November 2012 Newsletter

J. Lewis Research, Inc.

E-Newsletter

November 2012

http://www.jlewisresearch.com


The following enrolling studies are featured in this month’s edition of our newsletter:

MMR Vaccine (Ages 12-15 months)

MMR Vaccine (Ages 4-6)

Birth Control (Ages 18-50)

High Cholesterol (Ages 18-80)

9-valent HPV Vaccine (Ages 16-26)

Meningitis B Vaccine vs. Havrix (Ages 10-26)

Meningitis B Vaccine with TDaP and Menactra (Ages 10-12)

Licensed Hepatitis B Vaccine (Ages 20 and up)

Hypertension (Ages 18 and up)

Celiac Disease (Ages 18-75)

Swimmer’s Ear (Ages 6 months and up)

Adolescent Migraine (Ages 12-17)

Our Centerwatch profile


MMR VACCINE- Ages 12 to 15 months

Participating locations: Foothill Family Clinic and Foothill Family Clinic South


Measles, mumps, and rubella are serious diseases. Before vaccines they were very common, especially among children.

Measles

• Measles virus causes rash, cough, runny nose, eye irritation, and fever.

• It can lead to ear infection, pneumonia, seizures (jerking and staring), brain damage, and death.

 

Mumps

• Mumps virus causes fever, headache, muscle pain, loss of appetite, and swollen glands.

• It can lead to deafness, meningitis (infection of the brain and spinal cord covering), painful swelling of the testicles or ovaries, and rarely sterility.

 

Rubella (German Measles)

• Rubella virus causes rash, arthritis (mostly in women), and mild fever.

• If a woman gets rubella while she is pregnant, she could have a miscarriage or her baby could be born with serious birth defects.

 

These diseases spread from person to person through the air. You can easily catch them by being around someone who is already infected.

Measles, mumps, and rubella (MMR) vaccine can protect children (and adults) from all three of these diseases.

Thanks to successful vaccination programs these diseases are much less common in the U.S. than they used to be. But if we stopped vaccinating they would return.

For more from this article, please click on the link: http://www.cdc.gov/vaccines/pubs/vis/downloads/vis-mmr.pdf


Several vaccinations are recommended for children 12 to 15 months of age.

Our office is conducting a clinical research study comparing an investigational vaccine for Measles/Mumps/Rubella (MMR) with a US-licensed MMR vaccine when given at the same time as the Varicella, Hepatitis A and Pneumococcal disease vaccines.

To qualify for this clinical study, your child must be:

  • 12 to 15 months of age
  • Accompanied by a parent or guardian at each visit
  • Up to date on all current childhood vaccinations

 

To learn more about this important clinical research study, please call our office today. Our staff is available to provide more detail about this study and answer any questions you may have.

We look forward to hearing from you.


MMR VACCINE- Ages 4 to 6

Participating locations: Jordan River Family Medicine


IS YOUR CHILD BETWEEN 4-6 YEARS OF AGE?

NOW ENROLLING

A clinical research study is evaluating an investigational vaccine to prevent Measles/Mumps/Rubella (MMR) in children

To qualify for this clinical study, your child must be:

  • 4 to 6 years of age
  • Accompanied by a parent or guardian at each study visit
  • Up to date on all current childhood vaccinations

If your child joins this clinical study he/she will receive:

  • MMR vaccination
  • Study-related medical check-ups
  • Payment for the cost of travelling to study visits

If you or someone you know may be interested in participating in this vaccine study, ask your doctor for more information.


BIRTH CONTROL

Participating locations: Foothill Family Clinic and Jordan River Family Medicine


ATTENTION: A RESEARCH STUDY FOR WOMEN

Seeking a different kind of birth control pill?

Explore your options.

Local doctors are studying a new type of low dose investigational birth control pill. This clinical research study is studying an investigational birth control pill that uses hormones similar to those already in your body. If you’re a sexually active woman between18 and 50 and qualify for this study, you may receive at no cost:

  • Study birth control medication for a year
  • Study-related care from a local doctor
  • Possible reimbursement for time and travel

Ask your doctor for more information or contact our clinic to see if you may be eligible to participate.


