Efficacy, tolerability, and bone density outcomes of elagolix with add-back therapy for endometriosis-associated pain: twelve months of an ongoing randomized phase 3 trial.

Background: Elagolix, an approved oral treatment for endometriosis-associated pain, has been associated with hypoestrogenic effects when used as monotherapy. Hormonal add-back therapy has the potential to mitigate these effects.

Objective: To evaluate efficacy, tolerability, and bone density outcomes of elagolix 200 mg twice daily with 1 mg estradiol/0.

Surface tension between liquids containing antagonistic and regular salts.

We investigate theoretically the surface tension between two immiscible liquids containing antagonistic and regular salts. The mean-field model includes the electrostatic energy and the Gibbs transfer energy of the ions. We find the Donnan potential difference between the liquids and solve the Poisson-Boltzmann equation to calculate the potential and ion density profiles.

Low-Dose Elagolix for the Treatment of Heavy Menstrual Bleeding in Patients With Uterine Leiomyomas: A Randomized Controlled Trial.

Objective: To evaluate the safety and efficacy of elagolix 150 mg once-daily monotherapy in patients with heavy menstrual bleeding associated with uterine leiomyomas.

Methods: A phase 4, randomized, double-blind, placebo-controlled, 6-month treatment study was conducted in premenopausal patients aged 18-51 years with heavy menstrual bleeding (defined as menstrual blood loss greater than 80 mL during one menstrual cycle) associated with uterine leiomyomas. Patients were randomized 2:1 to receive elagolix 150 mg once daily or placebo.

Predicting Contrast-induced Renal Complications.

Chronic kidney disease is an independent risk factor for the development of coronary artery disease and overlaps with other risk factors such as hypertension and diabetes. Percutaneous coronary intervention is a cornerstone of therapy for coronary artery disease and requires contrast media, which can lead to renal injury. Identifying patients at risk for contrast-associated acute kidney injury (CA-AKI) is critical for preventing kidney damage, which is associated with both short- and long-term mortality.

Nucleation by a charged particle in fluids containing salt.

We present a model to describe ion-induced nucleation in fluids. Nucleation is induced by a charged molecular aggregate, a large ion, a charged colloid, or an aerosol particle. This model generalizes the Thomson model to polar environments.

Circulating Ectonucleotidases Signal Impaired Myocardial Perfusion at Rest and Stress.

Background Ectonucleotidases maintain vascular homeostasis by metabolizing extracellular nucleotides, modulating inflammation and thrombosis, and potentially, myocardial flow through adenosine generation. Evidence implicates dysfunction or deficiency of ectonucleotidases CD39 or CD73 in human disease; the utility of measuring levels of circulating ectonucleotidases as plasma biomarkers of coronary artery dysfunction or disease has not been previously reported. Methods and Results A total of 529 individuals undergoing clinically indicated positron emission tomography stress testing between 2015 and 2019 were enrolled in this single-center retrospective analysis.

Symptoms and associated impact in pre- and postmenopausal women with sexual arousal disorder: a concept elicitation study.

Background: Approximately 26% of adult women in the United States suffer from female sexual arousal disorder (FSAD), yet little has been done to compare the experience of FSAD in pre- and postmenopausal women, which is critical to enhance the current understanding of FSAD and inform the development and assessment of treatment options for these patient populations.

Aim: To explore the experience of condition-associated symptoms and the relative importance of FSAD symptoms, including their severity, bother, and impact, on participants' health-related quality of life (HRQoL) in pre- and postmenopausal women with FSAD.

Methods: In-depth, qualitative, semistructured concept elicitation interviews were conducted with premenopausal (n = 23) and postmenopausal (n = 13) women who were clinically diagnosed with FSAD by a trained sexual medicine clinician.

Phase lines in mean-field models with nonuniform external forces.

We look at the influence of external fields on systems described by generic free energy functional of the order parameter. The external force may have arbitrary spatial dependence, and the order parameter coupling may be nonlinear. The treatment generalizes seemingly disparate works, such as pure fluids, liquid and polymer mixtures, lipid monolayers, and colloidal suspensions in electric fields, fluids, and nematics in gravity, solutions in an ultracentrifuge, and liquid mixtures in laser radiation.

Contraceptive efficacy and safety of the 52-mg levonorgestrel intrauterine system for up to 8 years: findings from the Mirena Extension Trial.

Background: The 52-mg levonorgestrel-releasing intrauterine system is an established, long-acting contraceptive option with approved use for up to 7 years.

Objective: The Mirena Extension Trial evaluated the efficacy and safety of the 52-mg levonorgestrel-releasing intrauterine system during extended use beyond 5 and up to 8 years.

Study Design: This was a multicenter, single-arm study in the United States, enrolling existing users of the 52-mg levonorgestrel-releasing intrauterine system, aged 18 to 35 years, who have had the system for 4.

Liquid nucleation around charged particles in the vapor phase.

We theoretically investigate the nucleation of liquid droplets from vapor in the presence of a charged spherical particle. Due to field gradients, sufficiently close to the critical point of the vapor-gas system, the charge destabilizes the vapor phase and initiates a phase transition. The fluid's free energy is described by the van der Waals expression augmented by electrostatic energy and a square-gradient term.

Pneumatic Impedance of Spit Socks and N95 Masks: The Applicability to Death Investigation.

Introduction: Restrained subjects often spit on law enforcement and corrections officers and medical responders. Based on the droplet-transmitted risk of COVID-19, such spitting could be considered a potentially life-threatening assault. Officers commonly use "spit socks" over the head and neck of spitting subjects to reduce this risk.

