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
Novavax vaccine – Among a subgroup of HIV-negative participants, the vaccine was 60.1% efficacy against the B.1.351 South African variant.
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?
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.
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.
US National Library of Medicine
National Institutes of Health
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.
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.
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.
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
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.
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.
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.
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!
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.
We asked, “What motivates you to participate in clinical trials?” With over 160 responses, the answer is clear. People who participate in clinical trials are dedicated to helping others by improving medicine for future generations.
We also found that very few were participating in order to receive the stipend for time and travel. This says a lot about the type of people who are willing to participate in clinical trials. They are in it for the cutting edge treatment, and the need to help others.
There is truly only one way to improve healthcare, and that is to participate in clinical trials. Thank you to everyone who responded to our survey, and everyone who participates in these trials.
Can a type of seaweed really be used to treat Alzheimer’s disease? Some scientists think so, and it’s even being tested in clinical trials today. Oligomannate is extracted from seaweed and can be used as a potential therapy for Alzheimer’s. It is being developed by Shanghai Green Valley Pharmaceuticals and is given conditional approval by China. Now, 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 most commonly leads to dementia. When a brain is healthy, there are numerous nerve cells that connect the brain to different parts of the body. These nerve cells then transfer information back and forth relaying tasks. When a person has Alzheimer’s disease, misfolded proteins, called beta-amyloid, begin to build up and form plaque. This makes it harder for the nerves cells to communicate to the brain.
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 cause 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
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:
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
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
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:
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:
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
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
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,
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.
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!
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.
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:
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:
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
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.
Although GERD is a common condition affecting over 3 million Americans per year, if left untreated, it can lead to serious medical conditions.
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
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:
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:
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
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.
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:
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.
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.
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 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
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.
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:
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:
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
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:
Chronic pancreatitis, if unmanaged, can lead to:
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
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
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.
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:
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
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:
Seeking a doctor for treatment of narcolepsy is vital, but there are lifestyle changes that can be made to manage the disease as well. Examples include maintaining a consistent sleep schedule and planning to take frequent naps throughout the day. Otherwise, treatment for narcolepsy involves medication.
With a new understanding of narcolepsy, researchers are creating different ways for treating the disorder. Some programs are experimenting with ways to increase brain levels of histamine, a brain chemical that is effective in improving alertness.
Other researchers are working on ways to improve hypocretin, which are neurotransmitters that promote wakefulness and regulate sleep. Narcolepsy coupled with cataplexy is caused by a loss of brain cells that produce these neurotransmitters. The goal is to improve narcolepsy symptoms by restoring hypocretin production in the brain.
Sources: American Academy of Sleep Medicine, Narcolepsy Network, Sleep Education, Harvard Medical
Sleep apnea affects approximately 22 million adults in the US, yet 80% of sleep apnea cases remain undiagnosed. If undiagnosed, sleep apnea could lead to cardiovascular disease and diabetes. With cardiovascular disease being the number one killer of both men and women, it is vital to be seen by a doctor for treatment.
What is Sleep Apnea?
Sleep apnea is an obstructive condition that prevents your body from receiving an adequate amount of oxygen causing interruptions in regular sleeping patterns. There are two main types of sleep apnea, obstructive and central. Obstructive sleep apnea occurs when there is a blockage in the airway. The tongue relaxes and blocks the back of the throat while sleeping.
Central sleep apnea occurs when the brain fails to communicate to the muscles to breathe.
Both of these conditions can cause the body to lose oxygen and wake up frequently throughout the night. This can result in daytime fatigue and sleepiness. Other symptoms include loud snoring, morning headaches and insomnia.
How is Sleep Apnea Treated?
The only way to properly diagnose sleep apnea is through a sleep study. Sleep studies are done at a sleep laboratory or can be taken home depending on the physician’s orders. Once diagnosed, the patient may be given a positive airway pressure (PAP) machine. This machine is worn over the mouth and pumps air through the nose and throat to ensure airways stay open. Other treatments include mouthguards to keep the tongue from blocking airways, weight loss, and avoiding sleeping on one’s back.
For best practice, always talk to your doctor if you are having trouble sleeping through the night.
Already diagnosed with sleep apnea? Consider participating in clinical research trial. It is one of the best ways to help improve medical treatments and increase the knowledge that researchers have about sleep apnea.
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
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.
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:
Rare complications can occur. Infants and elderly adults are at highest risk for:
Prevention methods include:
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!
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.
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.
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:
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.
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.
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.
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!
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.
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.
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.
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.
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.
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.
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.
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.
New medicines are now being studied with ENCORE Research to find a cure for UC. Please call for more information, or to schedule an evaluation to see if this is an option for you.
We look forward to talking with you!
Hot flashes are sudden feelings of warmth. Your skin might redden, as if you’re blushing. Hot flashes can also cause sweating, and if you lose too much body heat, you might feel chilled afterward. Although other medical conditions can cause them, hot flashes most commonly are due to menopause. Hot flashes are the most common symptom of the menopausal transition. Frequency of hot flashes can range from a few a week to several an hour. They can be mild or severe enough to interfere with qualify of life. There are a variety of treatments for particularly bothersome hot flashes.
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.
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.
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.
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.
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.
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.
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.
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.
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
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.
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.
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.
There is currently no vaccine for the prevention of RSV, and because it’s a virus, antibiotics do not work. There are some treatments available, though usually pricey and used in extreme cases if you are already hospitalized.
The good news is there are several new preventative vaccines currently being developed. As an ENCORE Research community member, you have access to our cutting-edge research trials and are the first to know about new research. If you are interested in getting involved in any of our research studies, call your local office today!
Written by: Lana Borema
You may know that having normal cholesterol levels in your blood are important for helping prevent heart attacks and strokes. But you may not know that there is another factor in your blood work that can be just as important! It’s a blood test you can request, and the result will tell you if it’s important for you.
Lipoprotein(a) is a particle in your blood which carries cholesterol, fats, and proteins. The amount your body makes is inherited and determined by the time you are born. It does not change very much during your life and is not affected by diet or exercise.
Lipoprotein(a) is also known as Lp(a), L-p-a, Lipoprotein-little-a, and L-p-little-a. Some cholesterol and Lp(a) in your blood is normal. A high level of LDL, the bad cholesterol, increases your risk for heart attack or stroke. High levels of Lp(a) also increase your risk, even if your cholesterol numbers are normal! About 20 percent of people, or 1 in 5, have high levels of Lp(a). This blood test is not done as part of your usual blood testing but can be requested.
Reach healthy goals for your cholesterol results with dietary choices, exercise, and medication if needed.
Stay healthy, stay active, exercise, eat naturally, have fun, love, laugh!
Written by: Julia Baker, RN, adapted from a presentation by Albert Lopez, MD
On a sailing ship in 1747, twelve sailors who had begun the voyage feeling fine were overcome with fatigue. Their gums were swollen and sore, making it difficult to eat. Their teeth were falling out. Their legs were swollen and purple from bruising.
Dr. James Lind was a passenger on that ship, and he set out to find the cause. He set up what may have been the first clinical nutrition experiment. He decided on six groups of treatments, 2 sailors in each group:
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
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.
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.
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.
Since symptoms of many GI disorders can be the same, a thorough medical history, physical exam, and proper diagnostic testing is crucial to obtaining a correct diagnosis and treatment. Open communication with your gastroenterologist and health care providers is essential to appropriate management and treatment. Be sure to tell your doctor about symptoms that concern you and new problems that arise. Do not hesitate to ask questions to ensure your understanding of your diagnosis and any treatment prescribed. Being a partner in your health care can lead to a healthier, happier life!
Written By: Julie Baker, RN
Resource: World Journal of Gastroenterology
“Pneumonia” the old man’s friend. The most frequent “sendoff” in the pre antibiotic era. In the US infectious disease remains a leading cause of death primarily due to pneumonia. Each year the bacteria Streptococcus pneumonia (pneumococcal) disease kills thousands of adults. It is spread from person to person through, coughing, sneezing and close contact. People can carry the bacteria in their throat, nose and sinuses and show no symptoms of infection and still spread the bacteria to people who do become ill. Illness can range from upper respiratory tract infections; sinus, ears and throat to much more severe disease (invasive pneumococcal disease, IPD) defined as pneumonia, blood stream infection and meningitis. There are dozens of different types of pneumococcus that vary by polysaccharides in the capsule that surrounds them.
Vaccination against pneumococcal disease started in the pediatric age group and was quickly shown to be highly effective and then introduced to the adult population with similar results. It has been proven that vaccines against pneumococcus are safe and effective and DON’T CAUSE autism. Current recommendations are that adults 65 years old should receive 2 vaccines separated by at least one year. Re-vaccination with the same vaccine is generally not recommended. PCV13 followed by PPSV23 after 1 year. The number on the vaccine tells you how many different types of pneumococcus are covered. Long term studies have shown a 75% reduction in IPD in adults after one dose of PCV13 or PPSV23 for the covered types and an overall 45% reduction against pneumococcal infections in general. Estimates for the U.S. project a vaccine related reduction of 3,000 deaths and 30,000 cases of IPD over the next 3 years.
