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#news #biotech Ardelyx stock craters as FDA slaps biotech with dreaded ‘deficiencies’ tag on kidney drug

BioTech 365

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: Ardelyx stock craters as FDA slaps biotech with dreaded ‘deficiencies’ tag on kidney drug.Ardelyx stock craters as FDA slaps biotech with dreaded ‘deficiencies’ tag on kidney drug … Continue reading →

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Grand Rounds April 21, 2023: Personalised Cooler Dialysate for Patients Receiving Maintenance Haemodialysis (MyTEMP): A Pragmatic, Cluster-randomised Trial (Amit Garg, MD, MA, FRCPC, FACP, PhD; Stephanie N. Dixon, PhD MSc)

Rethinking Clinical Trials

The REB approved the MyTEMP request to use an altered patient consent process because the research was deemed of minimal risk to patients. MyTEMP worked with patients and caregivers to develop the trial, and Kidney Patient and Family Advisory Councils guided the choice of additional outcomes. degrees Celsius.

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Grand Rounds Ethics and Regulatory Series February 10, 2023: Informing and Consenting: What Are the Goals? (P. Pearl O’Rourke, MD; David S. Wendler, PhD, MA; Miguel Vazquez, MD; P. Michael Ho, MD, PhD)

Rethinking Clinical Trials

There are also concerns that obtaining consent could alter the “real-world” medical care being studied, may introduce an alteration of routine care, may introduce bias or make research impossible to conduct. Think about methods of notification, from detailed study-specific information to a general statement that research is being conducted.

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Grand Rounds July 8, 2022: Results From the COVID-OUT Trial, A Phase-3 Trial of Outpatient Treatment for Covid-19 Using Metformin, Ivermectin, and Fluvoxamine (Carolyn Bramante, MD, MPH; Thomas Murray, PhD; Jared Huling, PhD)

Rethinking Clinical Trials

Core Faculty, Program for Health Disparities Research. Trial participants were adults ages 30-85, who tested positive for SARS-CoV-2 within 3 days, with fewer than 7 days of symptoms, no known prior infection with SARS-CoV-2, no severe kidney, liver, or heart failure. Carolyn Bramante, MD, MPH. University of Minnesota Medical School.

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Grand Rounds September 16, 2022: Using Nationwide Registries to Conduct Pragmatic Randomized Trials: The DANFLU Program (Tor Biering-Sørensen, MD, PhD, MPH)

Rethinking Clinical Trials

Head of Cardiovascular Non-Invasive Imaging Research Laboratory. The national registries can be used to identify potential study participants who meet specific criteria and the e-BOKs system allows researchers to easily send invitations to potential participants, as well as follow up communications. Department of Biomedical Sciences.

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New Rare Disease Drugs and Research Advancements

XTalks

Rare Disease Day 2024, which falls on February 29 this year, is an opportunity to unite under a common cause: to bring attention to the challenges faced by those living with rare diseases and to push for advancements in research, treatment and policy. Sarepta hopes to clarify Elvidys’ effectiveness in older children in a confirmatory trial.

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Perfusion MRI and Other Perfusion Imaging Techniques for Clinical Trials

XTalks

We [Philips Pharma Solutions, formerly BioTel Research] have successfully ran multi-site DCE-MRI trials,” said Edward Ashton, PhD, VP, Oncology Imaging, Philips Pharma Solutions. For ASL MR perfusion, water molecules in arterial blood from a feeder artery are magnetically tagged and tracked until they reach the region of interest.