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NCT04766892
This is a Phase 2a proof-of-concept study to assess safety, tolerability, and preliminary efficacy of mavacamten treatment on biomarker levels in participants with heart failure with preserved ejection fraction (HFpEF) and elevation of NT-proBNP with or without elevation of cTnT. Data from this study will inform future study designs of mavacamten in patients with HFpEF.
NCT02797275
Exposure to secondhand tobacco smoke (SHS) is associated with diverse health effects in nonsmokers. Flight attendants (FA) who worked on commercial aircraft before the ban on tobacco smoking (exposed FAs) had high, long-term levels of occupational exposure to SHS and are a unique population for the study of long-term health effects of chronic exposure to SHS. In previous studies, we have shown that many never-smoking SHS-exposed FAs to have curvilinear flow-volume loops, decreased airflow at mid- and low-lung volumes, and static air trapping (elevated residual volume to total lung capacity ratio \[RV/TLC\]), abnormalities that are not diagnostic of overt Chronic Obstructive Pulmonary Disease (COPD), but do implicate the presence of an obstructive ventilatory defect, and are consistent with what has been recently described as preserved ratio impaired spirometry (PRISm). The main objective of the study is to determine the effect of a bronchodilator to counter the physiologic abnormalities that are observed in the population of never-smoking SHS-exposed FAs as both proof of concept of the presence of an obstructive lung disease and as a possible therapeutic option to counteract the adverse respiratory effects of chronic exposure to SHS.
NCT00769223
RATIONALE: Gathering information about the Gleason score, prostate-specific antigen (PSA) level, and cancer stage from patients who have undergone radiation therapy for prostate cancer may help doctors predict how patients respond to treatment and help plan the best treatment. PURPOSE: This clinical trial is studying the Gleason score, PSA level, and cancer stage in predicting outcome in patients who have undergone radiation therapy for localized prostate cancer.
NCT04061148
Develop a NIRSIT testing protocol that can be administered in the diagnostic setting and reliably distinguishes the symptoms and severity of depression, with the help of repeated measure (up to five visits per subject) comparison of patients being treated for Major Depressive Disorder with control, non-depressed subjects.
NCT05297734
This cluster-randomized comparative effectiveness trial compares a technology-based supportive cancer care (SCC) approach with a redesigned team-based supportive cancer care (SCC) approach.
NCT03305549
The Recovery After Dialysis-Requiring Acute Kidney Injury (RAD-AKI) Pilot Study is a 2-arm randomized clinical trial of hospitalized patients with dialysis-requiring acute kidney injury (RAD-AKI), comparing conventional thrice-weekly intermittent hemodialysis dialysis (control) to a "conservative dialysis strategy" in which hemodialysis is not continued unless specific metabolic or clinical indications for RRT are present. The overall hypothesis is that the current practice of thrice-weekly acute intermittent hemodialysis for AKI-D masks evidence of renal recovery and may actually delay or preclude recovery. The primary objective of this pilot study is to assess the safety and feasibility of the proposed intervention and study design.
NCT03718546
To compare donors to their non-donor counterparts and healthy controls as well as to generate trajectory classes based on longitudinal patterns of donor HRQoL and identify predictors of poor donor HRQoL.
NCT05480761
This is a Phase 4, U.S. only, multi-center study using a 7-day therapeutic response dose (TRD) of commercial Sucraid® to assess the response of treatment in 1100 symptomatic pediatric (6 months to 17 years old) subjects with low, moderate, and normal sucrase activity determined by a disaccharidase assay via EGD within 1 year of the Screening Visit. This study will also explore the relationship between known genetic CSID mutations and sucrase activities via (EGD) disaccharidase assay (low, moderate, and normal).
NCT04227600
Phase I/II, open-label, multicenter, multinational (Japan, Brazil and US),designed to evaluate the safety, pharmacokinetics and explore the efficacy for the treatment of mucopolysaccharidosis type I (MPS I).
