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 Randomized Trial of Post-Operative Biomarker-Guided Precision Medicine with Rivaroxaban and Atorvastatin for Cardiovascular Risk Reduction
The purpose of this randomized trial is to assess adherence to a low-dose direct oral anticoagulant and high-intensity statin versus usual care for 6 months in patients with post-operative abnormal troponin blood tests indicative of heart damage, termed “Myocardial Injury after Noncardiac Surgery” (MINS). The data obtained will be used to assess feasibility and optimize study design (entry criteria, study endpoints, sample size calculation, site selection) and recruitment strategies for the future randomized clinical trial studying biomarker-based care in post-operative patients at elevated CV risk.
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 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.
A prospective long-term confirmatory follow up trial in highly sensitized patients treated with imlifidase or standard of care in the ConfIdeS (20-HMedIdeS-17) trial
A controlled, randomized, efficacy Phase 3 trial (ConfIdeS, 20-MedIdeS-17) comparing imlifidase with standard of care (SoC) in enabling highly sensitized patients to kidney transplantation is performed by Hansa Biopharma to support an Accelerated Marketing Approval of imlifidase. The present trial is a confirmatory long-term follow-up of patients participating in the ConfIdeS trial intended to gather information on clinical endpoints representing a meaningful clinical benefit i.e., patient and graft survival, and graft function, on a long-term basis (2-5 years after randomization in the ConfIdeS trial), and to confirm the positive benefit-risk balance of imlifidase.
A prospective multicenter open-label randomized actively controlled parallel-group Phase 3 clinical trial to evaluate efficacy safety and tolerability of IMA203 versus investigator s choice of treatment in patients with previously treated unresectable or metastatic cutaneous melanoma (ACTengine IMA203-301)
This study is testing a new treatment, IMA203, for patients with advanced skin cancer (cutaneous melanoma) who have already received treatment before. It will compare IMA203 to standard treatments chosen by the doctor to see which works better and is safer. Patients will be randomly placed into one of two groups: one getting IMA203 with chemotherapy and immune-boosting medicine (IL-2), and the other getting a standard treatment. Patients must have a specific genetic marker (HLA-A*02:01) to join, which will be tested before the study. Doctors will check how long patients live without their cancer getting worse (PFS) and overall survival (OS). A safety board will monitor the study, and experts will review scan results to track cancer progression. Some patients may receive temporary treatments before starting the main study treatment. Patients will have regular check-ups, scans every 12 weeks, and quality-of-life assessments. They will stay in the study until their cancer worsens, they start another treatment, they choose to leave, or the study ends. After the study, those who received IMA203 may be asked to join a long-term follow-up study.
A Prospective Multicenter Randomized Two-Arm Single-blind Superiority Trial to Evaluate the Safety and Efficacy of the MagicTouch Sirolimus-Coated Balloon in the Treatment of Coronary Drug-Eluting Stent In-Stent Restenosis (MAGICAL ISR)
The treatment for narrowed or blocked arteries often involves stents, which are inserted into heart blood vessels to alleviate blockages. Drug-eluting stents (DES) release medication to prevent recurring blockages, known as restenosis. However, restenosis can still occur, sometimes necessitating further procedures. These may include placing additional stent layers or using balloon angioplasty (POBA) without new stents, though multiple layers can be a drawback. This study aims to compare the efficacy and safety of the MagicTouch™ Sirolimus-Coated Balloon combined with POBA versus POBA alone in patients with restenosis of prior DES. All participants will receive standard treatment for narrowed areas in previous DES with POBA. Some patients will also receive the MagicTouch™ balloon. The study will assess the effectiveness of adding this novel device to standard treatment.