News

GRID VIEW

No more posts
Heart-Failure.jpg

Listen to the article here:

Coming Soon

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



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


Turkey-and-Tryptophan.jpg

November 16, 2022 BlogMedEvidence

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



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.


Hawthorne-Effect-Lightbulb.jpg

Listen to the article here:


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



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


Cirrhosis-Hepatic-Encephalopathy.jpg


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



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


Variables-independent-dependent.jpg


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



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


1918-Influenza-Article.jpg

Listen to the article here:


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



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


Insulin-Resistance-The-Darkside-of-Diabetes.jpg

September 27, 2022 BlogDiabetesMedEvidence

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



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


Alzheimers-disease-Pathological-Tau-protein.jpg

Listen to the article here:


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



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


Kidney-Impariment.jpg

Listen to the article here:


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



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/


Human-Heart-EKG.jpg


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



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


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:

  1. Pro-atherogenic:  higher risk fatty deposits in the walls of arteries
  2. Pro-thrombotic:  promotes blood clots
  3. 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



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


Why-you-should-cosider-getting-a-fibroscan.jpg


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



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


Metabolic-Syndrome-When-Fat-Fights-Back.jpg


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



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


vaccines-2.jpg

Listen to the article here:


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



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


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



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


The-Fight-Against-Hypertension.jpg

Listen to the article here:


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



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


Celiac-Disease-Article.jpg


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



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.


Good-Medicine-is-only-half-the-picture.jpg

Listen to the article here:


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



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



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.


RSV.jpg


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



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


Bringing-Presbyopia-into-focus.jpg

June 12, 2022 BlogPresbyopia

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



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.


Migraine-Blog-Post-2022.jpg


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



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-Doesnt-Play-Favorites.jpg

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



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


NASH-Treatments-The-Quest-for-the-Holy-Grail.jpg

May 22, 2022 BlogNASH

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



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.


Clinical-Trials-Day-2022.jpg

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



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/


ADHD-or-Dementia.jpg

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.


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


Antibiotics.jpg


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.


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.


Glaucoma.jpg

May 1, 2022 BlogGlaucoma

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.


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.


Heartburn-NERD-GERD-4.jpg

Listen to the article here:

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!


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.


Crohns-DIsease.jpg

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


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.


Parkinsons-Blog-Post.jpg

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!

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).


Move-More.jpg

April 3, 2022 BlogExercise

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



On this month’s MedEvidence radio episode, Doctors Michael Koren, MD, Matthew Todd Braddock, DO, Jackson Downey, MD, Albert Lopez, DO and WSOS Radio Host Kevin Geddings discuss NASH, Fatty Liver, and Fibroscans.

This month’s MedEvidence! Radio will answer:

  • What is NASH?
  • What are the stages of NASH?
  • How do you treat NASH?
  • Is NASH reversible?
  • Is NASH related to cholesterol problems?

MedEvidence! Radio is a monthly live broadcast from WSOS 103.9 FM / 1170 AM with Kevin Geddings from St. Augustine, Florida. Dr. Michael Koren is a practicing cardiologist and CEO at ENCORE Research Group. He has been the principal investigator of 2000+ clinical trials while being published in the most prestigious medical journals.  Dr. Koren received his medical degree cum laude at Harvard Medical School and completed his residency in internal medicine with a fellowship in cardiology at New York Hospital/Memorial Sloan-Kettering Cancer Center/Cornell Medical Center.  On a personal note, Dr. Koren has a lifelong interest in history, technology, Public Health, and music. He has written two musical plays.


Listen to the full episode here:




Clinical Trials Day is celebrated around the world in May to recognize the day that James Lind started what is often considered the first clinical trial aboard a ship on May 20, 1747.

Here’s the story…

Also included in this month’s MedEvidence! Radio

  • Why we do Clinical Trials
  • Phases of Clinical Trials
  • Why you may want to participate in clinical trials

MedEvidence! Radio is a monthly live broadcast from WSOS 103.9 FM / 1170 AM with Kevin Geddings from St. Augustine, Florida. Dr. Michael Koren is a practicing cardiologist and CEO at ENCORE Research Group. He has been the principal investigator of 2000+ clinical trials while being published in the most prestigious medical journals.  Dr. Koren received his medical degree cum laude at Harvard Medical School and completed his residency in internal medicine with a fellowship in cardiology at New York Hospital/Memorial Sloan-Kettering Cancer Center/Cornell Medical Center.  On a personal note, Dr. Koren has a life-long interest in history, technology, Public Health, and music. He has written two musical plays.


Listen to the full episode here:


Diet-Exercise-Fatty-Liver.jpg

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-Neuropathy.jpg

March 20, 2022 BlogDiabetes

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


EoE-Blog-Post.jpg

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


Alzheimers-caregiver.jpg

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.


Blood-Pressure.jpg

February 20, 2022 BlogCardiovascular

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.





