The purpose of this study is to evaluate the efficacy and safety of sapablursen when added on to current standard of care (SOC) for Polycythemia Vera (PV) therapy. The study will be conducted in three sequential parts (Part 1a blinded treatment, Part 1b open-label treatment, & Part 2 long-term extension). Participants may receive treatment for up to 156 weeks.

Type: Interventional

Start Date: May 2026

open study

Background and Rationale Essential tremor (ET) affects over 6 million Americans and approximately 5% of adults over age 60. Patients with ET have a 10-20 times higher risk of developing Parkinson's disease (PD) compared to age-matched populations, with approximately 1% converting to PD annually. Post-mortem studies reveal Lewy body pathology in some ET patients, suggesting a subset may have prodromal PD. Current diagnostic tools (DaTscan, SYNTap) are either insufficiently sensitive for early disease, too expensive, or too invasive for routine screening. The Syn-One Test offers a minimally invasive approach to detect phosphorylated α-synuclein (P-SYN) pathology in skin biopsies. Primary Objectives 1. Identify which ET patients have P-SYN pathology indicative of prodromal PD 2. Predict which patients are most likely to phenoconvert to PD

Type: Observational

Start Date: Feb 2026

open study

This study is a preliminary evaluation of a smoking cessation intervention designed for pregnant women that combines text message support and financial incentives. The aims of this study are to determine the preliminary feasibility and acceptability of text message + incentives (intervention) vs. text message only (control).

Type: Interventional

Start Date: Apr 2026

open study

The main purpose of this study is to evaluate the safety and effectiveness of LY4268989 when compared to placebo in adult participants with moderately to severely active ulcerative colitis (UC). The study drug will be administered orally. The study will last up to approximately 108 weeks, excluding screening.

Type: Interventional

Start Date: Mar 2026

open study

Prostate cancer is the most common non-skin cancer among men in the United States. For some men, the cancer has already spread to other parts of the body at the time of diagnosis; this is called metastatic hormone-sensitive prostate cancer (mHSPC). Treatment for mHSPC has advanced significantly, with new standards of care involving androgen deprivation therapy (ADT) combined with drugs known as androgen receptor pathway inhibitors (ARPIs), sometimes alongside chemotherapy like docetaxel. Darolutamide is an ARPI that is approved by the FDA for treating mHSPC in a "triplet" combination with ADT and docetaxel. It is also used in a "doublet" combination with ADT alone. However, there is limited information on how darolutamide is used in real-world clinical settings for this condition, which creates a gap in knowledge for making treatment decisions. This study aims to fill that gap by analyzing real-world data from electronic medical records. The primary goal is to describe the characteristics of patients with newly diagnosed mHSPC who are treated with darolutamide (either as a doublet or triplet) in urology clinics across the US. The study will also examine drug use patterns and clinical outcomes for these patients. Additionally, the study will explore the characteristics of patients treated with other ARPIs (abiraterone acetate, enzalutamide, and apalutamide) and assess the feasibility of creating matched patient groups for future comparative research. Data will be collected retrospectively from a large network of community urology practices in the US.

Type: Observational

Start Date: Jul 2025

open study

The purpose of this clinical study is to learn about the safety and effects of the study medicine to help adults with obesity or overweight and type 2 diabetes lose weight. Being overweight or obese means carrying too much body weight. Type 2 diabetes is a condition where there is too much sugar in the blood. The study medicine is given by a shot under the skin in the belly area. The participants will be trained to do this at home once every week. About 660 out of 1000 adults will also receive the study medicine and about 330 out of 1000 adults will receive placebo. A placebo does not have any medicine in it but looks just like the medicine being studied. The investigators will compare the experiences of people receiving the study medicine to those of the people who do not. This will help us assess if the study medicine is safe and effective. People will take part in this study for about 21 months. During this time, they will have about 14 study visits at the site and 5 over the phone.

