Clinical study design

STAGGERING 85% OF BRITS WON'T BE ACHIEVING THEIR TEA 5-A-DAY THIS INTERNATIONAL TEA DAY

Retrieved on: 
Friday, May 19, 2023
Well, Tea, Biobank, UK Biobank, Nut, Autophagy, Marketing, Fair Trade Association of Australia and New Zealand, British Journal of Nutrition, Cardiovascular disease, International Tea Day, Health, Cancer, Nutrient, GP, TAP, Fruit, Thought, Blood, Panel, Public health, Polyphenol, Parkinson's disease, Risk, Data, Agriculture, Systematic review, Coffee, Nutritionist, TEA, Mortality, Journal of Agricultural and Food Chemistry, Research, Clinical study design, EGCG, News, Alzheimer's disease, Dietary supplement

LONDON, May 19, 2023 /PRNewswire/ -- Data1 reviewed by the Tea Advisory Panel reveals over 8 out of 10 Brits aren't hitting the sweet spot of five daily cuppas.

Key Points: 
  • Worryingly though, on the eve of International Tea Day, the data reveals cause for concern in relation to the low volume of tea many Brits drink.
  • International Tea Day – on 21st May 2023 – was launched by the United Nations2 to celebrate the world's appreciation for tea, and it's a good time to remind people about the benefits of drinking tea.
  • Tea Advisory Panel member Dr Tim Bond goes on to expand on the importance of International Tea Day, explaining: "International Tea Day aims to encourage the sustainable production and consumption of tea and raise awareness of the importance of our beloved cuppa to people around the world."
  • "Six of the nine different teas studied – green tea, oolong tea, black tea, safflower tea, ginger tea, and hibiscus tea – as well as their polyphenols (health-promoting plant chemicals), including flavan-3-ols and epigallocatechin gallate (EGCG), were found to regulate this process.

STAGGERING 85% OF BRITS WON'T BE ACHIEVING THEIR TEA 5-A-DAY THIS INTERNATIONAL TEA DAY

Retrieved on: 
Friday, May 19, 2023
Well, Tea, Biobank, UK Biobank, Nut, Autophagy, Marketing, Fair Trade Association of Australia and New Zealand, British Journal of Nutrition, Cardiovascular disease, International Tea Day, Health, Cancer, Nutrient, GP, TAP, Fruit, Thought, Blood, Panel, Public health, Polyphenol, Parkinson's disease, Risk, Data, Agriculture, Systematic review, Coffee, Nutritionist, TEA, Mortality, Journal of Agricultural and Food Chemistry, Research, Clinical study design, EGCG, News, Alzheimer's disease, Dietary supplement

LONDON, May 19, 2023 /PRNewswire/ -- Data1 reviewed by the Tea Advisory Panel reveals over 8 out of 10 Brits aren't hitting the sweet spot of five daily cuppas.

Key Points: 
  • Worryingly though, on the eve of International Tea Day, the data reveals cause for concern in relation to the low volume of tea many Brits drink.
  • International Tea Day – on 21st May 2023 – was launched by the United Nations2 to celebrate the world's appreciation for tea, and it's a good time to remind people about the benefits of drinking tea.
  • Tea Advisory Panel member Dr Tim Bond goes on to expand on the importance of International Tea Day, explaining: "International Tea Day aims to encourage the sustainable production and consumption of tea and raise awareness of the importance of our beloved cuppa to people around the world."
  • "Six of the nine different teas studied – green tea, oolong tea, black tea, safflower tea, ginger tea, and hibiscus tea – as well as their polyphenols (health-promoting plant chemicals), including flavan-3-ols and epigallocatechin gallate (EGCG), were found to regulate this process.

SeaStar Medical Reports First Quarter 2023 Financial Results and Provides a Business Update

Retrieved on: 
Monday, May 15, 2023
Insurance, Hospice and palliative medicine, Neutrophil, Chronic kidney disease, Marketing, HDE, SCD, Clinical trial, G&A, AKI, Dialysis, Sepsis, Acute kidney injury, CKRT, Hospital, Monocyte, Patient, Standard of care, Nephrology, Risk, Physician, HIV disease progression rates, Clinical study design, Acute respiratory distress syndrome, Mortality, ICU, R, FDA, Letter, Research, Safety, Pharmaceutical industry, Nursing, Security (finance)

DENVER, May 15, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (“SeaStar Medical” or the “Company”), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, reports financial results for the three months ended March 31, 2023 and provides a business update.

Key Points: 
  • DENVER, May 15, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (“SeaStar Medical” or the “Company”), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, reports financial results for the three months ended March 31, 2023 and provides a business update.
  • Approximately six million cases of adult AKI are diagnosed annually in the U.S., of which approximately 200,000 require CKRT.
  • The NEUTRALIZE-AKI trial is expected to enroll up to 200 patients at up to 30 U.S. medical centers.
  • Other expense for the first quarter of 2023 was $0.5 million, compared with other expense of $0.2 million for the first quarter of 2022.