What does a diabetic educational nurse want you to know about blood sugars, and what is a cardiovascular doctor doing in the diabetes space? Let’s find out! In part 2 of the MedEvidence diabetes series, Dr. Michael Koren and Sharon Smith will discuss:

🩺  4 Main Components of Type 2 Diabetes Care
💉  Newer Classes of Diabetic Drugs
❤️  Cardiovascular Safety
🔬  New and Past Clinical Research Trials

Dr. Michael Koren is a practicing cardiologist and CEO at ENCORE Research Group. He has been the principal investigator of 2000+ clinical trials while being published in the most prestigious medical journals. Dr. Koren received his medical degree cum laude at Harvard Medical School and completed his residency in internal medicine with a fellowship in cardiology at New York Hospital / Memorial Sloan-Kettering Cancer Center/ Cornell Medical Center.

Sharon Smith, RN, CDCES, is the VP of Recruitment at ENCORE Research Group and a Diabetic Educational Nurse with a passion for educating patients as well as staff on healthy lifestyle options without giving up on special treats.


Prefer to listen to the podcast without video? You can do that below!







In honor of American Diabetes Month, we are releasing the MedEvidence! Diabetes series. In this episode, Dr. Michael Koren and Diabetic Nurse Educator, Sharon Smith explain the basics of diabetes and the history of diabetic drugs.

In this issue, you will learn:
🩺Type 1 vs Type 2

💉History of Diabetic Drugs

❤️Cardiovascular Safety

Dr. Michael Koren, is a practicing cardiologist and CEO at ENCORE Research Group. He has been the principal investigator of 2000+ clinical trials while being published in the most prestigious medical journals. Dr. Koren received his medical degree cum laude at Harvard Medical School and completed his residency in internal medicine with a fellowship in cardiology at New York Hospital / Memorial Sloan-Kettering Cancer Center/ Cornell Medical Center.


Prefer to listen to the podcast without video? You can do that below!






MedEvidence Radio is a monthly live broadcast from WSOS 103.9 FM / 1170 AM with Kevin Geddings and Dr. Michael Koren from St. Augustine, Florida. This month’s MedEvidence Radio discusses all the various viruses coming our way this season.

We will dive into:

  • RSV – Respiratory Syncytial Virus
  • COVID
  • Flu
  • Developing a virus strategy plan
  • Vaccine effects
  • Antibody levels

Dr. Michael Koren, is a practicing cardiologist and CEO at ENCORE Research Group. He has been the principal investigator of 2000+ clinical trials while being published in the most prestigious medical journals. Dr. Koren received his medical degree cum laude at Harvard Medical School and completed his residency in internal medicine with a fellowship in cardiology at New York Hospital / Memorial Sloan-Kettering Cancer Center/ Cornell Medical Center.


Prefer to listen to the podcast without video? You can do that below!





MedEvidence! Radio is a monthly live broadcast from WSOS 103.9 FM / 1170 AM with Kevin Geddings and Dr. Michael Koren from St. Augustine, Florida. This month, Dr. Erich Schramm joins the conversation in discussing whether patients benefit from clinical research and, if so how?

Dr. Michael Koren, is a practicing cardiologist and CEO at ENCORE Research Group. He has been the principal investigator of 2000+ clinical trials while being published in the most prestigious medical journals. Dr. Koren received his medical degree cum laude at Harvard Medical School and completed his residency in internal medicine with a fellowship in cardiology at New York Hospital / Memorial Sloan-Kettering Cancer Center/ Cornell Medical Center.

Dr. Erich Schramm, MD, is a board-certified family physician in Ponte Vedra, Florida, with 22 years of experience. He is currently a principal investigator with ENCORE Research Group.


Prefer to listen to the podcast without video? You can do that below!





This week’s MedEvidence podcast concludes with episode 4 of our series about MedEvidence. Dr. Koren explains the passion, goals, and need for MedEvidence a trusted resource at a time when the world is filled with misinformation.  Meet the team behind MedEvidence, where we learn how medical truths are found. What hypothesis testing is, the history of finding truth through research, and Dr. Koren’s founding of  Jacksonville Center for Clinical Research.

Dr. Michael Koren, is a practicing cardiologist and CEO at ENCORE Research Group. He has been the principal investigator of 2000+ clinical trials while being published in the most prestigious medical journals. Dr. Koren received his medical degree cum laude at Harvard Medical School and completed his residency in internal medicine with a fellowship in cardiology at New York Hospital / Memorial Sloan-Kettering Cancer Center/ Cornell Medical Center.




This week’s MedEvidence podcast continues with episode 3, where we learn how medical truths are found. What hypothesis testing is, the history of finding truth through research, and Dr. Koren’s founding of  Jacksonville Center for Clinical Research.

Dr. Michael Koren, is a practicing cardiologist and CEO at ENCORE Research Group. He has been the principal investigator of 2000+ clinical trials while being published in the most prestigious medical journals. Dr. Koren received his medical degree cum laude at Harvard Medical School and completed his residency in internal medicine with a fellowship in cardiology at New York Hospital / Memorial Sloan-Kettering Cancer Center/ Cornell Medical Center.




