Who Oversees Clinical Trials?

Clinical trials are carefully conducted studies—using human volunteers—which are used to test potential medical treatments with an end goal of receiving an FDA approval for usages in a wider population. Any and all medical breakthroughs currently being used have, at some point, gone through the close observation during the clinical trial phases process. Because these treatments are being used on real subjects, it is important that these clinical trials are conducted in safe, ethical ways.

What are clinical trial regulations?

Before clinical research ensues, it must first be approved by an institutional review board (IRB). When conducting clinical trials, researchers should maintain communication with their study participants. Before volunteering to participate in a clinical trial, be sure that you are able to answer all of the important questions and that you know exactly what to expect. These should be laid out clearly in an informed consent form, which includes a summary of the clinical trial, treatment procedures and schedules, and risks and benefits. It will also lay out all of your rights as a volunteer, including the right to leave the study at any time.

How are clinical trial regulations enforced?

A Data Safety Monitoring Board (DSMB), which is a group of research and study topic experts, is required for all National Institutes of Health phase III clinical trials, in addition to earlier phase trials which involve more high-risk treatments. The DSMB reviews clinical trial data for any safety issues or differences in results among certain groups. Some trials may also be stopped early by the DSMB if they are causing harmful effects or revealing patient risks.

What is a Principal Investigator?

A Principal Investigator (PI) is the person in charge of conducting a clinical trial. The PI is responsible for ensuring that the study is following all regulatory requirements and meeting the international recognized standards for Good Clinical Practice (GCP). The PI is also responsible for making sure that all volunteers receive appropriate medical care related to the clinical trial.

What does it take for a study to become FDA-approved?

Before beginning a clinical trial, researchers must first submit an Investigational New Drug (IND) application to the FDA. This application should include data about side effects that may cause harm, manufacturing information, clinical protocols, and any prior human research data.

The FDA may be involved at any point in the drug development process—before completing an IND application, during the study (for guidance), and after the study to assess results. Developers may ask for help at any time, but are not required to take the FDA’s advice.   FDA-approval of the medical treatment itself takes place within a structured framework including analysis of target condition and currently available treatments, evaluation of benefits and risks from clinical research, and strategies for managing risks.  How can I learn more?

ClinicalTrials.gov and CenterWatch.com provide listings for clinical trials which are recruiting participants. Additionally, your own doctor and/or community hospital may be involved in clinical trials. You can always contact us to inquire about current research volunteer opportunities.

What Is the Placebo Effect?

“I’m a Cub Scout Camp Leader. When the kids start crying and want to go home, we just give them ‘homesick medicine’,” reads a submission on PlaceboArchive.org. “The kids always feel better within 15 minutes. The medicine is Tic-Tacs.”

“I was cutting onions one day, appreciating my contact lenses as they keep me from tearing up,” reads another submission. “After about a minute, I realized that I didn’t have my contact lenses in… I started tearing up within five seconds.”

The Power of the Mind

Our minds can do incredible things—they can even influence the ways our bodies respond to different situations. Similar to the above situations, many of us have likely experienced everyday examples of placebos: anything that seems to be a medical treatment, but isn’t. This phenomenon, called the “placebo effect,” is a significant part of clinical research.

While there are as many types of placebos as there are methods of medication, what all placebos share in common is that they do not contain any substances which affect health or wellbeing. In fact, many placebo pills are simply composed of sugar.

Why Use Placebos in Clinical Research?

Placebos, often used in studies of medical treatments, are used in clinical research as a controlled variable to test the effectiveness of said treatments. Volunteers in clinical trials will often be divided into groups; one group would receive the treatment in question, and the other would receive a fake treatment—the placebo—without knowing which one they are receiving. Researchers can then accurately compare the results of the experimental drug with the results of the placebo. If they both have the same reaction, this generally means that the drug is not effective.

The Placebo Effect
Ideally, volunteers in clinical trials would have no response to placebos, thus being able to determine the effectiveness of a studied drug with full accuracy. However, people can—and often do—have responses to placebos. One theory is that the placebo effect occurs because of a person’s expectations. If a volunteer in a clinical trial believes they are receiving a studied drug, they will likely expect the drug to do something. That person’s body will then be influenced to create similar effects to that of the actual drug.

The Placebo Effect: Helpful or Harmful?

For years, the placebo effect was considered to be an obstacle to overcome in clinical research. However, attitudes have evolved and researchers are looking into ways to utilize the placebo effect to its fullest potential. While the placebo effect may not speak directly to the effectiveness of a studied drug, it does speak to the complexity of our brain and body chemistry; the expectations which cause the placebo effect may involve genuine changes in brain chemistry, which cause a physiological reaction.

The placebo effect has opened doors to further research on the brain: if expectations of a medication can cause both positive and negative physical reactions, what else can our brains do?

Learn More About Clinical Studies

ClinicalTrials.gov and CenterWatch.com provide listings for clinical trials which are recruiting participants. Additionally, your own doctor and/or community hospital may be involved in clinical trials. You can always contact us to inquire about current research volunteer opportunities.

How Does Clinical Research Help Find Cures?

Spanning more than 200 countries and 50 states, clinical trials explore new, experimental therapies and medicinal treatments that will impact medicine for centuries to come. These treatments can range from new standard pill capsules to medical devices, from vaccines to blood products or gene therapies, and even behavioral or surgical procedures; but, every study Improves researcher’s understanding of the way drug therapies affect common ailments.

