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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


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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.


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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


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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.


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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.


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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


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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.


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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/


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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


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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.


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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.


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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.


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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.


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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).


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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



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:


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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


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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


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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


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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.


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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.




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

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[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


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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


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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


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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.

 


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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)

 


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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!

 


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

1.Memory Loss that Disrupts Daily Life 

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

2. Difficulty Completing Normal, Daily Tasks

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

3. Trouble with Planning or Problem Solving 

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

4. Confused about the Current Time or Place

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

5. Trouble with Vision and Depth Perception 

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

6. Difficulty Pronouncing Words or Writing 

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

7. Losing Important Items Often

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

8. Poor Judgement

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

9. Becoming Socially Distant

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

10. Mood Swings 

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

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

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

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


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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. 

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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


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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


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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!


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*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.


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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/

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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.

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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 


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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.

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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.


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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.


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December 7, 2020 CardiovascularCholesterol

For some patients, managing cholesterol creates a challenge. Statins are a safe and standard treatment but many people have very high levels of cholesterol that require more than statin drugs alone.  Others cannot easily tolerate statins.  Nonetheless, treating cholesterol saves lives and avoids heart attacks and strokes.

Thankfully, the future is here with new breakthroughs that can change the way we maintain healthy cholesterol levels due to continued research and clinical trial participants. We outline some of these exciting technologies below.

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. Firstly, ASOs targets the source of the disease resulting in a higher chance of success compared to therapies targeting downstream pathways. Secondly, ASOs are not metabolized by cytochrome P450 as most other drugs are. This significantly reduces the chance of one drug interacting with another drug in the body which could potentially cause more harm than good.

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, in this case the genes involved in creating cardiovascular diseases, and it has made great progress. 

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.

These technologies hold the potential to not only better manage cholesterol levels and thereby reducing heart attack and stroke risk, but many other conditions as well.

Source:

US National Library of Medicine
National Institutes of Health


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What is a Colonoscopy?

A colonoscopy is used to detect any changes in the large intestine and rectum. A long flexible tube, called a colonoscope, is inserted into the rectum during the exam. At the end of the tube is a tiny video camera that allows the provider to view the inside of the colon. 

During the colonoscopy, your provider may also remove some abnormal tissue or take tissue samples if needed. It is common practice to receive a sedative before the exam  to make you feel more comfortable, relaxed and decrease the chance of any pain.

Who Needs One and When?

Both men and women need colonoscopies around the age of 50. If you are at a high risk for developing colorectal cancer, cancer that affects the colon and the rectum, your provider may ask you to receive a colonoscopy at an earlier age.

You should reach out to your healthcare provider if you are having any symptoms of colorectal cancer because getting a colonoscopy could help prevent serious illness or even death. 

Symptoms include: 

    • Rectal bleeding
    • Dark-colored stools
    • Blood in your stool
    • Diarrhea or constipation that lasts for several days
    • Narrow stools
    • Abdominal cramps or pain
    • Unintended weight loss

Why are They Important?

There are many reasons why a colonoscopy is important. The main reason, as mentioned previously, is to test for colon cancer. Secondly, a colonoscopy investigates any problems with your intestines. If you are experiencing any abdominal pain or intestinal problems, let your doctor know beforehand. This way, your doctor can assess and find the answers to why you may be experiencing these issues. A colonoscopy also looks for abnormal tissues called polyps. A follow up colonoscopy might be necessary to remove all polyps to reduce your risk of colon cancer.

Are there any Enrolling Studies at ENCORE Research Group?

Colon cancer is the third most common cancer among men and women over the age of 50. More clinical trials are needed in order to reduce this number and save lives. If you are in need of a colonoscopy, you may qualify for an enrolling study at one of our ENCORE Research Group locations. Participating in research trials have many benefits, including free medical attention, access to new technology and the chance to move medicine forward creating a healthier nation.

Source: Borland Groover, American Cancer Society 


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October 28, 2020 Research in General

There are many reasons someone may think it’s scary to participate in a clinical trial. However, if you become more informed about how clinical trials work then those fears will vanish! Below are some common misconceptions  about clinical trial participation.

“I won’t be able to quit if I change my mind about participating.”

Many believe that once you sign the informed consent papers to participate, you are locked in until the trial is complete. This is a common misconception. Clinical trials rely on participants who volunteer. You are always able to leave a clinical trial. After you have taken an investigational injection or drug, you are allowed to leave. However, it is important to be open and honest with your clinical team about leaving the trial.

Research participants are guinea pigs.

Thinking about yourself strapped down in a lab while people poke you with needles sounds like a scene right out of a horror movie. It is far from the truth. There are strict guidelines for each clinical trial, and all require special attention to health concerns. There are also ethical and moral guidelines put in place by a committee for each trial, called the Institutional Review Board (IRB). This is a committee made up of health professionals to ensure each trial is ethical. There is a robust screening and preclinical testing process which can take up to six years to complete before a drug is ever given to a patient.

Will it Hurt?

This depends on the type of clinical trial you are participating in. Each process is different. The trials can include taking an investigational pill, undergoing a new procedures or getting an injection. One thing you can be sure of, your health will be closely monitored and you will be aware of all risks and procedures before participating in the trial. You will review and sign the “informed consent” document. This will ensure you know all the risks. The document ensures the patient knows everything involved and is free to choose whether or not to participate. If you ever feel unsure, do not be hesitant to ask your provider any questions!

Will I experience major side effects?

There is some risk when participating in a clinical trial.An investigational drug goes through a robust testing process. Before is is given to a patient, the results must suggest that it is highly likely to be safe and effective. Patients are closely monitored once given an investigational drug to ensure their safety. The informed consent and IRB both take part in ensuring the safety and ethics of every clinical trial.

 

 


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

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

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


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

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

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

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

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

 Source: Alzheimer’s News Today 


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

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

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

Digestive symptoms:

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

Non-Digestive Symptoms:

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

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

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

Source: Harvard Health, Celiac Disease Foundation 


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September 1, 2020 VaccinesVirus

The flu is a respiratory infection caused by a group of viruses. Symptoms range from mild to severe and most commonly include body aches, cough, fever, headache and sore throat. The flu is contagious, spreading through tiny droplets from a cough, sneeze or even talking. We hear about it every year in the fall and winter because the viruses tend to survive longer in those seasons.

The flu vaccine is created to protect against influenza strains A and B. Once an individual is vaccinated, the body’s immune system responds by developing antibodies that will be ready to combat future infection. It takes about two weeks after a person has been vaccinated to gain protection. It is not unusual to briefly experience mild fatigue and muscle aches soon after injection as this represents an appropriate immune response, but because the ingredients in the flu shot have been inactivated, it is not possible to get “the flu” from the vaccine.