Monitoring pneumococcal sub-types in the community allows us to produce more effective vaccines based on the sub-types identified. ENCORE Research Group is excited to participate in new pneumonia vaccine research! If you or someone you know may be interested in participating in our research, call our office to find out more!
Written By: Mitchell Rothstein, MD
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.
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!
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:
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.
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:
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!
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)
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.
During heart failure the heart is unable to pump blood effectively enough to meet the body’s demands. Because the heart cannot fulfill its primary duty, it will try to compensate by enlarging itself, increasing muscle mass or pumping faster. The body can also react by narrowing blood vessels and diverting blood away from less important tissues and organs. As heart failure worsens the compensations and symptoms begin to show.
Common symptoms of heart failure include: shortness of breath, fatigue, coughing, racing heart, excessive tiredness, loss of appetite, and chest pain. Risk factors for developing heart failure include diabetes, poorly controlled high blood pressure, high cholesterol, or family history of heart failure. If you think you might have symptoms of heart failure, it’s important to speak with your doctor as soon as possible.
There are about 5.7 million adults in the United States who have heart failure and it’s the leading cause of death in diabetics. In most cases, heart failure cannot be reversed once diagnosed. However, researchers are continuing to study ways to reverse heart failure as well as new and better ways to treat it. Currently, many of our ENCORE research sites have new heart failure research studies enrolling. If you or someone you know has heart failure, and are interested in participating, call our office to find out more!
Sleep is essential for the body to repair and restore itself. In fact, sleep is so important that humans spend approximately 30% of their lives sleeping. However, since the beginning of recorded time and undoubtedly before that, some people have struggled to sleep. Fortunately, over the last 50 years our understanding of how to improve and correct the body’s sleep systems has advanced tremendously. This research has led to new understanding of how people sleep and why about 30% of the US population struggles with sleep disorders such as insomnia.
Insomnia is defined as dissatisfaction with sleep quantity or quality associated with difficulty falling asleep or staying asleep, even when there is adequate sleep opportunity (7-8 hours). This can cause significant social or functional distress and impairment. The most common sleep disorder in the US is Insufficient Sleep Syndrome, in which sleep deprivation occurs from an inadequate amount of sleep. Insufficient Sleep Syndrome is voluntary, but unintentional, unlike insomnia. 1 A recent poll of US adults suggests an average sleep time of just over 6 hours which is 2 hours less than we were sleeping 100 years ago, however, our sleep need has remained constant.
In order to achieve quality sleep, many insomniacs often self-prescribe antihistamines and alcohol. These treatments often have negative short and long-term outcomes. The first recommended treatment is Cognitive Behavioral Therapy (CBT), but this involves a trained therapist as well as a significant time commitment. These aspects combined with the fact that it is not well reimbursed by insurance can make it prohibitive for many individuals. A more cost-efficient alternative can be self-directed computer-based programs. Traditional pharmaceutical sleep products (hypnotics) have focused on depressing the central nervous system directly, but these medications have limitations due to adverse effects such as hangover, amnesia, abuse liability and dependence.
To end on a positive note, new research is focusing on some different ways to treat insomnia. We are excited to be involved at two of our North Florida ENCORE Research Group offices. If you are interested in getting involved in any of our research studies, call your local office today!
The liver is the second largest organ in the body. Its function is to process everything we eat or drink and filter out any harmful substances from the blood. When there is too much fat in one’s liver, the filtration process is interrupted and can become a health problem.
It is estimated that 25% of the world has Non-alcoholic Fatty Liver Disease (NAFLD), a precursor to NASH or Non-Alcoholic Steatohepatitis. NASH is associated with obesity, cardiovascular disease, type 2 diabetes and metabolic syndrome. It is now the most common liver disorder in the United States and the number one reason for liver transplants.
Starting as Fatty Liver Disease and then progressing to NASH, the buildup of fat in the liver can lead to inflammation of the liver and liver cell damage. Progression of NASH leads to fibrosis or stiffening of the liver and cirrhosis or scarring of the liver. NAFLD and NASH are both silent diseases with few symptoms even if the diseases progress to cirrhosis.
Physicians can monitor liver function blood tests as well as abdominal ultrasounds and liver Fibroscans to determine if you are at risk of developing NAFLD and NASH. However, the only way to definitely determine of you have NASH is to perform a liver biopsy.
The most common treatment for fatty liver disease is weight loss to reduce the fat in the liver. It is estimated that losing up to 3 to 5% of your body weight can help reduce the fat in the liver. Losing 10% of body weight may help reduce inflammation and even fibrosis in the liver. Currently, there are no medications which have been approved to treat fatty liver disease; however, many are in late stage development with promising results.
To learn more about current clinical trial opportunities for fatty liver disease and NASH, please contact us.
Why do our volunteers want to participate in clinical trials? Volunteers are often motivated by a combination of several reasons. Here are 6 of the top reasons to participate.
We can’t promise relief from symptoms due to placebo and efficacy of the medication being tested. However, the Hawthorne Effect proves that patients who participate in a research trial have better outcomes than those not participating.
You might argue that to learn about a condition you can just look it up on the web, and we all do that. However, often these websites can be misleading or provide the worst-case scenario results, which don’t apply to most of us. Another option is to ask your primary physician, and that is a good thing to do. Unfortunately, physicians are often rushed or running behind and questions are forgotten. Participating in a clinical trial provides you ample one on one time with a research professional and physician so that all your questions can be answered.
When participating in a clinical trial, there is access to new cutting edge treatments that are not available yet to the public. There can even be access to medications that have been newly FDA approved, but are much too expensive to afford. Study required medications are most often provided at no cost!
Sponsors such as pharmaceutical companies, governments and foundations fund medical research through study grants. The grants fund local research sites for conducting the study so you don’t pay a thing. In fact, we don’t even ask you for your insurance information! Can you believe most studies compensate patients for time and travel?
Clinical Trials help shape the future of medicine and healthcare. Volunteer participation helps researchers discover more about health conditions and find better ways to treat them!
Having medical conditions that others don’t necessarily understand can make some people feel alienated. When involved in research, support staff understand the patient’s condition and what they may be experiencing and can provide moral and emotional support.
We will do everything we can to help find a trial that is a good fit for interested volunteers. New clinical trials are constantly enrolling so do not be discouraged if we don’t currently have the perfect trial for you. The majority of volunteers who completed a clinical trial are interested in participating in another one, so call us and find out your reason to participate!
When patients are diagnosed with an autoimmune disorder they often have many questions. How did this happen? What is happening inside me? What treatments are available? Autoimmune diseases can be extremely complex and are the subject of much current research. The immune system’s purpose is to identify and destroy threats to the body such as viruses, bacteria or parasites. However, when a person has an autoimmune disease such as Crohn’s Disease, Lupus, Sjogren’s (show-grins) syndrome the immune system becomes unable to distinguish foreign bodies from the body’s own healthy tissue. When this happens, the immune system begins to target healthy cells causing inflammation. Almost any aspect of the immune system can malfunction causing a plethora of conditions.
One such condition is Crohn’s Disease. Crohn’s is an autoimmune disease where the immune system specifically targets the gastrointestinal tract. Crohn’s can be difficult to diagnose due to the variety of symptoms associated with the disease. The symptoms vary from person to person and by which component of the GI tract is being targeted. If a doctor suspects Crohn’s Disease, diagnosis is confirmed via an upper and/or lower endoscopy. Those living with Crohn’s disease will agree that we need to find a cure ASAP!
Systemic Lupus Erythematosus(SLE) is a chronic autoimmune disease in which the immune system can cause damaging inflammation to any part of the body. Skin, joints and organs can all be affected. Flares can cause a wide variety of symptoms. Around half of those affected by lupus have what is called a butterfly rash on their face. Other common symptoms include inflammation or swelling of the joints, and fatigue.
Another inflammatory autoimmune disease is Sjogren’s Syndrome. Sjogren’s is typically identified by its most prevalent symptoms, which are dry eyes and dry mouth. These symptoms occur because the immune system targets the glands that produce saliva.1 In the past treatment has almost entirely consisted of treating the symptoms of the disease. However, new research is showing that Sjogren’s can lead to other complications and scientists are now working on specially devised treatments to nip the problem in the bud!
According to JCCR’s Steven Mathews, MD “the last generation of autoimmune treatments worked further down the mountain so to speak and focused on treating the avalanche of symptoms. Current treatments are looking at treating conditions higher up the mountain at the source and preventing the avalanche from occurring.” Richard Smith, RN elaborated that, “general immunosuppressants act like a hammer on the immune system, whereas the current drugs we are researching act like a fine scalpel only targeting the rogue immune cells.” Our mission at ENCORE Research Group has always been to help get cutting edge treatments approved by the FDA. We want to help deliver safe and effective treatments to everyone. This is only possible by conducting research studies on new investigational medications. If you are interested in taking part in one of our research studies call today.
At ENCORE Research Group it is our mission to help every patient that walks through our doors qualify for the clinical trial of their choice. Often times we get to experience the thrill of telling our patients that they successfully qualified and will soon enroll in the study. However, this is not always the case and we understand our patients’ frustration when they decide to commit to a trial only to later find out that they do not qualify. Here at ENCORE Research Group we were curious how this situation affected their thoughts about applying for future studies. This month, curiosity got the best of us and we reached out to some of our community members to find out!
