Health Solutions Insider (Fall 2009)

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Volume 2, Number 3 July/August 2009

Health Solutions

Insider

500 Helendale Rd Suite L20 Rochester, NY 14609 585.288.0890 www.rcrclinical.com

Advancing Medicine. Changing Lives.

Wasn’t it Bird Flu we were worried about? World health experts blind-sided by swine flu Since 2003, the world has been in emergency preparedness mode for pandemic bird flu. Since April of this year, there has been a surprise attack by a lethal and brand new strain of swine flu. As of this writing, swine flu has infected 40,000 people from 90 countries, resulting in 167 deaths. Fortunately, many of the bird flu preparations – enhanced disease surveillance & communication, as well as vaccine development – are aiding the rapid response to swine flu.

is through clinical research studies to determine if there is a good antibody response, or if there are different doses needed.

Phase 6

As the world races to produce a vaccine against swine flu, the One Billion Dollar Question remains, “will these investigational vaccines work?” The only way to find out

Rochester Clinical Research, with the help of hundreds of study volunteers from the community, has been working to test faster and more efficient ways of quickly producing large quantities of investigational flu vaccines. Several of our studies have tested investigational vaccines made quickly by growing the viruses in cell cultures (Vero cells), rather than the older & slower process using chick embryos. We have also tested investigational vaccines made with additives that make them more effective.

RCR would like to extend our sincere thanks to all of our past vaccine trial volunteers for being part of the solution! We appreciate your valuable contributions towards advancing new medical treatments.

Seeking Swift Solutions to Swine Flu (phew! Say that 5 times fast!)

A Pediatric Priority 57% of H1N1 cases are in children ages 5 to 25 years old The best way to combat influenza viruses is with preventative immunizations. Unfortunately, we do not currently have a vaccine to fight against the novel (new) swine flu strain that continues to spread throughout the world. Now that the virus is here, and here to stay, we need to prepare and respond together as a community. We must reduce the impact this global pandemic has on those most at risk: adolescents and children. A disproportionate amount of hospitalizations are occurring in younger populations. As reported by the CDC – the highest rate of swine flu related hospitalizations is in children under 5. The next highest rate is in 5-25 year olds, who make up 57% of all H1N1 reported cases. Potential Prevention Opportunity for Greater Rochester RCR has been selected to conduct clinical research trials of investigational vaccines for swine flu. These studies are for children aged 6 months to 17 years. But my child is afraid of needles… Because the studies require blood draws, we will be using a topical anesthetic, EMLA cream, which is are able to take some of the sting out of the procedure. If you have children that may be interested in these studies that are scheduling for July and August, please call Jane or Debbie now at 288-0890. Space is limited

UPCOMING RESEARCH STUDIES CONTACT US NOW

to see if you pre-qualify at

585.288.0890 volunteer@rcrclinical.com

Birth Control Migraines x 2

Seasonal Flu Vaccine

Low back pain Osteoporosis

Rheumatoid Arthritis

Swine flu Diabetics who snore


Tenets

Menstrual Migraines

New technologies bring new hope.

RCR abides by the Declaration of Helsinki which is a statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects.

A tip from the National Headache Foundation

Amazing advances have been made in pharmaceutical medicine in the last 10 years. Treatment options for headache sufferers have expanded dramatically. Occasionally, opportunities to participate in investigational drug research studies become available. These studies are usually conducted on a widespread basis by major pharmaceutical companies. While these studies are not ones in which the National Headache Foundation has an active part, we believe providing notice may be useful to headache sufferers who wish to inquire about participating.

Tenet - Physicians should abstain from engaging in research projects involving human subjects unless they are satisfied that the hazards involved are believed to be predictable. Physicians should cease any investigation if the hazards are found to outweigh the potential benefits.

For more info you can go to www.rcrclinical.com or visit www.headache.org or www.relieve-migraine.com

Could your migraines be connected to your period? Migraines afflict approximately 21 million US women - three times more women than men. So it makes sense that women’s migraines may be hormonally related. Studies have suggested that for many women, migraines may have something to do with changes in hormone levels that occur around the time of your period. This hormone-related migraine is often referred to as a Menstrual Migraine. When compared with migraines that occur at other times of the month, Menstrual Migraines have been reported to: •

Last longer - up to 72 hours

Be more severe

Occur more often with nausea and vomiting

Be more difficult to treat & occur more frequently

If you’re like many women with migraines, you may have Menstrual Migraine. Rochester Clinical Research is needs volunteers for an investigation drug research study for the treatment and prevention of Migraines associated with your period. If you are between the ages of 18 and 34 call us today and see if you may qualify.

Testimonial “Just a brief note of appreciation to you and your staff for the excellent attention and professional service received as a participant in one of your clinical trials. It was a pleasure to play a small part in your contribution to the advancement of medical research, and I sincerely hope that the study was as beneficial to your organization as it was to me. Looking forward to the possibility of assisting you again, and with best wishes for continued success.”

Meet the Receptionists The smiling faces that greet you at RCR

(L to R) Karen Green is a Mets fan who has been at RCR for 6 years. Karen enjoys gardening, playing piano, and reading. Her favorite book, American Fractal, was written by her son Tim. Sharon Grey is in her 10th year at RCR as Regulatory Specialist and early morning receptionist. She relaxes with yoga, gardening, photography, and traveling - her favorite trip was 2 weeks in Nova Scotia.