Some of the exciting breakthroughs that researchers are currently working on include:

  1. A new drug to treat Parkinson’s disease emerged in the medical world earlier this year after a clinical trial conducted by Newron Pharmaceuticals;
  2. A cancer treatment was recently approved after being produced by Novartis Pharmaceuticals;
  3. Studies are being conducted for slowing down and treating Alzheimer’s disease;
  4. Science backing the usage of daily vitamins and dietary supplements to prevent or slow illness would not exist without clinical trials.

But in order to conduct groundbreaking research, clinical researchers must first go through a lengthy process before study participants even enter the equation.

Preclinical Treatments

Before beginning clinical research among humans, drug developers must first conduct preclinical treatments either in a lab or with animals—in vitro or in vivo. They must then submit an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA).

The IND must include, but is not limited to, data from the preclinical trials and specific protocol for the study in question including volunteer selection criteria, length of study and whether there will be a control group. It is only after preclinical treatments, IND application approval, carefully monitored clinical trials and submission of a New Drug Application (NDA) that new medical treatments can be approved by the FDA.

Clinical trials are conducted in an attempt to answer questions about potential drug development:

  • How is it absorbed/distributed/metabolized/excreted?
  • What are the potential benefits and/or side effects?
  • What is the best dosage and usage method?
  • How are people of different groups (race, gender, age, etc.) affected?
  • How does it interact with other drugs or treatments?
  • How does it compare to similar drugs?  

Study Length

The duration of a clinical trial can range from several weeks to several years. Once a study is completed, it will take even more time to analyze the data and summarize the results, often in an academic or medical journal.

Many studies listed on ClinicalTrials.gov will include a summary of results within a year of the study’s completion. Even if the results did not quite meet the goals of the researchers, it is important to continuously share the results in order to keep researchers asking questions and moving forward in the research process.  

Significant breakthroughs in medical research have only been possible because of the participation of volunteer participation—healthy and unhealthy—in clinical trials.

Learn More About Clinical Research

ClinicalTrials.gov and CenterWatch.com are just two resources for finding clinical trials that are actively recruiting participants. Additionally, you can ask your own doctor or community hospital if they are involved in clinical trials, or check out the website of an organization focused on a specific disease or disability.

OCRC offers opportunities to become involved in clinical trials and research study, which can be found on our Current Studies page. You can always contact us to inquire further about volunteer opportunities.

How Does Clinical Research Help Improve Disease Management?

How Does Clinical Research Help Improve Disease Management?

For individuals struggling with physical pain, discomfort and pain management are a regular part of daily life. Chronic illness prevents millions of Americans from living their lives the way to their fullest and participating in the activities that would otherwise offer fulfillment.

But, the good news is that scientific advancements can truly make a difference in people’s lives. The innovative world of medical devices and joint replacements have revolutionized the way that people get around and the quality of life they experience. Also, when you participate in a clinical study, your contribution may improve healthcare for future generations to come.

Clinical Research Helps Improve Disease Prognosis

With every new study, researchers are providing more comprehensive treatment options for individuals managing chronic conditions. Here are some specific illnesses that clinical researchers are working to treat:

With regard to Neuromuscular diseases, clinical trials play a key role in the discovery and development of new treatments for neuromuscular diseases, like Parkinson’s disease. The National Parkinson Foundation (NPF) has been participating in one of the largest observational studies ever. Regarding their research, they note: “discoveries made in the laboratory can help people with Parkinson’s today and in the future. NPF is at the forefront of Parkinson’s research, and clinical studies are central to our vision. Every year, insights from the Project help optimize Parkinson’s care, leading to better quality of life for people with Parkinson’s today and better health for people with Parkinson’s tomorrow.” 

Additionally, the Muscular Dystrophy Association (MDA) has stated: “we know how critically important clinical trials are to finding treatments and cures, which is why we’ve committed, by 2020, to doubling our research investment in clinical trials and drug development.”

Another group of people who are directly impacted are those with Mesothelioma. According to the Mesothelioma center, “Clinical trials provide patients with access to cutting-edge treatments that can make a difference in their life expectancy, and they also play an essential role in future advancements in the fight against asbestos cancer.”

According to the National Center for biotechnology Information, the discovery of Herceptin, a commonly-prescribed antibody for individuals with breast cancer, was based upon research gathered from “a cohort of more than 9,000 breast cancer patients whose tumor specimens were consecutively received at the University of San Antonio.” This targeted therapy has prevented the growth and spread of breast cancer cells in women across the country, and is also prescribed to disrupt certain types of stomach cancers.

Many other forms of cancers are being addressed by clinical researchers. For a complete list of clinical study options, visit clinicatrials.gov.

Consider Being a Part of a Clinical Trial

At OCRC, we offer a variety of clinical trials and research studies in which you can participate in our state-of-the-art clinical research facility. The Phase I-IV clinical trials that we specialize in range from a few days to a few months. All study volunteers receive all treatments and medical care related to the trial. Additionally, participants may be compensated for their time and travel. Health insurance is never a requirement for participation.

If you are interested in volunteering, please tell us a little more about yourself in the Current studies section of the home page and we will contact you to determine your eligibility for current and future studies.

