patient enrollment Articles
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Anti-HIV and anti-inflammatory action of iodine-lithium-α-dextrin is accompanied by the improved quality of life in AIDS patients
Clinical efficacy, tolerability and safety of various doses of Iodine-Lithium-α-Dextrin (ILαD) monotherapy have been evaluated in 56 HIV-infected patients enrolled in double blind uncontrolled randomised study during 48 weeks follow-up period. ILαD was administered intravenously three times over five days with intervals of 23 weeks between treatments for a total of 12 infusions in 4 cycles. HIV-1 ...
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Therapeutic HL-Contact Lens versus Standard Bandage Contact Lens for Corneal Edema: A Prospective, Multicenter, Randomized, Crossover Study
Abstract Introduction. To compare the safety and efficacy of the Therapeutic Hyper-CL™ lens versus a standard bandage contact lens (PureVision B&L) for chronic corneal edema. Methods. Prospective, multicenter, randomized, crossover study. Chronic corneal edema patients were randomized to one of two arms. The first arm was fitted with the Therapeutic Hyper-CL™ lens while the ...
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Noninvasive Cardiac Event Monitoring to Detect Atrial Fibrillation After Ischemic Stroke, A Randomized, Controlled Trial
Background and Purpose - Atrial fibrillation (AF) elevates risk of recurrent stroke but is incompletely identified by standard investigation after stroke, though detection rates correlate with monitoring duration. We hypothesized that 7 days of noninvasive cardiac-event monitoring early after stroke would accelerate detection of AF and thus uptake of effective therapy. Methods - We ...
By Novacor
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ABILITY Diabetes Global enrolls thousandth patient: A Cardinal Milestone Achieved
ABILITY Diabetes Global (Randomized Comparison of Abluminus DES+ Sirolimus-Eluting Stents versus Everolimus-Eluting Stents in Coronary Artery Disease Patients with Diabetes Mellitus Global) started off with the index patient enrolment on 11th June 2020 in Italy (at the peak of the 1st wave of COVID-19 pandemic) by P.I. Prof. Antonio Colombo and the pace of enrolment since then has been steady and ...
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Results Published from FIH Study of Thrombolex’s Bashir Endovascular Catheter
February 9, 2021—Findings from the first-in-human (FIH) study assessing the safety and feasibility of the Bashir endovascular catheter (BEC; Thrombolex, Inc.) for the treatment of acute intermediate-risk pulmonary embolism (PE) were published by Akhilesh K. Sista, MD, et al in Circulation: Cardiovascular Intervention (2021;14). The BEC is a pharmacomechanical device designed to enhance ...
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Changes in MRE in HCV patients who achieve SVR
Abstract Almost all patients achieved sustained virological response (SVR) by direct-acting antivirals (DAA) therapy, but it is not clear as to what extent DAA therapy affects changes in liver fibrosis after achieving SVR. In this study, we investigated the changes of liver stiffness by magnetic resonance elastogaraphy (MRE) during DAA therapy. A total of 308 patients were enrolled in the study. ...
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Oncology - Complex Clinical Trials in The Fastest Growing Therapeutic Area
In the developed world, 1 in 4 people die from cancer or cancer-related disease, and cancer accounts for 13% of deaths globally. Oncology is the fastest growing therapeutic area by revenue and number of clinical trials. There’s been a huge emphasis on developing new treatments to improve survival in patients with cancer, but these trials have become a costly undertaking for sponsor ...
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Dyve Biosciences enrolls first patient in gout trial
Dyve Biosciences announced today that it enrolled its first patient in the Phase 2 clinical study of its DYV-700 topically administered therapeutic for acute gout treatment. Thousand Oaks, Calif.–based Dyve won FDA clearance to begin the Targets Phase 2 trial in December 2019. The double-blind, placebo-controlled, randomized clinical trial is set to evaluate the efficacy of DYV-700 in ...
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Combatting the Opioid Crisis with Cell Therapies for Chronic Back Pain
It’s no secret that opioid addiction is at an all-time high and represents a major public health threat. The CDC estimates that opioid addiction resulted in a record 72,000 drug overdose deaths in 2017 alone. What strikes me as one of the most tragic parts of this narrative is that so many of these deaths were people who became addicted to opioids after simply seeking relief ...
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Innovation Spotlight: Alucent Biomedical | Can we Make ‘Stents’ Obsolete?
As part of our ongoing Vascular Innovation Series in conjunction with The Way to My Heart, journalist Kym McNicholas interviewed Alucent Biomedical CEO, Dr. Myles Greenberg. Treatment for vascular blockages is getting a much-needed innovation makeover. Alucent’s first area of focus is one the most debilitating vascular diseases –peripheral artery disease, plaque build-up in mainly ...
