Frequently Asked Questions
Are Clinical Trials Safe?
Many people who have not previously participated in a clinical trial are concerned about the safety of participating. The safety of our volunteers is our number one concern! While participating in a clinical trial you have constant access to medical care and qualified staff who monitor your well-being with meticulous attention to detail. Our doctors, nurses, and study coordinators will support you throughout the clinical trial process.
All pharmaceutical research goes through an extensive preclinical testing process before it ever reaches human patients to make sure it is as safe and effective as possible. Every clinical trial in the US must pass rigorous regulations and be monitored by an Institutional Review Board (IRB) to ensure the risks of the trial are as minimal as possible and worthy of any possible benefits to the participant.
Can Being Overweight be Attributed to Genetics?
Studies done at Harvard School of Public Health show that genetics have a very small effect on being overweight. Weight is influenced by overall lifestyle factors; lifestyle factors a person is raised with, and those that a person chooses for themselves. It is important to make sustainable lifestyle changes to maintain ideal health and weight, rather than “dieting”.
How Are Hives and Angioedema Diagnosed?
Your doctor will conduct a detailed medical interview to find the possible cause of hives or angioedema. Since there is no specific test for diagnosing hives – or the associated swelling of angioedema – testing will depend on your medical history and a thorough examination by your primary doctor, allergist, immunologist or dermatologist.
Skin tests may be performed to determine the substance that is causing your symptoms. Routine blood tests are done to determine if a system-wide illness is present.
How Can Hives Be Managed?
There are a number of tactics you can use to help minimize your discomfort:
- Avoid hot water; use lukewarm water instead
- Use gentle, mild soap
- Apply cool compresses or wet cloths to the affected areas
- Try to work and sleep in a cool room
- Wear loose-fitting lightweight clothing
How do I know if I am qualified?
Because each research program is unique and has specific enrollment criteria, the best way to find out if you qualify for a clinical research study is to either call us or come in for a free evaluation. Whether you have a medical issue and want to explore research solutions or you are a healthy volunteer, come visit one of our research sites and find out more. There is never an obligation, and one of our experts will be happy serve you.
How do Patients Benefit from Participating in Clinical Trials?
There are numerous benefits from participating in a clinical trial. Many of our volunteers appreciate the access to cutting edge treatments. Others participate to receive potentially expensive study medications and treatments at no cost, as well as compensation for their time and travel. Lastly, our patients love the sense of community and civic service they feel knowing that their participation contributed to advancement of medicine.
How is a Spirometry Test Performed?
A spirometry test requires a patient to inhale and exhale forcefully into a tube attached to the spirometer; a computerized sensor that calculates and graphs the results.
Regular spirometry measurements are important for detecting the development of lung disease, and the effectiveness of current medications.
How is a Stress Test Performed?
A stress test requires an electrocardiogram to monitor the patient’s heart rhythm and vital signs while they are exercising.
The patient’s skin will be prepped with alcohol, and chest hair may be removed to allow for proper adhesion of the monitoring electrode.
The patient will then be instructed to walk or lightly jog, on the treadmill until the heart rate has reached a high enough level to record it as a stress test.
It is important for the patient to communicate any symptoms he/she may experience during the stress test to ensure the patient’s safety and well-being. The technologist will stop the stress test if the patient is unable to continue.
How Is An Ambulatory Blood Pressure Monitoring Test Performed?
The ambulatory blood pressure monitor is worn around the waist or shoulder, and connects to a blood pressure cuff on the arm of the patient.
The ambulatory blood pressure monitor is worn for 24 hours, so the blood pressure can be checked at various intervals throughout that time, including while the patient is asleep.
How is an Ankle Brachial Index Performed?
A patient’s blood pressure is taken below the knee, and on the upper arm using blood pressure cuffs.
The blood pressure in the leg is compared to the blood pressure in the arm
(BPleg / BParm). The lower the resulting number is, the greater risk a patient is at for having peripheral artery disease.
This procedure is generally a quick and simple diagnostic test to detect the presence or severity of peripheral artery disease.
How Is The Exercise-Induced Asthma Test Performed?
An initial spirometry test is performed to establish baseline lung function.
The patient will then exercise to stress the lungs enough to trigger any symptoms that confirm exercise induced asthma.
A second spirometry test is conducted to assess how lung function is affected by the stress of exercise.
How Is The Holter Monitor Used?
Electrodes attached to the Holter monitor are applied to the patient’s chest. The Holter monitor device is held securely in a pouch, and is either worn around the patient’s waist or clipped onto the pant.
The Holter monitor and electrodes will be worn all day and night for as long as the physician has instructed.
The patient may also be asked to keep a diary sheet to record any symptoms they may experience while wearing the Holter monitor. This will allow the technologist reading the Holter monitor results to correlate and document symptoms with the Holter monitor recording.
How Is The Loop Event Monitor Used?
The loop event monitor is small enough to fit into a pocket, and has 2 leads which end in adhesive electrodes. The patient can apply the electrode to their chest, and remove the electrodes and monitor when necessary.
The patient keeps the loop event monitor for two weeks, with the instruction to press a button when he/she experiences a cardiac event in order to record the heart’s rhythm.
The patient will need to return to the JBN office approximately every 4 days to download all current event recordings. At the end of the two-week monitoring period, the patient will return the loop monitor to the JBN office to be read and interpreted.
How long do the programs last?
Depending on the type of research, studies can last from a few weeks to several years. Each program is designed to collect specific information, but volunteers will know before enrollment how long the study is expected to last and exactly how many visits to the research site will be required.