Five Ways Clinical Research Helps Improve Medical Treatments

Five Ways Clinical Research Helps Improve Medical Treatments

The clinical research data gathered today will help pave the way for an improved understanding of disease and illness in the future. Both Researchers and manufacturers are continually making progress on new medications that will one day be prescribed to patients. Through scientific advances and trial and error, researchers are uncovering answers to complex health problems that millions of Americans face. Here are just a few ways that clinical research helps improve the latest medical treatments:

1. Generate scientific data

Researchers go to great lengths to understand how medications will impact segments of the greater population. Because no two people are alike – we all have unique DNA, environmental stresses and lifestyles – it is important that clinical trial data is representative and encompassing of all of these factors.

For instance, according to the National Institute of Health, women are more likely to struggle with depression, osteoarthritis and kidney disease. With these genetic predispositions in mind, the data researchers obtain about the effectiveness of associated treatments or therapies in women is particularly important.

2. Help researchers determine the effectiveness of current medical therapies and treatments

When testing a new medication or therapy, researchers look into the medication’s efficacy, potency, dosage, side effects and psychological impact on study volunteers. Healthy volunteers are imperative for researchers to fully understand the safety and effectiveness of new treatments that may one day potentially prevent, treat or cure diseases.

3. Contribute to scientific breakthroughs

Clinical trials are the testing grounds for future therapies and medications that will help improve the management of serious health conditions. The data gathered in clinical trials helps researchers better understand the effects of disease and illness on the body, and which medications offer the best treatment.

Many of today’s medical advances are the direct result of clinical trials. Researcher’s findings can help uncover cures for illnesses, enabling people to live longer and healthier lives.

4. Increase knowledge of disease progression

Many clinical studies address the ways illness progressively impacts the body. This information may help researchers identify superior intervention methods, which can contribute to an increased patient life expectancy and better quality of life.

Doctors also provide guidance and care, free-of-charge, and the patients provide doctors with important data. For individuals who meet the specific study criteria, this relationship can be particularly beneficial.

5. Help improve the lives of those with illness

Many clinical trial participants find it gratifying to help facilitate medical advancements that will improve lives, and possibly saves lives, down the road. According to National Institutes of Health (NIH), “Participants with an illness or disease also participate to help others, but also to possibly receive the newest treatment and to have the additional care and attention from the clinical trial staff.”

Life can be tough for individuals with chronic illnesses. The hope for a cure or a new therapy never fades and the more people who sign up for clinical trials, the better researcher’s odds are for finding new treatments.

Read more about cutting-edge medical innovations in our related blog, “The Latest Clinical Trial Innovations & Technologies.”

Research Toolbox: Nephrology

Research Toolbox: Nephrology

Not to be confused with nephology, the meteorological study of clouds, nephrology is a branch of medicine focused on kidney health and damage prevention. Because kidney disease is considered by many to be “a silent killer,” nephrologists typically work with patients to keep kidney functionality within a healthy range for their age. When the kidneys can no longer sufficiently cleanse the blood, nephrologists employ an artificial method of removing impurities and waste, known as dialysis.

What do nephrologists do?

Simply put, nephrologists are kidney doctors. The kidneys play such an important role in cleansing the blood that this special group of doctors undergoes additional training to comprehensively understand the outlook for individuals with kidney damage.

In practice, nephrologists rely heavily on urinalysis, or urine analysis, to detect signs of disease and declining health. Per Wikipedia, they also look for “blood in the urine (haematuria), protein in the urine (proteinuria), pus cells in the urine (pyuria) or cancer cells in the urine.” 

How do nephrologists aid in the prevention of kidney damage?

According to Wikipedia, “Nephrologists may provide care to people without kidney problems and may work in general/internal medicine, transplant medicine, immunosuppression management, intensive care medicine, clinical pharmacology, perioperative medicine, or pediatric nephrology.”

Because poor kidney functionality can cause a wide range of chronic illnesses, Nephrology specialists, or nephrologists, recommend a number of proactive measures to prevent kidney damage. Learn more about these preventative measures on our “What causes kidney disease?” blog post.

What is end-stage renal disease?

End-stage renal disease (ESRD) is the final stage of chronic kidney disease. It usually occurs after years of health problems like high blood pressure or diabetes. When the kidneys are no longer able to function and meet the body’s needs, end-stage renal disease sets in. ESRD may involve a kidney transplant for individuals who are deemed healthy enough for a transplant.

Where to find out more about kidney disease

  1. The National Kidney Foundation

“The National Kidney Foundation is the leading organization in the U.S. dedicated to the awareness, prevention and treatment of kidney disease for hundreds of thousands of healthcare professionals, millions of patients and their families, and tens of millions of Americans at risk.” Their website is an excellent kidney disease knowledge resource for those who are unfamiliar with the disease or are looking for proactive, preventative health measures.

  1. The American Kidney Fund

A truly philanthropic organization, the American Kidney Fund has assisted 1 out of every 5 kidney dialysis patients with health insurance premiums, transportation costs, & prescription medications since 1971.

  1. American Association of Kidney Patients

The American Association of Kidney Patients is dedicated to improving the quality of life for kidney patients through education, advocacy and the fostering of patient communities.” Active on social media and in Washington, D.C., this organization is particularly known for their advocacy and outreach efforts. Stay connected online and help make a difference in the kidney community.

Kidney disease clinical trial opportunities 

At OCRC, we work closely with the FDA and pharmaceutical companies to determine how chronic kidney disease affects they way medicines move through the body and are removed from the body. We are currently looking for participants for our Kidney disease study.

Volunteer qualifications include:

  • Ranging in age between 18-80
  • Presently have kidney impairment or disease

What Causes Kidney Disease?