Type: Interventional

Start Date: Feb 2026

open study

The objective of this study is to assess the preliminary effects of an integrated exercise and cognitive rehabilitation intervention (ECO), an exercise intervention (EXCAP), and a cognitive rehabilitation intervention (MAAT) as compared to usual care on objective cognition (Trail Making Test).

Type: Interventional

Start Date: Jul 2026

open study

This evaluates the impact of physician behaviors and other factors experienced during radiation treatment influence distress levels in cancer patients.

Type: Observational

Start Date: Nov 2025

open study

This phase III trial compares the effect of adding sonrotoclax to zanubrutinib versus zanubrutinib alone for the treatment of patients with untreated chronic lymphoblastic leukemia (CLL)/small lymphocytic lymphoma (SLL). Sonrotoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Zanubrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cell (a type of white blood cells) cancers such as mantel cell lymphoma at abnormal levels. This may help keep cancer cells from growing and spreading. Giving sonrotoclax and zanubrutinib may be more effective than zanubrutinib alone for the treatment of untreated CLL/SLL.

Type: Interventional

Start Date: Apr 2026

open study

This clinical trial compares how well a home-based personalized physical activity program (PAP) that is delivered by a digital application (app) (the ExerciseRx app) works compared to health education in improving physical activity for patients with bladder cancer that has not reached the muscle wall of the bladder (non-muscle invasive). For people who are not physically active, previous studies have shown that increasing step counts can reduce incidence of death, reduce frailty, and reduce healthcare costs. The ExerciseRx app tracks adherence to home exercise, adapts step count goals based on the patient's progress, and provides encouraging feedback and motivation from the healthcare team. Additional features include activity summaries, progress towards current goal, nudges, helpful facts about the benefits of activity, and ideas for how to incorporate daily movement. A home-based PAP using the ExerciseRx app may work better in increasing physical activity among patients with non-muscle invasive bladder cancer compared to a health education only group.

Type: Interventional

Start Date: Mar 2026

open study

The primary purpose of this study is to evaluate the safety and tolerability, determine the maximally tolerated dose (MTD) and/or recommended Phase 2 dose(s) (RP2D) of PT0511 in adult participants with solid tumors as monotherapy and in combination with cetuximab in participants with colorectal cancer (CRC).

Type: Interventional

Start Date: Nov 2025

open study

This study will evaluate the efficacy and safety of the combination of inavolisib plus enzalutamide compared with physician's choice of alternative androgen receptor pathway inhibitor (ARPi) or docetaxel in biomarker-selected participants with metastatic castrate-resistant prostate cancer (mCRPC) who have received one prior second-generation ARPi.

Type: Interventional

Start Date: Mar 2026

open study

The purpose of this study is to test the safety and efficacy of study drug LY4065967 for the treatment of diabetic peripheral neuropathic pain (DPNP). This trial is part of the chronic pain master protocol H0P-MC-CPMP (NCT05986292) which is a protocol to accelerate the development of new treatments for chronic pain.

Type: Interventional

Start Date: Feb 2026

open study

The goal of this study is to evaluate the feasibility of using information from wearable devices and self-reported symptoms to remotely monitor patients during immunotherapy. The main questions it aims to answer are: - Is the digital remote patient monitoring tool feasible and acceptable to patients? - Do the alerts and guidance improve symptom management, quality of life, and engagement with the care team during treatment? Participants will: - Complete a demographic questionnaire at the beginning of the study and quality-of-life and health questionnaires at the beginning, midpoint, and end of study. - As feasible: At the beginning and end of the study, complete an in-person physical function assessment measuring balance (Short Physical Performance Battery). If participant is randomly assigned to the intervention group, they will also: - Complete weekly symptom ratings via digital remote patient monitoring tool - Wear a Fitbit activity tracker for 90 days. - At the end of the study, complete a semi-structured interview to provide feedback on the study.

