About Diseases, Conditions, Treatments That RCR Studies

Cold Sores

What causes cold sores?

The herpes simplex virus. While there are 8 types of herpes viruses, it is mostly type 1 and occasionally type 2 that cause cold sores (also known as fever blisters, oral herpes, or herpes labialis). Recurrent cold sores are almost always caused by the type 1 virus. Why do some people get them so frequently?

The majority of people are exposed to the type 1 herpes simplex virus by direct contact with someone with cold sores before they are 10 years old. Most will develop a mild case of one or two cold sores. Some will have a more severe infection called “gingivostomatitis” that is characterized by dozens of painful cold sores on the tongue, gums, and lips, and often is accompanied by fever and sore throat. In severe cases of gingivostomatitis, children are hospitalized because of dehydration.

After the initial infection, whether mild or severe, the herpes virus that causes cold sores remains dormant, or latent, in the nerve root connected to the lips. Essentially, the virus “hides and waits”. Unrelated to the severity of the first episode of cold sores, and for unknown reasons, about 25% of exposed individuals will go on to have recurrent cold sores for the rest of their lives. Generally, the virus will be reactivated and cause cold sores as a response to stress, tiredness, illness, sunlight, fever, diet, menstruation or pregnancy. The frequency of outbreaks decreases after age 35.

What treatments are available?

There is no available cure for recurrent cold sores. Treatments that will decrease pain and speed healing include the topical creams acyclovir (Zovirax®), docosanol (Abreva®) or penciclovir (Denavir®). Oral medications include acyclovir (Zovirax®), famciclovir (famvir®), and valacylovir (Valtrex®).

What new treatments are being studied?

New antiviral medications are being developed, as are new routes of administration of existing medications. In one study being conducted at Rochester Clinical Research, the medication acyclovir (Zovirax®) is administered in a tablet that adheres to the patient’s upper gum and gets slowly absorbed, targeting the release of the medication to the area of the body affected by the herpes simplex virus. For more information on this or other studies at Rochester Clinical Research, please contact us.

For more information on Cold Sores, go to:
http://www.emedicinehealth.com/cold_sores/article_em.htm or http://www.mayoclinic.com/health/cold-sore/DS00358/DSECTION=1 [ Back to Top ]

Diabetes Studies

What is Diabetes?

Normally, the glucose we eat in the form of sugars and starches provides energy for our muscles and our brain cells. The glucose in our blood stream relies on the hormone insulin (produced in the pancreas) to get into the cells, where it can be utilized by the body. If the pancreas does not produce enough insulin, or if the insulin is being absorbed by abdominal fat cells (insulin resistance), then blood sugars levels will rise. By definition, diabetes is a fasting blood sugar (FBS) >126. The normal range is a FBS<100. Those with a FBS level 100-126 are said to have “Impaired Fasting Glucose”, a precursor to diabetes.

What are the symptoms of Diabetes?

When blood sugars rise, the body tries to get rid of the excess sugar by diluting it. Patients will note increased thirst and urination. Typically, the first sign of diabetes is increased urination at night. Fatigue, blurred vision, or increased appetite with weight loss can also occur.

What are the different types of Diabetes?

In some instances, the pancreas will stop working, and the individual will have to rely on insulin shots to regulate their glucose levels. This is known as type 1 diabetes. Much more common in our society is type 2 diabetes, which is generally caused by obesity. Being overweight makes the pancreas work harder, until it can no longer keep up with the increased demand, resulting in slowly rising blood sugars. Generally, type 2 diabetes is controlled by weight loss, diet, and oral medications; though some type 2 diabetics will require insulin for blood sugar control.

What are the risks and complications of Diabetes?

Unfortunately, uncontrolled diabetes can have severe consequences. Diabetes is the third leading cause of death after heart disease and cancer. Diabetics are at increased risk for heart attacks and strokes. The small blood vessels in the eyes, kidneys, and nerves can also be damaged, leading to retinopathy, nephropathy and diabetic neuropathy.

What types of studies are available for Diabetics at Rochester Clinical Research?

There are a number of exciting new treatments being developed for diabetes and for the symptoms of diabetic neuropathy (burning nerve pain, tingling, numbness, or weakness, usually starting in the feet and legs). The highly effective injectable diabetes medication Byetta (exenatide) was studied here at Rochester Clinical Research, as was the new oral medication Januvia (sitagliptin). We are expecting to do more studies for similar oral medications. For diabetic neuropathy, we are conducting several studies, including a new medication that not only treats the nerve pain of neuropathy, but actually helps to regenerate small nerve fibers. If you would like to participate in a study, please contact us.