This week’s MedEvidence podcast continues with episode 2, where we learn a little personal history about our founder, Dr. Michael Koren. From the gas attendant’s son to Harvard Medical School to ENCORE Research Group, who is the man behind the white coat?

Dr. Michael Koren, is a practicing cardiologist and CEO at ENCORE Research Group. He has been the principal investigator of 2000+ clinical trials while being published in the most prestigious medical journals. Dr. Koren received his medical degree cum laude at Harvard Medical School and completed his residency in internal medicine with a fellowship in cardiology at New York Hospital / Memorial Sloan-Kettering Cancer Center/ Cornell Medical Center.




This MedEvidence podcast is a four-part series. MedEvidence, What Is It and Why Does the World Need It?  Michelle McCormick asked Dr. Michael Koren why he created MedEvidence and why it’s so important in a world filled with misinformation.

You will learn how MedEvidence will:

  • MedEvidence is a truth-based interface to help people make medical decisions
  • How MedEvidence will help you understand confusing claims in medical news
  • Help you decipher medical scenarios that are difficult to sort through
  • Learn more about Clinical Research

Dr. Michael Koren, is a practicing cardiologist and CEO at ENCORE Research Group. He has been the principal investigator of 2000+ clinical trials while being published in the most prestigious medical journals. Dr. Koren received his medical degree cum laude at Harvard Medical School and completed his residency in internal medicine with a fellowship in cardiology at New York Hospital / Memorial Sloan-Kettering Cancer Center/ Cornell Medical Center.




This week’s MedEvidence podcast is on Medical Marijuana. Meet Dr. Charlie Booras, former Principal Investigator at Jacksonville Center of Clinical Research, and Baptist Primary Care physician who grew his practice into Booras MD as a tribute to his father after treating his ALS with medical cannabis as a medication. Dr. Michael Koren and Dr. Booras dive into the scientific basis for the efficacy of medical cannabis.

You will learn:

        • Florida Medical Marijuana Law and Process
        • THC vs. CBD
        • Health Benefits for Medical Marijuana
        • History of Marijuana
        • Learn more about Clinical Research
        • Learn more about BoorasMD

Dr. Michael Koren, is a practicing cardiologist and CEO at ENCORE Research Group. He has been the principal investigator of 2000+ clinical trials while being published in the most prestigious medical journals. Dr. Koren received his medical degree cum laude at Harvard Medical School and completed his residency in internal medicine with a fellowship in cardiology at New York Hospital / Memorial Sloan-Kettering Cancer Center/ Cornell Medical Center.


Prefer to listen to the podcast without video? You can do that below!






This week’s MedEvidence podcast is the second episode in a two-part series on Liquid Biopsy.

In this 24-minute episode Doctors, Michael Koren and Bharat Misra discuss liquid biopsy usage now & in the future of medical evaluations.

You will learn:

Dr. Michael Koren, is a practicing cardiologist and CEO at ENCORE Research Group. He has been the principal investigator of 2000+ clinical trials while being published in the most prestigious medical journals. Dr. Koren received his medical degree cum laude at Harvard Medical School and completed his residency in internal medicine with a fellowship in cardiology at New York Hospital / Memorial Sloan-Kettering Cancer Center/ Cornell Medical Center.

Dr. Bharat Misra is the Medical Director of ENCORE Borland Groover Clinical Research and has been a Principal Investigator of numerous clinical trials. He also serves on the board of directors at Memorial Hospital and Jacksonville Center for Clinical Research in Jacksonville, Florida. He completed his residency in internal medicine and fellowship in gastroenterology at the Nassau University Medical Center, State University of New York, and his Bachelor of Medicine and Bachelor of Surgery from Gandhi Medical College in India.


Prefer to listen to the podcast without video? You can do that below!





This week’s MedEvidence podcast is a two-part series on Liquid Biopsy: What is it & Do I Need One?

In this 22-minute episode Doctors, Michael Koren and Bharat Misra explain liquid biopsies and conditions that are subject to evaluations with liquid biopsies.

You will learn

Dr. Michael Koren, is a practicing cardiologist and CEO at ENCORE Research Group. He has been the principal investigator of 2000+ clinical trials while being published in the most prestigious medical journals. Dr. Koren received his medical degree cum laude at Harvard Medical School and completed his residency in internal medicine with a fellowship in cardiology at New York Hospital / Memorial Sloan-Kettering Cancer Center/ Cornell Medical Center.

Dr. Bharat Misra is the Medical Director of ENCORE Borland Groover Clinical Research and has been a Principal Investigator of numerous clinical trials. He also serves on the board of directors at Memorial Hospital and Jacksonville Center for Clinical Research in Jacksonville, Florida. He completed his residency in internal medicine and fellowship in gastroenterology at the Nassau University Medical Center, State University of New York, and his Bachelor of Medicine and Bachelor of Surgery from Gandhi Medical College in India.


Prefer to listen to the podcast without video? You can do that below!





“What New with the Flu?”  Dr. Michael Koren, Dr. Victoria Helow, and Michelle McCormick discuss Flu and COVID.

