127 results match your criteria: "Worldwide Clinical Trials[Affiliation]"
Dental sedation permit requirements for physician anesthesiologists in the United States and the European Union: a review.
Curr Opin Anaesthesiol
December 2024
Worldwide Clinical Trials, San Antonio, Texas, USA.
Purpose Of Review: This review addresses the dental sedation permit requirements for physician anesthesiologists in the United States and the European Union (EU). The regulatory landscape for office-based anesthesia, including dental settings, is often described as the 'Wild West' of patient safety, making it crucial to outline the similarities and differences in dental anesthesia regulations and offer practical guidelines for regulators.
Recent Findings: There is virtually no literature that addresses the issue of dental sedation permits for physicians.
Duration of anticoagulation for venous thromboembolism in pediatric patients: Evaluation of the Duration of Therapy for Thrombosis in Children (Kids-DOTT) trial outcomes at 2 years.
J Thromb Haemost
October 2024
CPC Clinical Research, Aurora, Colorado, USA; Division of Cardiology, School of Medicine, University of Colorado Denver Anschutz Medical Campus, Aurora, Colorado, USA.
Background: The Multicenter Evaluation of the Duration of Therapy for Thrombosis in Children multinational, randomized clinical trial revealed noninferiority of a 6-week vs 3-month duration of anticoagulation for the treatment of provoked venous thromboembolism (VTE) in patients <21 years old in regard to net clinical benefit at 1 year.
Objectives: To evaluate noninferiority at 2 years.
Methods: Patients whose repeat imaging 6 weeks after VTE diagnosis did not show complete veno-occlusion were randomized to discontinue anticoagulation vs receive a total 3-month course and followed for 2 years for the occurrence of symptomatic recurrent VTE (efficacy outcome) and clinically relevant bleeding (safety outcome).
Where Are Patients' Voices in Chronic Kidney Disease?
Clin J Am Soc Nephrol
November 2024
Université de Lorraine, Centre d'Investigations Cliniques-Plurithématique 14-33, Inserm U1116, CHRU Nancy, F-CRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), Nancy, France.
Article Synopsis
- TLR7 is a special protein in the body that can cause a disease called systemic lupus erythematosus (SLE) when it signals too much.
- DS-7011a is a new medicine designed to block TLR7 and was tested in a study with healthy people to see how safe it is and how well it works.
- The study found that DS-7011a was safe, led to fewer side effects, and worked well to reduce a specific immune response, which suggests it could help treat SLE in the future.
Altered activation of the dorsal anterior cingulate cortex during oddball performance in individuals at risk for Alzheimer's disease.
Span J Psychiatry Ment Health
July 2024
Psychiatry and Mental Health Group, Neuroscience Program, Bellvitge Biomedical Research Institute (IDIBELL), L'Hospitalet de Llobregat, Spain; Network Center for Biomedical Research on Mental Health (CIBERSAM), Carlos III Health Institute (ISCIII), Madrid, Spain; Department of Social Psychology and Quantitative Psychology, Institute of Neurosciences, University of Barcelona, Barcelona, Spain. Electronic address:
Article Synopsis
- Scientists studied how brain changes in older people could cause problems with thinking and feeling, particularly in those with mild cognitive issues and depression.
- They looked at 12 people with mild cognitive impairment, 24 people with late-life depression, and 26 healthy individuals using brain scans and tests over 2 years.
- The results showed that specific brain activity patterns could help doctors understand and spot early signs of thinking and mood problems that might lead to Alzheimer's disease.
Machine learning: implications and applications for ambulatory anesthesia.
Curr Opin Anaesthesiol
December 2024
Worldwide Clinical Trials, San Antonio, Texas, USA.
Article Synopsis
- Machine learning is being used in ambulatory anesthesia to make things run smoother, help doctors understand risks better, and improve care for patients.
- It can predict how long procedures will take and how long patients will stay after surgery, which helps with planning and resource use.
