Site for AN INTERVENTIONAL MULTI-CENTER INVESTIGATION OF SINGLE LEVEL TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) STABILIZED WITH PEDICLE SCREWS
Site for An interventional, multi-center (up to 15), prospective, non-blinded investigation of single-level TLIF stabilized with pedicle screws. The purpose is to intend to treat the study population by demonstrating clinical success (safety and efficacy) of the TLIF instrumented with pedicle screws with respect to composite endpoints.
Site for An Observational Longitudinal Prospective Long-Term Registry of Patients With Hypophosphatasia
Site for This multinational, multicenter, observational, prospective, long-term registry is designed to collect data on epidemiology, HPP history, clinical course, symptoms (including systemicaspects of disease), and burden of disease from patients of all ages who have a diagnosis of HPP. In addition, the Registry will collect data on asfotase alfa dosing, effectiveness of treatment, SAEs, ADAs against asfotase alfa, pregnancy and neonatal outcome data (for patients treated with asfotase alfa only), and targeted events.
Site for Biomarker and Edema Attenuation in IntraCerebral hemorrhage (BEACH)
Site for This first-in-patient phase 2a pilot study will assess the safety and tolerability of MW01-6-189WH (hereafter called MW189) in patients with Intracerebral Hemorrhage (ICH). This study will monitor exploratory radiographic and clinical endpoints, explore the use of biochemical biomarkers to demonstrate target engagement and biological response to a potential new therapy targeted to neuroinflammation and synaptic dysfunction mechanisms.
Site for CHRONIC VENOUS THROMBOSIS: RELIEF WITH ADJUNCTIVE CATHETER-DIRECTED THERAPY
To determine if EVT should be routinely used to treat DIO-PTS, we plan to perform a multicenter randomized clinical trial (the Chronic Venous Thrombosis: Relief with Adjunctive Catheter-Directed Therapy [C-TRACT] Trial) to establish whether EVT reduces PTS severity and improves health-related QOL with acceptable safety and costs. If so, this finding will fundamentally change DIO-PTS practice towards more frequent use of EVT. If EVT proves ineffective or unsafe, this finding will reduce or eliminate the use of potentially risky and expensive procedures. The C-TRACT Steering Committee includes accomplished DVT researchers who have specialized expertise with EVT, the conduct of multicenter DVT treatment trials (including the NHLBI-sponsored ATTRACT Trial), and the evaluation of PTS.
Site for Comparison of Anti-coagulation and anti-Platelet Therapies for Intracranial Vascular Atherostenosis
Site for CAPTIVA is a two-stage Phase III trial randomizing subjects with stroke attributed to 70-99% intracranial atherosclerotic stenosis (sICAS) to 12 months treatment of:1) ticagrelor (180 mg loading dose, then 90mg twice daily) + aspirin 81 mg / day, or2) low dose rivaroxaban (2.5mg twice daily) + aspirin 81 mg / day, or3) clopidogrel (600mg loading dose, then 75 mg daily) + aspirin 81 mg/day. The primary goal of the trial is to determine if the experimental arm(s) (rivaroxaban or ticagrelor or both) are superior to the clopidogrel arm for lowering the 1-year rate of the primary endpoint (ischemic stroke, intracerebral hemorrhage (ICH), or vascular death).
Site for DV0004 A MULTICENTER RANDOMIZED OPEN-LABEL STUDY TO EVALUATE THE SAFE AND EFFECTIVE USE OF THE PREFILLED SAFETY SYRINGE OR AUTO-INJECTOR FOR THE SUBCUTANEOUS SELF-INJECTION OF BIMEKIZUMAB SOLUTION BY SUBJECTS WITH ACTIVE PSORIATIC ARTHRITIS
Site for DV0004 is a Phase 3, multicenter, open-label, randomized, noncomparator, North America and Europe substudy to PA0012 in adult subjects with active psoriatic arthritis (PsA) to evaluate the safe and effective use of 2 single-use disposable self-injecting device presentations for the subcutaneous (sc) administration of bimekizumab solution (the investigational medicinal product [IMP]). To provide patients with PsA with options for the self-administration of bimekizumab, DV0004 will evaluate 2 investigational self-injecting device presentations, which are drugproduct (IMP) associated with a functional secondary packaging: the 1mL bimekizumab safety syringe (bimekizumab-SS-1mL) and the 1mL bimekizumab auto-injector(bimekizumab-AI-1mL).
