Rethinking Clinical Trials

SEPTEMBER 22, 2022

Professor in Translational Cardiology and Pragmatic Randomized Trials. Head of Center for Translational Cardiology and Pragmatic Randomized Trials. Department of Cardiology. DANFLU-1, Pragmatic Clinical Trials. The DECODE trial used registry data to identify patients with chronic kidney disease.

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Pharmaceutical Technology

JUNE 21, 2023

It can be used as a monotherapy or along with cholesterol-lowering medicines. The regulatory approval was based on the findings obtained from a double-blind, multinational, placebo-controlled, randomised clinical trial conducted in 5,522 chronic coronary disease patients.

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Drug Discovery World

JULY 31, 2023

DDW’s Reece Armstrong speaks to Hendrik Streefkerk , Chief Medical Officer and Drug Safety Officer of CellProthera about the company’s cell therapy for acute myocardial infarction (AMI) and why regenerative medicine could be key to treating cardiac diseases. T his is the market CellProthera wants to enter.

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Rethinking Clinical Trials

JUNE 7, 2023

The trial was designed to randomize 1,000 patients who had an On-X aortic valve replacement at least 3 months prior to randomization with either a standard dose of Apixaban (5mg) or continued warfarin (the standard of care). The trial took place at 64 sites, and randomized 863 patients. Learn more Read about the PROACT Xa study.

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Rethinking Clinical Trials

APRIL 13, 2023

Nudges and other behavioral interventions are prevalent in industries like business and entertainment, but there is an opportunity for nudges in medicine and health care delivery. Launched in 2016, the Penn Medicine Nudge Unit is the world’s first behavioral design team embedded within a health system.

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WCG Clinical

MAY 22, 2023

Despite the growing consensus around the need for diversity in clinical trials, the industry still has a long way to go. 4,5 In fact, lack of representation in clinical trials compromises generalizability of research findings. Increasing Diversity in Clinical Trials: Overcoming Critical Barriers. Current Problems in Cardiology.

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STAT News

AUGUST 3, 2022

Alnylam Pharmaceuticals’ treatment for an increasingly common heart disease succeeded in a closely watched clinical trial, the company said Wednesday, clearing the path to approval and affirming the promise of a drug analysts expect to reap blockbuster sales.

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Velocity Clinical Research

MARCH 7, 2024

It’s easy to hear the enthusiasm for clinical trials when William Cromwell, MD, FAHA, FNLA , Principal Investigator and a leader of the Velocity Cardiometabolic CARE Council , discusses their importance to patients yesterday, today, and tomorrow. You can also do that by researching, publishing and teaching.

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XTalks

NOVEMBER 19, 2021

Cardiac biomarkers can not only serve important roles in the diagnosis, management and prognosis of cardiac diseases, but they can also be significant tools in evaluating treatments in cardiovascular (CV) clinical trials. In CV clinical trials, cardiac biomarkers are most commonly included in efficacy and safety endpoints.

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XTalks

AUGUST 4, 2022

Cardiovascular clinical trials need to have a diversity plan because there can be a difference in disease burden when comparing people of different race and ethnicity. The US Food and Drug Administration (FDA) is emphasizing the need for diversity in clinical trials. The Diversity of the US Population.

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The Pharma Data

MAY 31, 2022

the completion of enrollment of its Phase 1 (Ph1), open-label trial of pluripotent stem cell-derived dopaminergic neurons in patients with Parkinson’s disease (PD). Ph1 clinical trial is to evaluate the safety, tolerability, and?preliminary?efficacy?of AG, announced?the The purpose of the?Ph1 preliminary?efficacy?of F.C.A.H.S. (PI)

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Velocity Clinical Research

DECEMBER 6, 2023

In addition to being one of Poland’s top recruiting sites in cardiology trials, ClinMedica also recruits patients across a broad range of therapeutic areas involving ambulatory medicine. About Velocity Clinical Research Velocity is the leading integrated site organization for clinical trials. and Europe.

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Scienmag

AUGUST 16, 2020

The […].