SeaStar Medical Reports 2022 Financial Results and Provides a Business Update

Retrieved on: 
Friday, March 31, 2023
Insurance, Common stock, Neutrophil, HDE, SCD, Clinical trial, G&A, LMAO, AKI, Dialysis, Sepsis, Acute kidney injury, CKRT, Hospital, Monocyte, Patient, Standard of care, Nephrology, Physician, HIV disease progression rates, Clinical study design, Conditional sentence, Acute respiratory distress syndrome, Mortality, ICU, R, Research, FDA, Safety, Cryptocurrency, Pharmaceutical industry, Nursing

DENVER, March 30, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (“SeaStar Medical” or the “Company”), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, provides a business update and reports financial results for the year ended December 31, 2022.

Key Points: 
  • DENVER, March 30, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (“SeaStar Medical” or the “Company”), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, provides a business update and reports financial results for the year ended December 31, 2022.
  • “We are focusing on executing near-term milestones that will advance our business,” said Eric Schlorff, SeaStar Medical CEO.
  • The NEUTRALIZE-AKI trial is expected to enroll up to 200 patients at up to 30 U.S. medical centers.
  • In March 2023 SeaStar Medical closed a $3.3 million first tranche of a $9.8 million private placement convertible debt offering.

Cytokinetics Presents Positive Results From Cohort 4 of REDWOOD-HCM and Long-Term Results From FOREST-HCM at the American College of Cardiology 72nd Annual Scientific Session

Retrieved on: 
Saturday, March 4, 2023
Research, Heart failure, Oxford Handbook of Clinical Medicine, Conference, Cytokinetics, Oregon Health and Science University Center for Women's Health, LVEF, American College, SAN, Disease, NYHA, Conference call, Cohort, Host, Research and development, Cardiology, Clinical study design, LVOT, New York Heart Association Functional Classification, Medical device, Pharmaceutical industry, Patient, HCM

SOUTH SAN FRANCISCO, Calif., March 04, 2023 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that positive results from Cohort 4 of REDWOOD-HCM (Randomized Evaluation of Dosing With CK-274 in Obstructive Outflow Disease in HCM), a Phase 2 clinical trial of aficamten in patients with non-obstructive hypertrophic cardiomyopathy (nHCM), were presented at the American College of Cardiology 72nd Annual Scientific Session (ACC.23). Additionally, 48-week data from FOREST-HCM (Follow-up, Open-Label, Research Evaluation of Sustained Treatment with Aficamten in HCM) were also presented at the meeting.

Key Points: 
  • Additionally, 48-week data from FOREST-HCM (Follow-up, Open-Label, Research Evaluation of Sustained Treatment with Aficamten in HCM) were also presented at the meeting.
  • At 10 weeks, patients in Cohort 4 experienced significant improvements in NT-proBNP, with an average decrease of 66% (p
  • The live audio of the conference call can also be accessed by telephone by registering in advance at the following link: Cytokinetics ACC.23 Conference Call .
  • An archived replay of the webcast will be available via Cytokinetics’ website for twelve months.

Cytokinetics Joins Global Initiative to Recognize International Rare Disease Day

Retrieved on: 
Wednesday, February 22, 2023
National Organization for Rare Disorders, European Organisation for Rare Diseases, NORD, Rare, Diagnosis, Breakthrough therapy, Organization, European Medicines Agency, Courage, FDA, Patient, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, SAN, Clinical study design, EMA, Cytokinetics, Obstruction, Orphan, Caregiver, Hypertrophic cardiomyopathy, Safety, Food, EURORDIS, Rare disease, Pharmaceutical industry, HCM, ALS

SOUTH SAN FRANCISCO, Calif., Feb. 22, 2023 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that it is joining the European Organisation for Rare Diseases (EURORDIS) and the National Organization for Rare Disorders (NORD) to recognize Rare Disease Day® on February 28, 2023.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., Feb. 22, 2023 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that it is joining the European Organisation for Rare Diseases (EURORDIS) and the National Organization for Rare Disorders (NORD) to recognize Rare Disease Day® on February 28, 2023.
  • Rare Disease Day® is an international campaign elevating the awareness and public understanding of rare diseases.
  • The initiative spotlights the more than 300 million people worldwide living with a rare disease, and the awareness efforts focused on bringing them more equitable access to diagnosis, treatment, care and social opportunity.
  • “We take great pride in joining forces with EURORDIS, NORD and millions worldwide for Rare Disease Day, an opportunity to recognize and honor the courage and resilience of those living with rare diseases, while we advocate for improved access to diagnosis, treatment and care,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer.

Palette Life Sciences Announces Publication of Barrigel® Pivotal Safety and Efficacy Clinical Trial Data in JAMA Oncology

Retrieved on: 
Thursday, February 9, 2023
Clinical study design, Assistant, Food, Food and Drug Administration, Safety, Hypofractionated high-dose intensity-modulated radiotherapy, Rectum, III, Radiation therapy, Harvard Medical School, Medical director, Hyaluronic acid, JAMA Oncology, Patient, Prostate, FDA, Dana–Farber Cancer Institute, Pivotal trial, Radiation, Toxicity, Randomized controlled trial, DO, Prostate cancer, Pharmaceutical industry, Medical imaging, MD

The publication is an international peer-reviewed journal and the definitive journal for scientists, clinicians, and trainees in the field of oncology.

