Almost everyone has taken acetaminophen (Tylenol, Panadol) at one point or another in their life for aches and pains or to reduce a fever, with good results. However, its effect on low back pain has never been studied until now. A news article just published by The New York Times, looks at a research study that recently compared acetaminophen to placebo, specifically for the treatment of low back pain. The study concluded that acetaminophen was no more effective than placebo for the treatment of acute low back pain. However, Dr. Koes, a professor of general practice at Erasmus University Medical Center in Rotterdam, Netherlands commented on this stating, “The fact that it’s no more effective than placebo does not mean that it doesn’t work for a given patient.”
Clinical research, always at the forefront of new treatments and medications, has recently shown very promising results in the fight against skin cancer. An article by The Independent addresses a “new radical form of cancer treatment, that relies on the body’s natural “killer cells” to attack tumors.” This new treatment has shown to have success in patients suffering from advanced skin cancer.
Mark Middleton, a professor of experimental cancer medicine at Oxford University said, “A number of phase-1 trials go nowhere but what we see here is a drug that works as predicted and has significant clinical activity. It is very, very exciting.” The article goes on to state that “Scientists hope that the approach can be adapted for a wide range of other tumors, such as prostate, lung and ovarian cancers.”
Although we do not do skin cancer research here at Horizons we do conduct many new treatment studies for a number of other skin conditions.
A recent news article in The Boston Globe highlights women in medical research. It may come as a surprise to some, but it has been seen that women are the minority percentage of participants in research. This percentage is troubling as we see the FDA approving drugs and devices equally for men and women when it has been proven that medications can affect the genders differently. For example: “Last year, the FDA had to cut in half the recommended dosage of the insomnia drug zolpidem (Ambien) for women, after the larger dose was associated with auto accidents the next morning blamed on lingering impairment that affected 15 percent of female users compared with only 3 percent of males. That finding was made more than two decades after Ambien was first approved by the FDA.”
As research has “barely scratched the surface in sex differences across diseases,” according to Brigham president Dr. Elizabeth Nabel, the fewer number of women in clinical research than men ,and the lack of studies to determine gender differences is something that needs attention.
Here at Horizons roughly 60% of our research participants are female.
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Hypertension, also known as high blood pressure is a condition in which the force of the blood pushing against the walls of the arteries is too high. This is a dangerous condition that can lead to complications such as organ damage, stroke, heart attack, heart failure, or kidney disease.
Blood pressure is calculated by using two measurements and is written as 120/80. In this case the 120 represents the pressure of the blood in the arteries at its highest point and the 80 represents the pressure at its lowest. A normal blood pressure level is below 120/80. A blood pressure reading of 140/90 or higher is considered hypertension. A reading between 120/80 and 140/90 is considered pre-hypertension and someone at this level is considered in danger of developing hypertension.
• Approximately 1 in 3 adults in the United States has high blood pressure.
• Almost another 1 in 3 has pre-hypertension.
• Hypertension causes about 1 out of 4 cases of kidney disease in the United States.
• Only about 1 in 2 U.S. adults with hypertension has it under control
• About 1 in 5 U.S. adults with high blood pressure don’t even know that they have it.
Unfortunately as can be seen by the statistics above hypertension is way too common. Around 73 million people have high blood pressure in this country and the older you are the more likely you are to have it. It is estimated that a person with normal blood pressure at age 55 still has a 90% chance of developing hypertension as they get older. According to a large population-based research study funded by the National Heart, Lung and Blood Institute, African-Americans are at greatest risk of developing hypertension followed by Caucasians and then Hispanics. The bad news for Hispanics is that they are more likely to not know that they have hypertension and therefore are at greater risk.
What are the symptoms of high blood pressure?
One of the reasons hypertension is so dangerous is because there are seldom any symptoms. A person can live years with hypertension with no signs until it is too late to prevent serious and perhaps life threatening damage.
