This study aims to develop a new blood test to detect and identify many different types of cancer, using a special technique that looks at tiny changes in your DNA. Some participants will be followed over time to see if this method can also find leftover cancer cells (after treatment), and if it could warn if the cancer comes back. However, this test still under development, so there are no results reported back to participants. The goal is to create a reliable tool that one day could help doctors diagnose and monitor cancer(s) more effectively.
This study aims to develop a new blood test to detect and identify many different types of cancer, using a special technique that looks at tiny changes in your DNA. Some participants will be followed over time to see if this method can also find leftover cancer cells (after treatment), and if it could warn if the cancer comes back. However, this test still under development, so there are no results reported back to participants. The goal is to create a reliable tool that one day could help doctors diagnose and monitor cancer(s) more effectively.
The purpose of this study is to find out if adding a drug called ribociclib to the usual hormone therapy drugs can lower the chance of your breast cancer coming back again. This study is for patients with locoregional, recrrent, resected hormonone receptor positive HER2 negative breast cancer. Endocrine therapy has already been approved by the FDA for your type of cancer. Ribociclib has already been approved by the FDA for your type of cancer that has not been removed by surgery or has spread to other parts of the body.
Receiving ribociclib with endocrine therapy is still being studied and to yet approved by the FDA. Ribociclib is taken as a pill and endocrine therapy is taken as an injection. Participants will receive ribociclib with endocrine therapy for up to 3 years and can receive endocrine therapy alone for an additional two years after stopping ribociclib. Participants can remain on the study for up to 5 years.
The purpose of this study is to see how well the combination of home-based transcranial direct current stimulation (tDCS) and prolonged exposure (PE) works in treating people with chronic pain (e.g., pain related to fibromyalgia, lower back pain, arthritis) and posttraumatic stress disorder (PTSD).
Participants must be a Veteran or Active-Duty service member with a diagnosis of PTSD and chronic musculoskeletal pain. Participants will receive 10 sessions of PE over 2 weeks (called Massed PE) and 10 sessions of tDCS.
This study is enrolling participants with symptomatic ATTR-CM (transthyretin amyloidosis cardiomyopathy). ATTR-CM is a rare and serious disease that occurs when a protein in the blood called transthyretin (TTR) builds up throughout the body, including in the heart and nerves. When the abnormal protein, known as amyloid, deposits in the heart, the heart muscle thickens and stiffens, causing the heart to fail. This research study is designed to test whether the medication nucresiran is safe and helps people with ATTR-CM, in comparison to the effects of placebo.
Nucresiran is considered investigational, meaning it is not currently approved by the U.S. Food and Drug Administration (FDA) for the treatment of ATTR-CM. Nucresiran is a TTR silencer. It is like a "quiet button" that turns down the amount of the disease-causing protein that is made. Because there is less TTR, there may be less buildup in the heart and other organs over time.
This is a randomized study meaning once eligibility is confirmed, participants will be assigned by chance, like drawing straws, to either receive nucresiran or placebo. You will have a 2 out of 3 chance of being assigned to nucresiran and a 1 out of 3 chance of being assigned placebo. Placebo is a substance that looks like the actual medication and is given the same way but contains no active substance. The study drug, which can be either nucresiran or placebo, will be given as an injection under the skin in the abdomen (avoiding the area around the navel), thigh, or the side or back of the upper arms. Neither the participants nor the study doctor will know who is assigned to nucresiran or placebo but this information can be made available if need be.
Participation in this study is expected to last for 5-8 years, Study related procedures include physical exams, vital signs, echocardiograms (ultrasound test of the heart), electrocardiograms, (ECG, a tracing of the heart's electrical activity), blood work, urine samples and questionnaires. Participants will also take Vitamin A daily. Study related risks include risks related to the study drug including injection site reactions, abnormal liver function or an allergic reaction. There may be risks related to study procedures including loss of confidentiality. There may not be any direct benefit, but the information learned may benefit others with ATTR-CM in the future.
This phase III trial compares durvalumab to the usual approach (patient observation) after surgery for the treatment of patients with early-stage non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The usual approach for patients who are not in a study is to closely watch a patient's condition after surgery and to have regular visits with their doctor to watch for signs of the cancer coming back. Usually, patients do not receive further treatment unless the cancer returns. This study will help determine whether this different approach with durvalumab is better, the same, or worse than the usual approach of observation. Giving durvalumab may help patients live longer and prevent early-stage non-small cell lung cancer from coming back as compared to the usual approach.