The flu vaccine is recommended for most people over six months of age and is given every year because:

The Circulating Flu Viruses Change

Influenza viruses undergo structural antigenic change and even mutation. Each February, flu experts gather and review the data to best decide what strains are predicted to circulate in the Northern Hemisphere during the upcoming flu season. Once the top 3 or 4 strains are identified, the viruses are grown then the vaccines manufactured using varying methods to create the safest and most effective flu shot. Typically, there is at least one and usually more than one new strain coverage included each year.

Immune Protection Declines Over Time                

Over time, the antibodies created in response to that year’s vaccine begin to lose their effectiveness, though some individuals who received annual flu shots over many years maintain reserve immunity capable of preventing or softening the blow of a new infection even if challenged with a novel strain. The CDC recommends a yearly flu shot around October. Another advantage to getting the flu shot is that you are less able to carry and spread the virus to others that may have an altered immune status. Due to the fact older individuals don’t mount as robust of an immune response following vaccination, it is especially important for those over 65 years old to get the vaccine annually.

The CDC estimated that in the 2018-2019 flu season there were approximately 490,600 hospitalizations and 34,200 deaths from the flu. It’s safe to say the flu is a dangerous but preventable illness. We thank all volunteers that have contributed to now FDA approved and currently enrolling flu vaccine programs. Your participation has helped to save lives. Visit our enrolling studies page for more information as we work together to further develop the best prevention for this serious disease.

Source: Centers for Disease Control and Prevention

https://pubmed.ncbi.nlm.nih.gov/9360364/

https://www.cdc.gov/flu/prevent/keyfacts.htm

https://www.sciencedaily.com/releases/2019/03/190320110619.htm


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August 28, 2020 Gastrointestinal

What is H. pylori?

H. pylori is short for helicobacter pylori, and it is a type of bacteria that grows in the stomach and can cause infection. This infection might be a lot more common than you think. With approximately 30-40% of the United States’  population containing the bacteria, there is no question as to how important more research needs to be done to combat it.

If left untreated, H. pylori may cause peptic ulcers, gastritis, or stomach cancer. However, it often does not have any symptoms at all.

What are the signs and symptoms?

Many who contract H. pylori experience no symptoms at all, however when symptoms do occur, here is what you can expect:

  • Unexplained weight loss
  • Frequent nausea
  • Burning or ache in the stomach 
  • Excessive burping
  • Loss of appetite 
  • Excessive bloating

How do I get H. Pylori?

Contracting H. pylori is common, and even more prevalent in developing countries. Some factors may increase your risk of infection like sharing a small, crowded living space, no access to clean water, and living with someone who has H. pylori.

Some ways to reduce your risk of infection are to wash your hands before eating and after using the bathroom.  Eat food that has been properly prepared and drink clean water.

When should I see a doctor?

As a good rule of thumb, you should always see a doctor if you have worsening stomach pains. You should also see a doctor if you have:

  • Stomach pain that does not go away
  • Trouble swallowing
  • Bloody or tarry stool 
  • Vomit that is bloody or dark brown

Researchers are studying new ways to treat H. pylori infection and ENCORE Research Group is conducting some of these clinical trials. If you would like to help move research and medicine forward, visit our enrolling studies page to see clinical trials that are enrolling now in your area.

Source: U.S. National Library on Medicine, Everyday Health, American Journal of Gastroenterology


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August 13, 2020 Vaccines

Adjuvant- Adjuvant is an element used in some vaccines that helps build a stronger immune response in patients receiving the vaccine. Essentially, it adds an extra boost to the vaccine and helps it work better.

Antibody- Antibodies is a blood protein that combines with substances the body believes to be foreign, such as bacteria, viruses and other alien substances in the blood. The antibodies work to combat these foreign substances.

Antigen- An antigen is a name given to a foreign substance in the body whose presence creates an immune response in the body. A good example of the body creating an immune response is the production of antibodies.

Placebo- A placebo is a harmless pill or vaccine that is given to patients in a clinical trial as a controlled group. When given a placebo, researchers can then determine if there is a psychological effect or physical one, compared to the actual vaccine or medication.

Titer- A titer test is a simple blood test to check for the presence of certain antibodies in the bloodstream.

Vaccination- A vaccination is a treatment using a vaccine to create an immunity to a certain disease or diseases.

Vaccine- A vaccine is a substance that is used to create the production of antibodies to produce an immunity against one or more diseases in the body. It is prepared by using an agent of a disease, its products, or a synthetic substitute to act as an antigen without actually inducing the disease.

Pathogen- In a broad sense, a pathogen is anything that can produce a disease. It is anything that can cause illness to the host.

Quadrivalent– a quadrivalent is a type of vaccine that works by creating an immune response against four different antigens, or foreign substances in the body such as viruses. A popular quadrivalent is Gardasil, which protects against 4 different strains of HPV.

Egg-Based- Egg-based vaccines are vaccines that are injected into fertilized eggs and then incubated for several days. This allows the virus to replicate and then the fluid containing the virus is harvested from the egg.

Cell-based- Cell based vaccines are created from mammalian cells lines rather than egg-based. The benefit of cell-based vaccines is the ability to mass produce vaccine supplies at a quicker rate.

Recombinant Vaccine- Instead of taking a strand of the virus, a recombinant vaccine involves inserting a DNA coding of an antigen which will  stimulate an immune response from the body.

Conjugate Vaccine- This is a type of vaccine that contains a combination of weak and strong antigens. The weak antigen is paired with the strong antigen to produce a stronger immune system response from the body.

Efficacy- Efficacy is the ability for a medication or vaccine to produce the intended result. 

Immunity– When you are immune to something, it means your body has a significant amount of biological defences to avoid infection, disease, or other unwanted antigen.

Inactivated Vaccine- Can also be called a killed vaccine. An inactive vaccine consists of virus particles, bacteria, or other pathogens that have been killed by heat or chemicals. The dead cells are then introduced into the body. The immune system can still learn from the inactivated virus’s antigens and learn how to fight the live version in the future.

Investigational- During a clinical trial’s investigational phase, the drug or medical procedure in question is not yet approved for general use. However, it is undergoing phases in clinical trials in hopes to become approved.

Live Vaccine- Live vaccines are a weakened form of the antigen that causes a disease. Since the vaccines are so similar to the original disease, the body forms a long-lasting immune response.

Source: CDC, National Institutes of Health, Healthline  


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Eosinophilic Esophagitis (EoE) is a chronic, immune-mediated disorder. It occurs in approximately 1 in 10,000 people and affects people of all age groups, with males being affected more frequently. EOE is associated with food allergies or other allergens, causing eosinophils (type of white blood cell) to migrate from the bone marrow (via blood) and settle in the esophagus causing inflammation to the esophagus. No one knows exactly why EoE occurs.  People with EoE tend to have allergic conditions such asthma, seasonal allergies, allergic rhinitis, and eczema.