It is recommended that you have your blood pressure checked at least every two years starting at age 18 and more often if you are in a higher risk group. Children usually have their blood pressure checked during yearly health exams and this is important also because about 2 million children and teens in the US have hypertension.
What are some of the common risk factors?
• Being overweight
• Lack of physical activity
• Eating too much salt
• Family history
• Drinking too much alcohol
A few ways to help control your blood pressure.
• Eat a heart-healthy diet, including potassium and fiber, and drink plenty of water.
• Exercise regularly … at least 30 minutes of aerobic exercise a day (walk, run, bike, etc.)
• If you smoke, quit … find a program that will help you stop.
• Limit how much alcohol you drink … one drink a day for women, two a day for men.
• Limit the amount of sodium (salt) you eat … aim for less than 1,500 mg per day.
• Reduce stress … try to avoid things that cause you stress. Yoga anyone?
• Maintain a healthy body weight … find a weight-loss program to help you, if necessary.
• And of course follow your physician’s advice.
Hypertension is a serious condition and if you have it you should know it. Have your blood pressure checked regularly. If you do have it keep it controlled either through lifestyle adjustments, medication, or both.
There is constantly being research done to further help in understanding and to improve treatment for high blood pressure. For those who live in or near Denver and are interested in knowing details on how to participate in a research study or to know what studies are currently enrolling volunteers at Horizons Clinical Research Center, LLC visit us at http://horizonscrc.com/LDBlog.
We conduct a lot of clinical studies for new treatments of Type 2 Diabetes. Of course the best course of action to take with diabetes is to avoid it entirely. Here is an article on a large study that was done over many years that those of you at risk for diabetes may find interesting.
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Many people probably have the misconception that psoriasis is strictly a skin disease, it’s not. Psoriasis is actually a disease of the body’s immune system that appears on the skin. This disease causes new skin cells to develop far faster than the body can eliminate old cells causing a buildup of the skin. With plaque psoriasis, which is by far the most common of the five types of psoriasis, these patches of built up skin, or plaques, can become thick and red with silvery scales. These patches are often painful, itch and can crack and bleed. Although there are five types of psoriasis approximately 80% of those with psoriasis have the plaque type so that is the one I will focus on here.
Psoriasis may be more common than you might expect with close to 7.5 million Americans and 125 million people worldwide affected by the disease according to the National Institute of Health. Plaque psoriasis is found about equally in males and females and is more prevalent in Caucasians than other races. Anyone can develop the disease but those with a family history of psoriasis are at greater risk of contracting it. It can develop at any age from infancy to old age but about 75% of people will first see it before the age of 40 with the majority of those first getting it between the age of 15 and 30. It can appear anywhere on the body but is most commonly found on the elbows, knees, lower back and scalp. It is important to note that it is not contagious.
Psoriasis is usually not just an itchy flaky scalp nor just a cosmetic problem but a serious disease. In worse case scenarios it can affect much of the body. The National Psoriasis Foundation considers a moderate case of psoriases as covering from 3% to 10% of the body’s surface area and more than 10% as severe. Studies have shown that close to 60% of people with psoriasis consider it to be a serious problem in their day to day lives ranging from the physical discomfort of itching and pain to actual disability and often psychological distress. Just the fact that psoriasis is a chronic disease, meaning that it is lifelong, can be depressing.
Although psoriasis is a chronic condition it will at times seem to disappear then flare up again, usually caused by some kind of trigger. Flare ups can happen only occasionally for some people or very frequently for others. Some common triggers that can cause a flare up include: various types of infections; an injury to the skin such as a cut, burn, bite, scrape, bruise, etc.; some medications; stress; perhaps weather; and others. Although there are no cures for psoriasis there are many treatments for when the condition flares up.