Thomas recently came to Jacksonville Center for Clinical Research (JCCR) to have an evaluation for a high triglyceride and weight loss study. Fortunately for Thomas, he was not eligible for the trial because his triglyceride level was too low. Thomas stated “it’s good that I am healthy enough not to be in this research study. But they are looking at another study that I may be interested in.” As you can see, Thomas was not discouraged that he did not qualify, but optimistic that he may qualify for a different study.
We also reached out to Latasha, who is new to research, and may qualify for a study that has a waiting list for interested participants. When discussing with her how some patients are not eligible to join a trial, she stated “I would want to know why I did not qualify, but that would not prevent me from trying to get in another trial.” Fortunately for Latasha and all of our participants, ENCORE Research Group is very transparent about the screening process and explains exactly why they may have been ineligible. Hopefully she will receive a spot in the study she applied for!
Mark was passionate about participating in a Sjogren’s research trial but did not qualify. He said “it’s not unusual for someone with Sjogren’s Disease not to qualify for studies with systemic therapies if they do not have the antibodies. But when you’re sick, your driving force is to get better for yourself and your family. I tried the conventional way but it did not work for me.” After doing more research on the specific clinical trial, Mark decided to pursue the FDA Expanded Access program. “It’s a relatively new program to help people get access to new medications.” Fortunately for Mark, he had the resources and insight to look into alternative treatment options.
We also asked an experienced researcher how she saw things. Linda Gray, site manager of the Nature Coast Clinical Research site in Inverness, Florida, has many gastrointestinal (GI) studies currently enrolling. Linda acknowledges that “some of our patients are not eligible for a study because they have mild disease, and the sponsors are looking for moderate to severe disease. If the disease is not measurable enough for objective data, we will not be able to tell if we’ve reversed it or slowed the progression. Our NASH studies include a liver biopsy to determine the extent of the disease to see if the patient is eligible.” It is unfortunate that this can limit access to drugs for those in need, but we have to believe that obtaining clear and objective data will help a greater number of people in the future.
The reality is, every clinical trial is different and has unique qualifying criteria. The pharmaceutical companies that sponsor clinical trials create the criteria in order to make the strongest case possible to the FDA on the drug’s safety and efficacy. While we would love to involve every one of our community members that are interested, it is just not always possible. The good news is that all seven of our research sites are always getting new clinical trials to enroll in! So, just because you didn’t qualify the first time doesn’t mean you won’t qualify for the next one! We look forward to working with you in the ENCORE community.
As I was perusing an ancient text I came across an excerpt on the disease known as diabetes. The earliest mention of the disease I could find was by a Greek physician called Aretaeus in the first century AD. Aretaeus identified diabetes and named it after its symptoms of thirst and sweet urine. When I researched the period I was astounded to find the diagnosing physicians were called “water tasters” and would either taste the urine or see if insects were attracted to it.
My research revealed that diabetes wasn’t well understood until the 20th century. It was then that researchers discovered insulin from the pancreas helped control blood sugar levels. A few decades later in 1961 the researchers at Ames Diagnostics created the first blood sugar monitor. This monitor was called Ames Reflectance Meter and was only available in doctor’s offices and hospitals due to its cost. Around this time a pioneering man named Richard Bernstein mounted a campaign to make blood sugar monitoring at home acceptable and easy. He was so passionate about the cause, at the age of 45 he went to medical school and became an endocrinologist. His efforts here led to millions of people being able to monitor their blood sugar at home. Now information about diabetes is growing exponentially. The thought that all of this diabetes research led from tasting urine to affordable blood sugar measuring is amazing!
At ENCORE research, we are passionate about advancing health care. Without research, we wouldn’t have these advances in diabetes management!
Heart disease currently accounts for 1 in 4 deaths in the United States. However due to new research breakthroughs there are now treatments available that may finally give us the means to fight back against heart disease. Historically heart disease has always been one of America’s most serious epidemics. It has been a leading cause of death since the turn of the 20th Century. Following World War II the National Heart, Lung and Blood Institute began a long term study known as the Framingham study to identify the cause of heart disease.
The Framingham study is an enormous observational study in the town of Framingham, Massachusetts. Researchers conducted physical examinations on participants every two years to study contributing factors to heart disease and are now on their 3rd generation of participants. The Framingham study identified many of the currently known risk factors such as high blood pressure and high cholesterol. Once high cholesterol was identified as a major risk factor, researchers began developing medications to combat cholesterol levels. Some of our most exciting research at Encore Research Group is for these new cholesterol lowering medications such as PCSK9 inhibitors.
PCSK9 inhibitors are an amazing class of drugs that allow us to lower LDL or “bad cholesterol” to previously unachievable levels. These drugs are usually injectable and have many advantages over traditional statin drugs. One such advantage is we are not seeing the muscle cramping associated with statin therapy. This is truly a breakthrough.
How low is too low? It is a question that researchers are actively addressing. So far we have not seen complications or health risks as a result of very low LDL. Some large studies that Encore Research has participated in will be releasing their results within the next year to more definitively answer this question. For now, there are many patients that have cholesterol levels that are difficult to budge but may respond to these new therapies.
Currently we are studying the effects of PCSK9 drugs in high risk populations such as diabetics. If you have high cholesterol levels that are not being adequately managed by your current medications, we may be able to help you get involved in a research study that may help get you back on track! As many of our readers know, most research studies offer access to medication at no cost to patients. Call us to find out how you can get involved today!
 CDC, NCHS. Underlying Cause of Death 1999-2013 on CDC WONDER Online Database, released 2015. Data are from the Multiple Cause of Death Files, 1999-2013, as compiled from data provided by the 57 vital statistics jurisdictions through the Vital Statistics Cooperative Program. Accessed Feb. 3, 2015.
Growing up, we’ve all heard the saying, “An apple a day, keeps the doctor away” and in most cases, an apple is a great fruit to eat! However, if you have Crohn’s Disease that might not always be the case. Those afflicted with Crohn’s Disease actually have to peel the skin off of fruits and vegetables with edible skin, however delicious it may be! The skin is an insoluble fiber that can aggravate Crohn’s symptoms causing more gas, bloating, diarrhea and pain. In severe cases, can even cause blockages.
The cause of Crohn’s Disease is still unknown. Scientists believe the cause to be a mixture of environmental, and genetic factors. Crohn’s Disease causes inflammation of the wall of the gastrointestinal (GI) tract. The GI tract is continuous starting at the mouth and ending at the anus. An interesting fact about the GI tract is, it can be considered to be outside of the body. The body changes the environment of the GI tract to be conductive to digesting and absorbing food to the inside of the body. If we followed the journey of the apple discussed earlier after masticating and swallowing the apple is moved down the esophagus, and into the stomach where it will be digested. Next the apple will pass through a sphincter and into the small intestine where the nutrients from the apple will be absorbed. Crohn’s most commonly occurs in the small intestine and during a flare up it is difficult to absorb necessary nutrients before the bolus is moved to the large intestine.
While the small intestine is most commonly affected, with Crohn’s, any part of the GI tract explained above can be affected. The inflammation caused by Crohn’s produces flare ups and can lead to many uncomfortable symptoms. A few of which are: diarrhea, pain, unintentional weight loss, ulcers, malaise, anemia, and anal fissures.
Research has produced many significant advances for Crohn’s Disease, but there are still many unanswered questions. Our research sites are devoted to finding answers to those pressing questions and providing a better outlook for the future of Crohn’s health management. You can be an integral part of shaping the path for future medicine, by participating in a clinical trial.
The practice of medicine has changed in major ways in recent years. Though many of these changes reflect good intentions, the real world consequences to patients often don’t match expectations. To understand this divide between reasonable intentions and the less salubrious reality from which we may collectively suffer, I’d like to share a recent anecdote that occurred at the airport when regulations ran amok.
During recent travel, I witnessed an unfortunate incident that you may have seen before. An airline gate agent stopped a member of our party and reprimanded her for carrying a small overnight suitcase, a computer bag and her pocketbook. The gate agent, working on behalf of the airline, stated that she had to follow FAA (Federal Aviation Authority) rules and only allow two bags on board even though the computer bag and pocket book were small. Unfortunately, when asked to “consolidate” the three bags into two, we had a problem. No bag really fit into any of the other bags. The agent wouldn’t “gate check” any of the bags so that we could pick it up when exiting the plane and running off to our next flight. Further, our discussion with the gate agent failed to alleviate our concern that, if checked to its “final destination,” we wouldn’t see a checked piece of luggage any time soon given the shortness of time for our connection.
The solution that followed satisfied no one. Over the next 10 minutes, embarking passengers stepped around the contents of the three bags which littered the entrance to the Jetway. At first, the gate agents ignored the situation, but as tempers flared due to the obstruction of foot traffic, an agent “helped” by aggressively stuffing the computer bag into the overnight bag. A busted zipper later, the bulging overnight bag limped down the Jetway led by a very unhappy customer.
