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.
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 Study of a Novel EEG Neurofeedback System for the Treatment of PTSD Using Machine Learning-Based Amygdala Biomarkers
The main purpose of this study is to confirm Prism training can help U.S. Veterans and civilians with post-traumatic stress disorder (PTSD). We will do this by running a large-scale study where some participants get actual neurofeedback treatment and others receive a pretend (sham) treatment.
A Prospective Study to Evaluate the Safety and Efficacy of the 10 GE Xenokidney in Patients with End-stage Renal Disease (ESRD)
Each year, only about 27,000 kidney transplants are performed in the United States, leaving over 90,000 people with end stage renal disease (ESRD) waiting for a kidney transplant. Central to the problem of prolonged wait-times is the fact that there are not enough donor organs available for all the ESRD patients who need them. However, over the past 5 years there have been exciting developments in a new type of transplant called kidney xenotransplantation, which may help people with ESRD who are struggling with long wait-times. In kidney xenotransplantation, a kidney from a genetically modified pig is transplanted into a person with ESRD. Special medicines, similar to those used in regular human-to-human transplants, help prevent the body from rejecting the new kidney. These pig kidneys can perform the same important functions as human kidneys, allowing the body to stay balanced and healthy. One big advantage of xenotransplantation is that it can drastically reduce wait-times since there is a more plentiful and easily available supply of pig kidneys compared to human donor kidneys. Patients who have received these pig kidneys have seen encouraging results— all the kidneys have started working right away, and patients have been able to stop dialysis after the transplant. NYU is excited to start a clinical trial, offering this pioneering treatment to ESRD patients who rely on dialysis. If you are interested in learning more about this trial, please reach out to our team for more information.
A Randomized Comparative Effectiveness Study of Staged Complete Revascularization with Percutaneous Coronary Intervention to Treat Coronary Artery Disease vs Medical Management Alone in Patients with Symptomatic Aortic Valve Stenosis undergoing Elective Transfemoral Transcatheter Aortic Valve Replacement: The COMPLETE TAVR Study
This study is being conducted in Aortic Stenosis patients who have undergone successful TAVR with a balloon expandable heart valve who also have coronary artery disease (CAD) or narrowing of the heart arteries.The study will compare:1. opening all suitable stenosis or blockages with an additional procedure (either during the same hospitalization as the TAVR or as a separate procedure) called percutaneous coronary intervention (PCI). This procedure opens or widens the stenosis with a stent thereby allowing blood to flow to the heart muscle. This procedure will happen within 45 days of your TAVR procedure. You will also receive optimal medical therapy.OR2. treating these additional stenosis or blockages with medication only and not opening them with an additional PCI procedure.
A Randomized controlled study of a health literacy-informed technology-based approach to support safe medication use by parents after discharge of infants from the neonatal intensive care unit
This is a randomized controlled study of parents of children to be discharged from the neonatal intensive care unit at Bellevue and Elmhurst hospitals. A total of 425 subjects will be recruited across two sites over preparatory phases and two primary study phases. Subjects will be assigned to 1 of 3 intervention groups: usual care, HELPix (health literacy-informed written materials and verbal counseling in addition to usual care), or HELPix + TECH (a health literacy-informed web application in addition to HELPix and usual care). Phase A is a pilot study, in which 120 parents will be enrolled at Bellevue Hospital and randomly assigned to usual care or HELPix + TECH. Phase B will take place at both Bellevue and Elmhurst Hospitals, and 225 subjects will be randomly assigned to usual care, HELPix, or HELPix + TECH. Parents will be screened and recruited, written informed consent will be obtained, and a brief survey will be administered on the day of the child’s expected discharge from the neonatal intensive care unit Subjects will then receive usual care followed by the intervention if randomized to one of those groups (Visit 1, Day 0). Medication knowledge, dosing, and adherence will be assessed in-person at a subsequent follow-up visit (Visit 2, Day ~1-7). Adverse events will be assessed via phone call (Visit 3, Day ~30-45). Additional data will be assessed using a chart review. There will be a preparatory phase before each of the 2 phases. For the preparatory phase before Phase A: 10 cognitive interviews will be conducted to assess parent comprehension/ acceptability of HELPix followed by 20 parent interviews focused on HELPix app usability.For the preparatory phase before Phase B: 12 cognitive interviews will be conducted to assess parent comprehension/ acceptability of HELPix. In addition to the cognitive interviews, 3 rounds of feedback with 6 parents per round will be conducted to iteratively refine the HELPix digital app. Once adapted, 20 parents will be asked about HELPix app usability.
A RANDOMIZED CONTROLLED TRIAL OF MAGNESIUM SULFATE AS AN ADJUNCTIVE ANALGESIC IN PROSTATE SURGERY
We will randomize prostate surgery patients to receive magnesium sulfate or not in the context of a standardized anesthetic. Postoperative pain scores and analgesic dose will be measured, in addition to the presence of shivering, quantitative neuromuscular blockade monitoring, drugs administered during anesthesia, and postoperative disposition (home or admission to hospital). We anticipate 110 subjects will give us 90% power to detect a 2 point difference in a 10 point pain score 30 minutes after awakening.
A randomized double-blind double-dummy parallel-group study comparing the efficacy and safety of remibrutinib versus teriflunomide in participants with relapsing multiple sclerosis followed by extended treatment with open-label remibrutinib
The purpose of this research study is to compare remibrutinib and teriflunomide safety and efficacy in patients with relapsing forms of Multiple Sclerosis (RMS).