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Evaluation of the Content Validity of the COVID-19 Symptoms Daily Diary.
Patient Relat Outcome Meas
January 2025
Merck & Co., Inc., Rahway, NJ, USA.
Introduction: The COVID-19 Symptoms Daily Diary (CSDD) is a patient-reported outcome measure designed to assess the severity of core COVID-19 symptoms in clinical trials. The preliminary version of the CSDD was developed based on regulatory guidance and the hallmark COVID-19 symptoms identified by the CDC. This study aimed to evaluate CSDD content validity, to determine whether it is fit for the purpose of supporting efficacy endpoints in clinical trials of treatments for COVID-19.
View Article and Find Full Text PDFSupervision, performance assessment, and recognition strategy (SPARS) - a multipronged strategy to strengthen medicines management in Nepal: pilot study methods and baseline results.
J Pharm Policy Pract
January 2025
USAID Medicines, Technologies, and Pharmaceutical Services (MTaPS) Program Nepal, Management Sciences for Health, Kathmandu, Nepal.
Background: Nepal piloted a multipronged supervision, performance assessment, and recognition strategy (SPARS), to improve medicines management (MM) in public health facilities. This paper describes the SPARS pilot intervention and reports on MM performance at baseline.
Methods: To build MM capacity at public sector health facilities, health workers were trained as MM supervisors to visit and supervise government health facilities, assess MM performance, and use the findings to provide support in MM practices.
Initial clinical experience with [Lu]Lu-PNT2002 radioligand therapy in metastatic castration-resistant prostate cancer: dosimetry, safety, and efficacy from the lead-in cohort of the SPLASH trial.
Front Oncol
January 2025
Department of Clinical Development, POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company, Indianapolis, IN, United States.
Introduction: SPLASH (NCT04647526) is a multicenter phase III trial evaluating the efficacy and safety of [Lu]Lu-PNT2002 radioligand therapy in metastatic castration-resistant prostate cancer (mCRPC). This study leveraged a lead-in phase to assess tissue dosimetry and evaluate preliminary safety and efficacy, prior to expansion into a randomized phase. Here we report those results.
View Article and Find Full Text PDFCharacteristics of Sluggish Cognitive Tempo among adults with ADHD: objective neurocognitive measures align with self-report of executive function.
Front Child Adolesc Psychiatry
July 2023
Department of Psychiatry, Icahn School of Medicine at Mount Sinai (ISMMS), New York, NY, United States.
Introduction: Sluggish Cognitive Tempo (SCT) is a syndrome characterized by cognitive hypo-arousal that often appears as daytime sleepiness or drowsiness, mental fogginess, being easily confused, having difficulty with holding and manipulating information in working memory, and being forgetful. Although it frequently co-travels with attention-deficit/hyperactivity disorder (ADHD) or other conditions and confers significantly greater impairment, there are few studies examining SCT among adults with ADHD. Understanding what features SCT confers in association with ADHD, distinct from other conditions associating with ADHD, is critically important to confirm if SCT is a distinct syndrome that requires special assessment methods and special, distinct treatment efforts to reduce its impact.
View Article and Find Full Text PDFClinical and surgical factors influencing screw breakage during hardware removal following periacetabular osteotomy.
J Hip Preserv Surg
December 2024
Department of Orthopedic Surgery, The University of Texas Health Science Center at Houston, 5420 W Loop South, Suite 2300, Houston, TX 77030, United States.
Periacetabular osteotomy (PAO) is a procedure used to treat patients with hip dysplasia. Current literature reports symptomatic hardware removal (HWR) rates of 13.6% following PAO.
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