Prospective, Randomized, Double- Masked Study to Evaluate the Effect of Rhopressa Versus Placebo on Intraocular Pressure (IOP) in Patients with Primary Open-Angle Glaucoma or Ocular Hypertension Post-Selective Laser Trabeculoplasty (SLT)

The purpose of this study is to collect data about how Rhopressa affects IOP in patients who have had an SLT procedure in both eyes.

开始日期2025-04-01

申办/合作机构

East Coast Institute For Research LLC

[+2]

NCT03495908

/ CompletedN/A

Efficacy and Safety Comparison Between U-100 Regular Human Insulin and Rapid Acting Insulin When Delivered by VGo Wearable Insulin Delivery in Type 2 Diabetes

The purpose of the study is to collect data about how well U-100 Regular Human Insulin can be used in the V-Go Insulin Delivery Device compared to U-100 Rapid Acting Insulin in the V-Go Insulin Delivery Device. The data collected will be used to see how much subjects' blood sugar levels change over time after they switch from using U-100 Rapid Acting Insulin to U-100 Regular Human Insulin within their V-Go Insulin Delivery Device.

开始日期2018-04-09

申办/合作机构

East Coast Institute For Research LLC

[+1]

NCT00995072

/ CompletedN/A

Comparative Effects of Nebivolol and Metoprolol on Female Sexual Function

Beta-blockers (BB) are an important treatment for high blood pressure and heart disease. However beta-blockers can cause sexual dysfunction (SD) and this common side effect limits successful use of this class of medications. Sexual side effects often result in drug discontinuation, compromising therapy goals. The investigators are conducting the study to determine if nebivolol, a newer beta blocker that is selective for receptors in the heart and causes vasodilation in the body causes fewer sexual side effects, or even improves sexual function, compared with metoprolol succinate.

开始日期2009-10-01

申办/合作机构

East Coast Institute For Research LLC

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2025-05-01·American Journal of Cardiovascular Drugs

Clinical Pharmacokinetics and Pharmacodynamics of Baxdrostat

Review

作者: Goldfaden, Rebecca F ; Alkhouri, Yazan ; Ashchi, Andrew ; Berner, Jason ; Bisharat, Mohannad ; Orey, Dontia ; Deeb, Wasim ; Ashchi, Andrea ; Sutton, David ; Kumar, Ashish ; Huston, Jessica

Patients with hypertension are at an increased risk of cardiovascular disease and death. Resistant hypertension, or hypertension that is unsuccessfully treated with multiple antihypertensive medications, further exacerbates the complications and negative outcomes for patients. A new pathway, via aldosterone synthesis inhibition, is currently being studied as a method to reduce blood pressure values in patients who are currently taking other antihypertensive medications. This review presents and discusses the current pharmacokinetic, pharmacodynamic, and clinical and scientific evidence pertaining to baxdrostat, a novel aldosterone synthase inhibitor.

2025-04-01·Urology

Clinical Performance and Safety for the Rechargeable InterStim Micro System in Non-Obstructive Urinary Retention Subjects: 6-Month Results From the Global Post-Market ELITE Study

Article

作者: Lavin, Victoria ; Krlin, Ryan ; Shah, Sagar ; Champs, Mylène ; Peyronnet, Benoît ; Goudelocke, Colin ; Elterman, Dean ; Sahai, Arun ; Papi, Bianca ; Xavier, Keith ; Malde, Sachin ; Smits, Martijn ; Perrouin-Verbe, Marie-Aimée ; Bukkapatnam, Raviender

OBJECTIVETo confirm the clinical performance and safety of the rechargeable InterStim Micro sacral neuromodulation system, we report the first results from the global ELITE study for the non-obstructive urinary retention cohort through 6 months of follow-up.METHODSSubjects were enrolled following successful therapy evaluation and neurostimulator implant. The primary objective was improvement in the number of clean intermittent self-catheterizations (CISC) per day at 3-months post-implant compared to baseline.RESULTSThe change in the number of CISC per day from baseline was -3.5 (95% CI: -4.77, -2.26; n = 23) at the 3-month follow-up, which was statistically significant (P <.001) and signifies that the primary objective was met. This change was sustained at 6-month follow-up, with a change of -3.5 (95% CI: -4.73, -2.29; n = 24). There was a reduction in post-void residual of 244 mL (95% CI: -334.6, -154; n = 22) at 3 months and 264 mL (95% CI: -366.43, -161.56; n = 21) at 6 months vs baseline. On the Patient Global Impression of Improvement, 88% and 79% of subjects reported that their bladder condition was better at 3 and 6 months, respectively, compared to before they were treated with InterStim Micro. Device-, procedure-, or therapy-related AEs included implant site pain (11.1%; 3/27), medical device site discomfort (7.4%; 2/27), and pain in extremity (7.4%; 2/27).CONCLUSIONThis study reports on the non-obstructive urinary retention population of the global ELITE study, demonstrating the efficacy and safety of the InterStim Micro system through 6 months of follow-up.

