This registration covers only Aim 1b, which focuses on testing usability. The study will include 20 participants who are breast cancer patients. Participants will be observed using the tool on their mobile devices, and their experience will be evaluated using a "think-aloud" method to capture their thoughts and reactions. Interviews will include open-ended questions about the content and format of the decision aid, with follow-up prompts to gather feedback on design elements (length, order, graphics), comprehension, ease of use, acceptance, and engagement with the tool. Knowledge will be measured using the Decision Quality Instrument before and after using the tool. Results will be analyzed to develop recommendations for the final version of the tool.

Type: Interventional

Start Date: Oct 2025

open study

The primary objective of this trial is to evaluate the effect of pegloticase 18 mg subcutaneously (SC) every two weeks with methotrexate (MTX) versus pegloticase 8 mg intravenously (IV) every two weeks with MTX on the response rate during Month 6, as measured by the sustained normalization of serum uric acid (sUA) to < 6 mg/dL for at least 80% of the time during Month 6.

Type: Interventional

Start Date: Feb 2026

open study

The goal of this prospective, randomized clinical trial is to learn whether pharmacogenomic (PGx)-guided comprehensive medication management delivered by pharmacists in community pharmacies will improve antidepressant treatment outcomes. The primary aim is to determine whether comprehensive medication management with review of PGx testing results improves depression symptoms, compared with usual care. Participants 18 years of age or older who have undergone PGx testing (e.g. through an independent biobanking study (Pitt+Me Discovery) who require initiation or adjustment of antidepressant therapy will be randomly assigned to receive either PGx-guided comprehensive medication management or usual care. Those who receive usual care will receive their PGx results at the end of the study. Researchers will compare the groups to assess whether PGx-guided care provided in partnership with community pharmacists and prescribers results in better depression and medication outcomes.

Type: Interventional

Start Date: Sep 2026

open study

This is an open-label, phase 1/1b study evaluating the safety, tolerability, pharmacokinetic (what the body does to the drug), pharmacodynamic (what the drug does to the body), and antitumor activity of CGT4255 in adult participants with advanced solid tumors with ERBB2 alterations or HER2 overexpression.

Type: Interventional

Start Date: Dec 2025

open study

The purpose of this study is to evaluate the efficacy of Pumitamig versus Pembrolizumab in participants with previously untreated advanced Non-Small Cell Lung Cancer and PD-L1 ≥ 50%.

Type: Interventional

Start Date: Mar 2026

open study

This is a single-center, prospective, single-arm feasibility study evaluating whether adult patients with periampullary neoplasms who are at high risk for postoperative pancreatic fistula after pancreaticoduodenectomy can be recruited and consented to undergo total pancreatectomy with islet autotransplantation as an alternative surgical approach. Feasibility will be assessed by annual accrual rate and consent yield among eligible patients approached. Participants who enroll will undergo open or robotic total pancreatectomy with islet autotransplantation. Perioperative safety, metabolic outcomes, and early oncologic outcomes will be collected prospectively through 12 months after surgery.

Type: Interventional

Start Date: Sep 2026

open study

The goal of this clinical trial is to evaluate if lirafugratinib is efficacious and safe to treat adult patients with previously treated, unresectable, locally advanced or metastatic solid tumors (excluding cholangiocarcinoma) harboring FGFR2 fusion or rearrangement. Participants will: - Take lirafugratinib regularly as instructed by their study doctor. - Visit the clinic as instructed for checkups and tests. - Keep a diary recording each time a dose of lirafugratinib is taken.

Type: Interventional

Start Date: Jun 2026

open study

This is a Phase 2, two-stage, adaptive, 1:1 randomized, double-blind, vehicle-controlled clinical study evaluating the efficacy, safety, and tolerability of GX-03 topical ointment in adult subjects with atopic dermatitis (eczema). Stage 1 (Completed): Stage 1 comprised an initial cohort of 50 subjects evaluated through Week 8. Following a pre-specified interim analysis conducted under the supervision of Independent Data Monitoring Committee (IDMC), treatment-response patterns, safety profiles, and endpoint parameters were assessed to optimize enrollment criteria and outcome measures for Stage 2. Stage 2 (Active/Recruiting): Stage 2 plans to enroll approximately 135 subjects across three baseline EASI severity strata (1.1 to 7.0, 7.1 to 15.9, and 16.0 and above) with a target of at least 120 subjects completing the 8-week treatment period. Enrollment for Stage 2 is specifically enriched for subjects presenting with significant pruritus (baseline Peak Pruritus Numeric Rating Scale [PP-NRS] of 7 or more) and baseline EASI of 1.1 or more.