Symptoms of EoE:  EoE symptoms can overlap with symptoms of a condition called gastroesophageal reflux disease (GERD). Patients with EoE experience symptoms described as,

  • “feeling like food is moving slowly”
  • “feeling food going down”
  • food getting stuck in the esophagus,
  • acid reflux, chest pain, nausea, vomiting,
  • failure to thrive (children), regurgitation and esophageal strictures.

If EoE is not controlled, the eosinophils will cause damage to the esophagus. Sometimes food that gets stuck in the esophagus (food impaction) may require emergency removal.

How is EoE Diagnosed? If you have symptoms of EoE, your doctor will order a procedure called an endoscopy (EGD). An EGD is required to confirm the diagnosis and is performed by a specialist called a gastroenterologist.  Patients are sedated for this procedure and a small flexible tube with a light and camera on the tip is inserted into the patient’s mouth. During the endoscopy, several biopsies of the esophagus will be taken and sent to the laboratory for analysis under a high-power microscope. EoE is confirmed when 15 or more eosinophils per high-power field are found (≥15 Eos/hpf).

How is EoE Treated? Many patients with EoE are initially treated for GERD using a medication called a proton pump inhibitor (PPI). However, most EoE patients do no respond to anti-GERD treatment. Treatment with PPIs is given for a minimum of 8 weeks followed by a repeat EGD and biopsy. If the eosinophil count remains elevated (≥15/hpf), the diagnosis of EoE is confirmed and a different treatment is given.

Patients with EoE are often referred to an allergy specialist for evaluation. Allergy testing can be done to identify which foods are triggering the EoE.

Treatment for EoE usually includes dietary management and/or medication, or treatment on a clinical trial.

  • Dietary treatment options include:

EOE Treatment Options

  • Corticosteroids is the type of medication commonly used to treat EoE. This is often in the form of an asthma inhaler, or a nebulizer solution that patients are instructed to swallow (instead of inhaling)

EOE Commonly used Corticosteroids

  • Treatment on a Clinical Trial – currently there are no medications approved by the Food and Drug Administration (FDA) for the treatment of EoE. Clinical trials are currently underway to test new and innovative therapies to manage this disease. All clinical trials are published on-line at clinicaltrials.gov

If you have symptoms of EoE, it is important that you seek medical care and discuss your symptoms with your doctor.

You can also learn more about EoE from advocacy organizations such as Apfed (apfed.org), or by joining an on-line patient communities such as Healtheo360 (healtheo360.com).

Research is currently being conducted around the United States for this condition. Here at ENCORE Research Group we have 3 research sites with a new opportunity for people who have Eosinophilic Esophagitis. If you’re interested in learning more about this research, please contact your local research office below!

 

Jacksonville:

ENCORE Borland Groover Clinical Research

904-680-0872

Fleming Island

Fleming Island Center for Clinical Research

904-621-0390

Inverness:

Nature Coast Clinical Research

352-341-2100


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July 27, 2020 Blog

 

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

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

Should I be concerned?

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

Other symptoms include:

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

How is the disease treated?

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

Some current treatments are:

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

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

Sources: Healthline, National Library of Medicine , FootCareMD


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

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

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

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

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

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

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

Source: Medical News Today, Medline Plus


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

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

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

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

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

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

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

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

Sources: Harvard Health, Boston University School of Medicine


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We are excited to announce another FDA approved drug that was tested at ENCORE Research Group’s Nature Coast Clinical Research office In Crystal River Florida. Upneeq™, is a drug to help adults with blepharoptosis, or ptosis, which is a condition where there is an abnormal drooping of the upper eyelid causing a loss in vision. Upneeq™ is currently the only FDA approved medical treatment for drooping eyelids (ptosis).

 

For more information about this, view the full press release here:

https://www.osmotica.com/

 



June 29, 2020 BlogCOVID 19Virus

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

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

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

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

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

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

Antibodies

Source:

cdc.gov

Amgen Powerpoint


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

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

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

Ulcerative Proctitis

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

Proctosigmoiditis

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

Left-sided colitis

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

Pancolitis

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

Acute severe ulcerative colitis

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

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

Resources: Cleveland Clinic, Crohn’s and Colitis


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

Symptoms of Crohn’s Disease

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

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

Long-Term effects of Crohn’s Disease

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

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

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

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

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



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May 26, 2020 BlogPancreatitis

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

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

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

Chronic pancreatitis, if unmanaged, can lead to:

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

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

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

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

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



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What Are Triglycerides?

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

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

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

Diet and Lifestyle Changes to reduce High Triglycerides

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

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

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

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

When Healthy Lifestyle Changes Are Not Enough

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

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

Director, ENCORE Lipid Center of Excellence


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

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

Symptoms

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

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

Treatment

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

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

Source: Generic and Rare Disease Information Center, Medline Plus


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

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

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

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

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

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

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

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

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


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March 19, 2020 ENCORE News

To our ENCORE Community and Industry Partners,

ENCORE is taking the COVID-19 crisis seriously, in part by understanding that clinical trials will provide the only durable solution to this crisis and other afflictions facing our community and country.

All of our ENCORE sites are open for business for both patient and industry visits. We have added precautions to minimize the risk of virus transmission to patients and employees and to ensure that ongoing clinical trials are completed.

We have instituted more frequent and aggressive cleaning and infection control procedures. We also ask anyone with acute influenza-like symptoms or those who have been in close contact with individuals that have tested positive for COVID-19 to reschedule after following the federal guidelines for 14-day self-isolation. In taking sensible precautions, we hope our patients and industry partners will feel comfortable that our ongoing operations don’t put our community at risk…only benefit it.

We do understand some of our industry partners have implemented additional requirements for their staff and we are prepared to accommodate them remotely or virtually in order to keep projects moving forward.

Analysis of Clinicaltrials.gov shows there are nearly 80 clinical trials worldwide for investigational new treatments and vaccines in development. About 15 of those have been expanded to take place in the United States, of which, we aim to take part.

Sincerely,

Michael Koren, MD, FACC, FAPCR, CPI Medical Director and Chief Executive Officer


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March 10, 2020 BlogSleep Apnea

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

What is Sleep Apnea?

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

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

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

How is Sleep Apnea Treated?

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

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

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


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February 8, 2019 ENCORE News

JACKSONVILLE, FL – ENCORE Research Group (ERG) and Borland Groover Clinic (BGC) announced today a clinical research joint venture. Effective March 1, 2019, Borland Groover Division of Research and Jacksonville Center for Clinical Research join forces under the newly organized entity, ENCORE Borland Groover Clinical Research (EBGCR). EBGCR will participate with seven other sites in Florida under the ENCORE umbrella. The partnership will bring the best of gastroenterology care and clinical research together with the goal of maximizing clinical trial opportunities for community patients and sponsors.