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The Pharma Data

AUGUST 30, 2021

Positive high-level results from the FoCus Phase III trial in Wilson disease showed ALXN1840 met the primary endpoint with a statistically significant improvement in daily mean copper mobilisation from tissues, demonstrating superiority compared with standard-of-care (SoC) treatments.

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The Pharma Data

AUGUST 22, 2021

Alexion is discontinuing CHAMPION-ALS, the global Phase III clinical trial of Ultomiris (ravulizumab) in adults with amyotrophic lateral sclerosis (ALS). The IDMC recommended that the trial be discontinued due to lack of efficacy. Data from the trial will be provided to inform ongoing research. CHAMPION-ALS.

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The Pharma Data

NOVEMBER 12, 2020

The DETOUR1 trial is the first-in-man trial of the FDA-designated Breakthrough Device, The Detour System, evaluating the safety and effectiveness of the novel procedure and device system for treating long, complex lesions in the superficial femoral artery (SFA). About the Company: PQ Bypass, Inc.

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Scienmag

AUGUST 31, 2020

EXPLORER-HCM trial presented in a Hot Line Session today at ESC Congress 2020 Sophia Antipolis, France – 29 Aug 2020: Mavacamten improves heart function and symptoms in patients with obstructive hypertrophic cardiomyopathy, according to results of the EXPLORER-HCM trial presented in a Hot Line session today at ESC Congress 2020.1 “The results (..)

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Scienmag

OCTOBER 15, 2020

Randomized trial studies device designed to reduce embolic events in patients undergoing TAVR NEW YORK – October 15, 2020 – The REFLECT II randomized clinical trial evaluating the safety and efficacy of a device designed to reduce cerebral embolization and ischemic stroke, complications of transcatheter aortic valve replacement (TAVR), (..)

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The Pharma Data

JANUARY 20, 2021

Trial designed to investigate the cardioprotective properties of CardiolRx(TM) in patients hospitalized with COVID-19 who have a prior history of, or risk factors for, cardiovascular disease. The DSMC comprises independent experts who will assess the patient safety data, and, if needed, critical efficacy endpoints of the trial.

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Cloudbyz

JUNE 27, 2024

Online platforms like ClinicalTrials.gov and the World Health Organization’s International Clinical Trials Registry Platform (ICTRP) provide comprehensive listings of ongoing and completed clinical trials, including information about the investigators involved (Jones et al., Clinical Trials Review , 8(4), 223-230. Harris, P.,

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Scienmag

NOVEMBER 20, 2020

AHA, ACC issue updated guidance for the evaluation and management of people with HCM The American Heart Association and the American College of Cardiology today released an updated guideline for managing patients with hypertrophic cardiomyopathy (HCM).

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Scienmag

NOVEMBER 16, 2020

SCORED trial of patients with diabetes and chronic kidney disease is first trial of an SGLT2 inhibitor to show benefit across the full range of albuminuria; SOLOIST shows an SGLT2 inhibitor is safe to start in patients hospitalized with heart failure Boston, MA — Less than a decade ago, the Food and Drug Administration approved […].

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ACRP blog

JANUARY 24, 2023

Raising Community Awareness to Optimize Impact Nevada’s first integrated health system was created in June 2021 when an affiliation agreement was signed between Renown Health and the University of Nevada, Reno, School of Medicine. Significant progress was achieved.

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The Pharma Data

OCTOBER 28, 2021

Bayer will present new renal and cardiovascular (CV) analyses from the comprehensive finerenone (Kerendia®) clinical trial program, including the Phase III FIGARO-DKD and FIDELIO-DKD studies, and the prespecified pooled analysis FIDELITY at the American Society of Nephrology (ASN)’s Kidney Week 2021 from 4-7 November.

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Medical Xpress

APRIL 3, 2023

A randomized clinical trial of Black patients eligible for an implantable cardioverter-defibrillator (ICD) has found that the use of a video-based decision support tool increased knowledge of but not assent to ICD implantation. The findings are published in Annals of Internal Medicine.