Site for HARP (Heart Attack Research Program) - NYU PI: Harmony Reynolds MD NYU Winthrop PI Kevin Marzo M.D.
Site for HARP (Heart Attack Research Program) - NYU PI: Harmony Reynolds, MD NYU Winthrop PI Kevin Marzo
Site for I-SPY 2 TRIAL -Investigation of Serial Studies to Predict your Therapeutic Response with Imaging and Molecular Analysis 2
Site for The I-SPY 2.2 protocol uses the same strategy as the I-SPY 2.0 protocol to optimize response, measuring the impact of each therapeutic regimen based on change in MRI volume as well as changes in other biomarkers.• Block A: Test the most promising novel agents without standard chemotherapy,• Targeted De-escalation: Patients who are predicted to have a complete response after Block A will proceed to surgical excision• Targeted early escalation: Patients with a poor imaging response at 3 weeks will repeat imaging at 6 weeks, and proceed to “Block B” if response is not identified.• Block B: Patients will proceed to the optimal treatment combinations (best-in-class for each subtype, based on results from I-SPY 2 and other practice changing trials)• Block C: Patients with persistent disease after Block B will proceed to AC (or AC+PD-1 for patients with TNBC), those with predicted complete response will proceed to definitive surgical resection.This approach allows evaluation of emerging new agents for their ability to achieve pCR alone or in combination with known effective agents and to optimize the sequence of therapy, minimizing toxicity and maximizing benefit. An important new tool to optimize therapy will be the use of Response Predictive Subtypes (RPS) in the I-SPY 2.2 protocol. Over the past decade, we have learned about better ways to classify tumors in order to best predict response to the kinds of agents that are being used in treatment today. All patients in the I-SPY 2.2 protocol will be classified usingthe standard receptor subtyping as well as new molecular profiles that allow us to generate an RPS for each patient. In summary, the I-SPY 2.2 protocol improvements include a combination of better tumor classification and the use of sequential regimens that will enable all patients in the trial to achieve the best response with the least toxicity.
Site for INHALE-1: A 26-week Primary Treatment Phase with 26-week Extension Open-label Randomized Clinical Trial Evaluating the Efficacy and Safety of Afrezza Versus Rapid-acting Insulin Analog Injections Both in Combination with a Basal Insulin in Pediatric Subjects with Type 1 or Type 2 Diabetes Mellitus
Site for MKC-TI-155 Part 2 is a Phase 3, open-label, randomized clinical study evaluating the efficacy and safety of Afrezza in combination with a basal insulin (i.e., the Afrezza group) versus insulin aspart or insulin lispro in combination with a basal insulin (i.e., the RAA injection group) in pediatric subjects with T1DM or T2DM. Following 26 weeks of randomized treatment (i.e., Afrezza or RAA injection combined with a basal insulin), subjects will enter a treatment extension where they will receive Afrezza until Week 52. The purpose of the treatment extension is to assess safety and efficacy with continued use of Afrezza.
Site for International CDKL5 Clinical Research Network
Site for Our research network is uniquely positioned to develop clinical trial readiness for CDD (by Cyclin-dependent kinase like 5 Deficiency Disorder) pairing exceptional experience in the development and validation of outcome measures with an extensive network of CDD experts and clinical trialists. Our goals are to 1) refine and validate appropriate quantitative COMs (Clinical Outcome Measures) and biomarkers and 2) conduct a multi-site clinical trial readiness study to ensure that they can be successfully implemented. We will test the hypothesis that CDD specific COMs can be refined to accurately and reproducibly track meaningful changes in future clinical trial.