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 Post-Market Clinical Evaluation of the Treatment of Femur Fractures with the Femoral Nail Greater Trochanter (GT) of the T2 Alpha Femur Antegrade GT/PF Nailing System
This prospective, multi-center, clinical investigation, designed to examine the safety and efficacy/performance of the Femoral Nail GT of the T2 Alpha Femur Antegrade GT/PF Nailing System. Over the past decades femoral nailing has become the treatment of choice for most femoral fractures. As an addition to the femoral nails, Stryker has created a new generation femoral implant, the T2 Alpha Femur Antegrade Greater Trochanter (GT) Nail.This device is not an experimental medical device and is approved by the United States Food and Drug Administration (FDA).
A prospective double-blinded randomized controlled trial evaluating effectiveness of lower tourniquet pressures in hand and upper extremity surgery
This study design is a prospective, double-blinded, randomized controlled trial evaluating the quality of bloodless surgical field with lower tourniquet pressures based on systolic blood pressure (SBP) compared to standard tourniquet pressures. A secondary goal is to evaluate the effect of lower tourniquet pressures on post-operative tourniquet site pain. The rationale behind the study is to provide evidence-based guidelines on tourniquet use to continue providing quality surgical care while minimizing pain and potential harm to patients. Patients undergoing hand and upper extremity surgery at our institution will be offered participation in this study. Consenting patients will be randomized in a double-blinded fashion to either standard tourniquet pressure of 250 mmHg or lower tourniquet pressures based on SBP. Demographic data will be recorded as well as details of the surgical procedure. Post-operatively, the operating surgeon will complete a questionnaire about the quality of bloodless surgical field and the patient will complete a questionnaire about post-operative pain. This study will enroll approximately 150 patients. Statistical analysis will be completed to analyze the effectiveness of the intervention.
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 randomized-controlled study to evaluate the effect of a standardized yoga practice on chronic back pain
Background:Chronic low back pain is notoriously difficult to treat and is a primary contributor to lost work days and excessive health expenditures, and whose treatment has, in part, contributed to the opioid crisis. Surgery is only an option in a minority of these patients, usually confined to those with structural instability. Yoga is an ancient modality whose benefits are currently being studied. There is enough data that the most recent ACP guidelines have included yoga as a treatment for chronic back pain, but more data needs to be generated regarding the efficacy of this modality in treating the chronic back pain population.Methods:We will perform a prospective, randomized trial with the hypothesis that yoga is superior (non-inferior) to usual care for chronic back pain. Inclusion criteria will be adult patients who have had chronic back pain (pain above the gluteal cleft of at least 3 months duration). Exclusion criteria will be patients who have an indication for surgery: fracture, infection, scoliosis, or spondylolisthesis. The study arm will involve a yoga protocol devised by Eddie Stern - a renowned Ashtanga yoga practitioner, and can include NSAIDs. The control arm will involve usual care - 6 weeks of physical therapy, NSAIDs, and epidural steroid injections. Outcome measures will be assessed by VAS, ODI, and SF-36 surveys to be given at 3 months, 6 months, 1 year, and 2 years.
A Prospective Randomized Controlled Trial to Assess the Management of Moderate Aortic Stenosis by Clinical Surveillance or Transcatheter Aortic Valve Replacement : The PROGRESS Trial
This is a randomized 1:1 trial in which subjects will receive transcatheter aortic valve replacement (TAVR) with the SAPIEN 3/SAPIEN 3 Ultra transcatheter heart valve or clinical surveillance and will stratified by the site.