HIGH CHOLESTEROL

Participating locations: Jordan River Family Medicine


Cholesterol is a waxy substance that’s found in the fats (lipids) in your blood. While your body needs cholesterol to continue building healthy cells, having high cholesterol can increase your risk of heart disease.

When you have high cholesterol, you may develop fatty deposits in your blood vessels. Eventually, these deposits make it difficult for enough blood to flow through your arteries. Your heart may not get as much oxygen-rich blood as it needs, which increases the risk of a heart attack. Decreased blood flow to your brain can cause a stroke.

High cholesterol (hypercholesterolemia) can be inherited, but is often preventable and treatable. A healthy diet, regular exercise and sometimes medication can go a long way toward reducing high cholesterol.

For more from this website, please click on the link: http://www.mayoclinic.com/health/high-blood-cholesterol/DS00178


  • Ages 18-80
  • 7 visits over 40 weeks

Please contact our participating location for more information!


UPDATED GARDASIL (9-VALENT HPV) VACCINE

Participating Locations: Foothill Family Clinic South


Human Papillomavirus (HPV) Vaccine

Every year in the United States, about 11,000 women are diagnosed with cervical cancer and almost 4,000 die from this disease. Most cases of cervical cancer and all cases of genital warts are caused by human papillomavirus (HPV). There are two HPV vaccines available to protect against the types of HPV that cause most cervical cancers. Both vaccines are usually given as a 3 shot series. Clinical trials and post-licensure monitoring data show that both vaccines are safe. Based on information available today, CDC continues to recommend HPV vaccination for the prevention of most types of cervical cancer. As with all approved vaccines, CDC and Food and Drug Administration (FDA) will continue to closely monitor the safety of HPV vaccines. Any problems detected with these vaccines will be reported to health officials, health care providers, and the public. Needed action will be taken to ensure the public’s health and safety.

Gardasil: FDA licensed Gardasil in 2006. Gardasil is recommended for 11- and 12 year-old girls, and also females 13 through 26-year-old who were not previously vaccinated. Gardasil is also recommended for 9- through 26- year-old males to protect against some genital warts. The safety of Gardasil was studied in clinical trials with over 29,000 females and males before it was licensed. This vaccine protects females against HPV types 6, 11, 16, and 18.

For more from this article, please follow the link: http://www.cdc.gov/vaccinesafety/vaccines/HPV/Index.html


  • For men and women ages 16-26
  • Must not have had HPV or HPV vaccines
  • 4 visits, 1 phone call over 7 months

MENINGITIS B VACCINE vs. HAVRIX (Ages 10-26)

Participating locations: Foothill Family Clinic and Foothill Family Clinic South


Meningitis

Meningitis is a disease caused by the inflammation of the protective membranes covering the brain and spinal cord known as the meninges. The inflammation is usually caused by an infection of the fluid surrounding the brain and spinal cord.

Meningitis may develop in response to a number of causes, usually bacteria or viruses, but meningitis can also be caused by physical injury, cancer or certain drugs.

The severity of illness and the treatment for meningitis differ depending on the cause. Thus, it is important to know the specific cause of meningitis.

There are 5 “types” of meningitis

Bacterial Meningitis

Caused by bacteria, like Neisseria meningitidis and Streptococcus pneumoniae. It can be a life-threatening infection that needs immediate medical attention. There are vaccines to prevent some kinds of bacterial meningitis.

Viral Meningitis

Caused by viruses, like enteroviruses and herpes simplex viruses. It’s serious, but rarely fatal in people with normal immune systems. There are vaccines to prevent some kinds of viral meningitis.

Fungal Meningitis

Caused by fungi like Cryptococcus and Histoplasma. Usually acquired by inhaling fungal spores from the environment. People with certain medical conditions like diabetes, cancer, or HIV are at higher risk of fungal meningitis.

Parasitic Meningitis

Caused by parasites and less common in developed countries. Parasites, like Angiostrongylus cantonensis can contaminate food, water and soil

Non-infectious Meningitis

Not spread from person to person, but can be caused by cancers, systemic lupus erythematosus (lupus), certain drugs, head injury, and brain surgery.