For more information on Diabetes, visit the Joslin Diabetes Center Website: http://www.joslin.org/LearnAboutDiabetes_Index_home.asp [ Back to Top ]

Gastroesophageal Reflux Disease (GERD)

What is GERD?

Gastroesophageal reflux disease results when highly acidic gastric juices chemically “burn” and irritate the lower esophagus. GERD occurs when the lower esophageal sphincter (LES) opens spontaneously, for varying periods of time, or does not close properly and stomach contents rise up into the esophagus. GERD is sometimes called acid reflux or acid regurgitation, because acidic digestive juices rise up with the food. The esophagus is the tube that carries food from the mouth to the stomach. The LES is a ring of muscle at the bottom of the esophagus that acts like a valve between the esophagus and stomach.

When acid reflux occurs, food or fluid can be tasted in the back of the mouth. When refluxed stomach acid touches the lining of the esophagus it may cause a burning sensation in the chest or throat called heartburn or acid indigestion. Occasional heartburn is common and does not necessarily mean one has GERD. Persistent reflux that occurs more than twice a week is considered GERD, and it can eventually lead to more serious health problems. People of all ages can have GERD.

What are the symptoms of GERD?

The main symptom of GERD in adults is frequent heartburn, also called acid indigestion—burning-type pain in the lower part of the mid-chest, behind the breast bone, and in the mid-abdomen. Most children under 12 years with GERD, and some adults, have GERD without heartburn. Instead, they may experience a dry cough, asthma symptoms, or trouble swallowing.

What causes GERD?

The reason some people develop GERD is still unclear. However, research shows that in people with GERD, the LES relaxes while the rest of the esophagus is working. Anatomical abnormalities such as a hiatal hernia may also contribute to GERD. A hiatal hernia occurs when the upper part of the stomach and the LES move above the diaphragm, the muscle wall that separates the stomach from the chest. Normally, the diaphragm helps the LES keep acid from rising up into the esophagus. When a hiatal hernia is present, acid reflux can occur more easily. A hiatal hernia can occur in people of any age and is most often a normal finding in otherwise healthy people over age 50. Most of the time, a hiatal hernia produces no symptoms.

Other factors that may contribute to GERD include obesity, pregnancy, or smoking. Common foods that can worsen reflux symptoms include citrus fruits, chocolate drinks with caffeine or alcohol, fatty and fried foods, garlic and onions, mint flavorings, spicy foods, or tomato-based foods, such as spaghetti sauce, salsa, chili, and pizza.

How is GERD treated?

See your health care provider if you have had symptoms of GERD and have been using antacids or other over-the-counter reflux medications for more than 2 weeks. Your health care provider may refer you to a gastroenterologist, a doctor who treats diseases of the stomach and intestines. Depending on the severity of your GERD, treatment may involve one or more of the following lifestyle changes, medications, or surgery.

Lifestyle Changes:
• If you smoke, stop.
• Avoid foods and beverages that worsen symptoms.
• Lose weight if needed.
• Eat small, frequent meals.
• Wear loose-fitting clothes.
• Avoid lying down for 3 hours after a meal.
• Raise the head of your bed 6 to 8 inches by securing wood blocks under the bedposts. Just using extra pillows will not help.
Medications:
Your health care provider may recommend over-the-counter antacids or medications that stop acid production or help the muscles that empty your stomach. You can buy many of these medications without a prescription. However, see your health care provider before starting or adding a medication. Some common medications for GERD:

