USA.

Centers for Disease Control and Prevention. (2021). Increased interseasonal Respiratory Syncytial Virus (RSV) activity in parts of the southern United States. Atlanta, USA.

Florida Department of Health. (2022). Respiratory Syncytial Virus (RSV) in Florida. Tallahassee, USA

Vision is our main way of interacting with the world, and it can be debilitating when our vision deteriorates. Unfortunately, presbyopia – the gradual loss of ability to focus on nearby objects – is basically inevitable. Presbyopia affects nearly 25% of the world population; almost 2 billion people. People usually see symptoms in their 40s, but the path starts in childhood.

The exact cause of presbyopia is unknown, but the effects are well documented. The eye’s lens is the bit that changes shape, allowing us to focus at different distances. During childhood, the lens gradually becomes less flexible. Since it can’t change shape as easily, we stop being able to focus as rapidly and accurately. It gets more difficult to focus at close or mid-lengths. There are four broad methods suggested for increasing focal range, each with its own trade-off.

Changing focus over time is the first method. Think of it like having several pairs of glasses. When focusing on close things you might use readers. Different glasses may be used for mid-length, or distance viewing. This is what our eyes do naturally (when we’re young at least!). So far there are no pharmaceutical or implantable devices that can accomplish this. Using several glasses is a good – if bulky – approximation for millions of people, however.

Changing focus depending on where you look is the second method. Bifocals are the classic example. This solution is quick and convenient. There are downsides, however. Changing from near to mid-focus can be jarring, vision can be blurry, and eye strain occurs sometimes. One often overlooked issue is that bifocals can introduce other dangers, such as falls due to unfocused areas near the feet when walking.

Changing focus between eyes is an interesting method. With this approach, one eye is corrected for close vision, and the other stays focused at a distance. Each eye only focuses narrowly, but together you can see across a wide range. Even though this is easy to try by putting in only one contact lens, it can be hard to get used to and lead to a loss of binocular vision. Judging distances of objects may be more difficult with this method, and it can be uncomfortable for some people.

The final method is to increase the focal range across distances. This is an innovative method where the eyes are changed to have more in-focus at the same time. If you’ve ever had an eye exam where they dilate your pupils, this is the opposite. The pupils are artificially constricted. This extends your depth of field, making it easier to focus on things near and far at the same time! Some side effects may include a loss in quality and contrast, and a loss of low-light sensitivity. One of the big hurdles researchers have is the precision required to pull this off successfully. Methods to induce increasing focal range can be permanent, such as with implanted lenses; but mitigation of side effects may be easiest with special eye drops. Some of these eye drops are being tested currently in clinical trials.

With so many different angles to attack presbyopia, and volunteers helping with clinical trials, we may be looking at a universal treatment soon!

Written by: Benton Lowey-Ball, B.S. Behavioral Neuroscience

Enrolling Studies

Source:

Chang, D. H., & Waring, G. O. (2021). Presbyopia Treatments by Mechanism of Action: A New Classification System Based on a Review of the Literature. Clinical Ophthalmology (Auckland, NZ), 15, 3733.

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ENCORE · There’s an Aura of Hope Around Migraine Relief

Have you ever had a headache that you couldn’t shake, even for hours or days? One that may make you nauseous or unable to function? Then you may have had a migraine. And you’re not alone. A survey from 1990 to 2010 found that about 15% of the world’s population have migraines each year. That makes migraines the third-highest source of long-term injury! Women are around twice as likely to get migraines than men.

Migraines can be broadly lumped into two categories based on frequency, episodic and chronic. People with episodic migraines experience between 0 and 14 days with migraines a month. More than that and the condition is called chronic migraine. The difference between these two categories isn’t set, and a small percentage of those with either condition may evolve or degrade into the other. Either way, migraines are debilitating. They last hours to days and may be accompanied by an aura: a visual indication of an impending bad day.

The exact underlying causes of migraines are unknown, but there are some areas where intervention is possible. The pain and debilitating effects of migraines are caused, at least in part, by something called vasodilation. This is just a fancy term for when blood vessels expand, allowing more fluid to pass through. Vasodilation can occur for many reasons, but one of the main suspects in migraines is a protein called CGRP (calcitonin gene-related peptide, for the curious). This protein acts on the coverings of the brain, causing vasodilation that inflames this area. It is unclear exactly what happens after this, but the end result is debilitating pain. It has even been shown that injecting CGRP can cause a migraine to start.

Interventions against this vasodilation are possible through a couple of different routes. One of the classic ways of tackling a migraine is through a medication called Dihydroergotamine, or DHE for short. This medication causes some arteries in the brain to constrict, counteracting the vasodilation from CGRP. This can “interrupt” the migraine and provide relief. This relief often effectively ends the migraine. DHE has been available for injection in the US for some time, though in other countries it is available as a nasal spray. Researchers are working to get approval for this method in the US as well.

Another intervention being researched is stopping the vasodilation at the source. There is ongoing research in stopping CGRP from acting on the brain coverings at all. This is a new avenue that may help provide migraine relief with fewer side effects. Research in this field is also ongoing, ask us about the different ways you can help provide research insight into relief for this real headache of a condition.

Written by: Benton Lowey-Ball, B.S. Behavioral Neuroscience

Enrolling Studies

Sources:

De Matteis, E., Guglielmetti, M., Ornello, R., Spuntarelli, V., Martelletti, P., & Sacco, S. (2020). Targeting CGRP for migraine treatment: mechanisms, antibodies, small molecules, perspectives. Expert review of neurotherapeutics, 20(6), 627-641.

Marmura, M. J. (2018). Triggers, protectors, and predictors in episodic migraine. Current pain and headache reports, 22(12), 1-9.

Shafqat, R., Flores-Montanez, Y., Delbono, V., & Nahas, S. J. (2020). Updated evaluation of IV dihydroergotamine (DHE) for refractory migraine: patient selection and special considerations. Journal of Pain Research, 13, 859.

Vos, T., Flaxman, A. D., Naghavi, M., Lozano, R., Michaud, C., Ezzati, M., … & Harrison, J. E. (2012). Years lived with disability (YLDs) for 1160 sequelae of 289 diseases and injuries 1990–2010: a systematic analysis for the Global Burden of Disease Study 2010. The lancet, 380(9859), 2163-2196.

Ulcerative colitis (UC) is a chronic and progressive autoimmune disorder that causes inflammation and ulcers to develop in the intestines, which can be very uncomfortable or debilitating. Ulcers are breaks or holes in the protective lining that can cause bloody diarrhea, with or without mucus. One of the significant symptoms of UC is a high urgency of bowel movements. Other symptoms include abdominal pain, bowel inflammation, and constipation. UC is not a fun condition to experience, to say the least! It is usually experienced in cycles of remission and relapse with periods of terrible high and thankfully low (or no) symptoms. The high periods can even lead to hospitalization.

UC can develop at any age but is more likely to develop in people 15 to 30 years old. Interestingly, there seems to be a lower chance of developing UC if your appendix has been removed or if you are a smoker. This disease doesn’t play favorites, so there is no difference between men and women developing UC. Racial differences may be minimal compared to differences in diet and lifestyle. For example, a diet that includes eating refined sugars and processed grains may increase the likelihood of developing the disease.

As mentioned above, diet can be a risk factor; this may be because of an immune response to the food. Research continues to show that the food you eat can affect all parts of the body. People with genetic factors have an immune system that attacks non-harmful gut bacteria, and low gut microbiota diversity may also be a risk factor.

Ulcerative colitis often presents with other diseases. Data suggests that there is a relationship between UC and rheumatoid arthritis. Some experts think joint pain and swelling may be part of the same immune response responsible for ulcerative colitis. Other comorbidities include acute hepatitis (liver inflammation) and occasional skin conditions.

Treatments for UC aim at inducing a period of remission. All of them come with side effects, so your doctors, specialist and primary care, should all be informed about the medications that you are taking. A particularly unpleasant and severe treatment is a colectomy or bowel resection, which removes part of the affected colon. 20-30% of people with UC may have to undergo this procedure.

The good news is that researchers continue to look for better ways to treat UC. With your help, we can make a difference! Visit our enrolling studies page to get involved in the latest clinical research.

Written by: Benton Lowey-Ball, B.S. Behavioral Neuroscience

Enrolling Studies

Sources:

Gajendran, M., Loganathan, P., Jimenez, G., Catinella, A. P., Ng, N., Umapathy, C., … & Hashash, J. G. (2019). A comprehensive review and update on ulcerative colitis. Disease-a-month, 65(12), 100851.

Lee, S. H., eun Kwon, J., & Cho, M. L. (2018). Immunological pathogenesis of inflammatory bowel disease. Intestinal research, 16(1), 26.

Attalla MG, Singh SB, Khalid R, Umair M, Epenge E. Relationship between Ulcerative Colitis and Rheumatoid Arthritis: A Review. Cureus. 2019;11(9):e5695. Published 2019 Sep 18. doi:10.7759/cureus.5695

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ENCORE · NASH Treatments – The Quest For The Holy Grail

The liver is a critical organ that has many functions. It balances the body’s energy budget, filters blood, and metabolizes drugs, for a start. Since the liver is so imperative, it goes without saying that when the liver starts to fail, a lot can go wrong. It is widely known that excessive alcohol consumption can damage the liver, but there are also other pathways to liver damage. One particularly dangerous pathway for liver disease is Non-Alcoholic Steatohepatitis or NASH which is the most severe form of non-alcoholic fatty liver disease. The exact cause of NASH is unknown.

NASH is a disease characterized by an accumulation of fat in the liver coupled with liver enlargement due to chronic inflammation and cell death. It is difficult to diagnose NASH. The symptoms, tiredness and/or pain in the upper right side of the abdomen, are not very specific to NASH or helpful in diagnosis. Most often, patients do not have symptoms at all until the later stages of the disease.

NASH is widespread, affecting between 3-5% percent of the worldwide population. It has been referred to as a modern lifestyle disease, with things like overeating and sedentariness contributing to it.

There are several risk factors for developing NASH:

Female
Aged 50+
Heart disease
High lipid levels (ie: cholesterol/triglycerides)
High blood pressure
Metabolic syndrome
Overweight or obesity
Type 2 diabetes
Insulin resistance
Genetic and environmental factors

NASH is a progressive liver disease, meaning it gets worse over time without treatment or lifestyle changes. The first step of NASH is fibrosis, where repeated scarring occurs. This scarring forms when the liver is repeatedly damaged and healed. NASH patients develop more severe forms of fibrosis about twice as fast as those with alcohol-induced liver damage. In NASH, unlike with alcoholic liver disease, the cause of damage is not always known. Fibrosis is scarring that is reversible with treatment.

If NASH progresses further, cirrhosis may occur. This is scarring and liver failure that is permanent, though people can live with it for years. In cirrhosis, the cells of the liver themselves suffer damage. The final two stages of NASH are hepatocellular carcinoma, a type of liver cancer, and death. Tackling NASH early on is vital to those suffering from this disease!

Unfortunately NASH is an understudied disease with few routes to recovery. Currently, the most effective treatment appears to be weight loss, accompanied by dietary and lifestyle changes. In scientific studies, this has been only achievable by about 50% of those with NASH. With this in mind, and only the early fibrosis stage of NASH being reversible, the search for medications that can treat NASH has been described as the “Quest for the Holy Grail.” There are currently no FDA-approved drugs to treat NASH. Several clinical trials exist and will continue to enroll and may lead to a treatment soon. If you have NASH, it’s important to consider participating in clinical trials to help find effective treatments. Find out which clinical trials are enrolling near you by visiting our enrolling studies page.

Written by: Benton Lowey-Ball, B.S. Behavioral Neuroscience

Enrolling Studies

Sources:

Povsic, M., Wong, O. Y., Perry, R., & Bottomley, J. (2019). A structured literature review of the epidemiology and disease burden of non-alcoholic steatohepatitis (NASH). Advances in therapy, 36(7), 1574-1594.

Sharma, M., Premkumar, M., Kulkarni, A. V., Kumar, P., Reddy, D. N., & Rao, N. P. (2021). Drugs for non-alcoholic steatohepatitis (NASH): quest for the holy grail. Journal of Clinical and Translational Hepatology, 9(1), 40.

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ENCORE · Be Ye Wondering About How Clinical Trials First Hit the Salty Sea?

Ahoy ye mateys! Have you ever wondered which enemy was the most dangerous to sailors during the 1700’s? James Lind, a Royal Navy surgeon, described a foe which “proved a more destructive enemy, and cut off more valuable lives, than the united efforts of the French and Spanish arms.” In order to conquer this threat, Lind employed a brand new weapon. This weapon was previously unknown to science, and has now been used to defeat countless foes. The enemy was scurvy, and the weapon was a clinical trial.

May 20, 2022 marks the 275th anniversary of that first clinical trial. Scurvy could lead to muscle pain, gum disease, fatigue, jaundice, and death. Remedies at the time varied widely and only anecdotal, word-of-mouth evidence for them was available. Every sailor who was afflicted with scurvy sought a cure, but the overall disease was caught in the doldrums without a solution for 150 years. Lind had bigger ambitions. His big insight wasn’t trying to treat just a few individuals for scurvy, but instead trying to solve the problem of scurvy on the scale of public health. Though he only had 12 participants in that first trial, how Lind compared different remedies showed his big-picture thinking. He sought not to give relief to just those 12 patients, but to quantify and share his results to cure the whole of the Royal Navy.

In this effort Lind laid the groundwork of the modern clinical research study. He started with a set of 12 patients with conditions “as similar as I could have them.” He controlled extraneous variables, giving all patients the same diet during the study and keeping them on the same boat. He split them into 6 random conditions:

A quart of cider per day
Elixir vitriol (sulfuric acid and alcohol), 3x daily
2 spoonfuls of vinegar, 3x daily
½ pint of seawater per day
2 oranges and 1 lemon per day
Bigness of nutmeg (a medicinal paste made of herbs and spices)

The results were clear; citrus gave quick and significant relief. Importantly, Lind didn’t leave his findings high and dry. He recorded and reported what he saw. Probably the most important aspect of Lind’s clinical trial was that he looked at the results in an unbiased way. He wrote extensively on the need to remove personal and societal bias:

“it is no easy matter to root out old prejudices, or to overturn opinions which have acquired an establishment of time, custom, and great authorities; it became therefore requisite for this purpose, to exhibit a full and impartial view of what has hitherto been published on scurvy.”

Today the same core ideas guide clinical trials, but there are many more safeguards for participants. A good clinical trial today is grounded in science, provides benefits to patients that should outweigh any risks, and treats patients with respect. Critically, clinical trials have informed consent; all participants join voluntarily and must have full knowledge of any risks before signing up. Trials also have oversight from Institutional Review Boards and have medical staff on site to help with any adverse reactions. Following Lind’s example, clinical trials also target specific conditions, have randomized patients, control conditions (as much as possible), and dutifully record and report their findings.

Though his aim was to blow scurvy out of the water, Lind ended up making waves in how scientists solve medical problems in general. His quantitative, balanced approach gave the world a system to tackle medical problems. On this International Clinical Trials Day we can help keep up the bounty of Lind’s legacy by volunteering as a clinical research trial participant and send some diseases to Davy Jones’ Locker!

Written by Benton Lowey-Ball, BS Behavioral Neuroscience

Enrolling Studies

Lind, J. (1753). A treatise of the scurvy: in three parts, containing an inquiry into the nature, causes, and cure, of that disease, together with a critical and chronological view of what has been published on the subject. Bulletin of the World Health Organization: the International Journal of Public Health 2004; 82 (10): 793-796.From https://www.jameslindlibrary.org/lind-j-1753/

Attention-deficit hyperactivity disorder (ADHD) is a disorder that is often diagnosed in childhood. When most people think of ADHD, they envision young children with an overabundance of hyperactivity and impulsiveness. However, there are three kinds of ADHD: hyperactive, inattentive, and combined presentation (inattentive and hyperactive). Researchers feel that inattentive ADHD is underdiagnosed because the symptoms present quite differently and are less noticeable. It is a chronic condition that causes attention difficulties, hyperactivity, mood swings, and impulsiveness.

In more recent years, it has come to light that ADHD might be associated with some memory loss. Other common reasons for memory loss include brain injuries, illnesses like Alzheimer’s or depression, effects of drugs and alcohol, and nutritional deficiencies. Other examples that can cause memory loss are age, stress, or lack of sleep.

Many people with ADHD go undiagnosed, especially if they have inattentive ADHD. Adults with ADHD do report memory loss, especially long-term memory. More recent studies have focused on why adults with ADHD have memory loss.

An article under the National Library of Medicine states that “it is well documented that adults with ADHD perform poorly on long-term memory tests. ”Their study concluded that adult ADHD reflects “a learning deficit induced at the stage of encoding.”

Researchers aren’t clear about ADHD and memory loss or whether having ADHD as an adult puts you at higher risk for developing dementia. Another study done in 2017 discussed the overlapping symptoms of ADHD and a type of dementia called mild cognitive impairment.

Continued research is essential to increase understanding of ADHD and the link between memory loss. ENCORE Research Group sites do not currently have any research studies for ADHD, but you can find some by searching clinicaltrials.gov. If you are experiencing memory loss, it’s vital to speak with your doctor about your symptoms. If you are over 50 and have memory loss, Jacksonville Center for Clinical Research offers a free memory screening assessment. You can contact us at (904)-730-0166.

ENROLLING STUDIES

Sources:

Skodzik T, Holling H, Pedersen A. Long-Term Memory Performance in Adult ADHD. J Atten Disord. 2017 Feb;21(4):267-283. doi: 10.1177/1087054713510561. Epub 2016 Jul 28. PMID: 24232170.

Callahan, B. L., Bierstone, D., Stuss, D. T., & Black, S. E. (2017). Adult ADHD: Risk Factor for Dementia or Phenotypic Mimic?. Frontiers in aging neuroscience, 9, 260. https://doi.org/10.3389/fnagi.2017.00260

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ENCORE · Could Antibiotics Be Causing Mental Decline?

Could our guts affect how smart we are? A new study of over 14,000 women provides evidence. The study followed middle aged, 50-60 year old women over seven years from 2014 to 2018. It found that the longer a person used antibiotics, the greater the mental decline. At the high end, two months of antibiotic use was correlated with a mental decline equal to aging an extra 3-4 years.

This study does not imply causation. All participants self-reported their data, meaning they answered questionnaires. This does not allow scientists to see a direct cause-effect relationship. Other confounding effects may have been in play. One is that participants who used more antibiotics were more likely to have been sick. The scientists in charge of this study attempted to account for these differences. Study scientists adjusted for:

Age and socioeconomic factors (education level, spousal education level)
Lifestyle (smoking, alcohol use)
General health (weight, physical activity, eating habits, multivitamin use)
Mental health (depression, antidepressant use)
Cardiovascular health (heart medication, blood pressure, cholesterol, history of heart attack)
Other big health issues (stroke, diabetes, emphysema)

After this they still found that antibiotic use was the leading indicator of mental decline.

The link between the gut and the brain is an area of intense and active investigation. Information can travel back and forth between the gut and the brain along a special route called the gut-brain-axis. This takes advantage of a large nerve, the vagus nerve. The vagus nerve directly links the digestive tract and the brain. Animal studies show that altering the gut bacteria can alter a host of mental processes. In developing animals, reducing gut bacteria alters how their brains develop. Animal stress hormone levels also vary in response to changes in gut bacteria levels. Several of these changes reverse or decline when normal bacterial levels are restored. More experimental information could help solidify the link between the gut and the brain.

Mehta, R. S., Lochhead, P., Wang, Y., Ma, W., Nguyen, L. H., Kochar, B., … & Chan, A. T. (2022). Association of midlife antibiotic use with subsequent cognitive function in women. Plos one, 17(3), e0264649.

ENROLLING STUDIES

Sources:

Carabotti, M., Scirocco, A., Maselli, M. A., & Severi, C. (2015). The gut-brain axis: interactions between enteric microbiota, central and enteric nervous systems. Annals of gastroenterology: quarterly publication of the Hellenic Society of Gastroenterology, 28(2), 203.

Heijtz, R. D., Wang, S., Anuar, F., Qian, Y., Björkholm, B., Samuelsson, A., … & Pettersson, S. (2011). Normal gut microbiota modulates brain development and behavior. Proceedings of the National Academy of Sciences, 108(7), 3047-3052.

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ENCORE · Glaucoma: Too Much Aqueous Humor Is Nothing To Laugh At

The eye is a fragile and carefully balanced organ. At the very front of the eye is a fluid-filled chamber called the anterior chamber. This is located between the clear cornea at the front and the pupil, where light enters the rest of the eye. The fluid that fills this area is called the aqueous humor. The aqueous humor is critically important for cleaning and bringing nutrients to the lens. It is like a clear version of blood. Another key job the aqueous humor performs is maintaining eye pressure.

The pressure in the eye needs to be maintained within a very specific range (12-22 mm Hg). Aqueous humor continuously flows through the front of the eye at a very slow rate (like blood, but slower). When the flow rate out of the eye gets disrupted, eye pressure increases.

Doctors call high eye pressure ocular hypertension. The major characteristic is increased eye pressure without other symptoms. When eye pressure causes damage to the optic nerve, we call it glaucoma. Glaucoma can occur in two ways, closed angle or open angle. Closed angle is sudden and a medical emergency. Open angle makes up almost all cases of glaucoma and is gradual in onset. Typical symptoms of open angle glaucoma are vision problems in the middle of sight. These can include trouble with reading, seeing faces, walking, and driving. Both types will cause permanent blindness if untreated.

Open angle glaucoma can happen to anyone, but is much more common with adults over 60 years old. Most cases are females, and black and Asian populations experience higher rates of the condition. There are several underlying reasons for open-angle glaucoma: vascular, anatomical, genetic, or immune. Because of this wide spread of causes, there are several risk factors:

Genetics / Family history
Diabetes
Extreme nearsightedness
Hypertension
Eye injury
Eye abnormalities
Steroid use
Smoking

Several treatments are available for glaucoma. These include surgical and medication-based treatments, and surgically implanted medications. The goal of all treatments is to increase the flow of fluid out, decrease the amount of fluid coming in, or to decrease the volume of the anterior chamber. Medications are quite effective when taken properly. Unfortunately, fewer than one third of patients adhere to doctor recommendations for glaucoma eye drops after a year. This is in spite of the condition being progressive in nature and leading to blindness. Effective implanted medication delivery systems may provide better outcomes for patients.

