cptrials

Asthma Peak Week

sjohnson@cptrials.com (Sherry Johnson) — Mon, 09 Sep 2024 12:44:28 GMT

Most have never heard the phrase “Asthma Peak Week,” but families who have members with asthma may have unknowingly experienced it. Here in the U.S., Asthma Peak Week refers to the 3 ^rd week in September due to a spike in asthma flares. And it’s not very convenient that it’s happening right when school is starting for most children. With 1 in 10 school-aged children having asthma and 13 million missed school days yearly from asthma, it’s understandable how research continues to focus on better management.

What are some reasons asthma commonly spikes during this time? One big reason is the pollen and mold counts- specifically ragweed which typically peaks during the month of September. Poor air quality is always a challenge for those with asthma. Classrooms for the new school year can be an environment a child may be sensitive to. This coupled with poor outdoor air quality can continue to be a struggle with hot summer temperatures still sweltering. Another common trigger for asthma can be colds and other respiratory infections. With the close proximity of students in a classroom, germs are bound to spread.

The combination of these triggers often makes Asthma Peak Week infamous at local medical offices and ER rooms. Those with moderate or severe asthma are at the greatest risk of hospitalizations. So what can you do to protect your child from flares during this time? With the help of your child’s PCP or asthma/allergist, make sure you are maximizing efforts to control allergies whether taking daily or as-needed medicine, home air filtration maintenance (clean a/c filters), and monitoring daily pollen count/air quality index. Make sure you have a copy of an Asthma Action Plan from your medical provider. This helps you to identify which asthma medications to take and when to take them based on symptoms. A copy of this plan should be with your school’s staff as well. Help your child to recognize their own symptoms of worsening asthma for a quicker response. Encourage them to alert their teacher or school nurse right away.

Asthma flares are never convenient, so make sure your child’s medications are available at home and at school. Have refills available before a prescription runs out. And ensure your child is taking each medicine correctly- especially inhalers with the use of a spacer if appropriate. General health maintenance is important to decrease the risk of complications of asthma flares. Keep your child updated with routine childhood and seasonal vaccines for their age. Encourage healthy hygiene with frequent hand washing, covering the face when sneezing/coughing, and avoiding others who are sick.

As research for asthma continues, see if your child may be eligible for one of our asthma studies today by clicking the menu above or calling anytime for more information.

References:

Asthma Statistics. Allergy & Asthma Network. (2024, August 13). https://allergyasthmanetwork.org/what-is-asthma/asthmastatistics/#:~:text=Over%2013%20million%20school%20days%20are%20missed%20annually,school%20in%20the%20previous%20year%20due%20asthma%2013 .

Back to School with Asthma: Tips for Parents. American Lung Association. (2023, August 8). https://www.lung.org/blog/asthma-back-to-school-tips .

Ogden, N. (Ed.). (2024, September 6). September Asthma Peak. Asthma & Allergy Foundation of America. https://aafa.org/asthma/living-with-asthma/september-asthma-peak-month/ .

Resist the Itch

sjohnson@cptrials.com (Sherry Johnson) — Fri, 16 Aug 2024 15:42:00 GMT

Resist the Itch

Don’t you hate those annoying itchy bug bites that never seem to stop? I was once told that bug bites left untreated will last about a week but using medicines can help them last about 7 days…go figure! For such little insects that we sometimes can’t even see (chiggers!), the itchy consequences can be pretty bothersome. With summer in full swing, the bites from some of these bugs can have greater consequences such as possible transmission of illnesses like Zika or West Nile Virus.

But what makes them so itchy? The bites themselves are not the problem (as opposed to a bite from a dog that can cause significant injury). The problem with bug bites is how our body reacts to the bug’s saliva and/or venom after that bite. Within minutes, the body reacts to the inflammation of the bite itself. A delayed reaction afterwards is when we notice the persistent itchiness which is the result of various defenses our body puts in action. The most severe of these reactions would be systemic allergic reactions (otherwise known as anaphylaxis) but that is relatively rare.

With the more common local reactions to bug bites, there are a few things to keep in mind. Always keep the area clean with simple soap and water. This includes after scratching the area so much that we make it bleed at times. In this situation, keeping the area covered with a band-aid is recommended. Using a cool pack to the area during the initial reaction can help with symptoms. Taking an oral antihistamine such as Zyrtec or Claritin is preferred over Benadryl due to a less drowsy side-effect. And remember, any itchy rash that gets hot and sweaty usually becomes itchier…Hello Summer!