Does this scenario prove airline excellence because the agents showed how well they can comply with government rules? Hardly! Most folks would conclude that this messy scenario wasn’t necessary. In complex situations, the empowerment of professionals to act judiciously given a set of circumstances leads to excellence. The above scenario required the gate agents to apply context while making an overall effort to comply with government regulations. Unfortunately an excellent result didn’t happen in this case.
Similarly, we face the issue of context and judicious interpretation every day in medicine. As a common example, computerized medical records, a well-intended effort to characterize complex information, often fail to convey the true story of a patient or the nuances that make each of us unique. Summarized, bullet point information can easily miss the point. The great composer Mozart famously observed that musical excellence doesn’t lie in the notes but actually in the space and timing in between the sounds. Medical excellence involves a similar concept. Health care providers must read “in between the lines” and understand and respond both to what is and isn’t stated.
What this concept means to the average patient depends on the circumstances. For example, some people with neck pain may need consideration for a heart condition (angina) whereas others should check in immediately for an MRI of the spine and others should book a massage. Distinguishing the underlying cause of the neck pain relies on both a description of the nature of the symptom and on understanding the quiescent pauses of relief between episodes of pain. Excellent clinicians make this distinction by asking the right questions. Excellence during the medical evaluations of headaches, arthritis, and memory problems, among other things, also require this same commitment to careful questioning.
Clinical research promotes excellence by demanding great attention to detail. During research programs, physician investigators and their staff members must extensively analyze many aspects of our patients’ health. This thorough analysis usually exceeds that which occurs at the time of general physician visits, a setting during which time pressed clinicians must limit their focus and move on to the next patient. Research also requires the deployment of state of the art technology. The combination of technology and attention to detail of symptoms, signs and lab values leads to an experience which most patients highly value and describe as a demonstration of medical excellence.
In sum, medical excellence involves more than compliance or automatically matching a disease with a drug. Medical excellence is a philosophy of understanding the needs of a patient and putting those needs in context through the development of an individual treatment plan. Clinical research promotes medical excellence by demanding a culture of detail and caring.
Let’s not dance around the issue: for many years now, news sources like CBS, CNN, The Atlantic, and The New Yorker have called research volunteers guinea pigs. You’ve probably said it yourself. I’m here today to tell you why we need to call research volunteers by another name: Heroes.
The term “guinea pig” is condescending to both volunteers and researchers. For volunteers, it takes away the enormity of their contribution by sounding like they have no choice in the matter. If you have ever taken a prescription medicine for any reason, even an antibiotic; someone has chosen to volunteer to make sure the medicine is safe and works. If medicines down the road are to work better, we need volunteers to keep agreeing to test them.
Calling subjects “guinea pigs” also disdains the research coordinators and doctors that supervise drugs trials. Before any volunteer is admitted into a trial, coordinators fully explain what the trial entails, making sure to answer any questions or concerns of the volunteer. If the volunteer agrees, they go through a screening process to make sure they are a good fit for the trial and that the trial is safe for them. During the trial, the volunteer tells the coordinator or doctor about any medical events, including colds, broken toes, or headaches. This is also for safety, and if anything happens, the volunteer is free to stop the study or change their mind about participating. Throughout the study, the volunteer’s health is closely monitored; patient safety is always first. If a volunteer decides they no longer want to be in a clinical trial, they can withdraw from the trial at any time and will not be coerced to stay.
Before any medicine hits the market it is tested for years, with data constantly being reviewed in between trials. New medicines will go through 3 – 4 clinical trials over many years, with safety and effectiveness being the top concerns.
So, why are volunteers not guinea pigs? Guinea pigs (or any animal for that matter) don’t willingly sign up to be a part of future healthcare that could save lives. Guinea pigs are cute, fat, fuzzy, and they eat their own poop (Coprophagy). But, they do not willingly agree to be part of a trial that could save lives down the road.
So I urge you, quit using the term guinea pig for volunteers, use the term hero instead! We can’t cure diseases without heroes.
If you have volunteered for a clinical trial before, YOU ARE A HERO! If you have never participated, become a research HERO today!
Recently, I had my first experience as a clinical research volunteer. Going in, I wasn’t quite sure what to expect, but it was better than I thought!
I have Multiple Sclerosis. I also have asthma, arthritis, hypothyroidism, high blood pressure, and migraines. I live with chronic pain, I’ve had multiple surgeries, and the list goes on. With all these illnesses and conditions I need prescription medications to function on a daily basis.
I’m your average Google symptoms and side effects checker. I think it’s very important since I’m on over 10 daily medications to treat my health issues. I see multiple specialists; and I can’t expect them to research and remember all the ways those medicines interact with the others I’m already on. So I try to be smart about it.
Being a research volunteer has some bad stigmas attached to it. Some people think you might grow a second head or something! I’m here to tell you, don’t believe those outlandish tales! Without volunteers like me, the drugs I’m taking that stop horrible leg cramps or make my migraines back off- wouldn’t have made it to the pharmacy shelves.
When a friend of mine mentioned that her daughter works at Jacksonville Center for Clinical Research, for some reason that statement humanized the whole idea of prescription medications for me.
So I googled them and found they had SO many opportunities for many of the medical problems I currently have. I filled out an online form to be contacted, and a bubbly, friendly lady called me. I wasn’t even sure what to say but she dove right in talking about the different issues I mentioned on the form. She gave me an idea of what they were looking for in the studies, and I answered her questions. It was easy. In no time she had singled out a study I might be perfect for and set up an appointment. We talked through most of it over the telephone and she had it all together when I arrived. It turned out I WAS the perfect fit. It was a study that only required me to come to 3 appointments over a 6 week period and paid me $400. Wow! Did that extra cash come in handy! While I was there everyone treated me like an old friend.
I am doing my part to help put good drugs on the shelves for myself and millions of other people.
Now I know what it’s like to be a hero.
Alzheimer’s disease is a degenerative brain disorder that was first described in 1906 by Dr. Alois Alzheimer. Since that time, Alzheimer’s disease has become the most common cause of dementia (accounting for 60-80% of cases). It is estimated that in 2016, 5.4 million American’s of all ages have Alzheimer’s disease. One in nine people age 65 and older has Alzheimer’s. JCCR has participated as a research center in clinical trials over the past several years to limit the devastating consequences of this difficult to treat disease.
The number of American’s with Alzheimer’s is anticipated to escalate rapidly with the aging of our population, with estimates ranging from 13.8 million to 16 million by 2050. This estimate assumes no medical breakthroughs to prevent or cure the disease.
Alzheimer’s is a slowly progressive brain disease that begins well before clinical symptoms emerge. The persistent accumulation of abnormal proteins in the brain lead to death of brain cells over time, which causes decline in cognitive function. Thus, a significant amount of protein accumulates in the brain over many years before a sufficient amount of brain injury has occurred to cause symptoms noticed by the patient or family/friends.
The medications currently approved by the U.S. Food and Drug Administration (FDA) for the treatment of Alzheimer’s temporarily improve symptoms by increasing the amount of specific neurotransmitters in the brain. However, they do not address the accumulation of abnormal proteins or brain cell injury and, thus, do not treat the underlying cause of the disease. The first medication approved by the FDA for the treatment of Alzheimer’s was donepezil in 1996. The last was memantine in 2003. There have been no new/novel treatments approved by the FDA for the treatment of Alzheimer’s since 2003. From 2002-2012, 244 drugs for Alzheimer’s were tested in clinical trials, and only one went on to receive FDA approval.
Currently, a worldwide quest is underway to find new treatments to stop, slow or even prevent Alzheimer’s. The last 10-years have seen tremendous growth in research on early detection, and researchers believe that early detection will be key in preventing, slowing and stopping the disease. There is a new wave of optimism in the scientific community about Alzheimer’s treatments.
As eloquently stated by Bill Thies, PhD, Senior Scientist in Residence with the Alzheimer’s Association: “Despite increasing momentum in Alzheimer’s research, we still have two main obstacles to overcome. First, we need volunteers for clinical trials. Volunteering to participate in a study is one of the greatest ways someone can help move Alzheimer’s research forward. Second, we need a significant increase in federal research funding. Investing in research now will cost our nation far less than the cost of care for the rising number of Americans who will be affected by Alzheimer’s in the coming decades.”
Here at JCCR, we understand the importance of recognizing cognitive decline and identifying Alzheimer’s in its early stages. Recent scientific breakthroughs provide hope that new treatments can prevent accumulation of abnormal proteins in the brain and markedly slow the disease. We want to help individuals and their healthcare providers identify the early signs of memory changes so that effective interventions can be initiated promptly. We want to help individuals maintain their memory function and their independence. We also want to facilitate participation in clinical trials that will help our understanding of memory disorders and lead to treatments that will help maintain memory function. We look forward to working with you and your healthcare providers.
Erin G. Doty, MD
Neurologist, Board Certified
Memory issues occur commonly and when they begin, one may worry about the onset of Alzheimer’s disease. While Alzheimer’s may cause memory loss, memory loss is also a symptom of many reversible conditions. Early memory testing is crucial to determine the cause of memory loss to help reverse it before it becomes permanent.