To get involved in the latest glaucoma research, contact our Nature Coast Crystal River office.

ENROLLING STUDIES

Sources:

Allison, K., Patel, D., & Alabi, O. (2020). Epidemiology of glaucoma: the past, present, and predictions for the future. Cureus, 12(11).

Li, F., Huang, W., & Zhang, X. (2018). Efficacy and safety of different regimens for primary open‐angle glaucoma or ocular hypertension: A systematic review and network meta‐analysis. Acta ophthalmologica, 96(3), e277-e284.

Robin, A. L., & Muir, K. W. (2019). Medication adherence in patients with ocular hypertension or glaucoma. Expert Review of Ophthalmology, 14(4-5), 199-210.

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ENCORE · NERD – Non-Erosive Reflux Disease

Chronic heartburn and acid reflux are symptoms of gastroesophageal reflux disease (GERD). This disease can result in the wearing away of the tube between the stomach and throat. When wearing away does not occur, a specific type of GERD occurs. This type is non-erosive reflux disease (NERD).

The rates of GERD in the US are very large, affecting 1 in 5 people. Most of those cases are actually the NERD type. This works out to 14% of Americans experiencing NERD. It affects men and women at equal rates, and in the USA rates are constant across racial lines.

Several factors can increase the chances of getting NERD. Your chances are increased with:

Age, peaking around 70 years old
Smoking
Drinking excessive coffee
Drinking excessive alcohol
Obesity
Eating large amounts of food
Eating fatty foods
Eating at night

NERD does not destroy the esophagus, but comes with its own host of issues. Heartburn and irritation of the food tube define NERD, and are uncomfortable on their own. It can also cause chest pain, vomiting, asthma, coughs, and sleeping problems. Furthermore, a major class of GERD-targeting drugs are less effective on the non-erosive form, NERD. These drugs are called proton-pump-inhibitors.

Proton pump inhibitors are the most effective medications for treating GERD. Major name-brand proton-pump-inhibitors include Prilosec, Protonix, Nexium, Prevacid, and several others. The generic names are omeprazole, pantoprazole, esomeprazole, and others. All of these work by reducing the stomach’s ability to make stomach acid, lowering its ability to burn. As a result, GERD is both less painful and less destructive to the esophagus.

Several people experiencing NERD are resistant to proton-pump-inhibitors. There are several possible reasons. In some patients, high concentrations of stomach acid isn’t the cause of their issues. In fact, only around half of NERD patients have abnormal acid levels, so lowering stomach acid may not be helpful as a treatment. These patients may have acid reflux even when acid levels are normal. They may also have a particularly sensitive esophagus. This could result in the feeling of heartburn even with lower acid levels. These patients need new treatments to help manage NERD. With luck, a clinical trial will pave the way to widespread adoption of an effective treatment soon!

ENROLLING STUDIES

Sources:

Ang, D., How, C. H., & Ang, T. L. (2016). Persistent gastro-oesophageal reflux symptoms despite proton pump inhibitor therapy. Singapore medical journal, 57(10), 546.

Dent, J., El-Serag, H. B., Wallander, M., & Johansson, S. (2005). Epidemiology of gastro-oesophageal reflux disease: a systematic review. Gut, 54(5), 710-717.

Hershcovici, T., & Fass, R. (2010). Nonerosive reflux disease (NERD)-an update. Journal of neurogastroenterology and motility, 16(1), 8.

ICRMD (2021, August 27). What is non-erosive reflux disease? ICRMD. Retrieved March 24, 2022, from https://icrmd.com/2021/08/27/what-is-non-erosive-reflux-disease/

Ribolsi, M., Cicala, M., Zentilin, P., Neri, M., Mauro, A., Efthymakis, K., … & Penagini, R. (2018). Prevalence and clinical characteristics of refractoriness to optimal proton pump inhibitor therapy in non‐erosive reflux disease. Alimentary Pharmacology & Therapeutics, 48(10), 1074-1081.

Yamasaki, T., & Fass, R. (2017). Reflux hypersensitivity: a new functional esophageal disorder. Journal of Neurogastroenterology and Motility, 23(4), 495.

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ENCORE · The Latest Treatments For Crohn’s Disease

Crohn’s disease is one of two types of irritable bowel disease. Unlike the more narrowly located Ulcerative Colitis, Crohn’s disease can be very widespread. Crohn’s disease is caused by inflammation of the bowel walls which can occur anywhere between the mouth and anus. This inflammation is frequently interspersed with healthy tissue. It affects the entire thickness of the bowel walls. Crohn’s is usually diagnosed by age 35 and affects 1.5 million people in the USA alone.

Crohn’s disease is an autoimmune disorder. That means your body’s immune system is mistakenly attacking healthy cells. It is also a multifactorial disease. This means there are several possible underlying causes for it. Scientists know that the causes include genetic and environmental factors. Some risk factors are a low fiber diet, high carb diet, altered microbiome, and the use of NSAID medication. Lifestyle factors that influence Crohn’s include sleep, stress, exercise, and smoking. Unlike ulcerative colitis, smoking doubles a person’s chance of developing Crohn’s disease.

Having such a large amount of possible causes makes Crohn’s disease very difficult to cure. So far researchers have only found ways to intermittently fix the symptoms of Crohn’s disease. Surgery has the best chance of providing long-term help however surgery comes with massive side effects. There are two classic drug-based solutions corticosteroids and immunomodulators. Corticosteroids reduce the body’s inflammatory response. Immunomodulators change how the immune system acts. The newest type of Crohn’s medication to market is biologics, which targets only specific parts of the immune system to keep effectiveness high and side effects low. Several of these are still in the research phase along with some brand new classes of oral drugs. To learn more about getting involved in Crohn’s disease research studies, visit our enrolling studies page or call your local ENCORE office today.

Written by: Benton Lowey-Ball, B.S. Behavioral Neuroscience

ENROLLING STUDIES

Source

Gajendran, M., Loganathan, P., Catinella, A. P., & Hashash, J. G. (2018). A comprehensive review and update on Crohn’s disease. Disease-a-month, 64(2), 20-57.

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ENCORE · Parkinson’s Disease and the Gut-Brain Axis

Parkinson’s disease is a brain disease known for producing problems with muscle movement. These problems can include shaking tremors, muscle stiffness, and difficulty with balance and walking. The direct cause of these problems is a decrease in dopamine production. Dopamine is a chemical in the brain used to communicate information between nerves. It is also used to direct motor function. The motor coordination part of the brain, the basal ganglia, requires dopamine to function. Without dopamine, the basal ganglia cannot coordinate your muscles well. This means you cannot coordinate smooth, balanced, and nuanced movements. The stereotypical shaking in Parkinson’s patients is the result. It is akin to what would happen if the traffic lights in a city were not receiving enough power. Cars would still get through town, but traffic would be slow, backed up, jerky, and would only get worse.

Parkinson’s is a progressive disease, meaning that it gets worse over time. It affects about 1% of those 65 and older and 3% of adults over 80. Additionally, it is expected that the number of people with Parkinson’s disease may increase by up to 30% by 2030. Though it can affect any older individual, it is more common in men. Genetic and environmental factors can increase the chance of getting Parkinson’s. These include being of European or South American descent, smoking, and exposure to pesticides. Surprisingly, there is also a link between Parkinson’s and your gut!

Your gut has a direct link to the brain through the gut-brain axis via a special nerve called the vagus nerve. The vagus nerve travels from the brain and some important parts of the digestive system (stomach, large, and small intestine). This nerve communicates a lot of information. It is partially responsible for mood, hunger, energy, and helps coordinate immune responses. Though the brain is the thinking center of the body, it needs input from the body to make decisions. Interestingly, 90% of vagus nerve information flows from the gut to the brain! Therefore, disruptions in the gut can have massive effects on how your brain functions. This appears to be true with Parkinson’s disease. Research shows that misfolded proteins called alpha-synuclein may be able to travel through the vagus nerve. This may damage the part of the brain responsible for muscle control, called the basal ganglia.

Research has found that disruptions of the gut can affect every system the vagus nerve touches. This might be one of the causes for some of Parkinson’s other effects, including non-motor disruptions. These can include rapid eye movement behavior disorder (RBD), mood disorders, cognitive problems like attention and learning, and even hallucinations.

So far, there are no therapies that can reverse the effects of Parkinson’s Disease. Doctors prescribe l-DOPA to replicate dopamine production in the brain. This helps the basal ganglia coordinate movement to reduce the symptoms of Parkinson’s. Unfortunately, we cannot yet reverse the progressive nature of the disease. Fortunately, clinical trials are aiming to discover disease-modifying treatments!

Enrolling Studies

Sources:

Breit, S., Kupferberg, A., Rogler, G., & Hasler, G. (2018). Vagus nerve as modulator of the brain–gut axis in psychiatric and inflammatory disorders. Frontiers in psychiatry, 44.

Kandel, E. R., Schwartz, J. H., Jessell, T. M., Siegelbaum, S., Hudspeth, A. J., & Mack, S. (Eds.). (2000). Principles of neural science (Vol. 4, pp. 1227-1246). New York: McGraw-hill.

Kouli, A., Torsney, K. M., & Kuan, W. L. (2018). Parkinson’s disease: etiology, neuropathology, and pathogenesis. Exon Publications, 3-26.

Lanciego, J. L., Luquin, N., & Obeso, J. A. (2012). Functional neuroanatomy of the basal ganglia. Cold Spring Harbor perspectives in medicine, 2(12), a009621.

NIH, National Institute on Aging. (2017). Parkinson’s Disease. https://www.nia.nih.gov/health/parkinsons-disease

Schwarz, P. B., & Peever, J. H. (2011).Dopamine triggers skeletal muscle tone by activating D1-like receptors on somatic motoneurons. Journal of neurophysiology, 106(3), 1299-1309.

Shaik, L., Kashyap, R., Thotamgari, S. R., Singh, R., & Khanna, S. (2020). Gut-brain axis and its neuro-psychiatric effects: A narrative review. Cureus, 12(10).

There are many good things about April. Spring is sprung, Easter egg hunts, and Earth Day. You may not have known, but April is also “Move More Month!” This April challenge is a great way to get into a good routine of getting up and moving! Exercise is such an excellent benefit for your health. Exercise has proven to help people sleep better, increase serotonin levels (happy hormone), and overall be healthier.

Some simple ways to get moving are going on walks, stretching, lifting small weights, riding a bike, and many more! It’s all about making small changes to get into a routine. Our ENCORE Research staff challenged themselves for April to get moving, even while at the office. Every hour we get up and move, doing a quick exercise. We find that setting a reminder alarm helps to keep us on track. We hope that you can follow along and get inspired to move more!

Here are some ideas to help get you started:

Easy:

Walk in place
Chair sits
Countertop plank
Countertop push-ups
Step-ups
Go for a walk

Medium:

Chair squats (not fully sitting)
Knees down Plank
Knees down push-ups
Hand slap step-up
Go for a walk/run (alternating)
Speed Clean (set a 5-minute timer)

Hard:

Squats
Planks
Push-ups
Stair (or bench) step-up
Go for a run

Healthy eating and exercise can help with not only your waistline but also cardiometabolic health. Carrying around extra fat can negatively affect your whole body; some areas of concern include the liver, heart, and joints. Although many people can maintain a healthy diet and exercise routine to keep the weight off, some folks need extra help with medication.

The liver is the largest organ inside your body and is integral in filtering harmful substances from your blood. When too much fat builds up in your liver, this is called fatty liver disease. This can progress to damaging and scarring of the liver. The scaring can ultimately lead to liver failure. Lifestyle changes, like healthy eating and exercise, are currently the only treatments for fatty liver disease, although many clinical trials are currently looking for a safe and effective therapy.

Heart disease remains the world’s leading killer. While extra fat itself does not directly cause heart attacks, it leads to other causes that can. High cholesterol, high blood pressure, and diabetes are among those that build up plaque in the arteries leading to heart attacks. ENCORE Research Group offices have many clinical trials in these areas!

Being overweight can affect your joints by raising your risk of developing osteoarthritis. The extra weight puts additional stress on your weight-bearing joints, such as your knees, which can cause additional wear and tear. Additionally, inflammation associated with weight gain might contribute to problems in other joints such as the hands.

For the folks who need more than just a healthy diet and exercise to help with medical conditions, the good news is that many new cutting-edge treatments are being studied and are available to you. Call your local ENCORE Research Group office today to get involved in our research trials.

Sources:
heathline.com
health.clevelandclinic.org
health.harvard.edu

Diabetic peripheral neuropathy is a type of nerve damage associated with diabetes that most commonly affects the peripheries of the body (toes, feet, legs, hands, and arms). Symptoms can range from mild to severe and can be painful, debilitating, or even fatal. The most common neuropathy symptom people seek medical attention for is pain. Since diabetic neuropathy currently does not have a cure, the best thing people can do is treat the pain and make sure their blood sugar levels are well controlled.

Diabetic neuropathy symptoms are often worse at night. Symptoms include:

Lack of sensation to pain or temperature in those areas
A tingling, burning or needle pricking feeling
Sharp pain or cramps
Extreme sensitivity to touch
Problems with balance and coordination

People who have had diabetes for at least 25 years have the highest rates of nerve damage. Neuropathies are also more common in people who cannot keep their blood sugar under control, have high blood pressure, or are obese.

Current treatment options for pain are limited by poor effectiveness and high rates of side effects, leaving many patients without adequate pain control. With chronic use, nonsteroidal anti-inflammatory drugs (NSAIDs) pose a potentially serious gastrointestinal and liver toxicity risk. Opioids are commonly prescribed for moderate-to-severe pain but are limited by safety and tolerability issues and have high abuse rates. Opioid-associated death rates have also increased over the past two decades.

Given the limited treatment options, combined with the risks and ineffectiveness of currently available treatments, developing new treatments is vital for better pain management and health outcomes. We are involved in many cutting-edge research trials at ENCORE Research Group, and some of our locations currently have research studies for painful diabetic peripheral neuropathy. To learn more about participating in our cutting-edge clinical trials, call our main office today! (904)-730-0166

What is EoE?
Eosinophilic esophagitis (EoE) is a chronic disease of the esophagus. Your esophagus is a muscular tube that carries food from your mouth to your stomach. EoE is when white blood cells (called eosinophils) build up in your esophagus.

What are the symptoms?
Some of the most common symptoms of EoE are:

Trouble swallowing
Chest pain or heartburn
Abdominal pain
Vomiting
Food getting stuck in your throat due to narrowing (this is a medical emergency)
Stunted growth or poor weight gain in children

How to get diagnosed.
Your doctor will most likely want you to have an endoscopy to diagnose EoE. An endoscopy is a procedure where an endoscope (a tube with a light and camera attached at the end) is inserted into the body to let your doctor look inside an organ. For an esophageal endoscopy, the endoscope is put in your mouth and down your throat to examine the esophagus. But don’t worry, you’re not awake for that part! Other ways you can be diagnosed are biopsies, blood tests, and an esophageal sponge.

Current research on EoE.
Science continues to move forward for new treatments of eosinophilic esophagitis, and we are delighted to be involved in these cutting-edge research trials at some of our ENCORE Research Group locations. To learn more about participating in our cutting-edge clinical trials, call our main office today! (904)-730-0166

ENROLLING STUDIES

Alzheimer’s is a devastating disease that affects 5.5 million people of all ages in the United States. Along with the diagnosis and reality of living with this disease, the families of these patients are now left with the question, “how will we take care of our loved one?” For many families, the option is having a designated person take care of the patient on their own. A caregiver is someone that assists with the daily needs of another person. There can be a “formal” caregiver, considered a paid person along with training, and an “informal” caregiver is a family or friend who provides care without pay. It can be a challenge for informal caregivers, especially with no training. Around 65.7 million people in the United States are informal caregivers. With that large of a statistic affecting a specific population, there are always great tips that can be provided.

Asking For Help

Taking care of someone with Alzheimer’s can be challenging. If it becomes too difficult for a caregiver, sometimes they feel guilty in asking for help. If taking care of someone becomes too emotionally and physically draining, there’s no shame in asking for help or even hiring someone to come in and help. The most important thing is making sure that your loved ones can get the best care they can get.

Staying Connected

Studies show that caregivers who stay in touch with their families and friends have better emotional health than those who feel isolated. Reaching out to express your feelings about being a caregiver and the challenges that come with it can help relieve stress. Staying in contact with other family members and keeping them updated on their loved ones allows them to step in and support when needed.

Making Your Health A Priority

Caregivers, along with the patient, must make sure their health is a priority. Without the caregiver in good health, they wouldn’t be able to provide the optimum care the patient needs. Along with regular check-ups, making sure you get yearly Flu shots, testing, and staying active is important. Being a caregiver can be physically demanding, and your health is just as important as the Alzheimer’s patient’s health.

Participate in Research for Alzheimer’s

There is currently no cure for Alzheimer’s, but there are clinical studies that the patient and caregiver can participate in. Since the caregiver needs to assist the patient with all that comes with being in a study, both the caregiver and the patient would receive a stipend. The more participants in Alzheimer’s studies, the more research is done, getting us closer to a cure! For more information on our currently enrolling Alzheimer’s disease studies, give our office a call.

How Do You Know If You Have High Blood Pressure?

The truth is, you don’t. The only way to really know if you have high blood pressure is by getting your blood pressure checked regularly. High blood pressure or hypertension (HTN) is known as the “silent killer” because it causes sudden heart attacks or strokes resulting in serious injury or possibly death with no warning.

The Effects of Hypertension

HTN causes more than just heart attacks and strokes. Prolonged HTN can cause serious illnesses such as:

Kidney Disease — HTN may cause damage to the arteries surrounding the kidney. The damage can affect the kidney’s ability to filter blood efficiently.
Heart failure — Heart failure occurs when the heart has to work harder to supply blood to the body, and HTN can cause extra work for the heart.
Loss of Vision — HTN can strain or damage blood vessels in the eyes.
Sexual Dysfunction — HTN can lead to erectile dysfunction in men or lower libido in women.
Angina — Over time, HTN can lead to heart disease or microvascular disease (MVD). Angina, or chest pain, is a common symptom.
Peripheral artery disease (PAD) — Atherosclerosis caused by high blood pressure can cause a narrowing of arteries in the legs, arms, stomach, and head, causing pain or fatigue.

How to Prevent a Visit from the “Silent Killer.”

One way to decrease your risk of heart disease from HTN is to know your numbers. Below is a chart from the American Heart Association that accurately details healthy vs. unhealthy blood pressure numbers.

The second way is to be aware of your risk.

There are many risk factors for HTN and being aware of them can give you the knowledge to make healthy changes.

Diet — Diet plays a considerable role in elevated blood pressure levels. Diets high in salty, fatty, and processed food increase your blood pressure, causing HTN. A good diet would be one that is high in vegetables, fruits, and lean meats.
Physical Activity — Regular physical activity improves blood circulation and decreases your risk for HTN.
Alcohol and tobacco use — Excessive alcohol and tobacco use can cause HTN and increase your risk of heart attack, stroke, and heart disease.

Other risk factors that you need to be aware of but are out of your control are:

Family history
Age
Gender
Race

Overcome Hypertension

How can you overcome hypertension? One way is to talk with your doctor about any medications or specific lifestyle changes you can make to reduce your risk. Another way is to participate in clinical trials. Clinical trials are a great tool to get to know your health more, receive one-on-one quality attention from a medical professional, and access to the latest therapies that are not currently on the market. ENCORE Research Group is currently enrolling in studies for hypertension. If you or someone you know would like to participate, please call 904-730-0166 or visit encoredocs.com.

Jacksonville Center for Clinical Research is Participating in ORCA-3, a Phase 3 Clinical Research Study Evaluating an Investigational Smoking Cessation Therapy

Jacksonville Center for Clinical Research is enrolling eligible volunteers into ORCA-3, a U.S. Phase 3 clinical research study evaluating the safety and efficacy of cytisinicline, an investigational therapy for smoking cessation in adults who smoke ten or more cigarettes per day, intend to quit smoking and have failed at least one previous attempt to stop smoking with or without therapeutic support.

A recent report showed, in 2020, for the first time in twenty years, there was an increase in cigarette purchases[1]. Despite the clearly defined health risks associated with cigarette smoking, it is estimated that there are 34 million adults who are current cigarette smokers.[2] Prescription medication and counseling have been shown to improve quit rates yet are used by a minority of those trying to quit. Among the 68% of smokers who want to quit, less than 7% reported using counseling and only 29% reported using pharmacotherapy, and less than 5% used both.^[3]

Cytisinicline is a plant-based, naturally-occurring investigational compound that is structurally similar to nicotine and is believed to aid in smoking cessation by binding more specifically to a certain nicotinic receptor in the brain. This binding partially stimulates dopamine release, which reduces nicotine cravings and the severity of nicotine withdrawal symptoms. It also directly inhibits nicotine binding, reducing the satisfaction typically associated with smoking.

The FDA-approved non-nicotinic smoking cessation therapies, varenicline and bupropion, can improve rates of smoking cessation, but they are associated with troublesome side effects. Additional treatment options are needed if we are to help more people successfully quit smoking and reduce their smoking-related health risks. While the benefits of quitting cigarette smoking are well understood in both the medical and consumer communities, it is encouraged that cigarette smokers make quitting a resolution for 2022 and to speak with their health care providers about options that can help them succeed, including potential clinical trial participation when appropriate.

ORCA-3 is being conducted to learn more about the effectiveness and safety of 3.0 mg cytisinicline for 6 and 12 week study treatment periods in combination with behavioral support in people trying to quit cigarette smoking. The research will also assess the safety and tolerability of the study drug.

Jacksonville Center for Clinical Research is a clinical site participating in ORCA-3. The study is open to adults at least 18 years of age who currently smoke ten or more cigarettes per day, intend to quit smoking, and have failed at least one previous attempt to stop smoking with or without therapeutic support. Participants must be willing to set a quit date within 5-7 days of starting treatment and be willing to actively participate in the study’s smoking cessation behavioral support provided throughout the study.

If you or someone you know is interested in joining the study, please call 904-730-0166

[1] Cigarette Report for 2020 – ftc.gov. (n.d.). Retrieved November 9, 2021, from https://www.ftc.gov/system/files/documents/reports/federal-trade-commission-cigarette-report-2020-smokeless-tobacco-report-2020/p114508fy20cigarettereport.pdf.

[2] Centers for Disease Control and Prevention. Current Cigarette Smoking Among Adults in the United States. Available at: https://www.cdc.gov/tobacco/data_statistics/fact_sheets/adult_data/cig_smoking/index.htm. Updated November 18, 2019.

