A multi-analyte assay of opioids in API and drug products using HPLC and HRMS.

Surveillance testing is an essential component to ensuring safe, effective, and high-quality drug products are available in the commercially marketed US supply chain. Surveillance allows the agency to assess product quality and monitor for potential adulteration of drug products being used by consumers. Opioid drug products can be adulterated to enhance the effect of the intended active ingredient.

Educational competencies for telehealth physical therapy: Results of a modified Delphi process.

Background: Telehealth is becoming more prevalent in physical therapy, involving a whole host of clinical services. These services are often provided without structured training in telehealth, and no formal curricula currently exist for this purpose.

Objective: To develop a set of educational competencies (ECs) to guide instruction of telehealth-related skills in entry-level programs (i.

Quality of New Domestic Hand Sanitizer Drug Product Manufacturers During COVID-19.

The FDA initiated a cross-sectional, statistically based sampling and testing study to characterize the quality of marketed alcohol-based hand sanitizer (ABHS) by evaluating the alcohol content and impurities present in ABHS products manufactured by establishments that registered with the FDA during March-April 2020. A stratified sampling design divided the population of manufacturers into independent groups based on each establishment's level of experience with FDA oversight and its geographic location. ABHS products were collected and analyzed by spatially offset Raman spectroscopy and gas chromatography with mass spectrometry (GC-MS).

WAGR, Sex Reversal, Bilateral Gonadoblastomas, and Intralobar Nephrogenic Rests: Uncertainties of Pre-Biopsy Chemotherapy in a High Risk Syndrome for Nephroblastoma.

WT1 deletions are associated with nephroblastomas, WT mutations are associated with 46, XY sex reversal. It is unclear why only a few WT1 deletions are associated with sex reversal. .

Elevated preoptic brain activity in zebrafish glial glycine transporter mutants is linked to lethargy-like behaviors and delayed emergence from anesthesia.

Delayed emergence from anesthesia was previously reported in a case study of a child with Glycine Encephalopathy. To investigate the neural basis of this delayed emergence, we developed a zebrafish glial glycine transporter (glyt1 - / -) mutant model. We compared locomotor behaviors; dose-response curves for tricaine, ketamine, and 2,6-diisopropylphenol (propofol); time to emergence from these anesthetics; and time to emergence from propofol after craniotomy in glyt1-/- mutants and their siblings.

Intratumoral Translocation Positive Heterogeneity in Pediatric Alveolar Rhabdomyosarcoma Tumors Correlates to Patient Survival Prognosis.

Alveolar rhabdomyosarcoma (ARMS) is characterized by one of three translocation states: (2;13) (q35;q14) producing PAX3-FOXO1, (1;13) (p36;q14) producing PAX7-FOXO1, or translocation-negative. Tumors with (2;13) are associated with greater disease severity and mortality than (1;13) positive or translocation negative patients. Consistent with this fact, previous work concluded that a molecular analysis of RMS translocation status is essential for the accurate determination of prognosis and diagnosis.

Long-term prognosis of patients treated by coronary sinus-based percutaneous annuloplasty: single centre experience.

Aims: This study aims to report long-term mortality, echocardiographic, and clinical outcomes of patients receiving treatment for functional mitral regurgitation (FMR) with the Carillon device.

Methods And Results: This was a single centre analysis of prospectively collected data from patients treated with the Carillon Mitral Contour System for symptomatic congestive heart failure despite guideline-directed medical therapy, who were included from a single centre from the TITAN II study. All patients presented with New York Heart Association (NYHA) class 2 or greater symptoms, grade 2+ to 4+ FMR, left ventricular enlargement, and reduced ejection fraction.

Missed radiographic and clinical findings in a case of non-idiopathic scoliosis resulting from chondroblastoma.

Purpose: Chondroblastoma is a cartilaginous neoplasm which rarely presents in the spine, where it has been shown to exhibit aggressive behavior. We present a case of a late diagnosis of a T12 chondroblastoma causing paraparesis in an 11-year-old girl. Several missed classical radiographic and clinical features are highlighted.

Regeneration and expansion of autologous full-thickness skin through a self-propagating autologous skin graft technology.

New autologous skin regeneration technology yielded full-thickness skin as evidenced by clinical observation and skin biopsy 5 months after surgery, providing relief for debilitating split-thickness skin graft contracture in a pediatric burn case.

The REDUCE FMR Trial: A Randomized Sham-Controlled Study of Percutaneous Mitral Annuloplasty in Functional Mitral Regurgitation.

Objectives: This study sought to evaluate the effects of the Carillon device on mitral regurgitation severity and left ventricular remodeling.

Background: Functional mitral regurgitation (FMR) complicates heart failure with reduced ejection fraction and is associated with a poor prognosis.