For example, certain over-the-counter medications have been associated with dementia. A recent study came out this month linking Benadryl to dementia. Benadryl has many uses, including allergy symptom relief. The active ingredient in Benadryl is diphenhydramine. This drug blocks the action of acetylcholine (anticholinergic effect) and is used as a sedative because it causes drowsiness. 1 Diphenhydramine is used in most over-the-counter sleeping pills, for motion sickness, and other allergy medications.
A study completed in 2015 at the University of Washington showed the longer and more consistently people took anticholinergics, the more likely they were to develop dementia. Other drugs that contain anticholinergics are used to treat diseases like asthma, incontinence, gastrointestinal cramps, and muscular spasms. They are also prescribed for depression and sleep disorders. 2
While we do not fully understand dementia, we do know that the neurotransmitter acetylcholine is important in brain processing and memory. We know that the acteylcholinesterase inhibitors (drugs like Aricept (donepezil), Exelon (rivastigmine) and Razadyne (galantamine) which inhibit the breakdown of acetylcholine, do provide symptomatic improvement in affected patients.
It would seem that taking a combination of acetylcholinesterase (cholinergic) with an anticholinergic drug (such as Benadryl) is probably not a good idea. In fact a recent study showed 16% of Alzheimer’s patients living independently were doing just that.
This 2015 study is backed up by another study that came out this month offering the most definitive proof yet, that anticholinergic drugs are linked with cognitive impairment and increased risk of dementia. Using brain imaging they found that patients taking anticholinergic drugs indeed had lower metabolisms and reduced brain sizes.
The bottom line is that given all the research evidence, you should be aware that these over-the-counter medicines may reduce the effectiveness of your prescription medicines. If you or a loved is worried about memory loss, the first step is to get tested to see if it’s from a treatable or reversible cause. Jacksonville Center for Clinical Research offers a professional memory screening for no cost to you. Make an appointment today to help put your mind at ease.
Incredibly, migraines are the third most prevalent disease, and the sixth most disabling disease in the world. In the US alone, 18% of women, 6 % of men, and 10 % of children experience migraines. It comes as no surprise that 1 in 4 US households include a migraine sufferer.
Why are migraines a big deal? Unlike normal episodic headaches, migraines are a chronic disease that significantly diminish quality of life. Migraines can be excruciatingly painful, debilitating, and often incapacitating for hours or even days.
Migraines have four stages: prodrome, aura, headache, and post-drome, though you may not experience all stages. Prodrome is usually one or two days prior to a migraine, you may notice changes or sensitivities that warn of an impending migraine such as: constipation, mood changes, food cravings, neck stiffness, frequent yawning, and increased thirst and urination. Auras are symptoms of the nervous system, typically visual disturbances, however they can also be sensory, motor, or verbal disturbances. Luckily, most people have migraines without aura. During the Headache attack you may experience a throbbing or pulsing pain on one or both sides of your head. Extreme sensitivity to light, sounds, smells, or touch. These can be accompanied by nausea and vomiting, blurred vision and lightheadedness. Post-drome is the final phase which lasts for about 24 hours after the headache attack. During post-drome you may feel drained, confused, moody and weak.
Once thought of as a psychological disorder, migraines are now considered a chronic neurological disease with many triggers. A trigger sets off events that excite a nerve which releases a variety of neurochemicals and causes cranial blood vessels to swell and inflame.
You’ve probably already heard about the many possible migraine triggers, but maybe you’re not quite able to nail down what’s triggering your migraines. Consider the overload of information your brain consumes daily: everything from social media, to millions of breaking news stories. Your brain literally can’t get a break from the constant intake of new information. This increase of information causes stress on the brain, which can reach an overload point and shut down the prefrontal cortex; thus triggering a migraine.
What should you do if you are experiencing migraines? The best thing to do is see your doctor. Why? If you are having true migraines, over the counter medications usually just don’t work, and taking them for migraines several times a month can lead to overuse. This will almost certainly cause rebound headaches! It’s a vicious cycle; don’t get stuck in it! Your doctor can help you figure out the right treatment for you.
Fortunately for migraine sufferers there is a bright future ahead, and I don’t mean in a bright light during a migraine attack kind of way. Clinical trials are showing promising results for new migraine treatments. You can be part of the future of migraine treatments by volunteering for a migraine clinical trial! Call today to get involved! As always, there is no cost, and no health insurance required.
Many doctors prescribe metformin to diabetic patients. Doctors trust the drug, particularly since the landmark United Kingdom Prospective Study that showed that overweight Type 2 diabetics on metformin lived longer and suffered fewer heart attacks than those with the same blood glucose levels achieved using insulin. The history of metformin provides a good example of how an unusual herb can become a powerful treatment.
Metformin originates from the plant Galega officinalis or French lilac, goat’s plant or goat’s rue. This plant was fed to goats to improve milk production. It grows as a perennial herb, 3 feet tall, with purple, blue or white flowers and was used in the Middle Ages to treat frequent urination, a side effect of diabetes. The Native American Seminole tribe used the insecticide roterone, found in the roots of Galega officinalis, in fishing. Fish were stunned by roterone, and were much easier to catch. This plant has powerful properties and is now widely considered poisonous.
Metformin was first described by scientists in 1920. Chemists found that they could make the active compound from this plant, guanidine, more tolerable to be ingested by bonding two guanidines together forming a biguanide. This compound, which could lower blood sugar, was first synthesized in 1929. However, insulin had also been discovered during this time and became the more popular option for controlling blood sugar. Metformin was neglected and ignored until 1950 when metformin was used to treat influenza. Doctors noted metformin decreased glucose levels.
In 1958, Metformin was finally released in the United Kingdom as a treatment of lowering blood sugars. This drug was clinically developed and called Glucophage (“glucose eater”). Glucophage was released in the United States in 1995 and quickly became a popular medicine. Finally after half a century, it’s potential was realized. Metformin has now become the world’s most widely prescribed anti-diabetic agent and is universally recommended as the first therapy for Type 2 diabetes.
Metformin works by lowering the rate of hepatic glucose production, which is three times higher in people with Type 2 diabetes. Probably through reduction of insulin resistance, metformin can reduce cardiac risk factors and may decrease cardiac events. Since metformin does not cause hypoglycemia (low blood sugar), it can be safely utilized in a variety of diseases such as pre-diabetes, gestational diabetes, polycystic ovary disease, sleep apnea, osteoporosis and cancers.
Metformin’s has also been noted to have a positive effect on longevity due to its anti-cancer effect. Since having Type 2 diabetes is a major risk for developing cancer (pancreas, bladder, ovary, breast, prostate, colon and liver) patients with Type 2 diabetes have a lower risk of developing these cancers if they are utilizing metformin.
This very economical and widely available medication has been shown to safely treat multiple diseases in addition to Type 2 diabetes and to improve longevity in both the diabetic and non-diabetic patient. Metformin has come a long way from its humble “roots”. Fortunately, research rediscovered this powerful perennial herb. And now metformin has ascended to being the drug of first choice for patients with Type 2 diabetes.
The word “tsunami” describes a huge wave caused by an underground disturbance. Diabetes falls under that definition in our view. According to a study in Diabetes and Endocrinology, two out of five American adults may develop Type II Diabetes in their lifetime. About 95% of US diabetics are Type II. Type II diabetes occurs due to a condition of insulin resistance. Insulin, a hormone produced in the pancreas, does not have a sufficient effect on blood sugar levels, despite high levels of production in Type II diabetics. Fortunately, thanks to clinical research, surviving this diabetic tsunami should soon become easier. New research breakthroughs may lead diabetes to “dry land.”
For those currently battling diabetes, recent technological breakthroughs may make pricking your finger a thing of the past! Researchers at Arizona State University developed a method of testing glucose through saliva. To use, one simply licks a biosensor strip. The biosensing device then uses an electrochemical analysis to calculate blood glucose levels instantly. The company overseeing the development of this technology hopes to have it on the market in the next few years.
While tracking your blood sugar should become simpler, new ways of taking your diabetes medication may help keep diabetics afloat. Scientists have developed a “smart patch” that contains live pancreatic beta cells. A “smart patch” uses a system of tiny needles – each about the size of an eyelash, to detect high blood glucose levels and automatically inject insulin when needed. The live beta cells used in the newest versions of the smart patch can control rising blood glucose levels for roughly 10 hours at a time. Since the beta cells stay outside of the body on the patch, one’s body should not reject the cells. Current testing has been successful in mice studies, but the patch has yet to be tested on humans. Maybe one day we will seek volunteers for the “smart patch” at all of our seven research sites!
Another interesting diabetes finding comes from researchers at the Ottawa Hospital. Scientists turned from puzzled to amazed when they discovered a bacteria-killing protein in the pancreas. The bacterial-killing protein called cathelicidin antimicrobial peptide (CAMP) is produced by the same cells that produce insulin. Hoping to find a link between CAMP and diabetes, they injected diabetes-prone rats with CAMP. Not only did the rats have a healthier, more regenerated pancreas, but they had an increase in beneficial gut bacteria. CAMP could be a breakthrough in diabetes treatment.
