This phase II MyeloMATCH treatment trial compares the usual treatment of azacitidine and venetoclax to the combination treatment of azacitidine, venetoclax and gilteritinib in treating older and unfit patients with acute myeloid leukemia and FLT3 mutations. Azacitidine is a drug that is absorbed into DNA and leads to the activation of cancer suppressor genes, which are genes that help control cell growth. Venetoclax 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. Gilteritinib is in a class of medications called kinase inhibitors. It works by blocking the action of a certain naturally occurring substance that may be needed to help cancer cells multiply. This study may help doctors find out if these different approaches are better than the usual approaches. To decide if they are better, the study doctors are looking to see if the study drugs lead to a higher percentage of patients achieving a deeper remission compared to the usual approach.

Type: Interventional

Start Date: Sep 2024

open study

The focus on this application is low-income, rural patients, since cardiovascular disease (CVD) prevalence is 40% higher among rural than urban residents. Health behavior counseling and follow-up care are required for patients with an elevated body mass index who have increased risk for CVD. Counseling is most effective when developed with, and tailored to, the patient and offered with resources that support healthy food intake and physical activity. Resource referral and follow-up is particularly important in rural low income residents who often have more severe social needs that impede healthy behaviors. The proposed research will leverage the candidate's digital health tool (PREVENT) for healthcare teams to use within the clinic visit. PREVENT visually displays patient-reported and electronic health record (EHR) data to facilitate counseling and deliver tailored physical activity and healthy food intake goals and resources. PREVENT may improve the quality of required care and promote cardiovascular health equity. This research will: 1) collaborate with rural and clinic partners to modify and integrate the PREVENT tool for low-income, rural patients with obesity (Aim 1); and 2) conduct a pilot pragmatic clinical trial of PREVENT to optimize feasibility, acceptability, appropriateness, and potential health equity impact.

Type: Interventional

Start Date: Aug 2024

open study

The main aim of this study is to learn about the effect of treatment with vedolizumab IV (vedolizumab) together with adalimumab or vedolizumab (VDZ) together with ustekinumab (UST) in adults with moderate to severe Crohn's Disease, and the effect of treatment with vedolizumab alone, after the dual targeted treatment. The study is conducted in two parts. In Part A, participants will receive the dual targeted treatment (vedolizumab together with either adalimumab or ustekinumab). In part B, participants will receive vedolizumab only. Part B will include participants who responded to the treatment in Part A. Each participant will be followed up for at least 26 weeks after the last dose of treatment.

Type: Interventional

Start Date: Apr 2024

open study

This phase III trial tests whether continuous or intermittent zanubrutinib after achieving a complete remission (CR) with rituximab works in older adult patients with mantle cell lymphoma (MCL) who have not received treatment in the past (previously untreated). Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Zanubrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. When zanubrutinib is used in MCL, the current standard of care is to continue administering the drug indefinitely until disease progression. This continuous treatment comes with clinical as well as financial toxicity, which could be especially detrimental in older patients. For patients who achieve a CR after initial zanubrutinib plus rituximab therapy, it may be safe and equally effective to stop treatment and restart zanubrutinib upon disease progression rather than continuing indefinitely in previously untreated older adult patients with MCL.

Type: Interventional

Start Date: Oct 2023

open study

The purpose of this open-label, multicenter, phase IIIb, single-arm study is to characterize the efficacy and safety of the combination of ribociclib and standard adjuvant endocrine therapy (ET) on invasive breast cancer-free survival (iBCFS), in a close to clinical practice patient population with HR-positive (HR+), HER2-negative (HER2-), Anatomic Stage Group III, IIB, and a subset of Stage IIA Early Breast Cancer (EBC).

Type: Interventional

Start Date: Feb 2024

open study

This study is designed as a multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in idiopathic immune complex mediated membranoproliferative glomerulonephritis.

Type: Interventional

Start Date: Oct 2023

open study

The purpose of this study is to look at pulmonary exacerbations in people with cystic fibrosis (CF) that need to be treated with antibiotics given through a tube inserted into a vein (intravenous or IV). A pulmonary exacerbation is a worsening of respiratory symptoms in people with CF that needs medical intervention. Both doctors and CF patients are trying to understand the best way to treat pulmonary exacerbations. This study is trying to answer the following questions about treating a pulmonary exacerbation: - Do participants have the same improvement in lung function and symptoms if they are treated with one type of antibiotic (called beta-lactams or β-lactams) versus taking two different types of antibiotics (tobramycin and β-lactams)? - Is taking one type of antibiotic just as good as taking two types?