[3] Adams AJ and Hudmon KS. Pharmacist prescriptive authority for smoking cessation medications in the United States. J Am Pharm Assoc. 2018;58(3):253-257. doi: 10.1016/j.japh.2017.12.015

Everyone should know these important signs.

Click play below to watch an informative video by the American Heart Association.

In 2020 heart disease killed twice as many people as COVID-19 in the United States.¹Some may find this surprising due to the lack of news coverage on heart disease. Historically heart disease has always been one of America’s most serious epidemics. It has been a leading cause of death since the turn of the 20th Century. Following World War II, the National Heart, Lung and Blood Institute began a long-term study known as the Framingham study to identify the cause of heart disease.

The Framingham study is an enormous observational study in Framingham, Massachusetts. Researchers conducted physical examinations on participants every two years to study contributing factors to heart disease and are now on their 3rd generation of participants. The Framingham study identified many currently known risk factors, such as high blood pressure and high cholesterol. Researchers began developing medications to combat cholesterol levels once high cholesterol was identified as a significant risk factor.

Some of our most exciting research at ENCORE Research Group is for new cholesterol-lowering medications such as Antisense Oligonucleotides (ASOs), Small Interfering RNA (siRNAs), and Adnectins.

Antisense oligonucleotides (ASOs) are short, synthetic single-stranded fragments of RNA that can reduce, restore, or modify protein expression. ASOs have been designed specifically to target high levels of LDL (bad cholesterol) in the bloodstream in a different way than current medications. They are also being studied to reduce lipoprotein a [Lp (a) or “Lp little a”] in patients with elevated levels by targeting a building block of the Lp(a).

Small interfering RNA (siRNAs) are another type of RNA therapy that is being used in clinical trials to reduce the risks of cardiovascular disease. Unlike ASOs which are single-stranded oligodeoxynucleotides, siRNAs are double-stranded RNA molecules. SiRNAs are used in the silencing of disease-causing genes for the treatment of atherosclerotic cardiovascular diseases.

Adnectins are a class of drugs used to target proteins. Adnectins can be rapidly developed to bind proteins or other necessary targets. Currently, adnectins are being used in clinical trials to bind with a human protein called PCSK9. This binding blocks the interactions between PCSK9 and LDL (bad cholesterol) receptors. As a result, the levels of LDL cholesterol in the body are lowered.

We are optimistic about these new technologies; they may give us the arsenal to fight back against heart disease.

If you have high cholesterol levels that are not being adequately managed by your current medications, we may be able to help you get involved in a research study that may help get you back on track! As many of our readers know, most research studies offer access to cutting-edge therapies at no cost to patients. Call us to find out how you can get involved today!

[1] CDC, https://www.cdc.gov/nchs/products/databriefs/db427.htm

Lipoprotein (a), or Lp(a), pronounced “LP little a”

Lp(a) has been referred to as the evil twin of the more familiar LDL (bad) cholesterol.

It consists of an LDL-like particle with an extra protein coil that makes the particle more sticky to burrow into and damage the arterial wall.

Lp(a) is a triple threat because it is:

Pro-atherogenic causing a higher risk of producing plaque in arteries
Pro-thrombotic meaning it promotes the formation of blood clots causing heart attacks and strokes
Pro-inflammatory – inflammation can irritate your blood vessels, promote the growth of plaque, loosen plaque in your arteries, and trigger blood clots¹

Lp(a) is determined by your genes. Exercise and dietary lifestyle changes have no effect on your level of Lp(a) but do contribute to your over health.

If you have experienced a heart attack or stroke before turning 60 years old, or have a family member who did, you could be at risk for elevated Lp(a).

As an ENCORE community perk, we can perform a complimentary blood draw to check your level of Lp(a).

To see a list of cutting-edge treatments for elevated Lp(a) currently enrolling in clinical trials, click the link below:

https://thefhfoundation.org/on-the-horizon-treatments-for-lipoproteina

If you are interested in participating in a clinical trial for elevated Lp(a), give our recruiting office a call today! (904) 730-0166

¹ https://www.hopkinsmedicine.org/health/wellness-and-prevention/fight-inflammation-to-help-prevent-heart-disease

Daily habits can be hard to break, and if your daily habit is smoking, it can feel nearly impossible! However, when you understand the addictive nature of tobacco, it’s easier to understand why many just can’t quit. In fact, within the last couple of years, 50% of smokers attempted to quit, but only about 8% were successful.

Smoking cessation becomes easier if you have a plan in place. Below is a comprehensive list that will aid in your journey to a healthier lifestyle without tobacco. So let’s quit smoking together!

The Plan

1. List your Reasons for Stopping

Stay motivated by writing down a list of reasons you want to stop smoking. Frequently referring back to this list will keep you aware of why you are doing what you are doing when times get hard.

Reasons can include:

Reducing your risk of heart disease. The risk of heart attack or stroke is decreased by 50% after two years of not smoking. After 15 years, your risk of heart attack is similar to that of a person who never smoked
Saving money! Smokers can save between $1,380 and $2,540 annually (depending on where they live) by quitting a pack-a-day habit.
Keeping friends and family away from second-hand smoke. Secondhand smoke causes nearly 34,000 premature deaths from heart disease each year in the United States among nonsmokers.

2. Pick a Quit Day

You control your destiny, so it is your responsibility to pick a quit day. If your quit day is too far out, you may find it hard to keep that motivation. But, on the other hand, you need to give yourself time to prepare.

Many believe it is best to wean off smoking, but studies have shown that the best results come from picking a day and quitting cold turkey.

3. Prepare for Your Quit Day

Research has shown that the best results come from counseling and medication for quitting smoking. These things take planning. Here is a list that may help you with that:

Talk to your doctor about medications. Some treatments can lessen your craving. It is essential to talk to your doctor and begin one on your quit day. There are also clinical trials where you can receive medications for free with no health insurance needed.

Find a support program. You can also talk to your doctor about support programs. There are many in-person or over-the-phone programs where you can speak with others about your journey.

Find helpful online tools and apps. Online tools for creating and implementing a quit plan are available from the National Cancer Institute (https://smokefree.gov/build-your-quit-plan) and the Truth Initiative (www.becomeanex.org/). These websites and apps can increase smoking cessation success.

Other tips include:

Making a list of triggers
Telling your friends and family, you are quitting
Cleaning your house of triggers
Getting your teeth professionally cleaned

4. Make your Quit Day Easier

Your quit day is approaching quickly; let’s prepare a set of rules to follow.

Don’t smoke, not even once
Be sure you know how to use your nicotine replacement therapy if you’ve chosen that method.
Read your “Reasons for Stopping” list
Drink plenty of water
Go for daily walks to stay active
Avoid stressful situations
Attend a class or call into a therapy/group session

EXTRA TIP: Find Clinical Trials near You

There are many reasons to join a clinical trial. First, it is free to join, you do not need insurance, and you may receive a stipend for time and travel. You will also get attentive care from a medical professional with frequent checkups to motivate you to stay on task. Lastly, you will feel good knowing you are improving your health and the health of future generations. For more information on clinical trials for smoking cessation, visit encoredocs.com or call 904-730-1066.

We are launching into the New Year by working our brains! Do you think you know all there is to know about clinical trials? Take the quiz and see! Just by taking the quiz, your Research Ready score will be raised in our system to ensure you are at the top of our list for studies! Select one option for each question and be sure to leave your name and email!

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Alzheimer’s Disease is devastating. An estimated 6.2 million Americans age 65 and older are living with Alzheimer’s dementia in 2021. Alzheimer’s is a brain disease that causes a slow memory decline. It can also affect your thinking, problem-solving, and reasoning skills. There are ten signs that you or a loved one may be experiencing early stages of Alzheimer’s Disease. If any of these signs persist, you should schedule an appointment with your doctor and come in for a free memory screening at Jacksonville Center for Clinical Research (JCCR).

1.Memory Loss that Disrupts Daily Life

A critical factor in spotting Alzheimer’s Disease’s early stages is noticing the memory loss of recently learned information. The memory loss examples include forgetting dates and events and asking the same questions multiple times.

2. Difficulty Completing Normal, Daily Tasks

It can be difficult for a person in the early stages of Alzheimer’s to complete daily tasks. For example, they may find it difficult to find familiar locations or do simple things such as making a grocery list or remembering the rules to a favorite game.

3. Trouble with Planning or Problem Solving

It can sometimes become difficult for those with Alzheimer’s to work with numbers. Tasks such as paying bills may get swept under the rug or have excessive errors. They also have difficulty planning things as simple as everyday errands.

4. Confused about the Current Time or Place

Alzheimer’s Disease can cause confusion and result in anxiety or panic. Frequently, they can forget where they are or how they got there.

5. Trouble with Vision and Depth Perception

Alzheimer’s Disease and vision issues can go hand-in-hand. For example, they may show difficulty reading, balancing, or distinguishing the depth and color of objects.

6. Difficulty Pronouncing Words or Writing

It can be difficult for someone with Alzheimer’s to join a conversation. They may stumble on their words. They may have trouble remembering names and often repeat themselves.

7. Losing Important Items Often

Everyone loses their keys, remote, or wallet every once in a while. However, someone suffering from the early stages of Alzheimer’s may often lose these things or put them in strange places. For example, they are putting their keys in the fridge.

8. Poor Judgement

Someone who has Alzheimer’s Disease may have poor judgment. Examples of this can be poor hygiene, trouble dealing with money, or acting irrationally.

9. Becoming Socially Distant

It can become difficult for people with Alzheimer’s to work or interact socially. You may notice them pulling away from normal social activities. They may start to have trouble keeping up with their favorite activity.

10. Mood Swings

Suffering from Alzheimer’s Disease can be extremely frustrating. It is common to experience sudden mood changes and sometimes act irrationally. They can quickly become confused, suspicious, depressed, or even fearful.

It is important to remember that we can have a natural decline in cognitive ability as we age. However, when that decline disrupts daily life, it is time to see a doctor for a memory screening.

Thankfully, there have been many breakthroughs in memory research, although there is still no cure for Alzheimer’s. Clinical trial studies are the only way to continue to learn about this disease in hopes of and finding a cure. If you or a loved one is currently experiencing any of these early symptoms of Alzheimer’s Disease, we encourage you to get a memory screening. ENCORE Research Group offers free memory screenings at our Jacksonville Center for Clinical Research location and has several studies enrolling for Alzheimer’s Disease.

For more information, visit encoredocs.com or call 904-730-0166.

ENROLLING STUDIES

The Hawthorne Effect is an interesting phenomenon where people alter their behavior due to the awareness of being observed. This effect was first discovered in the 1950s outside of Chicago. The experiment was done on factory workers, and it found that workers had a positive response to the extra attention given by managers who cared about them.

This same phenomenon has been noticed in clinical trials as well. “When you’re doing a clinical trial, and you’re involved with something that is being observed, your patients tend to do better regardless of how they are being medically treated.” Dr. Michael Koren, CEO of ENCORE Research Group, says. For example, if a patient is in a clinical trial for weight management, they may be more likely to lose weight if they must keep a log of everything they eat and present it to their study coordinator.

So what does that mean for you? It means that you have the chance to improve your health just by participating in a clinical trial, even if you happen to be on a placebo. Studies have shown that patients in clinical studies are more adamant and knowledgeable about their health in the first place. It is safe to say your health will likely improve no matter what study you participate in! To see what studies are available right now, visit our enrolling studies page!

ENROLLING STUDIES

*This assessment is only available at Jacksonville Center for Clinical Research*

If you are experiencing memory loss, you are not alone. According to the National Institutes of Health, roughly 40% of the population 65 and older experience associated memory impairment. Dementia is the broad category of cognitive impairment with subtypes like Alzheimer’s disease, Lewy Bodies, Vascular Dementia, and others. Although there have been many breakthroughs in memory research, there is still no cure for memory loss.

What is a Memory Assessment?

A memory assessment tests for cognitive impairment. The assessment is a 30-point test widely used to assess dementia and Alzheimers. The type of test we use is the MMSE or mini-mental state exam. The MMSE assessment is a crucial step toward making a diagnosis.

Who Should Be Tested?

Memory loss can be a sign of aging. However, there are differences between typical signs of aging and memory loss, leading to dementia and other diseases. If you can still work or live independently, likely, you are just showing signs of age-related memory loss. On the other hand, if your memory loss disrupts your life, it is time for a memory assessment.

Other signs to look out for include:

Asking the same questions repeatedly
Forgetting common words while speaking
Mixing up uncommon words like “Chair” and “TV’
Taking longer to complete familiar tasks
Putting items in odd places like your wallet in the fridge
Getting lost in familiar areas
Quick changes in mood or behavior for no reason

How Our Free Memory Assessment Works

If you are unsure or worried about yourself or a loved one, you can get an MMSE free of charge for ages 50 and up at our Jacksonville Center for Clinical Research location. If you decide to schedule an appointment, plan to be at our facility for about an hour and a half. During that time, one of our experienced clinical coordinators will ask you a series of specific questions about your memory.

The MMSE assesses orientation to time, orientation to place, word recall, calculations, naming, repetition, comprehension, reading, writing, and drawing. At your appointment, your clinical coordinator will also have you go through a memory questionnaire, asking about your daily symptoms.

Afterward, your results will be given to you, and there will be a clinical investigator on-site to answer any questions you may have. As mentioned, there is no cure for memory-loss-associated diseases, but the strides science has made in recent years have been astounding thanks to clinical trials.

If you or a loved one is experiencing severe memory loss, you may consider a clinical trial. There are many benefits to participating, including one-on-one personal care from a physician and access to the latest experimental medication. Jacksonville Center for Clinical Research, a member of ENCORE Research Group, is enrolling in memory loss and Alzheimer’s disease research studies. If you want to learn more or schedule an appointment, call 904-730-0166.

ENROLLING STUDIES

Psoriasis is a skin disease that can cause red, itchy patches on the skin. These patches are commonly found on the knees, elbows, and scalp. Psoriasis is an autoimmune disease, meaning it results from the body attacking itself. The red, scaly patches come from the body releasing white blood cells to attack a non-existent infection. This mistaken attack causes the skin cell process to multiply rapidly. As a result, the skin cells are pushed up to the skin’s surface, where they pile up. These extra skin cells create red, scaly, and inflamed areas at the skin surface.

For many, these symptoms tend to go through cycles, flaring for a few weeks or months then subsiding. Although unclear as to the exact cause, decades of research have concluded that genetics and the immune system are two major risk factors for psoriasis.

Does Psoriasis Affect More Than Just Your Skin?

It’s becoming more apparent that psoriasis affects more than just a person’s skin. In fact, recent studies have linked psoriasis to high cholesterol, heart attack, and stroke. One study notes a significant reduction in HDL, the good cholesterol, in psoriatic patients as well inhibited ability for the remaining HDL to do its job correctly. When this happens, the severity of psoriasis coverage increases.3 Another study, conducted by Northwestern Medicine and published in the Journal of Clinical Investigation, found that a specific category of immune cells called self-lipid reactive T-cells represent a yet to be determined link between high cholesterol and the symptoms of psoriasis. So one has to pose the question, will treating high cholesterol have a positive effect on the severity of psoriasis or vice versa?

Science is moving forward in the realm of psoriasis and we are fortunate to be involved in the process. If you are suffering from psoriasis, you can help change medicine by participating in research. ENCORE Research Group patients enjoy; access to the latest medicines and therapies at no cost and one-on-one, attentive care from a medical professional. You can move medicine forward and create better healthcare for future generations by participating in clinical trials. New research studies are always coming in, so head on over to the enrolling studies tab to see what study you are interested in volunteering for.

Source: plaquepsoriasis.com, American Journal of Managed Care, Northwestern Medicine https://www.ajmc.com/view/psoriasis-linked-to-high-cholesterol-levels-study-finds

https://pubmed.ncbi.nlm.nih.gov/22649206/

Three breakthrough products were approved by the FDA at the beginning of June:

Novo Nordisk’s Wegovy (semaglutide) for weight loss
Biogen’s Aduhelm (aducanumab) for Alzheimer’s Disease
Pfizer’s PREVNAR 20 (pneumococcal 20-valent conjugate vaccine) for the prevention of pneumonia

We had an informative Q&A session with Dr. Michael Koren recently to discuss the recent flurry of FDA approvals of medical products that were developed and then studied at ENCORE Research Group sites.

Q: Dr. Koren, how do you feel about these FDA approvals?

A: It is so gratifying to see the work of ENCORE Research Group’s dedicated people to help make these products available to the general public. Having experience with these products over several years makes me feel comfortable that the FDA made a sound decision.

Q: Can you comment on what it was like to be Principal Investigator for the Wegovy (semaglutide) clinical trials?

A: The understanding of metabolism and how that affects appetite represents a major advance in medicine. Patients who have been working with us over the last five years have had advanced access to semaglutide and many of my patients have had profound weight loss and improvement in their cardiovascular risk factors. It’s quite gratifying to see that this product will now be more broadly available.

Q: Are there any lessons for the general population?

A: The approval of these drugs exemplifies how our patients (ENCORE Community)

have access and opportunities to use medical products before they are available to the general public. In many cases these products provide advantages that are not seen with products already on the market. The fact that patients can get access to these products (or not, in a placebo-controlled environment) without any cost and with the extra benefits of the incredible dedicated staff that we have is perhaps my most gratifying experience.

Q: What’s the next semaglutide?

A: Yogi Berra always said “it’s tough to make predictions, especially about the future.” But even with my crystal ball low on batteries, I have a feeling that it will be major breakthroughs in the lipid space; the most exciting news since statins first came out. We know that the PCSK9 protein is a bad actor. We are excited because we have data from outcome studies that show decreased cardiovascular risk with the PCSK9 inhibitor therapies, Repatha and Praluent, however these therapies are expensive and difficult to make. New lipid therapies that we are studying include adnectins that neutralize the PCSK9 protein once secreted by the hepatocytes (liver cells). Other new therapies prevent the production of the PCSK9 protein in the first place, including siRNA (small interfering RNA) and ASOs (antisense oligonucleotides). siRNA are used to silence the gene that creates the PCSK9 protein. ASOs target and inhibit the source of PCSK9 protein production.

ENROLLING STUDIES

Yes, the latest indicator of this was released last week in the New England Journal of Medicine (NEJM). Novavax was far superior against a difficult to treat South African variant. It is a protein therapeutic, no genetic code!

Insider Edge! You don’t get this information unless you subscribe to our ENCORE Community. We are on the cutting edge of learning the information and data behind the science. We review scientific journals and find cutting-edge information which often does not get to the local news. We enjoy sharing this advanced information with you, our ENCORE Research Community.

Click the links below to dive deeper into this NEJM research!

AstraZeneca/Oxford vaccine – Vaccine efficacy against the B.1.351 South African variant was 21.9%.

https://www.nejm.org/doi/full/10.1056/nejmoa2102214

Novavax vaccine – Among a subgroup of HIV-negative participants, the vaccine was 60.1% efficacy against the B.1.351 South African variant.

https://www.nejm.org/doi/full/10.1056/NEJMoa2103055

ENROLLING STUDIES

You may have heard that people with diabetes are at a higher risk of contracting COVID-19. This is not the case. The truth is, people with diabetes are more likely to experience severe illness, long lasting effects, or even death if they are infected with COVID-19.

What We Know about Diabetes and COVID-19

In May, a nationwide multicentre observational study called the CORONADO study, observed the mortality risk in people with diabetes who were hospitalized for COVID-19. The study population was 88% type 2 diabetics and 12% type 1 diabetics. What they found was that one in ten diabetic patients hospitalized with COVID-19 died within seven days of hospital admission. One in five died within the first 28 days.

How Can We Improve These Numbers?

Metformin – Recent studies have shown that metformin decreased the mortality rate of diabetic patients with COVID-19. Those who took metformin had an 11% mortality rate compared to 24% with type 2 diabetes who were not taking metformin when admitted to the hospital. These studies heavily indicate a strong, positive relationship between metformin, COVID and diabetes.
Vaccine – another way to protect those battling diabetes from COVID-19 is to consider getting the vaccine. There have been three emergency use authorized vaccines: Pfizer, Moderna, and Johnson & Johnson. Each vaccine appears to be safe and effective in adults with diabetes. Rigorous clinical trials tested these vaccines for safety in adults of all ages, races and ethnicities and chronic health conditions.
- - - - How will the vaccine affect blood sugar levels?
        
        Receiving the vaccine can cause symptoms of illness that can increase your glucose levels. However, if carefully monitored and correctly hydrated side effects can be minimal.
        
        Do diabetes medications affect the vaccine?
        
        Currently, there is no evidence to suggest that the COVID-19 vaccine will interact with current medications. However, it may be helpful to avoid injecting insulin or placing a glucose sensor near your vaccine injection site for several days after receiving the vaccine.
        
        Should I get vaccinated if I have diabetes and other health conditions?
        
        Complications of diabetes include heart disease and kidney disease. These conditions put one at higher risk or death from COVID-19.
        
        Vaccination should be a priority for patients with type 2 diabetes who are at very high risk of severe COVID-19 to help protect this vulnerable population.

ENROLLING STUDIES

5 Things to Know about Lp(a)

Lipoprotein(a), or Lp(a), is an independent risk factor for atherosclerotic cardiovascular disease. Cardiovascular disease is the leading cause of death in both men and women in the US and globally . You may have heard of LDL cholesterol, or “bad cholesterol,” as a risk factor for heart disease, but Lp(a) can be just as dangerous. Lp(a) flies under the radar of many physicians. This is because the awareness of Lp(a) is still very low, very little is understood about the protein and the treatment options are limited.

What is LP(a)?

Lp(a), pronounced “LP little a,” is a protein that is attached to LDL cholesterol. It is composed of an LDL-like particle, but it has a second protein coiled around it. Recent studies have shown that people born with elevated Lp(a) can be two to four times as likely to have a heart attack or serious cardiac related risk. Lp(a) is present in 20% of the population.

What differentiates LP(a) from other heart disease risk factors?

LP(a) is so unique because it is a completely genetic risk factor. Meaning, having an elevated LP(a) is almost entirely determined by the genes you inherit. There is no evidence that a healthy lifestyle will lower your Lp(a). However, that does not mean those with high levels shouldn’t practice healthy habits. Reducing other risk factors that are determined by quality of health can still reduce the overall risk of heart disease.