What Causes Kidney Disease?

Approximately 26 million Americans live with kidney disease, without their conscious knowledge of the condition. Additionally, one in every three Americans are at risk for developing kidney disease. Many individuals overlook the symptoms of kidney disease because the signs are nonspecific and similar to other illnesses. High-risk individuals must have regular screenings, but anyone can have kidney damage without their knowledge.

A look at the underlying causes of kidney disease

The two leading causes of kidney disease have historically been high blood pressure and adult onset diabetes. However, recent research has indicated that acid reflux may result in a 20-50% increase for the development of kidney disease.

The treatment of Acid reflux, or heartburn caused by indigestion, involves preventative medications like Prilosec® (omeprazole), Nexium® (esomeprazole), or Prevacid® (lansoprazole). According to researchers at Johns Hopkins University, people who took two daily doses of these medications “had a higher risk compared to once daily dose users.”

Additionally, when certain medications are consumed over an extended time period, they can have a damaging effect on organs like the kidneys. Even common over-the-counter remedies like antacids or pain killers like ibuprofen can actually damage the kidneys when consumed excessively.

Kidney disease contributes to a number of chronic health concerns

Poor kidney functionality can cause a wide range of chronic illnesses. Here are some of the more common conditions associated with kidney damage and disease:

  • Heart disease: The leading cause of death of both men and women in the United States, heart disease symptoms include diseased vessels, structural problems, and blood clots. It results after the buildup of plaque in the arteries, which thickens and stiffens the walls of the organs and surrounding tissues.
  • Kidney failure: The final stage of chronic kidney disease, this condition exists when kidneys can no longer support the body’s needs. Once approximately 10-15% of kidney function remains, doctors may recommend dialysis or an organ transplant.
  • End Stage Renal Disease: After normal kidney function has been compromised, kidney disease results. Chronic kidney disease may lead to renal failure, or ESRD. This condition is very serious. According to healthline.com, “Without treatment, you may only be able to survive without your kidneys for a few months”
  • Bone disease: This condition may develop when certain substances, such as calcium, phosphate or vitamin D build-up within the body.
  • Anemia: Pale skin, weakness and chronic fatigue are commonly occurring side effects of this condition; which results when the body experiences a deficiency of erythropoietin, the hormone necessary to make new red blood cells.

Take preventative measures to avoid kidney damage

Keeping your body in overall good health is very important in the prevention of kidney damage. Like the old adage goes, “be good to your body and your body will be good to you!” Additionally, the following recommendations will help ensure the kidneys remain healthy well into old age:

  • Keep high blood pressure in check: Normal blood pressure helps ensure the kidneys are healthy and functioning normally. When blood pressure increases beyond what is considered healthy, the kidneys are forced to work harder and over time, the organs become less efficient at cleansing the body.
  • Monitor your cholesterol levels: Weight, diet, gender, alcohol use, stress levels and background are all factors in the development of high cholesterol. Exercising regularly and healthy eating habits are the best ways to prevent high cholesterol levels. Liver, thyroid and kidney health may also affect cholesterol levels.
  • Cease tobacco usage: Smoking or tobacco usage can cause a number of avoidable health problems like certain cancers, atherosclerosis, high blood pressure, and heart disease.
  • Stay at a healthy weight: Maintaining a healthy weight will help you avoid diseases like diabetes, high blood pressure and heart disease.
  • For more information about kidney disease prevention, visit our blog here and learn about the science behind kidney functionality and nephrology.

5 Ways to Give Back to Your Community this Holiday Season

5 Ways to Give Back to Your Community this Holiday Season

With so many errands to run and presents to track down, it can be easy to overlook the spirit of the holidays. It’s important to spread joy and show your loved ones how much you care; but, don’t forget to take time for those who are less fortunate and unable to provide for themselves. Here are just a few different ways that you can make a difference in the lives of people who truly need your help.

  1. Volunteer at a local hospital

There are a number of ways you can bring a smile to the face of people in the grips of illness. Think about what your special talents and what ways you’d like to serve. Perhaps you play a musical instrument, or you’re an expert crafter, or maybe you’d like to read to children – whatever way you choose – know that someone out there will appreciate your efforts more than you realize.

Also, remember that hospitals treat patients around the clock. You can plan around your busy work schedule and find a window of time to dedicate to helping others.

  1. Donate a toy to a child in need

Every child deserves to feel special, particularly on a big holiday like Christmas. Unfortunately, with expensive medical bills, many parents simply cannot afford to provide gifts for their little ones. Things like DVDs, stuffed animals, video games, or electronics all make great gifts. It may seem like a small gesture, but for a family in need, outside help lessens the financial responsibilities associated with gift giving.

  1. Give blood

Organizations like the American Red Cross look for blood donors year-round.  Every time an individual donates blood, they are literally saving lives. Nearly all people can comfortably spare some blood without any adverse side effects. Those who do experience temporary lightheadedness or dizziness.

Giving blood is particularly important if you a universal blood type. O blood types (positive and negative) are universal, meaning that can be transfused to any blood type.

  1. Donate supplies to our veterans

Give back to those who serve and sacrifice for our great nation. Organizations like the Disabled American Veterans (DAV) help soldiers get back on their feet after they return home from duty.

Two popular ways to help include: providing hospitals with assistance and finding meaningful ways to thank the vets for their services. Hospitals, nursery homes and clinics all rely upon volunteers to perform small, but important tasks. Appreciation for vets can come through assistance with housework, yard work, grocery shopping, or just being a friend and lending a sympathetic ear.

