New Research being conducted to Prevent the Most Common Cause of Hospital-acquired infection.

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Clostridium difficile (C. diff) is one of the most common causes of healthcare-related infections. It is estimated that each year in the United States, about a half million people get sick from C. difficile, and in recent years, C. difficile infections have become more frequent, severe, and difficult to treat.

C. diff is a type of bacteria that lives in the human intestines. Its spores can survive outside of the body for months. These spores are resistant to cleaning and are most commonly transmitted in healthcare settings. People can become infected by touching surfaces that are contaminated or by coming into contact with a healthcare worker that has the bacteria or spores on their hands.

People most at risk of getting sick due to C. diff are those who are taking antibiotics, being treated in a healthcare facility, the elderly and people who are already ill. This infection can cause symptoms that include frequent diarrhea, inflammation of the colon, fever, nausea and abdominal pain; in severe cases it can be life-threatening.

Rochester Clinical Research is conducting a study to evaluate the safety and efficacy of an investigational vaccine in reducing the chances of getting sick due to C. diff. The knowledge gained from this study may help others in the future. Eligible participants will receive study related tests and procedures at no cost and compensation may be available.  Call 585-288-0890 or email volunteer@rcrclinical.com to learn how you can help contribute to this important research study.

Check out our C. Diff study spotlight on WXXI News.



Patient Spotlight: Roselyn

Roselyn

RCR: How many/what studies have you participated in?

Roselyn: I’ve done 3-4 over a few years. The last one I remember was a study on a daily injection for Osteoporosis where I ended up being one of the people to get the placebo.

RCR: Why did you initially decide to participate in this study?

Roselyn: I’m a very altruistic person. I believe when I leave this world I will take my body with me, so I’d like to use it to help humanity while I am still here.

RCR: What did you enjoy about the study?

Roselyn: Nothing was difficult, everything was easy from start to finish

RCR: Is there anything that stuck out to you about RCR specifically?

Roselyn: The Nurses were very professional and gentle.

RCR: What would you like to say to people who are hesitant about Clinical Trials?

Roselyn: That they are helping the future. They are helping future generations not have to deal with diseases that we’ve dealt with in the past.



RCR Commercial

Check out our latest commercial

Produced in collaboration with Sundance Marketing, this video titled You and Me, represents what Rochester Clinical Research is all about, our volunteers. Without our loyal volunteers, we would be unable to live out our mission of – Advancing Medicine and Changing Lives.



Saying “It’s too late for me to quit smoking” is just an excuse

smoke

20 Minutes after quitting

your heart rate drops to a normal level

12 hours after quitting

the carbon monoxide level in your blood drops to normal

2 weeks – 3 months after quitting

your risk of having a heart attack drops and your lung function improves

1-9 months after quitting

your coughing and shortness of breath decrease

1 year after quitting

your added risk of coronary heart disease is half that of current smokers

5-15 years after quitting

your risk of having a stroke is half that of a smoker’s and your risk of getting cancer of the mouth, throat, or esophagus is half that of a smoker’s

10 years after quitting

your risk of getting bladder cancer or dying from lung cancer is about half that of a smoker’s. your risk of getting cervical cancer or cancer of the larynx, kidney or pancreas decreases

15 years after quitting

your risk of coronary heart disease is the same as that of a non smoker


Contact Rochester Clinical Research for more information on tips and tricks to quitting smoking 585-288-0890 or Text “info” to 87888



Local Neurologist and Headache Specialist, Dr. Joseph Mann and Rochester Clinical Research Join Forces

Dr. Joseph Mann, recipient of 2016 Headache Practitioner of the Year Award, has joined on as part of the Rochester Clinical Research staff.

Rochester, NY– Rochester Clinical Research is proud to announce that Dr. Joseph Mann, a prominent Rochester neurologist, has joined on as part of the staff. Dr. Mann was recently awarded the 2016 Headache Practitioner of the Year Award by the National Headache Society. Dr. Mann is board certified in both neurology and psychiatry and has sub-specialty certification in Headache Medicine.

