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.
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 multicenter study to examine the influence of repairing the sub-scapularis on outcomes after reverse arthroplasty: A randomized controlled trial.
Determine how repairing the subscapularis vs. not repairing the subscapularis when subjects are implanted with the AltiVate Reverse® Shoulder System for reverse total shoulder arthroplasty affects isometric and isokinetic internal rotational strength.
A Prospective Observational Sub-Study of the Global Hypophosphatasia Registry to Describe the Potential Risk of Immune-Mediated Loss of Pharmacological Effect of Asfotase Alfa in Participants with Hypophosphatasia (HPP)
This study collects observational Standard of Care (SOC) data in patients currently receiving asfotase alfa or about to start treatment with asfotase alfa as determined by the physician.
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.