This study is for people with high-risk, non-muscle invasive bladder cancer that has returned after treatment with BCG. Your cancer either did not fully respond to BCG or came back after initially responding, which is called BCG-exposed NMIBC. The purpose of this study is to find out if adding a chemotherapy drug called gemcitabine, given directly into the bladder through a catheter, to BCG works better than BCG alone. In this study, you will either receive BCG alone for up to 6 weeks or gemcitabine plus BCG for up to 10 weeks, called induction therapy. If the treatment is effective, you may continue with maintenance therapy, which is either BCG alone or gemcitabine plus BCG given over several weeks. After treatment, your doctor will monitor you for 5 years with regular checkups, cystoscopies, and CT scans to watch for side effects or recurrence. The main risks are that the study treatment may not work as well as usual care, and it may cause side effects such as pain with urination, urinary urgency, blood in the urine, bladder inflammation, or urinary tract infection. There may also be risks that study doctors do not yet know about.
There will be a total of 17 patients enrolled locally over the course of 42 months.
This study is an expanded access protocol for AMTAGVI that has not yet been released for commercial use.
Making the AMTAGVI product involves collecting immune cells from your cancer, growing more of them in the laboratory, and giving them back to you to treat your cancer. AMTAGVI is a commercially available treatment approved by the FDA (US Food and Drug Administration) for advanced melanoma. However, sometimes during the manufacturing of AMTAGVI, the final product is Out of Specification (OOS). This means that the test results for your product do not meet the accepted established criteria. The purpose of this study is to allow expanded access use of out of specification (OOS) AMATAGVI.
Expanded access is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. While this use involves an investigational product, this is not a research study.
Risks include vitiligo, swelling of the middle layer of the eye (uveitis), shortness of breath, and increased heart rate. There will be approximately 8-10 study visits over a 24-month period. Visit durations will vary. Patients may or may not benefit from receiving OOS AMTAGVI when compared to receiving no treatment at all.
This study is enrolling subjects with severe aortic regurgitation (when blood leaks back in the heart because the aortic valve does not close properly) into a randomized study. Typically valve replacement is performed to correct this condition. This study will compare a transcatheter aortic valve replacement (TAVR) using the JenaValve Trilogy Heart Valve System to open heart aortic valve surgery (SAVR). the JeneValve Trilogy Heart Valve System is considered investigational meaning it has not been approved yet by the Food and Drug Administration (FDA). A TAVR procedure is done by accessing a large blood vessel at the top of your leg and delivering the new valve as opposed to open heart surgery. This study will randomize subjects in a 1 to 1 fashion to TAVR or SAVR. Randomized means assigned by chance, so you will have a 50% chance of being assigned to the TAVR group and a 50% chance of being assigned to the SAVR group. The SAVR group will have the aortic valve replacement done by open heart surgery using a commercially available device.
Participation in this study will last about 10 years and include 15 visits. Study related testing includes physical exam, echocardiograms (ultrasound test of the heart), electrocardiograms (recording of heart's electrical activity), 6 minute hall walk, bloodwork and a questionnaire.
There are risks including risks related to the procedure and to study testing. There may be no benefit but the information learned may help in treating others in the future.
This study systematically evaluates the efficacy of a highly promising neuromodulation strategy - continuous theta burst (cTBS) transcranial magnetic stimulation - as a tool to change alcohol use behavior (Aim 1) and neurobehavioral concomitants of that behavior (Aim 2) in non-treatment seeking individuals with alcohol use disorder (AUD). In addition, we can begin to test prediction of individual treatment response based on an electrocortical signature of sign tracking (exploratory aim). This study is a double-blind, active sham-controlled study in community dwelling, non-treatment seeking individuals who meet DSM 5 criteria for AUD. Participants will be randomized to one of three groups: cTBS to ventromedial prefrontal cortex, cTBS to pre-supplementary motor area, or sham stimulation (10 sessions in one day). Participants will undergo comprehensive outcomes assessment, with measures including pre- and immediately post-cTBS clinical assessments (e.g., interview, Timeline Follow-back), alcohol craving tests, structural and fMRI, MRS, and EEG/ERP during salience- and cognitive flexibility-related tasks. To test alcohol craving and also use in alcohol-available settings, participants will complete a bar-lab session post-cTBS only (to avoid potential habituation to alcohol cues within the laboratory setting). Finally at 1-week post-treatment participants will complete craving and Timeline Follow-back measures remotely via REDCap.