Since the itchy bug bites can last several days, a practical approach should focus on prevention- especially when you’re talking about insects such as mosquitos that can transmit those infections mentioned earlier. Using a bug repelling product is important. But what should you look for on those labels to be safe and effective? The ingredient of DEET is important and has been heavily researched. Safe for children 2 months old and above, the percentage of DEET in the product refers to the length of protection it can provide. For example, a repellent with 10% DEET is expected to offer protection for 2 hours; 30% DEET about 5 hours. For children under 2 years of age, it is best to apply DEET on clothing instead of direct skin when possible and avoid the face and hands (arms are okay!). Application sticks and lotions may be better suited for younger children as well. It’s always best to wash the skin with soapy water when returning indoors to lessen the chance of skin irritation.

Here are some other ways to avoid those itchy “skeeter” bites:

Wearing loose-fit long sleeve shirts, pants, and fully covered shoes
Utilize mosquito netting over baby strollers/carriers
Avoid outdoor activity when mosquitos are most active- dust and dawn
Eliminate any standing/stagnate water around the house

But Which Pain Reliever?

sjohnson@cptrials.com (Sherry Johnson) — Thu, 01 Aug 2024 12:34:47 GMT

“I’ve got another migraine this morning and too many things to do today.”

“My shoulder is so sore after my son’s first baseball practice yesterday.”

“My back hurts from moving all those boxes yesterday.”

We’ve all said something like this before. Sometimes we just power through without needing to take something to help with the pain. But sometimes taking something over-the-counter (OTC) to help is best. But what can I take? What should I take?

A general pain reliever and fever reducer such as Tylenol is a common option. The generic is called acetaminophen. It’s available for all ages- children through older adults. It can help with pain and fever. For example, strep throat can cause throat pain and fever making acetaminophen a great option for treatment.

Another OTC option for pain is something like Advil or Aleve. These belong to a class of medications called NSAIDs (NonSteroidal Anti-Inflammatory Drugs). Advil and Motrin are brand names for the generic ibuprofen. Aleve is the brand name for naproxen. Similar to acetaminophen above, this NSAID group can treat pain and fever. Since inflammation is a trigger for pain, this medication group can also provide inflammation treatment when used more consistently over several doses or days.

Aspirin is also a medicine in the NSAID group. However, aspirin commonly has more interactions with other medicines you may take, may have the undesirable effect of thinning the blood (cause longer bleed times or make bleeding ulcers worse as examples), and should not be used with children unless specifically directed by a healthcare provider.

Aways be careful about combination products that may have a pain reliever included such as Excedrin Migraine as it already contains acetaminophen and aspirin. Make sure to follow labeled directions and do not go over the recommended 24-hour maximum dosage. Some NSAIDs such as ibuprofen and naproxen have different dosing strengths and schedules, so they should not be interchanged. Your medical history such as heart disease, ulcers/heartburn, kidney disease, or liver disease can affect which pain reliever is safest for you. For example, someone with liver disease may be instructed by their healthcare provider to avoid acetaminophen. Be informed! Always read the label and address any questions with your healthcare provider.

And don’t forget about other ways to combat painful ailments. With migraines for example, take a team approach by considering cold packs to the head area, warm shower to neck muscle area, restful regular sleep, relaxation/stress reduction techniques, regular exercise, minimizing eye strain (healthy electronic/phone use), regular meal schedule, and moderating caffeine intake.

If you suffer from pain due to migraines, consider participating in one of the current migraine studies at ClinPoint. Click the CURRENT + UPCOMING STUDIES for more information on our migraine and other studies we have.

Syndrome, Say What???

sjohnson@cptrials.com (Sherry Johnson) — Wed, 17 Jul 2024 14:16:02 GMT

Syndrome, Say What???

Around healthcare, you often hear the term syndrome. Metabolic syndrome…Carpal tunnel syndrome…Restless leg syndrome…Sudden infant death syndrome…Tourette syndrome…Irritable bowel syndrome. Sometimes we use the word so often out of habit but couldn’t really explain it to someone else if asked. Oftentimes, syndrome is used interchangeably with disease, but they shouldn’t be.

In the medical setting, disease refers to a pattern of established signs and symptoms related to a specific cause and process, i.e. cardiovascular disease, aka heart disease. The process within a disease is often more defined and predictable. On the other end of the spectrum, syndrome refers to a collection of signs and symptoms that does not have a well-defined process or specific cause at times, i.e. Irritable Bowel Syndrome (IBS). Syndrome is Greek in origin meaning “runs together.” We use this term for a group of symptoms that “run together” without the full understanding of why or how sometimes.

Frequently with a syndrome, we identify the various signs and symptoms a person has in order to categorize the ailment, thereby making the diagnosis of a particular syndrome. With IBS as an example, there is no specific test that establishes this diagnosis. If other potential causes are ruled out, and the criteria for IBS matches, then the syndrome can be diagnosed. For comparison, a failed exercise stress test allows the diagnosis of heart disease.

