This study is for patients that have been diagnosed with metastatic or advanced solid tumors. The study is testing an investigational drug called JZP898. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). The primary purpose of this study is to characterize the safety and tolerability profile of JZP898 monotherapy as well as JZP898 in combination with pembrolizumab. The drug is given to participants by infusion. The length of your participation in this study may vary depending on the number of treatment cycles you receive. This will depend on whether there are any changes in your health during the study and whether the study doctor feels you should continue receiving the study drug.
Patients are matched with this clinical trial based on their biomarker test results in the myeloMATCH study. This treatment trial is for adults (ages 18-59) with high-risk AML who have not started treatment yet. Doctors consider AML high risk if it has certain biomarkers that can make it harder to treat. Treatment plans for AML often involve several phases of treatment. The first phase aims to get rid of as many leukemia cells as possible. It helps make it easier for further treatment to keep the cancer under control. Usually, the first treatment patients receive for AML is a combination of 2 chemotherapy drugs, daunorubicin and cytarabine. The purpose of this study is to learn if other options for first treatment may work better for people with high-risk AML. The study doctors will test 4 new treatments and compare them to the usual chemotherapy. This is important because knowing AML is high-risk gives doctors more information about the cancer and how to treat it. People with high-risk AML may benefit from a different approach to treatment. Improving options for people in the first phase of treatment could make further phases of treatment more successful.
The 18 week study is designed to assess the efficacy and safety of the once daily E2086, in narcolepsy Type 1 and Type 2. Administered upon wakening, 3 different doses will be compared to a placebo. This study requires overnight sleep studies. The effects of E2086 on mean sleep latencies will be examined.
Individuals with obesity and a history of heart failure (condition where heart does not effectively pump) with a preserved or mildly reduced ejection fraction (measure of the heart's pumping ability) will be eligible for participation. Study participants will have a 50:50 chance to be randomly assigned to either the treatment (NNC0487-0111) or control (placebo) group. NNC0487-011 and placebo will be delivered in an injectable pen device for a subcutaneous, once weekly injection. Placebo means there is no active study treatment) Study participation will last approximately three years and begin with a screening period to ensure correct patient selection. After the screening period, 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 (test that records the heart's electrical activity) The study's primary objective is to demonstrate that study drug vs. once weekly placebo, with standard of care, reduces the risk of a composite heart failure outcome consisting of cardiovascular death, heart failure hospitalization, or urgent heart failure visit in patients with heart failure with a preserved or mildly reduced ejection fraction and obesity.
This study is enrolling patients with uncontrolled high blood pressure. This study will see if a medication called Zilebesiran can help lower blood pressure. Zilebesiran is an investigational medication meaning it is not approved for commercial use by the Food and Drug Administration (FDA) but it is approved for use in this study. This is a randomized study meaning if you are eligible, you will be assigned by chance, like the flip of a coin to receive Zilebesiran or placebo. Placebo will look like the study medication but will not contain any active ingredients. You and the study team will not know if you are taking Zilebesiran or placebo, both of which are given as an injection under the skin every six months. This study will last between 2.5 and 5 years and include 10-14 visits. Study related procedures include physical exams, medical history including medications, vital signs, blood and urine collection. and electrocardiogram (ECG - a recording of your heart's electrical activity)
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.
Marijuana is the most commonly used illicit drug. There is high demand for effective interventions for cannabis use disorder, yet few specific treatments for have been developed. This study will evaluate the efficacy of varenicline for reducing marijuana use in people who use marijuana frequently.
This study is for patients diagnosed with early-stage melanoma and are the age of 75 or older. The usual approach for patients who are not in a study is treatment with two surgical procedures, a wide local excision (WLE) plus a sentinel lymph node (SLN) biopsy, followed by immunotherapy. The purpose of this study is to find if performing the WLE alone is just as effective as the usual approach and if it leads to improvements in patients' overall well-being.
A wide local excision (A wide local excision (WLE) is a surgical procedure performed to cut out an abnormal lesion and some surrounding normal tissue; this is sometimes followed by a sentinel lymph node (SLN) biopsy, in which lymph nodes that cancer cells could spread to are removed as well. Immunotherapy is a type of cancer treatment that uses your body's immune system to identify and attack cancer cells.
Patients may participate in this study for up to 5 years. Procedures include a surgical biopsy, surveys, and regular visits with your doctor including follow-up study visits or phone calls every 6 months. There will be about 428 people taking part in this study, approximately 39 participants will be enrolled at MUSC.
Risks include infection, scarring, and bleeding. Participants may or may not receive a direct benefit from participating in this trial, however, information learned from the trial may help other people in the future.
The purpose of this study is to evaluate investigational treatments (study drug) for locally advanced/metastatic colorectal cancer. This study seeks to see if Fruquintinib in combination with TAS-102 improves overall survival when compared to Fruquintinib alone.The goal is to determine the optimal dose level, safety, and tolerability for the study drug.Treatment for this study may be up to 3 years. The procedures include blood and urine samples, questionnaires, infusions, and CT scans. Risks include high blood pressure, diarrhea, vomiting, reduced appetite, weight loss, hoarse voice, joint pain, and weakness. You may or may not receive a direct benefit from participating in this trial, however, information learned from the trial may help other people in the future.
This study is testing whether an investigational compound called oleoylethanolamide (OEA) may help reduce alcohol use in young adults with alcohol use disorder. Young adults ages 18-25 will be randomly assigned to receive either OEA (250mg per day) or a placebo for six weeks. Researchers will measure alcohol use, immune function, oral bacteria, and thinking and decision-making. Compensation is available for those who qualify.