With this new addition, Rochester Clinical Research will be able to not only continue with its long history of migraine research, but explore new areas of migraine research and other neurological and psychiatric areas such as: ADD, mild depression, mild cognitive impairment, as well as other headache disorders.

“We couldn’t be more proud to have Dr. Joseph Mann as part of the RCR staff. He’s an incredibly gifted neurologist and we’ve always admired the work he does and the relationships that he builds with his patients and colleagues. I look forward to working more closely with him and pursuing new and exciting opportunities” said Adam Larrabee, President of Rochester Clinical Research.

About Rochester Clinical Research

RCR was founded in 1994 to provide residents of the Greater Rochester Area access to clinical research studies and advance new medical treatments. Our unwavering commitment to providing efficient, friendly and caring service has helped us in becoming one of the leading research sites in the United States, noted for a large, loyal group of volunteers and frequent studies. RCR has conducted more than 650 research studies, involving more than 15,000 volunteers. For more information, visit www.RCRclinical.com.



Protected: 5 Questions and Answers: C. Difficile

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What do you really know about C. Diff? 90% of deaths related to C. Diff occur in individuals who are 65 years of age and older, and 1 in 5 people who are infected have recurring infections. In total, C. Diff accounts for roughly 14,000 deaths per year. Read on to learn more about C. Diff and an opportunity to help find a vaccine.

  1. How can you get C. Diff?
    1. Well, those at the highest risk are the elderly population, and those taking antibiotics. Most C. Diff cases are a result of ineffective, or lack of infection prevention and control measures.
  2. How do you know if you have it?
    1. Symptoms include fever, lack of appetite, nausea, watery diarrhea, and abdominal pain/tenderness.
  3. How does taking antibiotics contribute to C. Difficile?
    1. Elevated doses of certain antibiotics used over an extended period of time can increase the probability of contracting a C. Diff infection because antibiotics change the composition of bacteria in the gut. When there are fewer bacteria in the gut, it creates room for C. Diff to come in and produce toxins.
  4. How can you prevent C. Diff?
    1. Careful use of antibiotics, and taking the necessary infection prevention and control measures.
  5. Is C. Diff fatal?
    1. Diff can cause mild diarrhea, to life-threatening conditions such as: bowel perforation, sepsis, and even death.

Rochester Clinical Research is now seeking interested volunteers for an investigational study for a C. Diff vaccine. If you’re 50 years of age or older and fall within one or more of the categories below, you may qualify.

  • Visited the hospital at least once within the past 12 months, for 2 or more nights
    OR
  • Visited the emergency room at least twice within the past 12 months
    OR
  • Visited the doctors at least 12 times within the past 12 months
    OR
  • Live in a nursing facility
    OR
  • Taken an antibiotic within the past 3 months
  • Cannot have had C. Diff
  • **Please note, other conditions may apply**

Please click on the link below or call 585-288-0890 to learn more or see if you qualify.

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Ebola Vaccine – 100% Protection During Clinical Trial

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It’s great to see progress being made in the clinical research industry! An article released 12/23/16 via Beckers Hospital Review highlights great strides being made in Ebola Vaccine research. A study on a new, experimental vaccine displayed 100% efficacy during clinical trials involving thousands of subjects in Guinea, Africa.

Interested in reading more? Follow the link below!

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Americas become first region to eliminate measles

Vaccine Image

Reuters: After a 22-year vaccination effort against the measles, the Pan American Health Organization said on Tuesday that The Americas has become the first region in the world to have eradicated measles. This is a tremendous accomplishment, given that measles continues to infect tens of thousands of people on a global scale.

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Migraines – Not Just a “Bad Headache”

Migraines are often thought of as simply a “bad headache”. However, contrary to this common belief, they’re not. A migraine is comprised of multiple neurological symptoms – usually including a severe throbbing and persistent pain on one side of the head. Migraine attacks can last from 4 hours, to as long as 72 hours.

