This phase II trial tests how well cemiplimab and transarterial radioembolization (TARE) with yttrium-90 (Y90) SIR-Spheres, registered trademark, works in treating breast cancer that has spread from where it first started (primary site) to the liver (metastatic). Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. TARE is a treatment that uses radioactive microspheres, such as Y90 SIR-S Spheres, to both cause hepatic artery embolization and to deliver regional radiotherapy. Y90 SIR-S Spheres is an injectable form of the radioisotope yttrium Y 90 encapsulated in resin microspheres. When injected into the artery supplying the tumor, yttrium Y 90 resin microspheres block the tumor blood vessels and deliver the yttrium Y 90 directly to the tumor site, which may kill or slow tumor growth. Giving cemiplimab and Y90 SIR-Spheres by TARE to the tumor in the liver may kill more tumor cells in patients with metastatic breast cancer.

Type: Interventional

Start Date: Jan 2026

open study

The study will help us in understanding the neural mechanisms by which listeners with a cochlear implant detect speech in noisy environments.

Type: Interventional

Start Date: Nov 2024

open study

The purpose of this study is to determine if zigakibart is safe and effective for long-term use in patients with immunoglobulin A nephropathy (IgAN). This is an extension study for patients who have already completed an another zigakibart study.

Type: Interventional

Start Date: Jul 2025

open study

Women living with HIV have been shown to experience more frequent and severe hot flashes and night sweats (collectively known as vasomotor symptoms) as compared to women living without HIV. This correlates with disturbed sleep, increased depressive symptoms, increased anxiety, worse mental function, interference with activities of daily living including work, and worse overall quality of life. Hormone therapy is considered to be the most effective therapy for hot flashes and night sweats and the most appropriate choice to prevent bone loss at the time of menopause for women without HIV. However, the usefulness of hormone therapy has not been specifically studied in women living with HIV. This trial is being done to see if: - There is evidence to support the use of hormone therapy (estradiol with or without progesterone) for the treatment of hot flashes and night sweats in women living with HIV - Hormone therapy improves mental function, mood, sleep, quality of life, bone health, heart health, and inflammation in women living with HIV - Hormone therapy is safe and tolerable for women living with HIV

Type: Interventional

Start Date: Apr 2026

open study

(Effectiveness Aim 1) To test the comparative effectiveness of PreP for WINGS versus PrEP alone on primary outcomes of increasing PrEP initiation measured by self-report/medical records, recent adherence and longer-term adherence by self-report/medical records over the 6-month follow-up; and secondary outcomes of decreasing IPV, hazardous drinking, recidivism, and HIV risks. (Moderation Aim 2) To test if the effectiveness of WINGS+PrEP on study outcomes is moderated by key participant subgroups based on race/ethnicity, sexual orientation, age, education, incarceration history, IPV severity, substance use disorders (SUDs), digital access and literacy, housing stability, and medical mistrust.

Type: Interventional

Start Date: Mar 2026

open study

The purpose of this study is to look at the effects (good and bad) of a drug called 177Lu-PSMA-617 (also known as the study drug) when given to participants who have prostate specific membrane antigen (PSMA) positive liver cancer.

Type: Interventional

Start Date: Jun 2026

open study

The purpose of this study is to determine the proportion of participants who achieve undetectable measurable residual disease (uMRD) in previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

Type: Interventional

Start Date: May 2025

open study

Prospective, multicenter, two-arm, 2:1 randomized controlled trial (RCT) comparing the benefits in subjects with medial knee osteoarthritis who are treated with either the MISHA Knee System or with non-surgical treatment. This is the first randomized head-to-head study comparing outcomes from subjects treated with the MISHA Knee System.

Type: Interventional

Start Date: Feb 2025

open study

The purpose of this study is to evaluate the safety, efficacy, tolerability, and pharmacokinetics (PK) of FG-3246, a cluster of differentiation 46 (CD46) targeting antibody-drug conjugate (ADC), in the treatment of participants with mCRPC who have progressed following treatment with one prior second-generation androgen receptor signaling inhibitor (ARSI) in any setting and no prior taxane therapy in the mCRPC setting.

Type: Interventional

Start Date: Feb 2026

open study

The researchers are doing this study to find out whether the combination of abemaciclib and cabozantinib is a safe and effective treatment for people with metastatic clear cell renal cell carcinoma (ccRCC) and translocation-associated renal cell cancer (tRCC). The researchers will test different doses of the study drugs to find the highest doses that cause few or mild side effects in participants.

