A MULTI-CENTER PROSPECTIVE NON-RANDOMIZED PIVOTAL TRIAL EVALUATING THE SAFETY AND EFFECTIVENESS OF THE POLYMOTION HIP RESURFACING SYSTEM
This research study is being conducted to evaluate the safety and effectiveness of an investigational device, the Polymotion Hip Resurfacing System.
A Multi-Center Prospective Observational Study of Patients with Neuroinflammatory Disease
Patients meeting inclusion criteria for the study will be prospectively enrolled and followed over time to evaluate clinical variables and the natural history of these disorders. Additionally, we will analyze patient electroencephalograms, brain imaging studies, and collect blood, spinal fluid, tissue, and other biospecimens when available, for future biomarker, immunophenotyping, and genetic analyses.
A Multi-Center Prospective Registry to Evaluate the Continued Safety and Effectiveness of Arthrex Products used for Knee Sports Medicine Repair and Reconstruction
The study is being done to evaluate the effectiveness and safety profile of Arthrex knee products when used as standard of care for repair or reconstruction of soft tissues of the knee such as ligaments, tendons, or the meniscus.
A multi-center randomized blinded controlled study to evaluate the safety and efficacy of the Urocross Expander System and Retrieval System (EXPANDER-2)
The Urocross Expander System is indicated for the treatment of lowerurinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia(BPH) in men = 45 years old, and while implanted in the prostaticurethra.The Urocross Expander Implant is indicated for an indwell duration of 6months, after which it is retrieved under visualization, using the UrocrossRetrieval Sheath and a commercially available compatible grasper usedduring urological procedures.The Urocross Retrieval Sheath is indicated for use to retrieve theUrocross Expander Implant using a compatible flexible cystoscope andcompatible graspers commonly used during urological procedures.
A Multi-center Randomized Open-label Parallel-group Phase 2 Study to Evaluate the Efficacy and Safety of VS-101 in Combination with Chemoradiotherapy (CRT) in Patients with Head and Neck Cancer
This is a Phase 2 study testing the study medicine VS-101 (an oral radiosensitizer) in combination with Chemoradiotherapy (CRT) in patients with head and neck cancer. Patients will be divided into three groups. Group 1 will receive 2 mg of VS-101 in combination with CRT. Group 2 will receive 5 mg of VS-101 in combination with CRT. Group 3 will receive only CRT. All patients will have their blood samples taken to see how the study medicine is changing their cancer and how their bodies are handling the medicine. The study team will also do genetic testing for all patients in the hope of learning more about the study medicine and helping patients feel better. All patients will be monitored for side effects and safety throughout the study.
A Multi-centered Double-blind Randomized Placebo-controlled Parallel Group Phase 2 Study of TEV-56286 for the Treatment of Patients with Multiple System Atrophy
The study is evaluating the safety and effectiveness of "TEV-56286" to treat multiple system atrophy (MSA). The total duration of participation is just over one year.
A Multi-Centre Study in Patients Undergoing Total Hip Arthroplasty with the Smith+Nephew CATALYSTEM Primary Hip
This study will evaluate the use of the CATALYSTEM Primary Hip System for patients who require a total hip replacement. The CATALYSTEM is approved for use in patients that require a primary (or first-time) total hip replacement. The CATALYSTEM is the device that is placed in the femur, or long leg bone. The objective of this study is to track the performance of the CATALYSTEM in patients that receive it as part of their primary total hip replacement based on feedback from the subjects and the study doctors up to 5-years after surgery.