Migraines are an extraordinarily prevalent neurological disease, affecting 38 million men, women, and children in the U.S.

Below are some facts that may surprise you.

You probably know more migraine sufferers than you may be aware of.

  • Migraines are the 3rd most prevalent disease in the world
  • 12% of the U.S. population (including 10 percent of U.S. children) suffer from migraines
  • 18% of American women fall victim to migraines vs. 6% of men
  • Migraines are often hereditary

Migraines can be really, REALLY debilitating

  • Migraines are the 8th most disabling illness in the world
  • 10% of migraine sufferers have chronic migraine (having at least 15 migraine days per month)
  • 90% of migraine sufferers cannot work or function normally during their migraines

Migraines cost…A LOT

  • Costs associated with migraines are estimated to be north of $36 billion in the U.S.
  • Healthcare for households with a migraine sufferer are 70% higher than those without
  • American employers lose more than $13 billion each year as a result of lost work days due to migraines

Migraines are still largely a medical mystery and often go undiagnosed

  • More than half of all migraine sufferers are never diagnosed with migraines
  • Many migraine sufferers never seek medical attention for their pain
  • Only 4% of migraine sufferers ever seek a headache specialist

Source: Migraine Research Foundation
Despite migraines still being a medical mystery, there are new treatments being investigated. Rochester Clinical Research is at the forefront of this migraine research and has a multitude of study opportunities available. Follow the link below to learn more about these studies and to see if you qualify.

See Our Studies
 



12 Risk Factors of High Blood Pressure You Need to Know

Blood Pressure

There are many risk factors involved with high blood pressure, but the 12 listed below are among the most common. High blood pressure is a common condition where the long-term force of the blood against artery walls is high enough to cause health problems such as heart disease. Blood pressure is determined is by the amount of blood the heart pumps versus the amount of resistance to blood flow in the arteries. When increasing the volume of blood and narrowing the arteries, higher pressures arise – potentially resulting in high blood pressure.

  1. Age: As people age, the risk of high blood pressure is elevated. Around age 45, high blood pressure is more common in men. Women have a greater risk of developing high blood pressure after age 65.
  2. Race: High blood pressure is particularly common among African Americans, often developing at an earlier age than Caucasians.
  3. Family History: High blood pressure tends to be hereditary.
  4. Being Overweight/Obese: The more a person weighs, the more blood is required to supply oxygen and nutrients to tissues. As the volume of blood increases, so does the pressure on artery walls
  5. Lack of Physical Activity or Exercise: Individuals who are inactive tend to have higher heart rates. The higher your heart rate, the harder the heart must work – increasing the force on arteries.
  6. Use of Tobacco: Smoking or chewing tobacco has an immediate, temporary effect on your blood pressure. In addition, the chemicals in tobacco can potentially damage the lining of your artery walls – causing your arteries to narrow. This narrowing affect increases blood pressure. Secondhand smoke can also increase your blood pressure.
  7. High Sodium Diet: Having an excess of sodium in your diet causes your body to retain fluid, which contributes to an increase in blood pressure.
  8. Lack of Potassium in Your Diet: Potassium helps regulate the amount of sodium in your cells. Without enough, you may accumulate too much sodium in your blood.
  9. Prolonged Periods of Too Much Alcohol: Over time, excessive drinking can damage the heart. Having more than two drinks a day for man and more than one drink per day for women may affect blood pressure.
  10. Not Enough Vitamin D: While there are still uncertainties surrounding this statement, Vitamin D may affect an enzyme produced by your kidneys that affects blood pressure.
  11. Stress: High levels of stress may lead to a temporary increase in blood pressure. Attempting to alleviate stress through eating, drinking, or tobacco, you may contribute to problems with high blood pressure.
  12. Certain Chronic Conditions: Certain chronic conditions may increase the risk of high blood pressure, such as kidney disease, diabetes, and sleep apnea.

Source: www.mayoclinic.org

we are currently enrolling for a high blood pressure study. Follow the link below or give us a call at 585-288-0890 if you’d like to learn more about this opportunity.

