Elinzanetant for the Treatment of Vasomotor Symptoms Associated With Menopause: OASIS 1 and 2 Randomized Clinical Trials.

Importance: Safe and effective nonhormonal treatments for menopausal vasomotor symptoms (VMS) are needed.

Objective: To evaluate the efficacy and safety of elinzanetant, a selective neurokinin-1,3 receptor antagonist, for the treatment of moderate to severe menopausal vasomotor symptoms.

Design, Setting, And Participants: Two randomized double-blind phase 3 trials (OASIS 1 and 2) included postmenopausal participants aged 40 to 65 years experiencing moderate to severe vasomotor symptoms (OASIS 1: 77 sites in the US, Europe, and Israel from August 27, 2021, to November 27, 2023, and OASIS 2: 77 sites in the US, Canada, and Europe from October 29, 2021, to October 10, 2023).

Design of OASIS 1 and 2: phase 3 clinical trials assessing the efficacy and safety of elinzanetant for the treatment of vasomotor symptoms associated with menopause.

Objective: Elinzanetant is a selective neurokinin-1,3 receptor antagonist in development for the treatment of vasomotor symptoms (VMS) associated with menopause. The pivotal, double-blind, randomized, placebo-controlled phase 3 studies Overall Assessment of efficacy and Safety of elinzanetant In patients with vasomotor Symptoms (OASIS) 1 and 2 will assess the efficacy and safety of elinzanetant in women with VMS.

Methods: The OASIS 1 and 2 pivotal studies are designed in accordance with regulatory guidance.

Monitoring underwater volcano degassing using fiber-optic sensing.

Continuous monitoring of volcanic gas emissions is crucial for understanding volcanic activity and potential eruptions. However, emissions of volcanic gases underwater are infrequently studied or quantified. This study explores the potential of Distributed Acoustic Sensing (DAS) technology to monitor underwater volcanic degassing.

The Severity of Chronic Cough Diary (SCCD): development and content validation of a novel patient-reported outcome instrument for evaluating the symptom experience of chronic cough.

Background: Refractory chronic cough (RCC), a cough lasting longer than 8 weeks with an unexplained underlying etiology and unresponsive to conventional treatment, can have substantial effects on patients' quality of life. For assessment of the efficacy of antitussive medication in clinical trials in RCC, patient-reported outcome (PRO) instruments should be fit for purpose with appropriate content validity. Here we describe the qualitative testing of a newly developed PRO instrument: the Severity of Chronic Cough Diary (SCCD).

Patients' and clinicians' perspectives on item importance, scoring, and clinically meaningful differences for the Endometriosis Symptom Diary (ESD) and Endometriosis Impact Scale (EIS).

Background: The Endometriosis Symptom Diary (ESD) and Endometriosis Impact Scale (EIS) are patient-reported outcome measures developed to evaluate efficacy in clinical trials and clinical practice. The ESD is a daily electronic diary assessing symptom severity; the EIS is a weekly electronic diary assessing symptom impact. This study explored the importance of symptoms (ESD items) and impacts (EIS domains), perspectives on scoring algorithms, and clinically important difference (CID) thresholds to inform clinical trial score interpretation.

Validation of a menstrual pictogram and a daily bleeding diary for assessment of uterine fibroid treatment efficacy in clinical studies.

Background: To evaluate the psychometric and measurement properties of two patient-reported outcome instruments, the menstrual pictogram superabsorbent polymer-containing version 3 (MP SAP-c v3) and Uterine Fibroid Daily Bleeding Diary (UF-DBD). Test-retest reliability, criterion, construct validity, responsiveness, missingness and comparability of the MP SAP-c v3 and UF-DBD versus the alkaline hematin (AH) method and a patient global impression of severity (PGI-S) were analyzed in post hoc trial analyses.

Results: Analyses were based on data from up to 756 patients.

Comparing the EQ-5D-5L utility index based on value sets of different countries: impact on the interpretation of clinical study results.

Objective: To compare the country-specific value sets of the EQ-5D-5L utility index and to evaluate the impact on the interpretation of clinical study results. Six country value sets from Canada, England, Japan, Korea, Netherlands and Uruguay were obtained from literature. In addition, ten crosswalk value sets were downloaded from the EuroQol.

Patterns of missing data in the use of the endometriosis symptom diary.

Background: Endometriosis is a common, chronic condition in women of reproductive age that is characterized by the presence of functional endometriotic lesions outside the uterus. The Endometriosis Symptom Diary (ESD) is an electronic patient-reported outcome (ePRO) instrument that assesses women's experience of endometriosis symptoms, with pain scored using a 0-10 numeric rating scale. This study investigated patterns of data missing from the ESD in the VALEPRO study.

Mechanical and shape memory properties of porous NiTi alloys manufactured by selective laser melting.

Near equiatomic NiTi shape memory alloys were fabricated in dense and designed porous forms by Selective Laser Melting (SLM) and their mechanical and shape memory properties were systematically characterized. Particularly, the effects of pore morphology on their mechanical responses were investigated. Dense and porous NiTi alloys exhibited good shape memory effect with a recoverable strain of about 5% and functional stability after eight cycles of compression.

Prevalence of Antral Pseudocysts in the Pediatric Population.