“EBGCR represents a terrific opportunity for physicians within and across specialties to cooperate on world class clinical research. We believe that the new joint venture will facilitate access to trials for appropriate patients and qualified physicians” according to Dr. Michael Koren, CEO of ENCORE Research Group.

Dr. Kyle Etzkorn, CEO of BGC said, “Borland Groover Clinic provides state of the art GI care. Our research joint venture with ENCORE enables us to more broadly apply our knowledge and technology to clinical research development programs”.

The clinical research industry has become more challenging in recent years for a variety of reasons including greater regulatory scrutiny, increasing complexity of trials and the unpredictability
of the duration and success of individual projects. As Florida’s leading health providers, BGC and ERG strive to deliver easy access to the high potential, advanced, and innovative treatments offered in clinical trials.

For more information contact Cynthia Buda, RN, CCRC, EBGCR Lead at cbuda@encoredocs.com.

About ENCORE

ENCORE Research Group currently conducts research at seven locations in the State of Florida. Sites include Fleming Island Center for Clinical Research, Jacksonville Center for Clinical Research, Nature Coast Clinical Research – Crystal River, Nature Coast Clinical Research – Inverness, River City Clinical Research, St. Johns Center for Clinical Research and Westside Center for Clinical Research.  In addition, ERG has established an information technology division that conducts research training, develops software products for clinical trialists and serves as an incubator for web-based IT products that link physicians and their patients.

About Borland Groover Clinic

Over the past 70 years, Borland Groover has grown into one of Florida’s largest gastroenterology practices with more specialists, more locations and more hospital partnerships to deliver the most advanced treatments and the best possible patient care. BGC physicians provide care for more than 100,000 patients each year with digestive disorders and conditions that include inflammatory bowel disease, liver disease including hepatitis, irritable bowel syndrome, acid reflux disease, esophageal disorders and more. BGC physicians perform more than 50,000 colonoscopies a year, the only procedure used effectively for colon cancer prevention, and for diagnosing colonic disease.

Name of Press Contact: Cynthia Buda
Date: 08 Feb 2019
Phone: 904-621-0390
Email: cbuda@encoredocs.com


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August 2, 2018 ENCORE News

Register to attend our 17th annual Clinical Research Training for Physicians! This TransCelerate GCP approved course will earn you CME credits while exploring the ethical, legal, and medical nuances of being an investigator in clinical trials. The course takes place November 2nd and 3rd 2018 at the University of North Florida in Jacksonville, Florida. Visit investigatortraining.info for details on speakers, agenda, and registration.


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September 17, 2017 ENCORE News

ENCORE, now a nationally recognized research group, proudly announces the launching of the ENCORE Lipid Center of Excellence.  ENCORE stands for ENcouraging COmmunity Research and Education.  Our new Lipid Center extends our previous successes in this important area of public health.  Lipid problems account for a huge number of heart attacks, strokes and other vascular disease problems each year.

ENCORE CEO and Founder, Dr. Michael Koren, a cardiologist and renown researcher in the area of lipids, has had a long standing interest the treatment of challenging lipid disorders.  He will be leading the Center along with Lori Alexander, a Clinical Lipid Specialist and researcher who is very active with the National Lipid Association.  They both have been a part of ENCORE Research since its formation, and will be putting together resources to bring new lipid treatment studies to the Center.  Previous successes have involved major contributions in widely prescribed cholesterol drugs such as Lipitor and Crestor.

There are many exciting new medications currently being developed to treat conditions such as elevated lipoprotein (a), an important risk factor for heart disease, which will be conducted at the Lipid Center of Excellence.  These studies can offer an opportunity for the community to access cutting-edge treatments.  Join your fellow community members who have already derived educational and health awareness benefits from their participation in research studies.  Donna Toy, a wonderful, longstanding patient who has suffered many family losses from severe cholesterol problems may have said it best: “I have such peace of mind knowing that we can be helped in controlling our heart disease and learn more about our conditions with hands-on help.”

Patients can contact Sharon Smith at 904-730-0166 or Lori Alexander, Director at 904-730-0101 for more information on the Lipid Center of Excellence. Sponsors can contact Jolenne Wolfer 904-732-6683 jwolfer@encoredocs.com.


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June 22, 2016 ENCORE News

Jacksonville Center for Clinical Research (JCCR) University site has conducted over 1,000 clinical trials since 1997. Our four acre campus also houses the corporate offices for centralized site services for Encore Research Group (Our network of sites in the state of Florida). The impressive investigator panel includes more than 50 physicians conducting trials in 25 therapeutic areas. JCCR is well equipped to perform Phase 1 through Phase 4 studies, including first-in-human PK and PD protocols. Enhanced capabilities of our site include long-term stay facilities, and treadmill equipment, and an active inpatient trial team.

Management

  • Michael J. Koren, MD, FACC, CPI – Chief Executive Officer
  • Richard Smith, RN – Lead Coordinator

Facility Description

  • Multiple Bedrooms
  • Treadmill & Cardiorespiratory diagnostic capabilities room
  • Private bath with shower
  • 1 mile to emergency room
  • Full kitchen

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March 3, 2020 Virus

Our mission at ENCORE Research includes educating our community about health care news, particularly when standard media sources sensationalize the news. The coronavirus or COVID-19 story falls into this category. Patients and family members are asking, “How worried should we be?”

Our simple advice, “Don’t panic, but take sensible precautions.” Recent data, often reported incompletely, support the idea that we should think about COVID-19 as a bad strain of the flu.

New viruses are scary. Will these pathogens lead to minor nuisance illnesses like the common cold or horrible consequences like EBOLA, which kills nearly 90% of its victims? … or be more like the flu? Most people can understand and calibrate the severity of a virus based on their experience with the flu. Over the last decade, based on Center for Disease Control (CDC) statistics, the flu infects between 3-15% of all Americans each (mostly winter) season. Between 1 and 2% of flu victims require hospitalization and between 0.1 and 0.2% of victims die of complications of the illness. Death from the flu occurs mostly in infants, the very old and in folks with immune deficiency or other significant chronic illness.

For COVID-19, the initial reports of death rates of 4% in China and 10% in Iran now appear to reflect poor reporting (local officials and our media) and selective testing of patients. To make an accurate estimate of a death rate you need to know the total number of tests administered (which the media doesn’t typically report) to get a sense of whether all of the positive + tests are being captured. Otherwise, the death rate reflects what happens only to the sickest patients, those already on death’s door when they receive testing, rather than the full spectrum of disease.

As of this past weekend, we have good data to review to help us understand the true death rate of COVID-19. As of March 2, in South Korea, a hard hit country with a good healthcare system, the death rate is 0.51% (< 1%). South Korea has deployed extensive resources for testing of coronavirus. South Korea has now reported 22 deaths occurring among 4,335 patients infected by COVID-19 out more than 100,000 patients tested. The large number of tests and the relatively low number of positive tests helps us feel confident that South Korea has identified most patients with the illness, an essential part of the equation needed to determine the true death rate.

