Introduction Cannabis use is common in the USA and is associated with adverse outcomes across many domains, including sleep difficulties. Targeting insomnia with an evidence-based treatment could improve sleep and reduce frequent cannabis use. This randomised controlled trial (RCT) will compare evidence-based telemedicine-delivered cognitive-behavioural therapy for insomnia for adults with frequent cannabis use (CBTi-CB) against an active comparator, sleep hygiene education (SHE), for improving insomnia/sleep, associated daytime symptoms and cannabis use. The study will also determine the…
Objectives Spontaneous coronary artery dissection (SCAD) is a rare cause of acute coronary syndrome mainly affecting younger to middle-aged women. Physical activity has been discussed as a potential trigger for SCAD. This study aimed to explore the perceptions of physical activity among patients and their experiences of cardiac rehabilitation following the event. Design Qualitative descriptive study using digital focus groups and inductive qualitative content analysis. Setting Six digitally conducted focus groups (Zoom) in Sweden. Participants Twenty-six women and three men (median age 57…
Introduction Inappropriate mechanical ventilation plays a pivotal role in the development of ventilator-induced lung injury (VILI) and subsequent postoperative pulmonary complications (PPCs), thus individualised lung protective ventilation became a hot topic of research during the past decades. Despite promising results from early trials focusing on separated ventilatory parameters, the incidence of PPCs has not decreased significantly, hence a new conceptual direction emerged in the last few years by evaluating the potential role of mechanical power of ventilation (MP), since MP encompasses…
Introduction Impairment of the hypothalamic–pituitary–adrenal axis during critical illness, called Critical Illness-Related Corticosteroid Insufficiency (CIRCI), is frequent. There is no standard treatment for CIRCI. This trial aims to determine whether, through biomarker enrichment using CIRCI criteria, hydrocortisone and fludrocortisone, compared with placebo, improve organ dysfunction-free survival in critically ill patients. Methods and analysis French multicentre, placebo-controlled, double-blind superiority trial that will randomly assign adults with CIRCI to receive a 7-day course of…
The healthcare organizations getting this right are not defined by how much they’ve automated. They are defined by how deliberately they’ve protected the human touchpoints that drive trust, engagement, and outcomes. The post The Human Behind the Machine: Why Healthcare Must Resist the Rush To Automate appeared first on MedCity News .
As the Democratic Republic of the Congo is battling an Ebola disease outbreak caused by the Bundibugyo virus, the World Health Organization (WHO) has released its first comprehensive guidelines for the clinical management of filovirus disease which include all types of Ebola and Marburg viruses. The new guidelines highlight the importance of early supportive care to improve patient survival and health outcomes, outlining 16 evidence-based recommendations.
In this week’s View, Dr. Eagle highlights a study showing race and sex disparities in M-TEER outcomes, with Black patients presenting with more advanced disease, lower success, and higher heart failure readmissions than White patients, and women having lower success rates than men.
As air transportation for organs becomes more common, both in response to tech advancements and changing federal guidelines, the industry needs tools that synchronize communication between dispersed teams and can keep pace with air transport. The post Leveraging Technology to Navigate the New Era of Continuous Organ Distribution appeared first on MedCity News .
Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis — Ascend Laboratories, LLC · Class II · Ongoing · 360 30-count bottles
Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process. — Haleon US Holdings LLC · Class I · Ongoing · 35,883 boxes/carton
Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution — SUN PHARMACEUTICAL INDUSTRIES INC · Class II · Ongoing · N/A
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit — Breckenridge Pharmaceutical, Inc. · Class II · Ongoing · 359,676 bottles
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit — Breckenridge Pharmaceutical, Inc. · Class II · Ongoing · 14,729 bottles
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer. — Amneal Pharmaceuticals, LLC · Class III · Ongoing · 27,936 100-count bottles