Another risk factor that sets LP(a) apart is that it is an independent risk factor. It has been linked to heart disease in younger adults who are otherwise healthy and have no prior cardiovascular risks. Elevated LP(a) has affected the lives of many who are otherwise healthy. For example, Tennis legend Arthur Ashe, who had his first heart attack at age 36. Bob Harper, a celebrity fitness trainer was also affected and nearly died of a heart attack at age 52.

Who should be tested for Lp(a)?

Studies show that there is a higher risk of a cardiovascular event if Lp(a) levels start to rise above 30 mg/dl. There is an even greater risk at levels 50 mg/dl and higher. There are an estimated one in seven people at or above this threshold. If you’ve had a cardiac event but your cholesterol levels are normal, or you have a family member with heart disease at an early age, have a cardiovascular event despite normal lipid levels, have a family history of Lp(a), or have aortic valvular disease at an early age then you should get tested for Lp(a).

As mentioned, Lp(a) is a genetically mediated risk factor. “This means it runs in families,” Albert Lopez, MD, DO, FASPC, internal physician and lipid specialist in Jacksonville, FL says. “Those individuals that have it, you have a 50% chance of giving to your children.” Dr. Lopez believes there should be cascade screening, meaning asking family members if they have it and then getting tested.

No FDA approved remedies for Lp(a)

Currently there are no FDA approved remedies for elevated Lp(a). Statins, a widely known and used therapy that lowers LDL cholesterol does not reduce Lp(a) and has been shown to sometimes result in a slight increase. One therapy that has been shown to work is asphersis. This process filters a patient’s blood by circulating it through a machine and removing Lp(a) particles. However, this process is reserved for high-risk patients because it is extremely expensive, requires weekly visits and involves risks. After stopping apheresis, the Lp(a) levels begin to rise again.

New Advancements in Science regarding Lp(a)

Luckily, there are new drugs on the horizon that could potentially help those suffering from elevated Lp(a) levels. “What is exciting is that we are in totally nerd, sci-fi treatments now,” Dr. Lopez says. “We can actually stop your genes from making this protein by using a little snip that crinkles it up and doesnt let it read.” In other words, new studies are using gene silencing techniques to achieve a large and durable reduction of Lp(a).

These therapies and medicines are still in clinical trials now. ENCORE Research group is conducting research studies for people with elevated Lp(a) in hopes to find a drug that will lower Lp(a) levels. It is up to the public to participate in these research studies to help those suffering from elevated Lp(a) levels.

ENROLLING STUDIES

We asked, “What motivates you to participate in clinical trials?” With over 160 responses, the answer is clear. People who participate in clinical trials are dedicated to helping others by improving medicine for future generations.

We also found that very few were participating in order to receive the stipend for time and travel. This says a lot about the type of people who are willing to participate in clinical trials. They are in it for the cutting edge treatment, and the need to help others.

There is truly only one way to improve healthcare, and that is to participate in clinical trials. Thank you to everyone who responded to our survey, and everyone who participates in these trials.

Can a type of seaweed really be used to treat Alzheimer’s disease? Some scientists think so, and it’s even being tested in clinical trials today. Oligomannate is extracted from seaweed and can be used as a potential therapy for Alzheimer’s. It is being developed by Shanghai Green Valley Pharmaceuticals and has been given conditional approval by China. Oligomannate is in clinical trials in the U.S., Europe, and other countries, pending approval.

Alzheimer’s disease is a neurodegenerative disease that worsens over time and is the most common form of dementia. Amyloid plaques and tau tangles are widespread in Alzheimer’s and physically change the brain. Neurons die over the course of the illness, and neural networks become sparsely connected. This leads to the atrophy, or wasting away, of brain matter. This is a visible, significant loss of brain volume.

So how does Oligomannate work to stop these proteins from forming plaque?

In the preclinical studies, oligomannate was able to decrease the build-up of beta-amyloid protein in the brain, which in turn can improve cognitive function. Furthermore, oligomannate may be able to regulate the connection between microbiomes from the gut to the brain, reduce harmful metabolites produced by these microbiomes, and lessen inflammation. All of which help to reduce the symptoms of Alzheimer’s disease.

More research needs to be done before it is FDA-approved in the US. Want to play a part in finding a possible treatment for one of the most devastating diseases? Consider participating in a research study! To see what is enrolling, visit our enrolling studies page. Your help is needed to move medicine forward.

Source: Alzheimer’s News Today

ENROLLING STUDIES

The questions that have many people puzzled are finally going to be answered: What is gluten and is it actually bad for you? Gluten is a mixture of two types of proteins. It is responsible for the elastic texture of dough. These proteins are commonly found in wheat, rye, oats and barley. Gluten helps food keep its shape and acts like a glue that holds certain foods together.

For those with celiac disease, gluten can be particularly dangerous. Gluten triggers an immune response in people with the disease, resulting in damages in the lining of the small intestine. These damages can obstruct a person’s ability to absorb nutrients from food and lead to problems like osteoporosis, infertility, nerve damage, and seizures.

Adults with celiac disease show many digestive and other symptoms including:

Digestive symptoms:

Diarrhea
Fatigue
Weight loss
Bloating and gas
Abdominal pain
Nausea and vomiting
Constipation

Non-Digestive Symptoms:

Iron deficiency causing anemia
Rashes on the skin
Mouth ulcers
Headaches and fatigue
Joint pain
Corrupt functioning of the spleen (hyposplenism)

Gluten can be found in many different kinds of foods. It may be present in more foods than you think. The main foods to look out for which contain high amounts of gluten are processed foods, such as canned or boxed items, sweets, including cakes, pies and candies, cereals, bread, beer, pasta and more.

Currently, the only treatment for celiac disease is to completely eradicate gluten from a person’s diet, which can be difficult. In order to help those suffering from this disease, it is imperative to do more research including participating in clinical trials. If you have celiac disease and want to be at the forefront of medicine, click the “enrolling studies” tab for more information about current clinical trials.

Source: Harvard Health, Celiac Disease Foundation

ENROLLING STUDIES

Plantar Fibromatosis, or Ledderhose disease, is a rare condition. It stems from a disease called plantar fibroma, where the tissue hardens and a growth begins in the arch of your foot. Plantar Fibromatosis is diagnosed when the tissue hardens to an excessive amount, and many lumps form on the bottom of the foot.

The disease can affect one or both feet. It also can affect anyone at any age, but it is more prevalent in middle-aged or older people. The growths are not cancerous but can cause severe pain.

Should I be concerned?

As mentioned, plantar fibromatosis can cause pain and any out-of-the-ordinary pain should be a cause for concern resulting in a talk with your doctor.

Other symptoms include:

Pain in your foot and ankle joints
Tightening of the tissue and skin
Foot feeling as if they are asleep “pins-and-needles sensation”

How is the disease treated?

When it comes to treatment, we still have more to do in order to fully treat and relieve the pain for those suffering with plantar fibromatosis.

Some current treatments are:

Wearing soft shoe inserts in order to relieve pressure around lumps
Stretching, massaging, and icing the bottom of the feet to relieve pain
Taking anti-inflammatory drugs such as Ibuprofen, or Motrin
Physical therapy
Injections of steroids into the bottom of the feet to reduce inflammation and relieve pain
If all fails, your doctor might recommend surgery

There are newer treatments and research on plantar fibromatosis, including a treatment that uses injections on an enzyme, called collagenase, to break down the thicker tissue on the bottom of the foot. This exciting research is one of the few treatments being tested that would actually resolve these painful lesions. More research is needed in order to cure plantar fibromatosis for good, so those with the disease can live their lives without the painful lumps. Currently, ENCORE Research Group is conducting clinical trials for plantar fibromatosis. For more information on our current studies click the “enrolling studies” tab.

Sources: Healthline, National Library of Medicine , FootCareMD

ENROLLING STUDIES

At some point in our lives we have all experienced acid reflux. Maybe it was after eating something spicy, or any acidic food like a tomato or certain dairy products and you felt a burning sensation in your throat. GERD, or gastroesophageal reflux disease is similar to acid reflux. GERD is a long-term condition where acid from your stomach overflows into the esophagus. If you experience acid reflux that occurs more than twice a week, your doctor may diagnose you with GERD.

If you are experiencing these below symptoms more than twice a week, it may be time to see a doctor.

Heartburn after eating
Chest Pain (Please see a doctor if you are experiencing chest pain, especially coupled with shortness of breath, jaw pain or arm pain. You could be experiencing a heart attack).
Difficulty swallowing
Regurgitation of food or liquid
Feeling on having a lump in your throat

Although GERD is a common condition affecting over 3 million Americans per year, if left untreated, it can lead to serious medical conditions.

Esophageal Stricture – which is the narrowing of the esophagus. Frequent backup of stomach acid into the esophagus can begin to cause significant damage causing scar tissue to form. The scar tissue can act as a barrier making it extremely difficult to swallow.
Esophageal Ulcer – or, in other words, an open sore in your esophagus. This happens when the stomach acid begins to wear down on the tissue causing sores which can bleed, cause pain and further increase difficulty swallowing.
Barrett’s Esophagus – This happens when there begins to be precancerous changes to the esophagus. These changes can cause an increased risk of esophageal cancer.

With certain lifestyle changes and medication, GERD can be treated. However, more research is needed to understand why there is a steady increase in Americans with GERD.

Currently, ENCORE Research Group has enrolling studies for GERD taking place in Crystal River and Jacksonville. Visit our Enrolling Studies page to see what’s enrolling at a research site near you.

Source: Medical News Today, Medline Plus

ENROLLING STUDIES

Low testosterone levels in men, or hypogonadism, may affect more men in the U.S. than you think. In fact, it is estimated the 4 to 5 million men in the U.S. have experienced this.

Hypogonadism is a deficiency in male gonadal function resulting in insufficient testosterone secretion. This can be caused by testicular failure or hypothalamic-pituitary axis dysfunction, or both. As a result, it is difficult for a man to maintain testosterone-dependent functions.

Men can be diagnosed with hypogonadism at any age, but it is more prevalent in older males. Some of the signs and symptoms of low testosterone include:

Loss of libido and erectile dysfunction
Depressive symptoms
A decrease in cognitive abilities
A loss of energy
A negative effect on bone mass
A decrease in muscle mass
Impaired sperm production

As a man ages, their testosterone levels start to decrease by 1 to 2% naturally every year beginning at age 40. The higher the percent, the worse the symptoms. However, there are risk factors that can speed up this process. These risk factors include:

Injury or infection
Chemotherapy or radiation treatment for cancer
Medications, including hormones used to treat prostate cancer and corticosteroid drugs
Chronic illness
Stress
Alcoholism
Obesity

In order to diagnose low testosterone a doctor must give a physical exam, review the symptoms, and review the results of multiple blood tests. Once diagnosed, low testosterone therapy could be an option, but not the first choice. This is because increased levels of testosterone are a major risk factor for prostate cancer. However, there are other ways to help slow hypogonadism, such as a skin patch or injections.

The latest studies suggest that low testosterone levels in adult men is often underdiagnosed and under tested. This could be due to easily attributing these symptoms to age, or it being looked over by both medical professionals and patients. Participating in clinical trials is the best way to help increase knowledge and find new treatments for low testosterone.

Sources: Harvard Health, Boston University School of Medicine

ENROLLING STUDIES

There are five forms of antibodies that the human body makes. There are two forms that are relevant for COVID 19, Igm and IgG.

Igm is a big molecule, which is the first molecule that your body makes when you are exposed to a particular antigen or virus. This is an acute phase type of antibody.

IgG is a long-term antibody that has memory for your immune system and also protects you long-term. The actual length of long-term protection is not known.

Typically, when you have antibody testing, you are tested for both Igm and IgG. These tests are not perfect. If someone tests positive for Igm but not IgG, we’re not sure if they are protected.

If someone has no Igm antibodies and lots of IgG antibodies, they’re likely protected due to the long-term memory of IgG.

The length of time the antibodies remain detectable following an infection is not known.

Antibodies

Source:

cdc.gov

Amgen Powerpoint

ENROLLING STUDIES

Ulcerative Colitis is a rare inflammatory bowel disease (IBD) with less than 200,000 cases per year. Ulcerative colitis can cause long-term effects on the body including inflammation and ulcers in the digestive tract. This can affect the innermost lining of the large intestine as well as the rectum.

The symptoms of ulcerative colitis can range from mild to severe. Symptoms include rectal bleeding, bloody diarrhea, abdominal cramps and pain. Those who have Ulcerative Colitis are also at a greater risk of developing colon cancer.

Doctors usually diagnose the different types of ulcerative colitis according to its location in the large intestine. The different types of ulcerative colitis include:

Ulcerative Proctitis

This is when the inflammation is in the area closest to the rectum. Rectal bleeding may be a sign of this disease, and it tends to be the mildest form.

Proctosigmoiditis

This type of ulcerative colitis is confined to the rectum as well as the lower end of the colon (sigmoid colon). Symptoms include abdominal cramps, bloody diarrhea, and the inability to move bowels, even though you feel as though you need to.

Left-sided colitis

If you have sharp pain on your left side, bloody diarrhea, abdominal cramping or weight loss, you may be experiencing left-sided colitis. This happens when inflammation extends from the rectum through the sigmoid and descending colon.

Pancolitis

Pancolitis often affects the entire colon. This can cause severe bloody diarrhea, abdominal cramps and pain, fatigue and weight loss.

Acute severe ulcerative colitis

This form of colitis is rare. It is a severe form and it affects the entire colon. It can cause severe pain, profuse bloody diarrhea, fever and complete loss of appetite.

Although rare, ulcerative colitis can cause an abundance of health problems. It is imperative to participate in clinical trials in order to move medicine forward and help find effective treatments for ulcerative colitis sufferers.

Resources: Cleveland Clinic, Crohn’s and Colitis

ENROLLING STUDIES

Crohn’s disease is a chronic irritable bowel disease (IBD). In those with crohn’s disease, an abnormal immune system causes chronic inflammation in the digestive tract. IBD affects nearly 3 million Americans, and there is still no known cure.

Symptoms of Crohn’s Disease

A person living with crohn’s disease can experience many symptoms and the severity can range from no pain at all to immobilizing. The symptoms include:

Diarrhea
Abdominal pain
Cramping
Weight Loss
Blood in Stools
Fatigue
Nausea and vomiting
No appetite
Anemia
Fever

Long-Term effects of Crohn’s Disease

Living with crohn’s disease can take its toll on the body long term. If left unmanaged, crohn’s disease can worsen and cause extreme pain and health concerns. Over time, crohn’s disease can cause severe damage to the GI tract. This can lead to:

Fistulas. When excessive inflammation causes ulcers to form on the intestine, a fistula can form. A fistula is when two parts of the intestine connect to form a tunnel to drain the pus from the infected area.
Intestinal Abscesses. This is caused by an excess of bacteria in the abdomen.
Intestinal Blockages. This is a blockage that keeps food or liquid from passing through the small or large intestine. Symptoms can include severe abdominal pain, vomiting and inability to pass gas or stool.
Internal Bleeding. This internal bleeding is caused by tears in the bowel wall due to inflammation in the colon. It is often the cause for diarrhea or bloody stool, a common symptom of crohn’s disease.

Crohn’s disease can be managed and those with the disease can live a very fulfilling life. The main goal of management is to treat the inflammation, which should reduce the severity of the symptoms and hopefully lead to long-term remission.

As mentioned, there is no known cure for crohn’s disease. The only way to find a cure and help those living with crohn’s disease is to participate in clinical trials to further research and hopefully, find a cure.

Resources: Centers for Disease Control and Prevention, Crohn’s and Colitis Foundation, Bladder and Bowel

ENROLLING STUDIES

Chronic pancreatitis is inflammation of the pancreas that does not heal but worsens over time. When you have chronic pancreatitis, your digestive enzymes begin to digest the pancreas itself. The pancreas is a small gland behind the stomach that secretes digestive juices into the small intestine. Eventually, chronic pancreatitis can damage a person’s digestive system and ability to make pancreatic hormones.

Some common causes of chronic pancreatitis are, but not limited to:

Alcoholism
Family history
Autoimmune diseases
A blocked pancreatic duct
A genetic mutation such as mutations of the cystic fibrosis

Chronic pancreatitis, if unmanaged, can lead to:

Diabetes- Chronic pancreatitis causes damage to the insulin-producing cells resulting in diabetes, a chronic condition where there is an abnormally high level of sugar in the blood.
Pancreatic Cancer- If you have chronic pancreatitis, you are at an increased risk of developing pancreatic cancer by two to three
Malnutrition- Chronic pancreatitis can cause your pancreas to produce fewer enzymes that are needed to break down and process nutrients from your Overtime, this may lead to malnutrition and significant weight loss.

Although there are many complications that may arise if you are living with chronic pancreatitis, the disease is treatable if caught in time. For chronic pancreatitis the treatments can be a hospital visit to treat dehydration, pain medication and a lifestyle change to a low-fat diet.

According to the type of pancreatitis that you have, other surgeries may be required.

One of the worst symptoms of pancreatitis is the severe abdominal pain. Currently, the only remedy for this is pain medication. In order to better understand and treat this pain more research needs to be done. The goal is to improve the quality of life and the risk of complications when living with pancreatitis.

Sources: MedlinePlus, Pancreatic Cancer Action, National Institute of Diabetes and Digestive and Kidney Diseases, National Pancreatitis foundation

ENROLLING STUDIES

What Are Triglycerides?

Triglycerides are a type of fat (lipid) found in your blood. You get them in two ways – from the food you eat and from what your liver makes. Eating too many calories, especially from high carbohydrate foods, could lead to high triglycerides (hypertriglyceridemia), as could certain medications. High triglycerides could also be a sign of diabetes or thyroid problems, or be genetic.

Almost 1 in 3 Americans have high triglycerides. When you have excess triglycerides, they are stored in the fat cells for later use. When they are needed, your body releases them as fatty acids, which fuel body movement, create heat, and provide energy for the body processes.

A fasting blood test can tell where your triglyceride level falls. For good health, your triglyceride level should be less than 150 mg/dL. Borderline high levels are 150-199 mg/dL. High is 200-499 mg/dL. Very high is more than 500 mg/dL

Diet and Lifestyle Changes to reduce High Triglycerides

Consume less sugar and refined carbohydrates – limit white breads, white rice, white potatoes, sweetened beverages, sugary cereals, cakes and cookies. Instead choose whole grain breads, quinoa or wild rice, and fresh fruits and vegetables. Aim for 30 grams of fiber a day.

Choose Healthy fats – use unsaturated fats such as olive and avocado oils. Eat fish, poultry, less red meat, and enjoy some meatless meals.

Limit your intake of alcohol – for some people drinking even a little bit can have a big effect on triglycerides.

One of the best ways to lower triglycerides is with regular exercise. Aim for an average of 40 minutes of moderate to high intensity exercise on 3 to 4 days a week. Taking a brisk walk every day works for many people.

When Healthy Lifestyle Changes Are Not Enough

Your doctor may recommend medication to help lower your high triglycerides, such as nicotinic acid (niacin), fibrates, omega-3-fatty acids (fish oil) or statins. There are also some new medications being developed that may not only lower your triglycerides, but reduce your risk of heart disease overall. Many of our research sites are participating in these important clinical trials. We invite you to contact one of our sites near you to see if you could benefit from one of these programs.

Lori Alexander, MSHS, RDN, CCRC, CLS, FNLA

Director, ENCORE Lipid Center of Excellence

ENROLLING STUDIES

Idiopathic hypersomnia (IH) is a rare neurological sleep disorder that can drastically affect a person’s life. Those suffering from IH have a hard time staying awake and alert during the day. They may fall asleep at inappropriate times and not notice.

There is no FDA approved treatment for IH. Some can take medication, typically taken for narcolepsy, to improve symptoms. Unlike narcolepsy, scheduled naps will not help those suffering from IH. A key symptom that differentiates IH from other sleep disorders is long naps that are not refreshing with no known cause.

Symptoms

IH’s symptoms are severe and typically disrupt daily activities. It can be difficult to drive, work, go to school and do other daily tasks we take for granted. To better understand IH we need to learn the symptoms. Common symptoms include:

Chronic excessive daytime sleepiness: sleepiness during the day that makes it hard to perform tasks
Sleeping 9 hours or more over 24-hour periods yet not feeling refreshed upon waking up
Non-refreshing daytime napping
Sleep drunkenness: waking up and feeling the desire to go back to sleep
Experiencing problems with memory, attention and concentration
Headaches

Treatment

As mentioned, there is no known FDA approved treatment for IH. The treatment is usually aimed at addressing the excessive daytime sleepiness over other symptoms, typically with medication. What really sets IH apart and differentiates it from other sleeping conditions is that it usually can not be improved through lifestyle changes. Those with IH do not have energizing sleep, so frequent planned naps and improving sleep at night typically do not work.

Participating in clinical trials is one of the best ways to find a cure for IH, or improve the symptoms and create a better quality of life.

Source: Generic and Rare Disease Information Center, Medline Plus

ENROLLING STUDIES

Narcolepsy is a sleep disturbance characterized by a disabling level of daytime sleepiness. It is estimated that one in every 2,000 Americans suffer from narcolepsy, yet about 25% have been diagnosed and are receiving treatment.

Those suffering from narcolepsy can experience “sleep attacks” that are repeated throughout the day. They can even occur during daily routines like eating, walking or driving and are not as a result of inadequate sleep.

Going undiagnosed, narcolepsy can be socially disabling and isolating leading to depression. Type 2 diabetes can also occur in people with untreated narcolepsy. Unfortunately, only about 5% of patients seen in a sleep lab are narcolepsy patients. In order to improve these numbers and better diagnose narcolepsy, it is vital to know the early symptoms.

Symptoms of narcolepsy usually occur in young adults ages 15 to 25. Symptoms can include:

Excessive daytime sleepiness (EDS): This is the primary symptom of narcolepsy. You may have sudden urges to fall asleep, even if you have had a full night’s sleep.
Hallucinations: Some narcolepsy patients experience very real hallucinations while sleeping. These hallucinations are typically a presence in the room and can be very disturbing and disruptive.
Sleep paralysis: You might lose the ability to move while either falling asleep or waking up. Sleep paralysis can be paired with hallucinations.
Disturbed nighttime sleep: About 50% of people with narcolepsy have troubles sleeping through the night, often times waking up frequently.
Memory problems: EDS can cause memory problems. You may not remember something someone told you because you were not fully awake at the time.
Cataplexy- Is a sudden loss in muscle tone and only happens if you have narcolepsy coupled with cataplexy. Cataplexy can occur when there is extreme emotion, for example being surprised. Your muscles can become weak or even paralyzed.