Having diabetes is a big deal, and high sugar levels are themselves often less of a risk than other associated features of diabetes. In fact complications, such as high cholesterol levels and weight gain can be more problematic. High levels of cholesterol increase your risk of having a heart attack or stroke. Weight gain leads to higher blood sugar levels, high blood pressure and arthritis in weight bearing joints. We have several studies which target these complications. Many studies targeting cholesterol are enrolling right now at any of our sites, so if you have diabetes, heart disease, or even just high cholesterol give us a call and we can find the right fit for you! We also have a diabetes study enrolling with a medication that is said to cause weight loss at our Fleming Island, St. Johns, and Inverness offices. The future of diabetes management is looking bright! These research studies and new technologies coming down the pipeline may be just the life raft you’ll need to stay afloat in the diabetic tsunami.
As each year comes and goes we seem to go through the same cycle. We end the year by reflecting on what we accomplished (or didn’t) over the course of the past year and how we can improve over the next year. Many of us set specific goals which we call our ‘New Year’s Resolutions’. These goals range from budgeting to personal growth to accomplishing a specific task. One topic we all seem to consider though is improving our own health. One person may try a new fad diet and another may set a goal to start exercising once a week. One thing most people don’t consider is participating in a clinical trial.
Why would you make participating in a clinical trial part of your New Year’s Resolution? There are many reasons that participating in a clinical trial can improve your health. In the very least people should consider participating due to the Hawthorne effect. Patients receiving individual care in a trial tend to do better than those not in a trial regardless of whether or not they receive placebo. Also, patients may improve their health by receiving new medications or feeling more compelled to take their medications regularly. The many beneficial effects of participating in a trial can combine to make a real difference!
Here at ENCORE we are thankful for the patients that have put their trust in us over the past year. Our patients make us who we are and are an integral part of the ENCORE family. Moving forward into 2017 our New Year’s Resolution is to give our patients their best experience with us yet! Our goal is to help you with your health goals. If there is something we can help you with then we would love to go on that journey with you. Happy New Year!
Written by: Dr. Jeff Jacqmein
As we are beginning to prepare for vaccine season here at ENCORE Research now is a great time to inform you of some of the recent advancements in the field. There are many vaccines in the pipeline (1) and with volunteers like you we look forward to helping bring them to market. I have selected four major developments to share with you that demonstrate how the field is evolving and the technology is improving.
Recently there has been major concern worldwide about the spread of Zika virus, which is especially worrisome to pregnant patients. The National Institutes of Health is using a piece of DNA with genes that code for Zika, but are not infective to create a new vaccine. When the vaccine is injected into the arm muscle, the body reads the genes and creates virus-like particles which the body then thinks is an infection and then mounts a complete and lasting immune response. However, this is not the only way DNA is being used in vaccine creation.
DNA cloning has transformed the vaccine development process to shorten the average vaccine approval time while increasing safety. Previously, vaccine approval took 10-15 years to progress from laboratory development to clinical trials. Researchers can now genetically engineer cows or rabbits with human DNA to gather more accurate information on safety, efficacy and potency of vaccines in pre-clinical trials. This is important because it results in a safer and more effective product reaching patients in clinical trials sooner.
Pertaining to vaccine efficacy is the third advancement I would like to share with you, which is development of new vaccine adjuvants. Adjuvants are added to a vaccine to help the recipient create a stronger and longer-lasting immune response. According to a recent article in Immune Network, there are six new classes of vaccine adjuvants in clinical development. These developments are critically important because although recent vaccines are safer, they tend to provoke a weaker immune response when compared to past inoculations for smallpox and polio. An example of this is many older people requiring a Herpes Zoster booster vaccine to prevent shingles.
Lastly, is the invention of Nanopatch technology. Historically, vaccines needed to be stored frozen or refrigerated until just prior to dosing. This requirement significantly limited vaccine distribution, especially in remote locations. Nanopatch technology, does not have the same temperature requirement making it more practical for helping end diseases in countries where refrigeration is not readily available. The skin vaccination patch contains thousands of vaccine-coated microprojections that penetrate the skin and deliver the vaccine into localized immune cells. This technology could revolutionize the field!
Although we have more tools than ever, clinical scientific progress would be stunted without you, our volunteers. While it may be in self-interest to enroll in a vaccine trial aimed at keeping your cancer in remission (2), it is an act of service to your fellow man to dedicate yourself to a typical vaccine clinical trial. Because of you, we helped to bring the meningitis B vaccine to market within two years of major college campus outbreaks (3). It is recognized that adults who receive successful vaccines help prevent the spread of contagious disease and ultimately protect those who cannot be immunized for health or other reasons. I regularly appreciate our volunteers when I am able to prescribe an FDA-approved vaccine to a private practice patient. It is truly rewarding to work together to help prevent disease.
Dr. Dan here; this month of June I am leaving my desk and going out in the field to work as a volunteer physician on several different islands. First, I will be travelling to the Republic of Vanuatu, located in the South Pacific. Luckily for me the last recorded case of cannibalism in Vanuatu occurred in 1969, so that should not be a problem! Unfortunately, mosquito borne diseases are still an endemic. Malaria is present on all the islands of Vanuatu, but fortunately for visitors there are medications for prevention and treatment.
Another mosquito borne disease is dengue which causes as many as 400 million infections per year worldwide. A “bone-crushingly” painful flu-like disease, dengue can be fatal in severe forms, especially among children. At present there is no approved vaccine in the United States. Thankfully just last year the first dengue fever vaccine got the green light in 3 countries: Mexico, the Philippines and Brazil.
More than 1.4 million cases of dengue were reported in Brazil alone in 2015. Sanofi saw the need and developed a vaccine with the help of the Jacksonville Center for Clinical Research. We enrolled multiple patients in this vaccine study here in Jacksonville. Many of you may remember taking part in this clinical trial.
Sanofi’s vaccine is designed to coax the body’s immune system into making antibodies against all four forms of dengue. It is a live virus comprised of an attenuated yellow fever virus (yellow fever and dengue viruses have the same genus). For the vaccine, however, the virus is genetically engineered to include genes encoding for dengue proteins. Other dengue vaccines are also in development but none have received approval.
It is not a perfect vaccine; in clinical trials it only reduced the chances of developing the disease by about 60 percent. From the U.S. perspective it remains unclear how a vaccine would be used domestically, whether it would be used in areas that have already seen dengue including Hawaii or Florida or perhaps among those traveling to dengue endemic countries. The Food and Drug Administration is currently reviewing the application for the approval of the vaccine in the United States. Until the vaccine is available I will need to wear a lot of DEET and long sleeves on my travels.
I am proud of the work done here at JCCR and I want you to know that when you volunteer for these vaccine studies, your contributions have worldwide effects. Hopefully you will consider being a part of our next vaccine study to help combat the deadly disease of meningitis. Contact our Jacksonville, St. Johns, or Westside office to learn more about the meningitis vaccine trial.
Heart Disease is a general term for heart conditions that negatively impact the heart’s ability to perform its vital functions. On average 1 in 4 American deaths each year are due to heart disease. Fortunately, each year new discoveries are made that allow us to treat heart disease more successfully. Here are three of the latest discoveries.
One of the symptoms of heart failure is fluid retention, which can lead to kidney
problems. Diuretics are currently the standard treatment for fluid retention, however there is a new treatment where a catheter in inserted through the neck so that it surrounds a major lymphatic vessel. The excess fluid is removed from the lymphatic system and then pumped back into the circulatory system where it is removed by the kidneys. This new treatment avoids some of the negative side effects of oral diuretics such as low blood pressure and decreased kidney function.
2. Beta Blockers: Old dog, new tricks?
A new study at York University in Toronto has analyzed the effect of beta blockers on
coronary gene expression in patients with heart failure. Researchers found that beta blockers “largely reverse the pathological pattern of gene expression observed in heart failure.” More research is needed to determine whether beta blockers can be used to protect against heart failure.
3. Tick saliva saving lives?
While ticks are often the subject of nightmares researchers now believe they can lead to a dream solution for myocarditis, heart attack and stroke. Ticks use proteins called ‘evasins’ to escape their host’s detection by blocking the host’s inflammatory response. Researchers are now isolating these evasins in a ‘bug to drug’ formula. Hopefully these drugs will be able treat a variety of inflammatory diseases.
At ENCORE Research Group we conduct cutting edge research similar to those seen above. While we do not have any ‘bug to drug’ studies at this time, we do have a heart failure study involving a new use for an already FDA approved medication. If you are interested in learning more about our current studies visit our “Enrolling Studies” tab at the top of the page.
Hot flashes and night sweats, medically known as vasomotor symptoms (VMS), are the most commonly reported menopausal symptom. A hot flash is “characterized by a sudden increase of blood flow, often to the face, neck, and chest, that causes the sensation of extreme heat and profuse sweating.” 1 Hot flashes are currently being studied around the world to better understand them. The great news for women struggling to deal with them is that answers are being found! Studies have already helped to clarify possible causes, what may trigger them, how they may relate to other health problems, how they affect quality of life, and what can be done to decrease them.
In a clinical trial of more than 3,000 midlife women, 60-80% experienced hot flashes at some point during the transition to menopause. During menopause, hormone levels fluctuate in the body, which has been shown to be associated with hot flashes. Interestingly, scientists have found that even though all women have hormone changes during their menopause years, not all women have hot flashes. Therefore, other factors must be involved, and further studies are needed.