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The Pharma Data

NOVEMBER 8, 2021

In the FIGARO-DKD study, presented at ESC Congress 2021 and published in the New England Journal of Medicine, the prevalence of the first secondary endpoint, a compound of time to order failure, a sustained drop of estimated glomerular filtration rate (eGFR) ? cases in the finerenone arm and 395 (10.8)

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Scienmag

OCTOBER 19, 2020

Randomized clinical trial finds no mortality risk or benefit associated with drug-coated devices in the treatment of peripheral artery disease NEW YORK – October 18, 2020 – A large subgroup analysis of a randomized clinical trial showed neither a mortality risk nor benefit associated with the use of paclitaxel drug-coated devices (DCD) (..)

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Delveinsight

DECEMBER 29, 2020

Audentes Therapeutics’ ASPIRO Trial Free to Proceed. The Food and Drug Administration (FDA) decided to lift the clinical ban from Audentes Therapeutics’ ASPIRO trial, which was aimed at investigating its AT132 for the treatment of X-linked myotubular myopathy (XLMTM), a rare neuromuscular disease. . The post A USD 4.2

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Scienmag

APRIL 2, 2021

Formerly the ICD Registry, the new name reflects expanded offerings and aligns with other quality programs Effective immediately, the American College of Cardiology is offering the EP Device Implant Registry, which will include data on ICD and CRT-D procedures previously captured in the NCDR ICD Registry as well as provide the flexibility to capture (..)

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Medical Xpress

APRIL 17, 2023

Experiments at 48 elderly care facilities in China find that salt substitutes lowered diastolic blood pressure and resulted in fewer cardiovascular events, according to a paper titled "Salt substitution and salt-supply restriction for lowering blood pressure in elderly care facilities: a cluster-randomized trial," published in Nature Medicine.

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The Pharma Data

MARCH 31, 2023

The positive opinion is based on final data from the 52-week Phase III PANORAMA-HF trial – the largest pediatric heart failure study ever conducted – and extrapolation of adult heart failure data from the Phase III PARADIGM-HF trial to pediatric patients 3,4.

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Drug Discovery World

OCTOBER 19, 2022

Following the news that the number of clinical trial recruiting sites in Ukraine has dropped by half since the Russian invasion, DDW’s Diana Spencer examines clinical trial data from analytics company Phesi and speaks to Dr Olena Karpenko , Clinical Research Director at Medical Center Ok!Clinic+ Ongoing clinical trials.

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Velocity Clinical Research

JANUARY 3, 2024

The acquisition of KO-MED is Velocity’s first foray into Oncology research, which accounts for roughly 40-50% of clinical trials globally. In most cases, the participant of a clinical trial benefits from taking part, which is of great importance, especially in oncological trials. and Europe.

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pharmaphorum

FEBRUARY 25, 2022

. “While Jardiance may not be effective in all patients with heart failure, this approval is a significant step forward for patients and our understanding of heart failure,” says Norman Stockbridge, MD, PhD, director of the Division of Cardiology and Nephrology in the FDA’s Center for Drug Evaluation and Research.

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Scienmag

MAY 16, 2021

A unique commission that today issued major new recommendations aimed at fully understanding and reducing the global burden of heart disease in women was led by Roxana Mehran, MD, Professor of Medicine, and Population Health Science and Policy, and Director of Interventional Cardiovascular Research and Clinical Trials at the Icahn School of Medicine (..)

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Scienmag

MARCH 10, 2021

Credit: AlphaMed Press Durham, NC – Results of a clinical trial released in STEM CELLS Translational Medicine provide evidence that treating patients with an injection of bone marrow cells may lead to a reduction in brain injury after a stroke. The study was conducted by Muhammad E. Haque, Ph.D., Savitz, M.D.,

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Scienmag

DECEMBER 3, 2020

In a randomized, controlled clinical trial, researchers found that patients who received genetic test results about the side effects of cholesterol-lowering medications did not have worse outcomes after one year A person’s genetic make-up can influence whether they might experience side effects from certain medications.

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