Pharmacokinetics and safety of bictegravir in pregnant and postpartum persons with HIV and their infants.

Background: Limited data exist on bictegravir pharmacokinetics in pregnancy among persons with HIV (PWH) and infant washout.

Setting: Nonrandomized, open-label, multi-center phase-IV prospective study of bictegravir pharmacokinetics and safety in pregnant PWH and their infants.

Methods: Steady-state 24-hour pharmacokinetic sampling of oral bictegravir 50 mg once daily (a component of fixed-dose combination bictegravir/emtricitabine/tenofovir alafenamide) during the 2nd and 3rd trimesters and postpartum was performed.

Pediatric glossopharyngeal neuralgia with incidental trigeminal compression treated using microvascular decompression: illustrative case.

Background: Glossopharyngeal neuralgia (GPN) is a rare condition typically manifesting as paroxysms of sharp, lancinating pain localized to the middle ear and auditory canal, base of the tongue, tonsillar fossa, and region just inferior to the angle of the mandible. Vascular compression is a common etiology, and microvascular decompression (MVD) has been established as a safe and efficacious treatment in adults. With the exception of one report of an adult patient undergoing the procedure for symptomatology that began in adolescence, there are no published cases of MVD for GPN in pediatric patients to the author's knowledge.

The key role of sufficiency for low demand-based carbon neutrality and energy security across Europe.

A detailed assessment of a low energy demand, 1.5 C compatible pathway is provided for Europe from a bottom-up, country scale modelling perspective. The level of detail enables a clear representation of the potential of sufficiency measures.

Successful Reimplantation of Extruded Ulnar Diaphyseal Segment: A Case Report and Review of Literature.

Case: A 32-year-old man presented with a type II open both-bone forearm fracture and segmental bone loss because of complete extrusion of a diaphyseal fragment (3 cm) of ulna. The patient presented to our level 1 trauma center after a motor vehicle collision. The extruded segment underwent sterilization and immediate reimplantation with internal fixation approximately 6 hours after arrival.

Management of Elbow Terrible Triad Injuries: A Comprehensive Review and Update.

The "terrible triad" of the elbow, encompassing elbow dislocation, radial head fracture, and coronoid process fracture, remains a formidable challenge in orthopaedic practice. Typically, stabilizing structures in the elbow fail from lateral to medial through a posterolateral rotatory force after a fall onto an outstretched upper extremity. Surgery is often needed to repair the lateral ligamentous complex, replace or fix the radial head, possibly repair the anterior capsule or fix the coronoid, and consider medial repair or application of an internal versus external fixator.

Spectral Features Analysis for Print Quality Prediction in Additive Manufacturing: An Acoustics-Based Approach.

Quality prediction in additive manufacturing (AM) processes is crucial, particularly in high-risk manufacturing sectors like aerospace, biomedicals, and automotive. Acoustic sensors have emerged as valuable tools for detecting variations in print patterns by analyzing signatures and extracting distinctive features. This study focuses on the collection, preprocessing, and analysis of acoustic data streams from a Fused Deposition Modeling (FDM) 3D-printed sample cube (10 mm × 10 mm × 5 mm).

Application of Delta T1 maps for quantitative and objective assessment of extent of resection and survival prediction in glioblastoma.

Background And Objectives: Gross-total resection (GTR) and low residual tumor volume (RTV) have been associated with increased survival in glioblastoma. Largely due to the subjectivity involved, the determination of GTR and RTV remains difficult in the postoperative setting. In response, the objective of this study is to evaluate the clinical efficacy of an easy-to-use MRI metric, called delta T1 (dT1), to quantify extent of resection (EOR) and RTV, in comparison to radiologist impression, to predict overall survival (OS) in glioblastoma patients.

Pharmacokinetics and Safety of Remdesivir in Pregnant and Nonpregnant Women With COVID-19: Results From IMPAACT 2032.

Background: Pregnant people with coronavirus disease 2019 (COVID-19) experience higher risk for severe disease and adverse pregnancy outcomes, but no pharmacokinetic (PK) data exist to support dosing of COVID-19 therapeutics during pregnancy. We report PK and safety data for intravenous remdesivir in pregnancy.

Methods: IMPAACT 2032 was a phase 4 prospective, open-label, nonrandomized opportunistic study of hospitalized pregnant and nonpregnant women receiving intravenous remdesivir as part of clinical care.

Impact of postsurgical rehabilitation on outcomes for degenerative cervical myelopathy.

Objective: Despite widespread use, there is limited evidence to support postsurgical rehabilitation to enhance neurological recovery after surgery for degenerative cervical myelopathy (DCM). Outcomes research for DCM seldom accounts for the effect of postsurgical rehabilitation. The aim of this study was to quantify the impact of postsurgical rehabilitation on outcomes after surgery for DCM.

Safety and pharmacokinetics of oral and long-acting injectable cabotegravir or long-acting injectable rilpivirine in virologically suppressed adolescents with HIV (IMPAACT 2017/MOCHA): a phase 1/2, multicentre, open-label, non-comparative, dose-finding study.

Background: Combined intramuscular long-acting cabotegravir and long-acting rilpivirine constitute the first long-acting combination antiretroviral therapy (ART) regimen approved for adults with HIV. The goal of the IMPAACT 2017 study (MOCHA [More Options for Children and Adolescents]) was to assess the safety and pharmacokinetics of these drugs in adolescents.