Seeking a doctor for treatment of narcolepsy is vital, but there are lifestyle changes that can be made to manage the disease as well. Examples include maintaining a consistent sleep schedule and planning to take frequent naps throughout the day. Otherwise, treatment for narcolepsy involves medication.

With a new understanding of narcolepsy, researchers are creating different ways for treating the disorder. Some programs are experimenting with ways to increase brain levels of histamine, a brain chemical that is effective in improving alertness.

Other researchers are working on ways to improve hypocretin, which are neurotransmitters that promote wakefulness and regulate sleep. Narcolepsy coupled with cataplexy is caused by a loss of brain cells that produce these neurotransmitters. The goal is to improve narcolepsy symptoms by restoring hypocretin production in the brain.

Sources: American Academy of Sleep Medicine, Narcolepsy Network, Sleep Education, Harvard Medical

Sleep apnea affects approximately 22 million adults in the US, yet 80% of sleep apnea cases remain undiagnosed. If undiagnosed, sleep apnea could lead to cardiovascular disease and diabetes. With cardiovascular disease being the number one killer of both men and women, it is vital to be seen by a doctor for treatment.

What is Sleep Apnea?

Sleep apnea is an obstructive condition that prevents your body from receiving an adequate amount of oxygen causing interruptions in regular sleeping patterns. There are two main types of sleep apnea, obstructive and central. Obstructive sleep apnea occurs when there is a blockage in the airway. The tongue relaxes and blocks the back of the throat while sleeping.

Central sleep apnea occurs when the brain fails to communicate to the muscles to breathe.

Both of these conditions can cause the body to lose oxygen and wake up frequently throughout the night. This can result in daytime fatigue and sleepiness. Other symptoms include loud snoring, morning headaches and insomnia.

How is Sleep Apnea Treated?

The only way to properly diagnose sleep apnea is through a sleep study. Sleep studies are done at a sleep laboratory or can be taken home depending on the physician’s orders. Once diagnosed, the patient may be given a positive airway pressure (PAP) machine. This machine is worn over the mouth and pumps air through the nose and throat to ensure airways stay open. Other treatments include mouthguards to keep the tongue from blocking airways, weight loss, and avoiding sleeping on one’s back.

For best practice, always talk to your doctor if you are having trouble sleeping through the night.

Already diagnosed with sleep apnea? Consider participating in clinical research trial. It is one of the best ways to help improve medical treatments and increase the knowledge that researchers have about sleep apnea.

Chikungunya (chik·un·gun·ya) virus or CHIKV is an infection spread by a two types of Aedes mosquitoes, the yellow fever and Asian tiger species. These are the same mosquitoes that transmit Dengue and Zika virus. The name “chikungunya” derives from the Tanzanian word meaning “to become contorted”, and describes the stooped appearance of sufferers with joint pain. The virus is spread when a mosquito bites (feeds on) an infected individual then passes it on to a non-infected person on a subsequent bite. The Asian tiger mosquito has gradually become the dominant species in the US and is recognized for its ability to survive colder temperatures, therefore posing risk for infection spread into Florida and southeast USA. In 2019, Chikungunya virus infections were identified in 26 US states.

Symptoms:

Most patients who become infected develop high fever and joint pains within approximately a week. The severity varies but some patients experience debilitating aches which continue for years. The pain is caused by the immune system attacking itself causing inflammation of the tissue. Other symptoms of CHIKV viruses include:

Headache
Rash
Muscle pain
Pink eye
Bent posture

Rare complications can occur. Infants and elderly adults are at highest risk for:

Retinitis (inflammation of the retina in the eye which can cause permanent damage)
Myocarditis (inflammation of the heart muscle which can lead to heart failure)
Cranial nerve injury leading to facial pain, dizziness, hearing loss, facial twitch

Prevention:

Prevention methods include:

Mosquito repellent (DEET, picaridin, or lemon eucalyptus applied to skin; permethrin applied to clothing)
When practical, wear long sleeves and pants when exposed to Aedes mosquitoes
When traveling to other countries, stay in places with air conditioning, window and door screens, netting
Isolate the infected person from mosquitoes to prevent a fresh bite which can lead to spread to the next person

Treatments:

There is currently no antiviral therapy approved for Chikungunya. Treatments are focused on helping to relieve symptoms and spread.

Due to public health concerns over the potential for disease outbreak, the FDA granted “Fast Track” status in 2018 for development of the first effective and safe vaccine to prevent virus spread. You can help improve the future of medicine by participating in clinical trials. To learn more about participating in clinical research, visit our enrolling studies page or call us today!

References:

https://www.who.int/news-room/fact-sheets/detail/chikungunya
https://www.cdc.gov/chikungunya/hc/clinicalevaluation.html
http://edis.ifas.ufl.edu/in696
https://www.mosquito.org/page/repellents

The old saying goes: Men are from Mars and Women are from Venus. This exaggeration is- well… an exaggeration, but there are some differences between male and female heart health that causes an inkling of truth to shine out through the expression. The most common kind of heart disease, among both men and women, is coronary artery disease. Coronary artery disease is caused when cholesterol plaque is built up inside the arteries, and if left untreated coronary artery disease can obstruct blood flow to the heart muscle and lead to a heart attack.

When experiencing a heart attack, the individual will usually experience chest pain, shortness of breath, and pain in their left arm, but these symptoms are not universal. Remember when we were talking about the differences between men and women? Women are more likely to experience uncommon heart attack symptoms than men are! These symptoms can include indigestion, pain in both arms, unusual fatigue and abdominal discomfort. Physicians are still uncertain why women are more likely to experience unusual symptoms. There are some theories about hormonal changes and the difference in valve and vessel sizes, but for the most part it is still unknown.

Lowering your risk of a heart attack, however, is not a mystery. Research shows staying active, eating healthy, and monitoring your blood pressure and cholesterol levels regularly leads to decreased cardiovascular risk. Research also shows that individuals involved in clinical research have better health care outcomes than those who are not.

We are currently enrolling in studies that may help you lower important factors like elevated triglycerides and cholesterol which may help lower your risk of cardiovascular events.

References:

https://www.hopkinsmedicine.org/heart_vascular_institute/centers_excellence/womens_cardiovascular_health_center/patient_information/health_topics/menopause_cardiovascular_system.html
https://www.lahey.org/article/differences-between-mens-and-womens-hearts/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3018605/
https://www.clinicaltrials.gov

Glaucoma is a common eye disease that can gradually steal your vision. The term glaucoma refers to a collection of eye diseases that damage the optic nerve. This damage can lead to permanent vision loss or even total blindness. Glaucoma is considered a major cause of blindness in the general population.

A major concern is that glaucoma often presents no early symptoms but continues to cause gradual, un-reversable damage. In most cases, glaucoma is diagnosed in people who are older than 40 but can still develop at an earlier age. An estimated 3.54% of adults between 40 and 80 years have been diagnosed with some type of glaucoma.

Causes Of Glaucoma

In most types of glaucoma, the eye’s drainage system becomes clogged so the intraocular fluid cannot drain. As the fluid builds up, it causes pressure to build inside the eye. High pressure damages the sensitive optic nerve and results in vision loss.

People are more likely to develop glaucoma if they:

Are over the age of 40
Have a family history of glaucoma
Have high blood pressure, heart disease, diabetes, or sickle cell anemia
Are of African American, Irish, Russian, Japanese, Hispanic, Inuit, or Scandinavian descent
Take certain steroid medications such as prednisone
Have had an injury to your eye or eyes
Have high eye pressure (ocular hypertension)

Current Treatments Available

Unfortunately, there is not currently a cure for glaucoma. However, there are several therapies that can help reduce eye pressure and the rate of damage to the optic nerve. Current approved treatment options for glaucoma include eyedrops, oral medications, laser surgery, or microsurgery.

Clinical Research Advancements

New clinical trials for glaucoma are focused on more innovative ways to treat the disease. Researchers are studying everything from electric current stimulation to slow release eye implants to help find relief for patients with glaucoma.

You can help advance medical research by participating in a clinical trial! Contact any of our offices to see what clinical trials are enrolling today.

References:

https://www.aaojournal.org/article/S0161-6420(14)00433-3/abstract
https://www.mayoclinic.org/diseases-conditions/glaucoma/symptoms-causes/syc-20372839
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4927811/

Cholesterol has earned a bad reputation over the years. However, it is required by every part of your body for day to day functions. In fact, cholesterol is so important to daily function, that every cell in the body can make cholesterol from basic materials, except your eyelashes! So how do you reconcile these two completely different ideas? The cholesterol that circulates in your blood stream is the extra stuff that your body is trying to get rid of. This extra cholesterol is what can cause damage to arteries, heart disease, and increase your risk for stroke.

So, what is cholesterol? It is a type of waxy, fat-like substance, also called a lipid. Since cholesterol is a fat, it can’t travel alone in the bloodstream. It would end up as useless globs (imagine bacon fat floating in a pot of water). To get around this problem, the body packages cholesterol and other lipids into minuscule protein-covered particles that mix easily with blood. These tiny particles, called lipoproteins (lipid plus protein), move cholesterol and other fats throughout the body.1

LDL (low-density lipoprotein) is considered the “bad”, unhealthy cholesterol that can build up in the arteries and form deposits called plaques.

HDL (high-density lipoprotein) is the “good”, healthy kind of cholesterol that transports excess LDL cholesterol to the liver to be removed from the body.

PCSK9 is a protein in our body that regulates the circulating levels of LDL “bad” cholesterol. Decreasing the PCSK9 proteins in the body will reduce LDL levels and reduce the risk of heart attack and stroke.

There are currently two FDA approved medications that have been very successful in blocking the PCSK9 protein once it has been made. They are Repatha and Praluent. However, the medications are expensive and not approved for all patients under their insurance.

Scientists believe it would be even more powerful to prevent the PCSK9 protein from being made in the first place. Currently being studied are a new class of molecules called antisense oligonucleotides (ASO). ASOs are pieces of DNA that short-circuit the production of PCSK9, resulting in reduced LDL levels and associated risks.

When you participate in a clinical research study, you gain access to these types of cutting-edge therapies at no cost and before the general population. Contact us to schedule a free consultation to see if you qualify for one of our clinical research studies. If you qualify for one of our clinical trials, your health will be closely monitored by our team of expert medical professionals throughout the trial.

Reference:

https://www.health.harvard.edu/heart-health/how-its-made-cholesterol-production-in-your-body

According to current studies, more than 8 million Americans suffer from psoriasis, but what is it really? By definition, psoriasis is a condition that causes skin cells to multiply rapidly, and consequently build-up on the surface of the skin. This can cause scaly, red patches that are often itchy, painful, and sore. While the exact cause is unclear, psoriasis is thought to be related to an immune system issue with T-cells and other white blood cells, called neutrophils, in the body. T-cells normally travel through the body to defend against internal intruders, such as viruses or bacteria. But if you have psoriasis, the T-cells attack healthy skin cells by mistake, as if to heal a wound or to fight an infection, thus causing a scaly build-up of skin cells on the surface.

While it is considered a chronic condition, fortunately psoriasis can be managed through a variety of methods. Check out our top tips for managing psoriasis and its symptoms below!

Avoid Stressors

While stress is never 100% avoidable, you can give your body a fighting chance and help prevent psoriasis flare-ups by staying away from certain internal and external stressors. It’s a well-known fact that tobacco and alcohol can compromise even the healthiest of immune systems, but if you suffer from psoriasis, you’ll want to avoid that second glass of wine or after supper cigarette. Additionally, why you may not be able to avoid stress at work or home, adopting some easy stress release practices, such as yoga or meditation, may help reduce stress enough to prevent your immune system from going into overdrive.

Treat Your Skin Right

Did you know bathing or showering in hot water could make your psoriasis worse? Hot water is notorious for drying out the skin and causing flare-ups. We recommend soaking or showering in lukewarm water to help prevent a painful trigger. Additionally, a lukewarm bath with epsom salts, milk, or olive oil could help relieve the painful symptoms of psoriasis. In fact, mixing a tablespoon of olive oil with your body moisturizer actually helps to seal in essential moisture, and adds an additional layer of topical protection when applied to active psoriasis breakouts.

Consider Participating in a Clinical Trial

Modern medicine continues to make incredible strides in helping to manage psoriasis, with Jacksonville Center for Clinical Research on the front lines of exploring new and exciting treatments. Contact us to schedule a free consultation to see if you qualify for one of our clinical research studies. If you qualify for one of our clinical trials, your health will be closely monitored by our team of expert medical professionals throughout the trial. It is an accepted statistic that people who participate in clinical trials generally improve their overall health, as they are given access to cutting edge clinical techniques and healthcare experts dedicated to their individual needs.

More than just diarrhea…

Inflammatory Bowel Diseases include Crohn’s Disease and Ulcerative Colitis. These diseases cause inflammation in the digestive tract. Both diseases can have similar symptoms such as diarrhea, urgency, abdominal pain and cramping, fatigue, and rectal bleeding.

What’s the difference between Crohn’s and Ulcerative Colitis?

Crohn’s Disease can cause inflammation anywhere in the digestive tract, from the mouth to the anus. Ulcerative Colitis (UC) affects only the colon (also known as large intestine or large bowel). UC causes ulcers along with the inflammation and puts those affected at a higher risk of developing colon cancer.

What causes Ulcerative Colitis?

Physicians used to believe that stress and diet choices caused ulcerative colitis. Physicians now believe that UC was already present, and can be aggravated by these factors.

Research has shown that the immune system plays a role in developing Ulcerative Colitis.

My own immune system is giving me this disease?

There is no clear cause of UC. Medical science shows that an overactive immune system may be to blame. This can lead to continuous inflammation of the colon, and Ulcerative Colitis.

Many of the medicines currently prescribed to treat UC suppress (decrease the activity of) the immune system.

Is there a cure?

There is currently no medical cure for UC. Medical treatment is available to help manage it. American hospitals experience 500,000 visits per year and 46,000 hospitalizations for Ulcerative Colitis. In severe cases, surgical removal of the colon does cure ulcerative colitis.

The Good News

New medicines are now being studied with ENCORE Research to find a cure for UC. Please call for more information, or to schedule an evaluation to see if this is an option for you.

We look forward to talking with you!

Hot flashes are sudden feelings of warmth. Your skin might redden, as if you’re blushing. Hot flashes can also cause sweating, and if you lose too much body heat, you might feel chilled afterward. Although other medical conditions can cause them, hot flashes most commonly are due to menopause. Hot flashes are the most common symptom of the menopausal transition. Frequency of hot flashes can range from a few a week to several an hour. They can be mild or severe enough to interfere with qualify of life. There are a variety of treatments for particularly bothersome hot flashes.

Symptoms

During a hot flash, you might have a sudden feeling of warmth, a flushed appearance with red blotchy skin, rapid heartbeat, perspiration, a chilled feeling as the hot flash lets up.

Causes

The cause of hot flashes isn’t known, but it’s likely related to several factors. These include changes in reproductive hormones and in your body’s thermostat, which becomes more sensitive to slight changes in body temperature.

Complications

Nighttime hot flashes (night sweats) can wake you from sleep and, over time, can cause chronic insomnia. There is some association with hot flashes and increased risk of heart disease and bone loss.

Don’t suffer in silence!

Diagnosis

Your doctor can usually diagnose hot flashes based on a description of your symptoms. Your doctor might suggest blood tests to check whether you’re in menopausal transition. Before your appointment: make a list of your symptoms, how many hot flashes you have a day and how severe they are, medications, herbs, vitamins and supplements you take, including doses, questions to ask your doctor.

Treatment

Discuss the pros and cons of various treatments with your doctor. There are prescription and non-prescription medications available. Hot flashes subside gradually for most women, even without treatment, but it can take several years for them to stop.

Lifestyle and home remedies

If your hot flashes are mild you may be able to manage them with lifestyle changes without medication. Keep cool. Dress in layers so that you can remove clothing when you feel warm. Use a fan or air conditioner. Lower the room temperature. Sip a cold drink. Watch what you eat and drink. Hot and spicy foods, caffeinated beverages, and alcohol can trigger hot flashes. Relax. Meditation; slow, deep breathing; or other stress-reducing techniques may help. Don’t smoke. Smoking is linked to increased hot flashes. as well as your risk of many serious health conditions, Lose weight. If you’re overweight or obese, losing weight might help ease your hot flashes.

Mind and body approaches

A growing body of evidence suggests that certain techniques can help ease hot flashes. Mindfulness meditation: This type of meditation has you focus on what’s happening from moment to moment. Acupuncture: Some studies indicate that acupuncture might reduce the frequency and severity of hot flashes. Hypnosis: Some research indicates that hypnosis might help relieve hot flashes. Cognitive behavioral therapy: This type of talk therapy may help you cope better with hot flashes.

Dietary supplements

People often assume that “natural” products cause no harm. However, all supplements may have potentially harmful side effects, and supplements can also interact with medications you’re taking for other medical conditions. Always review what you’re taking with your doctor.

Clinical trials

Research is underway to find new and better treatments for managing hot flashes. This may be an especially attractive option if your hot flashes are frequent and severe enough to interfere with your quality of life. Research can give you an option other that hormone therapy, for those that wish to avoid hormones.

Written by: Julia Baker, RN, CCRC

Resource: www.mayoclinic.org

A contagious virus that can cause infections in the lungs and respiratory tract.

You may have heard of the respiratory syncytial virus, in fact most people encounter RSV more than once, sometimes within the same year. Throughout older childhood and most of adulthood you may catch RSV during the winter and experience symptoms similar to the common cold. Symptoms range from mild to severe and include nasal congestion, cough, fever, wheezing, lethargy, and difficulty breathing.

What is so concerning about RSV?

It’s known that RSV shows severe symptoms in infants. However, recent studies have seen an increasing percentage of infected older adults with severe respiratory complications requiring hospitalization and occasional fatality.

I’ve had RSV before, so my immune system knows how to respond.

As we age, we encounter a natural degradation of our immune systems. While you may have encountered RSV in the past, infection after 65 years of age could entail severe respiratory complications as the immune system loses its ability to fight the virus. Studies show that RSV causes approximately 170,000 hospitalizations and around 14,000 deaths per year among older adults.

What can I do if I get infected?

There is currently no vaccine for the prevention of RSV, and because it’s a virus, antibiotics do not work. There are some treatments available, though usually pricey and used in extreme cases if you are already hospitalized.

The good news is there are several new preventative vaccines currently being developed. As an ENCORE Research community member, you have access to our cutting-edge research trials and are the first to know about new research. If you are interested in getting involved in any of our research studies, call your local office today!

Written by: Lana Borema

You may know that having normal cholesterol levels in your blood are important for helping prevent heart attacks and strokes. But you may not know that there is another factor in your blood work that can be just as important! It’s a blood test you can request, and the result will tell you if it’s important for you.

Lipoprotein(a) is a particle in your blood which carries cholesterol, fats, and proteins. The amount your body makes is inherited and determined by the time you are born. It does not change very much during your life and is not affected by diet or exercise.

Lipoprotein(a) is also known as Lp(a), L-p-a, Lipoprotein-little-a, and L-p-little-a. Some cholesterol and Lp(a) in your blood is normal. A high level of LDL, the bad cholesterol, increases your risk for heart attack or stroke. High levels of Lp(a) also increase your risk, even if your cholesterol numbers are normal! About 20 percent of people, or 1 in 5, have high levels of Lp(a). This blood test is not done as part of your usual blood testing but can be requested.

Here are some reasons an Lp(a) blood test may be important for you:

Having high levels of LDL, even while taking medicine to treat it.
You or a family member have had a heart attack or stroke at an early age, men younger than 55 years old and women less than 65 years old.
You or a family member developed high blood pressure at an early age.
A family member has high Lp(a). If an adult has high Lp(a), their children have a 1 in 2 chance of inheriting it.
Having FH, Familial Hypercholesterolemia, an inherited condition of very high cholesterol levels.

Get tested, ask your nurse or doctor if you have questions.

Join a clinical trial. Jacksonville Center for Clinical Research currently has an enrolling study, call 904-730-0166 for more information. If you are eligible for this study, Lp(a) testing is provided at no cost to you.
Ask your Doctor to order the lab test. Several labs perform it:
- Cleveland Heart Lab / Quest
- HDL labs
- Boston Heart Diagnostics

Be aware of your personal risks.

Reach healthy goals for your cholesterol results with dietary choices, exercise, and medication if needed.

Stay healthy, stay active, exercise, eat naturally, have fun, love, laugh!

Written by: Julia Baker, RN, adapted from a presentation by Albert Lopez, MD

On a sailing ship in 1747, twelve sailors who had begun the voyage feeling fine were overcome with fatigue. Their gums were swollen and sore, making it difficult to eat. Their teeth were falling out. Their legs were swollen and purple from bruising.

Dr. James Lind was a passenger on that ship, and he set out to find the cause. He set up what may have been the first clinical nutrition experiment. He decided on six groups of treatments, 2 sailors in each group:

drank one quart of cider a day
gargled with sulfuric acid
had two spoonfuls of vinegar, 3 times a day
drank ½ pint seawater a day
drank barley water
ate two oranges and 1 lemon a day

Within six days, the sailors who ate the oranges and lemon felt better and were able to work again. The other sailors in the experiment felt worse. The ill sailors were suffering from a lack of vitamin C, now known as Scurvy. They had plenty of fresh fruits and vegetables when they first set out on the voyage. But fresh foods ran out on the long voyage, and they suffered symptoms from this lack. After this finding, sailors often brought lime juice aboard ship because it could be stored longer. This is how sailors earned the nickname “limey”.

1747 was well before the requirement of informed consent of the patient, detailed eligibility criteria, protocols and regulations, which are a foundation of today’s clinical research. Nevertheless, it is an interesting example of a method of discovering the best treatment for a disabling condition.

Scientific minds are still seeking solutions for medical problems. Modern clinical research is strictly regulated for the safety and well-being of the research volunteer. Great progress has been made in medical science over the last decades. This progress could not happen without dedicated volunteers. Participation in clinical trials can be a rewarding endeavor for both investigators and volunteers alike.

Written by: Julia Baker, RN, CCRC

Resources:
https://askabiologist.asu.edu
https://www.umass.edu/nibble/infofile/limey.html

Gastroenterology is the medical specialty concerned with the structure and function of the digestive tract (also called gastrointestinal [GI] tract). Some symptoms that can indicate disease or dysfunction of the GI tract include nausea, vomiting, weight loss, heartburn, regurgitation, abdominal pain, abdominal bloating, rectal bleeding, constipation, and diarrhea. Digestion of food and fluids is a very complex process, so persistent symptoms may require a gastroenterologist’s evaluation to determine the cause. Knowing the cause of symptoms can then lead to proper treatment and control or management.