  1. Participate in a clinical trial

Many of today’s advances are direct results of clinical studies, and because of the diligent work of researchers, people have lived longer and healthier lives. These trials are the testing grounds for the future therapies available to the American public, and the medications that help improve drug management.

Clinical trials generate new scientific findings, leading to new innovations that can change the future of modern medicine. Additionally, improved medical care and treatment options for common diseases like diabetes, leukemia and lymphoma can truly impact millions of people.

If you are interested in participating in a clinical trial, please tell us a little more about yourself in the Contact section of the home page and we will respond to you to determine your eligibility for current and future studies.

What Causes Low Testosterone Levels?

What Causes Low Testosterone Levels?

One in every six American men experiences low testosterone levels. The condition is so common that Low-T (as it’s abbreviated) affects approximately 13-15% of all American men. Most people who have not personally managed Low-T levels may be familiar with the hormone testosterone, but may not grasp the symptoms and prevalence of the condition. Read below to learn more about how this important hormone affects male and female physical development. 

What Is Testosterone?

A hormone found in both genders, testosterone is present in much higher levels in men than women. As boys mature during puberty, the testicles produce increasingly more testosterone. Many physical changes accompany this time period, including deepening of the voice, the presence of facial and body hair and increased height and body mass.

What role does testosterone serve?

According to Healthline.com, “testosterone stimulates sperm production and a man’s sex drive and also helps build muscle and bone mass.” Testosterone is responsible for red blood cell production and fat distribution throughout the body. It is also a required hormone for the creation of babies.

Within the ovaries, women’s bodies produce a fraction of the amount of testosterone that men’s bodies need. Known as a sex hormone, this hormone affects bone mass, reproductive tissues, growth and behavior.

What are the symptoms of low testosterone?

After age 30, the male body slows down production of the hormone and testosterone levels decrease every year thereafter. As levels continue to drop, men can experience fatigue, low sex drive and a decrease in muscle tone and mass.

Some of the physical changes associated with low testosterone are:

  • Increased body fat (especially around the mid-section)
  • Decreased libido or sex drive
  • Bone fragility
  • Exhaustion or malaise
  • Altered cholesterol
  • Lowered sperm count
  • Insomnia or sleep apnea
  • Hot flashes

Additionally, certain conditions like testicular cancer, COPD, obesity, diabetes, HIV, kidney or liver disease, or drug addiction can exacerbate the symptoms of low testosterone. If low testosterone levels are present in a patient, doctors will monitor hormone levels via urine or blood tests throughout treatment.

Early detection of Low-T: Watch for these symptoms

  • Note a sharp decrease in libido or erectile dysfunction

A dramatic decrease in sexual desire or difficulty maintaining an erection can be signs of low testosterone. Per Healthline, “Testosterone alone doesn’t cause an erection, but it stimulates receptors in the brain to produce nitric oxide — a molecule that helps trigger an erection. When testosterone levels are too low, a man may have difficulty achieving an erection prior to sex or experience spontaneous erections (for example, during sleep).”

  • Pay attention to your energy levels

Sudden moodiness, a lack of mental concentration or excessive fatigue may be attributed to low testosterone levels. You may notice that you are constantly tired, even though you sleep the same number of hours every night. Perhaps focusing on your work is growing increasingly difficult. Be sure to keep in mind that hormone levels can be at fault for the abrupt changes in your motivation.

  • Sudden weight gain or hair loss

Certain symptoms can have a variety of root causes. Weight gain and hair loss can be wrongly attributed to stress, however, in men over 50, low testosterone is often the culprit. Additionally, low testosterone levels can cause specific fat distribution patterns. One such pattern is known as Gynecomastia, which involves swollen or enlarged breast tissue. While this is not usually a serious medical issue, it can be frustrating or unpleasant for the individual experiencing the condition.

A Look Back at Modern Medicine: How Did We Get Where We Are Today?

A Look Back at Modern Medicine: How Did We Get Where We Are Today?

Hundreds of years ago, herbs and plants were used as natural remedies for everything from headaches to mouthwash to poor digestion. Leaves, nuts and berries, known as botanicals, were all cultivated in an attempt to cure disease.

We’ve come a long way since those days. Today, routine immunizations are administered to toddlers, and as adults, we head to the doctor for annual check-ups as a preventative health measure. Modern doctors and researchers are committed to furthering medical developments and collectively improving our quality of life.

Here is a timeline highlighting some of the most significant modern medicine innovations:

Germs as a Cause of Disease

Chemist Louis Pasteur, known for pasteurization, was the first to make the connection between microorganisms and disease. Prior to his groundbreaking work, germs known as pathogens were not acknowledged as a cause of illness. His research laid the foundation for researchers for years to come.

Smallpox

Smallpox was a viral disease, with symptoms including rash, pustules and flu-like feelings. In the late 18th century, physician Edward Jenner experimented with exposing patients to the cowpox virus. Jenner’s was the very first vaccination developed to help prevent the spreading of a disease. Many consider him to be one of the most influential members of immunology.

Fleming’s Breakthrough Penicillin Discovery

In 1928, Scottish scientist Alexander Fleming discovered the first true antibiotic, capable of killing microorganisms, or pathogens. To this day, penicillin is still commonly used to cure bacterial infections like staph or strep throat. Fleming would later receive a Nobel prize for his scientific contributions.