The Phases of a Clinical Trial
Clinical trials are divided into different states called phases. The early phase trials look at whether a drug is safe and its side effects. Later phase trials aim to test whether the new treatment is better than existing treatments.
- Phase I involves the testing of IP’s (investigational products) for safety in humans for the first time. Phase I trials typically involve a small number of either healthy volunteers or people with the disease/condition.
- Phase II trials continue to monitor the safety of the IP and determine its effective dose. These trials involve several hundred volunteers.
- Phase III trials measure the effectiveness of the IP to treat a designated condition. These trials are large scale and involve hundreds to thousands of volunteers.
- Phase IV trials are often required by the FDA and are designed to measure long term safety and efficacy of IP’s after they are approved.
What are Clinical Trials?
Clinical trials are controlled research studies that monitor the safety and effectiveness of medications or devices for human use. Clinical trials involve many different aspects of research. Some trials test new, cutting edge medications, while others test new combinations or applications of medications that have not been previously approved. All trials, however, require the participation of volunteers in order to advance medicine as a whole. The volunteers are medical heroes!
What are Hives/Urticaria?
Hives, also known as urticaria, are an outbreak of swollen, pale red bumps, patches or welts that appear suddenly on the skin. Hives usually cause itching, but may also burn or sting.
Hives can last for a few hours or days, and can appear anywhere on the body, including the face, lips, tongue, throat or ears.
Hives vary in size (from as small as a pencil eraser to as large as a dinner plate), and may join together to form larger areas, known as plaques.
What Causes Hives and Angioedema?
It is nearly impossible to determine the direct cause of Hives and Angioedema in most patients. Hives and Angioedema form in response to histamine and from blood plasma that leaks out of small blood vessels in the skin.
Histamine is a chemical released from specialized cells along the skin’s blood vessels. Allergic reactions to chemicals in foods, insect stings, sunlight exposure or medicines can all cause histamine release, which, in turn, causes hives or angioedema.
What Does It Mean To Be Allergic To Penicillin?
Penicillin is widely known/ used as an antibiotic. It’s also the most common cause of drug allergies.
Allergic responses to penicillin are not typically categorized as dangerous anaphylactic reactions. Their symptoms include rashes, itchy eyes, hives or swelling in the face, tongue or lips.
If you experience symptoms of a penicillin allergy, see your family doctor, and request a referral to an allergist as soon as possible.
What is a Keto Diet?
A Keto Diet can be summarized as a low-carb diet, because the process requires a person to eat 50 grams or less of carbohydrates in a day. You can also initiate the ketosis process via a prescribed medical, protein based, meal replacement diet.
What Is Ambulatory Blood Pressure?
Ambulatory Blood Pressure simply means that a patient’s blood pressure is measured periodically throughout a 24-hour period using a small, portable monitor.
What is Angioedema?
Angioedema are similar to hives, but the swelling occurs beneath the skin, instead of on the surface. Angioedema is characterized by deep swelling around the eyes, lips and sometimes swelling of the genitals, hands, and feet.
Angioedema generally lasts longer on the body than hives – approximately 24 hours.
Occasionally, severe and prolonged tissue swelling can be disfiguring. Rarely, angioedema of the throat, tongue or lungs can block the airways, causing difficulty breathing, which may become life threatening.
What Is Exercise-Induced Asthma?
Exercise-Induced Asthma causes tightness in the chest, wheezing, shortness of breath, and coughing.
Exercise-Induced Asthma (EIA), also referred to as exercise-induced bronchoconstriction, can be triggered by the physical stress of exercise, and causes a narrowing of a patient’s airways.
What is Ketosis?
Ketosis is a naturally occurring metabolic state in the body, which uses fat as the primary energy source rather than carbohydrates.
What Is Loop Event Monitoring?
A loop event monitor is small, portable device that a patient will take home to wear while performing normal daily activities for two weeks.
The device is approximately the size of a match box, and has 2 leads that end in adhesive electrodes. The patient can attach the electrodes to their chest, and remove as needed.
What Is Spirometry?
Spirometry is a measure of airflow into and out of the lungs, as well as an assessment of general lung function and capacity.
Spirometry is used to diagnose asthma, exercise-induced asthma, chronic obstructive pulmonary disease (COPD), and many other respiratory conditions.
What Is the Treatment for Hives and Angioedema?
The best treatment for hives and angioedema is to identify and remove the trigger. Should that not be the case, your doctor will provide you with Antihistamines for relief from your symptoms. These drugs may be taken on a regular schedule to help prevent hives and the associated swelling from forming.
Chronic hives may be treated with antihistamines or a combination of medications. When antihistamines don’t provide relief, oral corticosteroids may be prescribed.
For severe hive or angioedema outbreaks, an injection of epinephrine or a steroid medication may be needed.
When Should I Call the Doctor About Hives or Angioedema?
If hives or Angioedema occur with any of the following symptoms, contact your doctor right away:
- Difficulty breathing
- Tightness in the chest
- Swelling of the tongue, lips or face
Who are we?
As a premier clinical research organization, we have conducted hundreds of clinical trials providing patients access to cutting edge medical research. JBN research studies are carried out by our team of dedicated professionals including the physicians and the study coordinators but most importantly, the patients.
Who pays for this research?
Sponsors such as pharmaceutical companies, governments and foundations fund medical research through study grants. The grants provide the funding to conduct the study at local research sites, so you don’t pay a thing. In fact, we don’t even ask for your insurance information.