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10 Things You Should Know About Clinical Trials

1. What is a Clinical Trial?
A clinical research study or “trial” is a scientific study evaluating a new treatment that has shown promise in laboratory studies. It is through these studies or trials that doctors find new and better ways to prevent, detect, diagnose, control and treat illnesses.

2. Who can participate in a clinical trial?
Before joining a clinical trial, a participant must meet specific requirements in order to qualify. All clinical trials have guidelines about who can participate and these guidelines are based off of factors such as age, gender, previous treatment history, and other medical conditions. If you think you may be a good fit for a particular trial you should contact the research site and consult your doctor.

3. How long does it take a drug to go through the clinical trial process before it is publicly available?
The Food and Drug Administration (FDA) requires that clinical trials be performed on all new and improved medications before that new treatment becomes available for public use. It is only after many years of laboratory testing that drugs are approved to enter the clinical trial phases. In some cases it can take from 10-15 years for a drug to go through all phases of the clinical trial process.

4. What are the benefits of participating in a clinical trial?
A well designed and well executed clinical trial is a great way for eligible participants to play an active role in their own health care, gain access to new research treatments before they are widely available, and also help others by contributing to medical research.

5. What are the risks of participating in a clinical trial?
Like any other form of research, various uncertainties and unforeseen events can occur. In some cases participants may experience unpleasant side effects, and very rarely, may experience serious or even life-threatening side effects as a result of the treatment. This is why it’s always important to consult your doctor prior to participation.

6. Can someone stop participating in a clinical trial after it has begun?
A participant can leave a clinical trial at any time. When withdrawing from the trial, the participant should let the research team know about it, and the reasons for leaving the study.

7. What should someone consider before participating in a clinical trial?

  • What is the purpose of the study?
  • Who is going to be in the study?
  • Why do researchers believe the new treatment being tested may be effective? Has it been tested before?
  • What kinds of tests and treatments are involved?
  • How do the possible risks, side effects and benefits in the study compare with my current treatment?
  • How might this trial affect my daily life?
  • How long will the trial last?
  • Will hospitalization be required?
  • Who will pay for the treatment?
  • Will I be reimbursed for other expenses?
  • What type of long-term follow up care is part of this study?
  • How will I know that the treatment is working?
  • Will results of the trials be provided to me?
  • Who will be in charge of my care?

8. Does a person continue to work with a primary health care provider while in clinical trials?
Yes. Most clinical trials provide short-term treatments related to a designated illness or condition, but do not provide extended or complete health care. In addition, by having the health care provider work with the research team, the participant can ensure that other medications or treatments will not conflict with the study requirements.

9. Clinical trials need more participants!!
According to a recent article in The Wall Street Journal, fewer than 10% of Americans participate in clinical trials and nearly 40% of clinical trials are unable to find enough volunteers to meet their enrollment goals. When this happens, delays are caused in the clinical trial process which increases the amount of time it takes to bring new medications and drugs to the public.

10. Where can someone go to learn about what clinical research studies are currently available?
To find out what clinical research studies are available, people can visit www.clinicaltrials.gov, or www.RCRclinical.com to see some of the studies that are currently enrolling in the Rochester-area. You can also speak to someone on our recruitment team by calling (585) 288-0890.



5 Eye Opening Facts You May Not Have Known About High Blood Pressure

  1. Roughly 70 million American adults have high blood pressure
  2. Only half of individuals have their high blood pressure under control
  3. High blood pressure accounts for over $46 billion in costs each year to our nation
  4. There are nearly 1000 deaths each day as a result of high blood pressure
  5. Roughly 7 out of 10 people experiencing their first heart attack have high blood pressure

If the facts above are not justification enough for the importance of getting your high blood pressure under control – high blood pressure is a major risk factor for heart disease and stroke. Both heart disease and stroke are leading causes of death in the US.  High blood pressure can often go years unnoticed. Even without any signs or symptoms, damage to the blood vessels and heart takes place, increasing your risk of heart attack or stroke.