Treatments for psoriasis include many topical medications for mild cases, light therapy for when the condition is moderate and systemic treatment (medication taken by pill or injection) for severe cases, or a combination of treatments when one alone may not be working sufficiently. There is also a great deal of research being conducted into the disease itself and treatments for it. We have conducted a number of research studies for new psoriasis treatments here at Horizons Clinical Research Center, LLC and it has been exciting to see the effectiveness of some of these new medications. If you or someone you know has psoriasis and would be interested in participating in one of these studies and would like to know more you can visit our website at www.horizonscrc.com for more information or call us at 303-399-4067. The National Institute of Health also has a good website with information about psoriasis at www.nih.gov as does the National Psoriasis Foundation at www.psoriasis.org
For many people the thought of participating in a clinical research study brings up images of mad scientists eagerly rubbing their hands together over a human “guinea pig”. Okay, we have Hollywood to thank for that. Now I can’t speak for all clinical research sites but here at Horizons Clinical Research Center, LLC our study participants find a setting far more comfortable and inviting than is found in the movies, or for that matter at most health care facilities. Our volunteers are not only treated with care and respect but as though they are VIPs, which indeed they are. It is thanks to our volunteers and many thousands more like them that new medications and treatments are being developed to improve all of our lives.
No, our volunteers don’t find any mad scientists here but they do find friendly health care professionals who are eager to assure that their research experience is one that they will be very glad they participated in. That is why we receive so many new volunteers who have been referred to us by past study participants. Those past participants know that they can recommend their friends and family with confidence. From their own personal experience they know that anyone they recommend to participate in a research study at Horizons may not only see their health condition improve but that they will also receive far more attentive and constant medical care for their condition than they might otherwise receive. This is not to mention that all of this care plus their clinic visits, lab assessments, medical exams and study medication are free of charge, and they receive compensation for their time and travel. These are admittedly excellent benefits and great reasons to participate in a study, but we hear time and again from our study participants how much they really want to help find new and better treatments for the afflictions they suffer from. They not only want to help find better treatments for themselves but also for the many others who suffer from the same medical condition that they do.
The participation of volunteers in a research study is the only means of obtaining the three primary objectives of researchers when conducting a study. Those objectives are to determine how well a new medication works, what potential side effects there may be, and to show that the medication is safe when used as directed. During the course of a study there is careful and constant monitoring through a number of clinic visits and follow-up tests to measure the effect the medication is having, and to insure the participant’s safety. I should also note that many of the studies that we conduct at Horizons Clinical Research Center, LLC are Phase III and IV studies. This means that the medications that we are testing have already been through at least two previous human trials and in the case of Phase IV studies the medication has already been FDA approved.
So if the thought of participating in a clinical research study has never occurred to you, or if it has and you have dismissed it because you didn’t want to be a “guinea pig”, you may want to reconsider. Here at Horizons Clinical Research Center, LLC we conduct studies in the areas of Dermatology, Internal Medicine and Women’s Health. This means that we conduct studies for new treatments for such conditions as acne, psoriasis, overactive bladder, type 2 diabetes, post-menopausal low sex drive, high cholesterol, hypertension, and many more. So now the question is, “To be or not to be a “research volunteer”?
Horizons Clinical Research Center, LLC can be reached by calling 303-399-4067, e-mailing email@example.com or visiting their website at www.horizonscrc.com
We are currently conducting research studies for treatments of type 2 diabetes which persuades me to write a little about the seriousness of this disease.
Over the past few decades the number of people with diabetes has been increasing rapidly worldwide. The principal reasons being increased obesity and lack of exercise. It is estimated that nearly 24 million adults and children now have diabetes in the United States with approximately 30% of those unaware that they have the disease. There may be up to another 57 million cases of people who are pre-diabetic. It has been found that the two ethnic/racial groups with the highest rates of the disease are Latinos and African Americans.
Type 2 diabetes is the most common form of diabetes. One of two things occur in the body with this type of diabetes; either the body does not supply sufficient insulin, or the body is unable to adequately use the insulin that it does produce. Insulin is important because it enables the body to use the glucose in our blood for energy. Glucose is broken down from the sugars and starches that are in the foods we eat and provides the energy that our cells need. If the insulin that is needed to transfer that energy to the cells is either missing or not working well then glucose builds up in the blood and can cause diabetes complications.
