Runnemede, New Jersey

MyAirvo 3 (High Flow Nasal Therapy; HFNT) for COPD Patients in the Home

Objectives: Primary Objective: To determine if HFNT delivered by myAirvo 3 increases the time to first moderate exacerbation orsevere exacerbation or all-cause mortality in patients with moderate to very severe COPD Secondary Objectives: To determine if HFNT delivered by myAirvo 3 1. increases the time to first severe exacerbation 2. increases the time to first exacerbation (moderate or severe) 3. reduces severe exacerbation frequency 4. reduces moderate and severe exacerbation frequency 5. reduces hospitalization duration 6. improves quality of life 7. reduces dyspnea 8. reduces PCO2 9. is safe and well tolerated 10. determine if any of the objectives are related to duration of daily HFNT use 11. Assess cost effectiveness of HFNT use Exploratory objectives: Develop objective definitions of exacerbations of differing levels of severity based on myAirvo 3 device or electronic diary collected measures of heart rate, respiratory rate, oxygen saturation, and dyspnea measured by modified visual analog score. Endpoints: Primary Endpoint: The time to first moderate or severe exacerbation or all-cause mortality. Primary Safety Endpoint: All data on adverse events, including reported to be not, possibly, probably, or definitely related to the use of myAirvo 3 device. Secondary Endpoints: - Rate of severe exacerbation, rate of moderate and severe exacerbations, - Time to moderate exacerbation, time to severe exacerbation, time to moderate or severe exacerbation - Hospitalization durations, from per visit data - Quality of life by St George's Respiratory Questionnaire and SF-12 - Dyspnea, calculated mMRC and TDI over time - Hours of daily HFNT use - Impact of hours of daily HFNT use on any outcome - PCO2 - Assess patient phenotype most likely to benefit from HFNT. - Assess cost effectiveness of HFNT use Exploratory endpoints: - Development of objective definitions of exacerbations of differing levels of severity based on myAirvo 3 device or electronic diary collected measures of heart rate, respiratory rate, oxygen saturation, and dyspnea measured by modified visual analog score. - HFNT settings (flow rate and temperature)

Registry of Patients With Brain Tumors Treated With STaRT (GammaTiles)

Patients (N=600) with surgically resected (R) brain tumors of any pathology who have undergone STaRT are eligible. Data collected will include local control, overall survival, QOL, neurocognition, functional decline, and surgical and radiation associated AE's. Data will be collected at 1, 3, 6, 9,12, 18 and 24 months, then every 6 months through 5 years. RESULT: Data will be used to benchmark clinical outcomes of STaRT therapy and allow for comparisons to existing standard-of-care treatments. This will be the first observational registry study of R+STaRT, delivered by Cs-131 sources in permanently implanted resorbable collagen tile carriers. The outcome measures captured will allow for evaluation of the potential risks and benefits of this treatment approach for patients in a real-world setting.

Treatment of Systemic Lupus Erythematosus (SLE) With N-acetylcysteine

Subjects will take NAC in a dose range of 2.4 g/day to 4.8 g/day which will be titrated to tolerance during an initial 3-month open label period. After the 3-month open label period, patients in each arm will continue taking equal numbers of capsules representing a dosage that has been titrated to tolerance. As an example, the patients tolerating 2.4 g/day, or 4 capsules containing 600 mg of NAC, after 3 months will be randomized to take 4 NAC or 4 placebo (2.4 g/day dextrose) capsules twice daily for the 9 subsequent months. The primary outcome variable will be the response (yes/no) in the SLE Respinder Index or SRI at Month 12 (reduction ≥ 4 points in SELENA-SLEDAI score and therefore also called SRI-4; no new BILAG A organ domain score and no more than 1 new BILAG B organ domain score; and no worsening in Physician's Global Assessment (PGA) score) by ≥ 0.3 points versus baseline). A positive response will also require no treatment failure, defined as the need for non-protocol treatment, i.e., new or increased immunosuppressives or antimalarials; increased or parenteral corticosteroids; or premature discontinuation from study treatment. Corticosteroids can be tapered off at the investigator's discretion, based on disease activity. Four weeks after randomization, once tapered, corticosteroids can only be increased again to the dosage preceding the last taper step; any larger increase will be deemed a treatment failure. In addition, any increase in corticosteroid dosage during the last 3 months of the trial will result in declaration of treatment failure. We will monitor tolerance and safety, and assess SLEDAI, BILAG, FAS, PROMIS, ASRS, prednisone use, liver and bone marrow function as secondary outcomes.

Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure

The study is a prospective, multi-center, randomized, nonblinded study to evaluate the safety and effectiveness of the Aortix System versus standard of care medical therapy in patients hospitalized with acute decompensated heart failure (ADHF) and persistent congestion despite usual medical management.Eligible ADHF patients with diuretic resistance (irrespective of ejection fraction) will be enrolled and randomized 1:1 to either the Aortix system or standard of care medical management. Randomization will be stratified by ejection fraction.. An additional registry arm will enroll patients who are considered candidates for advanced therapies in the near-term, but need improvement in their renal function to be able to receive additional medical therapies. All eligible enrolled registry subjects will receive Aortix system support. Planned study population is male or female patients 21 years of age or greater, with acute decompensated heart failure and diuretic resistance who remain congested despite standard of care medical therapy. This study will enroll up to 295 subjects with heart failure at 45 clinical sites in the United States and up to 5 OUS sites. The randomized study includes up to 215 subjects and the Advanced HF registry includes up to 80 subjects.

Product Surveillance Registry

Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products

All Medtronic market-released leads and all market-released IPG, ICD and CRT devices are eligible to be included in this study.