But how do we develop criteria to make the diagnosis of a syndrome? Many times this involves a group of specialists in a particular area of medicine that develop the criteria based on available data and experience. For IBS, a collective committee known as the Rome Foundation made up of scientists and medical professionals developed the criteria to help guide clinicians in diagnosing someone with IBS. There are even multiple categories of IBS based on the predominance of symptoms such as experiencing mostly diarrhea, mostly constipation, or a combination of the two.

Treating syndromes can be difficult as well since many times the exact underlying cause of syndromes is so poorly understood. Often, the focus of treatment shifts to treating the symptoms. Because of this lack of knowledge around the cause, various syndromes are surrounded with ongoing research for better understanding, management, and prevention. This is just one of the reasons our focus at ClinPoint Trials involves research for conditions such as IBS. Check out our Current + Upcoming Studies link for more information on our IBS studies and more.

Asthma & Ozone (or Knozone)

sjohnson@cptrials.com (Sherry Johnson) — Tue, 02 Jul 2024 16:52:05 GMT

Asthma & Ozone (or Knozone)

Asthma affects around 25 million Americans and approximately 5.5 million children- MILLION! Having an asthma attack due to allergies and air quality should be on everyone’s mind, especially since we know that children are less likely than adults to recognize early asthma symptoms. Terms who have likely heard such as “ozone days” or “air quality days” don’t say a whole lot…or do they? And what are some common asthma triggers from the great outdoors?

Asthma may be triggered by the temperature, humidity, pollen count, air pollution, wind, and stormy weather. Other environmental triggers may include smoke from grilling or fires (wildfire smoke can travel hundreds of miles) and even pool/spa chemicals. Some of these triggers such as air pollution commonly peak during the warmer months just when many of us spend more time outdoors.

But how do they cause problems? Well, when tiny particles become airborne, we are susceptible to inhaling them. Our body has some natural defenses such as the hair and first layer of the inner nose. The nose also acts as a humidifier to improve the exchange of air in our lungs. Then we have a cough reflex to expell the buildup of mucus produced by our body when called into action. In fact, mucus production is one of the mechanisms asthma affects directly. Still, a high concentration of very small air contaminants or pollutants can reach our lungs, and this happens everyday to all of us. But a person with asthma cannot tolerate it as much as a person with no chronic lung disease.

We’ve all been in a car ride behind that diesel truck that you suddenly smell inside your own vehicle. We might cough a bit, breath a little more shallow a few times before our vehicles separate. We forget about that truck after a few minutes. Imagine someone with asthma who cannot recover so quickly, possbily lasting minutes to hours or until using their rescue inhaler. Many times an asthma attack is not from one single trigger though. It’s a combination of that “perfect storm”: hot/humid weather, high pollen count, physical exertion such as swimming, while all of this taking place near a busy traffic area full of smog. And that’s where the “ozone” effect can happen. Ozone occurs naturally in much higher levels of the atmosphere- and we need it there! But increasing gasses that contribute around the atmosphere level where we breathe is not so good. It also contributes to that hazy look aournd large cities on some days. The extra fossil fuel use and engine emmissions around these concentrated areas can cause irritation to the airway and lungs.

So how can I tell if it’s a bad day to be outside, especially if you have asthma? Just looking at the smog of a city skyline is not very reliable. Consider a few great resources at your fingertips. TV/ news stations usually report on several triggers you can monitor: pollen counts, UV index, and air quality. Follow an app on your phone of your favorite local news station. Another great resource is from the EPA (www.airnow.gov), which reports on real-time pollution levels with the Air Quality Index value (AQI). Generally speaking, a person with asthma can be affected with AQI level above 50 (may need to modify outdoor activity). A level above 100 is considered unhealthy for those with asthma (may need to avoid outdoor activity).

What else can I do about outdoor activity now that I know the air quality…the Knozone? Everyone can benefit from these tips, but those with asthma should be extra cautious:

Limit outdoor activity during peak hours of 11am to 8pm when air quality may be at its worse
Avoid or modify outdoor exercise/strenuous activity to be less stressful on the body
Utilize air conditioned areas to improve the natural breathing process in the lungs
Stay on top of your allergies with medication under the direction of a medical professional
Follow your Asthma Action Plan and always have your rescue inhaler with you.

So many millions of Americans have asthma, and it’s a big research topic too. Consider joining our list of asthma research studies…check out our CURRENT + UPCOMING STUDIES above!

Childhood Migraines

sjohnson@cptrials.com (Sherry Johnson) — Tue, 18 Jun 2024 18:55:01 GMT

Childhood Migraines

Any adult who has experienced the occasional migraine knows how miserable it can be. And imagine if you have a migraine more often- monthly? Weekly? Well, children have migraines as well. In fact, we know migraines can occur at any childhood age, and the prevalence often increases into adolescence. For a child with recurring headaches, accurate diagnosis is most important for proper management since distinct types of headaches often have different treatment guidelines.