Type: Interventional

Start Date: Jun 2026

open study

The purpose of this research study is to test whether Brief Behavioral Treatment for Insomnia (BBTI) delivered over the phone or Brief Mindfulness Training (BMT) delivered over the phone is better able to improve the symptoms of insomnia, reduce chronic pain, and slow the pace of biological aging in individuals with HIV and Chronic Pain.

Type: Interventional

Start Date: Feb 2026

open study

The purpose of this study is to evaluate the safety and efficacy of solbinsiran in lowering triglycerides and other lipid measures compared to placebo in participants with severe hypertriglyceridemia. Participants will receive two subcutaneous injections.

Type: Interventional

Start Date: Dec 2025

open study

Esophageal squamous cell carcinoma (ESCC) remains a highly lethal cancer worldwide, largely due to late diagnosis. Current screening methods such as upper endoscopy are invasive, operator-dependent, and limited in their ability to detect early-stage lesions. To address this clinical need, the SYNERGY study seeks to develop a non-invasive, blood-based biomarker assay that integrates cell-free microRNAs (cf-miRNAs) and exosomal microRNAs (exo-miRNAs) to detect ESCC at an early and potentially curable stage. This multicenter translational study includes discovery, training, and validation phases using preoperative plasma or serum samples. By combining the tumor specificity of exosomal miRNAs with the systemic sensitivity of cf-miRNAs, SYNERGY aims to construct a robust diagnostic model with high sensitivity and specificity for early ESCC detection.

Type: Observational

Start Date: Jan 2025

open study

This is a two-arm pilot randomized trial that assesses the feasibility and preliminary efficacy of a digital story and values clarification intervention (Considering alloHCT: Opportunities for Patient Reflection During Decision-Making via Digital Stories [CHORDS]) compared to usual care among patients with myeloid cancers considering allogeneic hematopoietic cell transplantation (alloHCT).

Type: Interventional

Start Date: Jan 2026

open study

"Gold-standard" medications for opioid use disorder (MOUD) treatment combines FDA-approved medications, primarily methadone and buprenorphine, with behavioral therapies to provide "whole-patient" treatment. Prior to the pandemic, methadone and buprenorphine were subject to greater federal regulations than medications for other substance use disorders, including medication for alcohol use disorder (MAUD), which created barriers to MOUD initiation and retention. These barriers were exacerbated by physical distancing and diminished clinic capacities during the COVID-19 pandemic. To prevent healthcare disruption and expand access to MOUD treatment during the public health emergency, federal and state authorities implemented several MOUD policy changes during the pandemic to reduce barriers to MOUD initiation and retention, which subsequently became permanent. This study is an evaluation of the impacts of these policies on treatment use, retention, and patient outcomes pre- and post-MOUD policy implementation.

Type: Observational

Start Date: Jun 2026

open study

This study is testing three ways to deliver Early Intervention (EI) services for toddlers with developmental disabilities (DD). Children enrolled in EI speech therapy will receive one of three approaches: 1. Therapist Delivered EI: For 28 weeks, the child's speech therapist will work directly with the child to support their communication. 2. Caregiver Coaching EI: For 28 weeks, the child's speech therapist will coach the caregiver on how to support their child's communication. 3. Combined EI Approach + Parent-Led Education Program: For 14 weeks, the caregiver will take part in a parent-led education program while the speech therapist works directly with the child to support their communication. During the next 14 weeks, the speech therapist will coach the caregiver on how to support their child's communication. The goal of this study is to identify which approaches are most effective so that all families can benefit fully from EI services.

Type: Interventional

Start Date: Feb 2026

open study

The EpiCORE study aims to identify cfDNA-based epigenetic markers predictive of response to first-line chemotherapy (FOLFOX or FOLFIRI) in metastatic colorectal cancer (mCRC). By integrating 5-methylcytosine (5mC) and 5-hydroxymethylcytosine (5hmC) profiling, this study seeks to establish a non-invasive biomarker panel capable of distinguishing responders from non-responders.

