The purpose of the study is to assess whether the addition of a TNFi-biologic (tumor necrosis factor inhibitor) medication to methotrexate (MTX) is superior to adding a targeted synthetic DMARD (disease-modifying anti-rheumatic) medication to MTX for people with active RA despite current MTX treatment.
A Phase 2/3 Adaptive, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of VX-147 in Subjects Aged 18 Years and Older With APOL1-mediated Proteinuric Kidney Disease
This is a study of the prevalence of APOL1 alleles in adults who are of recent African ancestry or geographic origin. The study will enroll up to a total of approximately 2500 subjects into 2 groups. Group 1 includes subjects with FSGS, and Group 2 includes subjects with other forms of proteinuric nondiabetic CKD. No study drug will be administered.
The objective of the trial is to assess the efficacy, safety, and tolerability of BI 685509 compared with placebo on a background of local standard of care (SOC) therapy in the treatment of adult patients with early progressive dcSSc and vasculopathy
Severe skeletal muscle loss (wasting) and catabolic weight loss are highly common among patients with heart failure with reduced ejection fraction (HFrEF). This prospective randomized controlled trial will compare changes in the muscle mass in the arms and the legs (appendicular lean mass) in patients with HFrEF randomized between 3 groups of no, low or high dose protien supplementation. The dietary protein supplementation will be Ensure(R) products manufactured by Abbott Nutrition.
This research is being done to study a potential method of improving blood flow and oxygen delivery to the organs of patients on VA-ECMO. This study involves positioning the return cannula in the aorta, which is the main artery that carries blood away from the heart. We aim to prove that returning oxygenated blood to the aorta is safe and feasible. We also aim to better understand the effects that this method may have on the forces that affect blood flow and heart function.
Persistent corneal epithelial defect (PCED) is a persistent non-healing corneal defect or wound. KPI-012 is a novel, human bone-marrow derived human mesenchymal stem cell (hMSC) secretome composed of biologically active components, which have been shown in preclinical studies and early clinical trials to facilitate corneal healing. This study will investigate the efficacy and safety of KPI-012 eye drops 4 times daily for 8-weeks for healing of PCED.
This phase II trial studies the effect of duvelisib or CC-486 and usual chemotherapy consisting of cyclophosphamide, doxorubicin, vincristine, etoposide, and prednisone in treating patients with peripheral T-cell lymphoma. Duvelisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
This phase III trial compares the effects of olanzapine versus megestrol acetate in treating loss of appetite in patients with cancer that has spread to other places in the body (advanced). Olanzapine may stimulate and increase appetite. This study aims to find out if olanzapine is better than the usual approach (megestrol acetate) for stimulating appetite and preventing weight loss.
This study explores changes in heart function before and after activation of Impella or ECMO devices used to support subjects in cardiogenic shock.
Abbott developed the AMPLATZER™ PFO Occluder as a minimally invasive, transcatheter PFO closure treatment to further reduce the risk of recurrent stroke among patients with PFO and cryptogenic stroke beyond that achieved with medical management. This additional risk reduction is achieved by blocking the pathway for a venous embolism from reaching the body's arterial system and the brain.
To evaluate the systemic exposure of treprostinil after inhaled administration in subjects with idiopathic pulmonary fibrosis (IPF)
This is a Phase 3, open-label, follow-up study to evaluate the long-term safety and efficacy of sotatercept when added to background PAH therapy for the treatment of PAH. Participants eligible to enroll in the study will have participated in and completed the relevant study requirements of the PAH sotatercept clinical studies. Participants who have discontinued from a previous PAH sotatercept clinical study will not be eligible to enroll in this LTFU study.
This trial has two parts. Part A, an initial non-randomized Safety Run-In Phase to confirm the safety and tolerability at the selected dose range level of BNT113 in combination with pembrolizumab. Part B, the Randomized Phase of BNT113 in combination with pembrolizumab versus pembrolizumab monotherapy to generate pivotal efficacy and safety data in the first line setting in patients with unresectable recurrent or metastatic HPV16+ HNSCC expressing PD-L1 with CPS ≥1. Randomization will be stratified by PDL1 CPS <20 vs PD-L1 CPS ≥20, and prior chemotherapy (yes vs no).
Study LTI-401 is an open-label, multicenter study which will evaluate the safety and tolerability of LIQ861 in subjects who have WHO Group 1 & 3 PH.
Utilize fresh tumor tissue to aid the development of future therapies for brain cancer.
Briefly, a cell immunotherapy consisting of a patient’s autologous glioblastoma tumor cells, called ‘IGV-001’, is being tested in clinical trials. In order to advance clinical and product development of IGV-001, Imvax is seeking access to patient material to test key product parameters in a laboratory setting.
This is a multicenter, prospective cohort study aimed at facilitating identification of individuals with ATTR-CA. We will identify subjects with previous LSS surgery who have evidence of TTR amyloid deposits in their spinal specimens. Those with localized TTR in their spinal tissue will be invited to an on-site visit and be evaluated for the presence of clinical manifestations of ATTR cardiac amyloidosis (ATTR-CA).
This phase III trial compares the effects of nivolumab with chemo-immunotherapy versus chemo-immunotherapy alone in treating patients with newly diagnosed primary mediastinal B-cell lymphoma (PMBCL).
ASPIRE is a randomized, double-blinded, phase III clinical trial designed to test the efficacy and safety of anticoagulation, compared with aspirin, in patients with a recent ICH and high-risk non-valvular AF (CHA2DS2-VASc score ≥ 2). Seven hundred patients will be enrolled over 3.5 years and followed for study outcomes for a minimum of 12 months and maximum of 36 months. The primary efficacy outcome is any stroke (hemorrhagic or ischemic) or death from any cause. The secondary efficacy outcome is the change in the modified Rankin Scale score.
Rheumatoid arthritis (RA) is a chronic, slowly progressive condition for which numerous treatment options are available. The therapies vary in mechanism of action, mode of administration, side- effect (adverse event) profile, and cost. While consensus treatment guidelines are available, identifying an optimal treatment sequence is often based on clinician choice with treatment changes based on tolerability and short- term outcome. The N-of-1 trial will evaluate individual participant and aggregate data. Individual participants will be enrolled and randomized to a sequence of three U.S.