The South Korean death rate likely reflects a maximum rate of death. We suspect that the death rate will be lower in the US since we have had more warning and will intervene earlier with antiviral medications and support.

The low death rate is good news. Unfortunately, this good news has a down side. Because of the mild illness that results from infection in most folks who contract it, COVID-19 will likely spread extensively before it winds down. Ironically, there is a tradeoff between viral spread and lethality. The worst viruses, like EBOLA, kill most infected people, but do not spread widely because people get sick quickly and have far fewer contacts. With the flu or COVID-19, people may have minor symptoms that allow them to function in society and spread the virus. Governor DeSantis of Florida announced the first confirmed cases in the state on Sunday (March 1) and more cases will certainly occur, probably many more cases.

Another part of our mission at ENCORE involves helping to get new medical therapies to patients. We participate as an active research site in the medical product development system. We have already received contact about our ability to test a coronavirus vaccine in healthy patients wishing to avoid illness. These studies focus on prevention. We have assured the manufactures of the vaccines that we are poised and ready to jump in for the clinical study.

Many antiviral drugs “sit on the shelves” of pharmaceutical companies that have had proven efficacy against the SARS and MERS viruses – similar in structure but more deadly than COVID-19. We have no reason to believe that some of these drugs will not work against COVID-19, but they remain untested. At this time, since we do not have any patients with COVID-19 at our clinics, we will not participate in the treatment studies. However, if things change, we will respond.

So, what to do now?

If you would like to be on standby as a volunteer for a healthy patient vaccine study let us know. Contact – 904-730-0166 or Jaxresearch.com. In the meantime, wash your hands like crazy, keep hand sanitizer in the car and/or office, and use it at least 5 times a day during cold and flu season!

Michael J. Koren, MD, FACC, CPI


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

 

Symptoms:

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

  • Headache
  • Rash
  • Muscle pain
  • Pink eye
  • Bent posture

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

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

 

Prevention:

Prevention methods include:

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

 

Treatments:

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

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

 

References:

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

 


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February 4, 2020 BlogCardiovascular

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

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

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

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

 

References:

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


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January 7, 2020 BlogGlaucoma

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

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

 

Causes Of Glaucoma

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

 

People are more likely to develop glaucoma if they:

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

 

Current Treatments Available

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

 

Clinical Research Advancements

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

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

 

 

References:

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


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December 11, 2019 BlogCholesterol

 

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

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

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

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

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

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

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

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

 

Reference:

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

 


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November 5, 2019 BlogDermatologyPsoriasis

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

 

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

 

  1. Avoid Stressors

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

 

  1. Treat Your Skin Right

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

 

  1. Consider Participating in a Clinical Trial

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


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More than just diarrhea…

 

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

 

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

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

 

What causes Ulcerative Colitis?

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

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

 

My own immune system is giving me this disease?

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

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

 

Is there a cure?

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

 

The Good News

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

 

We look forward to talking with you!


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August 6, 2019 BlogHot Flashes

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

 

Symptoms

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

 

Causes

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

 

Complications

Nighttime hot flashes (night sweats) can wake you from sleep and, over time, can cause chronic insomnia. There is some association with hot flashes and increased risk of heart disease and bone loss.

 

Don’t suffer in silence!

Diagnosis

Your doctor can usually diagnose hot flashes based on a description of your symptoms. Your doctor might suggest blood tests to check whether you’re in menopausal transition. Before your appointment: make a list of your symptoms, how many hot flashes you have a day and how severe they are, medications, herbs, vitamins and supplements you take, including doses, questions to ask your doctor.

 

Treatment

Discuss the pros and cons of various treatments with your doctor. There are prescription and non-prescription medications available. Hot flashes subside gradually for most women, even without treatment, but it can take several years for them to stop.

 

Lifestyle and home remedies

If your hot flashes are mild you may be able to manage them with lifestyle changes without medication.  Keep cool.  Dress in layers so that you can remove clothing when you feel warm. Use a fan or air conditioner. Lower the room temperature. Sip a cold drink.  Watch what you eat and drink. Hot and spicy foods, caffeinated beverages, and alcohol can trigger hot flashes.  Relax. Meditation; slow, deep breathing; or other stress-reducing techniques may help.  Don’t smoke. Smoking is linked to increased hot flashes. as well as your risk of many serious health conditions,  Lose weight. If you’re overweight or obese, losing weight might help ease your hot flashes.

 

Mind and body approaches

A growing body of evidence suggests that certain techniques can help ease hot flashes. Mindfulness meditation: This type of meditation has you focus on what’s happening from moment to moment. Acupuncture: Some studies indicate that acupuncture might reduce the frequency and severity of hot flashes. Hypnosis: Some research indicates that hypnosis might help relieve hot flashes. Cognitive behavioral therapy: This type of talk therapy may help you cope better with hot flashes.

 

Dietary supplements

People often assume that “natural” products cause no harm. However, all supplements may have potentially harmful side effects, and supplements can also interact with medications you’re taking for other medical conditions. Always review what you’re taking with your doctor.

 

Clinical trials

Research is underway to find new and better treatments for managing hot flashes.  This may be an especially attractive option if your hot flashes are frequent and severe enough to interfere with your quality of life.  Research can give you an option other that hormone therapy, for those that wish to avoid hormones.

 

Written by: Julia Baker, RN, CCRC

Resource: www.mayoclinic.org

 

 


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July 9, 2019 BlogVirus

A contagious virus that can cause infections in the lungs and respiratory tract.

You may have heard of the respiratory syncytial virus, in fact most people encounter RSV more than once, sometimes within the same year. Throughout older childhood and most of adulthood you may catch RSV during the winter and experience symptoms similar to the common cold. Symptoms range from mild to severe and include nasal congestion, cough, fever, wheezing, lethargy, and difficulty breathing.

 

What is so concerning about RSV?

It’s known that RSV shows severe symptoms in infants. However, recent studies have seen an increasing percentage of infected older adults with severe respiratory complications requiring hospitalization and occasional fatality.

 

I’ve had RSV before, so my immune system knows how to respond.

As we age, we encounter a natural degradation of our immune systems. While you may have encountered RSV in the past, infection after 65 years of age could entail severe respiratory complications as the immune system loses its ability to fight the virus. Studies show that RSV causes approximately 170,000 hospitalizations and around 14,000 deaths per year among older adults.

 

What can I do if I get infected?

There is currently no vaccine for the prevention of RSV, and because it’s a virus, antibiotics do not work. There are some treatments available, though usually pricey and used in extreme cases if you are already hospitalized.

 

The good news is there are several new preventative vaccines currently being developed. As an ENCORE Research community member, you have access to our cutting-edge research trials and are the first to know about new research. If you are interested in getting involved in any of our research studies, call your local office today!

