Pacific Research Network, Inc.

A Note About Clinical Trials: Clinical trials are a means by which to learn about newer ways to treat and diagnose many medical issues. In this process, pharmaceutical companies also learn about the safety and effectiveness of their medication. Clinical trials require a team effort between the investigators and the volunteers. Whether joining a trial for a brief time or for many months, clinical trials afford the opportunity to learn more about our medical concerns. Trials are not a substitute for regular medical care. The goal of participation should be to learn and share information so that others may benefit in the future.

ALZHEIMER'S DISEASE (AD)
ANXIETY (GAD)
DEPRESSION (MDD)
HEADACHE / MIGRAINE
HEALTHY SUBJECT TRIALS
 INSOMNIA
MILD COGNITIVE IMPAIRMENT (MCI)
NARCOLEPSY
OBESITY
RESTLESS LEG SYNDROME (RLS)
 SEXUAL DYSFUNCTION
SLEEP APNEA
SMOKING CESSATION
SOCIAL PHOBIA

Alzheimer's Disease (AD):

According to recent estimates, as many as 5 million Americans have Alzheimer's disease (AD), and that number continues to grow. Without effective treatment or prevention, the number of people with AD will increase since the risk of AD increases with age. The number of people age 65 and older is expected to double from 36 million in 2008 to 72 million by 2030. Consequently, the number of people with AD doubles for every 5-years beyond age 65. AD poses physical and emotional challenges for more and more families and their caregivers, in addition to those with the disease. The growing number of people with AD and the costs associated with the disease places a heavy economic burden on society.

Although we still do not know the cause of AD, we believe that damage to the brain begins as early as 10 to 20 years before any problems are evident. Tangles begin to develop deep in the brain, in an area called the entorhinal cortex, while plaques form in other parts. As more and more plaques and tangles develop in particular brain areas, healthy neurons begin to work less efficiently. They lose their ability to function and communicate with each other and eventually they die. This damaging process spreads to a nearby structure, called the hippo-campus, which is essential in forming memories. As the death of neurons increases, affected brain regions begin to shrink. By the final stage of AD damage is widespread and brain tissue has shrunk, significantly. Participation in a clinical trial may benefit you by improving memory or slowing the progression of loss, as well as the sponsor of a research trial.

Anxiety:

People with generalized anxiety disorder (GAD) go through the day filled with exaggerated worry and tension, even though there may be little provocation. They may anticipate disaster, are overly concerned about health issues, money, family problems, or difficulties at work. Sometimes just the thought of getting through the day produces anxiety.

GAD is diagnosed when a person worries excessively about a variety of everyday problems for at least 3-6 months. People with GAD cannot seem to get rid of their concerns, even though they usually realize that their anxiety is more intense than the situation warrants. They typically may:

or experience physical symptoms such as:

GAD affects about 6.8 million adult Americans, and about twice as many women as men. Though the risk is highest between childhood and middle age, GAD affects all ages. GAD may be diagnosed when someone spends at least 3 months worrying excessively about everyday problems. Volunteering for a clinical trial may allow the participant to understand about their anxiety as well as benefit those conducting the research.


Depression:

In the United States alone, more than 6 million men and 12 million women suffer from depression. Not everyone experiences depressive symptoms the same way. The severity, frequency, and duration of the symptoms vary depending on the individual's age, health, and environment.

Symptoms include:

Regardless of age, sex, education or race, depression can interfere in your life for no apparent reason. Whether it is hormones, coping problems, or brain chemistry, you may consider participation in a clinical trial for depression. Treating depression is not an exact science. More research is required to determine the most effective medications for different populations with the least side effects.


Headache / Migraine:

The pain of a migraine headache is often described as an intense pulsing or throbbing pain in one area of the head. Migraine is three times more common in women than in men. It is often accompanied or preceded by:

People with migraine tend to have recurring attacks triggered by:

For many years, scientists believed that migraines were linked to the dilation and constriction of blood vessels in the brain. Investigators now believe that underlying causes may be linked to inherited abnormalities in genes that control the activities of certain cell populations in the brain.