However, the way migraines affect your child can have more consequences than “just a bad headache.” Studies show us that success in high school and college often builds on success from the elementary and junior high years. So as we see children with migraines often miss more school days, this translates to less time learning in front of a teacher- the foundation of educational development during these years can become compromised. Sometimes a child may even be labeled as uncooperative by school leaders due to the child’s lack of classroom participation from the migraine symptoms.

The social aspect of migraines can have far-reaching effects as well. School children may be isolated from social situations due to their symptoms (if you’ve ever had a migraine then you know how sensitive any noise can be). Other children may dismiss your child from a group activity or even bully the child due to a perceived faking of migraine symptoms. Your child may even avoid sports or exercise because the activity worsens their migraine symptoms. At home, parents often find themselves missing work when they stay home to care for their child during a migraine episode. Siblings often become resentful towards the migraine child from having to “keep quiet” and “not so loud” to not worsen the ailing child.

So, with migraines affecting a child in multiple ways, what can you do? It takes a coordinated effort with your PCP, teachers, and school nurses. Keep a journal of symptoms to aid your PCP in an accurate diagnosis. The PCP may even refer you to a headache specialist (neurologist). At school, communicate up front and regularly with the staff regarding days when migraine symptoms are present for alternative activities and accommodations.

Ongoing research is addressing the management of migraine flare-ups and prevention of migraines. Many treatment medications available for adults are being studied for children as well. Maybe participating in one of these migraine studies is right for your child…

Sunscreen... With a Little Bit of Science!

sjohnson@cptrials.com (Sherry Johnson) — Wed, 05 Jun 2024 12:41:51 GMT

Sunscreen... With a Little Bit of Science!

As most kids are out of school and families spend a greater time outdoors, protection from excessive sun exposure is more important. While appropriate sun exposure is beneficial for the body’s vitamin D activation and positive effects on mood, protection from the harmful effects of the sun’s rays become essential. Aside from a sunburn, excessive sun exposure can contribute to skin cancers, pigment darkening, and photoaging. Per the American Academy of Dermatology, 1 in 5 Americans will develop cancer of the skin during their lifetime with excessive sun exposure contributing greatly to that stat. And skin cancer is one of the most preventable types of cancers.

So what are some of the ways to not just beat the heat but beat the sun? Avoiding the peak time (10am to 4pm) when the sun’s rays are strongest is a great start but not always possible. Wearing clothes that are UV-ray protective is a good option when having to be out in the sun. Look for a label that includes UPF- ultraviolet protection factor. This signifies the material blocks out some of the UV rays ranging from good protection (UPF15-24), very good protection (25-39), to excellent protection (40-50)…the higher the UPF, the greater the protection��.

Probably the most common way to beat the sun is using sunscreen- more importantly, using the right sunscreen the right way! Sunscreens help to protect us from sunburn reactions and are categorized by SPF- sun protection factor. So what do I need to think about when choosing a sunscreen? The American Academy of Dermatology recommends using a sunscreen with at least these 3 things on the label:

Minimum SPF of 30
Broad spectrum
Water/sweat resistant.

Water/sweat resistant label implies the SPF is adequate for about 40-80 minutes of activity in wet conditions. But this protection time decreases as sunscreen is rubbed off as most water activities will do. The sunscreen must be applied liberally in the beginning (15-30 minutes before sun exposure) and each time to all sun-exposed areas of the skin (up to max of every 2 hours). And remember you can still get sunburnt on cloudy days even when you can’t see the sun. Up to 80% of the sun’s rays can travel through the clouds down to our skin on these days!

What about the younger kids? The American Academy of Pediatrics does not recommend sunscreen use for babies under 6 months of age. Focus on keeping them in the shade, covered in cool clothing (such as that UPF clothing we already talked about), and wearing a hat. And hats are a great idea for all ages- find one with at least a 3” brim all the way around to help protect the ears and neck from the UV rays. Consider using a FUN-colored sunscreen with children to make it less drab for a parent to apply sunscreen.

Don’t forget to accessorize while protecting your eyes with sunglasses that are marked with at least 99% UV protection. And remember that lighter-colored skin is more susceptible to sunburn than darker skin. If you have sensitive skin, look for a sunscreen with “titanium dioxide” or “zinc oxide.”

From the Lab to Your Medicine Cabinet

sjohnson@cptrials.com (Sherry Johnson) — Tue, 06 Oct 2020 17:49:04 GMT

Understanding Clinical Trials and the Purpose of Volunteers

By: Marisa Sibley

Originally published in the May/June 2017 issue of Ellis County LIVING Magazine

When I was a child, I struggled with asthma. To help my condition, my doctor gave me an inhaler that contained a preventative asthma medication. It was easy to use and it helped make physical activities easier for me. I was able to play my favorite sports without fearing I wouldn't be able to breathe. This helped give me a better quality of life as a child. I no longer struggle with asthma, but I am thankful that there was a treatment available to help my condition.