Type: Interventional

Start Date: Apr 2023

open study

This Phase II/III trial will evaluate the what kind of chemotherapy to recommend to patients based on the presence or absences of circulating tumor DNA (ctDNA) after surgery for colon cancer.

Type: Interventional

Start Date: Jul 2022

open study

Diffusion Basis Spectrum Imaging (DBSI) represents a potential leap forward in improving prostate cancer early detection: a non-invasive and accurate imaging test for clinically significant prostate cancer.

Type: Interventional

Start Date: Feb 2020

open study

The primary objective of this study is to evaluate the effectiveness of belimumab and intravenous rituximab co-administration at inducing a complete or partial remission (CR or PR) compared to rituximab alone in participants with primary membranous nephropathy. Background: Primary membranous nephropathy (MN) is among the most common causes of nephrotic syndrome in adults. MN affects individuals of all ages and races. The peak incidence of MN is in the fifth decade of life. Primary MN is recognized to be an autoimmune disease, a disease where the body's own immune system causes damage to kidneys. This damage can cause the loss of too much protein in the urine. Drugs used to treat MN aim to reduce the attack by one's own immune system on the kidneys by blocking inflammation and reducing the immune system's function. These drugs can have serious side effects and often do not cure the disease. There is a need for new treatments for MN that are better at improving the disease while reducing fewer treatment associated side effects. In this study, researchers will evaluate if treatment with a combination of two different drugs, belimumab and rituximab, is effective at blocking the immune attacks on the kidney compared to rituximab alone. Rituximab works by decreasing a type of immune cell, called B cells. B cells are known to have a role in MN. Once these cells are removed, disease may become less active or even inactive. However, after stopping treatment, the body will make new B cells which may cause disease to become active again. Belimumab works by decreasing the new B cells produced by the body and, may even change the type of new B cells subsequently produced. Belimumab is approved by the US Food and Drug Administration (FDA) to treat systemic lupus erythematosus (also referred to as lupus or SLE). Rituximab is approved by the FDA to treat some types of cancer, rheumatoid arthritis, and vasculitis. Neither rituximab nor belimumab is approved by the FDA to treat MN. Treatment with a combination of belimumab and rituximab has not been studied in individuals with MN, but has been tested in other autoimmune diseases, including lupus nephritis and Sjögren's syndrome.

Type: Interventional

Start Date: Mar 2020

open study

The Idiopathic Pulmonary Fibrosis Prospective Outcomes (IPF-PRO) Registry started recruiting in 2014 with the objective of studying Idiopathic Pulmonary Fibrosis. In 2018, the registry expanded to include recruitment of participants with other chronic fibrosing interstitial lung diseases (ILDs) with progressive phenotype also referred to as progressive fibrosing interstitial lung diseases in the Chronic Fibrosis Interstitial Lung Disease with Progressive Phenotype (ILD-PRO) Registry. When the third phase of the registry begins, the IPF-PRO registry will enroll additional patients with idiopathic pulmonary fibrosis. This IPF-PRO registry is a prospective registry that will collect information regarding the natural history, health care interactions, participant reported questionnaire data to assess quality of life, and the methods of treatment of participants with a diagnosis of idiopathic pulmonary fibrosis (IPF) or of another chronic fibrosing interstitial lung disease (ILD) with progressive phenotype established at the enrolling centers. In addition, blood samples and chest image studies will be collected and banked for future research projects.

Type: Observational [Patient Registry]

Start Date: Jun 2014

open study

The objective of this study is to generate preliminary data to establish the feasibility and effectiveness of transauricular vagus nerve stimulation (taVNS) to improve post-operative outcomes of moderate to severe degenerative cervical myelopathy (DCM)

Type: Interventional

Start Date: Apr 2026

open study

The goal of this open-label dose escalation and expansion study is to evaluate the safety and tolerability of NKT5097 in adults with advanced/metastatic tumors (emphasis on breast cancer and solid tumors with CCNE1 amplification). Main questions to answer include: - What is the recommended dose for expansion and/or Phase 2, for both monotherapy and in combination with ET - What medical issues/symptoms do participants experience when taking NKT5097 as monotherapy as well as in combination with ET

Type: Interventional

Start Date: Mar 2025

open study

The purpose of this study is to evaluate the safety and efficacy of Navlimetostat (BMS-986504) monotherapy in participants with advanced or metastatic Non-small Cell Lung Cancer (NSCLC) with homozygous MTAP deletion after progression on prior therapies.