- While machine learning offers great benefits, there are challenges like understanding how the models work and making sure they are fair and useful for everyone.
Re-discover the value of protein binding assessments in hepatic and renal impairment studies and its contributions in drug labels and dose decisions.
Clin Transl Sci
May 2024
Clinical Pharmacology-Drug Development Solution, ICON plc, Langen, Germany.
Article Synopsis
- Small molecule drugs can attach to proteins in the blood, and how much of the drug is free (not attached) affects how it works and is removed from the body.
- In studies about liver (HI) and kidney (RI) problems, only some drugs mention how they bind to proteins, and this can change how much the dose should be adjusted.
- Understanding free drug levels in patients with HI and RI helps doctors make better treatment decisions based on safety and effectiveness.
Relative Bioavailability of Cenobamate Administered as a Crushed Tablet, Either Orally or via Nasogastric Tube, versus an Intact Whole Tablet.
J Clin Pharmacol
August 2024
Worldwide Clinical Trials, San Antonio, TX, USA.
Article Synopsis
- Cenobamate is a medicine for adults with a type of seizures called focal seizures, and it usually comes as a tablet you swallow.
- Some people can’t swallow whole tablets, so researchers studied if crushed cenobamate tablets or using a tube to give it can work just as well as the whole ones.
- They found that crushed tablets worked the same way without causing serious problems, so now patients can take cenobamate in different ways, either by swallowing it crushed or through a tube.
Methods for Neuroscience Drug Development: Guidance on Standardization of the Process for Defining Clinical Outcome Strategies in Clinical Trials.
Eur Neuropsychopharmacol
June 2024
Valis Bioscience, Berkeley, CA, USA.
Article Synopsis
- Neuroscience clinical trials often fail, so choosing the right outcomes early on is really important for finding new treatments in mental and brain health.
- A group called The Outcomes Research Group is trying to create better ways to pick outcomes for these trials to improve the chances of success.
- This article gives guidelines on how to standardize the process for choosing outcomes in neuroscience research, helping researchers do better work and avoid risks.
Population pharmacokinetic rationale for intravenous contezolid acefosamil followed by oral contezolid dosage regimens.
Antimicrob Agents Chemother
April 2024
MicuRx Pharmaceuticals, Inc., Foster City, California, USA.
Article Synopsis
- Contezolid is a new type of antibiotic that shows promise for treating certain skin infections in people with diabetes.
- It comes in two forms: one is taken by mouth, and the other is given through an IV.
- The study helps figure out the best way to use these medicines safely and effectively by looking at how they work in the body for both healthy volunteers and patients.
Sensitivity of Pharmacokinetics to Differences in the Particle Size Distribution for Formulations of Locally Acting Mometasone Furoate Suspension-Based Nasal Sprays.
Mol Pharm
November 2023
Department of Pharmaceutics, College of Pharmacy, University of Florida, 1345 Center Drive, Gainesville, Florida 32610, United States.
Article Synopsis
- The FDA looks at different types of studies to make sure nasal sprays work the same way for people.
- This study compared two versions of a nasal spray with different particle sizes to see how quickly they work in the body.
- The results showed that the smaller particles dissolved faster and were better at getting the medicine into the system than the larger particles.
Pharmacokinetics, Metabolism, and Excretion of Intravenous [14C]Difelikefalin in Healthy Subjects and Subjects on Hemodialysis.
Clin Pharmacokinet
September 2023
Cara Therapeutics, Inc., 4 Stamford Plaza, 107 Elm Street, 9th Floor, Stamford, CT, 06902, USA.
Article Synopsis
- Difelikefalin is a new medicine approved for treating itching in patients with severe kidney problems who are on dialysis in the USA and Europe.
- In a study, researchers gave this medicine to 12 adult males, half healthy and half on dialysis, to see how their bodies handled it.
- Results showed that patients on dialysis had much higher levels of the medicine in their system compared to healthy subjects, and most of the drug exited through feces instead of urine in dialysis patients.