The “Flu Shot”

The first influenza vaccination was developed in 1933, after researchers determined that the illness was caused by influenza virus types A and B. According to eMedicine Health, the vaccination was used to protect US troops in World War II. These vaccines “were not as purified as more modern vaccines, and the impurities in vaccines were thought to contribute to side effects such as fever, aches, and fatigue.” Today, similar symptoms may appear after a flu shot, but rest assured, the vaccination is designed to prevent the virus.

Polio Vaccination

Jonas Salk is credited with developing the vaccine for polio, which he announced to the general public on a radio show in 1953. Polio was a debilitating viral disease capable of immobilizing anyone afflicted. Wealthy and poverty-stricken children alike contracted polio; with famous Americans like Franklin D. Roosevelt suffering from the crippling disease. Fortunately, the polio vaccination has been widely used since 1961 and the disease itself has been virtually eliminated in the U.S.

The First Heart Transplant

In 1967, the first successful heart transplant was performed by Dr. Christiaan Barnard, lasting just over six hours. This time-consuming, invasive surgery, relies on the replacement of an unhealthy heart with a healthy heart from a donor. In addition to saving countless lives, Dr. Barnard’s surgical advances paved the way for future organ transplants.

Hepatitis A, B, and C

Hepatitis spreads through bodily fluid contact, like blood, saliva or semen. The disease causes inflammation of the liver and can lead to cirrhosis, liver failure, and liver cancer. Per Wikipedia,” The first Hepatitis B vaccine was approved in the US in 1981.” Additionally, “The first hepatitis A vaccine was approved in Europe in 1991 and the United States in 1995.” Hepatitis A and B are both routine immunizations for young children and have been since 1994. There is no vaccine available as of yet for Hepatitis C, but several vaccines are currently under development.[2]

Modern day Innovations

Today, stem cell research allows scientists to generate organs for qualifying patients. Livers and artificial kidneys are being developed by doctors to prevent patients from the long and stressful wait for healthy organs. According to Discover Magazine, “by making embryos, then removing stem cells from the embryo and cultivating them to grow into tissues that could cure diseases, replace organs and heal injuries.”

Learn more about modern medical innovations in our related blog, “The Latest Clinical Trial Innovations & Technologies.”

What is kidney dialysis?

What is kidney dialysis?

Kidneys are small fist-sized organs on either side of the abdomen that purify blood and help rid the body of waste. You might not be fully aware of the importance of your kidneys, but they play an important role in your body. From regulating blood pressure and mineral balances to regulating fluids, to creating red blood cells; if your kidneys are impaired, your health and wellbeing will eventually be compromised.

What is dialysis?

Kidney dialysis is a common procedure designed to mimic the functionality of the kidneys. This life-saving treatment helps restore salts, removes waste and fluids in the blood, stabilizes blood pressure and helps the body reach a healthy balance.

What are the different types of kidney dialysis?

Hemodialysis patients typically visit a treatment center three times per week and stay between 2-4 hours. According to The National Kidney Foundation, patients visit “a special building that is equipped with machines that perform the dialysis treatment. Additionally, the hemodialysis machine “adds the proper materials to purified water for the dialysis machines.”

Peritoneal Dialysis, inversely, relies on a catheter or a tube to clean the blood internally. Blood remains within arteries and veins while it is filtered and the impurities exit the body via the catheter.

What are the symptoms of kidney damage?

Kidney damage signs include fatigue, frequent urination, itchy skin, tissue inflammation, excessive water retention, high blood potassium, shortness of breath, loss of appetite and anemia. Not all of these symptoms are present in all patients, and it is important not to assume that just because one or more of these symptoms are present that an individual needs kidney dialysis.

What is the purpose of kidney dialysis?

Proper kidney functionality is imperative to good health, mobility and longevity. When the kidneys are compromised, an individual’s waste will quickly build up within the bloodstream. Eventually, enough waste in the blood may lead to a coma or death.

Kidney dialysis helps treat:

  • Acute Kidney Injury: This condition may result from a sudden drop of blood flow, certain infections, serious urinary blockages or ingesting poison. Dialysis may only be temporary in this case, requiring just a few sessions.
  • Diabetic Kidney Disease: Patients with Diabetic Kidney Disease experience a “leak in abnormal amounts of protein from the blood into the urine,” according to patient.info. Healthy kidneys pass trace amounts of albumin to the urine stream. Additionally, “a raised level of albumin in the urine is the typical first sign that the kidneys have become damaged by diabetes.”
  • End-Stage Renal Disease: As the kidneys increasingly work to keep up with the needs of the body, Chronic Kidney Disease may develop. Diabetes and high blood pressure are often to blame for this serious health problem, which typically evolves over years. This condition may often precede a kidney transplant for patients who are blessed with a blood-type-matched donor.

Learn more about kidney disease

At OCRC, we are working to help create a better future for those impacted by chronic kidney disease. We are currently in need of volunteers for our Kidney disease study.

Volunteer qualifications include:

  • Ranging in age between 18-80
  • Presently have kidney impairment or disease

Currently seeing a nephrologist and taking medicine such as Procrit® or Aranesp® for low blood count, or PhosLo® or Renagel® for high blood phosphorus

If you are interested in participating, please tell us a little more about yourself in the Contact section of the home page and we will respond to you to determine your eligibility for current and future studies.