Type: Interventional

Start Date: Feb 2025

open study

The goal of this clinical trial is to test the effectiveness of an evidence-based multi-level intervention for weight loss and the feasibility, fidelity, and sustainability of implementing the intervention in low-income and underserved people living with obesity in Louisiana. The main questions it aims to answer are: - Will an evidence-based multi-level obesity intervention (called LA-CEAL CONNECT) in adults living with obesity in low-income and underserved communities achieve weight loss at 6 months compared to enhanced usual care? - Will LA-CEAL CONNECT sustain weight loss at 12 months? - Will LA-CEAL CONNECT improve waist circumference, diet quality, physical activity, quality of life, and blood pressure at 6 and 12 months? - Will LA-CEAL CONNECT be feasible to implement in adults living with obesity in low-income and underserved communities? Researchers will compare the LA-CEAL CONNECT multilevel weight loss intervention to enhanced usual care to evaluate if LA-CEAL CONNECT leads to greater weight loss and greater changes in waist circumference, diet, physical activity, quality of life, and blood pressure than enhanced usual care. Participants in both arms will: - Receive health literacy-tailored educational materials and resources for weight loss - Visit the clinic site for baseline, 6-month and 12-month study visits to collect clinical and survey measurements Participants in the CONNECT intervention arm will also: - receive health coaching - self-monitor weight and physical activity using digital technologies - attend group meetings to identify and increase utilization of community health and wellness resources

Type: Interventional

Start Date: Mar 2025

open study

The study regimen will be administered on an outpatient basis and all medications are administered intravenously (IV). Subjects will receive treatment on Day 1 and Day 15 of each 28-day cycle consisting of the following: nanoliposomal irinotecan at 50 mg/m2, followed by oxaliplatin 60 mg/m2, followed by leucovorin at 400 mg/m2 30 minutes after completion of oxaliplatin, followed by 5-FU 2400 mg/m2 60 minutes after leucovorin completion. Subjects will receive up to 6 cycles of NALIRIFOX then based on response and per physician discretion, de-escalated maintenance treatment with NALIRIFOX minus oxaliplatin may continue. Subjects will continue de-escalated maintenance treatment until progression per RECIST 1.1, intolerable toxicity or physician/subject choice to discontinue.

Type: Interventional

Start Date: Jun 2025

open study

This is an open-label study to be conducted in adults with hypertriglyceridemia (HTG) and severe hypertriglyceridemia (SHTG). Each participant must have completed all required visits per protocol in the parent study AROAPOC3-2003 (USA and Canada participants only; NCT# 05413135), AROAPOC3-3001(Canada and Japan participants only; NCT05089084), AROAPOC3-3003 (NCT06347003), AROAPOC3-3004 (NCT06347016) or AROAPOC3-3009 (Argentina, Italy, South Africa, and Spain; NCT06347133). Subjects who previously met all eligibility requirements for AROAPOC3-3003 or AROAPOC3-3004 and were not permitted to proceed to randomization per the Sponsor's direction in order to prevent excessive over-enrollment may also be enrolled in this trial. The subjects must meet all other applicable eligibility criteria prior to enrollment and have an HbA1c results of <=10% within 30 days prior to Day 1. Subjects entering this OLE from AROAPOC3-2003 must meet the following additional criteria to be considered for enrollment in addition to applicable eligibility criteria: 1. HbA1c ≤10% within 30 days prior to Day 1 2. Completed AROAPOC3-2001 prior to entry into AROAPOC3-2003 AND fulfill either (c) or (d) 3. Baseline fasting TG level of ≥500 mg/dL and prior history of acute pancreatitis at the time of enrollment into AROAPOC3-2001 4. Baseline fasting TG level of ≥1000 mg/dL at the time of enrollment into AROAPOC3-2001 All eligible participants will receive plozasiran administered subcutaneously (SC) approximately every 3 months for 24 months. Participants will be counseled to remain on the specified low-fat diet throughout the study in accordance with local standard of care.

Type: Interventional

Start Date: Apr 2025

open study

This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with Afimkibart (also known as RO7790121) in participants with moderately to severely active Crohn's disease (CD).

Type: Interventional

Start Date: May 2025

open study

This is a phase 1/2, dose-escalation, clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of DT-7012 (an anti-CCR8 monoclonal antibody) as a single agent and in combination with an immune checkpoint inhibitor in adult participants with selected advanced solid tumors.

Type: Interventional

Start Date: Jun 2025

open study

The primary objective of this study is to evaluate the safety and tolerability of a single dose of INS1201 via IT administration in ambulatory male participants with DMD.

Type: Interventional

Start Date: Jul 2025

open study

The purpose of the study CTQJ230A12304, is to evaluate the efficacy, safety, and tolerability of pelacarsen (TQJ230) compared to placebo in participants with ASCVD who have elevated lipoprotein(a) (Lp(a)), and who are on background inclisiran treatment for elevated low-density lipoprotein cholesterol (LDL-C).

Type: Interventional

Start Date: Apr 2025

open study

Adults 18 years of age and older or above legal age with lung fibrosis related to systemic autoimmune rheumatic disease can participate in this study. People can only take part if they show no improvement in lung function after standard treatment with immunosuppressant medicine. The main purpose of this study is to find out how a medicine called nerandomilast affects the lungs in people with systemic autoimmune rheumatic disease. Participants are put into 2 groups randomly, which means by chance. One group takes nerandomilast tablets and the other group takes placebo tablets. Placebo tablets look like nerandomilast tablets but do not contain any medicine. Participants take a tablet 2 times a day for at least 26 weeks and up to 1 year. Participants continue immunosuppressant treatment for their underlying rheumatic disease. Participants are in the study for about 7.5 to 13 months depending on when they join the study. During this time, they visit the study site about 9 to 10 times. At study visits, participants have lung function tests. At select visits, chest imaging is performed. Participants fill in questionnaires about their symptoms and quality of life. The results between the 2 groups are compared to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.