For me it was an asthma medication and in inhaler. For some it may be insulin or a blood sugar monitor. For others it may simply be an over the counter medication for a common cold or a headache.

All medications of medical devices available for use by the general population are so only because of individuals who were first willing to volunteer to participate in clinical trials.

Clinical trials are research studies that seek to answer questions about medical treatments, medical devices or medical strategies. All medical treatments and devices start as ideas. Those ideas are then developed and tested in the laboratory. If the research on these new developments is promising and the Food and Drug Administration (FDA) approves further research testing, then the idea may move forward into clinical trials with human volunteers.

All potential treatments and devices are tested first in Phase 1 trials, which will only assess whether or not the products are safe for human use. If the products show to be generally safe, then the treatments or devices will continue into Phase 2 and 3 trials with larger numbers of volunteers. These trials continue to answer questions about safety, but also begin to assess how well a product works to improve patient outcomes, if it will benefit a patient, or if the product causes unexpected harm. The FDA monitors and reviews the research data on investigational treatments and devices very closely during all phases of clinical trials and can stop the trials at any time.

After all trials are completed, the FDA may or may not decide to approve a new treatment or device. Only after FDA approval will these ideas turned treatments end up in our medicine cabinets. Research then continues on these treatments or devices after they enter the marketplace.

There are many reasons why people choose to participate in clinical trials The top reasons include to advance medicine, to help improve the lives of others, to help improve their own medical condition or to supplement their own standard health care.

If you choose to join a clinical trial, you can expect to first be thoroughly informed about the study, what the study is testing, information about study appointments and procedures, potential risks and benefits, and your role as a participant.The study doctor, also called an Investigator, will assess whether or not you would be eligible to participate in the study. your eligibility may depend on your medical history, medications you are taking, or other diagnostic tests or exams.

Throughout the course of your participation in a trial, you can expect your health to be monitored very closely by the Investigator and the study team. This is done through a series of visits to the clinical research site before, during and after a study treatment or device is received or used. Since you are a volunteer, your study-related care is provided free of charge. You may also receive compensation for your time and travel.

Had no one ever participated in clinical trials for asthma, I may not have had access to a medication that helped my condition improve as a child. Clinical trials are the gateway to advancing medical knowledge and patient care for generations to come. Whether you are a healthy person or have a chronic medical condition, you can help to move medicine forward through participation in a clinical trial. It is truly a gift that keeps on giving.

If you are interested in participating in a clinical trial in the future or would like more information, reach out to your local clinical research site to speak with a member of the study team about how you can get involved.

Learn more at www.cptrials.com. You can reach her at (972) 937-1640 or marisas@cptrials.com for more information.

Hitting the Mark in Migraines

sjohnson@cptrials.com (Sherry Johnson) — Tue, 06 Oct 2020 17:43:18 GMT

Getting Help for Migraines

By: Marisa Sibley, CCRC

Originally published in the July/August 2017 Issue of Ellis County Living Magazine

I met Laura for the first time in the summer of 2015. She came to my office for her first visit as a volunteer for a clinical research study for migraine headaches. “How are you today?” I asked. “Not great,” she said. “I’ve had a migraine for three days. None of the medications I have used have helped my pain.” As we continued to discuss her condition, she informed me that she experienced a migraine headache nearly 20 days each month. Her condition was debilitating. It hindered her ability to work, to enjoy quality time with her family, and to perform normal, day-to-day tasks.

Laura was far from alone. According to the Migraine Research Foundation, 38 million people in the U.S. suffer from migraine headaches, with three times as many women experiencing symptoms than men. Migraine headaches are more severe than typical headaches. Besides being associated with costly healthcare, the condition also takes an economic toll, costing the U.S. an estimated $13 billion annually. During a migraine attack, an individual experiences pain that throbs or pulses, usually on one side of the head. They typically cause individuals to have sensitivities to lights and sounds, and may even cause blocked vision or dizziness. In addition to the pain, moderate to severe nausea and vomiting are common.

There are several different over the counter and prescription medications that are approved by the U.S. Food and Drug Administration (FDA) for use by individuals with migraines. These may include non-steroidal anti-inflammatory drugs (NSAIDS), triptans, or other non-migraine treatments. Despite their common use, these treatments are only designed to treat pain after symptoms of a migraine start.

Investigational new treatments that block calcitonin gene-related peptide (CGRP), a protein found in the body to be in high levels during inflammation, are making their way towards likely FDA approval for the treatment of migraine headaches. Treatments of this class are being developed to stop migraines before symptoms start. In clinical trials, these treatments have shown to have positive safety profiles and be effective in reducing the number of days each month an individual experiences a migraine headache.

