A Phase III Randomized Double-blind Placebo-controlled Multicenter Trial to Evaluate the Efficacy and Safety of Diamyd to Preserve Endogenous Beta Cell Function in Adolescents and Adults with Recently Diagnosed Type 1 Diabetes Carrying the Genetic HLA DR3-DQ2 Haplotype
The purpose of this study is to test the safety and effectiveness of an investigational drug called Diamyd®. Diamyd® is considered “investigational” in this research study, because it has not been approved for treatment of type 1 diabetes by regulatory authorities in any country, including the Food and Drug Administration (FDA) in the United States. It is hoped that Diamyd® will help the body preserve its ability to produce insulin by stopping or delaying the immune system’s attack on beta cells. In order to determine if Diamyd® is effective, a comparison must be made between Diamyd® and placebo. A placebo does not contain any active ingredient. Researchers use a placebo to see if a study drug works better or is safer than not taking anything at all.
A Phase III Randomized Double-Blind Placebo-Controlled Non-Inferiority Multi-Center Study of the Effects of Stopping Hydroxychloroquine in Elderly Lupus Disease
This study aims to develop evidence-based protocols for managing older patients with systemic lupus erythematosus (SLE), a topic that has been largely overlooked. Hydroxychloroquine (HCQ) is an effective medication for SLE, helping to reduce disease activity and keep symptoms stable. While HCQ is generally safer than traditional immunosuppressants regarding infections, long-term use can lead to retinal toxicity, with studies showing that nearly a third of patients may experience retinal damage. As lupus patients live longer, they may develop other health issues that affect how HCQ is processed in the body, potentially increasing the risk of toxicity compared to its benefits. Given that disease activity often decreases with age, this study will investigate whether HCQ can be safely stopped in stable patients aged 60 and older. Participants will be randomly assigned to receive either a placebo or continue with HCQ and will be monitored every two months for one year to track disease activity and flares.
A Pilot Phase II Open-Label Single-Center Study of Sodium-Glucose Cotransporter-2 Inhibitor Empagliflozin in Major Depressive Disorder
This is an open-label, single arm clinical trial preliminarily testing the antidepressant effects of empagliflozin in patients with major depressive disorder (MDD), and assessing its feasibility, safety and tolerability in this patient population. The study aims to enroll 16 subjects, and will collect clinical and laboratory data at screen, baseline, weeks 2, 4 and 6 (the endpoint). The primary outcome will be change in depression severity, compared to baseline, following drug administration as assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS). In exploratory analysis, we will study the relationship between ketogenesis and response, as well as the effect of treatment on markers of brain bioenergetic metabolism and neural insulin resistance by studying differences in the molecular cargo of brain derived exosomes before and after administration of the study drug.
A pilot proof of concept study of the Effects of Administration of SCFA in Rheumatoid Arthritis Inadequate Responders (EASi-RAIR)
This study is a pilot, proof of concept study to determine the effects of administering an oral SCFA supplement to RA patients with inadequate response to methotrexate. We will include up to 65 participants to obtain a sample size of at least 25 participants taking the oral supplement. We hypothesize that oral SCFA will change the participants’ gut microbiome and regulatory immune responses. Clinical data to assess for adverse events, stool, urine samples and peripheral blood will be collected at baseline, 1 month, with an optional 2 month time-point and optional visit up to 12 months following starting treatments with the next line of therapy. Fecal microbiome will be analyzed. Adaptive immune responses will be analyzed from participant blood samples.
A pilot proof of concept study the contribution of eye-hand coordination impairment to functional deficits in stroke
We propose a quantitative assessment of eye-hand function in 30 stroke patients and 30 age- and sex-matched healthy adults. To explore structural and functional changes in frontoparietal networks are critical for eye-hand coupling and efficient performance of visually guided activities of daily living. We expect results from our proposal will provide a foundation for an improved understanding of eye-hand coordination in functional deficits and functional recovery, post-stroke. This advanced knowledge will provide the basis for future translational research to develop new clinical assessments and interventional approaches to address EHdC in stroke survivors. Achieving the aims of this proposal will also address the current gap between motor recovery and functional recovery in stroke survivors with EHdC. We seek to characterize frontoparietal microstructure associated with EHdC and to identify how they relate to the motor ability of the eye, the hand, and clinical measures of functional recovery in MCA stroke.