Dr. Michael Koren, is a practicing cardiologist and CEO at ENCORE Research Group. He has been the principal investigator of 2000+ clinical trials while being published in the most prestigious medical journals. Dr. Koren received his medical degree cum laude at Harvard Medical School and completed his residency in internal medicine with a fellowship in cardiology at New York Hospital / Memorial Sloan-Kettering Cancer Center/ Cornell Medical Center.

Dr. Victoria Helow, is a well-respected pediatrician, clinical research investigator at ENCORE Research Group, and practicing emergency room physician.


Prefer to listen to the podcast without video? You can do that below!





Wrapping up this month’s MedEvidence! podcast series on “What to do after a Heart Attack or Stroke?”  Doctors, Michael Koren and Albert Lopez, DO discuss treatments, medications, and clinical research you need to know as a post-heart event patient.

You will learn:

  • Treatment therapies to use after a heart attack or stroke
  • What is Lp(a)
  • Male vs Female Symptoms
  • Cardiovascular Disease Research

Dr. Michael Koren, is a practicing cardiologist and CEO at ENCORE Research Group. He has been the principal investigator of 2000+ clinical trials while being published in the most prestigious medical journals. Dr. Koren received his medical degree cum laude at Harvard Medical School and completed his residency in internal medicine with a fellowship in cardiology at New York Hospital / Memorial Sloan-Kettering Cancer Center/ Cornell Medical Center.

Dr. Albert Lopez, DO practices Internal Medicine with Millennium Physician Group in Jacksonville, Florida. He is also a Principal Investigator with ENCORE Research Group specializing in lipid clinical trials. Dr. Lopez, DO completed his residency at the University of Pennsylvania and his Doctor of Osteopathic Medicine at Nova Southeastern University in Miami, Florida. He is known as one of the earliest evidence-based physicians in Jacksonville utilizing nutrition and lifestyle for disease prevention.
I believe in “N” of one” because “N of one” is about the patient. If it is not about the patient, then it is about nothing. – Dr. Albert Lopez, DO


Prefer to listen to the podcast without video? You can do that below!





This month’s MedEvidence! podcast is a three-part series on “What to do after a Heart Attack or Stroke?” In the first MedEvidence segment we established that people who have had either a heart attack or stroke have a high risk for a repeat procedure or event. We also discussed knowing who’s on your Heart Health Team, PCP, specialist, and family. What’s abnormal, normal, and what to do when symptoms last greater than 20 minutes? In this 15-minute episode, Doctors, Michael Koren and Albert Lopez DO discuss the Risk Factors You Need to know for your heart health.

You will learn:

      • What modifiable risk factors are
      • What non-modifiable risk factors are
      •  What you can do to help your risk factors
      • How clinical trials and research find other drug benefits
      • How to be involved in a clinical trial

Dr. Michael Koren, is a practicing cardiologist and CEO at ENCORE Research Group. He has been the principal investigator of 2000+ clinical trials while being published in the most prestigious medical journals. Dr. Koren received his medical degree cum laude at Harvard Medical School and completed his residency in internal medicine with a fellowship in cardiology at New York Hospital / Memorial Sloan-Kettering Cancer Center/ Cornell Medical Center.

Dr. Albert Lopez, DO practices Internal Medicine with Millennium Physician Group in Jacksonville, Florida. He is also a Principal Investigator with ENCORE Research Group specializing in lipid clinical trials. Dr. Lopez, DO completed his residency at the University of Pennsylvania and his Doctor of Osteopathic Medicine at Nova Southeastern University in Miami, Florida. He is known as one of the earliest evidence-based physicians in Jacksonville utilizing nutrition and lifestyle for disease prevention.
I believe in “N” of one” because “N of one” is about the patient. If it is not about the patient, then it is about nothing. – Dr. Albert Lopez, DO


Prefer to listen to the podcast without video? You can do that below!





This MedEvidence! podcast is a three-part series on “What to do after a Heart Attack or Stroke?” In this episode, Doctors, Michael Koren and Albert Lopez, DO help you identify your heart health team.

You will learn:

    • Who do I call if I think I’m having a heart attack?
    • What are my risks for another event?
    • How can my family help?
    • How to find a clinical trial

Dr. Michael Koren, is a practicing cardiologist and CEO at ENCORE Research Group. He has been the principal investigator of 2000+ clinical trials while being published in the most prestigious medical journals. Dr. Koren received his medical degree cum laude at Harvard Medical School and completed his residency in internal medicine with a fellowship in cardiology at New York Hospital / Memorial Sloan-Kettering Cancer Center/ Cornell Medical Center.

Dr. Albert Lopez, DO practices Internal Medicine with Millennium Physician Group in Jacksonville, Florida. He is also a Principal Investigator with ENCORE Research Group specializing in lipid clinical trials. Dr. Lopez, DO completed his residency at the University of Pennsylvania and his Doctor of Osteopathic Medicine at Nova Southeastern University in Miami, Florida. He is known as one of the earliest evidence-based physicians in Jacksonville utilizing nutrition and lifestyle for disease prevention.
I believe in “N” of one” because “N of one” is about the patient. If it is not about the patient, then it is about nothing. – Dr. Albert Lopez, DO


Prefer to listen to the podcast without video? You can do that below!