For more from this article, please click on the link: http://www.cdc.gov/meningitis/index.html


MENINGITIS B VACCINE (WITH TDaP AND MCV4)

Participating locations: Foothill Family Clinic, Foothill Family Clinic South and Jordan River Family Medicin


What is meningococcal disease type B (MnB)?

Meningococcal disease type B (MnB) is caused by a certain type of bacteria that can make your child very sick. No vaccine to prevent MnB is currently available.

Your child (ages 10-12) may be eligible to take part in a clinical trial to test an investigational vaccine for MnB.


LICENSED HEPATITIS B VACCINE

Participating locations: Foothill Family Clinic


We are only looking for those with Type 2 Diabetes at this point in the study


Research Study of a Hepatitis B Vaccine

In Adults 20 years of age and older with or without Type 2 Diabetes

What is this study about? Are you interested?

This study will test how the body responds to a hepatitis B vaccine for adults with or without type 2 diabetes.

  • You may join this study if:
  • You are 20 years of age or older
  • Within the past 5 years, you have had type 2 diabetes OR never had diabetes
  • You have never had a hepatitis B vaccine
  • You have never had hepatitis B infection
  • The study team will tell you what else is needed to join this study

HYPERTENSION

Participating locations: Foothill Family Clinic, Foothill Family Clinic South and Jordan River Family Medicine


High blood pressure has many risk factors, including:

  • Age. The risk of high blood pressure increases as you age. Through early middle age, high blood pressure is more common in men. Women are more likely to develop high blood pressure after menopause.
  • Race. High blood pressure is particularly common among blacks, often developing at an earlier age than it does in whites. Serious complications, such as stroke and heart attack, also are more common in blacks.
  • Family history. High blood pressure tends to run in families.
  • Being overweight or obese. The more you weigh, the more blood you need to supply oxygen and nutrients to your tissues. As the volume of blood circulated through your blood vessels increases, so does the pressure on your artery walls.
  • Not being physically active. People who are inactive tend to have higher heart rates. The higher your heart rate, the harder your heart must work with each contraction — and the stronger the force on your arteries. Lack of physical activity also increases the risk of being overweight.
  • Using tobacco. Not only does smoking or chewing tobacco immediately raise your blood pressure temporarily, but the chemicals in tobacco can damage the lining of your artery walls. This can cause your arteries to narrow, increasing your blood pressure. Secondhand smoke also can increase your blood pressure.
  • Too much salt (sodium) in your diet. Too much sodium in your diet can cause your body to retain fluid, which increases blood pressure.
  • Too little potassium in your diet. Potassium helps balance the amount of sodium in your cells. If you don’t get enough potassium in your diet or retain enough potassium, you may accumulate too much sodium in your blood.
  • Too little vitamin D in your diet. It’s uncertain if having too little vitamin D in your diet can lead to high blood pressure. Vitamin D may affect an enzyme produced by your kidneys that affects your blood pressure.
  • Drinking too much alcohol. Over time, heavy drinking can damage your heart. Having more than two drinks a day can raise your blood pressure.
  • Stress. High levels of stress can lead to a temporary, but dramatic, increase in blood pressure. If you try to relax by eating more, using tobacco or drinking alcohol, you may only increase problems with high blood pressure.
  • Certain chronic conditions. Certain chronic conditions also may increase your risk of high blood pressure, including high cholesterol, diabetes, kidney disease and sleep apnea.

Sometimes pregnancy contributes to high blood pressure, as well.

For more from this website, please click on the link: http://www.mayoclinic.com/health/high-blood-pressure/DS00100/DSECTION=risk-factors


YOU MAY QUALIFY FOR A CLINICAL RESEARCH STUDY

About 76 million Americans struggle with high blood pressure, also known as hypertension. It may be difficult to control, but without adequate treatment high blood pressure can cause health complications. Physicians in our area are conducting a clinical research study to evaluate an investigational combination of FDA-approved oral medicines intended to treat hypertension.

You may qualify if:

  •  You have been diagnosed with hypertension
  • Can attend up to 15 visits over 16 weeks
  • Qualified participants will receive at no cost:
  • All study-related medical evaluations, including an evaluation by a physician
  • All study-related exams, monitoring and medicine

You may be compensated for your time and travel. Health insurance is not necessary.

Space is limited!


