In the effort to find better treatments for moderate acne, which often relies on long-term antibiotic use, researchers are exploring alternative options. While isotretinoin, a vitamin A derivative, is highly effective for severe acne, its side effects limit its use for milder cases. A recent study from our institution investigated a new approach: weekly isotretinoin dosing. The results were promising, with acne improvement and no major side effects. This suggests that weekly isotretinoin could be a successful alternative for moderate acne in both males and females. To validate these findings, we propose a randomized controlled trial comparing weekly isotretinoin to daily doxycycline over four months. This study could confirm the safety and effectiveness of weekly isotretinoin, as well as shed light on patient satisfaction, and long-term results compared to standard antibiotics. This research may offer a breakthrough in treating moderate acne while addressing concerns about antibiotic overuse.
The InnAVasc Arteriovenous Graft is made from the same materials as standard care grafts, but with added medically safe materials that may make the graft easier to identify, safer to stick for dialysis, more durable, and less likely to bleed after your dialysis session when compared to standard care grafts. The InnAVasc Arteriovenous Graft is an investigational product, which means that this is not yet approved by government agencies like the U.S. Food and Drug Administration (FDA), but preliminary tests in the laboratory and in animals have proven safe enough to be allowed to be used in human clinical studies such as this.
Approximately 105 subjects will take part in this research at approximately 30 different medical facilities/hospitals in the United States. This will be the third time (3rd study) the InnAVasc Arteriovenous Graft will be used in human subjects.
This is a Phase 2 study measuring the effectiveness and safety of an antibody treatment called AK117 combined with a drug called azacitidine in patients with newly diagnosed higher-risk myelodysplastic syndromes (HR-MDS). AK117 is an "investigational" (not yet FDA approved) treatment, azacitidine is FDA approved. The primary purpose of the study is to find the best dose of AK117 for future trials. The study will enroll approximately 90 patients randomized in 3 groups (like flipping a coin), with each group receiving either AK117 in doses of 30mg/kg, 20mg/kg, or a placebo, in combination with azacitidine. The study includes a screening period, treatment period, and follow-up period over the course of 3 years. Patients will receive AK117 or a placebo every 2 weeks in combination with azacitidine every 4 weeks. The main risk is that medical treatments often cause side effects. Patients may have none, some, or all of the effects listed or not listed in the protocol, and they may be mild, moderate, or severe. There is no direct benefit in participating in this study.
This is a research study to find out if Qutenza 8% capsaicin topical system is safe and effective when treating subjects with lower back pain (LBP) that is caused by damage at or near the nerve's root in the lower back leg (lumbosacral radiculopathy) which is pain that can move all the way down the back of the leg. The pain may also start outside of the spinal cord, in the peripheral nerves and may also be felt all the way down the back of the leg (neuropathic LBP). Qutenza 8% capsaicin, the study drug, is currently FDA approved to treat nerve pain after a shingles outbreak in addition to a type of nerve pain in the feet associated with diabetes. In this study a maximum of four patches per visit (sized 14cm x 20 cm) will be used to deliver the Qutenza 8% capsaicin to your skin.
If a subject meets the qualifications for this study, in addition to their standard of care for their LBP, they will be treated with Qutenza 8% capsaicin topical system and can expect to have a total of 5 visits in a 12 month period. Each visit will require subjects to fill out several surveys and receive treatment patches for their LBP (your doctor will decide if you will need to be retreated at each visit based on your symptoms). This is an open-label study and all participants will receive Qutenza 8% capsaicin topical system. The study visits are estimated to take 90 minutes upwards to 120 minutes.
The purpose of this study is to get feedback on an existing augmented reality (AR) software developed by researchers at Wayne State University (phase I) and then use the refined software, along with Prolonged Exposure (PE) therapy to treat Veterans and military personnel with posttraumatic stress disorder (PTSD).
AR involves wearing goggles through which you can see the real world, however virtual objects can be added to the environment (for example, like in the popular phone game Pokemon Go).
The technology was originally designed to help first responders, specifically police and firefighters, to overcome their avoidance of normal life situations caused by their trauma experience and PTSD. This includes a crowded party, a grocery store, a police roll call room and a fire station. This technology is now being expanded to include other common scenarios that military personnel and Veterans with PTSD may avoid.
This study will occur in 2 phases. Phase 1 will focus on getting feedback on the AR program from people who have completed PE therapy before to refine the technology. In phase 2, 40 Veterans and military personnel will be randomly selected to receive PTSD therapy + the refined AR technology or PE therapy alone.
This study is open to Veterans and active duty military personnel. All study activities will take place at the Ralph H. Johnson VA Health Care System and surrounding community-based outpatient clinics. This study is not open to civilians/non military personnel at this time.