At ClinPoint Trials, we were able to work with Eli Lilly and Company and patient volunteers from the community on a clinical trial for a treatment called galcunezumab, a CGRP antibody developed to prevent migraine headaches. In a recent press release, Eli Lilly revealed positive results in Phase 3 clinical trials for patients who experienced migraine headaches. These studies compared galcunezumab to placebo, an inactive substance. While the treatment did not completely stop patients from experiencing migraines, those that received it did experience significantly fewer headaches per month compared to patients that received placebo.

“Migraine prevention will be significantly improved with the emergence of treatments such as galcunezumab,” says Dr. Thomas Ledbetter, Principal Investigator at ClinPoint Trials. “While we were blinded to what treatment group the patients were assigned, we had several patients in this study who were so excited to have their migraines finally under control after years of suffering using traditional therapies.”

There is indeed hope for people like Laura that live with migraine headaches and cannot find a treatment that works for them. While it may be a few more years before we see new treatments for migraine headaches receive FDA approval and hit the market for use, we can hold onto hope that we are on the edge of a breakthrough.

Alzheimer's Awareness: Making Progress Together

sjohnson@cptrials.com (Sherry Johnson) — Tue, 06 Oct 2020 17:37:01 GMT

Alzheimer's Disease Awareness

By: Marisa Sibley, CCRC

Originally published in the November/December 2017 Issue of Ellis County LIVING Magazine

I remember sitting in my undergraduate neuroscience class listening to my favorite professor explain the intricacies of the human brain. As the most complex organ in the human body, it produces our every thought, action, memory, feeling and experience of the world. It was ironic to even consider wrapping my mind around its complexity. As medicine and technology has advanced over time, we have been able to study more and more about certain areas of the brain, how they function, and how they affect other parts of the body. Yet, there is still a great amount of information about the brain that is unknown. We have questions that we do not yet have answers to, which can be frustrating for individuals and families that are affected by neurological diseases like Alzheimer’s.

According to the Alzheimer’s Association, Alzheimer’s disease is the most common form of dementia, which is a general term for the loss of cognitive abilities, like memory, that negatively impact an individual’s daily life. An estimated 5.5 million Americans are currently living with Alzheimer’s disease. It is not a normal part of aging, although the greatest risk factor for the disease is increasing age. Alzheimer’s is a progressive disease with symptoms of memory loss and the lack of ability to carry on a conversation and respond to the environment. These symptoms worsen as time passes, which can be extremely frustrating for individuals and families that are affected.

Alzheimer’s disease is one of the most complex diseases clinical researchers have ever studied. Just as the brain is complicated, the disease is complicated. Current treatments for Alzheimer’s only help to slow the worsening of symptoms, such as memory loss and confusion, and improve the quality of life for those with the disease and their family or caregivers. There are no current medicines that treat the underlying cause of the disease. However, clinical researchers are going boldly in their efforts, seeking to pinpoint what causes Alzheimer’s and working to develop better ways to not only treat the disease but to prevent it from developing.

Alzheimer’s disease and other dementias are estimated to cost the United States health care system over $259 billion by the end of 2017 with costs projected to increase into the trillions of dollars by 2050. The research industry is therefore racing to develop new treatments for the disease. PhRMA, an organization that supports the search for new treatments and cures for disease, reports that there are 87 potential new treatments in clinical trials regulated by the Food and Drug Administration for Alzheimer’s disease. Researchers are currently focusing on developing treatments that, for example, target the immune system to enable it to fight the disease or help to lower inflammation in the brain, which has been found to be associated with Alzheimer’s disease.

“For years, research has been focusing on the symptoms of Alzheimer’s disease. We are on the edge of discovering the root cause of this terrible illness. 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.” – Dr. Thomas Ledbetter, Medical Director at ClinPoint Trials

The number of new treatments being studied in clinical trials for Alzheimer’s will continue to rise as we learn more about the science of the disease. Since 1998, here have been 123 potential treatments halted in clinical trials while only four treatments were approved by the U.S. Food and Drug Administration. Despite the frustration of these setbacks, the knowledge gained about the disease and about what treatments show promise versus those that don’t is critical to the advancement of medicine for Alzheimer’s.

“The number of treatments in the research pipeline for Alzheimer’s alone is hope enough that there will one day be a cure for the disease. It is exciting to consider that our very own neighbors may soon be able to have an opportunity to take part in finding a cure by participating in clinical trials for Alzheimer’s disease.” – Sherry Johnson, BSN, Site Director and Research Nurse at ClinPoint Trials

It is crucial for all of us, as we all know individuals affected by Alzheimer’s, to keep watch of opportunities to participate in clinical trials for the disease. ClinPoint Trials hopes to provide these opportunities to participate in finding the cure for Alzheimer’s to individuals in the Ellis County and surrounding areas in the near future.