Clinical Research Toolbox

While Americans face unique health risks, thanks to modern clinical research and medical advancements, our overall life expectancy has increased in the past 100 years. Clinical trial participants provide researchers with invaluable data, but with so many different study options, it can be overwhelming to find the right study, with applicable requirements, in a convenient location. Here are a few different resources that prospective volunteers should bookmark to simplify the process of finding and signing up for a clinical study.

Clinicaltrials.gov

As a service of the U.S. National Institutes of Health, clinicaltrials.gov provides a full database of:

  • Currently-enrolling clinical trial studies;
  • Clinical study requirements;
  • Study glossaries and FAQs; and
  • Data and resources about clinical studies.

The website was established due to the Food and Drug Administration Modernization Act of 1997 (FDAMA). “FDAMA required the U.S. Department of Health and Human Services (HHS), through NIH, to establish a registry of clinical trials information for both federally and privately funded trials conducted under investigational new drug applications to test the effectiveness of experimental drugs for serious or life-threatening diseases or conditions.”

 

Stay informed with the clinicaltrials.gov full list of open clinical studies

This website aggregates all of the different clinical trials across the country. Currently, 229,011 studies are in progress across all 50 States and in 193 countries. Clinical researchers are looking for diverse participants – with study topics ranging from mental health to HIV/AIDS, to cancer to alcoholism. Anyone who is interested in clinical trials can sort the studies by topic, location, enrollment status or required pre-existing conditions.

 

The National Institutes of Health

The National Institutes of Health (NIH), “serves as the nation’s medical research agency — making important discoveries that improve health and save lives.” With a goal of promoting the health and wellbeing of Americans, the organization is made up of 27 different components, each which focus on a different part of the body or illness, with respective budgets, staff, and facilities. “Some research is performed on campus in state-of-the-art laboratory facilities, although more than 80% of research activities are conducted by scientists working in every state and around the world.”

Under the U.S. Department of Health and Human Services, the goal of NIH is to foster creative discoveries and innovative research to improve Americans’ health; develop, maintain and expand new scientific knowledge to help prevent disease; to hold researchers to the highest level of accountability; and to ensure the public’s return on investment with regard to research.

 

The U.S. Food & Drug Administration

The U.S. Food & Drug Administration, or the FDA, protects consumers health and wellbeing by regulating medications and medical devices, intended for consumption by the general public. The FDA is also “responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health.”

Additionally, the Center for Drug Evaluation and Research, under FDA authority, monitors all products consumers interact with – from whitening toothpaste to homeopathic lotions to back pain relief – medications across the board are reviewed by this important government agency. Visit their website to learn more about the latest drug technologies and approvals.

 

Learn more about the clinical study process

If you are interested in learning more about clinical trials, our staff at OCRC is happy to offer tours at our state-of-the-art clinic to volunteers who meet study criteria. Visitors receive a firsthand experience in our clean and stress-free space located in sunny Orlando, FL. Additionally, if any prospective clinical trial volunteers have questions or are seeking trials for a particular condition, we are available to help them find a location that may be recruiting, even if we do not have any related open studies.

Understanding the outlook for post-menopausal women

While menopause is a ubiquitous experience for women the world-over, the duration and intensity of the experience are as unique as the females themselves. When hormone fluctuations, night sweats, and insomnia subside and post-menopause sets in, new risks evolve for serious health concerns that all women should be aware of.

What is menopause?

At the onset of menopause, a woman’s estrogen levels will decrease, causing her menstrual cycle to change, and eventually conclude. Unless a woman had her ovaries removed at a young age, she will undoubtedly experience the symptoms of menopause.

Menopause happens in phases, typically beginning in a woman’s late 30s of early 40s. It frequently lasts around four years but can be longer or shorter depending on the individual. Additionally, once menopause occurs, pregnancy is no longer a viable option.

What are the signs of post-menopause?

Post-menopause usually occurs in a woman’s late 40s or early 50s. Women who have not had their period in over a year are considered postmenopausal.

While menopause only lasts a few years, post-menopause may actually stretch on for up to 10 years. During this time, the best way for women to combat their decreasing estrogen levels is to prioritize their health, diet and sleep habits.

What are the most common post-menopausal concerns?

Once the symptoms associated with menopause cease, it is important for women to monitor certain health concerns. According to the Cleveland Clinic, “as a result of a lower level of estrogen, postmenopausal women are at increased risk for a number of health conditions, such as osteoporosis and heart disease.”

Key concerns include:

  1. Risk for cardiovascular disease
  2. Bone density decline and/or osteoporosis
  3. Narrowing or hardening of the arteries
  4. Heart attack or stroke
  5. Unregulated salt intake, blood pressure or cholesterol

Women have unique health concerns as they age, and the same can be said of men. While men commonly struggle with prostate concerns or cancers, women need to keep an eye on bone density and breast tissue changes.

Take control of post-menopausal symptoms and experience

Here are a few tips to help you manage this temporary condition:

  1. Daily vitamins: Amazon offers a variety of different supplements specially designed for a woman’s changing needs.
  2. Education: Barnes & Noble offers many different books about menopause, authored by both doctors and every day women with helpful stories and tips.
  3. Stay active: Addressing cardiovascular health can dramatically improve energy levels, weight management, and life expectancy. There are a number of exercise routines and gyms to choose from, and there is a program suited to every woman’s unique needs.

It’s not all bad news…

The good news for all women is that there are extensive resources about this topic. Yes, there are additional concerns associated with menopause and post-menopausal health, but there are also a lot of positives, too. The days filled with cramps, acne breakouts, and unusual food cravings will be gone, along with concerns surrounding unplanned pregnancies. Changes associated with the aging process are inevitable, but a good attitude is the key to enjoying life to its fullest.