Research has found that symptomatic women have small changes in core body temperature. This is believed to trigger the body’s mechanisms to cool the body, resulting in sweating and hot flashes. However, the promise of understanding and relieving hot flashes lies in continued research.
Women with hot flashes may be able to participate in helping to find answers which can lead to better treatments. To learn more about current clinical trial opportunities for Hot Flashes, and other conditions please contact our office.
Writen by: Mike Mass, MD
Rheumatoid arthritis (RA) is an autoimmune disease that is localized in the joints but may also result in serious systemic symptoms. In the joints, RA begins in the lining tissue known as synovium. In RA inflammatory cells are stimulated in the synovium and release substances that will both activate other inflammatory cells and cause direct breakdown in the adjacent bone. If this inflammatory process is not interrupted it will immediately cause severe damage to the joint and, on occasion, other organs in the body.
Until recently, the only treatments available helped the symptoms of inflammation, such as pain and tenderness, but did little to stop the destructive process. The first drug that had some limited benefit was gold salts, but it was toxic and had to be monitored carefully. Low doses of a cancer drug (Methotrexate) were tried and proved effective in treating the symptoms of inflammation and also slowed down the destructive process in many patients and was a mainstay of therapy until the last decade.
As the understanding of the autoimmune abnormality increased, various substances released from inflammatory cells were identified. Initially, the most promising of these was known as tumor necrosis factor (TNF). While in other studies it had affected some tumor growth, it was also found to be a major cause of damage in RA. A group of anti-TNF monoclonal antibodies is on the market and has proven to be quite effective in a large number of patients. The search has continued for other substances that will either modify the autoimmune response or inactivate substances that cause damaging inflammation. Recently another protein has been identified that is present in the synovium and when activated will initiate a whole range of responses that result in a proliferation of synovial cells which then go on to damage the joint. This particular substance is part of a larger group of proteins known as “Integrins.” It is hoped that by giving a monoclonal antibody directed against the particular integrin a major portion of damaging inflammation will be shut down. A clinical trial of this antibody just opened at Jacksonville Center for Clinical Research University Blvd. Office and we are currently seeking volunteers. Call today to see if you qualify! 904-730-0166
If you have high cholesterol you may dread going to your doctor, especially if they are going to complete a cholesterol blood test. You know they prescribed a statin, but the muscle cramping you experience after taking it just isn’t worth it. How do you tell your doctor that the medication they prescribed just isn’t working for you? You are not alone, and there are options available for you.
We all know that having excess cholesterol in our blood is a bad thing, but why is it so bad? High cholesterol has often been called ‘The Silent Killer’. In fact, according to the CDC heart disease is responsible for 1 in 4 American deaths every year. High cholesterol is known to cause plaque formation in arteries, constricting blood flow to vital organs in your body. Even worse, cholesterol plaques can become dislodged from the walls of the arteries potentially causing blood clots. Both heart attacks and strokes can be caused by plaques reaching the heart or brain respectively. If lifestyle changes such as a good diet and exercise can’t bring down your cholesterol numbers, you may need a medication. The most common cholesterol lowering medications to date are statins such as Crestor, Lipitor, or Zocor. These medicines have been life saving for many people that can tolerate them. However, some people are intolerant to statins and will experience side effects such as painful muscle cramps, inflammation and more.
If you are allergic to or can’t handle statins what can you do? It is crucial to keep your cholesterol levels down, lowering your risk for a heart attack and stroke. You may try one of the medications already on the market for people with statin intolerance such as Zetia, Juxtapid and Repatha. However, each of these drugs have their own risks. Zetia can cause symptoms similar to those caused by statins. Juxtapid, a newer medication, has been found to significantly reduce LDL bad cholesterol by 40-50%. Sadly, it also caused diarrhea, nausea, vomiting or abdominal pain in 28% of patients. In 2015 the FDA approved Repatha, a new class of drug called a PCSK9 inhibitor that is very successful in lowering LDL. Unfortunately, due to the cost of development and production the annual cost is around $14,000 dollars making it unaffordable for most people.
If you’ve had trouble taking statins in the past you may be asking “what do I do now”? Many of our participants are looking for alternative treatments or want to be part of cutting edge research. I encourage you to check out the cholesterol research studies we are conducting at many of our research centers. You may qualify for a new oral medication or to receive PCSK9 in an upcoming study! The medicines being researched for people who cannot take statins may significantly alter the future of cardiovascular disease. We need your help to bring these new medications to market!
 “Heart Disease Fact Sheet.” Centers for Disease Control and Prevention. Centers for Disease Control and Prevention, 16 June 2016. Web. 27 Apr. 2017.
 Orrange, Sharon, MD. “Finally, a Non-Statin Cholesterol Medication That Works: Introducing Juxtapid.” The GoodRx Prescription Savings Blog. N.p., 06 June 2014. Web. 27 Apr. 2017.
Medical progress has made the lives of folks with autoimmune conditions such as psoriasis and psoriatic arthritis (PsA) better than ever before. These conditions have been extremely difficult to treat successfully in the past. Now thanks to advancements in medicine using biological agents more people are living free of psoriasis and PsA flare ups.
Psoriasis is most commonly known for the raised, white or greyish patches that appear on the skin. These patches can progress to thick, scale-like plaques which may harden and become cracked. The severity of psoriasis is measured both by how much psoriasis a person has on their body and how much it affects their quality of life. For example, psoriasis can have a serious impact on one’s daily activities even if it involves a small area, such as the palms of the hands or soles of the feet.
Psoriatic arthritis is an inflammatory form of arthritis affecting the joints and is often accompanied by skin psoriasis. Early diagnosis and treatment of PsA can help prevent or limit extensive joint damage that occurs in later stages of the disease. Symptoms are similar to the discomfort associated with osteoarthritis (OA). One way to tell the two conditions apart is determining whether the arthritis is symmetrical or not. PsA usually affects major joints of the body symmetrically, while OA commonly affects one particular joint such as the left knee or right hip. An accurate diagnosis may require x-rays and blood tests. Once diagnosed an effective treatment plan may begin.
In the past, doctors could only treat psoriasis topically and with limited success. In the 1950’s researchers discovered methotrexate, an immune suppressant, and in the 1970’s it was approved for use in patients not responding to topical treatments. This medication and others like it are still used today, however there can be many possible side effects when suppressing the immune system. Through many years of research and clinical trials, researchers have now discovered biologics. Biologics are genetically-engineered human or animal based proteins designed to target the specific inflammatory pathways caused by psoriasis and PsA. Because of the large molecule size and complexity of biologics, they must be injected in order to be absorbed. Fortunately, injections are only needed once a month or every several months to be effective in most cases. There are several biologics currently FDA approved, however because of the recent discovery and high production costs, biologics can be extremely expensive through insurance.
At Encore Research Group, we are currently investigating many new and exciting biologic drugs for psoriasis and psoriatic arthritis. We are actively looking for qualified participants in North East Florida. Research provides participants with many great benefits. Some advantages of participating in a study include cutting-edge therapies, study-related medication at no cost and a stipend for time and travel. If you are interested in learning more about research, or our current studies please visit our website for more information. Without participants today, there won’t be new medications tomorrow!
Changes in mood are very common after childbirth. In fact, many new moms experience what is often called the baby blues, which can include mood swings, crying episodes, difficulty sleeping and anxiety. Baby blues usually only lasts up to a few weeks. However, feeling intensely depressed, overwhelmed, or anxious, could be something called postpartum depression, or PPD.
Postpartum Depression is a type of depression that can occur both during and after childbirth. It can consist of both major and minor depressive episodes and is thought to be caused by a combination of hormonal changes and fatigue due to pregnancy. Common symptoms include: feelings of sadness, hopelessness, loss of interest or pleasure, agitation or anxiety. PPD is one of the most common medical complications during pregnancy and the postpartum period. “According to the Centers for Disease Control, 11 to 20% of women who give birth each year have postpartum depression symptoms. If you settled on an average of 15% of four million live births in the US annually, this would mean approximately 600,000 women get PPD each year in the United States alone.” 1
In 58% of the women who develop PPD, the onset begins prior to delivery, with the remaining starting within 4 months of delivery. There are multiple risk factors for PPD, the most common include: a past history of depression, stress, poor social and financial support, young age, and single marital status. It is important to identify pregnant and postpartum women with depression because untreated PPD and other mood disorders can have devastating effects on women, babies, and families. Each expectant mother should be aware of the risks of PPD and should be proactive in procuring help. There are several screening tools used now by most obstetricians and hospitals on a routine basis in order to identify women with depression symptoms.
If diagnosed with PPD, there are multiple treatment options available including psychological therapy, pharmaceutical therapy or a combination of both. Presently, the pharmaceutical treatments on the market consist of either tricyclic antidepressants and/or selective serotonin reuptake inhibitors (SSRIs) such as Fluoxetine or Sertraline. We are now researching new ways to treat PPD with the hormones allopregnanolone and ganaxolone. Allopregnanolone is the neurosteroid metabolite of progesterone and is thought to play a major role in returning the body to equilibrium after trauma. Ganaxolone is the synthetic equivalent of allopregnanolone. Hopefully, these new medications will become the next golden standard to PPD care.