In this final 30-minute episode Doctors, Michael Koren and Bharat Misra dive into new treatments in clinical trials for Fatty Liver Disease and NASH.

You will learn

Dr. Michael Koren, is a practicing cardiologist and CEO at ENCORE Research Group. He has been the principal investigator of 2000+ clinical trials while being published in the most prestigious medical journals. Dr. Koren received his medical degree cum laude at Harvard Medical School and completed his residency in internal medicine with a fellowship in cardiology at New York Hospital / Memorial Sloan-Kettering Cancer Center/ Cornell Medical Center.

Dr. Bharat Misra is the Medical Director of ENCORE Borland Groover Clinical Research and has been a Principal Investigator of numerous clinical trials. He also serves on the board of directors at Memorial Hospital and Jacksonville Center for Clinical Research in Jacksonville, Florida. He completed his residency in internal medicine and fellowship in gastroenterology at the Nassau University Medical Center, State University of New York, and his Bachelor of Medicine and Bachelor of Surgery from Gandhi Medical College in India.


Prefer to listen to the podcast without video? You can do that below!





This month’s MedEvidence! Hour is a three-part series on You Cannot Live without Your Liver.   In this 14-minute Part 2 episode Doctors, Michael Koren and Bharat Misra answer your questions on Fibroscans.

  • Who should receive a Fibroscan
  • How often should I get a Fibroscan
  • Should I ask my primary doctor for a Fibroscan
  • Liver Biopsy vs. Fibroscan
  • Insurance and Fibroscan
  • What should I do after my Fibroscan
  • How to find a free Fibroscan

Dr. Michael Koren, is a practicing cardiologist and CEO at ENCORE Research Group. He has been the principal investigator of 2000+ clinical trials while being published in the most prestigious medical journals. Dr. Koren received his medical degree cum laude at Harvard Medical School and completed his residency in internal medicine with a fellowship in cardiology at New York Hospital / Memorial Sloan-Kettering Cancer Center/ Cornell Medical Center.

Dr. Bharat Misra is the Medical Director of ENCORE Borland Groover Clinical Research and has been a Principal Investigator of numerous clinical trials. He also serves on the board of directors at Memorial Hospital and Jacksonville Center for Clinical Research in Jacksonville, Florida. He completed his residency in internal medicine and fellowship in gastroenterology at the Nassau University Medical Center, State University of New York, and his Bachelor of Medicine and Bachelor of Surgery from Gandhi Medical College in India.


Prefer to listen to the podcast without video? You can do that below!





This month’s MedEvidence is a three-part series on the liver.   In this 12-minute episode Doctors, Michael Koren and Bharat Misra discuss technologies to diagnose dysfunctions of the liver.

You will learn:

  • Technologies in clinical research
  • What a fibroscan is
  • Why your doctor may not be offering you a fibroscan
  • Liver biopsy vs. MRI vs. fibroscan

Dr. Michael Koren, is a practicing cardiologist and CEO at ENCORE Research Group. He has been the principal investigator of 2000+ clinical trials while being published in the most prestigious medical journals. Dr. Koren received his medical degree cum laude at Harvard Medical School and completed his residency in internal medicine with a fellowship in cardiology at New York Hospital / Memorial Sloan-Kettering Cancer Center/ Cornell Medical Center.

Dr. Bharat Misra is the Medical Director of ENCORE Borland Groover Clinical Research and has been a Principal Investigator of numerous clinical trials. He also serves on the board of directors at Memorial Hospital and Jacksonville Center for Clinical Research in Jacksonville, Florida. He completed his residency in internal medicine and fellowship in gastroenterology at the Nassau University Medical Center, State University of New York, and his Bachelor of Medicine and Bachelor of Surgery from Gandhi Medical College in India.


Prefer to listen to the podcast without video? You can do that below!





In this episode, Dr. Michael Koren and Michelle McCormick wrap up their discussion on how clinical trials find the truth as well as truth vs. faith and the conclusion of lady tasting tea. Could she actually tell whether the milk or tea was put in first?

Dr. Michael Koren is a practicing cardiologist and CEO at ENCORE Research Group. He has been the principal investigator of 2000+ clinical trials while being published in the most prestigious medical journals. Dr. Koren received his medical degree cum laude at Harvard Medical School and completed his residency in internal medicine with a fellowship in cardiology at New York Hospital / Memorial Sloan-Kettering Cancer Center/ Cornell Medical Center.


Prefer to listen to the podcast without video? You can do that below!





In this episode, Dr. Michael Koren and Michelle McCormick walk through the history of Clinical Trials. From Biblical stories of Daniel through the smallpox pandemic to our present COVID pandemic. How far have we come and where do we go from here?