Purpose: The purposes of this study were to determine the previously unreported prevalence of antral pseudocysts in an exclusively pediatric dental population, characterize their presentation, and investigate potential correlates to the presence of these lesions.

Methods: A tripartite chart review was conducted of 2,000 five- to 21-year-old pediatric dental patients at Yale-New Haven Hospital for the presence of antral pseudocysts identifiable on panoramic radiographs. Demographic, medical, and dental variables potentially influencing their pathogenesis were analyzed via descriptive statistics, odds ratios, and Fisher's exact test.

Osteonecrosis of the Jaw in Association With Chemotherapy in the Setting of Cutaneous T-Cell Lymphoma.

T-cell lymphomas (TCLs) account for approximately 15 to 20% of all non-Hodgkin lymphomas in the United States. The most common form of TCL is cutaneous TCL (CTCL), with Sézary syndrome and mycosis fungoides being the most prevalent subtypes. Sézary syndrome is the more aggressive form and often is referred to as a late-stage variant of mycosis fungoides.

Health outcomes in US children with abdominal pain at major emergency departments associated with race and socioeconomic status.

Objective: Over 9.6 million ED visits occur annually for abdominal pain in the US, but little is known about the medical outcomes of these patients based on demographics. We aimed to identify disparities in outcomes among children presenting to the ED with abdominal pain linked to race and SES.

Pediatric Patient and Hospital Characteristics Associated With Treatment of Peritonsillar Abscess and Peritonsillar Cellulitis.

Objective: To identify patient and hospital characteristics associated with the choice of treatment for pediatric patients who present in the acute setting with peritonsillar abscess/cellulitis (PTA/PTC).

Study Design: A retrospective cohort study was performed using Healthcare Cost and Utilization Project emergency department, ambulatory, and inpatient state databases for the years 2010 and 2011. Children aged 0 to 17 years were identified using International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) diagnosis code for PTA/PTC.

Metals for bone implants. Part 1. Powder metallurgy and implant rendering.

New metal alloys and metal fabrication strategies are likely to benefit future skeletal implant strategies. These metals and fabrication strategies were looked at from the point of view of standard-of-care implants for the mandible. These implants are used as part of the treatment for segmental resection due to oropharyngeal cancer, injury or correction of deformity due to pathology or congenital defect.

Pediatric soft tissue oral lesions.

This article provides an overview of common color changes and soft tissue oral nodular abnormalities in children and adolescents. The clinical presentation and treatment options to address these conditions are presented in a concise approach, highlighting key features relevant to the oral health care professional.

Characteristics and direct costs of academic pediatric subspecialty outpatient no-show events.

Background: Clinic no shows (NS) create a lost opportunity for provider-patient interaction and impose a financial burden to the healthcare system and on society. We aimed to: (1) to determine the clinical and demographic factors associated with increased NS rates at a children's hospital's subsubspecialty clinics and (2) to estimate the direct institutional financial costs associated with NS events.

Methods: A comprehensive database was generated from all clinic encounters for 15 subspecialty outpatient clinics (five surgical and 10 medical) between September 12, 2005 and December 30, 2010.

The biocompatibility of dense and porous Nickel-Titanium produced by selective laser melting.

Nickel-Titanium shape memory alloys (NiTi-SMA) are of biomedical interest due to their unusual range of pure elastic deformability and their elastic modulus, which is closer to that of bone than any other metallic or ceramic material. Newly developed porous NiTi, produced by Selective Laser Melting (SLM), is currently under investigation as a potential carrier material for human mesenchymal stem cells (hMSC). SLM enables the production of highly complex and tailor-made implants for patients on the basis of CT data.

Rehospitalization in the first 2 years of life in children born preterm.

Aim: Aim of the study is to investigate the frequency of and predictors for rehospitalization within the first 2 years of life among preterm infants.

Methods: All children born before 32 weeks of gestation in Northern Tyrol between January 2003 and July 2008 were prospectively enrolled. Data on rehospitalizations were obtained from hospital admission records.

Bispectral index monitoring of sedation depth in pediatric dental patients.

The bispectral index (BIS) monitor records electroencephalogram waveforms and provides an objective measure of the hypnotic effect of a sedative drug on brain activity. The aim of this pilot study was to use the BIS monitor to evaluate the depth of procedural sedation in pediatric dental patients and to assess if the BIS monitor readings correlate with a validated pediatric sedation scale, the University of Michigan Sedation Scale (UMSS), in determining the level of sedation in these patients. Thirty-five pediatric dental patients requiring sedation were studied prospectively.

Frontotemporal dementia or frontotemporal lobar degeneration--overview of a group of proteinopathies.

Frontotemporal dementia is the second most common early onset dementia after Alzheimer disease. Frontotemporal dementias are a complex group of dementias. The clinical diagnosis can be perplexing because of concurring psychiatric and neurologic syndromes.

Preliminary assessment of pediatric health care quality and patient safety in the United States using readily available administrative data.

Objectives: With >6 million hospital stays, costing almost $50 billion annually, hospitalized children represent an important population for which most inpatient quality indicators are not applicable. Our aim was to develop indicators using inpatient administrative data to assess aspects of the quality of inpatient pediatric care and access to quality outpatient care.

Methods: We adapted the Agency for Healthcare Research and Quality quality indicators, a publicly available set of measurement tools refined previously by our team, for a pediatric population.