CELIAC DISEASE

Participating locations: Foothill Family Clinic


The traditional approach to diagnosing celiac disease is a three-step process:

  • Perform a biopsy of the lining of the small intestine. This is a surprisingly easy procedure which takes only a few minutes, although small children are usually sedated first, which adds to the cost and complexity of the biopsy. If the villi are damaged (flattened or atrophied mucosa), go to step 2.
  • Place the patient on a gluten-free diet for six months or longer and then perform another biopsy.  If the villi are healed, go to step 3.
  • Put gluten back in the diet for six months or longer, and then perform a third biopsy. If the villi are again damaged, then the diagnosis is complete. At this point, the patient goes on a gluten-free diet for life.

Many doctors now feel that step number three is unnecessary, and some feel that even the second biopsy may be unnecessary. Part of the reason for this change in thinking is the development of three useful antibody blood tests: Endomysial, reticulin (IgA), and gliadin (IgG and IgA). If the patient has been eating gluten regularly and all three tests come back positive, there is a very high chance that the patient has celiac disease. If all three tests come back negative, then it is very likely that the patient does not have celiac disease. Mixed results, which often occur, are inconclusive.

For more from this website, please follow the link: http://www.celiac.com/articles/5/1/How-is-celiac-disease-diagnosed/Page1.html


Do you or someone you know have Celiac Disease?

Follow a Gluten-free diet?

Still experiencing symptoms when exposed to gluten?

Interested in Celiac Research?

Alba Therapeutics is sponsoring a clinical trial locally for Celiac Disease. The purpose of the research study is to look at how effective and safe an investigational medication is when it is given to subjects who have celiac disease. The study will include people who have been diagnosed with celiac disease and have been on a gluten-free diet for 12 months or more before study entry.

You may qualify for the study if you:

  • Are between the ages of 18 and 75 and have been diagnosed with celiac disease
  • Have biopsy proven celiac disease and positive serology test results
  • for 12 months or more before study entry
  • Have been on a gluten-free diet for 12 months or more before study entry
  • Are still experiencing symptoms when exposed to gluten
  • Have positive serum anti-tTG (IgA or IgG) or DGP (IgA or IgG) antibodies at      screening
  • Are willing to maintain your current diet for the duration of the study
  • Satisfy other inclusion criteria

To participate in a survey to determine whether or not you qualify and to connect to a study site near you, call Research at a participating location.


SWIMMER’S EAR

Participating locations: Foothill Family Clinic South


Swimmer’s ear

Swimmer’s ear is inflammation, irritation, or infection of the outer ear and ear canal. The medical term for swimmer’s ear is otitis externa.

Swimmer’s ear may be acute or chronic.

Causes

Swimmer’s ear is fairly common, especially among teenagers and young adults. It is occasionally associated with middle ear infection (otitis media) or upper respiratory infections such as colds.

Swimming in polluted water can lead to swimmer’s ear. Water-loving bacteria such as Pseudomonas, as well as other bacteria or fungi (in rare cases), can cause ear infections.

Other causes of swimmer’s ear include:

  • Inflammation and irritation of the bone and tissues at the bottom of the skull (malignant otitis externa)
  • Scratching the ear or inside the ear
  • Getting something stuck in the ear

Trying to clean wax from the ear canal, especially with cotton swabs or small objects, can irritate or damage the skin.

Long-term (chronic) swimmer’s ear may be due to:

  • Allergic reaction to something placed in the ear
  • Chronic skin conditions such as eczema or psoriasis

Symptoms

  • Drainage from the ear — yellow, yellow-green, pus-like, or foul smelling
  • Ear pain, which may get worse when you pull on the outer ear
  • Hearing loss
  • Itching of the ear or ear canal

For more from this article, please click on the link: http://www.nlm.nih.gov/medlineplus/ency/article/000622.htm


You don’t have to be a swimmer to get swimmer’s ear.

If you are experiencing pain, itching or swelling of the outer ear, you may have a type of ear infection called acute otitis externa (AOE), also known as swimmer’s ear. While swimmer’s ear is most commonly caused by swimming, it can also occur from the use of hearing aids, headphones (or “earbuds”) and various types of hearing protection.