November is National Alzheimer’s Disease Awareness Month. Visit www.alz.org and www.PhRMA.org to learn more.

Learn more about ClinPoint and opportunities to participate in clinical trials at www.cptrials.com .

Winning the Battle Against Diabetes

sjohnson@cptrials.com (Sherry Johnson) — Tue, 06 Oct 2020 17:30:40 GMT

Fighting Diabetes + Winning

By Marisa Sibley, CCRC

Originally published in the January/February 2018 Issue of Ellis County LIVING Magazine

“The greatest victory is that which requires no battle.” – Sun Tzu, The Art of War

I was introduced to Type 2 Diabetes as a young child. Not because I struggled with the condition, but because I had family members who did. I watched them take daily medication, check their blood sugar throughout the day, and eventually perform insulin injections before they would eat their meals. Unfortunately, all of these things were necessary to help manage their condition and help their bodies function properly.

In 2015, 30.3 million Americans, or 9.4% of the population, had diabetes. This is a number that has only continued to rise. However, what is perhaps even more staggering is the number of individuals with pre-diabetes (i.e. blood glucose levels higher than normal but not high enough to be diagnosed with diabetes). According to the Centers for Disease Control and Prevention (CDC), approximately 86 million Americans age 20 and older (37% of the population) have pre-diabetes.

This equates to 1 out of every 3 people. Of this group, 90% don’t know they have it.

“Diabetes can lead to potentially serious health complications. Generally, the effects of high blood sugar are separated into vascular complications such as blocked arteries in the heart, legs, and brain leading to heart attack and strokes, as well as damage to the kidneys, nerves in the feet, and blindness. Individuals with pre-diabetes still have the opportunity to change the course of their health through prevention efforts.” – Dr. Thomas Ledbetter, Medical Director and Principal Investigator

Prevention of diabetes starts with understanding how our bodies function and how the condition develops. When we eat, our bodies break down the carbohydrates in our food into a sugar called glucose. Our pancreas releases a hormone called insulin, which acts as a key to let this glucose into our cells to use for energy to function. For individuals with pre-diabetes, the cells don’t respond normally to insulin. That is, the body develops a sort of resistance to insulin. In effect, the pancreas attempts to make more insulin to try to keep up with the amount of glucose in the blood and get the cells to respond to insulin’s message. Eventually the pancreas cannot keep up with the demand, leading to the amount of glucose in the blood to rise and setting the stage for Type 2 Diabetes down the road.

So what can we do to prevent developing diabetes?

Maintain a healthy weight . Research suggests that an overweight person losing 7% of their body weight can lower their risk of developing diabetes by 60%.
Engage in a physical activity you enjoy at least five days out of the week for 30 minutes per day.
Nourish your body by eating well and intuitively. Pay attention to your physical signal for hunger, eat slowly, and stop eating when you are full. Consider incorporating fiber-rich fruits and vegetables, whole grains and legumes, and lean proteins like chicken or fish into your meals.
Limit the intake of added sugars. The average adult needs 6-11 servings of carbohydrates per day according to the National Dietary Guidelines. Depending on your height and weight, activity level and gender, your intake needs may vary. A Registered Dietitian (RD) can help you assess your specific carbohydrate and other macronutrient needs.
Check your blood sugar and HbA1c , which is a value that reflects your blood glucose levels over an average of three months. This can be done with a simple blood test.

I am 25 years old. I want to believe that I have a long, healthy life ahead of me. This may be out of my control. For example, a contributing factor to the development of Type 2 Diabetes is genetics. Diabetes runs in my family, so I am certainly at risk. However, regardless of outcomes, I believe that my choices today matter. All of us, but especially my generation, have the opportunity to engage in an exciting victory against pre-diabetes, avoiding the battle all together through efforts of prevention, potentially changing the health of our population for generations to come.

ClinPoint Trials will be hosting free health screenings for adults, starting January 19th and 20th, 2018. Assessments will include, but are not limited to blood pressure, blood glucose, and HbA1c. Call (972) 937-1640 to schedule your free health screening today.

If you have been diagnosed with Type 2 Diabetes, you may qualify for a clinical research study. Call the ClinPoint Trials offices for more information about upcoming studies for Type 2 Diabetes.

What To Know About Anemia and Kidney Disease

sjohnson@cptrials.com (Sherry Johnson) — Tue, 06 Oct 2020 16:48:40 GMT

Anemia + Kidney Disease: What To Know

What is Anemia?