Type: Interventional

Start Date: Sep 2025

open study

The purpose of this study is to determine whether [225Ac]Ac-PSMA-617 (AAA817), given for up to 6 cycles at a dose of 10 Megabecquerel (MBq) +/- 10%, plus androgen receptor pathway inhibitor (ARPI), improves the radiographic progression free survival (rPFS) compared to investigator's choice of standard of care (SOC) (ARPI change or taxane-based chemotherapy or [177Lu]Lu-PSMA-617 (AAA617)) in adult participants with PSMA-positive metastatic castration resistant prostate cancer (mCRPC) treated with another ARPI as last treatment and who have not been exposed to a taxane-containing chemotherapy in the mCRPC setting nor have received any prior PSMA-targeting radioligand therapy.

Type: Interventional

Start Date: Jul 2025

open study

The purpose of this Phase 3b study is to assess the efficacy, safety and tolerability of remibrutinib after switching from ocrelizumab and compared to continuous ocrelizumab treatment, in patients living with relapsing multiple sclerosis (plwRMS).

Type: Interventional

Start Date: Jun 2025

open study

This is a 3-part Phase 2 randomized study evaluating the safety and efficacy of the mutant-selective PI3Kα inhibitor, zovegalisib (RLY-2608), in adults and children with PIK3CA Related Overgrowth Spectrum (PROS) and malformations driven by PIK3CA mutation. Part 1 is a dose selection, Part 2 is a basket design with exploratory single-arm cohorts for various subpopulations of participants, and Part 3 is randomized, double-blinded study vs placebo.

Type: Interventional

Start Date: Jun 2025

open study

The goal of this study is to create a non-invasive diagnostic test to rule out gynecological cancer in females aged 45 and older with abnormal uterine or postmenopausal bleeding.

Type: Observational

Start Date: Jul 2024

open study

This is a multicenter retrospective comparative cohort study. The index surgery for this study is primary or revision long-segment posterior thoracolumbar (TL) instrumented fusion using either a supplementary rod construct or a dual-rod construct. Eligible patients who already had index surgery, will be identified for enrollment through a review of medical records of the participating surgeons at the study sites.

Type: Observational

Start Date: Mar 2025

open study

The study is a prospective, longitudinal, non-interventional, multicenter study of participants with HNSCC who will have tissue and blood based molecular biomarker profiling during their standard of care treatment.

Type: Observational [Patient Registry]

Start Date: Aug 2024

open study

This first-in-human (FIH) dose-escalation and dose-validation/expansion study will assess KO-2806, a farnesyltransferase inhibitor (FTI), as a monotherapy and in combination, in adult patients with advanced solid tumors.

Type: Interventional

Start Date: Oct 2023

open study

SISTER is a Phase-II, prospective, randomized, placebo-controlled, blinded, dose finding trial that aims to determine the safety and preliminary efficacy of TS23, a monoclonal antibody against the alpha-2 antiplasmin (a2-AP), in acute ischemic stroke.

Type: Interventional

Start Date: Mar 2024

open study

This phase III trial compares hepatic arterial infusion (HAI) (pump chemotherapy) in addition to standard of care chemotherapy versus standard of care chemotherapy alone in treating patients with colorectal cancer that has spread to the liver (liver metastases) and cannot be removed by surgery (unresectable). HAI uses a catheter to carry a tumor-killing chemotherapy drug called floxuridine directly into the liver. HAI is already approved by the Food and Drug Administration (FDA) for use in metastatic colorectal cancer to the liver, but it is only available at a small number of hospitals, and most of the time it is not used until standard chemotherapy stops working. Standard chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Adding HAI to standard chemotherapy may be effective in shrinking or stabilizing unresectable colorectal liver metastases.

Type: Interventional

Start Date: Oct 2023

open study

The purpose of this clinical study is to collect performance and safety data for post-market Medtronic devices indicated for cranial and/or spinal indication(s). Subjects are enrolled and followed postoperatively to 24 months. The Ailliance clinical study is intended to collect data congruous with routine clinical care practices.

Type: Interventional

Start Date: May 2023

open study

This is a first-in-human, multicenter, Phase 1/2, open-label study designed to evaluate the safety and tolerability of XTX301 as monotherapy in patients with advanced solid tumors.

Type: Interventional

Start Date: May 2023

open study