• Antacids, such as Alka-Seltzer, Maalox, Mylanta, Rolaids, and Riopan, are usually the first drugs recommended to relieve heartburn and other mild GERD symptoms. Calcium carbonate antacids, such as Tums, Titralac, and Alka-2, can also be a supplemental source of calcium. They can cause constipation as well.
• Foaming agents, such as Gaviscon, work by covering your stomach contents with foam to prevent reflux.
• H2 blockers, such as cimetidine (Tagamet HB), famotidine (Pepcid AC), nizatidine (Axid AR), and ranitidine (Zantac 75), decrease acid production. They are available in prescription strength and over-the-counter strength. These drugs provide short-term relief and are effective for about half of those who have GERD symptoms.
• Proton pump inhibitors include omeprazole (Prilosec, Zegerid), lansoprazole (Prevacid), pantoprazole (Protonix), rabeprazole (Aciphex), and esomeprazole (Nexium), which are available by prescription. Prilosec is also available in over-the-counter strength. Proton pump inhibitors are more effective than H2 blockers and can relieve symptoms and heal the esophageal lining in almost everyone who has GERD.
• Prokinetics help strengthen the LES and make the stomach empty faster. This group includes bethanechol (Urecholine) and metoclopramide (Reglan). Metoclopramide also improves muscle action in the digestive tract. Prokinetics have frequent side effects that limit their usefulness—fatigue, sleepiness, depression, anxiety, and problems with physical movement.

Surgery:

Surgery is an option when medicine and lifestyle changes do not help to manage GERD symptoms. Surgery may also be a reasonable alternative to a lifetime of drugs and discomfort.

• Fundoplication is the standard surgical treatment for GERD. Usually a specific type of this procedure, called Nissen fundoplication, is performed. During the Nissen fundoplication, the upper part of the stomach is wrapped around the LES to strengthen the sphincter, prevent acid reflux, and repair a hiatal hernia.
• Endoscopic techniques used to treat chronic heartburn include the Bard EndoCinch system, NDO Plicator, and the Stretta system. These techniques require the use of an endoscope to perform the anti-reflux operation. The EndoCinch and NDO Plicator systems involve putting stitches in the LES to create pleats that help strengthen the muscle. The Stretta system uses electrodes to create tiny burns on the LES. When the burns heal, the scar tissue helps toughen the muscle. The long-term effects of these three procedures are unknown.

What are the long-term complications of GERD?

Chronic GERD that is untreated can cause serious complications. Inflammation of the esophagus from refluxed stomach acid can damage the lining and cause bleeding or ulcers—also called esophagitis. Scars from tissue damage can lead to strictures—narrowing of the esophagus—that make swallowing difficult. Some people develop Barrett’s esophagus, in which cells in the esophageal lining take on an abnormal shape and color. Over time, the cells can lead to esophageal cancer, which is often fatal. Persons with GERD and its complications should be monitored closely by a physician.

Studies have shown that GERD may worsen or contribute to asthma, chronic cough, and pulmonary fibrosis.

What new therapies are being tested?

Newer medications that are extended-release inhibitors of stomach acid production are being developed. If you have GERD and would like to participate in a study please contact Rochester Clinical Research, either through this website, or by calling, (585) 288-0890.

For more general information on GERD, go to the following web sites:
American College of Gastroenterology www.acg.gi.org
American Gastroenterological Association www.gastro.org
International Foundation for Functional Gastrointestinal Disorders www.aboutgerd.org [ Back to Top ]

Healthy Volunteer Studies

What is a “Healthy Volunteer Study”?

When a company makes a new laboratory machine to analyze blood, or when a new methodology is developed for doing a lab test on blood, those medical advancements need to be tested. Whether it is the calibration of the machine, or to develop standards for “normal” vs. “abnormal” for a new test, blood samples from a wide range of people are needed in order to test the new machine or the new test.

The healthy volunteer studies conducted at Rochester Clinical Research typically involve drawing several tubes of blood from the study volunteer, for which the volunteer receives a small monetary stipend, and the satisfaction of helping others by advancing medical science. RCR is currently enrolling patients for a “healthy volunteer study.” [ Back to Top ]

High Cholesterol

What is Cholesterol?

Cholesterol is a lipid that is produced in the liver, circulates in the blood stream, and is important in the function of cell membranes and in the formation of many of the body’s hormones. Some cholesterol is synthesized by the body; some is ingested through our diets.

Why are high cholesterol levels dangerous?

High levels of total cholesterol and LDL (low density lipoprotein) contribute to the formation of atherosclerotic plaque build-up on the inside walls of blood vessels. If the build-up blocks an artery, or breaks loose and forms a clot “downstream” in a smaller blood vessel, the result can be a heart attack or a stroke.

There is a direct and exponential relationship between elevated cholesterol levels and the incidence of coronary heart disease. Coronary heart disease is the leading cause of death for both men and women of all races and ethnicities in the United States. In the U.S., more people die of heart attacks every year than die of all the forms of cancers combined.

How often should I get tested?