NCT05254002
Finerenone works by blocking a group of proteins, called mineralocorticoid receptor. An increased stimulation of mineralocorticoid receptor is known to trigger injury and inflammation in the kidney and is therefore thought to play a role in CKD. Empagliflozin lowers blood sugar levels by increasing the excretion of glucose from the blood into the urine. In this study, the researchers want to learn how well the combination of finerenone and empagliflozin helps to slow down the worsening of the participants' kidney function compared to either treatment alone. For this, the level of protein in the urine will be measured. The investigators also want to know how safe the combination is compared to either treatment alone. Depending on the treatment group, the participants will either take the combination of finerenone and empagliflozin, or finerenone together with a placebo, or empagliflozin together with a placebo, once a day as tablets by mouth. A placebo looks like a treatment but does not have any medicine in it. Importantly, the participants will also continue to take their other current medicine for CKD and T2D. The participants will be in the study for up to 7.5 months and will take the study treatments for 6 months. During the study, participants will visit the study site 7 times. The study team will: * collect blood and urine samples * check the participants' vital signs * do a physical examination including height and weight * check the participants' heart health by using an electrocardiogram (ECG) * monitor the participants' blood pressure * ask the participants questions about how they are feeling and what adverse events they may be having An adverse event is any problem that happens during the trial. Doctors keep track of all events that happen in trials, even if they do not think the events might be related to the study treatments.
NCT04778410
The goal of this clinical study is to learn more about the safety and dosing of the study drug, magrolimab (Mag), in combination with anti-leukemia therapies in participants with acute myeloid leukemia (AML).
NCT03745716
A Phase III, multicenter, randomized study to compare the rate of complete response (CR) and duration of CR, in patients with TP53-mutated MDS who will receive APR-246 and azacitidine or azacitidine alone.
NCT04631406
Evaluation of the safety and tolerability of escalating doses of NR1 administered intracerebrally at a single time-point post-injury to subjects with chronic ISS with or without cortical stroke.
NCT04843332
The purpose of this randomized controlled trial is to evaluate whether a trained community health worker (CHW) who engages with newly diagnosed patients after a diagnosis of cancer can effectively improve knowledge and receipt of evidence-based precision medicine cancer care services among low-income and minority patients.
NCT03834753
This research study will examine the safety and effectiveness of ONS-5010 in participants with AMD. The goal is to prevent vision loss by evaluating the effectiveness of ONS-5010 as compared with ranibizumab.
NCT02785042
This prospective, single-arm clinical multicenter study intends to measure normal structural parameters of the optic nerve head, the peripapillary retinal nerve fiber layer, and the macula using the Heidelberg Spectralis OCT device. This study is conducted in Hispanic descent volunteers. The main goal of the study is to provide the range of these structural parameters in normal eyes. The study will include at least 240 normal volunteers.
NCT03235544
This is a Phase 2, open-label, 2-cohort study designed to evaluate the efficacy and safety of 2 parsaclisib treatment regimens in participants with relapsed or refractory mantle cell lymphoma (MCL) previously treated either with or without a Bruton's tyrosine kinase (BTK) inhibitor.
NCT05227144
The purpose of this study is to establish the Recommended Phase 2 Dose (RP2D), safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antimyeloma activity of ORIC-533 in patients with multiple myeloma who have exhausted available treatment options
NCT03298477
Prospective, multicenter, single arm study with consecutive, eligible subject enrollment at each site. All subjects will undergo the Endovascular Aneurysm repair procedure with the Nellix System.
NCT05225584
This Phase 1a/1b study will evaluate the safety, tolerability and the pharmacokinetics/pharmacodynamics (PK/PD) of KT-333 in Adult patients with Relapsed or Refractory (R/R) Lymphomas, Large Granular Lymphocytic Leukemia (LGL-L), T-cell prolymphocytic leukemia (T-PLL), and Solid Tumors. The Phase 1a stage of the study will explore escalating doses of single-agent KT-333. The Phase Ib stage will consist of 4 expansion cohorts to further characterize the safety, tolerability and the pharmacokinetics/pharmacodynamics (PK/PD) of KT-333 in Peripheral T-cell Lymphoma (PTCL), Cutaneous T-Cell Lymphoma (CTCL), LGL-L, and solid tumors.