Key Points: 
  • The publication is an international peer-reviewed journal and the definitive journal for scientists, clinicians, and trainees in the field of oncology.
  • “Palette Life Sciences is extremely proud of our safety and efficacy data being published in JAMA Oncology and is proud to advance better health outcomes for the approximately 290,000 men in the U.S. who are diagnosed with prostate cancer each year,” said Per G. Langö, Chief Executive Officer and Board Director of Palette Life Sciences.
  • “Despite these benefits, HFRT has been associated with greater acute Grade 2+ GI toxicity compared with conventional radiation therapy.
  • Hyaluronic Acid Spacer for Hypofractionated Prostate Radiation Therapy: A Randomized Clinical Trial.

Late-Breaking ACQFORCE FLUTTER Trial Meets Primary Endpoint for Safety and Efficacy with the First Gold-Tipped Contact Force Sensing Ablation Catheter

Retrieved on: 
Monday, February 6, 2023
Arrhythmia, CE marking, Safety, Thermal conductivity, Gold, Pulmonary vein, PMA, AFIB, Ablation, Kishan Chand Parwani, Clinical study design, Atrial flutter, IDE, Physician, Catheter ablation, Patient, Blazer, Platinum, Cardiology (journal), Superior, Cardiology, Electrophysiology, Baptist Health, Atrial fibrillation, Temperature, Medical imaging, Pharmaceutical industry

“AcQBlate’s novel gold tip ablation catheter performed extremely well during the clinical IDE atrial flutter cases.

Key Points: 
  • “AcQBlate’s novel gold tip ablation catheter performed extremely well during the clinical IDE atrial flutter cases.
  • The AcQBlate FORCE sensing ablation catheter and system, which received CE Mark in 2020, is commercially available in Europe.
  • The AcQBlate FORCE sensing ablation catheter was designed to provide consistent, effective therapeutic delivery during cardiac ablation procedures.
  • AcQForce Flutter Trial Clinical Results: Force Sensing RF Ablation with Low Flow Gold Tip Catheter for Typical Flutter.

Acutus Medical Announces Acceptance of the AcQForce Flutter Abstract for Presentation during the Late-Breaking Clinical Trials and First Report Investigations sessions at the 2023 AF Symposium

Retrieved on: 
Thursday, December 29, 2022
Gold, AFIB, PMA, Thermal conductivity, Temperature, Superior, Arrhythmia, Clinical study design, Catheter ablation, Platinum, Pulmonary vein, FDA, Clinical trial, Medical imaging

This abstract – including full study results - will be presented on Friday, February 3, 2023.

Key Points: 
  • This abstract – including full study results - will be presented on Friday, February 3, 2023.
  • The AcQForce Flutter clinical study was submitted to the FDA as part of Acutus’ PMA submission for the AcQBlate Force Sensing Ablation Catheter, the only force-sensing ablation catheter with a gold tip electrode, and System.
  • To learn more about Acutus Medical’s complete portfolio of diagnostic, access and therapy products, please visit https://acutusmedical.com .
  • Linhart M. et al., Superiority of Gold Compared to Platinum Tip Irrigated Catheter Ablation of the Pulmonary Veins and the Cavotricuspid Isthmus: A Randomized Study Comparing Tip Temperatures and Cooling Flow Requirements.

Abbott Launches the World's Smallest Implantable, Rechargeable Spinal Cord Stimulation System for Chronic Pain

Retrieved on: 
Monday, December 19, 2022
Virginias, Life, Pain, IPhone, Physician, Medical device, Quality of life, De Ridder, SCS, Hyperreflexia, NYSE, Parenteral nutrition, Chronic pain, Food, FDA, Comparison, Apple, BURST, Randomized controlled trial, Regulation of tobacco by the U.S. Food and Drug Administration, Skin, Clinical study design, XR, Spinal cord, Health, Eterna, NANS, Systematic review, Meta-analysis, Patient, Spine, Eucalyptus diversicolor, Deer, Proclaim!, MRI, Caregiver, Gauge (instrument), PMID, Electric battery, Dentistry, Pharmaceutical industry, Poultry, Brain

Clinically proven therapy: The Eterna SCS system features Abbott's proprietary BurstDR stimulation, which mimics natural firing patterns found in the brain7 to deliver superior**8 pain relief.

Key Points: 
  • Clinically proven therapy: The Eterna SCS system features Abbott's proprietary BurstDR stimulation, which mimics natural firing patterns found in the brain7 to deliver superior**8 pain relief.
  • "Eterna is the smallest rechargeable spinal cord stimulator on the market, provides the longest therapy between charges and offers an optimized recharging experience – all key features when selecting the best overall system.
  • For U.S. important safety information on the Abbott Eterna spinal cord stimulation system, visit: https://bit.ly/3Wgpude .
  • Comparison of Spinal Cord Stimulation Waveforms for Treating Chronic Low Back Pain: Systematic Review and Meta-Analysis.