Global cross-sectional survey of women with vasomotor symptoms associated with menopause: prevalence and quality of life burden.

Objective: To determine prevalence and health-related quality of life (HRQOL) of moderate-to-severe vasomotor symptoms (VMS) in postmenopausal women in Europe, the US, and Japan, and among subgroups of women not taking hormone therapy (HT).

Methods: Screening surveys were sent to a random sample of women aged 40 to 65 years; full questionnaires followed to those who completed them and met inclusion criteria. Women with successfully treated VMS, breast cancer, or on HT for medical conditions were excluded.

Efficacy, safety, and tolerability of a levonorgestrel/ethinyl estradiol transdermal delivery system: Phase 3 clinical trial results.

Objective: To assess the contraceptive efficacy, safety, and tolerability of a contraceptive transdermal delivery system, (TDS; TWIRLA) containing levonorgestrel (LNG) and ethinyl estradiol (EE).

Study Design: This single-arm, open-label, multicenter, 1-year (13 cycle), phase 3 study enrolled sexually active women ≥18 years old at risk for pregnancy irrespective of body mass index (BMI). Women used patches in 28-day cycles (3 consecutive administrations of 7-day patches followed by 7 days off-treatment/patch-free week).

Predicting Contrast-Induced Renal Complications.

Chronic kidney disease is a major risk factor for developing coronary artery disease, serving as an independent risk factor while overlapping with other risk factors. Percutaneous coronary intervention is a cornerstone of therapy for coronary artery disease and requires contrast media, which can contribute to renal injury. Identifying patients at risk for contrast-induced nephropathy is critical for preventing renal injury, which is associated with short- and long-term mortality.

Surface tension in liquids containing antagonistic ions.

We use a modified Poisson-Boltzmann formalism to examine immiscible electrolytes containing dissolved antagonistic ions with arbitrary preferential solubilities. We solve the nonlinear equation and obtain an analytical expression for the potential profile, ion densities, and surface tension. Our model takes into account the dependence of the Debye lengths in the two liquids on the preferential solvation.

Usability of daily SF36 questionnaires to capture the QALD variation experienced after vaccination with AS03-adjuvanted monovalent influenza A (H5N1) vaccine in a safety and tolerability study.

Background: This study aims to describe the short-term reactogenicity of the AS03-adjuvanted H5N1 vaccine expressed through adverse events (AEs) and quality-adjusted life-day (QALD) scores. The AEs are likely to be short-term and therefore the quality of life (QoL) questionnaire, SF-36v2, was administered daily to record changes over seven days. A more sensitive application of this instrument should allow for a better understanding of short-term tolerability of adjuvanted vaccines.

Investigating intervention dose frequency for children with speech sound disorders and motor speech involvement.

Background: Treatment outcome data for children with severe speech sound disorders with motor speech involvement (SSD-MSI) are derived from Phase I clinical research studies. These studies have demonstrated positive improvements in speech production. Currently there is no research examining the optimal treatment dose frequency for this population.

Cirrhotic cardiomyopathy: the liver affects the heart.

Cirrhotic cardiomyopathy historically has been confused as alcoholic cardiomyopathy. The key points for diagnosis of cirrhotic cardiomyopathy have been well explained, however this entity was neglected for a long time. Nowadays the diagnosis of this entity has become important because it is a factor that contributes significantly to morbidity-mortality in cirrhotic patients.

Oral 17β-estradiol/progesterone (TX-001HR) and quality of life in postmenopausal women with vasomotor symptoms.

Objective: The aim of the study was to describe the effects of TX-001HR (17β-estradiol [E2] and natural progesterone [P4] in a single oral capsule) on menopause-specific quality of life in women with moderate to severe vasomotor symptoms (VMS).

Methods: The REPLENISH study (NCT01942668) was a phase 3, randomized, double-blind, placebo-controlled, multicenter trial which evaluated four E2/P4 doses in postmenopausal women with VMS and a uterus. Women with moderate to severe hot flushes (≥7/d or ≥50/wk) were included in a VMS substudy.

Ulipristal Acetate for Treatment of Uterine Leiomyomas: A Randomized Controlled Trial.

Objective: To assess the efficacy and tolerability of ulipristal acetate, a selective progesterone receptor modulator, for treatment of symptomatic uterine leiomyomas.

Methods: This phase 3, double-blind, double-dummy, placebo-controlled trial randomized premenopausal women (18-50 years) with uterine leiomyomas and abnormal uterine bleeding to once-daily 5 mg ulipristal, 10 mg ulipristal, or placebo in two 12-week treatment courses separated by a drug-free interval of two menses. Coprimary end points were rates of and time to amenorrhea during course 1.

Electrical weapons and excited delirium: shocks, stress, and serum serotonin.

It has been suggested that a CEW (conducted electrical weapon) exposure could elicit a stress response that could cause ExDS (excited delirium syndrome). There are some parallels between the signs of ExDS and serotonin syndrome (SS). Electroconvulsive therapy raises serotonin levels and therefore provides a plausible link between CEW applications and elevated serotonin levels.

Mortality Predictors in the Surgical Treatment of Active Infective Endocarditis.

Introduction: Active infective endocarditis is associated with high morbidity and mortality. Surgery is indicated in high-risk conditions, and the main determinants of mortality in surgical treatment should be evaluated.

Objective: To identify mortality predictors in the surgical treatment of active infective endocarditis in a long-term follow-up.