Methods: In this phase 1/2, multicentre, open-label, non-comparative, dose-finding study, virologically suppressed adolescents (aged 12-17 years; weight ≥35 kg; BMI ≤31·5 kg/m) with HIV-1 on daily oral ART were enrolled at 15 centres in four countries (Botswana, South Africa, Thailand, and the USA).

Concentrations of remdesivir and GS-441524 in human milk from lactating individuals diagnosed with COVID-19.

Findings from this study provide further reassuring evidence that infant exposure through human milk received from lactating individuals who require treatment with remdesivir is negligible.

Midline Sacral Fractures: Review of the Literature.

Introduction: Sacral fractures are an important consideration in high-energy traumas associated with injuries to the pelvic ring that confer much of pelvic stability. A midline longitudinal sacral fracture (MLS) is a relatively rare fracture pattern, with only 23 cases of MLS fractures reported in the literature to date. This systematic review evaluates overall mechanisms of MLS injury, associated injuries, complications, management, and fracture prognosis.

Brief Report: Dolutegravir Plasma Protein Binding and Unbound Concentrations During Pregnancy and Postpartum.

Background: Clinical interpretation of the reduced dolutegravir (DTG) plasma concentrations reported during pregnancy is complicated by its high plasma protein binding. Plasma proteins significantly decrease during pregnancy, and understanding changes in DTG protein binding and its therapeutically active unbound concentrations are necessary to evaluate the impact of pregnancy changes on DTG pharmacokinetics.

Methods: Retrospective assessment of plasma samples from pregnant women living with HIV enrolled in the International Maternal Pediatric Adolescent AIDS Clinical Trials Network P1026s study receiving 50 mg DTG film-coated tablets once daily as part of clinical care.

Pharmacokinetics and safety of first-line tuberculosis drugs rifampin, isoniazid, ethambutol, and pyrazinamide during pregnancy and postpartum: results from IMPAACT P1026s.

Physiological changes during pregnancy may alter the pharmacokinetics (PK) of antituberculosis drugs. The International Maternal Pediatric Adolescent AIDS Clinical Trials Network P1026s was a multicenter, phase IV, observational, prospective PK and safety study of antiretroviral and antituberculosis drugs administered as part of clinical care in pregnant persons living with and without HIV. We assessed the effects of pregnancy on rifampin, isoniazid, ethambutol, and pyrazinamide PK in pregnant and postpartum (PP) persons without HIV treated for drug-susceptible tuberculosis disease.

Efficacy, Safety, and Tolerability of Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate Fixed-Dose Combination Tablets in Adolescents Living With HIV: Results Through Week 96 from IMPAACT 2014.

Background: IMPAACT 2014 study is a phase I/II, multicenter, open-label, nonrandomized study of doravirine (DOR) co-formulated with lamivudine (3TC) and tenofovir disoproxil fumarate (TDF) as fixed-dose combination (DOR FDC) in adolescents with HIV-1. We report the efficacy, safety, and tolerability of DOR FDC through 96 weeks.

Methods: Participants were adolescents aged 12 to <18 years who weighed at least 45 kg and who were either antiretroviral (ARV)-naïve or virologically suppressed without documented resistance mutations to DOR/3TC/TDF.

Functional and Radiographic Outcomes of Cavernous Meningiomas Based on Treatment Modality.

 Cavernous sinus meningiomas (CSMs) are challenging given their proximity to neurovascular structures. Treatments include surgery, radiation, or observation. There are little data comparing outcomes based on treatment.

Cannabidiol Exposure Through Maternal Marijuana Use: Predictions in Breastfed Infants.

Background And Objective: Knowledge about exposure to cannabidiol (CBD) in breastfed infants can provide an improved understanding of potential risk. The aim was to predict CBD exposure in breastfed infants from mothers taking CBD and CBD-containing products.

Methods: Cannabidiol concentrations in milk previously attained from data collected through an existing human milk research biorepository were used to simulate infant doses and identify subgroups.

Open surgical ligation of a thoracic spinal epidural arteriovenous fistula causing thoracic myelopathy: illustrative case.

Background: Spinal epidural arteriovenous fistulas (eAVFs) are rare spinal vascular malformations characterized by an abnormal connection from the paraspinal and paravertebral system to the epidural venous plexus. This contrasts with the more frequently seen spinal dural AVF, where the fistula is entirely intradural. Although endovascular repair is commonly performed for spinal eAVF, few cases require open surgical ligation.

Atraumatic Exertional Compartment Syndrome of the Medial Foot: Case Report.

Introduction: Acute compartment syndrome is a surgical emergency that is mainly diagnosed clinically. Acute exertional compartment syndrome of the medial compartment of the foot is a rare condition most often result from strenuous exercise. Early diagnosis is most often a clinical examination, however, laboratory and magnetic resonance imaging (MRI) can assist in the diagnosis if clinician uncertainty persists.

Translating Clinical Pharmacology Data in Pregnancy to Evidence-Based Guideline Recommendations: Perspectives From the HIV Field.

Pharmacokinetic (PK) studies in pregnant, postpartum, and breastfeeding people are critical to informing appropriate medication use and dosing. A key component of translating PK results in these complex populations into clinical practice involves the systematic review and interpretation of data by guideline panels, composed of clinicians, scientists, and community members, to leverage available data for informed decision making by clinicians and patients and offer clinical best practices. Interpretation of PK data in pregnancy involves evaluation of multiple factors such as the study design, target population, and type of sampling performed.