2022-01-01·American Journal of Cardiovascular Drugs4区 · 医学

A Review of the Clinical Pharmacology of Pelacarsen: A Lipoprotein(a)-Lowering Agent

4区 · 医学

Review

作者: Niman, Stephanie ; Ashchi, Majdi ; Goldfaden, Rebecca F ; Hardy, Jennifer ; Choksi, Rushab ; Huston, Jessica ; Hartmann, Heather ; Bisharat, Mohannad

Patients with genetically associated elevated lipoprotein(a) [Lp(a)] levels are at greater risk for coronary artery disease, heart attack, stroke, and peripheral arterial disease. To date, there are no US FDA-approved drug therapies that are designed to target Lp(a) with the goal of lowering the Lp(a) level in patients who have increased risk. The American College of Cardiology (ACC) has provided guidelines on how to use traditional lipid profiles to assess the risk of atherosclerotic cardiovascular disease (ASCVD); however, even with the emergence of statin add-on therapies such as ezetimibe and proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, some populations with elevated Lp(a) biomarkers remain at an increased risk for cardiovascular (CV) disease. Residual CV risk has led researchers to inquire about how lowering Lp(a) can be used as a potential preventative therapy in reducing CV events. This review aims to present and discuss the current clinical and scientific evidence pertaining to pelacarsen.

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2023-11-28

·PRNewswire

Provident Healthcare Partners Advises East Coast Institute for Research in its Partnership with Gauge Capital

BOSTON and NEW YORK, Nov. 28, 2023 /PRNewswire/ -- Provident Healthcare Partners ("Provident"), a leading healthcare investment banking firm, announced it has advised East Coast Institute for Research ("ECIR") in its partnership with Gauge Capital to provide a growth investment for the Company. ECIR is a preeminent Southeast clinical research site management organization with eight sites in Florida and Georgia, 14 partnered provider practices, and 26 principal investigators. Led by Rushab Choksi and Rebecca Goldfaden, ECIR manages all aspects of the Phase II – Phase IV trial process and holds deep sponsor relationships across several indications including cardiovascular, dyslipidemia, diabetes, obesity, and ophthalmology. The transaction represents Gauge Capital's entrance into the clinical research site sector. Provident's deal team was led by Managing Director Eric Major and Vice President Conor Duffey. Axia Legal Services served as legal counsel to ECIR and McDermott Will & Emery served as legal counsel to Gauge Capital. "We're very excited to partner with Gauge on this next chapter of growth for ECIR. Through the process with Provident, we were able to evaluate multiple high-quality partners in parallel and are confident we chose the right team at Gauge to take our organization to the next level. We look forward to continuing to provide the same dedicated clinical research support to other practices nationally," commented Rushab Choksi, Co-Founder of ECIR. "Rebecca, Rushab and the rest of the ECIR team have developed a differentiated and highly scalable research site network in the Southeast," noted Major. "The Gauge team separated themselves as an ideal partner for ECIR given their dedicated thesis in the research site space and strong track record of providing growth capital for founder-led healthcare organizations." About East Coast Institute for Research ECIR is a comprehensive site management organization partnered with specialty provider practices serving the Florida and Georgia markets since 2007. The Company is dedicated to developing innovative research involving the latest medications and devices not yet available to the public. The Company is led by Rushab Choksi and Rebecca Goldfaden who both look forward to driving continued expansion throughout the Southeast and United States. Visit to learn more. About Gauge Capital Gauge Capital is a leading middle-market private equity firm based in Southlake, Texas. Gauge invests in five key sectors: business services, food & consumer, government & industrial services, healthcare, and technology. The Firm manages more than $3.0 billion in capital and in 2020, 2021, 2022, and 2023, Inc. Magazine named Gauge one of the top private equity firms for founders. In 2021, 2022, and 2023 Gauge was also named to the Top 50 PE Firms in the Middle Market by Grady Campbell. In 2022, Gauge ranked in the top five out of 517 private equity firms in the HEC Paris – DowJones Small-Cap Buyout Performance Ranking. Visit for more information. About Provident Healthcare Partners Provident is a leading healthcare investment banking firm specializing in merger and acquisition advisory, strategic planning, and capital formation services for healthcare companies. The firm has a comprehensive knowledge of all healthcare services subsectors, including pharma services. Provident also has unsurpassed experience and insight into the M&A process, which includes working with a multitude of investors such as private equity firms and strategic consolidators. For additional information, visit or follow Provident on LinkedIn. SOURCE Provident Healthcare Partners LLC

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