What should you do to help control it? Take your medications as prescribed (follow the directions on the bottle). If your blood pressure is still not under control after taking medication, get with your doctor to come up with a better plan. Maintaining a healthy weight and getting on a heart healthy eating plan with foods lower in sodium can help immensely.

Source: www.CDC.gov

Rochester Clinical Research has vast experience in high blood pressure research. We have been conducting high blood pressure studies for over 20 years. True to form, we are currently enrolling for a high blood pressure study. Follow the link below or give us a call at 585-288-0890 if you’d like to learn more about this opportunity.

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5 Facts About Meningitis and Why Vaccination is Important

  1. There are 5 forms of meningitis
    • Bacterial Meningitis: Can cause life-threatening infections that need immediate medical attention. Vaccines are available to prevent some types of bacterial meningitis.
    • Viral Meningitis: Can be caused by viruses like enteroviruses, arboviruses and herpes simplex viruses. This form of meningitis is severe, but less severe than bacterial.
    • Fungal Meningitis: Caused by fungi like Cryptococcus and Histoplasma. It’s usually contracted by inhaling spores. Those with diabetes, cancer, or HIV are at higher risk of getting fungal meningitis.
    • Parasitic Meningitis: True to its name, this form is caused by parasites and is less prevalent in developed countries.
    • Non-Infectious Meningitis: In some cases, meningitis isn’t spread from person-to-person but however, is instead caused by certain conditions like: cancer, lupus, drugs, head injury, or brain surgery.
  2. Infants are at a higher risk for contracting bacterial meningitis however, people of any age are at risk
  3. The most effective way to protect you or your children against bacterial meningitis is through vaccination.
  4. There are vaccines for three types of bacteria that can cause meningitis:
    • Neisseria meningitidis(meningococcus),
    • Streptococcus pneumoniae(pneumococcus)
    • Haemophilus influenzaetype b (Hib)
  5. The CDC recommends vaccination for all based on age and risk factors.

Why is vaccination important?

Meningococcal disease can be absolutely devastating. This is a disease that can be deadly to even the most healthy individuals. While this disease is fairly uncommon, it is most prevalent amongst teens and young adults – resulting in permanent disabilities or even death. The chances of getting meningitis can be drastically reduced and in most cases, prevented through vaccination.

Source: www.CDC.gov



Obesity: The Challenges, and Changes

Author: Tammi Shlotzhauer, MD

Obesity in America has become an epidemic. Yes, it is true that the average American consumes too many calories in a day. And, in our busy society we often don’t find time for the exercise that we all so badly need. Even if we are committed to a program, the mixed messages on exactly what and how much you should eat are mind boggling. Fad diets are rampant.

When people have already become overweight, the challenges increase. Our bodies are masters at holding on to weight. We are programmed with evolutionary safety mechanisms that helped us in times of famine 10,000 years ago, but sabotage us today when we are trying to lose weight. Our actual body chemistry changes – all in an effort to avoid weight loss. When we start losing weight, protein messengers are sent from our fat cells, stomach and other tissues to the brain saying “hold on to calories, not much food around”. Our whole metabolism changes, burning off less calories. This is responsible for the frustrating plateau that we commonly hit in our weight loss initiatives. Even the hunger response is programmed to increase.

The complex changes that occur in the body are just beginning to be understood. New medications are being studied which attempt to interrupt that cycle and reduce that programmed hunger sensation. RCR is currently studying one of these new therapies. Of course, the first step to weight management is eating a balanced diet and participating in an exercise program under the direction of your doctor. If these measures are not successful, it is comforting to know that new therapies are being devised to break the vicious cycle of obesity.

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Hot Flashes: The Reality, Reason, and (Potential) Relief

Author: Tammi Shlotzhauer, MD

Well gals, trading in a menstrual period for hot flashes isn’t always a great deal for many of us. Hot flashes are the most frequent symptom of menopause affecting 2/3 of women. For some, this feeling of heat, redness, flushing and sweating may be a mild nuisance deserving of our jokes about “the change”.  For others, hot flashes are no laughing matter. They can be disabling causing insomnia, anxiety, distraction, and the need to change clothing- not easy in a work environment. It also gives others the false impression that you are stressed, afraid, or not in control and creates embarrassment for many.