What’s the Difference between IBS and IBD?

Irritable Bowel Syndrome (IBS)

IBS is a common GI disorder that can considerably reduce the quality of life. It affects as many as 5%-20% of individuals worldwide. It occurs more often in women than in men, and is more commonly diagnosed in patients younger than 50 years of age. Symptoms range from diarrhea to constipation, or a combination of the two. Abdominal pain or discomfort often exist alongside abdominal distension.

Diagnosis of IBS is made after obtaining a medical history, physical exam, and diagnostic testing to learn if any disease process is causing the symptoms. There is evidence to show that IBS can be a result of genetics, environment and social learning, dietary or intestinal microorganisms, low-grade inflammation and/or dysfunction of muscular movements, secretions and sensation.

Many patients with IBS ignore their symptoms, believing they are a normal part of everyday life. The good news is that with proper diagnosis, there are ways to treat or manage the symptoms. Don’t ignore persistent symptoms, there is help available.

Inflammatory Bowel Disease (IBD)

IBD is not the same as IBS, and understanding the difference is important for proper treatment. The symptoms can be the same, but the problem causing the symptoms is very different. Inflammatory bowel disease includes Crohn’s Disease (CD) and Ulcerative Colitis (UC). Crohn’s Disease can cause inflammation through the walls of the GI tract and can affect any part of the GI tract. Ulcerative Colitis commonly includes inflammation of the GI mucosa and is limited to the colon (large intestine). Recent research showed that some factors that can lead to IBD includes genetic susceptibility, environment, intestinal microorganisms, and immune responses. Medications are directed at treating the active inflammation, which can then decrease or control the symptoms.

Conclusion

Since symptoms of many GI disorders can be the same, a thorough medical history, physical exam, and proper diagnostic testing is crucial to obtaining a correct diagnosis and treatment. Open communication with your gastroenterologist and health care providers is essential to appropriate management and treatment. Be sure to tell your doctor about symptoms that concern you and new problems that arise. Do not hesitate to ask questions to ensure your understanding of your diagnosis and any treatment prescribed. Being a partner in your health care can lead to a healthier, happier life!

Written By: Julie Baker, RN

Resource: World Journal of Gastroenterology

“Pneumonia” the old man’s friend. The most frequent “sendoff” in the pre antibiotic era. In the US infectious disease remains a leading cause of death primarily due to pneumonia. Each year the bacteria Streptococcus pneumonia (pneumococcal) disease kills thousands of adults. It is spread from person to person through, coughing, sneezing and close contact. People can carry the bacteria in their throat, nose and sinuses and show no symptoms of infection and still spread the bacteria to people who do become ill. Illness can range from upper respiratory tract infections; sinus, ears and throat to much more severe disease (invasive pneumococcal disease, IPD) defined as pneumonia, blood stream infection and meningitis. There are dozens of different types of pneumococcus that vary by polysaccharides in the capsule that surrounds them.

Vaccination against pneumococcal disease started in the pediatric age group and was quickly shown to be highly effective and then introduced to the adult population with similar results. It has been proven that vaccines against pneumococcus are safe and effective and DON’T CAUSE autism. Current recommendations are that adults 65 years old should receive 2 vaccines separated by at least one year. Re-vaccination with the same vaccine is generally not recommended. PCV13 followed by PPSV23 after 1 year. The number on the vaccine tells you how many different types of pneumococcus are covered. Long term studies have shown a 75% reduction in IPD in adults after one dose of PCV13 or PPSV23 for the covered types and an overall 45% reduction against pneumococcal infections in general. Estimates for the U.S. project a vaccine related reduction of 3,000 deaths and 30,000 cases of IPD over the next 3 years.

Monitoring pneumococcal sub-types in the community allows us to produce more effective vaccines based on the sub-types identified. ENCORE Research Group is excited to participate in new pneumonia vaccine research! If you or someone you know may be interested in participating in our research, call our office to find out more!

Written By: Mitchell Rothstein, MD

What causes a heart attack?

A heart attack (myocardial infarction) means that blood flow to the heart muscle has been decreased enough to cause damage to the heart muscle. Some causes of blocked blood flow include blood clots, cholesterol build up, and rupture of plaque within the blood vessel. For those who have already suffered a heart attack, it is important to reduce the risk of recurrent attacks. Research has shown that there are several steps that can be taken to help reduce the risk of recurrent heart attacks.

Proven things you can do to prevent heart attacks

Lower cholesterol
Lower triglycerides
Lower blood pressure
Stop smoking and avoid secondhand smoke
Eat fish
Increase physical activity as allowed by your doctor. Inactive people have nearly twice the risk of heart disease as those who are active.
Talk with your doctor about medicines that can decrease blood clotting

Medications that can reduce risk of heart attack

Cholesterol lowering medication, which include statins and non-statins
Triglyceride lowering medications
Medications that decrease inflammation

Current research is underway to study improving health after a heart attack

Weight loss: Heart attack is three times higher in those who are obese than in those who are lean.
New medications for those with unique cholesterol metabolizing problems.
Anti-inflammatory medications targeting inflammation in blood vessels.

At ENCORE Research Group we have clinical research studies for many of the risk factors mentioned above. Participating in a research study can help keep you motivated on your journey to better health. If you are interested in participating in any of our research studies, call your local office today!

Thank You for a Great Year!

As an ENCORE community member, we hope you have enjoyed hearing from us this year. Each month we strive to provide you with accurate information on health topics that are relevant to you and our enrolling studies. 2018 has been a momentous year for us and has seen complete many trials for novel medications that we believe will improve global health. We are thankful for dedicated volunteers like you that make this possible!

This month we would like to do something a little different and provide you with insight into clinical trials. A lack of clinical trial education is routinely cited as the number one barrier to enrolling trial participants. Clinical trials are required by the FDA to prove the safety and effectiveness of new medications and volunteer participants are necessary to complete these trials. We understand that this concept is often intimidating. However, there are several measures in place to make our trials as safe as possible, including:

Physicians in charge of all study activities
Pre-Clinical Testing
Institutional Review Boards (IRBs)
Informed Consent Forms
Routine Participant Labs and Clinical Assessments
Clinical Trial Data Safety Monitoring Boards

Investigational products are thoroughly studied during pre-clinical testing before the trials are designed and the first human participant is enrolled. Pharmaceutical companies spend millions of dollars to bring medications to market and they want to be nearly certain that the medication will fulfill its intended purpose. However, volunteers are needed to complete the FDA clinical trials. When designing the trial protocols, participant safety is always the number one priority!

Every trial is overseen by an Institutional Review Board (IRB). The purpose of the IRB is to protect the rights and welfare of human research participants. The IRB evaluates the possible risks and benefits of the trial before it is allowed to open. They are also responsible for approving the trial protocol and the informed consent. Along with the consent form, a discussion with our medical staff allows you to make an informed decision on whether or not the trial is in your best interest. Lastly, participants in the study are continuously monitored for safety and there are many tests completed during the trials to alert researchers at the first sign of potentially serious side effects. We hope that every patient that has worked with us has felt that it has been a safe and positive experience!

Thank you again for helping us improve global health and find new ways to treat medical ailments! 2019 is going to be another exciting year at ENCORE Research and we hope to get the chance to work with everyone reading this letter.

Happy Holidays,
ENCORE Research

If diabetes is brought up to a member of the general public, they will usually be aware that the condition affects a person’s ability to regulate their blood sugar. However, they may not realize what is involved beyond checking blood sugars and possibly injecting insulin. On the other hand, most people that have been diagnosed with diabetes know that it is a very complex condition. Uncontrolled, high blood sugar affects everything from your head to your toes! If you have been diagnosed with diabetes, it is extremely important to manage and control your blood sugars. This will help minimize and prevent complications that arise from uncontrolled diabetes.

There is a common saying that “diabetes will not kill you, but its complication will.” Excess sugar in the blood causes damage to the small blood vessels and nerves. This in turn leads to damage to various diabetic complications including:

Alzheimer’s Disease
Blindness
Depression
Diabetic nephropathy or kidney damage
Diabetic neuropathy or nerve damage
Diabetic ulcers
Erectile dysfunction
Gastroparesis

Although there is not a cure for diabetes there are many effective avenues available to help manage and prevent the complications resulting from diabetes. ENCORE Research Group is working tirelessly to find new therapies for these conditions. If you would like to experience the science firsthand and help to move medicine forward, consider volunteering for a clinical trial!

Is GERD just heartburn, or is it something more? Check out our PowerPoint to find out the latest information and gain some tips on how to help reduce symptoms.

Researchers are continuing to study GERD and new ways to treat it. Currently, some of our ENCORE research sites have new GERD research studies enrolling. If you or someone you know has GERD, and are interested in participating, call your local office to find out more!

Click here to view the GERD powerpoint

Gluten Free. This has become a household term. Everyone has heard of gluten free diets, but not everyone comprehends why this distinction is necessary. For people with celiac disease, gluten can be devastating, and it is essential for food labeling to be correct. Celiac disease is an autoimmune disorder where the ingestion of gluten leads to damage in the small intestine. (1) Even ingesting minuscule quantities of gluten, such as crumbs from a toaster, can trigger intestinal damage. This damage can prevent the body from properly absorbing nutrients. Celiac disease is hereditary and is estimated to affect 1% of people worldwide.

There are more than 200 known symptoms of celiac disease, which can make it a nightmare to diagnose. It is estimated that there are 2.5 million undiagnosed Americans. When you mention celiac, most people think of digestive symptoms however, only around one-third of adults with the disorder experience digestive symptoms like diarrhea. Common symptoms include: fatigue, joint pain, arthritis, fatty liver, depression or anxiety, peripheral neuropathy, migraines, canker sores, and skin rash. If left untreated, Celiac disease can lead to many long-term health complications. Unfortunately, the only way to accurately diagnose celiac disease is to have an endoscopic biopsy. Once a diagnosis is made, the challenge of managing the condition begins.

Currently, the only effective treatment for celiac disease is to follow a strict gluten-free diet. However, the future is not bleak. Researchers from around the world are working to find effective pharmaceutical treatments. COUR Pharmaceuticals is researching a drug which aims to reprogram the body’s immune system to tolerate gluten subsequently reversing the signs and symptoms of Celiac disease.(2) Additionally, the Journal of Biological Chemistry notes that scientists have discovered a protein associated with celiac disease can be inactivated, paving the way for new treatment possibilities.(3)

References:

https://celiac.org/celiac-disease/understanding-celiac-disease-2/what-is-celiac-disease/
https://www.courpharma.com/pipeline-and-programs/
https://www.sciencedaily.com/releases/2018/02/180223122343.htm

The heart is vital (literally), so it’s important to keep it in tip-top shape! The rest of the body depends on the heart to deliver blood and oxygen to all its cells and organs. If the heart becomes damaged, it can lead to what is known as heart failure. Keeping your heart healthy not only involves proper diet and exercise, but also involves making sure conditions that can cause heart damage are properly managed.

Some conditions that can damage the heart are:

cardiomyopathy
coronary artery disease
diabetes
heart attacks
high blood pressure

During heart failure the heart is unable to pump blood effectively enough to meet the body’s demands. Because the heart cannot fulfill its primary duty, it will try to compensate by enlarging itself, increasing muscle mass or pumping faster. The body can also react by narrowing blood vessels and diverting blood away from less important tissues and organs. As heart failure worsens the compensations and symptoms begin to show.

Common symptoms of heart failure include: shortness of breath, fatigue, coughing, racing heart, excessive tiredness, loss of appetite, and chest pain. Risk factors for developing heart failure include diabetes, poorly controlled high blood pressure, high cholesterol, or family history of heart failure. If you think you might have symptoms of heart failure, it’s important to speak with your doctor as soon as possible.

There are about 5.7 million adults in the United States who have heart failure and it’s the leading cause of death in diabetics. In most cases, heart failure cannot be reversed once diagnosed. However, researchers are continuing to study ways to reverse heart failure as well as new and better ways to treat it. Currently, many of our ENCORE research sites have new heart failure research studies enrolling. If you or someone you know has heart failure, and are interested in participating, call our office to find out more!

Sleep is essential for the body to repair and restore itself. In fact, sleep is so important that humans spend approximately 30% of their lives sleeping. However, since the beginning of recorded time and undoubtedly before that, some people have struggled to sleep. Fortunately, over the last 50 years our understanding of how to improve and correct the body’s sleep systems has advanced tremendously. This research has led to new understanding of how people sleep and why about 30% of the US population struggles with sleep disorders such as insomnia.

Insomnia is defined as dissatisfaction with sleep quantity or quality associated with difficulty falling asleep or staying asleep, even when there is adequate sleep opportunity (7-8 hours). This can cause significant social or functional distress and impairment. The most common sleep disorder in the US is Insufficient Sleep Syndrome, in which sleep deprivation occurs from an inadequate amount of sleep. Insufficient Sleep Syndrome is voluntary, but unintentional, unlike insomnia. 1 A recent poll of US adults suggests an average sleep time of just over 6 hours which is 2 hours less than we were sleeping 100 years ago, however, our sleep need has remained constant.

In order to achieve quality sleep, many insomniacs often self-prescribe antihistamines and alcohol. These treatments often have negative short and long-term outcomes. The first recommended treatment is Cognitive Behavioral Therapy (CBT), but this involves a trained therapist as well as a significant time commitment. These aspects combined with the fact that it is not well reimbursed by insurance can make it prohibitive for many individuals. A more cost-efficient alternative can be self-directed computer-based programs. Traditional pharmaceutical sleep products (hypnotics) have focused on depressing the central nervous system directly, but these medications have limitations due to adverse effects such as hangover, amnesia, abuse liability and dependence.

To end on a positive note, new research is focusing on some different ways to treat insomnia. We are excited to be involved at two of our North Florida ENCORE Research Group offices. If you are interested in getting involved in any of our research studies, call your local office today!

http://www.sleepeducation.org/sleep-disorders-by-category/hypersomnias/insufficient-sleep-syndrome

The liver is the second largest organ in the body. Its function is to process everything we eat or drink and filter out any harmful substances from the blood. When there is too much fat in one’s liver, the filtration process is interrupted and can become a health problem.

It is estimated that 25% of the world has Non-alcoholic Fatty Liver Disease (NAFLD), a precursor to NASH or Non-Alcoholic Steatohepatitis. NASH is associated with obesity, cardiovascular disease, type 2 diabetes and metabolic syndrome. It is now the most common liver disorder in the United States and the number one reason for liver transplants.

Starting as Fatty Liver Disease and then progressing to NASH, the buildup of fat in the liver can lead to inflammation of the liver and liver cell damage. Progression of NASH leads to fibrosis or stiffening of the liver and cirrhosis or scarring of the liver. NAFLD and NASH are both silent diseases with few symptoms even if the diseases progress to cirrhosis.

Physicians can monitor liver function blood tests as well as abdominal ultrasounds and liver Fibroscans to determine if you are at risk of developing NAFLD and NASH. However, the only way to definitely determine of you have NASH is to perform a liver biopsy.

The most common treatment for fatty liver disease is weight loss to reduce the fat in the liver. It is estimated that losing up to 3 to 5% of your body weight can help reduce the fat in the liver. Losing 10% of body weight may help reduce inflammation and even fibrosis in the liver. Currently, there are no medications which have been approved to treat fatty liver disease; however, many are in late stage development with promising results.

To learn more about current clinical trial opportunities for fatty liver disease and NASH, please contact us.

Why do our volunteers want to participate in clinical trials? Volunteers are often motivated by a combination of several reasons. Here are 6 of the top reasons to participate.

The potential of finding relief from their symptoms

We can’t promise relief from symptoms due to placebo and efficacy of the medication being tested. However, the Hawthorne Effect proves that patients who participate in a research trial have better outcomes than those not participating.

To learn more about their condition

You might argue that to learn about a condition you can just look it up on the web, and we all do that. However, often these websites can be misleading or provide the worst-case scenario results, which don’t apply to most of us. Another option is to ask your primary physician, and that is a good thing to do. Unfortunately, physicians are often rushed or running behind and questions are forgotten. Participating in a clinical trial provides you ample one on one time with a research professional and physician so that all your questions can be answered.

Access to new cutting-edge treatments

When participating in a clinical trial, there is access to new cutting edge treatments that are not available yet to the public. There can even be access to medications that have been newly FDA approved, but are much too expensive to afford. Study required medications are most often provided at no cost!

Receiving medical care at no cost

Sponsors such as pharmaceutical companies, governments and foundations fund medical research through study grants. The grants fund local research sites for conducting the study so you don’t pay a thing. In fact, we don’t even ask you for your insurance information! Can you believe most studies compensate patients for time and travel?

Making a difference

Clinical Trials help shape the future of medicine and healthcare. Volunteer participation helps researchers discover more about health conditions and find better ways to treat them!

Moral and emotional support

Having medical conditions that others don’t necessarily understand can make some people feel alienated. When involved in research, support staff understand the patient’s condition and what they may be experiencing and can provide moral and emotional support.

We will do everything we can to help find a trial that is a good fit for interested volunteers. New clinical trials are constantly enrolling so do not be discouraged if we don’t currently have the perfect trial for you. The majority of volunteers who completed a clinical trial are interested in participating in another one, so call us and find out your reason to participate!

When patients are diagnosed with an autoimmune disorder they often have many questions. How did this happen? What is happening inside me? What treatments are available? Autoimmune diseases can be extremely complex and are the subject of much current research. The immune system’s purpose is to identify and destroy threats to the body such as viruses, bacteria or parasites. However, when a person has an autoimmune disease such as Crohn’s Disease, Lupus, Sjogren’s (show-grins) syndrome the immune system becomes unable to distinguish foreign bodies from the body’s own healthy tissue. When this happens, the immune system begins to target healthy cells causing inflammation. Almost any aspect of the immune system can malfunction causing a plethora of conditions.

One such condition is Crohn’s Disease. Crohn’s is an autoimmune disease where the immune system specifically targets the gastrointestinal tract. Crohn’s can be difficult to diagnose due to the variety of symptoms associated with the disease. The symptoms vary from person to person and by which component of the GI tract is being targeted. If a doctor suspects Crohn’s Disease, diagnosis is confirmed via an upper and/or lower endoscopy. Those living with Crohn’s disease will agree that we need to find a cure ASAP!

Systemic Lupus Erythematosus(SLE) is a chronic autoimmune disease in which the immune system can cause damaging inflammation to any part of the body. Skin, joints and organs can all be affected. Flares can cause a wide variety of symptoms. Around half of those affected by lupus have what is called a butterfly rash on their face. Other common symptoms include inflammation or swelling of the joints, and fatigue.

Another inflammatory autoimmune disease is Sjogren’s Syndrome. Sjogren’s is typically identified by its most prevalent symptoms, which are dry eyes and dry mouth. These symptoms occur because the immune system targets the glands that produce saliva.1 In the past treatment has almost entirely consisted of treating the symptoms of the disease. However, new research is showing that Sjogren’s can lead to other complications and scientists are now working on specially devised treatments to nip the problem in the bud!

According to JCCR’s Steven Mathews, MD “the last generation of autoimmune treatments worked further down the mountain so to speak and focused on treating the avalanche of symptoms. Current treatments are looking at treating conditions higher up the mountain at the source and preventing the avalanche from occurring.” Richard Smith, RN elaborated that, “general immunosuppressants act like a hammer on the immune system, whereas the current drugs we are researching act like a fine scalpel only targeting the rogue immune cells.” Our mission at ENCORE Research Group has always been to help get cutting edge treatments approved by the FDA. We want to help deliver safe and effective treatments to everyone. This is only possible by conducting research studies on new investigational medications. If you are interested in taking part in one of our research studies call today.

At ENCORE Research Group it is our mission to help every patient that walks through our doors qualify for the clinical trial of their choice. Often times we get to experience the thrill of telling our patients that they successfully qualified and will soon enroll in the study. However, this is not always the case and we understand our patients’ frustration when they decide to commit to a trial only to later find out that they do not qualify. Here at ENCORE Research Group we were curious how this situation affected their thoughts about applying for future studies. This month, curiosity got the best of us and we reached out to some of our community members to find out!

Thomas recently came to Jacksonville Center for Clinical Research (JCCR) to have an evaluation for a high triglyceride and weight loss study. Fortunately for Thomas, he was not eligible for the trial because his triglyceride level was too low. Thomas stated “it’s good that I am healthy enough not to be in this research study. But they are looking at another study that I may be interested in.” As you can see, Thomas was not discouraged that he did not qualify, but optimistic that he may qualify for a different study.

We also reached out to Latasha, who is new to research, and may qualify for a study that has a waiting list for interested participants. When discussing with her how some patients are not eligible to join a trial, she stated “I would want to know why I did not qualify, but that would not prevent me from trying to get in another trial.” Fortunately for Latasha and all of our participants, ENCORE Research Group is very transparent about the screening process and explains exactly why they may have been ineligible. Hopefully she will receive a spot in the study she applied for!

Mark was passionate about participating in a Sjogren’s research trial but did not qualify. He said “it’s not unusual for someone with Sjogren’s Disease not to qualify for studies with systemic therapies if they do not have the antibodies. But when you’re sick, your driving force is to get better for yourself and your family. I tried the conventional way but it did not work for me.” After doing more research on the specific clinical trial, Mark decided to pursue the FDA Expanded Access program. “It’s a relatively new program to help people get access to new medications.” Fortunately for Mark, he had the resources and insight to look into alternative treatment options.

We also asked an experienced researcher how she saw things. Linda Gray, site manager of the Nature Coast Clinical Research site in Inverness, Florida, has many gastrointestinal (GI) studies currently enrolling. Linda acknowledges that “some of our patients are not eligible for a study because they have mild disease, and the sponsors are looking for moderate to severe disease. If the disease is not measurable enough for objective data, we will not be able to tell if we’ve reversed it or slowed the progression. Our NASH studies include a liver biopsy to determine the extent of the disease to see if the patient is eligible.” It is unfortunate that this can limit access to drugs for those in need, but we have to believe that obtaining clear and objective data will help a greater number of people in the future.