There are many complications that can arise from diabetes if it is left undiagnosed or untreated. Some of these complications can included kidney failure, blindness, heart disease, nerve damage, vascular disease leading to amputation, and death. In 2006 diabetes was the 7th leading cause of death in the United States. Approximately 75% of adults with diabetes also have high blood pressure which presents its own health risks. Diabetes can be a silent disease with little to no symptoms until damage has already been done. That is why it is so important to be tested regularly if you are in a high-risk group, have a family history of diabetes, or are overweight.
Testing for diabetes is a simple A1c blood test that doesn’t require fasting. This test measures the average glucose levels in the blood over the past two to three months. Early detection of the disease can make a huge difference in a person’s future quality of life, and diabetes is usually preventable through diet changes and increased exercise if discovered when a person is still pre-diabetic. With an estimated 5.7 million people in the United States living with undiagnosed diabetes and maybe ten times that who are pre-diabetic it is clear to see why testing is so important.
While screening patients for research studies unrelated to diabetes we have actually discovered a number of people (usually Latinos) who unknowingly were diabetic. These people had a life threatening disease and didn’t know it. Fortunately because they were interested in participating in a research study their condition was discovered, but that knowledge should not be left to chance.
Diabetes is a serious disease and those that know they have it are hopefully taking the necessary steps to control it. Those who could be diabetic but are undiagnosed, or those who are potentially at risk for it, will hopefully have themselves tested in order to know if they may be in jeopardy of the disease.
For more information on diabetes statistics visit the 2007 National Diabetes Fact Sheet at http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2007.pdf. The American Diabetes Association has an excellent website which is very informative on diabetes in both English and Spanish at www.diabetes.org.
To learn more about participating in a research study and to see what studies are currently enrolling volunteers at Horizons Clinical Research Center, LLC, visit www.horizonscrc.com or call 303-399-4067.
According to a recent poll conducted by CenterWatch, the global center for research trial information, a full 75% of the general public state that they have little to no knowledge about clinical research. That means that most people are unaware that there may be a clinical research study available that is investigating a new treatment for a health condition that they have. Qualified participants in these studies typically receive all clinic visits, study related medical exams and laboratory assessments, possibly other medical procedures and tests that are often very expensive, and study medication, all at no charge. In addition to all this medical care participants also often receive compensation for their time and travel.
It may seem a bit difficult to believe that someone can receive all of these medical benefits and also get paid, but study participants are an extremely important and integral part of developing new treatments and medications. The many new medications that become available every year to improve the quality of our lives are thanks in large part to the thousands of study volunteers across the United States, and in fact the world, who participate in the research studies that are necessary to prove the efficacy and safety of new medicines.
It is worthwhile for pharmaceutical companies that develop new medical drugs to pay for the care and compensation of study participants, and indeed to assure that they are treated very well. Without these volunteers it would be impossible to bring new medications to market and of course the very existence of these pharmaceutical companies depends on the new medical products they develop. The involvement of volunteers in the testing of new medications is actually just the final part of a long and complex process in the development of new medicines.
In brief, new drug research begins with perhaps years of laboratory experiments, then extensive testing in animals, and finally, if approved by the Food and Drug Administration (FDA), testing in people. The clinical testing of new drugs in people is usually done in three initial phases by research sites carefully selected by the pharmaceutical company doing the research. It is only after this required testing has been completed that a drug is submitted to the FDA for approval.
Phase I studies are mainly concerned with determining the safety of a new drug. This first phase involves only a few healthy volunteers and is designed to assess what occurs to the drug in the human body as well as to examine the side effects that occur as dosage levels are increased.
