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The PROPHECI trial: a phase II, double-blind, placebo-controlled, randomized clinical trial for the treatment of pseudoxanthoma elasticum with oral pyrophosphate.
Trials
January 2025
Université Côte d'Azur, CNRS, LP2M, Nice, France.
Background: /aims. Pseudoxanthoma Elasticum (PXE, OMIM 264800) is an autosomal, recessive, metabolic disorder characterized by progressive ectopic calcification in the skin, the vasculature and Bruch's membrane. Variants in the ABCC6 gene are associated with low plasma pyrophosphate (PPi) concentration.
View Article and Find Full Text PDFTAD-SIE: sample size estimation for clinical randomized controlled trials using a Trend-Adaptive Design with a Synthetic-Intervention-Based Estimator.
Trials
January 2025
Department of Electrical and Computer Engineering, Princeton University, Princeton, 08544, NJ, USA.
Background: Phase-3 clinical trials provide the highest level of evidence on drug safety and effectiveness needed for market approval by implementing large randomized controlled trials (RCTs). However, 30-40% of these trials fail mainly because such studies have inadequate sample sizes, stemming from the inability to obtain accurate initial estimates of average treatment effect parameters.
Methods: To remove this obstacle from the drug development cycle, we present a new algorithm called Trend-Adaptive Design with a Synthetic-Intervention-Based Estimator (TAD-SIE) that powers a parallel-group trial, a standard RCT design, by leveraging a state-of-the-art hypothesis testing strategy and a novel trend-adaptive design (TAD).
Prevalence and associated factors of parental refusal rates for routine immunisation: a cross-sectional study in Peshawar, Khyber Pakhtunkhwa, Pakistan-2024.
BMC Public Health
January 2025
Institute of Public Health & Social Sciences (IPH&SS), Khyber Medical University (KMU), Peshawar, Pakistan.
Background: Vaccine hesitancy is a serious public health problem globally, particularly in low- and middle-income countries like Pakistan. This study aims to determine the vaccination refusal rate, associated factors and perceptions of parents who refused routine immunisation within Peshawar, Khyber Pakhtunkhwa, Pakistan.
Methods: A cross-sectional study conducted in July-2024, among 340 parents of children aged 0-59 months.
Sedoanalgesia with dexmedetomidine in daily anesthesia practices: a prospective randomized controlled trial.
BMC Anesthesiol
January 2025
Department of Anesthesiology and Reanimation, Faculty of Medicine, Van Yüzüncü Yıl University, Van, Turkey.
Background: Patient safety is important in daily anesthesia practices, and providing deep anesthesia is difficult. Current debates on the optimal anesthetic agents highlight the need for safer alternatives. This study was justified by the need for safer and more effective anesthetic protocols for outpatient hysteroscopic procedures, particularly those conducted outside the operating room.
View Article and Find Full Text PDFComparison of GLP-1 Receptor Agonists Combined with Metformin Versus Metformin Alone in the Management of PCOS: A Comprehensive Meta-Analysis.
Reprod Sci
January 2025
Department of Obstetrics and Gynecology, Renmin Hospital of Wuhan University, Wuhan, 430064, China.
This study compared the efficacy and safety of glucogan-like peptide-1 receptor agonists (GLP1RAs) combined with metformin versus metformin alone in women with polycystic ovary syndrome (PCOS). A systematic search of "PubMed", "EMBASE", "Cochrane Library", and "Web of Science", "Google Scholar" was conducted up to September 2024. Studies were included if they were RCTs investigating the combination of GLP1RAs and metformin in women diagnosed with PCOS.
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