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Rho kinase inhibition in Amyotrophic Lateral Sclerosis - Case Study
REAL is a phase 2a open-label study to assess preliminary safety, tolerability, and effect on clinical outcomes as well as neurodegeneration biomarkers of BRAVYL in patients with ALS. The study will enroll approximately 20 patients, all of whom will be treated with BRAVYL for 24 weeks. ...
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Paxlovid: Spring of Caronic Anhydrides
On February 16, 2022, the data on Paxlovid previously published by Pfizer and submitted to the FDA were published in the New England Journal of Medicine (NEJM). This NEJM article published viral load data that Paxlovid reduced viral load by 0.868 log10 compared to controls for 5 days of treatment, which equates to a remarkable 7.38-fold reduction in viral load. This pivotal study (NCT04960202) ...
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Spine-Intra-Abdominal Pressure (SIAP) - Case Study
The SIAP study investigates the effect of using Ergotrics' Inflatable Prone Support (IPS) on intra-abdominal pressure (IAP) during spine surgery. Study background The objective of this study is to demonstrate the ability of the inflatable Prone Supports (IPS) to lower the IAP of patients in the prone position. Whenever the patients’ position is changed to prone, the IAP is increased due to ...
By Ergotrics NV
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Ancora Heart sees positive early results with Accucinch in systolic heart failure
Ancora Heart Inc., a Santa Clara, Calif.-based company looking to help those with heart failure, is heralding results from an interim analysis of patients treated in a U.S. early feasibility study evaluating the safety of the investigational Accucinch ventricular repair system. The multicenter, nonrandomized, prospective study is assessing the system in patients with symptomatic heart failure ...
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A Paradigm Shift in the Treatment of Venous Thromboembolic Disease
PE is the most common preventable cause of death among hospital patients in the United States. VTE is a leading cause of death and disability worldwide and has the third-highest mortality rate out of any cardiovascular disease, behind myocardial infarctions and stroke. Unlike myocardial infractions and stroke, where mortality has improved considerably, VTE has seen an increase in cases, with no ...
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ReActiv8-B Trial 2-Year Data Publication in Neuromodulation
Abstract Background Impaired neuromuscular control and degeneration of the multifidus muscle have been linked to the development of refractory chronic low back pain (CLBP). An implantable restorative-neurostimulator system can override the underlying multifidus inhibition by eliciting episodic, isolated contractions. The ReActiv8-B randomized, active-sham-controlled trial provided ...
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A Combination of Ramucirumab Plus Pembrolizumab Lengthened Survival For Some Lung Cancer Patients
A study conducted under the Lung Cancer Master Protocol (Lung-MAP) found that when treated with a combination of ramuzumab (Cyramza) and Keytruda, Patients with advanced NSCLC whose cancer progressed during prior immunotherapy lived significantly longer than when treated with one of the current standard therapies for this cancer. The hazard ratio (80% confidence interval) for overall survival ...
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Vectorious Begins the VECTOR-HF II Study of its Implantable In-Heart Sensor for Left Atrial Pressure-Guided Patient Self-Management of Heart Failure
For the first time, heart failure patients can have full visibility of their hearts’ LA pressure and self-adjust their medication to stop further deterioration and avoid hospitalizations April 26, 2022 08:30 AM Eastern Daylight Time TEL AVIV, Israel–(BUSINESS WIRE)–Vectorious Medical Technologies Ltd., today announced that it has enrolled the first six patients in the ...
By Vectorious
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‘First In-Heart Microcomputer,’ EVAR Suture-Delivery Catheter Named Top CRT Innovations
The “world’s first in-heart microcomputer” and an endovascular aortic repair (EVAR) suture-delivery catheter were recognized Saturday as the best innovations of CRT 2021 Virtual. The judges chose the V-LAP implantable microcomputer (Vectorious Medical Technologies Ltd.), presented by Tal Hasin, MD, of Shaare Zedek Medical Center, Jerusalem. CRT audience members voted for ...
By Vectorious
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Emerging therapy for HFpEF: SGLT2 inhibitors
Recent clinical trials investigating sodium-glucose cotransporter 2 inhibitors (SGLT2i) have highlighted that this drug is highly effective in treating patients with heart failure with preserved ejection fraction (HFpEF). HFpEF is a complex disease which accounts for more than half of all heart failure (HF) hospital admissions and is an increasing disease burden. [1] The prevalence of HFpEF is ...
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