It is recommended by the American Heart Association to test cholesterol every 5 years for people aged 20 years or older. It is recommended to have cholesterol tested more frequently than 5 years if a person: has total cholesterol of 200 or more, is a man over age 45 or a woman over age 50, has HDL (good) cholesterol less than 40 , or other risk factors for heart disease and stroke.

What are the recommended levels of cholesterol?

The acceptable levels will vary from individual to individual depending upon age and other risk factors. As a general rule, total cholesterol should be < 200, triglyceride levels <150, LDL (“bad” cholesterol) levels are optimally < 100, near optimal is 100-129, borderline high 130-159, high is defined as > 160, while very high is >190. High density lipoprotein (HDL or “good” cholesterol) should be > 40 in men, and >50 in women.

What treatments are available?

A low cholesterol, low fat diet is the most important intervention. Regular aerobic exercise can help to raise HDL levels. Over the counter supplements such as flax seed, fish oil capsules, and red yeast rice tablets have been shown to be beneficial. For those requiring medications, there are several families of medicines; statins, such as simvastatin (Zocor®) or atorvastatin (Lipitor®), cholesterol absorption inhibitors, such as ezetimibe (Zetia®), Bile acid sequestrants such as cholestyramine (Questran®), Nicotinic acid such as Niacin (immediate, sustained, and extended release, Niaspan®), and the fibrates such as gemfibrozil (Lopid®) or fenofibrate (Tricor®).

What new therapies are being tested?

Newer medications that work be inhibiting cholesterol absorption or production are being developed. If you have high cholesterol, and would like to participate in a study please contact us. If you do not know your cholesterol levels, Rochester Clinical Research offers a free cholesterol screening visit that only requires a small amount of blood from the finger tip.

For more general information on cholesterol, go to the following web sites:

National Library of Medicine (www.nlm.nih.gov/medlineplus/healthtopics.html)
National Cholesterol Education Program of the National Heart, Lung, and Blood Institute of the NIH (www.nhlbi.nih.gov/chd)
American Heart Association (www.americanheart.org) [ Back to Top ]

Vaccinations

What are Vaccines?

Vaccines are immunizations that generally come in the form of shots, and help our bodies to defend against a number of infectious diseases. Vaccines typically contain a killed or much weakened virus or protein that stimulates our body to produce antibodies against a specific disease.

How many vaccines are there?

Currently, there are 27 licensed vaccines in the U.S., to help prevent diseases like tetanus, polio, influenza, measles, mumps, hepatitis, and HPV/cervical cancer.

Can a vaccine cause the disease it is supposed to prevent?

Most of our current vaccines are inactivated (killed), so that they cannot cause disease. A few vaccines use weakened or attenuated viruses, so they could theoretically cause disease, but generally do not.

What kinds of vaccines need to be studied?

There are several vaccines in development for treating diseases like bird flu, anthrax, TB, and Malaria. The hope is to find a bird flu vaccine that doesn’t depend on chicken embryos for its manufacturing, so that hundreds of millions of doses could be quickly produced in the event of a global outbreak of bird flu. We call our volunteers “everyday heroes”, because they help to come up with solutions to some of the world’s biggest problems, such as the threat of pandemic bird flu.

For more information on Avian Influenza (Bird Flu), see: http://www.pandemicflu.gov/

For more general information on immunizations, go to: http://www.cdc.gov/vaccines/ [ Back to Top ]

Insomnia

How is insomnia defined?

Insomnia is a symptom or syndrome rather than a disease that results in decreased quantity or quality of sleep. It is characterized by difficulty falling asleep, staying asleep, or simply having “unrefreshing” sleep. It is a very common problem, and is more common in women than men.

Insomnia can be of transient, short, or chronic duration. For many people, insomnia is related to an underlying problem such as situational stress, anxiety, grief, or depression, or to a medical problem such as sleep apnea or restless legs syndrome. Circadian rhythm disorders related to shift work or jet lag also contribute to insomnia. People with insomnia can experience daytime fatigue or sleepiness, inability to concentrate, irritability, anxiety, depression, or forgetfulness.

If you suffer from insomnia, you should consult your doctor, as there may be an underlying disorder causing your problem.

What do sleep experts recommend for insomnia?

Go to bed and wake up at the same time every day, including weekends.

Establish a relaxing bedtime routine: take a bath, read a book or do something calming before bed.

Make sure your sleep environment is dark, quiet, cool, and comfortable.