Five Things You Didn’t Know About Clinical Trials

Every year, researchers work with thousands of volunteers to collect new data about medications; and shortly thereafter, new treatments enter the marketplace in part, due to the impactful findings collected. Clinical studies are essential to the current U.S. drug-approval process, to establishing medication efficacy and safety, and to the future of medical innovation.

Here are a few interesting facts about clinical studies that you might not already know:

  1. Sponsors enlist the help of medical researchers to facilitate clinical studies

Sponsors manage and monitor clinical studies to ensure continual progress. Either an individual or an organization may sponsor a clinical trial, but this role is always critical to the study’s outcome.

Additionally, sponsors are in charge of:

  • Selecting and hiring a principal investigator entrusted to oversee the study;
  • Keeping the FDA apprised of study findings; and
  • Ensuring budget adherence and upholding investor relations.
  1. An Institutional Review Board (IRB) determines the viability and soundness of all newly-proposed studies.

An IRB determines which studies are approved for the respective clinical study phases, and also ensures the well-being of all participants throughout the clinical trial process. These researchers, doctors and members of the medical community defend the ethical rights of all study volunteers.

With volunteer safety and welfare being a top priority for Institutional Review Boards, trial protocols and research methods are closely examined to prevent any unnecessary risks or dangers.

  1. Medications are still monitored well after entering the market place.

Post-market surveillance examines the long-term safety and effectiveness of new medications and seeks to expose any previously unidentified side-effects. The Federal Drug Administration (FDA) explains, “These activities are designed to generate information to quickly identify poorly performing devices and other safety problems, accurately characterize real-world device performance and clinical outcomes, and facilitate the development of new devices, or new uses for existing devices.”

With regard to medical devices, the FDA also keeps a watchful eye on tracking, device malfunctions, injuries or deaths and product registrations.

  1. Many organizations reimburse participants for travel and time.

In addition to certain private organizations, the federal government provides clinical trial funding. Clinical research facilities have differing policies, and it is important to carefully review volunteer compensation and reimbursement policies prior to enrolling and participating in a clinical study.

At OCRC, all study participants receive study treatments and medical care related to the trial. Additionally, participants may be compensated for time and travel. Health insurance is never a requirement.

  1. Today, there are more than 226,579 clinical studies underway.

Clinical researchers work in many different locations, across all 50 states, to advance medical knowledge and to improve the health and wellbeing of the general population. Clinical studies are performed at hospitals, medical clinics and at cancer centers. This is often the case because of the innovative therapies available at cancer centers.

Researchers are currently looking for volunteers with diverse backgrounds, ages, ethnicities and health conditions to enroll in current clinical studies. Learn more at clinicaltrials.gov.

How Does The Body Metabolize Medication?

When medications make their way through the human body, they encounter different organs before finally being released in the bloodstream. While the process may sound straightforward, different drugs dissolve at different rates, different formulas, and dosages breakdown differently – and, everybody’s body metabolizes medication uniquely. These are just a few of the many complexities behind the nature of drug absorption and metabolism.

How does medication enter the bloodstream?

The vast majority of medications are taken orally and are broken down within the gastrointestinal tract. Once the medication arrives, it is broken down by stomach acids before it passes through the liver and then enters the bloodstream. Certain medications may stay in the bloodstream longer – it all depends on the dosage and drug family consumed. 

What factors influence medication absorption?

There are several factors at play when determining the overall time required for medication to fully digest. The following factors all impact an individual’s sensitivity to and absorption of medication:

  • Age
  • Weight
  • Gender
  • Time of day taken
  • Level of physical activity
  • Level of stress
  • Content of stomach and PH level
  • Presence of other medications

Gastric acids may prevent or slow the breakdown of certain medications. Additionally, when a medication is metabolized in the liver, its potency will decrease along with its effectiveness before the therapeutic reaches the bloodstream.

According to Merck, in order “to be absorbed, a drug given orally must survive encounters with low pH and numerous GI secretions, including potentially degrading enzymes.” This research exemplifies the reasoning behind doctor’s common orders to take a medication with a full stomach. There is science behind the reason why it’s advisable to follow his or her orders.

How long does it take for the body to absorb medication?

The method of drug consumption affects the rate at which the medicine travels throughout the bloodstream. The solubility of the medication also affects how long it will take for the medication to dissolve. In general, it typically takes approximately 30 minutes for most medications to dissolve.

When a medication is coated in a special coating – which may help protect the drug from stomach acids – often times it may take longer for the therapeutic to reach the bloodstream. For example, an aspirin may dissolve in a matter of minutes, while gel caps may take much longer, due to their gel coating. These pills may also be easier to swallow, so it is important to weigh the pros and cons of different medications.

How is medication administered?

  • A tablet, capsule or syrup taken orally
  • Tablets or pills dissolved sub-lingual
  • Medication Inhaled or droplets administered to eyes, ears, nose or throat
  • Injection via IV or intravenously in a vein
  • Rectal administration
  • As a patch or gel applied to the skin
  • Controlled-release

Certain medication forms are associated with more potent medications. For example, intravenous medications may be more potent than capsule. A sublingual tablet typically moves more quickly through the circulatory system, and is thus rapidly metabolized. The same is true of rectal medications, where a significant number of blood vessels are present.