Some of what you will learn:

  • History of Clinical Research
    • Daniel and King Nebuchadnezzar
    • Newgate Prison
    • Cotton Mather & Onesimus
  • Current Vaccine Trials
    • Chickenpox
    • Shingles
    • Covid
    • Flu
    • RSV
  • Future of COVID

Dr. Michael Koren is a practicing cardiologist and CEO at ENCORE Research Group. He has been the principal investigator of 2000+ clinical trials while being published in the most prestigious medical journals. Dr. Koren received his medical degree cum laude at Harvard Medical School and completed his residency in internal medicine with a fellowship in cardiology at New York Hospital / Memorial Sloan-Kettering Cancer Center/ Cornell Medical Center.


Prefer to listen to the podcast without video? You can do that below!





In this second episode, Dr. Michael Koren, New York Central High School alumni, and Michelle McCormick take us back to high school minus having that awkward conversation about asking your date to prom.  Listen to find out what your high school classes have to do with clinical trials.

Some of what you will learn:

  • What makes a good hypothesis
  • Statistical concepts
  • Statistical methods involved in carrying out a study
  • The vocabulary of clinical research
  • History of clinical research
    • Newgate Prison
    • Daniel and King Nebuchadnezzar
    • Pepsi vs. Coke

Dr. Michael Koren is a practicing cardiologist and CEO at ENCORE Research Group. He has been the principal investigator of 2000+ clinical trials while being published in the most prestigious medical journals. Dr. Koren received his medical degree cum laude at Harvard Medical School and completed his residency in internal medicine with a fellowship in cardiology at New York Hospital / Memorial Sloan-Kettering Cancer Center/ Cornell Medical Center.


Prefer to listen to the podcast without video? You can do that below!





In a four-part series on What are Clinical Trials & Why are they important, in this first episode Dr. Michael Koren and Michelle McCormick talk about The Science of Clinical Trials, What makes a good Clinical Trial, good?

What do these things have in common?

  • R.A. Fisher
  • Lady Tasting Tea
  • Truth vs Faith
  • Experiments
  • Clinical Trials

Dr. Michael Koren, is a practicing cardiologist and CEO at ENCORE Research Group. He has been the principal investigator of 2000+ clinical trials while being published in the most prestigious medical journals. Dr. Koren received his medical degree cum laude at Harvard Medical School and completed his residency in internal medicine with a fellowship in cardiology at New York Hospital / Memorial Sloan-Kettering Cancer Center/ Cornell Medical Center.


Prefer to listen to the podcast without video? You can do that below!





In the final episode of Kicking the Nicotine Habit, It’s a Brain Thing. The MedEvidence! doctors roll out the clinical trials on Cytisinicline, an approved therapy in central and Eastern West Europe for the past 20 years.

This month Dr. Michael Koren and Michelle McCormick talk with Dr. Mitchell Rothstein, a clinical Pulmonary and Sleep Medicine physician for 30 years in the Jacksonville, Florida area.  Dr. Rothstein is the Medical Director of the Phase 1 unit at Jacksonville Center for Clinical Research.

Inside this episode:

  • Cytisinicline
  • Alpha4beta2 Nicotine Receptor
  • Clinical Trials to help quit smoking

Prefer to listen to the podcast without video? You can do that below!





Part 3 in a 4 part series on Kicking the Nicotine Habit, It’s a Brain Thing. The MedEvidence doctors continue their discussion on smoking while diving into nicotine replacement therapies.

This month Dr. Michael Koren and Michelle McCormick talk with Dr. Mitchell Rothstein, a clinical Pulmonary and Sleep Medicine physician for 30 years in the Jacksonville, Florida area.  Dr. Rothstein is the Medical Director of the Phase 1 unit at Jacksonville Center for Clinical Research.

Inside this episode:

  • Nicotine Replacement Therapies
  • Quit smoking medications
  • E-cigarettes & Vaping
  • IQOS – heated tobacco products

Prefer to listen to the podcast without video? You can do that below!





Part 2 in a 4 part series on Kicking the Nicotine Habit, It’s a Brain Thing. Today the doctors dive into the behavioral habits of smoking and give you 5 strategies you can start NOW.

This month Dr. Michael Koren and Michelle McCormick talk with Dr. Mitchell Rothstein, a clinical Pulmonary and Sleep Medicine physician for 30 years in the Jacksonville, Florida area.  Dr. Rothstein is the Medical Director of the Phase 1 unit at Jacksonville Center for Clinical Research.

Inside this episode:

  • Do you want to stop smoking?
  • How do you get to that point?
  • Behavioral Modification strategies
  • 5 Things you can do today to stop smoking

Prefer to listen to the podcast without video? You can do that below!





Part 1 in a 4 part series on Kicking the Nicotine Habit, It’s a Brain Thing.

This month Dr. Michael Koren and Michelle McCormick talk with Dr. Mitchell Rothstein, a clinical Pulmonary and Sleep Medicine physician for 30 years in the Jacksonville, Florida area.  Dr. Rothstein is the Medical Director of the Phase 1 unit at Jacksonville Center for Clinical Research.

Inside this episode:

  • What makes smoking harmful?
  • What makes smoking so addictive?
  • Preventable form of Cardiovascular factors

Prefer to listen to the podcast without video? You can do that below!