Local doctors in your area are conducting a research study for effectiveness of investigational antibiotic drops for acute otitis externa (AOE). Individuals 6 months of age or older with swimmer’s ear may be eligible to participate.

Visit our website for more information: SplashSwimmersEarStudy.com


ADOLESCENT MIGRAINE

Participating locations: Foothill Family Clinic, Foothill Family Clinic South, and Jordan River Family Medicine


Many everyday things can trigger (cause) a migraine headache. Depending on your sensitivity, it might be red wine, caffeine withdrawal, emotional stress, or skipped meals.

To take control of migraines, you must understand your migraine pattern. The first step is tracking your migraines by using a headache diary. Make notes of activities before — or when — a migraine occurred. What were you eating? What were you doing? How much sleep did you get the night before? Did anything stressful or important happen that day?

Common Migraine Triggers

Some common migraine triggers can include:

  • Emotional stress
  • Menstrual periods
  • Changes in normal sleep pattern
  • Extreme fatigue
  • Specific foods and beverages
  • Excess caffeine intake or withdrawal
  • Skipping meals; fasting
  • Changing weather conditions
  • Exercise
  • Smoking
  • Bright and flickering lights
  • Odors

Foods Additives and Chemicals That Can Trigger Migraines

Natural chemicals in foods, food additives, and beverages can also trigger migraines.

These include:

  • Tyramine, a substance found naturally in aged cheeses, and also found in red wine, alcoholic drinks, and some processed meats.
  • Food additives/preservatives such as nitrates and nitrites found in hot dogs, ham, sausage and other processed or cured meats, salads in salad bars.
  • Monosodium glutamate (MSG).
  • Alcohol — specifically the impurities in alcohol or by-products your body produces as it metabolizes alcohol.

Other Common Food or Beverage Migraine Triggers:

Some specific foods and drinks are migraine triggers for some people. They include:

  • Aged cheeses: blue cheese, mozzarella, feta, cheddar, parmesan
  • Alcohol: red wine, beer, whiskey, champagne
  • Caffeine: coffee, chocolate, tea, colas, sodas
  • Pepperoni, hot dogs, luncheon meats
  • Bread and other baked goods
  • Dried fruits
  • Smoked or dried fish
  • Potato chips
  • Pizza, peanuts, chicken livers, and other specific foods

To Avoid Your Migraine Triggers

For people susceptible to migraine triggers, the best way to prevent a headache is to avoid the triggers. Follow these tips:

  • Watch what you eat and drink. If you get a headache, write down any food or drink you had before getting it. If you see a pattern over time, eliminate that item!
  • Eat regularly. Skipping meals can trigger migraines in some people.
  • Curb the caffeine. Excess caffeine (in any food or drink) can cause migraines. But be careful: Cutting back abruptly may also cause      migraines.
  • Be careful with exercise. Although doctors advise getting regular exercise to stay healthy, exercise can trigger headaches. You may need to take an anti-inflammatory drug to prevent exercise migraines.
  • Get regular sleep. Changes in your normal sleep habits can cause migraines. Being overly tired can also trigger migraines.
  • Learn to cope with stress. Emotional upsets and stressful events are common migraine triggers. Anxiety, worry, fatigue, and      excitement can intensify a migraine’s severity. Learn to cope with stress better — through counseling, biofeedback, relaxation training, and possibly taking an antidepressant.

If you have questions about these migraine triggers, talk to your doctor. By taking steps to avoid your triggers, you can take control of your headaches — and your life.

For more from this website, please follow the link: http://www.webmd.com/migraines-headaches/avoiding-migraine-triggers


Trial of Evaluation and Efficacy of Nasal spray for ZOMIG®

Does your child experience migraine headaches? If the answer to this question is yes, and your child is 12-17 years of age, and experiences two or more migraine headaches a month, he or she may be eligible to join a clinical research study looking at an investigational treatment for migraine headaches.

The study will involve 3-4 visits to our clinic. Your child would be given a nasal spray containing study medication to take when a migraine headache occurs.

For more information, please contact Research


COMING SOON!


FLU TREATMENT– Check our website often for more details. Once the study is underway, we will need to see you within 48 hours of onset!


DUST MITE ALLERGIES- Ages 5 and up