 

Written by: Lana Borema

 


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June 11, 2019 BlogCholesterol

You may know that having normal cholesterol levels in your blood are important for helping prevent heart attacks and strokes.  But you may not know that there is another factor in your blood work that can be just as important!  It’s a blood test you can request, and the result will tell you if it’s important for you.

 

Lipoprotein(a) is a particle in your blood which carries cholesterol, fats, and proteins. The amount your body makes is inherited and determined by the time you are born.  It does not change very much during your life and is not affected by diet or exercise.

 

Lipoprotein(a) is also known as Lp(a), L-p-a, Lipoprotein-little-a, and L-p-little-a.  Some cholesterol and Lp(a) in your blood is normal.  A high level of LDL, the bad cholesterol, increases your risk for heart attack or stroke. High levels of Lp(a) also increase your risk, even if your cholesterol numbers are normal!  About 20 percent of people, or 1 in 5, have high levels of Lp(a). This blood test is not done as part of your usual blood testing but can be requested.

 

Here are some reasons an Lp(a) blood test may be important for you: 

  •  Having high levels of LDL, even while taking medicine to treat it.
  • You or a family member have had a heart attack or stroke at an early age, men younger than 55 years old and women less than 65 years old.
  • You or a family member developed high blood pressure at an early age.
  • A family member has high Lp(a). If an adult has high Lp(a), their children have a 1 in 2 chance of inheriting it.
  • Having FH, Familial Hypercholesterolemia, an inherited condition of very high cholesterol levels.

 

Get tested, ask your nurse or doctor if you have questions.

  • Join a clinical trial.  Jacksonville Center for Clinical Research currently has an enrolling study, call 904-730-0166 for more information. If you are eligible for this study, Lp(a) testing is provided at no cost to you.
  • Ask your Doctor to order the lab test. Several labs perform it:
    • Cleveland Heart Lab / Quest
    • HDL labs
    • Boston Heart Diagnostics

 

Be aware of your personal risks.

Reach healthy goals for your cholesterol results with dietary choices, exercise, and medication if needed.

Stay healthy, stay active, exercise, eat naturally, have fun, love, laugh!

 

Written by: Julia Baker, RN, adapted from a presentation by Albert Lopez, MD


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On a sailing ship in 1747, twelve sailors who had begun the voyage feeling fine were overcome with fatigue.  Their gums were swollen and sore, making it difficult to eat.  Their teeth were falling out.  Their legs were swollen and purple from bruising.

 

Dr. James Lind was a passenger on that ship, and he set out to find the cause.  He set up what may have been the first clinical nutrition experiment.  He decided on six groups of treatments, 2 sailors in each group:

 

  1. drank one quart of cider a day
  2. gargled with sulfuric acid
  3. had two spoonfuls of vinegar, 3 times a day
  4. drank ½ pint seawater a day
  5. drank barley water
  6. ate two oranges and 1 lemon a day

 

Within six days, the sailors who ate the oranges and lemon felt better and were able to work again.  The other sailors in the experiment felt worse.  The ill sailors were suffering from a lack of vitamin C, now known as Scurvy. They had plenty of fresh fruits and vegetables when they first set out on the voyage.  But fresh foods ran out on the long voyage, and they suffered symptoms from this lack. After this finding, sailors often brought lime juice aboard ship because it could be stored longer. This is how sailors earned the nickname “limey”.

 

1747 was well before the requirement of informed consent of the patient, detailed eligibility criteria, protocols and regulations, which are a foundation of today’s clinical research.  Nevertheless, it is an interesting example of a method of discovering the best treatment for a disabling condition.

 

Scientific minds are still seeking solutions for medical problems.  Modern clinical research is strictly regulated for the safety and well-being of the research volunteer.  Great progress has been made in medical science over the last decades.  This progress could not happen without dedicated volunteers. Participation in clinical trials can be a rewarding endeavor for both investigators and volunteers alike.

 

Written by: Julia Baker, RN, CCRC

Resources:
https://askabiologist.asu.edu
https://www.umass.edu/nibble/infofile/limey.html

 

 

 


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April 9, 2019 BlogGastrointestinal

Gastroenterology is the medical specialty concerned with the structure and function of the digestive tract (also called gastrointestinal [GI] tract).  Some symptoms that can indicate disease or dysfunction of the GI tract include nausea, vomiting, weight loss, heartburn, regurgitation, abdominal pain, abdominal bloating, rectal bleeding, constipation, and diarrhea.  Digestion of food and fluids is a very complex process, so persistent symptoms may require a gastroenterologist’s evaluation to determine the cause.  Knowing the cause of symptoms can then lead to proper treatment and control or management.

 

What’s the Difference between IBS and IBD?

Irritable Bowel Syndrome (IBS)

IBS is a common GI disorder that can considerably reduce the quality of life.  It affects as many as 5%-20% of individuals worldwide.  It occurs more often in women than in men, and is more commonly diagnosed in patients younger than 50 years of age.  Symptoms range from diarrhea to constipation, or a combination of the two.  Abdominal pain or discomfort often exist alongside abdominal distension.

Diagnosis of IBS is made after obtaining a medical history, physical exam, and diagnostic testing to learn if any disease process is causing the symptoms. There is evidence to show that IBS can be a result of genetics, environment and social learning, dietary or intestinal microorganisms, low-grade inflammation and/or dysfunction of muscular movements, secretions and sensation.

Many patients with IBS ignore their symptoms, believing they are a normal part of everyday life.  The good news is that with proper diagnosis, there are ways to treat or manage the symptoms. Don’t ignore persistent symptoms, there is help available.

 

Inflammatory Bowel Disease (IBD)

IBD is not the same as IBS, and understanding the difference is important for proper treatment.  The symptoms can be the same, but the problem causing the symptoms is very different. Inflammatory bowel disease includes Crohn’s Disease (CD) and Ulcerative Colitis (UC).  Crohn’s Disease can cause inflammation through the walls of the GI tract and can affect any part of the GI tract.  Ulcerative Colitis commonly includes inflammation of the GI mucosa and is limited to the colon (large intestine). Recent research showed that some factors that can lead to IBD includes genetic susceptibility, environment, intestinal microorganisms, and immune responses. Medications are directed at treating the active inflammation, which can then decrease or control the symptoms.

 

Conclusion

Since symptoms of many GI disorders can be the same, a thorough medical history, physical exam, and proper diagnostic testing is crucial to obtaining a correct diagnosis and treatment. Open communication with your gastroenterologist and health care providers is essential to appropriate management and treatment.  Be sure to tell your doctor about symptoms that concern you and new problems that arise.  Do not hesitate to ask questions to ensure your understanding of your diagnosis and any treatment prescribed.  Being a partner in your health care can lead to a healthier, happier life!