Avoid or limit your use of stimulants like caffeine (coffee, tea, sodas, chocolate), decongestants, or tobacco before bed.

Avoid or limit your intake of alcohol before going to sleep. Alcohol’s depressant effect helps people fall asleep, but not to stay asleep.

Exercise regularly, but avoid exercise within a few hours before going to bed.

Learn to reduce or manage the stress in your life.

Avoid daytime naps.

Use the bed only for sleep and sex; keep the bedroom free from distractions like television, computers, and work. Remember that the multispectrum light of TV stimulates the central nervous system.

Avoid going to sleep hungry, but also avoid eating just before bedtime, as this not only adversely effects sleep, but can also cause gastro esophageal reflux disease (GERD).

Get out of bed if you can’t fall asleep within 15–20 minutes. Read under a dim lamp until you are drowsy. Only spend time in bed when you are actually sleepy or sleeping.

Don’t watch the clock—it can cause anxiety about sleep.

Keep a journal or sleep log to record both good and poor nights' sleep. This can help you recognize patterns and expose activities that trigger sleeplessness.

What treatments are available?

Medications that currently are available by prescription are known to improve sleep by reducing the amount of time it takes to fall asleep, increasing sleep duration, and/or reducing the number of awakenings during sleep. There are several types of prescription sleeping pills, such as the benzodiazepines like temazepam (Restoril). There are also the newer medications such as zolpidem (Ambien®), zaleplon (Sonata®), and eszopiclone (Lunesta®).

Over-the-counter medications that are available for the treatment of insomnia are mainly sedating antihistamines, such as diphenhydramine (Benadryl®).

What new treatments are being studied?

Rochester Clinical Research is performing a clinical trial on medication for those individuals who have difficulty staying asleep, and suffer from frequent awakenings in the night. To participate, please contact us.

For more general information on Insomnia, go to:

http://www.sleepassociation.org/index.php?p=insomnia
http://familydoctor.org/online/famdocen/home/articles/110.html [ Back to Top ]

Migraine Headaches

What is a migraine headache?

The pain of a migraine headache usually begins gradually, intensifies over minutes to one or more hours, and resolves gradually at the end of the attack. The headache is typically dull, deep, and steady when mild to moderate in severity; it becomes throbbing or pulsatile when severe. Migraine headaches are worsened with moving the head rapidly, light, sneezing, straining, constant motion, or physical exertion; many migraine sufferers try to get relief by lying down in a darkened, quiet room. In 60 to 70 percent of people, the pain occurs on only one side of the head. In adults, a migraine headache usually lasts a few hours, but can last from four to 72 hours.

Migraine headaches are often accompanied by nausea and vomiting, as well as sensitivity to light and noise. Between 10 and 20 percent of people with migraine also experience nasal stuffiness and runny nose, tearing, or changes in skin tone or body temperature.

The symptoms of a migraine attack may be severe and alarming but in most cases there are no lasting health effects when the attack ends.

Migraine is the most common cause of disabling headache, affecting 35 million Americans. About 15 percent of women and 6 percent of men experience migraine. The condition is often hereditary; if you have migraines, it is very likely that another family member suffers from them too.

Migraine is characterized by recurrent attacks, with pain often on one side of the head that may be throbbing or pounding, accompanied by other symptoms such as nausea, vomiting and sensitivity to light and sound, and to head movement. Although migraine can occur at any time of day or night, they tend to affect people in the morning.

Episodes can last from several hours to several days and often are disabling. During the attack, pain may travel from one part of the head to another and may radiate down the neck into the shoulder. Scalp tenderness occurs in the majority of patients during or after an attack. Signs and symptoms of migraine headaches include:

• Throbbing or pounding pain
• Nausea and vomiting
• Scalp tenderness
• Sensitivity to light or sound
• Worsening of pain with movement
• Visual disturbances, such as flashes of light or blind spots in your vision
• Abnormal body sensations, called paresthesias, such as tingling, numbing or prickling • Diarrhea
• Dizziness or vertigo

Migraine triggers — Many conditions are potential triggers of migraine headache. A partial list appears in the table (show table 2).

Migraines can be triggered by stress, worry, menstrual periods, birth control pills, physical exertion, fatigue, lack of sleep, hunger, head trauma, and certain foods or drinks that contain chemicals such as nitrites, glutamate, aspartate, tyramine.

