Did you know that lower back pain is the #1 leading cause of disability worldwide?According to the American Chiropractic Association, about 31 million Americans are currently suffering from lower back pains. Though many other options are available, at GMI we would like to offer something that is more beneficial to you. Participating in one of our clinical trials focused on Chronic Lower Back Pain can not only improve the pain but can also improve one's access to free health care services. We provide consultation appointments and physical exams at no cost to you, and insurance not required, should you choose to participate in our research.
The Princeton, NJ site is currently enrolling patients for the Chronic Lower Back Pain study in which the patient must be 18 - 75 years old, have a clinical diagnosis of moderate-to-severe low back pain for more than 6 months in order to be eligible for the study. If you or anyone you know suffers from chronic lower back pain, please contact us today.
Depression affects approximately 14.8 million American adults each year, being more prevalent in women than in men. Depression can be caused by a combination of genetic, biological, environmental, and psychological factors. There are a number of risk factors for depression such as family history, major life changes, trauma, or certain physical illnesses and medications. There are a number of treatments for depression.
Here at Princeton Medical Institute we offer the NeuroStar TMS (Transcranial Magnetic Stimulation) therapy. This treatment uses precise target magnetic pulses in key areas within the brain that are associated with depression, while the patient is awake and alert. The experience of watching TMS take place is different than other treatments because there is the ability to see the patient progress each day for 6 weeks. While we might not be able to see the treatment working immediately, knowing that this treatment can help people living with depression is a wonderful experience to be a part of.
Clinical trials are part of clinical studies that involve using human volunteers to test specific interventions, such as drugs, devices, vaccines, or changes in diet. The participants receive these interventions according to the protocol that is developed by the investigators. The protocol provides the research coordinators with information about what is being tested, who is eligible to participate, and the schedule for how to proceed during the full length of the trials.
Clinical trials can include comparing the interventions being tested to something that is already available, to a placebo with no active ingredient, or to no intervention at all. The most important aspects being measured in these trials are the safety and efficacy of what is being tested. The new interventions need to be safe for the participants to use and need to work well enough in their favor, with the benefits outweighing the risks. Once the participants are enrolled in a trial, their progress is monitored regularly to ensure that the drug is safe and effective.
In order for the drug or any other intervention to be approved by the FDA, there are five phases that the clinical trials must go through:
Phase 0: Preliminary
Drug is given to a limited number of subjects to assess how it interacts with the human body.
Phase 1: Safety
Drug is given to a small number of healthy volunteers, with safety being the emphasis. The goal of this phase is to find any side effects and adverse events that the drug might cause.
Phase 2: Efficacy and safety
Drug is given to a larger group of people to gather preliminary data on the effectiveness of the drug in people with a certain disease or condition. Participants receiving the drug are compared to participants receiving a placebo or a different drug. Safety continues to be evaluated.
Phase 3: Final confirmation of efficacy and safety
Drug is given to an even larger group of people to confirm its effectiveness and safety before it can be approved by the FDA. The studies may include studying the drug in different populations, different dosages, or in combination with other drugs.
Phase 4: Post FDA Approval
The effectiveness and safety of the drug is evaluated after the drug is made available on the market.