This month’s MedEvidence guest, Dr. Steven Toenjes, MD, a board-certified neurologist, former staff neurologist in the U.S. Navy, and an award-winning director of neurology residents at the Uniformed Services University of Health Sciences and decorated Navy veteran, joins Dr. Michael Koren and Michelle McCormick to discuss the future of Alzheimer’s research and what your gut has to do with Alzheimer’s.


Prefer to listen to the podcast without video? You can do that below!





What are all the hullabaloos about Aduhelm, the first new Alzheimer’s drug approval since 2003? This month’s MedEvidence guest, Dr. Steven Toenjes, MD, a board-certified neurologist, former staff neurologist in the U.S. Navy, and an award-winning director of neurology residents at the Uniformed Services University of Health Sciences and decorated Navy veteran joins Dr. Michael Koren and Michelle McCormick to discuss the first new Alzheimer’s drug approval since 2003 and the controversy over FDA’s approval of Biogen’s Aducanumab (Aduhelm).


Prefer to listen to the podcast without video? You can do that below!





In Part 2: Is it Alzheimer’s or Something Else? Drs. Toenjes and Koren begin by answering the popular question, “When do you know something is wrong? Followed by explaining amyloid proteins, DNA structure, Alzheimer’s therapy, and the research behind it.

Dr. Steven Toenjes, MD, a board-certified neurologist, former staff neurologist in the U.S. Navy, and an award-winning director of neurology residents at the Uniformed Services University of Health Sciences and decorated Navy veteran, joins Dr. Michael Koren and Michelle McCormick to discuss Alzheimer’s disease in a four-part series.


Prefer to listen to the podcast without video? You can do that below!





This month’s MedEvidence guest, Dr. Steven Toenjes, MD, a board-certified neurologist, former staff neurologist in the U.S. Navy, and an award-winning director of neurology residents at the Uniformed Services University of Health Sciences and decorated Navy veteran joins Dr. Michael Koren and Michelle McCormick to discuss Alzheimer’s disease in a four-part series.

With over six million Americans believed to have Alzheimer’s disease and the sixth leading cause of death in the United States, MedEvidence breaks down Dementia vs. Alzheimer’s, including diagnosis and treatments.


Prefer to listen to the podcast without video? You can do that below!





In this final episode on longevity, Dr. Michael Koren, Dr. Victoria Helow, and Michelle McCormick talk about medical research and apply its wisdom to maximize a healthy lifestyle. Topics discussed:

  • Aspirin: Doses, Purposes & Populations
  • Types of anti-inflammatories
  • Importance of Cholesterol numbers
  • RNA Technology
  • Viruses
  • Vaccines
  • Hugging vs. Handshake
  • Becoming Part of Advancing Science

Related articles:


Prefer to listen to the podcast without video? You can do that below!





What is the formula to living longer? In this third episode in our four-part series Dr. Michael Koren, Dr. Victoria Helow, and Michelle McCormick apply medical research to fish, nuts, sex, sunscreen, and more.

Related articles:


Prefer to listen to the podcast without video? You can do that below!





Can medical research help us live longer? In this four-part series Dr. Michael Koren, Dr. Victoria Helow, and Michelle McCormick discuss the relevant medical evidence and apply its wisdom to discover the secrets to longevity.

Related articles:


Prefer to listen to the podcast without video? You can do that below!





Can medical research help us live longer? In this four-part series Dr. Michael Koren, Dr. Victoria Helow, and Michelle McCormick discuss the relevant medical evidence and apply its wisdom to discover the secrets to longevity.

Related articles:


Prefer to listen to the podcast without video? You can do that below!




February 16, 2022 ENCORE NewsUncategorized

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


Heart-Disease-2020.jpg

In 2020 heart disease killed twice as many people as COVID-19 in the United States.1 Some 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


LPA-Evil-Twin.jpg

January 30, 2022 Blog

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


Quit-Smoking.jpg

January 18, 2022 BlogUncategorized

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.

 


Olpasiran-MJK.jpg

January 17, 2022 ENCORE News

Jacksonville Cardiologist and JCCR Founder, Dr. Michael Koren M.D., published as first author an article in the prestigious journal Nature Medicine about a new, first-in-class Lp(a) lowering therapy called Olpasiran.  Lp(a) is the lipoprotein that includes an LDL particle and the apolipoprotein a (protein portion that surrounds the LDL molecule) called LPA.  Olpasiran prevents the LPA gene from forming apolipoprotein a; therefore, Lp(a) is not made.

Lipoprotein a, Lp(a), is an independent risk for cardiovascular disease.  It is associated with a higher risk of heart attack or stroke and is pro-inflammatory. There are currently no pharmacotherapies directly targeting Lp(a) available for clinical use.

Still confused? Go to https://www.nature.com/articles/s41591-021-01634-w for more details on this exciting breakthrough.

(Images from FH Foundation)

 


MedEvidence.jpg

January 4, 2022 Uncategorized

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!

