The BRIDGES Clinical Trial (GTM-105) is a phase 3 clinical trial for people who have been newly diagnosed with a glioblastoma (GBM) brain tumor and need surgery. The purpose of this study is to find out if adding GammaTile® during surgical removal of a brain tumor improves survival outcomes compared to standard of care treatment. GammaTile is an FDA-cleared, implantable radiation therapy device placed directly in the surgical cavity at the time of tumor removal surgery. Each GammaTile is made of a 2 cm × 2 cm collagen square that contains four radioactive sources (about the size of a grain of rice). Once implanted, GammaTile begins delivering radiation immediately, right where the tumor was removed. Participants will be randomized into one of two groups (like flipping a coin), with 2 participants being randomized to receive GammaTile for every 1 participant receiving standard care. Participants randomized into the standard care arm will undergo tumor removal surgery followed by 6 weeks of external beam radiation therapy (EBRT) and oral chemotherapy (temozolomide, TMZ), followed by additional cycles of TMZ. Participants in the GammaTile arm will have the GammaTile placed into their surgical site, and also receive all the standard care treatments. However, the radiation course will be four weeks instead of six weeks, because GammaTile will deliver part of the radiation dose. Participants can expect to be enrolled in this trial for up to three years. The most common side effects from the procedures in this trial include radiation brain injury, surgical complications, infections and fatigue.

Both external radiation and GT are FDA cleared for the treatment of malignant (cancerous) brain tumors and available to patients. The experimental part of the study is comparing standard of care to standard of care plus GT for this type of brain tumor.

This study is recruiting pediatric patients who have been diagnosed with Favorable Histology Wilms Tumor (FHWT). Wilms Tumor is the most common type of kidney cancer in children, and FHWT is the most common subtype. The goal of the study to improve outcomes within cohorts of FHWT patients with current long-term EFS rates at or below 80% and maintain outcomes despite therapy reduction within cohorts of FHWT patients with current long-term EFS rates at or above 84%. Common side effects of treatment in regards to this study include nausea, vomiting, hair loss, and fatigue (tiredness). Participants will receive the medications through an IV in their arm and orally. Study participation is expected to be approximately 5 years.

This is a randomized, double-blind, placebo-controlled, multicenter, parallel-group
study of the efficacy and safety of 2 weight-based treatment groups of plecanatide
versus placebo in children and adolescent participants 6 to less than 18 years of age with FC. Randomization will be stratified by sex to ensure balance across treatment groups.

Approximately 30 participants will be randomized to each of the Placebo, Low
Dose, and High Dose groups, within age group. Low Dose and High Dose will be
assigned once daily treatments based on the weight of the participant at
randomization to achieve weight-based dosing of 0.025 to 0.05 mg/kg in the Low
Dose treatment group and 0.05 to 0.1 mg/kg in the High Dose treatment group.

The FIORELLO study is for pediatric patients who 1) Have heart failure and left ventricular systolic dysfunction associated with dilated cardiomyopathy or congenital heart disease and 2) Have successfully completed the FIORE trial. Study participants will receive the study drug finerenone, which has not yet been FDA approved for this specific pediatric population. The study will last 9 months and the objective is to show that finerenone in addition to standard of care is safe when given long-term to pediatric patients with left ventricular systolic dysfunction.

This is a pilot study that will be performed to assess whether a series of once weekly in-home visits over a month (total of 4 visits) after discharge from a hospital with a heart failure diagnosis can help reduce re-hospitalization rates. To accomplish this, subjects will perform a once weekly telehealth visit with a heart failure provider and the following will be completed: symptom questionnaires, blood work, and a video of the neck veins to document physical exam once weekly during the study period. The videos and labs will be sent to the remote care team, who can use this data to manage the subject's medications. The study team will collect information regarding the study participant's frequency of hospital readmissions following enrollment.

The primary objective of this study is to evaluate real-life persistence on lenacapavir (LEN) pre-exposure prophylaxis (PrEP) at W52 in diverse clinical settings in the US.

This is a non-interventional study where information is being gathered about how individuals decide if and when to use pre-exposure prophylaxis for HIV prevention over a 2-year period, and when they do, how consistently individuals use pre-exposure prophylaxis and specific kinds of pre-exposure prophylaxis, like lenacapavir. Participants must be at least 18 years or older and willing and able to comply with all study requirements.

This trial is testing V118C in infants and toddlers.

V118C is an experimental vaccine. Vaccines help to prevent illness by teaching the body's immune system how to fight infections. The immune system is a network of organs and cells that fight infections. If it works, V118C may prevent an illness called pneumococcal disease. This is an illness caused by certain germs. These germs can cause infections, some of which may be serious, in the ears, nose, lungs, blood, or brain.

This trial will compare V118C to a vaccine called PCV20. PCV20 is approved to prevent pneumococcal disease in infants and toddlers.

This study explores whether clear aligners used in orthodontic treatment release very small plastic particles, known as microplastics, into the mouth. While aligners are made from safe medical-grade plastics, everyday use such as chewing, temperature changes, and saliva exposure may cause the material to gradually wear down. We will collect saliva samples from patients before starting aligner treatment and after several months of use to see if these particles can be detected. Advanced laboratory techniques will be used to identify and analyze any plastic particles present.

Our preliminary findings suggest that small plastic-related compounds may already be present in patients wearing aligners, but this study aims to confirm and better understand this in real clinical conditions. The goal is to determine how much exposure may occur and what types of materials are involved. This information will help improve the safety of orthodontic materials and guide future recommendations for both patients and providers.

This study is for patients that have been diagnosed with relapsed and refractory multiple myeloma (RRMM). This study is testing and investigational drug called KTX-1001. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). The primary purpose of this study is to test the safety and tolerability of KTX-1001 and to find out how it is processed by the body. The drug is given to participants by mouth. Participants in this study can expect to be in this study until disease progression, unacceptable toxicity, or withdrawal from the study. The total duration of the study may be approximately 4 years.

This study aims to improve the early identification of depression and substance use concerns during pregnancy and after childbirth by developing an artificial intelligence (AI) tool that uses information already collected in electronic health records. The goal is to help healthcare providers identify individuals who may be at risk for mental health or substance use problems earlier, allowing for timely support and treatment. Researchers will also work closely with patients, healthcare providers, and community partners to ensure the AI tool is trustworthy, easy to use, fair, and able to fit into routine healthcare settings.
The study includes two components. First, researchers will use existing electronic health record data from pregnant patients to develop and test an AI model that can predict the likelihood of depression or substance use concerns. Second, pregnant or postpartum individuals and obstetric healthcare providers will participate in a one-time virtual interview/focus group to share their perspectives on the use of AI in maternal healthcare. Feedback from these interviews/focus groups will help refine the AI tool and support its future implementation in clinical care.