This study is for patients that have been diagnosed with high risk neuroblastoma. This study is testing an investigational drug called Dinutuximab, which will be combined with standard care induction and transplant. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA).
The primary purpose of this study is to compare treatment outcomes of participants who are assigned to early chemoimmunotherapy (Dinutuximab and Sargramostim) during Induction to treatment outcomes of participants who are not assigned to treatment that includes early chemoimmunotherapy. Participants will be randomized to the standard of care arm of the trial or the standard of care arm plus chemoimmunotherapy (like flipping a coin). The investigational drug is given to participants through IV infusion. Participants in this study can expect to be in this study for a total of five years.

Atrial fibrillation (AF) is an arrhythmia in which the heartbeat becomes irregular due to abnormal electrical signals in the upper chambers of the heart, called the atria. This leads to ineffective pumping of blood by the atria. Complications related to atrial fibrillation are heart failure, stroke, heart palpitations and fatigue. This study is motivated by the need to address the increasing prevalence of AF, which is the most common sustained arrhythmia worldwide. While treatment options for AF include the use of antiarrhythmic drugs which are a group of medications used to treat irregular heartbeats, and catheter ablation procedures, the latter have been associated with significantly better outcomes. Participation in this study consists of 2 phases, 1- randomization 2- ablation procedure and follow-up period.
The randomization to the different groups is considered the research part of the study. Subjects will have equal chance of being randomized (like tossing a coin) to one of two AF ablation treatment groups. All follow up will be according to stand of care practices. Risks include stroke, pericarditis, acute and delayed perforation, hemolysis, acute kidney injury, and coronary artery spasm.

This study is designed as a prospective, multi-centered, double-blind, randomized, delayed-stimulation/ sham-stimulation controlled 12-month study to evaluate the effectiveness and safety of bilateral stimulation of the subcallosal cingulate white matter (SCCwm) using the Infinity™ Deep Brain Stimulation (DBS) system as an adjunctive treatment of non-psychotic unipolar Major Depressive Disorder (MDD) for adults who are experiencing a Major Depressive Episode (MDE) with inadequate response to 4 or more antidepressant treatments.

The purpose of this research study is to learn how Deep Brain Stimulation (DBS), which targets a part of the brain called the subthalamic nucleus (STN), may affect thinking and memory in people with Parkinson's Disease (PD). We plan to include about 55 people with PD who have already had DBS surgery at MUSC's Clinical DBS Program.

As part of the study, participants will attend two visits after their DBS surgery. The first visit, which will last about three hours, includes going over the study information and consent form, collecting background information (demographics), and completing tests that measure thinking and memory (cognitive assessments). The second visit, also about three hours, will involve an MRI scan to look at how the brain's networks change when the DBS device is turned on and off.

These findings may help doctors and researchers make better decisions about which patients are most likely to benefit from DBS surgery and how to choose the best stimulation settings to reduce unwanted changes in thinking and memory.

The study is for patient that are receiving camizestrant as a treatment. The main purpose of study is to change the dosage of camizestrant from 150mg to 75mg. This change was prompted by updated, emerging data from ongoing studies showing
no difference in efficacy between the 75 mg and 150 mg doses. Subject can expect to be in this study for up to 24 months.

Currently, there are no FDA-approved medications for the treatment of irritability associated with Autism Spectrum Disorder (ASD). This study is designed to look at the efficacy and safety of lumateperone (CAPLYTA) for the treatment of irritability associated with ASD among pediatric participants between the ages of 5 to 17 years.

It is a 6-week study, and the study drug will be compared to a placebo. Following this study, there will be an opportunity to participate in an open-label extension study where all participants will be on the active study medicine.

This study is studying the investigational medication EDG-7500 for the treatment of obstructive and non obstructive hypertrophic cardiomyoapthy. Investigational means it is not approved for sale by the Food and Drug Administration (FDA) The study will test to see if the medication can help the heart expand and fill to help its workload. The study has 4 Parts, each of varying durations. The study will last a minimum of 6 weeks to a maximum of 18 months. Study related procedures include physical exam, electrocardiogram (ECG) - a tracing of the heart's electrical activity, echocardiogram (echo) - ultrasound test of the heart, blood and urine collection, possible genetic testing, and exercise testing. Risks related to the study medication include atrial fibrillation (fast irregular heartbeat), constipation, diarrhea, dizziness/lightheadedness and upper respiratory infection. Other study related risks include loss of confidentiality, unknown risks and risks related to procedures.

This is a Phase 3b, multicenter, open-label study to evaluate transmural healing and the disease modifying effect of guselkumab in participants aged 18 years or older, with active Crohn's disease. Eligible participants must be diagnosed with luminal Crohn's disease (confirmed by radiography, histology, and/or endoscopy) for a minimum of 3 months, have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or Advanced therapy (for example, biologic or jak inhibitor), or have medical contraindications to such therapies. Participants with active moderate‐to‐severe Crohn's disease will be enrolled in this study. About 112 participants will take part in this study worldwide at approximately 90 study sites. Participants will be in the study for about 104 weeks and will need to visit the study site approximately 28 times, this number may also vary depending on the study treatment group and whether the option of self-administration of the study drug at home at certain timepoints.

This study is enrolling subjects with heart failure and a reduced ejection fraction meaning the heart does not pump enough blood to meet the body's needs. This study is researching an investigational device (study device) called the Alleviant ALV1 System. Investigational means it has not been approved for commercial use by the Food and Drug Administration. (FDA) This study will test the safety and effectiveness of the Alleviant ALV1 System. The Alleviant ALV1 System is intended to create a shunt (an opening) in the heart to allow for proper blood flow through the heart which may improve your symptoms. No device is left in your heart it is just used to create the shunt. This is a randomized study which means subjects are assigned by chance to either have the study device create this shunt or not have the study device create the shunt. Randomization is 50/50 meaning there is a 50% chance to have the study device create a shunt and a 50% chance the study device will not be used. Using the study device to create the shunt is performed during a right heart catheterization (RHC) so all subjects will undergo the RHC but only 50% will have the shunt. Neither the subjects nor the study doctor will know which group subjects are randomized to but other study staff will know in the event this information is needed. All subjects will stay overnight in the hospital after the procedure. Other study related procedures include echocardiograms - ultrasound test of the heart, electrocardiograms (ECG) - a tracing of the heart's electrical activity, blood work, questionnaires, 6 minute hall walk test, and assessments of heart failure status. Risks include risks related to the study device including blood vessel damage from placing the device in the vein to get to the heart, risks from the right heart catheterization such as bleeding or bruising, abnormal heart beats, and risks related to study related procedures. There may be risks that are not known at this time. Participation in this study is expected to last about 60 months and include approximately 15 in person visits and 3 telephone calls.

Co-occurring post-traumatic stress disorder (PTSD) and alcohol use disorder (AUD) disproportionately affects Veterans and has significant negative impacts on the safety, wellbeing, and quality of life of Veterans, their romantic partners, and their families. However, treatments that address co-occurring PTSD-AUD and restore Veterans' psychosocial functioning are lacking. This project is designed to learn more to facilitate improving treatment approaches aimed at reducing symptoms of co-occurring PTSD-AUD and improving functioning among Veterans and their partners. The goal of this project is to learn from Veterans, family members, and treatment providers in order to inform an adaptation of a brief dyadic AUD intervention to be delivered alongside integrated PTSD-AUD treatment for Veteran couples.