While Phase I determines the primary safety of a new drug it is in Phase II that researchers begin to test its beneficial effects on people who have the condition that the new medication is being developed to treat. In Phase III the study involves large-scale testing with the purpose of developing a more comprehensive understanding of the study drug’s effectiveness, benefits, and the range of possible adverse effects. This is the final phase of testing before a drug can be submitted to the FDA for approval.
During all the phases of a research study participant safety and the protection of the participant’s rights are always of prime importance. Research volunteers have the right to expect that their exposure to risk is minimized. All medical procedures that a participant receives must not pose any undue risk to the health of the volunteer. Participants have the right to privacy and by law every research site must protect a volunteer’s personal information. Participation in a study must also be truly voluntary and every participant has the right to withdraw from a study at any time and for any reason.
To learn more about participating in a research study and to see what studies are currently enrolling volunteers at Horizons Clinical Research Center, LLC, visit www.horizonscrc.com/LDBlog
Horizons Clinical Research Center, LLC (Horizons) is a local Denver research center dedicated to conducting clinical research trials in the specialties of internal medicine, women’s health, and dermatology. These trials are conducted for a number of prestigious international pharmaceutical companies who trust in the quality and integrity of Horizons’s work. Our board certified physicians are highly experienced in their specialties and in conducting clinical trials. Horizons conducts studies for investigational medications that are in phases II to IV. Our research center is also unique in Denver in that our full-time staff are all bilingual in English and Spanish allowing us to recruit many study participants from our large Spanish speaking population.
Horizons’ mission is to provide high quality and reliable data to the pharmaceutical companies striving to advance today’s medicine, while rigorously maintaining the safety, well-being and confidentiality of our volunteer participants. Some of the studies that we have conducted, or are currently conducting, include treatments for psoriasis, atopic dermatitis, actinic keratosis, acne, overactive bladder in women, overactive bladder in men and women, post-menopausal symptoms, high cholesterol, type II diabetes, hypertension with type II diabetes, endometriosis, acute low back pain, chronic low back pain, and post-menopausal low sexual desire.
The staff at Horizons prides its self on the care and treatment given each and every study participant. The following are a few comments by our study participants that attest to the effort made by the staff to treat each patient as a VIP. To see more comments and to learn more about clinical research and Horizons please visit our website at www.horizonscrc.com.
“I feel I was treated exceptionally well in all areas. The staff here is excellent!” Angelo
“I liked the people working at this clinic. They were professional and friendly. It was a pleasure to be a part of their team work. Everything was great!” Irina
“I thought it was great, appointments were always available at convenient times and the staff were great!” Sarah
“Isabel Arnold, RN is a true professional and a total asset to this clinical research center. She was a total delight to work with! The entire experience was First Class! I always felt very comfortable and was given great care! My compliments to the staff and clinic.” Nancy
“I appreciate the opportunity and was pleased with the service and results.” Anthony
“Everything went excellent! I wish more people would get involved with these studies. It would help millions of people.” Thomas
“I felt I was treated with the utmost respect and I enjoyed this experience to participate in the research study. I also feel I have benefited.” Colleen
“Excellent staff with professional delivery. Flexible with appointment times. I have been involved in other studies and this care has been excellent!” Joan
“The Doctor and staff were very professional and great to work with. Thank you!” James
“I came in with a lot of doubt towards the treatment but am leaving very impressed.” Lindsay
“I do believe studies like this are beneficial to a public who may not be able to afford Actinic Keratosis drug treatments at current costs.” Alan
“HCRC and the staff are incredibly competent and I would recommend their facility to anyone.” Joan
“Elizabeth has been such a joy. I appreciate the way she kept things calm and comfortable, even the blood draw!” Sandy
“The medication really helped me. I hope it reaches the market soon.” Gloria
“My participation in this study has been very important to me. My condition has improved and I hope that this medicine helps everyone with this same type of affliction. My heartfelt appreciation to Isabel and to all who work at Horizons.” Beatriz
“I would do it (participate) again. Very nice experience and great people!” Steven