D.V.R., Rochester, NY

Liz Saitta has been greeting folks with a big smile since moving here from Florida 7 years ago. At home in Clarkson, Liz is busy caring for her 3 children; Anna, Sarah & Joey.

Note: This testimonial represents the experience of one research study participant and may not reflect the experiences of others or yourself.

Insider Visit Advice:

H2O

If your study involves “fasting labs” drink plenty of water. It keeps you from getting dehydrated, and makes it easier to draw your blood.


Summer Sun and the Vitamin D-fense!

?

Short durations of sunlight will enhance your vitamin D Vitamin D is necessary for calcium and phosphate absorption and metabolism for healthy bones and teeth. Its primary food sources include fortified milk, butter, whole eggs and salmon. Vitamin D is made in the skin when exposed to sunlight. It is manufactured from cholesterol within cells that lie beneath the skin’s surface. Vitamin D deficiencies are common among those who live in areas with cold, overcast weather. Low Vitamin D levels can play a role in bone loss and bone thinning resulting in chronic diseases such as osteoporosis.

How do I know what my blood level is? A simple blood test can tell you if your level is normal. For low levels eating more foods high in Vitamin D, taking a supplement, or spending limited time in the sun without sunscreen can help.

What is SPF? SPF (Sun Protection Factor) rating is calculated by comparing the amount of time needed to produce sunburn on sunscreen-protected skin to the amount of time needed to cause sunburn on unprotected skin. If a person who normally burns in 10 minutes without sunscreen wears an SPF 2 rating - it would now take 20 minutes to turn red. If that person wears an SPF of 15, it would take 15 times longer to burn, or 150 minutes. Even with this protection, sunscreen wears off, so it needs to be reapplied at least every two hours.

But be careful when seeking the sun! Folks have avoided the sun because of concerns about skin cancer. In order to synthesize vitamin D levels in the skin, there is no need to soak up rays for hours. Only 10 to 15 minutes of sun exposure three times per week can do the trick!

Approximately one ounce of sunscreen, enough to fill a shot glass, is considered the amount needed to cover the exposed areas of the body properly.

RCR offers free screenings

Shine a new light on Osteoporosis Osteoporosis causes bones to become weak, thin and brittle, making them fragile. If you have osteoporosis and are currently taking alendronate, you may be eligible for a research study of an investigational oral medication. You must be at least 60 years old to qualify. Call Jane or Deb at 288-0890 for more info about this study.

More Insider Visit Advice:

RCR offers free blood pressure, cholesterol, and diabetes screenings as a community service. Call us to schedule a fasting appointment: 585.288.0890. We’ll review the results with you, and send them to your doctor. $150 Value

Take action…know your numbers. …and reduce your risk of a heart attack, today! RECRUITMENT

Before the first visit to our office, we will send you a medical history form to fill out. If you lose it, you can find it on our website at www.rcrclinical.com , click on Volunteer Medical History Form. To save time, please have both sides of the medical history filled out, sign the bottom and make sure to bring it with you to your first appointment.


Advancing Medicine. Changing Lives.

500 Helendale Rd Suite L20 Rochester, NY 14609 585.288.0890 www.rcrclinical.com

What’s Inside Swine surprise

1

Priority # 1 - our children

1

Patient Protection

2

Menstrual Migraines

2

Meet our Receptionists

2

Good Defense with Vitamin D

3

Shine a new light on Osteoporosis

3

What does SPF stand for?

3

A killer worse than Cancer

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Lower your Lipids to Lengthen your Life

Worried about Cancer? Be more concerned about heart disease, and take steps to prevent it.

SURGEON GENERAL’S WARNING:

More Americans will die of heart attacks this year than from all the various forms of cancer - lung, breast, cervical, colon, etc. – combined. The risk of heart disease increases with smoking, high blood pressure, diabetes, physical inactivity and obesity, but one of the most direct risks is that of elevated blood cholesterol levels. Cholesterol is a soft, fatty substance that your body needs to function properly, but too much of it can plug-up the arteries that carry oxygen to your heart muscle, causing a heart attack. Lowering your total cholesterol by 10% (say from 220 to 200) will decrease your risk of a heart attack by 15%. Raising your HDL, the “good” cholesterol, by just 5 points can lower your risk by 25%. Beware of saturated fat – your body converts it to cholesterol. Read nutrition labels and check serving sizes. Dietary cholesterol and trans fat are also your enemies. Eat a low-fat, low cholesterol diet to lower your LDL. Get regular exercise to increase your HDL. Walking 30 minutes a day will do it.

Excessive consumption of high fat foods can lead to heart disease and early death.

Do you know your numbers? If not, we offer free cholesterol testing here at RCR. We get results 5 minutes after pricking your finger. Call us for a ‘free screen’ at 288-0890.

Are You a Part of the Solution? For additional information about volunteering for one of these clinical trials or if you just have questions about clinical research, visit www. rcrclinical.com and click on Volunteer Application or the “Learn About Our Studies” box.

Publisher and Editor: Adam Larrabee editor@rcrclinical.com Contributing Writers: Michael Brennan, FNP & Vicky Fink, RD ©2009 Rochester Clinical Research


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