We are starting two new clinical trials for Postpartum Depression (PPD) with these hormones at our Jacksonville location. If you know an expectant mother or someone experiencing PPD please have them call (904)730-0166 to learn more about our clinical trial opportunities. If you live near our Nature Coast offices, please talk with your doctor and visit clinicaltrials.gov for clinical trials near you.
Ask anyone who has had a Clostridium difficile (C. difficile, or C. diff) infection and they will probably tell you that it was one of the worst experiences of their life. Imagine the worst flu you’ve ever had but on steroids! C. diff is affectionately referred to as “deadly diarrhea” and with symptoms such as watery diarrhea 10 to 15 times a day that’s no joke! It can also come with a multitude of other symptoms such as: severe abdominal pain/cramping, rapid heart rate, fever, blood or pus in the stool, nausea, dehydration, and kidney failure.
What is C. Diff?
C. diff is one of the many different types of bacteria that lives in our intestines. It may sound gross but bacteria in your intestines are completely normal and you need a good balance of them to remain healthy. When something such as antibiotic use throws off the balance in your intestines C. diff may start to grow out of control and begin release toxins that attack the lining of the intestines which leads to that deadly diarrhea.
Is C. Diff contagious?
C. diff is contagious, so even if you were not recently on antibiotics, you can still catch C. diff by contact with a contaminated surface. Spores from C. diff bacteria come from human feces, soil, water and animal feces. These spores can also live for weeks or months outside the body.
Who is at risk?
C. diff is most often associated with doctor or healthcare facility visits or recent antibiotic use. There is a higher risk for adults ages 50 and over, especially those that have frequent doctor visits or have had any type of recent surgery or a hospitalization.
What can you do to lower your risk?
Good handwashing practices, especially after doctor or healthcare facility visits are a great start to lowering your risk of getting a C. diff infection. Another way is to take probiotics daily anytime you take an antibiotic. The reason for this is because when you take an antibiotic it not only kills off the bad bacteria, but it also kills off the good bacteria, giving C. diff a chance to thrive. Taking a probiotic, even if it’s just store bought yogurt, helps feed and rebalance your good gut bacteria. These are not fool proof, but they may help.
A Vaccine to prevent C. Diff?
While Handwashing and probiotics are certainly a must, researchers agree they are still not enough when it comes to preventing this life-threatening infection. Which is why we are involved in a cutting-edge research study working on the development of a new vaccine for C. diff prevention. If you are interested in volunteering, this study is for people ages 50 and up who have been recently hospitalized, have an upcoming surgery, or have frequent healthcare contact. If you are not sure if you qualify, please give our office a call or click below on the site that is closest to your location to sign up and we will be glad to answer any questions!
Jacksonville Center for Clinical Research
Joint pain is an ancient disease. Dinosaur skeletons, cavemen remains, and ancient Egyptian mummies all have evidence of it. In 1886 an English doctor named John Kent Spender coined the term “osteoarthritis” (OA) which led to the modern understanding of the disease.
To relieve the pain and suffering of OA, ancient healers tried various concoctions, some of which persist until today. . More than 2500 years ago, Egyptian physicians treated OA with ointments containing fat, oil, honey or bone marrow, often added to various dry ingredients such as: flour, baking soda, cumin and incense. 1 The father of medicine, Hippocrates, observed that “Swelling and joint pain, ulcers, those of a gouty nature and muscle strain are usually improved by cold water, which reduces swelling and eliminates the pain, as a moderate degree of numbness eliminates pain”. Another Greek physician named Dioscorides floated a less enduring idea. He recommended using ivy. This treatment proved less effective although the subsequent itching may have distracted patients from thinking about their joints.
Acupuncture, an effective therapy for some folks, is another ancient treatment that has remained virtually unchanged over many years. An older medicinal approach using willow bark leaves remains in use today. These leaves contain salicylic acid. An understanding of the benefits of salicyclic acid ultimately led to a breakthrough by a French chemist named, Charles Frederic Gerhardt. Gerhardt’s claim to fame involved the chemically synthesize of Aspirin or acetylsalicylic acid in 1897 that improved upon salicylic acid.
In more recent years, clinical research has helped to shed some light on this painful disease. Though there is no cure for OA, researchers have found many treatments to manage symptoms. Science has proven that physical activity is one of the most beneficial ways to manage OA. The CDC recommends exercises such as: brisk walking, bicycling, swimming and muscle strengthening activities. It’s important for you to get moving and keep moving! Losing weight can also help relieve additional stress on your weight bearing joints.
If older therapies haven’t worked for you or someone you know, there is always the promises of modern medicine. Thanks to years of clinical research there are some great medications available both over-the-counter and by prescription. Analgesics such as Tylenol, opioids (narcotics) and tramadol are pain relievers. Nonsteroidal anti-inflammatory drugs (NSAIDs) are the most common anti-inflammation medication. NSAIDs include: aspirin, ibuprofen, naproxen, and Celebrex. Corticosteroids are powerful anti-inflammatory medicines most notably given by injection in a doctor’s office. Hyaluronic acid naturally occurs in joint fluid, acting as a shock absorber and lubricant. Hyaluronic acid is given by injection in a doctor’s office.2 We don’t suggest using any treatments without first checking with your doctor!
The future for OA treatments looks bright. You can participate in the path to the future by participating in a clinical trial. We have many programs available at no charge. Please give us a call so we can see which program works best for you!
Familial Chylomicronemia Syndrome (FCS) is a rare genetic disorder characterized by the build-up of chylomicrons, which are rich in triglycerides, a type of fat in your blood. The human body naturally produces an enzyme to eliminate the chylomicrons called lipoprotein lipase (LPL). However, people with FCS either do not have the LPL enzyme or it does not function properly. Due to the buildup of chylomicrons and very high triglycerides, they live at risk of severe recurrent abdominal pain and potentially fatal pancreatitis, as well as decreased quality of life in many areas.
To this day, there is no treatment for FCS; the current medications used for lowering triglyceride levels do not work for people with FCS since they are designed to work on the LPL enzyme. Currently, the only option is to follow an ultra-low or no fat diet, which is very difficult to maintain long term. People with FCS also must avoid alcohol, sweets, and simple carbohydrates due to their effect on raising triglycerides.
Lori Alexander is Director of the Lipid Center of Excellence at Jacksonville Center for Clinical Research. She is a Registered Dietitian Nutritionist and board member of the National Lipid Association (NLA) and the Foundation of the National Lipid Association. Lori has been coordinating clinical trials with Akcea, one involving a new potential treatment for people with FCS called volanesorsen (Waylivra).
Recently, Lori was asked to testify on behalf of people with FCS. On May 10, 2018 she traveled to the Food and Drug Administration (FDA) Headquarters in Bethesda, MD to testify in front of FDA Endocrinologic and Metabolic Drugs Advisory Committee. She was accompanied by Akcea scientists who shared clinical trial data, and some people diagnosed with FCS who got to share their stories, some of whom saw great relief from volanesorsen during the clinical trials. During her testimony she encouraged the approval of volanesorsen (Waylivra), “Treatment with volanesorsen offers hope to these people, many who have been struggling for years without medical therapy”. 1
After hearing from the Akcea scientists, the people with FCS and Lori’s testimony, the advisory committee voted 12-8 in favor of recommending volanesorsen’s approval to the FDA! The FDA has set a date for the completion of its review on August 30, 2018. 2
Photo Credit: National Lipid Association
I recently stumbled across the work of Professor John Norcross, the “undisputed” guru on all matters related to New Year’s resolutions. Who knew? I guess a guru may exist for nearly all things. Professor Norcross surveyed and followed a few hundred folks who made New Year’s resolutions and compared them to those who did not commit themselves to goals as the calendar year turned.
Here are a few fun facts from the Professor’s findings:
We can draw solace from Professor’s Norcross’s most persuasive finding: those who made New Year’s Resolution were 10 times more likely to change unwanted behaviors than those who didn’t make them. Yes, setting goals works and the New Year, fresh with the feelings of optimism and renewal, seems like the perfect time to make them.
We have an exciting agenda of educational programs called “Learn with the Leaders” that we will highlight throughout the year. In January, we will talk to people about how they can help themselves with autoimmune disease, cholesterol problems, diabetes, and memory loss. Please make an effort to attend these sessions.
Participating in a research study has lots of unintended benefits but perhaps most importantly the benefit of having a team help you stick with a program. Let’s resolve to keep our resolutions this year, or at least double the amount of time until we break them.
– Michael J. Koren, MD FACC CPI FAPCR
Reference: Journal of Clinical Psychology, 58(4), 397-405
THE RESULTS ARE IN!
We would like to wish a big heartfelt THANK YOU to all our volunteers that participated in this international (PCSK9) high cholesterol study of 1300 volunteers completed in 18 countries.
Jacksonville FL volunteers lead the world in this study with ground breaking results! Our own CEO Dr. Michael J. Koren was the lead international investigator and lead author on the study. Results published in Jama Cardiology.