 


10-Early-Signs-of-Alzheimers-Disease.jpg

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.


Vuity.jpg

December 1, 2021 ENCORE News

First FDA Approved Therapy for Presbyopia (Age-Related Blurry Near Vision)

Vuity is the first FDA-approved therapy for presbyopia, and ENCORE Research Group helped make it a success.

12/1/21- Jacksonville, FL- Nature Coast Clinical Research Crystal River (NCCR-CR), a part of ENCORE Research Group, hosted clinical trials that led to the FDA approval of VUITY™. VUITY is the first FDA-approved therapy to treat presbyopia. 

“The FDA approval of VUITY™ is so important because it treats a very common condition for anyone who is reaching 40,” Nina Smith, site manager at NCCR-CR. “We are happy to be a part of such a successful trial!”

Many adults find themselves using reading glasses, holding text further away, and increasing the font size and brightness on screens due to presbyopia. Presbyopia shows its signs nearing the age of 40 and affects over 128 million adults in the United States. 

VUITY is a once-daily eye drop prescription that works as early as 15 minutes and lasts up to 6 hours. Clinical trials have shown that it improves near-sighted vision without impacting distance vision. VUITY’s success rate prompted other clinical trials as well to treat presbyopia. ENCORE Research Group is enrolling in new VUITY studies to test the product further. See the details below for more information on participation. 

ENCORE Research Group is a premier clinical research organization with multiple research offices in Florida; three are located in Jacksonville. ENCORE Research Group sites have conducted more than 2,500 clinical trials over 24 years and have worldwide recognition for providing patients access to cutting-edge medical research. 

###

People interested in participating in a clinical research trial can visit encoredocs.com or call our headquarters office at (904) 730-0166

 

Contact: Sharon Smith

Phone: 904-730-1066

Email: ssmith@encoredocs.com


RSV-First-mRNA-Vaccine.jpg

November 18, 2021 ENCORE News

First Messenger RNA, RSV Vaccine Patient Dosed in Jacksonville, Florida

The first patient in a phase 2 study in the United States received a new, investigational Respiratory Syncytial Virus (RSV) vaccine in Jacksonville Center for Clinical Research.

11/17/2021- Jacksonville, Fl – Jacksonville Center for Clinical Research, a member of ENCORE Research Group, became the first in the United States to dose a new, investigational, Messenger RNA (mRNA), RSV vaccine to a patient in a phase 2 trial sponsored by Moderna, Inc. This helps the U.S.  become closer to finding a preventative vaccine for RSV. RSV commonly has symptoms similar to influenza, COVID, and other highly pathogenic viruses.

“It is exciting to be a part of history,” Amber DeVries, study coordinator for the trial, says. “More than anything, though, it is an important step toward finding a vaccine for a virus that can be deadly.”

RSV infection rate has been on the rise, with cases skyrocketing in the summer of 2021. The cases were increasing so rapidly that the CDC issued a Health Alert on June 10, 2021. RSV is a virus that mainly affects children and adults over 65. RSV may cause severe complications to immunocompromised people.

“We should talk about and protect ourselves from the dangers of RSV,” Dr. Michael Koren, CEO of ENCORE Research Group, says. “COVID has captured our focus and rightfully so, but RSV cases have risen and continue to increase. Teamwork from the ENCORE Research Group, Moderna, and the clinical trial participants, has brought us one step closer to eradicating this virus.”

The RSV vaccine uses the same mRNA technology as the breakthrough COVID vaccines. The mRNA technology provides real-time instructions to make the proteins necessary to help our immune system fight off RSV. Many physicians and scientists believe mRNA has significant potential to improve patients’ lives.

ENCORE Research Group is a premier clinical research organization with multiple research offices in Florida; three are located in Jacksonville. ENCORE Research Group sites have conducted more than 2,500 clinical trials over 24 years and have worldwide recognition for providing patients access to cutting-edge medical research.

 

People interested in participating in a clinical research trial can visit encoredocs.com or call our headquarters office at (904) 730-0166

 

Contact: Sharon Smith

Phone: 904-730-1066

Email: ssmith@encoredocs.com


The-Hawthorne-Effect-Facebook-Cover-1200x676.jpg

November 17, 2021 BlogClinical Trials

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!


Types-of-Psoriasis.jpg

*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.


1-e1625166255198.png

July 1, 2021 BlogPsoriasis

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

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

FDA-approved-1200x627.png

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.

Copy-of-covid-e1622829726787.png

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 


Copy-of-Diabetes-.png

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.

LPA-blog.jpg

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.


FDA-Approved-Hyperoxaluria.png

December 8, 2020 ENCORE News

We are proud to announce that the US Food and Drug Administration (FDA) has approved lumasiran (now called OXLUMO™) for the treatment of primary hyperoxaluria type 1 (PH1). PH1 is a rare disorder that affects the kidneys causing severe pain in both children and adults.

ENCORE Research Group played a significant role in the clinical development of OXLUMO™ and we could not be prouder of all of our staff. However, none of this would be possible without the commitment and heroism of our patients who dedicated their time to improve medicine.