The exact cause of hot flashes is unclear. One theory is that when estrogen levels drop, a false message is sent to the hypothalamus, a part of your brain that regulates your body temperature. That message is that your body temperature is too high. The brain then sends out its chemical messengers to direct the blood vessels near the surface of the skin to dilate in an effort to cool off the body. It also prompts sweating which decreases body temperature. These changes create the “hot mess” called a hot flash.

Some people can control hot flashes with simple measures such as avoiding caffeine, alcohol, spicy foods, heat and stress (Did  I say simple?). There are numerous herbs and natural remedies which also help some people but these remedies are not studied or quality controlled to the extent pharmaceutical treatments are. Researchers having been trying to create medications that mimic the estrogen-like benefits you want such as temperature regulation without triggering the unwanted side effects of estrogen such as growth of uterine or breast tissue. One of the classes of medications under investigation are the SERMs (selective estrogen receptor modulators). RCR is currently investigating one of these new therapies. Clearly, simple measures are always best to control mild symptoms of menopause if they are effective and feasible. However, science is helping us to design new therapies to help control more challenging cases.

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Local Neurologist and Headache Specialist, Dr. Joseph Mann and Rochester Clinical Research Team Up to Present on Revolutionary Migraine Treatment

“Migraine Treatments: What Was, What Is, What Will Be”, on February 17th at 6:30 PM at the DoubleTree by Hilton on Jefferson Rd. in Henrietta.

ROCHESTER, NY – The last noteworthy advancement in migraine treatment was over 15 years ago, so saying that better therapies are badly needed would be an understatement. Currently, there are a limited number of preventive treatments for migraines worldwide which cause side effects and are ineffective. However, with advancements in medicine, prevention could be just around the corner. At the forefront of migraine research is Rochester Clinical Research. RCR is consistently chosen to conduct clinical studies on these novel migraine treatments as part of the FDA approval process.

It is estimated that about 35% of episodic migraineurs would benefit from migraine prevention therapies. There are 4 FDA approved migraine preventive medications available in the United States. Among those treated, some experience significant adverse events preventing their use, and others receive no benefit at all. Unlike the currently available prevention strategies, new therapies focus on blocking very specific pathways in the body that lead to migraine. This specificity should lead to improved effectiveness with less side effects. New treatments currently being studied could require less frequent doses and significantly lower the number of monthly migraine episodes for sufferers.

Neurologist and Headache Specialist, Dr. Joseph Mann, in partnership with Rochester Clinical Research, will be presenting “Migraine Treatments: What Was, What Is, What Will Be”, on February 17th at 6:30 PM at the DoubleTree by Hilton on Jefferson road in Henrietta.

If you suffer from migraines, this is an event you won’t want to miss. For more information or to register, please call (585) 288-0890, or Register Here.

About Rochester Clinical Research

RCR was founded in 1994 to provide residents of the Greater Rochester Area access to clinical research studies and advance new medical treatments. Our unwavering commitment to providing efficient, friendly and caring service has helped us in becoming one of the leading research sites in the United States, noted for a large, loyal group of volunteers and frequent studies. RCR has conducted more than 600 research studies, involving more than 10,000 volunteers.



Together to Develop a Vaccine

ROCHESTER, N.Y. – Currently there is no vaccine on the market for RSV in the very young and elderly population. Rochester Clinical Research will be investigating a vaccine for this in an upcoming clinical research study. Respiratory syncytial virus (RSV) long known as the leading viral cause of severe lower respiratory tract disease in infants and young children worldwide, is increasingly being recognized as a significant cause of serious illness in elderly adults. The burden of RSV is well known and results in frequent visits to a healthcare provider as often as the seasonal flu.