The reality is, every clinical trial is different and has unique qualifying criteria. The pharmaceutical companies that sponsor clinical trials create the criteria in order to make the strongest case possible to the FDA on the drug’s safety and efficacy. While we would love to involve every one of our community members that are interested, it is just not always possible. The good news is that all seven of our research sites are always getting new clinical trials to enroll in! So, just because you didn’t qualify the first time doesn’t mean you won’t qualify for the next one! We look forward to working with you in the ENCORE community.

As I was perusing an ancient text I came across an excerpt on the disease known as diabetes. The earliest mention of the disease I could find was by a Greek physician called Aretaeus in the first century AD. Aretaeus identified diabetes and named it after its symptoms of thirst and sweet urine. When I researched the period I was astounded to find the diagnosing physicians were called “water tasters” and would either taste the urine or see if insects were attracted to it.

My research revealed that diabetes wasn’t well understood until the 20th century. It was then that researchers discovered insulin from the pancreas helped control blood sugar levels. A few decades later in 1961 the researchers at Ames Diagnostics created the first blood sugar monitor. This monitor was called Ames Reflectance Meter and was only available in doctor’s offices and hospitals due to its cost. Around this time a pioneering man named Richard Bernstein mounted a campaign to make blood sugar monitoring at home acceptable and easy. He was so passionate about the cause, at the age of 45 he went to medical school and became an endocrinologist. His efforts here led to millions of people being able to monitor their blood sugar at home. Now information about diabetes is growing exponentially. The thought that all of this diabetes research led from tasting urine to affordable blood sugar measuring is amazing!

At ENCORE research, we are passionate about advancing health care. Without research, we wouldn’t have these advances in diabetes management!

Heart disease currently accounts for 1 in 4 deaths in the United States.[1] However due to new research breakthroughs there are now treatments available that may finally give us the means to fight back against heart disease. Historically heart disease has always been one of America’s most serious epidemics. It has been a leading cause of death since the turn of the 20th Century. Following World War II the National Heart, Lung and Blood Institute began a long term study known as the Framingham study to identify the cause of heart disease.

The Framingham study is an enormous observational study in the town of Framingham, Massachusetts. Researchers conducted physical examinations on participants every two years to study contributing factors to heart disease and are now on their 3rd generation of participants. The Framingham study identified many of the currently known risk factors such as high blood pressure and high cholesterol. Once high cholesterol was identified as a major risk factor, researchers began developing medications to combat cholesterol levels. Some of our most exciting research at Encore Research Group is for these new cholesterol lowering medications such as PCSK9 inhibitors.

PCSK9 inhibitors are an amazing class of drugs that allow us to lower LDL or “bad cholesterol” to previously unachievable levels. These drugs are usually injectable and have many advantages over traditional statin drugs. One such advantage is we are not seeing the muscle cramping associated with statin therapy. This is truly a breakthrough.

How low is too low? It is a question that researchers are actively addressing. So far we have not seen complications or health risks as a result of very low LDL. Some large studies that Encore Research has participated in will be releasing their results within the next year to more definitively answer this question. For now, there are many patients that have cholesterol levels that are difficult to budge but may respond to these new therapies.

Currently we are studying the effects of PCSK9 drugs in high risk populations such as diabetics. If you have high cholesterol levels that are not being adequately managed by your current medications, we may be able to help you get involved in a research study that may help get you back on track! As many of our readers know, most research studies offer access to medication at no cost to patients. Call us to find out how you can get involved today!

[1] CDC, NCHS. Underlying Cause of Death 1999-2013 on CDC WONDER Online Database, released 2015. Data are from the Multiple Cause of Death Files, 1999-2013, as compiled from data provided by the 57 vital statistics jurisdictions through the Vital Statistics Cooperative Program. Accessed Feb. 3, 2015.

Growing up, we’ve all heard the saying, “An apple a day, keeps the doctor away” and in most cases, an apple is a great fruit to eat! However, if you have Crohn’s Disease that might not always be the case. Those afflicted with Crohn’s Disease actually have to peel the skin off of fruits and vegetables with edible skin, however delicious it may be! The skin is an insoluble fiber that can aggravate Crohn’s symptoms causing more gas, bloating, diarrhea and pain. In severe cases, can even cause blockages.

The cause of Crohn’s Disease is still unknown. Scientists believe the cause to be a mixture of environmental, and genetic factors. Crohn’s Disease causes inflammation of the wall of the gastrointestinal (GI) tract. The GI tract is continuous starting at the mouth and ending at the anus. An interesting fact about the GI tract is, it can be considered to be outside of the body. The body changes the environment of the GI tract to be conductive to digesting and absorbing food to the inside of the body. If we followed the journey of the apple discussed earlier after masticating and swallowing the apple is moved down the esophagus, and into the stomach where it will be digested. Next the apple will pass through a sphincter and into the small intestine where the nutrients from the apple will be absorbed. Crohn’s most commonly occurs in the small intestine and during a flare up it is difficult to absorb necessary nutrients before the bolus is moved to the large intestine.

While the small intestine is most commonly affected, with Crohn’s, any part of the GI tract explained above can be affected. The inflammation caused by Crohn’s produces flare ups and can lead to many uncomfortable symptoms. A few of which are: diarrhea, pain, unintentional weight loss, ulcers, malaise, anemia, and anal fissures.

Research has produced many significant advances for Crohn’s Disease, but there are still many unanswered questions. Our research sites are devoted to finding answers to those pressing questions and providing a better outlook for the future of Crohn’s health management. You can be an integral part of shaping the path for future medicine, by participating in a clinical trial.

The practice of medicine has changed in major ways in recent years. Though many of these changes reflect good intentions, the real world consequences to patients often don’t match expectations. To understand this divide between reasonable intentions and the less salubrious reality from which we may collectively suffer, I’d like to share a recent anecdote that occurred at the airport when regulations ran amok.

During recent travel, I witnessed an unfortunate incident that you may have seen before. An airline gate agent stopped a member of our party and reprimanded her for carrying a small overnight suitcase, a computer bag and her pocketbook. The gate agent, working on behalf of the airline, stated that she had to follow FAA (Federal Aviation Authority) rules and only allow two bags on board even though the computer bag and pocket book were small. Unfortunately, when asked to “consolidate” the three bags into two, we had a problem. No bag really fit into any of the other bags. The agent wouldn’t “gate check” any of the bags so that we could pick it up when exiting the plane and running off to our next flight. Further, our discussion with the gate agent failed to alleviate our concern that, if checked to its “final destination,” we wouldn’t see a checked piece of luggage any time soon given the shortness of time for our connection.

The solution that followed satisfied no one. Over the next 10 minutes, embarking passengers stepped around the contents of the three bags which littered the entrance to the Jetway. At first, the gate agents ignored the situation, but as tempers flared due to the obstruction of foot traffic, an agent “helped” by aggressively stuffing the computer bag into the overnight bag. A busted zipper later, the bulging overnight bag limped down the Jetway led by a very unhappy customer.

Does this scenario prove airline excellence because the agents showed how well they can comply with government rules? Hardly! Most folks would conclude that this messy scenario wasn’t necessary. In complex situations, the empowerment of professionals to act judiciously given a set of circumstances leads to excellence. The above scenario required the gate agents to apply context while making an overall effort to comply with government regulations. Unfortunately an excellent result didn’t happen in this case.

Similarly, we face the issue of context and judicious interpretation every day in medicine. As a common example, computerized medical records, a well-intended effort to characterize complex information, often fail to convey the true story of a patient or the nuances that make each of us unique. Summarized, bullet point information can easily miss the point. The great composer Mozart famously observed that musical excellence doesn’t lie in the notes but actually in the space and timing in between the sounds. Medical excellence involves a similar concept. Health care providers must read “in between the lines” and understand and respond both to what is and isn’t stated.

What this concept means to the average patient depends on the circumstances. For example, some people with neck pain may need consideration for a heart condition (angina) whereas others should check in immediately for an MRI of the spine and others should book a massage. Distinguishing the underlying cause of the neck pain relies on both a description of the nature of the symptom and on understanding the quiescent pauses of relief between episodes of pain. Excellent clinicians make this distinction by asking the right questions. Excellence during the medical evaluations of headaches, arthritis, and memory problems, among other things, also require this same commitment to careful questioning.

Clinical research promotes excellence by demanding great attention to detail. During research programs, physician investigators and their staff members must extensively analyze many aspects of our patients’ health. This thorough analysis usually exceeds that which occurs at the time of general physician visits, a setting during which time pressed clinicians must limit their focus and move on to the next patient. Research also requires the deployment of state of the art technology. The combination of technology and attention to detail of symptoms, signs and lab values leads to an experience which most patients highly value and describe as a demonstration of medical excellence.

In sum, medical excellence involves more than compliance or automatically matching a disease with a drug. Medical excellence is a philosophy of understanding the needs of a patient and putting those needs in context through the development of an individual treatment plan. Clinical research promotes medical excellence by demanding a culture of detail and caring.

Let’s not dance around the issue: for many years now, news sources like CBS, CNN, The Atlantic, and The New Yorker have called research volunteers guinea pigs. You’ve probably said it yourself. I’m here today to tell you why we need to call research volunteers by another name: Heroes.

The term “guinea pig” is condescending to both volunteers and researchers. For volunteers, it takes away the enormity of their contribution by sounding like they have no choice in the matter. If you have ever taken a prescription medicine for any reason, even an antibiotic; someone has chosen to volunteer to make sure the medicine is safe and works. If medicines down the road are to work better, we need volunteers to keep agreeing to test them.

Calling subjects “guinea pigs” also disdains the research coordinators and doctors that supervise drugs trials. Before any volunteer is admitted into a trial, coordinators fully explain what the trial entails, making sure to answer any questions or concerns of the volunteer. If the volunteer agrees, they go through a screening process to make sure they are a good fit for the trial and that the trial is safe for them. During the trial, the volunteer tells the coordinator or doctor about any medical events, including colds, broken toes, or headaches. This is also for safety, and if anything happens, the volunteer is free to stop the study or change their mind about participating. Throughout the study, the volunteer’s health is closely monitored; patient safety is always first. If a volunteer decides they no longer want to be in a clinical trial, they can withdraw from the trial at any time and will not be coerced to stay.

Before any medicine hits the market it is tested for years, with data constantly being reviewed in between trials. New medicines will go through 3 – 4 clinical trials over many years, with safety and effectiveness being the top concerns.

So, why are volunteers not guinea pigs? Guinea pigs (or any animal for that matter) don’t willingly sign up to be a part of future healthcare that could save lives. Guinea pigs are cute, fat, fuzzy, and they eat their own poop (Coprophagy). But, they do not willingly agree to be part of a trial that could save lives down the road.

So I urge you, quit using the term guinea pig for volunteers, use the term hero instead! We can’t cure diseases without heroes.

If you have volunteered for a clinical trial before, YOU ARE A HERO! If you have never participated, become a research HERO today!

Recently, I had my first experience as a clinical research volunteer. Going in, I wasn’t quite sure what to expect, but it was better than I thought!

I have Multiple Sclerosis. I also have asthma, arthritis, hypothyroidism, high blood pressure, and migraines. I live with chronic pain, I’ve had multiple surgeries, and the list goes on. With all these illnesses and conditions I need prescription medications to function on a daily basis.

I’m your average Google symptoms and side effects checker. I think it’s very important since I’m on over 10 daily medications to treat my health issues. I see multiple specialists; and I can’t expect them to research and remember all the ways those medicines interact with the others I’m already on. So I try to be smart about it.

Being a research volunteer has some bad stigmas attached to it. Some people think you might grow a second head or something! I’m here to tell you, don’t believe those outlandish tales! Without volunteers like me, the drugs I’m taking that stop horrible leg cramps or make my migraines back off- wouldn’t have made it to the pharmacy shelves.

When a friend of mine mentioned that her daughter works at Jacksonville Center for Clinical Research, for some reason that statement humanized the whole idea of prescription medications for me.

So I googled them and found they had SO many opportunities for many of the medical problems I currently have. I filled out an online form to be contacted, and a bubbly, friendly lady called me. I wasn’t even sure what to say but she dove right in talking about the different issues I mentioned on the form. She gave me an idea of what they were looking for in the studies, and I answered her questions. It was easy. In no time she had singled out a study I might be perfect for and set up an appointment. We talked through most of it over the telephone and she had it all together when I arrived. It turned out I WAS the perfect fit. It was a study that only required me to come to 3 appointments over a 6 week period and paid me $400. Wow! Did that extra cash come in handy! While I was there everyone treated me like an old friend.

I am doing my part to help put good drugs on the shelves for myself and millions of other people.

Now I know what it’s like to be a hero.

Tracy

Alzheimer’s disease is a degenerative brain disorder that was first described in 1906 by Dr. Alois Alzheimer. Since that time, Alzheimer’s disease has become the most common cause of dementia (accounting for 60-80% of cases). It is estimated that in 2016, 5.4 million American’s of all ages have Alzheimer’s disease. One in nine people age 65 and older has Alzheimer’s. JCCR has participated as a research center in clinical trials over the past several years to limit the devastating consequences of this difficult to treat disease.

The number of American’s with Alzheimer’s is anticipated to escalate rapidly with the aging of our population, with estimates ranging from 13.8 million to 16 million by 2050. This estimate assumes no medical breakthroughs to prevent or cure the disease.

Alzheimer’s is a slowly progressive brain disease that begins well before clinical symptoms emerge. The persistent accumulation of abnormal proteins in the brain lead to death of brain cells over time, which causes decline in cognitive function. Thus, a significant amount of protein accumulates in the brain over many years before a sufficient amount of brain injury has occurred to cause symptoms noticed by the patient or family/friends.

The medications currently approved by the U.S. Food and Drug Administration (FDA) for the treatment of Alzheimer’s temporarily improve symptoms by increasing the amount of specific neurotransmitters in the brain. However, they do not address the accumulation of abnormal proteins or brain cell injury and, thus, do not treat the underlying cause of the disease. The first medication approved by the FDA for the treatment of Alzheimer’s was donepezil in 1996. The last was memantine in 2003. There have been no new/novel treatments approved by the FDA for the treatment of Alzheimer’s since 2003. From 2002-2012, 244 drugs for Alzheimer’s were tested in clinical trials, and only one went on to receive FDA approval.

Currently, a worldwide quest is underway to find new treatments to stop, slow or even prevent Alzheimer’s. The last 10-years have seen tremendous growth in research on early detection, and researchers believe that early detection will be key in preventing, slowing and stopping the disease. There is a new wave of optimism in the scientific community about Alzheimer’s treatments.

As eloquently stated by Bill Thies, PhD, Senior Scientist in Residence with the Alzheimer’s Association: “Despite increasing momentum in Alzheimer’s research, we still have two main obstacles to overcome. First, we need volunteers for clinical trials. Volunteering to participate in a study is one of the greatest ways someone can help move Alzheimer’s research forward. Second, we need a significant increase in federal research funding. Investing in research now will cost our nation far less than the cost of care for the rising number of Americans who will be affected by Alzheimer’s in the coming decades.”

Here at JCCR, we understand the importance of recognizing cognitive decline and identifying Alzheimer’s in its early stages. Recent scientific breakthroughs provide hope that new treatments can prevent accumulation of abnormal proteins in the brain and markedly slow the disease. We want to help individuals and their healthcare providers identify the early signs of memory changes so that effective interventions can be initiated promptly. We want to help individuals maintain their memory function and their independence. We also want to facilitate participation in clinical trials that will help our understanding of memory disorders and lead to treatments that will help maintain memory function. We look forward to working with you and your healthcare providers.

Erin G. Doty, MD
Neurologist, Board Certified

Memory issues occur commonly and when they begin, one may worry about the onset of Alzheimer’s disease. While Alzheimer’s may cause memory loss, memory loss is also a symptom of many reversible conditions. Early memory testing is crucial to determine the cause of memory loss to help reverse it before it becomes permanent.

For example, certain over-the-counter medications have been associated with dementia. A recent study came out this month linking Benadryl to dementia. Benadryl has many uses, including allergy symptom relief. The active ingredient in Benadryl is diphenhydramine. This drug blocks the action of acetylcholine (anticholinergic effect) and is used as a sedative because it causes drowsiness. 1 Diphenhydramine is used in most over-the-counter sleeping pills, for motion sickness, and other allergy medications.

A study completed in 2015 at the University of Washington showed the longer and more consistently people took anticholinergics, the more likely they were to develop dementia. Other drugs that contain anticholinergics are used to treat diseases like asthma, incontinence, gastrointestinal cramps, and muscular spasms. They are also prescribed for depression and sleep disorders. 2

While we do not fully understand dementia, we do know that the neurotransmitter acetylcholine is important in brain processing and memory. We know that the acteylcholinesterase inhibitors (drugs like Aricept (donepezil), Exelon (rivastigmine) and Razadyne (galantamine) which inhibit the breakdown of acetylcholine, do provide symptomatic improvement in affected patients.

It would seem that taking a combination of acetylcholinesterase (cholinergic) with an anticholinergic drug (such as Benadryl) is probably not a good idea. In fact a recent study showed 16% of Alzheimer’s patients living independently were doing just that.
This 2015 study is backed up by another study that came out this month offering the most definitive proof yet, that anticholinergic drugs are linked with cognitive impairment and increased risk of dementia. Using brain imaging they found that patients taking anticholinergic drugs indeed had lower metabolisms and reduced brain sizes.

The bottom line is that given all the research evidence, you should be aware that these over-the-counter medicines may reduce the effectiveness of your prescription medicines. If you or a loved is worried about memory loss, the first step is to get tested to see if it’s from a treatable or reversible cause. Jacksonville Center for Clinical Research offers a professional memory screening for no cost to you. Make an appointment today to help put your mind at ease.

1- https://www.medicinenet.com
2- https://www.healthline.com

Incredibly, migraines are the third most prevalent disease, and the sixth most disabling disease in the world. In the US alone, 18% of women, 6 % of men, and 10 % of children experience migraines. It comes as no surprise that 1 in 4 US households include a migraine sufferer.

Why are migraines a big deal? Unlike normal episodic headaches, migraines are a chronic disease that significantly diminish quality of life. Migraines can be excruciatingly painful, debilitating, and often incapacitating for hours or even days.

Migraines have four stages: prodrome, aura, headache, and post-drome, though you may not experience all stages. Prodrome is usually one or two days prior to a migraine, you may notice changes or sensitivities that warn of an impending migraine such as: constipation, mood changes, food cravings, neck stiffness, frequent yawning, and increased thirst and urination. Auras are symptoms of the nervous system, typically visual disturbances, however they can also be sensory, motor, or verbal disturbances. Luckily, most people have migraines without aura. During the Headache attack you may experience a throbbing or pulsing pain on one or both sides of your head. Extreme sensitivity to light, sounds, smells, or touch. These can be accompanied by nausea and vomiting, blurred vision and lightheadedness. Post-drome is the final phase which lasts for about 24 hours after the headache attack. During post-drome you may feel drained, confused, moody and weak.

Once thought of as a psychological disorder, migraines are now considered a chronic neurological disease with many triggers. A trigger sets off events that excite a nerve which releases a variety of neurochemicals and causes cranial blood vessels to swell and inflame.

You’ve probably already heard about the many possible migraine triggers, but maybe you’re not quite able to nail down what’s triggering your migraines. Consider the overload of information your brain consumes daily: everything from social media, to millions of breaking news stories. Your brain literally can’t get a break from the constant intake of new information. This increase of information causes stress on the brain, which can reach an overload point and shut down the prefrontal cortex; thus triggering a migraine.

What should you do if you are experiencing migraines? The best thing to do is see your doctor. Why? If you are having true migraines, over the counter medications usually just don’t work, and taking them for migraines several times a month can lead to overuse. This will almost certainly cause rebound headaches! It’s a vicious cycle; don’t get stuck in it! Your doctor can help you figure out the right treatment for you.

Fortunately for migraine sufferers there is a bright future ahead, and I don’t mean in a bright light during a migraine attack kind of way. Clinical trials are showing promising results for new migraine treatments. You can be part of the future of migraine treatments by volunteering for a migraine clinical trial! Call today to get involved! As always, there is no cost, and no health insurance required.

Many doctors prescribe metformin to diabetic patients. Doctors trust the drug, particularly since the landmark United Kingdom Prospective Study that showed that overweight Type 2 diabetics on metformin lived longer and suffered fewer heart attacks than those with the same blood glucose levels achieved using insulin. The history of metformin provides a good example of how an unusual herb can become a powerful treatment.

Metformin originates from the plant Galega officinalis or French lilac, goat’s plant or goat’s rue. This plant was fed to goats to improve milk production. It grows as a perennial herb, 3 feet tall, with purple, blue or white flowers and was used in the Middle Ages to treat frequent urination, a side effect of diabetes. The Native American Seminole tribe used the insecticide roterone, found in the roots of Galega officinalis, in fishing. Fish were stunned by roterone, and were much easier to catch. This plant has powerful properties and is now widely considered poisonous.

Metformin was first described by scientists in 1920. Chemists found that they could make the active compound from this plant, guanidine, more tolerable to be ingested by bonding two guanidines together forming a biguanide. This compound, which could lower blood sugar, was first synthesized in 1929. However, insulin had also been discovered during this time and became the more popular option for controlling blood sugar. Metformin was neglected and ignored until 1950 when metformin was used to treat influenza. Doctors noted metformin decreased glucose levels.

In 1958, Metformin was finally released in the United Kingdom as a treatment of lowering blood sugars. This drug was clinically developed and called Glucophage (“glucose eater”). Glucophage was released in the United States in 1995 and quickly became a popular medicine. Finally after half a century, it’s potential was realized. Metformin has now become the world’s most widely prescribed anti-diabetic agent and is universally recommended as the first therapy for Type 2 diabetes.

Metformin works by lowering the rate of hepatic glucose production, which is three times higher in people with Type 2 diabetes. Probably through reduction of insulin resistance, metformin can reduce cardiac risk factors and may decrease cardiac events. Since metformin does not cause hypoglycemia (low blood sugar), it can be safely utilized in a variety of diseases such as pre-diabetes, gestational diabetes, polycystic ovary disease, sleep apnea, osteoporosis and cancers.

Metformin’s has also been noted to have a positive effect on longevity due to its anti-cancer effect. Since having Type 2 diabetes is a major risk for developing cancer (pancreas, bladder, ovary, breast, prostate, colon and liver) patients with Type 2 diabetes have a lower risk of developing these cancers if they are utilizing metformin.