Type: Observational

Start Date: Jun 2024

open study

INHALE-1st is a Phase 2, single-arm, multi-center, clinical study evaluating the safety and efficacy of Afrezza in combination with subcutaneously-injected basal insulin (BI) for youth 10 to <18 years old with newly diagnosed stage 3 type 1 diabetes (T1D). The study will also evaluate the effect of an Afrezza plus BI reigmen on participant and parent/legally authorized representative satisfaction. Participants will be followed for 13 weeks during the main phase followed by an optional Extension Phase for participants continuing to use Afrezza in combination with BI for up to 26 weeks.

Type: Interventional

Start Date: Feb 2026

open study

This is a feasibility trial of a digital mental health intervention aimed at adolescents (ages 14-18) with nonsuicidal self-injury and who are not currently engaged in mental health treatment. The study has two arms: a self-guided DMHI and an active control which will involve the delivery of non-interactive psychoeducational content via the same app interface. The primary goals of this project are to evaluate the feasibility of the intervention and trial procedures in preparation for a fully-powered randomized-controlled trial.

Type: Interventional

Start Date: Jun 2026

open study

The purpose of this study is to determine safe and effective dose (recommended phase 2 doses [RP2Ds]) of JNJ-89862175 in Part 1 (dose escalation), and to further evaluate how safe JNJ-89862175 is at the RP2Ds in Part 2 (dose expansion) in participants with advanced stage solid tumors.

Type: Interventional

Start Date: Oct 2025

open study

In this study, researchers will learn more about the effects and safety of BIIB115, also known as salanersen. Specifically, researchers will learn more about how salanersen works in babies who have been diagnosed with SMA through genetic testing but have not yet started showing signs or symptoms. Most people with SMA have changes in a gene called survival motor neuron 1, also known as SMN1. These changes lower the amount of SMN protein in their bodies. Without enough of this protein, motor neurons and muscles cannot work properly. A similar gene called SMN2 can help replace some of the lost SMN protein in the body. Salanersen works by helping the SMN2 gene to make more SMN protein. In this study, participants will have either 2 SMN2 copies or 3 SMN2 copies. The higher the copy number, the less severe the participant's SMA is. The main goal of this study is to see if starting salanersen before signs or symptoms appear can prevent signs or symptoms of SMA or make them less severe. Researchers will use different tests to learn if motor symptoms are changing, including the World Health Organization (WHO) motor milestones. The main questions researchers want to answer in this study are: - How many participants with 2 copies of the SMN2 gene can sit without support at 12 months? - How many participants with 3 copies of the SMN2 gene can walk alone at 18 months? Researchers will also learn more about: - The effects on participants' motor symptoms and how many new movement milestones participants achieve. - How many participants stay free of SMA symptoms - How much salanersen gets into the fluid surrounding the brain and spinal cord. - How much salanersen gets into the blood. - How many participants have adverse events or serious adverse events. Adverse events are health problems that may or may not be caused by the study drug. This study will be done as follows: - First, participants will be screened to check if they can join the study. The screening period will be up to 28 days. - This is an "open label" study. This is a study in which the participants, study doctor, and site staff know which study drug participants are receiving. In this study, all participants will receive salanersen through an intrathecal injection, or one that is given into the fluid surrounding the brain and spinal cord. - There will be 2 parts in this study. During Part 1, participants will receive 2 doses of salanersen, about 12 months apart from each other. Part 1 will last up to 25 months. - During Part 2, participants will continue to receive salanersen. They will receive up to 3 doses, 12 months apart from each other. Part 2 will last up to 36 months. - During Part 1, participants will have up to 11 clinic visits and up to 3 phone calls. During Part 2, participants will have up to 7 clinic visits and up to 12 phone calls.

Type: Interventional

Start Date: Apr 2026

open study