A Pilot Proof of Concept Study with Paired-Design on the Effectiveness of Metal Related Artifact Reduction of Hip Arthroplasty Implants or Other Metallic Hardware Using Radiofrequency Pulse Polarization Optimization in 3T MRI
This is a single-center single-arm clinical trial with a paired design which compares the effectiveness of 3T MRI with (modified) and without (standard) radiofrequency pulse polarization optimization in reducing metal-related artifacts in patients with hip arthroplasty implants or other metallic hardware. Twenty participants with symptomatic primary total hip arthroplasty or other metallic hardware will be imaged with both methods. The results of the two methods will be compared in reference to the size of the artifact-degraded regions, visibility of the normal structures and the rate of abnormality detection.
A Pilot Study Examining Conscious Awareness and Cognitive Experiences During Deep Hypothermic Circulatory Arrest
This study aims to use methods developed in the AWARE II study (NYU IRB #17-00241) to diagnose awareness during Deep Hypothermic Circulatory Arrest (DHCA) procedures.Our overall hypothesis is that mental and cognitive activity as well as conscious awareness may occur during cardiac standstill states, including DHCA and that this may be related to underlying cortical activity. The purpose of this proposal is to refine study methods originally developed for use during CPR to measure cerebral oxygenation and function using cerebral oximetry and EEG, as well as tests of consciousness and awareness.
A pivotal prospective multicentre single-arm study evaluating the safety and efficacy of a dexamethasone eluting Slim Modiolar electrode array (EA32D)
The purpose of this study is to test a new type of cochlear implant called the Cochlear™ Nucleus® CI632D cochlear implant including a Slim Modiolar dexamethasone eluting electrode. This study will evaluate the safety of the CI632D implant and determine whether the slow release of dexamethasone directly inside the cochlea provides additional benefits.
A pivotal prospective open-label multi-center study of safety and effectiveness of cochlear implantation in an expanded population of adults with bilateral sensorineural hearing loss
The purpose of this research study is to examine the safety and effectiveness of cochlear implantation (CI) in an expanded population of adults who do not meet the current Food and Drug Administration (FDA) indications. Fifty adults will participate in the study. The FDA-approved CochlearTM Nucleus® CI systems are designed to provide useful hearing. The system works by converting sound in the environment into electric pulses that stimulate the auditory nerve, allowing the brain to perceive sound. The CochlearTM Nucleus® CI system has implanted and external components. The cochlear implant is surgically implanted under the skin behind the ear. The external components include all commercially approved sound processors, and associated fitting software, accessories, and cables. For the purposes of this study, the commercially approved Cochlear™ Nucleus® system will be used outside the currently approved indications for use in individuals who have more hearing in one or both ears than the traditional cochlear implant population.
A Platform Study of RAS(ON) Inhibitor Combinations in Patients with RAS-Mutated Non-Small Cell Lung Cancer (NSCLC)
This study is designed to test how effective a new drug called AZD0486 (BITE for CD19) is for patients relapsed/refractory B-cell acute lymphoblastic leukemia (R/R B-ALL) who have already tried at least 1-2 other treatments. This study has three parts: Part A will test increasing doses of AZD0486 to find a dose with few side effects; Part B will test up to two doses from Part A to decide the best dose to use in the next phase; and Part C will use the best dose from Part B to see how well it works in more patients. AZD0486 will be given as an IV infusion on certain days of each 28-day cycle, with close monitoring for side effects. Side effects and effectiveness will be checked regularly, and the study will continue until enough data is collected to understand how well AZD0486 works and how safe it is.