This very economical and widely available medication has been shown to safely treat multiple diseases in addition to Type 2 diabetes and to improve longevity in both the diabetic and non-diabetic patient. Metformin has come a long way from its humble “roots”. Fortunately, research rediscovered this powerful perennial herb. And now metformin has ascended to being the drug of first choice for patients with Type 2 diabetes.

The word “tsunami” describes a huge wave caused by an underground disturbance. Diabetes falls under that definition in our view. According to a study in Diabetes and Endocrinology, two out of five American adults may develop Type II Diabetes in their lifetime. About 95% of US diabetics are Type II. Type II diabetes occurs due to a condition of insulin resistance. Insulin, a hormone produced in the pancreas, does not have a sufficient effect on blood sugar levels, despite high levels of production in Type II diabetics. Fortunately, thanks to clinical research, surviving this diabetic tsunami should soon become easier. New research breakthroughs may lead diabetes to “dry land.”

For those currently battling diabetes, recent technological breakthroughs may make pricking your finger a thing of the past! Researchers at Arizona State University developed a method of testing glucose through saliva. To use, one simply licks a biosensor strip. The biosensing device then uses an electrochemical analysis to calculate blood glucose levels instantly. The company overseeing the development of this technology hopes to have it on the market in the next few years.

While tracking your blood sugar should become simpler, new ways of taking your diabetes medication may help keep diabetics afloat. Scientists have developed a “smart patch” that contains live pancreatic beta cells. A “smart patch” uses a system of tiny needles – each about the size of an eyelash, to detect high blood glucose levels and automatically inject insulin when needed. The live beta cells used in the newest versions of the smart patch can control rising blood glucose levels for roughly 10 hours at a time. Since the beta cells stay outside of the body on the patch, one’s body should not reject the cells. Current testing has been successful in mice studies, but the patch has yet to be tested on humans. Maybe one day we will seek volunteers for the “smart patch” at all of our seven research sites!

Another interesting diabetes finding comes from researchers at the Ottawa Hospital. Scientists turned from puzzled to amazed when they discovered a bacteria-killing protein in the pancreas. The bacterial-killing protein called cathelicidin antimicrobial peptide (CAMP) is produced by the same cells that produce insulin. Hoping to find a link between CAMP and diabetes, they injected diabetes-prone rats with CAMP. Not only did the rats have a healthier, more regenerated pancreas, but they had an increase in beneficial gut bacteria. CAMP could be a breakthrough in diabetes treatment.

Having diabetes is a big deal, and high sugar levels are themselves often less of a risk than other associated features of diabetes. In fact complications, such as high cholesterol levels and weight gain can be more problematic. High levels of cholesterol increase your risk of having a heart attack or stroke. Weight gain leads to higher blood sugar levels, high blood pressure and arthritis in weight bearing joints. We have several studies which target these complications. Many studies targeting cholesterol are enrolling right now at any of our sites, so if you have diabetes, heart disease, or even just high cholesterol give us a call and we can find the right fit for you! We also have a diabetes study enrolling with a medication that is said to cause weight loss at our Fleming Island, St. Johns, and Inverness offices. The future of diabetes management is looking bright! These research studies and new technologies coming down the pipeline may be just the life raft you’ll need to stay afloat in the diabetic tsunami.

As each year comes and goes we seem to go through the same cycle. We end the year by reflecting on what we accomplished (or didn’t) over the course of the past year and how we can improve over the next year. Many of us set specific goals which we call our ‘New Year’s Resolutions’. These goals range from budgeting to personal growth to accomplishing a specific task. One topic we all seem to consider though is improving our own health. One person may try a new fad diet and another may set a goal to start exercising once a week. One thing most people don’t consider is participating in a clinical trial.

Why would you make participating in a clinical trial part of your New Year’s Resolution? There are many reasons that participating in a clinical trial can improve your health. In the very least people should consider participating due to the Hawthorne effect. Patients receiving individual care in a trial tend to do better than those not in a trial regardless of whether or not they receive placebo. Also, patients may improve their health by receiving new medications or feeling more compelled to take their medications regularly. The many beneficial effects of participating in a trial can combine to make a real difference!

Here at ENCORE we are thankful for the patients that have put their trust in us over the past year. Our patients make us who we are and are an integral part of the ENCORE family. Moving forward into 2017 our New Year’s Resolution is to give our patients their best experience with us yet! Our goal is to help you with your health goals. If there is something we can help you with then we would love to go on that journey with you. Happy New Year!

Written by: Dr. Jeff Jacqmein

As we are beginning to prepare for vaccine season here at ENCORE Research now is a great time to inform you of some of the recent advancements in the field. There are many vaccines in the pipeline (1) and with volunteers like you we look forward to helping bring them to market. I have selected four major developments to share with you that demonstrate how the field is evolving and the technology is improving.

Recently there has been major concern worldwide about the spread of Zika virus, which is especially worrisome to pregnant patients. The National Institutes of Health is using a piece of DNA with genes that code for Zika, but are not infective to create a new vaccine. When the vaccine is injected into the arm muscle, the body reads the genes and creates virus-like particles which the body then thinks is an infection and then mounts a complete and lasting immune response. However, this is not the only way DNA is being used in vaccine creation.

DNA cloning has transformed the vaccine development process to shorten the average vaccine approval time while increasing safety. Previously, vaccine approval took 10-15 years to progress from laboratory development to clinical trials. Researchers can now genetically engineer cows or rabbits with human DNA to gather more accurate information on safety, efficacy and potency of vaccines in pre-clinical trials. This is important because it results in a safer and more effective product reaching patients in clinical trials sooner.

Pertaining to vaccine efficacy is the third advancement I would like to share with you, which is development of new vaccine adjuvants. Adjuvants are added to a vaccine to help the recipient create a stronger and longer-lasting immune response. According to a recent article in Immune Network, there are six new classes of vaccine adjuvants in clinical development. These developments are critically important because although recent vaccines are safer, they tend to provoke a weaker immune response when compared to past inoculations for smallpox and polio. An example of this is many older people requiring a Herpes Zoster booster vaccine to prevent shingles.

Lastly, is the invention of Nanopatch technology. Historically, vaccines needed to be stored frozen or refrigerated until just prior to dosing. This requirement significantly limited vaccine distribution, especially in remote locations. Nanopatch technology, does not have the same temperature requirement making it more practical for helping end diseases in countries where refrigeration is not readily available. The skin vaccination patch contains thousands of vaccine-coated microprojections that penetrate the skin and deliver the vaccine into localized immune cells. This technology could revolutionize the field!

Although we have more tools than ever, clinical scientific progress would be stunted without you, our volunteers. While it may be in self-interest to enroll in a vaccine trial aimed at keeping your cancer in remission (2), it is an act of service to your fellow man to dedicate yourself to a typical vaccine clinical trial. Because of you, we helped to bring the meningitis B vaccine to market within two years of major college campus outbreaks (3). It is recognized that adults who receive successful vaccines help prevent the spread of contagious disease and ultimately protect those who cannot be immunized for health or other reasons. I regularly appreciate our volunteers when I am able to prescribe an FDA-approved vaccine to a private practice patient. It is truly rewarding to work together to help prevent disease.

Dr. Dan here; this month of June I am leaving my desk and going out in the field to work as a volunteer physician on several different islands. First, I will be travelling to the Republic of Vanuatu, located in the South Pacific. Luckily for me the last recorded case of cannibalism in Vanuatu occurred in 1969, so that should not be a problem! Unfortunately, mosquito borne diseases are still an endemic. Malaria is present on all the islands of Vanuatu, but fortunately for visitors there are medications for prevention and treatment.

Another mosquito borne disease is dengue which causes as many as 400 million infections per year worldwide. A “bone-crushingly” painful flu-like disease, dengue can be fatal in severe forms, especially among children. At present there is no approved vaccine in the United States. Thankfully just last year the first dengue fever vaccine got the green light in 3 countries: Mexico, the Philippines and Brazil.

More than 1.4 million cases of dengue were reported in Brazil alone in 2015. Sanofi saw the need and developed a vaccine with the help of the Jacksonville Center for Clinical Research. We enrolled multiple patients in this vaccine study here in Jacksonville. Many of you may remember taking part in this clinical trial.

Sanofi’s vaccine is designed to coax the body’s immune system into making antibodies against all four forms of dengue. It is a live virus comprised of an attenuated yellow fever virus (yellow fever and dengue viruses have the same genus). For the vaccine, however, the virus is genetically engineered to include genes encoding for dengue proteins. Other dengue vaccines are also in development but none have received approval.

It is not a perfect vaccine; in clinical trials it only reduced the chances of developing the disease by about 60 percent. From the U.S. perspective it remains unclear how a vaccine would be used domestically, whether it would be used in areas that have already seen dengue including Hawaii or Florida or perhaps among those traveling to dengue endemic countries. The Food and Drug Administration is currently reviewing the application for the approval of the vaccine in the United States. Until the vaccine is available I will need to wear a lot of DEET and long sleeves on my travels.

I am proud of the work done here at JCCR and I want you to know that when you volunteer for these vaccine studies, your contributions have worldwide effects. Hopefully you will consider being a part of our next vaccine study to help combat the deadly disease of meningitis. Contact our Jacksonville, St. Johns, or Westside office to learn more about the meningitis vaccine trial.

Three New Breakthroughs in Heart Disease

Heart Disease is a general term for heart conditions that negatively impact the heart’s ability to perform its vital functions. On average 1 in 4 American deaths each year are due to heart disease. Fortunately, each year new discoveries are made that allow us to treat heart disease more successfully. Here are three of the latest discoveries.

Dialysis for Heart Failure?

One of the symptoms of heart failure is fluid retention, which can lead to kidney

problems. Diuretics are currently the standard treatment for fluid retention, however there is a new treatment where a catheter in inserted through the neck so that it surrounds a major lymphatic vessel. The excess fluid is removed from the lymphatic system and then pumped back into the circulatory system where it is removed by the kidneys. This new treatment avoids some of the negative side effects of oral diuretics such as low blood pressure and decreased kidney function.

2. Beta Blockers: Old dog, new tricks?

A new study at York University in Toronto has analyzed the effect of beta blockers on

coronary gene expression in patients with heart failure. Researchers found that beta blockers “largely reverse the pathological pattern of gene expression observed in heart failure.” More research is needed to determine whether beta blockers can be used to protect against heart failure.

3. Tick saliva saving lives?

While ticks are often the subject of nightmares researchers now believe they can lead to a dream solution for myocarditis, heart attack and stroke. Ticks use proteins called ‘evasins’ to escape their host’s detection by blocking the host’s inflammatory response. Researchers are now isolating these evasins in a ‘bug to drug’ formula. Hopefully these drugs will be able treat a variety of inflammatory diseases.

At ENCORE Research Group we conduct cutting edge research similar to those seen above. While we do not have any ‘bug to drug’ studies at this time, we do have a heart failure study involving a new use for an already FDA approved medication. If you are interested in learning more about our current studies visit our “Enrolling Studies” tab at the top of the page.

Hot flashes and night sweats, medically known as vasomotor symptoms (VMS), are the most commonly reported menopausal symptom. A hot flash is “characterized by a sudden increase of blood flow, often to the face, neck, and chest, that causes the sensation of extreme heat and profuse sweating.” 1 Hot flashes are currently being studied around the world to better understand them. The great news for women struggling to deal with them is that answers are being found! Studies have already helped to clarify possible causes, what may trigger them, how they may relate to other health problems, how they affect quality of life, and what can be done to decrease them.

In a clinical trial of more than 3,000 midlife women, 60-80% experienced hot flashes at some point during the transition to menopause. During menopause, hormone levels fluctuate in the body, which has been shown to be associated with hot flashes. Interestingly, scientists have found that even though all women have hormone changes during their menopause years, not all women have hot flashes. Therefore, other factors must be involved, and further studies are needed.

Research has found that symptomatic women have small changes in core body temperature. This is believed to trigger the body’s mechanisms to cool the body, resulting in sweating and hot flashes. However, the promise of understanding and relieving hot flashes lies in continued research.

Women with hot flashes may be able to participate in helping to find answers which can lead to better treatments. To learn more about current clinical trial opportunities for Hot Flashes, and other conditions please contact our office.

Sources:

http://www.obgyn.net/menopause/managing-menopause-part-1-vasomotor-symptoms
NIH.gov

Writen by: Mike Mass, MD

Rheumatoid arthritis (RA) is an autoimmune disease that is localized in the joints but may also result in serious systemic symptoms. In the joints, RA begins in the lining tissue known as synovium. In RA inflammatory cells are stimulated in the synovium and release substances that will both activate other inflammatory cells and cause direct breakdown in the adjacent bone. If this inflammatory process is not interrupted it will immediately cause severe damage to the joint and, on occasion, other organs in the body.

Until recently, the only treatments available helped the symptoms of inflammation, such as pain and tenderness, but did little to stop the destructive process. The first drug that had some limited benefit was gold salts, but it was toxic and had to be monitored carefully. Low doses of a cancer drug (Methotrexate) were tried and proved effective in treating the symptoms of inflammation and also slowed down the destructive process in many patients and was a mainstay of therapy until the last decade.

As the understanding of the autoimmune abnormality increased, various substances released from inflammatory cells were identified. Initially, the most promising of these was known as tumor necrosis factor (TNF). While in other studies it had affected some tumor growth, it was also found to be a major cause of damage in RA. A group of anti-TNF monoclonal antibodies is on the market and has proven to be quite effective in a large number of patients. The search has continued for other substances that will either modify the autoimmune response or inactivate substances that cause damaging inflammation. Recently another protein has been identified that is present in the synovium and when activated will initiate a whole range of responses that result in a proliferation of synovial cells which then go on to damage the joint. This particular substance is part of a larger group of proteins known as “Integrins.” It is hoped that by giving a monoclonal antibody directed against the particular integrin a major portion of damaging inflammation will be shut down. A clinical trial of this antibody just opened at Jacksonville Center for Clinical Research University Blvd. Office and we are currently seeking volunteers. Call today to see if you qualify! 904-730-0166

If you have high cholesterol you may dread going to your doctor, especially if they are going to complete a cholesterol blood test. You know they prescribed a statin, but the muscle cramping you experience after taking it just isn’t worth it. How do you tell your doctor that the medication they prescribed just isn’t working for you? You are not alone, and there are options available for you.

We all know that having excess cholesterol in our blood is a bad thing, but why is it so bad? High cholesterol has often been called ‘The Silent Killer’. In fact, according to the CDC heart disease is responsible for 1 in 4 American deaths every year.[1] High cholesterol is known to cause plaque formation in arteries, constricting blood flow to vital organs in your body. Even worse, cholesterol plaques can become dislodged from the walls of the arteries potentially causing blood clots. Both heart attacks and strokes can be caused by plaques reaching the heart or brain respectively. If lifestyle changes such as a good diet and exercise can’t bring down your cholesterol numbers, you may need a medication. The most common cholesterol lowering medications to date are statins such as Crestor, Lipitor, or Zocor. These medicines have been life saving for many people that can tolerate them. However, some people are intolerant to statins and will experience side effects such as painful muscle cramps, inflammation and more.

If you are allergic to or can’t handle statins what can you do? It is crucial to keep your cholesterol levels down, lowering your risk for a heart attack and stroke. You may try one of the medications already on the market for people with statin intolerance such as Zetia, Juxtapid and Repatha. However, each of these drugs have their own risks. Zetia can cause symptoms similar to those caused by statins. Juxtapid, a newer medication, has been found to significantly reduce LDL bad cholesterol by 40-50%. Sadly, it also caused diarrhea, nausea, vomiting or abdominal pain in 28% of patients.[2] In 2015 the FDA approved Repatha, a new class of drug called a PCSK9 inhibitor that is very successful in lowering LDL. Unfortunately, due to the cost of development and production the annual cost is around $14,000 dollars making it unaffordable for most people.

If you’ve had trouble taking statins in the past you may be asking “what do I do now”? Many of our participants are looking for alternative treatments or want to be part of cutting edge research. I encourage you to check out the cholesterol research studies we are conducting at many of our research centers. You may qualify for a new oral medication or to receive PCSK9 in an upcoming study! The medicines being researched for people who cannot take statins may significantly alter the future of cardiovascular disease. We need your help to bring these new medications to market!

References:

[1] “Heart Disease Fact Sheet.” Centers for Disease Control and Prevention. Centers for Disease Control and Prevention, 16 June 2016. Web. 27 Apr. 2017.

[2] Orrange, Sharon, MD. “Finally, a Non-Statin Cholesterol Medication That Works: Introducing Juxtapid.” The GoodRx Prescription Savings Blog. N.p., 06 June 2014. Web. 27 Apr. 2017.

Medical progress has made the lives of folks with autoimmune conditions such as psoriasis and psoriatic arthritis (PsA) better than ever before. These conditions have been extremely difficult to treat successfully in the past. Now thanks to advancements in medicine using biological agents more people are living free of psoriasis and PsA flare ups.

Psoriasis is most commonly known for the raised, white or greyish patches that appear on the skin. These patches can progress to thick, scale-like plaques which may harden and become cracked. The severity of psoriasis is measured both by how much psoriasis a person has on their body and how much it affects their quality of life. For example, psoriasis can have a serious impact on one’s daily activities even if it involves a small area, such as the palms of the hands or soles of the feet.

Psoriatic arthritis is an inflammatory form of arthritis affecting the joints and is often accompanied by skin psoriasis. Early diagnosis and treatment of PsA can help prevent or limit extensive joint damage that occurs in later stages of the disease. Symptoms are similar to the discomfort associated with osteoarthritis (OA). One way to tell the two conditions apart is determining whether the arthritis is symmetrical or not. PsA usually affects major joints of the body symmetrically, while OA commonly affects one particular joint such as the left knee or right hip. An accurate diagnosis may require x-rays and blood tests. Once diagnosed an effective treatment plan may begin.

In the past, doctors could only treat psoriasis topically and with limited success. In the 1950’s researchers discovered methotrexate, an immune suppressant, and in the 1970’s it was approved for use in patients not responding to topical treatments. This medication and others like it are still used today, however there can be many possible side effects when suppressing the immune system. Through many years of research and clinical trials, researchers have now discovered biologics. Biologics are genetically-engineered human or animal based proteins designed to target the specific inflammatory pathways caused by psoriasis and PsA. Because of the large molecule size and complexity of biologics, they must be injected in order to be absorbed. Fortunately, injections are only needed once a month or every several months to be effective in most cases. There are several biologics currently FDA approved, however because of the recent discovery and high production costs, biologics can be extremely expensive through insurance.

At Encore Research Group, we are currently investigating many new and exciting biologic drugs for psoriasis and psoriatic arthritis. We are actively looking for qualified participants in North East Florida. Research provides participants with many great benefits. Some advantages of participating in a study include cutting-edge therapies, study-related medication at no cost and a stipend for time and travel. If you are interested in learning more about research, or our current studies please visit our website for more information. Without participants today, there won’t be new medications tomorrow!

Changes in mood are very common after childbirth. In fact, many new moms experience what is often called the baby blues, which can include mood swings, crying episodes, difficulty sleeping and anxiety. Baby blues usually only lasts up to a few weeks. However, feeling intensely depressed, overwhelmed, or anxious, could be something called postpartum depression, or PPD.

Postpartum Depression is a type of depression that can occur both during and after childbirth. It can consist of both major and minor depressive episodes and is thought to be caused by a combination of hormonal changes and fatigue due to pregnancy. Common symptoms include: feelings of sadness, hopelessness, loss of interest or pleasure, agitation or anxiety. PPD is one of the most common medical complications during pregnancy and the postpartum period. “According to the Centers for Disease Control, 11 to 20% of women who give birth each year have postpartum depression symptoms. If you settled on an average of 15% of four million live births in the US annually, this would mean approximately 600,000 women get PPD each year in the United States alone.” 1

In 58% of the women who develop PPD, the onset begins prior to delivery, with the remaining starting within 4 months of delivery. There are multiple risk factors for PPD, the most common include: a past history of depression, stress, poor social and financial support, young age, and single marital status. It is important to identify pregnant and postpartum women with depression because untreated PPD and other mood disorders can have devastating effects on women, babies, and families. Each expectant mother should be aware of the risks of PPD and should be proactive in procuring help. There are several screening tools used now by most obstetricians and hospitals on a routine basis in order to identify women with depression symptoms.

If diagnosed with PPD, there are multiple treatment options available including psychological therapy, pharmaceutical therapy or a combination of both. Presently, the pharmaceutical treatments on the market consist of either tricyclic antidepressants and/or selective serotonin reuptake inhibitors (SSRIs) such as Fluoxetine or Sertraline. We are now researching new ways to treat PPD with the hormones allopregnanolone and ganaxolone. Allopregnanolone is the neurosteroid metabolite of progesterone and is thought to play a major role in returning the body to equilibrium after trauma. Ganaxolone is the synthetic equivalent of allopregnanolone. Hopefully, these new medications will become the next golden standard to PPD care.

We are starting two new clinical trials for Postpartum Depression (PPD) with these hormones at our Jacksonville location. If you know an expectant mother or someone experiencing PPD please have them call (904)730-0166 to learn more about our clinical trial opportunities. If you live near our Nature Coast offices, please talk with your doctor and visit clinicaltrials.gov for clinical trials near you.

1: https://postpartumprogress.org/the-facts-about-postpartum-depression/

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The Role of Apolipoprotein C-III (apoC-III) in Atherosclerosis and Cardiovascular Disease

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Use a weak virus

Use a dead pathogen

Use part of a virus or bacteria

Target a dangerous product

Get the body to do the work

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Everyone should know these important signs.

The Plan

1. List your Reasons for Stopping

2. Pick a Quit Day

3. Prepare for Your Quit Day

4. Make your Quit Day Easier

EXTRA TIP: Find Clinical Trials near You

1.Memory Loss that Disrupts Daily Life

2. Difficulty Completing Normal, Daily Tasks

3. Trouble with Planning or Problem Solving

4. Confused about the Current Time or Place

5. Trouble with Vision and Depth Perception

6. Difficulty Pronouncing Words or Writing

7. Losing Important Items Often

8. Poor Judgement

9. Becoming Socially Distant

10. Mood Swings

Does Psoriasis Affect More Than Just Your Skin?

Novo Nordisk’s Wegovy (semaglutide) for weight loss

Biogen’s Aduhelm (aducanumab) for Alzheimer’s Disease

Pfizer’s PREVNAR 20 (pneumococcal 20-valent conjugate vaccine) for the prevention of pneumonia

Should I be concerned?

How is the disease treated?

Symptoms of Crohn’s Disease

Long-Term effects of Crohn’s Disease