Certain medications and chemicals can also trigger a migraine, including nitroglycerin (used to treat chest pain), estrogens, hydralazine (used to treat high blood pressure), perfumes, smoke, and organic solvents with a strong odor. [ Back to Top ]

Oral Contraceptive Studies

What are oral contraceptives?

“The Pill”, as it is commonly known, is a combination of progesterone and estrogen that prevents ovulation. First licensed in 1960, birth control pills are over 99% effective when taken as directed, and are generally safe. Currently, over 100 million women worldwide rely on oral contraceptives pills (OCPs) as their form of birth control.

What types of studies are being conducted on birth control pills?

Medical researchers are creating new oral contraceptives that provide greatly flexibility of dosing. Pills that extend the intervals between menstrual cycles are being developed, as are pills with lower hormone dosages. There is also research being conducted to look at the secondary benefits of OCPs, such as decreased symptoms of Pre-Menstrual Syndrome (PMS), or decreased facial acne. At Rochester Clinical Research a study is underway to establish the effectiveness of a flexible dosing pattern for an extended cycle OCP.

For more information on oral contraceptives, see the Medline website: http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a601050.html [ Back to Top ]

Osteoarthritis of the Knee

What is Osteoarthritis?

Osteoarthritis (OA) is the most common type of arthritis, and is characterized by a gradual loss of cartilage from the joints. Although OA can affect almost any joint, it most often affects the hands, knees, hips, and spine. Common symptoms include pain, stiffness, some loss of joint motion, and changes in the shape of affected joints.

OA is strongly associated with the wear and tear on joints during a lifetime, but it is no longer considered a normal part of aging. Studies suggest that the risk of OA is also influenced by other factors, including heredity, obesity, and occupation. It is a chronic condition that gradually worsens over time; however, osteoarthritis treatments can relieve pain and help you remain active. Taking steps to actively manage your osteoarthritis may help you gain control over your osteoarthritis pain.

What are the risk factors for getting OA of the knee?

• Age: Most common in those over 40.
• Gender: For unknown reasons, women are 2-3 times more likely then men to develop knee osteoarthritis.
• Occupation: Repetitive squatting or kneeling increases risk, as does history of previous injury or trauma
• Weight: Obesity is the most important modifiable risk factor.

What treatments are available?

Current medical therapies include the use of pain medication such as acetaminophen (Tylenol®), or anti-inflammatory medications such as ibuprofen (Advil®) or naprosyn (Aleve®). Topical capsaicin cream (Zostrix®) is beneficial in some patients. Weight loss can dramatically help the pain and alter the course of knee OA. Rest, exercise, physical therapy, and heat or cold treatments can be beneficial. Alternative therapies like acupuncture, Tai chi or yoga may help. Some patients will benefit from joint injections, and the most severe cases will require surgical knee replacement.

One of the focuses of current research is medications that prevent cartilage breakdown. Rochester Clinical Research is conducting research on new therapies for osteoarthritis; please contact us if you would like more information. For more general information about osteoarthritis, contact:

The Arthritis Foundation, www.arthritis.org or go to the Mayo Clinic website: for an extended cycle OCP.

For more information on oral contraceptives, see the Medline website: http://www.mayoclinic.com/health/osteoarthritis/DS00019/DSECTION=1 [ Back to Top ]

Smoking Cessation

What are the risks of smoking?

Simply stated, smoking is the single most avoidable cause of disease, disability, and death in the United States. About half of the people who smoke will die of smoking-related problems. Smoking directly contributes to more than 440,000 deaths per year in the U.S.

In addition to causing almost 90% of all lung cancers, smoking also increases the risk of cancers of the head & neck, esophagus, pancreas and bladder. Smoking also doubles an individual’s risk of developing coronary artery disease and dying of a heart attack.

Smoking is the number one cause of emphysema, chronic bronchitis and chronic obstructive pulmonary disease. Asthma and sudden infant death syndrome (SIDS) are more common among children exposed to second-hand smoke. Exposure to second-hand smoke leads to the deaths of an additional 35,000 people a year by coronary artery disease.

Smoking increases the risk of peptic ulcer disease, as well as the risks of osteoporosis and hip fractures in women. It causes premature skin wrinkling, and increases the risk of sexual dysfunction (impotence).

What are the benefits of quitting?