This new study for elderly patients will be to examine the efficacy of the vaccine in the prevention of acute RSV-associated respiratory disease in adults 60 and over.

“Currently physicians usually recommend over the counter medications to help relieve respiratory symptoms often accompanying RSV infection,” said Dr. Matthew Davis, the principal investigator for the study. “The vaccination has the potential to be a highly beneficial and effective approach to limit RSV infection in elderly adults as well as other high-risk adult and pediatric populations.”

Rochester Clinical Research is currently seeking healthy volunteers over 60 to join this trial. Participants will be provided with the study drug, study-related care, and compensation for their time and travel. Those interested who would like more information are encouraged to call Rochester Clinical Research at 585-288-0890.

 

About Rochester Clinical Research:

Rochester Clinical Research was founded in 1994 with the objective of providing the Greater Rochester area with access to a premier clinical research facility. The goal of the organization is to advance new medical treatments and improve the quality of life for individuals everywhere. Rochester Clinical Research puts great pride in the relationships it has with its sponsors, volunteers, and staff. The organization strives toward advancing new medicines and catching up with diseases before they become a problem.

 

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The Next Big Thing in Heart Health

Research study of new cholesterol medication being done in Rochester

ROCHESTER, N.Y. – Will PCSK9 inhibitors finally reach FDA approval? Will this be a breakthrough cholesterol lowering medication? This is what Rochester Clinical Research is hoping to find out – with help from the community.

This new study for patients with high cholesterol will be testing the most important new class of drugs in cardiology since statin medications. Cardiovascular disease due to atherosclerosis (CVD) is currently the leading cause of death worldwide.

The aim of this trial is to ultimately determine if the investigational medication helps the body remove more LDL cholesterol (bad cholesterol), which in turn may lower blood LDL levels. The investigational medication requires an injection just beneath the skin (subcutaneous injection) every 2-4 weeks.

“They are going to be easy to take auto-injectors the patients can do at home,” said Dr. Matthew Davis, a principal investigator for the study. “PCSK9 inhibitors are anticipated to be the next blockbuster medication for people with high cholesterol.”

Rochester Clinical Research is currently seeking volunteers that have had or currently have high cholesterol to join this trial. Participants will be provided with the study drug, study-related care, and compensation for their time and travel. Those interested who would like more information are encouraged to call Rochester Clinical Research at 585-288-0890. Or text “INFO” to 87888

 

About Rochester Clinical Research:

Rochester Clinical Research was founded in 1994 with the objective of providing the Greater Rochester area with access to a premier clinical research facility. The goal of the organization is to advance new medical treatments and improve the quality of life for individuals everywhere. Rochester Clinical Research puts great pride in the relationships it has with its sponsors, volunteers, and staff. The organization strives toward advancing new medicines and catching up with diseases before they become a problem.

 

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Getting Over the Fear of a Placebo

So what is this thing called a placebo? Why is it used? Why is it necessary? Most of all, why shouldn’t I be worried about it?

One of the leading reasons why individuals turn down clinical trials is due to the fear of receiving something called a placebo. We can understand that. No one wants to volunteer their time pursuing an investigational treatment just to find out they didn’t receive the investigational treatment. We’re here to tell you that just because a ‘placebo’ is incorporated into a research trial does not mean your volunteering is not worthwhile.

What is a placebo?

If you are unaware, a placebo is a replication of a treatment that does not contain the active ingredient. A placebo is harmless and those that receive a placebo as part of a clinical trial are typically placed in a ‘control group’. Those that receive the investigational treatment are placed in a group known as the ‘active group’. Before a placebo is used in any research study, it is reviewed and approved by an ethical review board to ensure its use is moral and constructive.

Why is a placebo used?

Using a placebo is one of the most efficient ways to calculate the effectiveness of a new treatment. By pairing the data of those that received a treatment with those that received a placebo, researchers can make a definitive calculation as to whether a drug was effective through comparison. Placebos are a major factor in being able to measure how useful an investigative treatment was during the study.

Will I know if a placebo is part of my study?