A Multi-phase Dose-Escalation followed by an Open-label Randomized Crossover Study of Oral ASTX030 (Cedazuridine and Azacitidine Given in Combination) Versus Subcutaneous Azacitidine in Subjects with Myelodysplastic Syndromes (MDS) Chronic Myelomonocytic Leukemia (CMML) or Acute Myeloid Leukemia (AML)
Study ASTX030-01 is being conducted in subjects with myelodysplastic syndromes (MDS), MDS/myeloproliferative neoplasms (MPN) including chronic myelomonocytic leukemia (CMML), or acute myeloid leukemia (AML) who are candidates to receive treatment with single agent azacitidine based on local country approvals and/or local institutional standard practice.Study ASTX030-01 is designed to move efficiently from Phase 1 to Phase 3.• Phase 1 is an open-label Dose Escalation Stage (Stage A) followed by a Dose Expansion Stage (Stage B) of oral ASTX030 (cedazuridine in combination with azacitidine). Multiple doses/formulations will be evaluated. New formulations will generally be investigated in Phase 1 Stage A. Approximately 54 (Stage A) and 24-64 (Stage B) subjects will be treated in Phase 1. As of Amendment 1, an assessment of food effect (12 subjects) on the PK of ASTX030 was implemented for Phase 1 Stage B and is described below and in Section 5.3.1.As of Amendment 2, each additional dose level/formulation selected by the DSRC forevaluation in Phase 1 Stage B will be evaluated in approximately 12-24 additional subjects or as determined by the DSRC (ie, if emerging data indicates that this dose level/formulation does not achieve parity with SC azacitidine, fewer subjects may be evaluated).• Phase 2 is a randomized open-label crossover study comparing oral ASTX030 to SCazacitidine administered using the once daily × 7 days dosing schedule for each 28-day cycle as detailed in Section 1.3.1. It is expected that up to approximately 60 subjects will be treated at the RP2D depending on the number of doses/formulations tested in Phase 2.• Phase 3 is a randomized open-label crossover study comparing oral ASTX030 FDC tablet(s) to SC azacitidine administered using the once daily × 7 days dosing schedule for each 28-day cycle as detailed in Section 1.3.1. Depending on the intrapatient variability observed during Phase 2, it is expected that between approximately 75 and 115 subjects will be randomized in Phase 3.This study is designed to assess the safety and tolerability, pharmacokinetics, and clinical activity of ASTX030 and identify an oral dose combination of ASTX030 that yields azacitidine systemic exposure that approximates parity to that of SC azacitidine alone (based on total cycle azacitidine AUC0-24).
A Multi-Phase Study Examining Hospital to Home Transitions for Children with Medical Complexity
The overarching objective of this study is to make it easier for parents of children with medical complexity (CMC) to take care of their children after discharge home from the hospital and reduce the chance of post-hospitalization morbidity (meaning bad outcomes such as readmissions) after discharge. CMC, or those with multiple chronic conditions, progressive conditions, or technology dependence, are at high risk for post-hospitalization morbidity. This study will take place in 3 phases at 2 sites: Bellevue Hospital Center (BHC) and Hassenfeld Children’s Hospital (HCH). We will recruit parents of CMC with a prior or current admission at these two sites, as well as pediatricians who care for these children in the inpatient setting for the following 3 aims: - In Aim 1, we will interview parents of CMC and pediatricians to understand their views on what makes it challenging, and what can make it easier, for parents to understand and follow the instructions they get from the hospital about how to take care of their CMC after leaving the hospital. We will also ask pediatricians what may make it difficult to provide relevant education to families. We hypothesize that we will identify several contributing factors.- In Aim 2, we will design a tool to make it easier for parents to understand and follow the discharge instructions for their CMC. We will use structure of existing tool, findings from Aim 1, and extensive interviews and testing of the tool with parents and pediatricians as we design the new tool. We hypothesize that we will successfully design a tool that will be usable by both parents and pediatricians.- In Aim 3, we will use a randomized controlled trial (RCT) to study the impact of the tool on parent comprehension and adherence (or how well they can follow) their child's discharge instructions, as well as its impact on post-discharge morbidity (such as readmissions and emergency department visits). Parents will be randomized to either receive usual hospital care and instructions or the intervention/tool (in addition to the usual care and instructions). We will also ask parents who receive the intervention about its usability. We hypothesize that, compared to subjects who receive usual care, subjects in the intervention group will have higher comprehension and adherence, and their children will have lower post discharge morbidity. Parents will find the intervention to be usable.
A multicenter open label Phase 2 study to evaluate the efficacy and saftey of Sutetnib maleate capsule in locally advanced or metastatic NSCLC
This study is for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR mutations. The main goal is to see if a medicine called sutetinib (which may be able to stop or slow down the cancer from growing) can help these patients. The study team wants to check if the medicine has few side effects and how it works in the body. They'll do this study with two groups of patients, one with the gene changes from the start, and the other group who got them later. The study team is doing this because there are no good treatments for these patients right now, and earlier tests showed this medicine might help some of them. Patients will take the medicine for a few weeks, and doctors will watch to see if it helps with the cancer.