Type: Interventional

Start Date: Jul 2025

open study

This is a Phase 1, open label, dose-escalation study to evaluate the safety, expansion, persistence, and preliminary clinical activity of lentivirally transduced autologous T cells expressing anti-CD64 chimeric antigen receptors (CAR) expressing tandem CD3ζ and 4-1BB (CD3ζ/4-1BB) costimulatory domains in subjects with refractory or relapsed (R/R) acute myeloid leukemia (AML). This CAR T cell product will be referred to as "CD64 CAR T" which is CD64 directed, autologous, genetically modified CAR T cells. The primary objective of the study is to identify the safety profile and maximum tolerated dose (MTD) of CD64 CAR T in subjects with R/R AML as determined by the defined DLTs using a standard Bayesian Optimal Interval (BOIN) design.

Type: Interventional

Start Date: Dec 2026

open study

The purpose of this global, multicenter, Phase 3 study is to evaluate the efficacy and safety of enpatoran over 24 weeks in participants with active cutaneous manifestations of lupus erythematosus with or without systemic disease. Study details include: Study Duration: Up to 35 weeks. Treatment Duration: 24 weeks. Visit Frequency: every 4 weeks, with the exception of the Week 2 televisit. Study Intervention Name: Enpatoran, Placebo. Intervention Form: Film-coated tablet.

Type: Interventional

Start Date: Mar 2026

open study

The purpose of this study is to assess the safety and tolerability of BMS-986525 alone and in combination with Pumitamig in participants with Relapsed/Refractory Small Cell Lung Cancer

Type: Interventional

Start Date: Feb 2026

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

Headaches such as tension-type, migraine, and cervicogenic (neck-related) headaches are among the most common and disabling conditions worldwide. and are often associated with tight or sensitive muscles at the base of the skull, which can contribute to headaches. Dry needling involves inserting a very thin, sterile needle into tight muscle areas known as trigger points to relieve pain and muscle tension. When applied to the deep neck muscles, including those beneath the skull, dry needling may reduce headache symptoms. The suboccipital region contains important structures such as the vertebral artery, greater occipital nerve, and spinal cord, which requires precise needle placement to maintain safety. Many needling techniques used in this region have not been validated for accuracy or safety in living subjects. This study will use real-time ultrasound imaging to guide dry needling of the rectus capitis posterior major muscle and directly visualize nearby structures to minimize risk. The main goals of this research are to examine the effects of a single session of ultrasound-guided dry needling on headache symptoms and to confirm the safety, accuracy, and consistency of the proposed needling technique using ultrasound imaging.

Type: Interventional

Start Date: Mar 2026

open study

Acute myeloid leukemia (AML) is an aggressive blood cancer, withwith few options for participants who relapse after treatment or who don't respond to treatment. This study will assess the adverse events and how pivekimab sunirine moves through the body in pediatric participants with relapsed or refractory (R/R) AML. Pivekimab sunirine is a drug being evaluated in the treatment of AML. This is an open label, single arm study, participants will be enrolled in 1 of the 3 cohorts based on their age and will receive pivekimab sunirine at a dose based on their weight. Around 18 pediatric participants with a diagnosis of AML will be enrolled in the study at approximately 30 sites around the world. Participants will receive intravenous (IV) pivekimab sunirine alone. The total study duration is approximately 28 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, and checking for side effects.

Type: Interventional

Start Date: May 2026

open study

The purpose of the study is to evaluate the safety and effectiveness of the Tensi+ device using Transcutaneous Posterior Tibial Nerve Stimulation (TPTNS) for treating patients suffering from OAB symptoms urinary frequency, urgency, with or without urge urinary incontinence.

Type: Interventional

Start Date: May 2026

open study

The main goal of the study is to check if MH002 works and is safe to use. In a previous study in 45 patients with Ulcerative Colitis, MH002 was found to have favorable effects. In this study, 2 different doses will be tested, and long-term treatment effects will be investigated. MH002 is a live biotherapeutic product (LBP). This is a biological medicine containing live bacteria used to restore the normal function of a gut that is damaged by ulcerative colitis (UC). Ulcerative colitis is a bowel disease that causes inflammation and sores in the gut.