There are two ways to approach the treatment of migraine headache with drugs: either to prevent the attacks or to relieve the symptoms during the attacks. Many people with migraine use both approaches by taking medications originally developed for epilepsy and depression to prevent future attacks. They treat attacks when they happen with drugs called triptans that relieve pain and restore function. Hormone therapy may help some women whose migraines seem to be linked to their menstrual cycle. Stress management strategies, such as exercise, relaxation, biofeedback, and other therapies are designed to help limit discomfort, and reduce the occurrence and severity of a migraine. Volunteering for a clinical trial assists both the participant and the company who is interested in learning more effective and efficient ways of managing this condition.


Healthy Subject Trials:

Some clinical research studies are looking at drug safety and dosage. Often, healthy subjects are sought to test the drug being researched in comparison with volunteers that have the disease or ailment. It is important to note that inclusion and exclusion criteria are still used to identify appropriate participants in order to safeguard safety and insure that researchers learn the information they are seeking.



Insomnia:

Primary insomnia is a condition in which you have trouble falling or staying asleep. People do not need to have stress in their lives to have these difficulties. Some people with insomnia may fall asleep easily but wake up too soon. Other people may have the opposite problem, or they have trouble with both falling asleep and staying asleep. The end result is poor-quality sleep that does not leave you feeling refreshed when you wake up. Without a "regular" night's sleep, people are prone to more medical concerns. Although insomnia can occur more often in women than in men, 54 million Americans suffer from some form of sleeping disorder. It can cause excessive daytime sleepiness and a lack of energy. Long-term insomnia can cause you to:

Insomnia can be mild to severe depending on how often it occurs and for how long. Chronic insomnia means having symptoms at least 3 nights per week for more than a month. Insomnia that lasts for less time is known as short-term or acute insomnia. Left untreated for extended period of time can cause problems in everyday life activities. Prolonged insomnia can lead to:

The most common sleep disorder is called "Secondary insomnia". More than 8 out of 10 people are believed to have secondary insomnia. Secondary means that the insomnia is a symptom or a side-effect of some other problem. Some of the problems that can cause secondary insomnia include:

By contrast, primary insomnia is not a side-effect of medicines or other medical problems. It is its own disorder and generally persists for at least 1 month or longer.


Mild Cognitive Impairment (MCI):

Mild cognitive impairment (MCI) is a condition in which a person recognizes some memory loss greater than expected for his or her age. However, people with MCI do not have the personality changes or cognitive problems that characterize AD.

MCI has several types. The type most associated with memory loss is called amnestic MCI. People with this condition have more memory problems than normal for their age, but their symptoms are not as severe as those of people with AD. More people with MCI go on to develop AD than people without MCI. Researchers are not yet sure why some people with MCI do not progress to AD, nor can they say who will or will not develop AD. Studying memory is best accomplished by evaluating memory consistently over time. Participation in a clinical trial may benefit you and the company interested in the data.

Narcolepsy:

Narcolepsy is a disorder that causes periods of extreme daytime sleepiness. People who have this disorder (rarely) can fall asleep suddenly, even if they are in the middle of talking, eating, or another activity. Most people who have narcolepsy have trouble sleeping at night, as well. Narcolepsy may also cause:

Hypocretin, a chemical in the brain, helps control levels of wakefulness. People who have narcolepsy have low levels of this chemical. What causes these low levels is not well understood. Researchers think that certain factors may work together to cause a lack of hypocretin. Examples include heredity; brain injuries; contact with toxins, such as pesticides; and autoimmune disorders. (Autoimmune disorders occur when the body's immune system attacks the body's healthy cells). Participation in a clinical trial allows for learning more about your sleep issues while benefiting the company who relies on this information.


Obesity:

The prevalence of obesity ((body mass index) BMI =30)) continues to be a health concern for adults, children and adolescents in the United States. The rise of obesity is a concern because of its implications for the health of Americans. Obesity increases the risk of many diseases and health conditions including:

Studies are being frequently conducted to determine causes of obesity, assist with weight loss, and provide answers to many other questions.


Restless Leg Syndrome:

Restless legs syndrome (RLS) is a disorder that causes a strong urge to move your legs. Strange and unpleasant feelings in your legs stimulates the urge to move them. Moving your legs relieves the urge and unpleasant sensations. People who have RLS describe the unpleasant feelings as creeping, crawling, pulling, itching, tingling, burning, aching, or electric shocks. The urge occurs when you're resting and inactive. It tends to be worse in the early evening and later at night with temporary relief in the morning.