Smoking cessation has major and immediate health benefits for men and women of all ages. The earlier a person quits, the greater the benefits. People who quit smoking before age 50 reduce their risk of dying over the next 15 years by one-half, as compared to those who continue to smoke. One year after stopping smoking, the risk of dying from coronary heart disease is reduced by about one-half and continues to decline with time. Smoking cessation reduces the risk of lung cancer within five years of stopping, although former smokers still have a higher risk of lung cancer than those who have never smoked.

The risks of peptic ulcer disease, osteoporosis and hip fractures all decrease with quitting.

There is a secondary benefit to quitting; saving money. With cigarettes averaging more than $5 a pack, a 2 pack per day smoker will save $3,650 dollars a year.

Are there any risks to quitting?

Yes. The process of quitting can lead to withdrawal symptoms from nicotine that includes irritability, anxiety, insomnia, or depression. Some people experience intense cravings for cigarettes. The oral medications to help people quit can decrease these symptoms and cravings.

Also, weight gain can result from quitting smoking, as many smokers replace smoking with eating. An exercise program and eating a reasonable diet can minimize such weight gain. It must be emphasized that the benefits of quitting smoking are much greater than the risks of gaining weight.

What is available to help me quit?

Nicotine replacement products can help relieve withdrawal symptoms people experience when they quit smoking. Nicotine patches, nicotine gum and nicotine lozenges are available over-the-counter, and a nicotine nasal spray and inhaler are currently available by prescription. Nicotine replacement therapies are helpful in quitting when combined with a behavior change program such as the American Lung Association's Freedom from Smoking online program (available at www.lungusa.org) which addresses psychological and behavioral addictions to smoking and strategies for coping with urges to smoke.

The oral medication bupropion (Zyban®, Wellbutrin®) is an anti-depressant that can decrease cravings and help people to quit. Bupropion may be more effective than nicotine replacement therapy, and combining the two may be even more effective. More effective still is varenicline (Chantix®) that works in the brain to reduce nicotine withdrawal symptoms and cigarette cravings, but patients need to be monitored for mood or behavioral changes.

What new treatments are being studied?

New therapies to help smokers quit are currently being developed. Rochester Clinical Research is performing clinical trials on an extended-release form of varenicline (Chantix®), as well as an exciting new vaccine to help smokers quit. For more information on this or other studies at Rochester Clinical Research, please contact us.

For more information on smoking and to get help with quitting, go to:
National Heart, Lung and Blood Institute (www.nhlbi.nih.gov/)
American Lung Association (www.lungusa.org/)
American Heart Association (www.americanheart.org) [ Back to Top ]

Weight Loss Studies

Am I overweight?

For adults, overweight and obesity ranges are determined by using weight and height to calculate a number called the “body mass index” (BMI). BMI is used because, for most people, it correlates with their amount of body fat.

• An adult who has a BMI between 25 and 29.9 is considered overweight.
• An adult who has a BMI of 30 or higher is considered obese.
The CDC offers an online body-mass index calculator.

What are the risks of being overweight?

Currently, two-thirds of the adult U.S. population is considered overweight or obese, with experts calling the problem an “epidemic”. Both genetic and environmental factors play a role, with overeating and sedentary lifestyles contributing to the problem.

Being overweight can cause a number of other medical problems, including diabetes, hypertension, high cholesterol, heart disease, sleep apnea, osteoarthritis and/or depression.

What are the benefits of participating in a weight loss study?

Volunteers in weight loss studies at Rochester Clinical Research have access to new therapies for weight loss before they become available to the general public. Studies vary between 3 months to several years in length, and typically involve a decreased calorie diet and an exercise program.

The accountability of regular office visits, coupled with routine educational visits with our registered dietician, enable our volunteers to be successful with their weight loss goals, regardless of whether they are on study drug or placebo. [ Back to Top ]

Rochester Clinical Research performs clinical research trials and studies for pharmaceutical and biotechnology companies. We rapidly recruit and screen quality volunteers to participate in clinical studies, and we maintain a large database of volunteers. Study volunteers receive free study-related medical care, investigational medicines, and a monetary stipend to compensate for their time and travel. RCR studies include therapeutic areas and drug categories such as weight loss, diabetes, hypertension, high cholesterol, flu vaccines, and smoking cessation. Our state-of-the-art medical office facility is staffed by highly qualified, caring physicians, investigators, and nurses. RCR is located in Rochester NY and serves the Finger Lakes region of New York.