Type: Interventional

Start Date: Apr 2026

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

This clinical trial evaluates an educational program called Algorithm-Enabled Patients Activated in Cancer Care Through Teams (A-PACT) for reducing unplanned hospital visits and improving goals of care conversations with providers among patients with solid cancers. A-PACT is an educational program where lay health workers (educators) help patients talk with their health care team about issues that matter most to them (goals of care). During A-PACT sessions, patients receive assistance in formulating health care and end of life care preferences, assistance in completing advance directives, guidance on how to engage in these conversations with family members, friends, and clinical teams, and encouragement to discuss these topics with their clinical team. A-PACT may reduce unplanned hospital visits and improve goals of care communication with providers among patients with solid cancers.

Type: Interventional

Start Date: Aug 2026

open study

This study is researching an experimental drug called ALN-ANG3 (called "study drug"). The study is focused on participants who have diabetic kidney disease. The aim of the study is to see how safe and effective the study drugs are. The study is looking at several other research questions, including: - What side effects may happen from taking the study drug - How much study drug is in the blood at different times

Type: Interventional

Start Date: Jan 2026

open study

This pilot randomized controlled trial evaluates the feasibility, acceptability, and accessibility of SUPPORT-T, a digitally delivered palliative care intervention for patients with Progressive Pulmonary Fibrosis (PPF) and their caregivers. The intervention includes a 9-week digital application guided by a nurse interventionist and quarterly virtual support groups over one year. Participants will be recruited from rural South Carolina and urban New York City. The study compares SUPPORT-T to Enhanced Usual Care and aims to inform a future multi-site trial.

Type: Interventional

Start Date: Jan 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

ACTIVE is a prospective, single-arm, phase I/IIa study examining an active surveillance strategy for small, screen-detected, luminal breast cancer. Patients aged 70 or older with clinical stage I ER+/HER2- breast cancer are eligible. The goal of this clinical trial is to learn if an active surveillance strategy (serial imaging rather than therapeutic intervention) is a safe approach to monitor small breast cancers. The main question to answer is the proportion of participants who experience tumor progression by 12 months.

Type: Observational

Start Date: Nov 2025

open study

This is a Phase III, randomized, double-blinded, Sham-controlled, multi-center study in subjects with single-level, symptomatic lumbar (L3- S1) intervertebral disc degeneration. The study will have a 52-week primary period followed by 52 week Follow-up Period (total of 104 weeks). The study protocol will be approved by the Institutional Review Board (IRB) or Independent Ethics Committee (IEC), and the study will be conducted in accordance with Good Clinical Practice (GCP). All subjects will provide written informed consent prior to Screening. Approximately 162 subjects will be enrolled in the study. Up to 45 days prior to treatment, subjects will be screened for study inclusion, which includes obtaining baseline MRI and X-ray imaging. Imaging results for subjects initially eligible for study participation will be sent to a central imaging vendor for review and confirmation of eligibility, including the number of levels with degeneration. Subjects meeting all inclusion/exclusion criteria will be assigned to the corresponding treatment arm group and subsequently randomized to IDCT or Sham. Randomization will occur approximately 7 to 14 days prior to the scheduled treatment administration date. Overall, 162 subjects will be enrolled and randomized to IDCT or Sham in a 2:1 ratio. - IDCT (n=108) - Sham (n=54)

Type: Interventional

Start Date: Dec 2025

open study

This study is being done to learn more about a new medicine called PF-08634404 and how it works when used with other cancer medicines in people who have advanced solid tumors. An advanced solid tumor is a type of cancer that has spread beyond its original location and cannot be removed by surgery or cured with standard treatments. To join in the study, participants must: - Be 18 years or older - Participants with advanced non-small cell lung cancer (NSCLC), a type of lung cancer that has spread to other parts of the body The study will look at: - Whether PF-08634404 is safe to use with other cancer medicines. - What side effects may happen. A side effect is anything the medicine does to your body that is not part of treating your disease. - Whether the combination of PF-08634404 and other cancer medicines can help treat solid tumors. The study has different parts, each testing PF-08634404 with a different cancer medicine: - Part A will test PF-08634404 with a medicine called sigvotatug vedotin. - Part B will test PF-08634404 with a medicine called PF-08046054/SGN-PDL1V Participants will receive the study medicines through an intravenous (IV) infusion (injected into the vein) at the study clinic. All treatments will take place at clinical trial sites, where trained medical staff will monitor participants during and after each visit.

Type: Interventional

Start Date: Jan 2026

open study

The purpose of this study is to evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-75098 alone and in combination with BGB-43395 and fulvestrant in participants with advanced solid tumors.

Type: Interventional

Start Date: Dec 2025

open study