RLS can range from mild to severe based on:

One type of RLS usually starts earlier in life (before age 45) and tends to run in families. Once this type of RLS begins, it usually persists in varying degrees throughout your life. Another type of RLS occurs later in life (after age 45). It generally doesn't run in families. This type tends to have a more acute onset. The symptoms usually don't get worse with age. Participation in a clinical trial may benefit you and the company interested in learning more about the cause and treatment of RLS.


Sexual Dysfunction:

Sexual dysfunction is a common occurrence in both men and women; almost everyone will have some experience with it in some form or another before middle age. It is only when it becomes frequent or troublesome, that we usually seek help. Common problems in women include; lack of desire, lack of pleasure, and/or painful intercourse. Typical problems in men include erectile dysfunction and lack of desire. Underlying medical problems, medications, alcohol or even emotional stress can cause what is know as "secondary impotence". Most therapeutic interventions have been aimed at men through medication used to treat impotence. The use of estrogen compounds, administered in various ways (including creams) has had some success in women. Treatment should always begin with a thorough history so that the cause or causes of the problem are understood to assist in reaching the best outcome.


Sleep Apnea:

Sleep apnea is a common disorder in which you have one or more pauses in breathing and/or shallow breaths while you sleep. They often occur 5 to 30 times or more, an hour. Typically, normal breathing then starts again, sometimes with a loud snort or choking sound (snoring). Sleep apnea usually is a chronic (ongoing) condition that may disrupt your sleep 3 or more nights each week. These breathing issues transition you out of a deep or restorative sleep into a light sleep where your breathing pauses or becomes shallow. This results in poor sleep quality that makes you tired during the next day. Sleep apnea is one of the leading causes of excessive daytime sleepiness.

Sleep apnea often goes undiagnosed unless doctors are questioning the quality of your sleep. There are no blood tests for the condition. Most people who have sleep apnea don't know they have it because it only occurs during sleep. As a result, a family member and/or bed partner may first notice signs related to breathing, snoring, or sleep and inform you of their concerns.

The most common type of sleep apnea is obstructive sleep apnea (OSA). This most often means that the airway is collapsed or is blocked during sleep. The blockage may cause shallow breathing or breathing pauses. When you try to breathe, any air that squeezes past the blockage can cause loud snoring. Obstructive sleep apnea happens more often in people who are overweight, but it can affect anyone. Participation in a clinical trial may benefit you and assist the company exploring new treatment options.

Smoking Cessation:

Tobacco use is the number one preventable cause of death and disease in California. Despite significant gains in the last 20 years, 4 million Californians still smoke and youth smoking has increased for the first time in a decade. Some pharmaceutical companies are actively investigating medications that they hope will assist in smoking cessation. Nicotine products promote a physical addiction that may require intervention. Medications being researched are hoped to block the nicotine from entering the brain and others that are aimed at reducing the cravings and/or pleasure of smoking.


Social Phobia:

Social phobia, also called social anxiety disorder, is diagnosed when people become overwhelmingly anxious and excessively self-conscious in everyday social situations. People with social phobia have an intense, persistent, and chronic fear of being watched and judged by others and of doing things that will embarrass them. They can worry for days or weeks before a social situation. This fear can become so severe that it interferes with work, school, and other ordinary activities. Consequently, it can make it hard to make and keep friends.

While many people with social phobia realize that their fears about being with people are excessive or unreasonable, they are unable to overcome them. Even if they manage to confront their fears and be around others, they are usually very anxious beforehand, are intensely uncomfortable throughout the encounter, and worry about how they were judged for hours afterward.

Social phobia can be limited to one situation, such as:

Physical symptoms that often accompany social phobia include:

Social phobia affects about 15 million American adults. Women and men are equally likely to develop the disorder, which usually begins in childhood or early adolescence.


Special thanks to the following organizations for their indication explanations used in whole or in part for this webpage:

National Heart, Lung, and Blood Institute
National Institutes of Health
Department of Health and Human Services
Alzheimer's Disease Education and Referral(ADEAR)
National Institute of Neurological Disorders and Stroke
Department of Health and Human Services, Centers for Disease Control and Prevention (CDC)
American Lung Association of California