Anemia is a medical condition characterized by a short or low supply of red blood cells. Red blood cells are responsible for carrying oxygen from your lungs to the rest of your body. This gives you the energy you need for all sorts of daily activities.

What Are the Symptoms of Anemia?

There are several symptoms associated with anemia.

Looking pale or feeling tired/low on energy
Having a poor appetite
Having trouble thinking or difficulty thinking clearly
Experiencing dizziness, headaches, rapid heartbeat or short of breath
Feeling depressed

How Do You Know if You Have Anemia?

You cannot rely on symptoms alone to know if you have anemia. Not everyone experiences symptoms. A great way to find out if you have anemia is to have your doctor perform a simple blood test to measure your hemoglobin level. This should be done at least once per year. Hemoglobin is the part of the red blood cells that carry oxygen from the lungs to the rest of your body. Low hemoglobin levels often determine a diagnosis of anemia.

What Causes Anemia + How Do You Treat It?

The way anemia is treated depends on what it is caused by, which can vary person to person. If anemia is caused by chronic kidney disease, treatment options usually include drugs called erythropoiesis stimulating agents (ESAs) and extra iron supplementation. ESAs assist in the production of red blood cells and are usually injected under the skin. If you have low iron levels, your body doesn't have adequate resources to make red blood cells. Low iron levels also cause ESAs to not be as effective as they could be. Iron supplements may be provided in pill form or as an infusion directly into a vein.

What Causes Someone With Chronic Kidney Disease to Get Anemia?

The kidneys are responsible for making a very important hormone called erythropoietin (EPO). Hormones act as messengers that help you to stay healthy. EPO drives the body to make red blood cells. Someone with kidney disease doesn't make enough of the EPO hormone. As a result, the red blood cell count drops and anemia is developed. It is an extremely common issue for individuals with kidney disease. Anemia can develop at any stage of kidney disease, and is especially common in individuals that have diabetes, are African-American, have moderate or severe loss of kidney function (stage 3 or 4 chronic kidney disease), have kidney failure (stage 5 kidney disease), or are female.

Visit with your doctor for more information about anemia and chronic kidney disease.

If you have been diagnosed with anemia due to chronic kidney disease, you may qualify for a clinical research study. Call the ClinPoint Trials offices at (972) 937-1640 for more information.

What to Expect When You're a Clinical Trial Volunteer

sjohnson@cptrials.com (Sherry Johnson) — Tue, 06 Oct 2020 16:38:12 GMT

What Can You Expect as a Clinical Trial Volunteer?

May 4, 2018

By Marissa Sibley, MS, CCRC

Originally published in the May/June 2018 Issue of Ellis County Living Magazine

The experience of participating in a clinical trial is often misunderstood. When I talk to people unfamiliar with clinical trials about participation, the first response I usually receive is, “You want me to be a guinea pig?” Being a human lab rat is the most common stereotype associated with participating in a clinical trial, unfortunately due to historical bad examples. Today clinical trials are highly regulated and monitored to assure that research is ethical and that the safety of the participant is protected to the fullest extent. So let’s clear the air. What is it really like to participate in a clinical trial?

Volunteering for a clinical trial will always start with informed consent. Informed consent is the process by which you learn the details about a clinical trial in order to make an informed decision about whether participating is right for you. We start with the informed consent document. This document provides an in-depth look at the purpose of the research study, information about the medication or product under investigation, the study procedures, your responsibilities as a volunteer, risks, benefits and more. The consent document is not a contract, but you must sign it to state that you have read and understand the information in order to participate in a clinical trial. Through the duration of a trial, you can ask questions to the Investigator (Doctor) and his/her study staff at any time. The important thing to remember is that your participation is voluntary, and you can choose to withdraw from the study at any time and for any reason.

Once you have agreed to participate in a clinical research study, you will be asked to come to the research clinic for a number of visits. Depending on the length of this study, this could be only a couple of visits up to several over a long period of time. At each visit, you will receive the study medication, laboratory tests (for example, HbA1c for Type 2 Diabetes studies), ECGs and vital sign assessments, and physical examinations/visits with the doctor at no cost. Participating in a research study may also involve keeping a diary or completing questionnaires about your health. Your health is followed very closely during a research study, perhaps in more depth than you would receive as standard care. Once a study is over, follow-up care is also provided. This may include alternative treatments that are available, learning more about your condition, and any other information about your participation in the study that may be available (for example, results of the trial).

At the end of the day, our thoughts and perceptions of clinical trials tend to stray far from the reality of what it is like to participate. Our physicians at ClinPoint Trials, Dr. Ledbetter, Dr. Pickens, Dr. Linguist and Dr. Haque, are passionate about seeing medicine advance and call on our community to learn more about how they can be involved in advancing medicine for the future generations. If you are interested in learning more about clinical trials or participation, contact or visit the ClinPoint Trials offices.