You will always be informed if a placebo is involved in a study that you have expressed interest in. And placebos are only incorporated into trials where the condition being treated is non-life threatening and the placebo is deemed safe for use. Worth noting is that if you do in fact receive a placebo as part of trial, your condition will not worsen from study participation. A placebo is purposelessly harmless and you may in fact still benefit through the medical attention you receive as part of the study.

Why shouldn’t I be worried about receiving a placebo?

There are many reasons why you should relax when it comes to potentially receiving a placebo. The most important reason being that we treat every patient the same way. Meaning placebo or not, your safety and care is our top priority. We make sure every volunteer is safe and secure throughout every trial. And to be honest, in almost every trial involving a placebo, we are even unaware of who receives a placebo and who does not which eliminates any bit of bias that could arise.

As previously mentioned, the most important reason why research studies integrate a placebo is due to its effectiveness in measuring results. The goal of clinical research is to make strides toward improving the condition of life for those in need. Our goal is overseeing this research in the safest environment possible. Placebos allow us to achieve both of these goals by enhancing the capabilities of a research study without increasing any sort of risk. You would be amazed at the list of today’s common drugs that were approved through use of a placebo trial.

It is important to reaffirm that the contribution of those that receive a placebo as part of a trial is just as meaningful as anyone else’s. You volunteered, you provided valuable data, and you have made a significant difference. You will still be rewarded for your time and travel.
The name of the game is advancing medicine and changing lives and every second you volunteer is part of a continued effort in turning goals into reality. If that is not reason enough for you to be a fan of them, give us a call to ask us any lingering questions you have.

http://www.trialsphere.com/placebo-effect/

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4 Hard Questions to Ask Yourself Before Joining a Clinical Trial

nurse with patientIf you’re new to the concept of clinical research, you probably have a lot of questions. That’s understandable. It can be a bit puzzling at first – we understand!

As you move through the enrollment process, you will undoubtedly learn more about the way things work. You will be heavily educated on what you’re getting yourself into.

But on a high level, what are the major questions you should ask yourself before taking the first step of calling to start the enrollment process? Consider the following four questions:

  1. What exactly am I getting out of participation?

This is perhaps the most important question for anyone who has never experienced a clinical study. More often than not, volunteers will return for another trial. In fact, CISCRP reports that 95% of volunteers would consider participating in another trial.

Back to what you will actually get out of participation. While there are many benefits to participation, the most popular reasons include learning more about your condition, access to new medication or healthcare, and compensation for your time and travel. These are real takeaways from participation.

We think the most significant takeaway is the internal feeling that you contributed to something that will help someone beyond yourself.

  1. How am I going to be protected?

This is an essential question for anyone considering participation.

As every hospital, doctor’s office and health clinic is governed by ethical and legal codes, the same guidelines apply to clinical research studies. In addition, our organization is federally regulated to make sure we protect our patients to the fullest. All study plans and designs are carefully controlled and overseen by government agencies, institutional review boards and our staff.

Your protection is our job and we do not allow patients to go uninformed. We keep everyone in the know at all times, protecting your well-being and privacy at every turn.

  1. Why are you having this study in the first place?

Clinical trials are conducted to uncover answers to specific questions. In doing so, new medications, vaccines, devices and technologies can move toward FDA approval. FDA approval means someone somewhere who needs this new treatment can now access it.

There is a specific reason for every trial. And every trial aims at advancing treatment and the quality of life for someone with a condition or illness. Clinical studies are never purposeless and without them we’d have no progress in medication and treatment.

  1. What is going to happen to me during the trial?

Deep breath! We are not about to send you into some dangerous and confusing situation which we hope you make it through. We take it one step at a time, tell you what you can expect and what the trial is designed to achieve. Every trial is different, but one thing remains the same: your contribution and volunteering keeps alive the hopes and dreams of those living with potentially treatable conditions and illnesses.

There you have it: four hard questions you want the answer to before joining a trial. Do you have another question on your mind that you need an answer to? Call us today.

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