Type: Interventional

Start Date: Sep 2025

open study

The goal of this clinical trial is to learn if BGB-B455 can treat advanced or metastatic solid tumors expressing claudin 6 (CLDN6), a protein that is found on some tumors. The main questions it aims to answer are: - What is the recommended dosing for BGB-B455? - What medical problems do participants have when taking BGB-B455? The study has two parts: - Phase 1a: dose escalation and safety expansion - Phase 1b: dose expansion

Type: Interventional

Start Date: Mar 2025

open study

Low blood pressure, also known as hypotension, is very common during major surgery under general anesthesia. Prolonged or severe hypotension can lead to complications such as kidney injury after surgery that slow down patient recovery. Anesthesiologists commonly administer medications called vasopressors to treat low blood pressure during surgery. These medications help raise the blood pressure back up to a safe range. Two vasopressor medications are commonly used for this purpose: norepinephrine and phenylephrine. Each of these medications has slightly different effects on the heart and blood vessels (cardiovascular system). It remains unknown which of these standard medications is better for treating low blood pressure during surgery. The goal of this clinical trial is to determine which of these two medications is better at preventing injury to the kidneys after major noncardiac surgery as well as other complications such as heart problems. Major surgeries are defined as those lasting at least two hours under general anesthesia. This trial will randomize about ten centers in North America to use either norepinephrine or phenylephrine as the primary medication to treat low blood pressure in adults undergoing major noncardiac surgery. Each hospital will prioritize one of the drugs each month, and the assigned drug will rotate each month at each hospital. No further participant involvement will be required as de-identified data are collected as part of standard medical care.

Type: Interventional

Start Date: Apr 2025

open study

The purpose of this research study is to find out if adding radiation prior to chemoimmunotherapy and surgery is effective for people with non-small cell lung cancer (NSCLC) who have the potential for surgery. Standard of Care Chemoimmunotherapy: For this study, standard of care chemotherapy will be used. This means this is the type of chemotherapy that is normal for your cancer. In addition to the chemotherapy, you will also receive the immunotherapy drug, nivolumab. This will be administered intravenously once every 3 weeks for up to 3 cycles (i.e. 9 weeks of total systemic therapy), prior to surgical resection assessment. This combination is made up of the chemotherapy drugs carboplatin or cisplatin along with pemetrexed, paclitaxel or gemcitabine, and the immunotherapy drug is nivolumab. The chemotherapy is used to kill cancer cells, and the immunotherapy enables your immune system to attack cancer cells. Stereotactic Body Radiation Therapy (SBRT) SBRT is when radiation is delivered at higher doses over a smaller period of time. For this study, you will receive three doses of radiation delivered every other day, for three total days. The final dose of radiation will happen within 7 days of starting chemoimmunotherapy. You will be followed for up to 100 days following your last chemoimmunotherapy dose to monitor for potential side effects. Following this you will continue with your standard follow up with your doctor. During the standard follow-up time, study staff will review your charts to see if there have been any new updates with your cancer following treatment so they can tell how this treatment affects how long patients live and whether it helps avoid recurrence of the cancer.

Type: Interventional

Start Date: Apr 2025

open study

HNC364 is a new pro-drug of rasagiline as a long-acting injection for deep IM deltoid injection, for the treatment of Parkinson"s disease (PD). As a pro-drug of rasagiline, HNC364 will readily and completely convert to rasagiline after the IM administration. This is a non-randomized, open-label, Phase 1 study to evaluate the relative bioavailability of HNC364 injectable suspension relative to AZILECT® (rasagiline tablets), to assess the safety and tolerability of multiple IM dose HNC364 injectable suspension dose administration in healthy adult subjects.

Type: Interventional

Start Date: May 2026

open study

The main purpose of this study is to evaluate the safety and efficacy of novel study interventions and combinations in participants with Colorectal Cancer (CRC).

Type: Interventional

Start Date: Mar 2025

open study

This study will evaluate the efficacy and safety of the combination of inavolisib plus a cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) and letrozole versus placebo plus a CDK4/6i and letrozole in the first-line setting in participants with endocrine-sensitive PIK3CA-mutated hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), advanced breast cancer (ABC).

Type: Interventional

Start Date: Apr 2025

open study

The goal of this observational study is to learn about the real-world effects of selected obesity medications in adults undergoing medical weight management. The main outcomes of interest are changes in body composition, routine clinical markers, muscular performance, and nutritional intake over the course of treatment. Additionally, the influence of lifestyle factors on changes in these outcome variables will be examined. Participants beginning treatment with selected obesity medications will undergo periodic body composition and muscular performance testing, as well as complete online surveys about their nutritional intake and physical activity and exercise participation. Additionally, routinely collected clinical information will be evaluated.

Type: Observational

Start Date: Jan 2025

open study