This phase III study is for participants with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) that is negative for a type of virus called human papilloma virus (HPV). If decided to participate in this study, participants will be receive either ficlatuzumab in combination with cetuximab, or placebo in combination with cetuximab. There are 3 Arms participants will be randomly assigned to: Arm 1 will receive ficlatuzumab (10mg/kg by intravenous (IV) infusion) and cetuximab (by IV infusion), Arm 2 will be given ficlatuzumab (20mg/kg by IV infusion) and cetuximab, and Arm 3 will receive placebo and cetuximab. The effectiveness of the 2 different ficlatuzumab groups (Arm 1 and Arm 2) will be compared at the first on-study scan, and the more successful Arm will began enroll more participants. This study is estimated to last approximately 5 years. Study drugs will be administered until disease progression or unacceptable toxicity, withdrawal of consent, death, or until the Sponsor terminates the study (whichever comes first). The main risk associate with the trial are swelling of your lower legs or arms, fatigue, shortness of breath, vomiting, diarrhea or constipation, bone pain, decreased appetite, anemia, high level of liver enzymes in your blood, dizziness, infusion reactions, cardiopulmonary arrest, pulmonary (lung) toxicity, skin reactions, inflammation of the mouth, low blood counts, liver problems, infection, headache, allergic reactions, and there may be unknown risks. This treatment can not guarantee the cancer will get better, since it may stay the same or get worse. What is discovered from this study may help other people in the future. The alternative to this study is not participating in this study and receiving HNSCC in patients who have previously received immunotherapy including chemotherapy with other treatment drugs or another clinical trial.
Individuals with obesity and a history of heart or kidney-related disease will be eligible for participation. Study participants will have a 50:50 chance to be randomly assigned to either the treatment (retatrutide) or control (placebo) group. Retatrutide is currently considered an investigational medication as it has not been approved by the FDA for the treatment of obesity or any other medical condition at this time. Study participation will last approximately 5 years and begin with a screening period to ensure correct patient selection. Research clinic visits will occur every 4 weeks initially and then every 12 weeks. Some visits may be completed virtually through telehealth or by phone. Study procedures include but are not limited to: blood draws, questionnaires, self injection of study medication, medical history review, vital signs, and electrocardiogram. The medication will be injected subcutaneously once a week. The medication's purpose is to facilitate weight loss and decrease a subject's risk for heart or kidney related disease progression or events.
Study LTI-401 is an open-label, multicenter study which will evaluate the safety and tolerability of LIQ861, the study drug, in subjects who have World Health Organization (WHO) Group 1 & 3 Pulmonary Hypertension. The purpose of this research study is to evaluate the long-term safety and tolerability of LIQ861 in patients with WHO Group 3 Pulmonary Hypertension associated with interstitial lung disease (PH-ILD). The investigational form of Treprostinil in this study is called LIQ861, it is delivered to your lungs using a hand-held device called a dry powder inhaler (DPI). Dose levels may be adjusted by the Study Doctor between 26.5 micrograms to 318 micrograms based on your PH-ILD symptoms. The study will include approximately 60 subjects and participation will last 52 weeks.
Adolescence is a time of development in the brain and microbiome, including the microbiome present in the mouth called the oral microbiome. Alcohol use often begins and escalates during adolescence, which can cause changes to the oral microbiome leading to changes in the brain. The alcohol specific changes to the oral microbiome and the brain may make adolescents more vulnerable to a lifelong struggle with alcohol use disorder. This study will collect (1) saliva to assess the composition of the oral microbiome and (2) brain measurements using magnetic resonance imaging (MRI) across adolescents who may or may not use alcohol. Findings from this study will help form a more thorough understanding of the biological consequences of adolescent alcohol use, with the long-term goal of informing novel prevention and intervention efforts.
This study is for subjects that have been diagnosed with Follicular Lymphoma.
This study is testing an investigational drug(s) called Epcoritamab that is not approved by the FDA (Food and Drug Administration). The purpose of this study is to see if the combination of the study drug epcoritamab with rituximab and lenalidomide has a better response rate than standard of care chemoimmunotherapy in the treatment of follicular lymphoma. The total study treatment duration is up to 2.5 years. You may stop the study treatment early if you do not respond after 6 months, your disease worsens, you no longer tolerate the study drug(s), or you withdraw from the study.
Once you finish the study treatment or discontinued study treatment early, you will continue to the Post-Study Treatment Follow Up Period, you will come back to the study clinic every 6 months for the first 3 years and then yearly to have imaging scans and blood work to check if your disease is in remission or worsen.
If your disease worsens or if you start a new FL treatment, you will enter the Long-term Follow Up Period, you will be called by telephone or your health record will be reviewed to check on your well-being and to see what your next treatment plan will be. This follow-up may last up to 15 years.