 

Written By: Julie Baker, RN

Resource: World Journal of Gastroenterology


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March 12, 2019 BlogPneumoniaPulmonary

“Pneumonia” the old man’s friend. The most frequent “sendoff” in the pre antibiotic era. In the US infectious disease remains a leading cause of death primarily due to pneumonia. Each year the bacteria Streptococcus pneumonia (pneumococcal) disease kills thousands of adults. It is spread from person to person through, coughing, sneezing and close contact. People can carry the bacteria in their throat, nose and sinuses and show no symptoms of infection and still spread the bacteria to people who do become ill. Illness can range from upper respiratory tract infections; sinus, ears and throat to much more severe disease (invasive pneumococcal disease, IPD) defined as pneumonia, blood stream infection and meningitis. There are dozens of different types of pneumococcus that vary by polysaccharides in the capsule that surrounds them.

 

Vaccination against pneumococcal disease started in the pediatric age group and was quickly shown to be highly effective and then introduced to the adult population with similar results. It has been proven that vaccines against pneumococcus are safe and effective and DON’T CAUSE autism. Current recommendations are that adults 65 years old should receive 2 vaccines separated by at least one year. Re-vaccination with the same vaccine is generally not recommended.  PCV13 followed by PPSV23 after 1 year. The number on the vaccine tells you how many different types of pneumococcus are covered. Long term studies have shown a 75% reduction in IPD in adults after one dose of PCV13 or PPSV23 for the covered types and an overall 45% reduction against pneumococcal infections in general. Estimates for the U.S. project a vaccine related reduction of 3,000 deaths and 30,000 cases of IPD over the next 3 years.

 

Monitoring pneumococcal sub-types in the community allows us to produce more effective vaccines based on the sub-types identified. ENCORE Research Group is excited to participate in new pneumonia vaccine research! If you or someone you know may be interested in participating in our research, call our office to find out more!

 

Written By: Mitchell Rothstein, MD

 


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February 5, 2019 BlogCardiovascular

What causes a heart attack?

A heart attack (myocardial infarction) means that blood flow to the heart muscle has been decreased enough to cause damage to the heart muscle.  Some causes of blocked blood flow include blood clots, cholesterol build up, and rupture of plaque within the blood vessel.  For those who have already suffered a heart attack, it is important to reduce the risk of recurrent attacks. Research has shown that there are several steps that can be taken to help reduce the risk of recurrent heart attacks.

 

Proven things you can do to prevent heart attacks

  • Lower cholesterol
  • Lower triglycerides
  • Lower blood pressure
  • Stop smoking and avoid secondhand smoke
  • Eat fish
  • Increase physical activity as allowed by your doctor. Inactive people have nearly twice the risk of heart disease as those who are active.
  • Talk with your doctor about medicines that can decrease blood clotting

 

Medications that can reduce risk of heart attack

  • Cholesterol lowering medication, which include statins and non-statins
  • Triglyceride lowering medications
  • Medications that decrease inflammation

 

Current research is underway to study improving health after a heart attack

  • Weight loss: Heart attack is three times higher in those who are obese than in those who are lean.
  • New medications for those with unique cholesterol metabolizing problems.
  • Anti-inflammatory medications targeting inflammation in blood vessels.

 

At ENCORE Research Group we have clinical research studies for many of the risk factors mentioned above. Participating in a research study can help keep you motivated on your journey to better health. If you are interested in participating in any of our research studies, call your local office today!

 

 


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December 12, 2018 BlogResearch in General

Thank You for a Great Year!

 

As an ENCORE community member, we hope you have enjoyed hearing from us this year. Each month we strive to provide you with accurate information on health topics that are relevant to you and our enrolling studies. 2018 has been a momentous year for us and has seen complete many trials for novel medications that we believe will improve global health. We are thankful for dedicated volunteers like you that make this possible!

 

This month we would like to do something a little different and provide you with insight into clinical trials. A lack of clinical trial education is routinely cited as the number one barrier to enrolling trial participants. Clinical trials are required by the FDA to prove the safety and effectiveness of new medications and volunteer participants are necessary to complete these trials. We understand that this concept is often intimidating. However, there are several measures in place to make our trials as safe as possible, including:

  • Physicians in charge of all study activities
  • Pre-Clinical Testing
  • Institutional Review Boards (IRBs)
  • Informed Consent Forms
  • Routine Participant Labs and Clinical Assessments
  • Clinical Trial Data Safety Monitoring Boards

 

Investigational products are thoroughly studied during pre-clinical testing before the trials are designed and the first human participant is enrolled. Pharmaceutical companies spend millions of dollars to bring medications to market and they want to be nearly certain that the medication will fulfill its intended purpose. However, volunteers are needed to complete the FDA clinical trials. When designing the trial protocols, participant safety is always the number one priority!

 

Every trial is overseen by an Institutional Review Board (IRB). The purpose of the IRB is to protect the rights and welfare of human research participants. The IRB evaluates the possible risks and benefits of the trial before it is allowed to open. They are also responsible for approving the trial protocol and the informed consent. Along with the consent form, a discussion with our medical staff allows you to make an informed decision on whether or not the trial is in your best interest. Lastly, participants in the study are continuously monitored for safety and there are many tests completed during the trials to alert researchers at the first sign of potentially serious side effects. We hope that every patient that has worked with us has felt that it has been a safe and positive experience!

 

Thank you again for helping us improve global health and find new ways to treat medical ailments! 2019 is going to be another exciting year at ENCORE Research and we hope to get the chance to work with everyone reading this letter.

 

Happy Holidays,
ENCORE Research


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November 6, 2018 BlogDiabetes

If diabetes is brought up to a member of the general public, they will usually be aware that the condition affects a person’s ability to regulate their blood sugar. However, they may not realize what is involved beyond checking blood sugars and possibly injecting insulin. On the other hand, most people that have been diagnosed with diabetes know that it is a very complex condition. Uncontrolled, high blood sugar affects everything from your head to your toes! If you have been diagnosed with diabetes, it is extremely important to manage and control your blood sugars. This will help minimize and prevent complications that arise from uncontrolled diabetes.

There is a common saying that “diabetes will not kill you, but its complication will.” Excess sugar in the blood causes damage to the small blood vessels and nerves. This in turn leads to damage to various diabetic complications including:

  • Alzheimer’s Disease
  • Blindness
  • Depression
  • Diabetic nephropathy or kidney damage
  • Diabetic neuropathy or nerve damage
  • Diabetic ulcers
  • Erectile dysfunction
  • Gastroparesis

Although there is not a cure for diabetes there are many effective avenues available to help manage and prevent the complications resulting from diabetes. ENCORE Research Group is working tirelessly to find new therapies for these conditions. If you would like to experience the science firsthand and help to move medicine forward, consider volunteering for a clinical trial!



October 9, 2018 BlogGastrointestinalGERD

Is GERD just heartburn, or is it something more? Check out our PowerPoint to find out the latest information and gain some tips on how to help reduce symptoms.

 

Researchers are continuing to study GERD and new ways to treat it. Currently, some of our ENCORE research sites have new GERD research studies enrolling. If you or someone you know has GERD, and are interested in participating, call your local office to find out more!

 

Click here to view the GERD powerpoint


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Gluten Free. This has become a household term. Everyone has heard of gluten free diets, but not everyone comprehends why this distinction is necessary. For people with celiac disease, gluten can be devastating, and it is essential for food labeling to be correct. Celiac disease is an autoimmune disorder where the ingestion of gluten leads to damage in the small intestine. (1) Even ingesting minuscule quantities of gluten, such as crumbs from a toaster, can trigger intestinal damage. This damage can prevent the body from properly absorbing nutrients. Celiac disease is hereditary and is estimated to affect 1% of people worldwide.

 

There are more than 200 known symptoms of celiac disease, which can make it a nightmare to diagnose. It is estimated that there are 2.5 million undiagnosed Americans. When you mention celiac, most people think of digestive symptoms however, only around one-third of adults with the disorder experience digestive symptoms like diarrhea. Common symptoms include: fatigue, joint pain, arthritis, fatty liver, depression or anxiety, peripheral neuropathy, migraines, canker sores, and skin rash. If left untreated, Celiac disease can lead to many long-term health complications. Unfortunately, the only way to accurately diagnose celiac disease is to have an endoscopic biopsy. Once a diagnosis is made, the challenge of managing the condition begins.

 

Currently, the only effective treatment for celiac disease is to follow a strict gluten-free diet. However, the future is not bleak. Researchers from around the world are working to find effective pharmaceutical treatments. COUR Pharmaceuticals is researching a drug which aims to reprogram the body’s immune system to tolerate gluten subsequently reversing the signs and symptoms of Celiac disease.(2) Additionally, the Journal of Biological Chemistry notes that scientists have discovered a protein associated with celiac disease can be inactivated, paving the way for new treatment possibilities.(3)

References:

  1. https://celiac.org/celiac-disease/understanding-celiac-disease-2/what-is-celiac-disease/
  2. https://www.courpharma.com/pipeline-and-programs/
  3. https://www.sciencedaily.com/releases/2018/02/180223122343.htm

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The heart is vital (literally), so it’s important to keep it in tip-top shape! The rest of the body depends on the heart to deliver blood and oxygen to all its cells and organs. If the heart becomes damaged, it can lead to what is known as heart failure. Keeping your heart healthy not only involves proper diet and exercise, but also involves making sure conditions that can cause heart damage are properly managed.

 

Some conditions that can damage the heart are:

  • cardiomyopathy
  • coronary artery disease
  • diabetes
  • heart attacks
  • high blood pressure

 

During heart failure the heart is unable to pump blood effectively enough to meet the body’s demands. Because the heart cannot fulfill its primary duty, it will try to compensate by enlarging itself, increasing muscle mass or pumping faster. The body can also react by narrowing blood vessels and diverting blood away from less important tissues and organs. As heart failure worsens the compensations and symptoms begin to show.

 

Common symptoms of heart failure include: shortness of breath, fatigue, coughing, racing heart, excessive tiredness, loss of appetite, and chest pain. Risk factors for developing heart failure include diabetes, poorly controlled high blood pressure, high cholesterol, or family history of heart failure. If you think you might have symptoms of heart failure, it’s important to speak with your doctor as soon as possible.

 

There are about 5.7 million adults in the United States who have heart failure and it’s the leading cause of death in diabetics. In most cases, heart failure cannot be reversed once diagnosed. However, researchers are continuing to study ways to reverse heart failure as well as new and better ways to treat it. Currently, many of our ENCORE research sites have new heart failure research studies enrolling. If you or someone you know has heart failure, and are interested in participating, call our office to find out more!

 


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June 5, 2018 BlogInsomnia

Sleep is essential for the body to repair and restore itself. In fact, sleep is so important that humans spend approximately 30% of their lives sleeping. However, since the beginning of recorded time and undoubtedly before that, some people have struggled to sleep. Fortunately, over the last 50 years our understanding of how to improve and correct the body’s sleep systems has advanced tremendously. This research has led to new understanding of how people sleep and why about 30% of the US population struggles with sleep disorders such as insomnia.

Insomnia is defined as dissatisfaction with sleep quantity or quality associated with difficulty falling asleep or staying asleep, even when there is adequate sleep opportunity (7-8 hours). This can cause significant social or functional distress and impairment. The most common sleep disorder in the US is Insufficient Sleep Syndrome, in which sleep deprivation occurs from an inadequate amount of sleep. Insufficient Sleep Syndrome is voluntary, but unintentional, unlike insomnia. 1 A recent poll of US adults suggests an average sleep time of just over 6 hours which is 2 hours less than we were sleeping 100 years ago, however, our sleep need has remained constant.

In order to achieve quality sleep, many insomniacs often self-prescribe antihistamines and alcohol. These treatments often have negative short and long-term outcomes. The first recommended treatment is Cognitive Behavioral Therapy (CBT), but this involves a trained therapist as well as a significant time commitment. These aspects combined with the fact that it is not well reimbursed by insurance can make it prohibitive for many individuals. A more cost-efficient alternative can be self-directed computer-based programs. Traditional pharmaceutical sleep products (hypnotics) have focused on depressing the central nervous system directly, but these medications have limitations due to adverse effects such as hangover, amnesia, abuse liability and dependence.

To end on a positive note, new research is focusing on some different ways to treat insomnia. We are excited to be involved at two of our North Florida ENCORE Research Group offices. If you are interested in getting involved in any of our research studies, call your local office today!

 

  1. http://www.sleepeducation.org/sleep-disorders-by-category/hypersomnias/insufficient-sleep-syndrome

 


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January 9, 2018 BlogNASH

The liver is the second largest organ in the body.  Its function is to process everything we eat or drink and filter out any harmful substances from the blood.  When there is too much fat in one’s liver, the filtration process is interrupted and can become a health problem.

It is estimated that 25% of the world has Non-alcoholic Fatty Liver Disease (NAFLD), a precursor to NASH or Non-Alcoholic Steatohepatitis.  NASH is associated with obesity, cardiovascular disease, type 2 diabetes and metabolic syndrome. It is now the most common liver disorder in the United States and the number one reason for liver transplants.

Starting as Fatty Liver Disease and then progressing to NASH, the buildup of fat in the liver can lead to inflammation of the liver and liver cell damage.   Progression of NASH leads to fibrosis or stiffening of the liver and cirrhosis or scarring of the liver. NAFLD and NASH are both silent diseases with few symptoms even if the diseases progress to cirrhosis.

Physicians can monitor liver function blood tests a