Methods: In this blinded, randomized, proof-of-concept, sham-controlled trial, 120 patients receiving optimal heart failure medical therapy were assigned to a coronary sinus-based mitral annular reduction approach for FMR or sham.

Eruptive xanthoma in the setting of hypertriglyceridemia and pancreatitis.

Background: Undifferentiated dermatologic complaints are often encountered in the emergency department. While a patient's exposures, risk factors, and comorbidities may help guide emergency department evaluation, the accurate diagnosis of dermatologic findings is critical to allowing rapid identification and treatment of disease.

Case: In this vignette we discuss a case of eruptive xanthoma in a 33-year-old male with diabetic ketoacidosis and pancreatitis.

Fatal Scopulariopsis brumptii in a Pediatric Immunocompromised Host.

Scopulariopsis species cause a broad range of disease, from superficial skin infections to often fatal disseminated disease in the immunocompromised that is refractory to standard antifungal treatment. This report describes the first case of fatal disseminated Scopulariopsis brumptii in a pediatric patient with hyper-IgM syndrome status post bone marrow transplant.

Pediatric Chondromyxoid Fibroma-Like Osteosarcoma.

Chondromyxoid fibroma-like osteosarcoma (CMF-OS) is a low-grade osteosarcoma, often misdiagnosed on initial biopsy as a benign lesion, with five cases previously described. We report a 13-year-old male with an intramedullary lytic CMF-OS of the right tibial proximal metaphysis with cortical destruction and soft tissue extension. Diagnosis was based on malignant new bone formation, increased mitotic figures, lamellar bone permeation with bony destruction, and correlation with imaging studies.

Unusual case of neonatal hypercalcemia.

We present a rare case of neonatal hyperparathyroidism secondary to a homozygous calcium sensing receptor (CASR) mutation, diagnosed by the genetics team. The CASR mutation is a homozygous inactivating mutation at the calcium sensing receptor. Inactivation of the receptor leads to hypercalcemia and activation leads to hypocalcemia.

Randomized controlled study of excimer laser atherectomy for treatment of femoropopliteal in-stent restenosis: initial results from the EXCITE ISR trial (EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis).

Objectives: The purpose of this study was to evaluate the safety and efficacy of excimer laser atherectomy (ELA) with adjunctive percutaneous transluminal angioplasty (PTA) versus PTA alone for treating patients with chronic peripheral artery disease with femoropopliteal bare nitinol in-stent restenosis (ISR).

Background: Femoropopliteal stenting has shown superiority to PTA for lifestyle-limiting claudication and critical limb ischemia, although treating post-stenting artery reobstruction, or ISR, remains challenging.

Methods: The multicenter, prospective, randomized, controlled EXCITE ISR (EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis) trial was conducted across 40 U.

Plasma FGF23 and the risk of stroke: the Northern Manhattan Study (NOMAS).

Objective: To examine fibroblast growth factor 23 (FGF23) as a risk factor for incident stroke in a racially/ethnically diverse population-based urban cohort.

Methods: Stroke-free Northern Manhattan Study participants with FGF23 measurements (n = 2,525) were followed for a mean of 12 (±5) years to detect incident strokes. We used Cox proportional hazards models to estimate the association of baseline FGF23 with incident total, ischemic, and hemorrhagic stroke.

Histologic differences in placentas of preeclamptic/eclamptic gestations by birthweight, placental weight, and time of onset.

With preeclampsia/eclampsia (PE/E), infants more often are either large or small for gestational age. We explored whether the differences in infant birthweight (BW), placental weights (PW), or time of onset are associated with histologic features of maternal vascular underperfusion. A retrospective chart identified 243 PE/E gestations between 2007 and 2010.

Photoablation using the turbo-booster and excimer laser for in-stent restenosis treatment: twelve-month results from the PATENT study.

Purpose: To evaluate the performance of the Turbo Elite laser catheter in combination with the Turbo-Booster guiding catheter for the treatment of femoropopliteal in-stent restenosis (ISR).

Methods: The PATENT study (Photoablation Using the Turbo-Booster and Excimer Laser for In-Stent Restenosis Treatment) was a multicenter prospective industry-sponsored registry involving 5 European centers. Patients with symptomatic femoropopliteal ISR (Rutherford categories 2-5) and an ankle-brachial index ≤0.

Protein timing and its effects on muscular hypertrophy and strength in individuals engaged in weight-training.

The purpose of this review was to determine whether past research provides conclusive evidence about the effects of type and timing of ingestion of specific sources of protein by those engaged in resistance weight training. Two essential, nutrition-related, tenets need to be followed by weightlifters to maximize muscle hypertrophy: the consumption of 1.2-2.

Necrotizing enterocolitis and cytomegalovirus infection in a premature infant.

Necrotizing enterocolitis is the most common gastrointestinal emergency in neonates. The etiology is considered multifactorial. Risk factors include prematurity, enteral feeding, hypoxia, and bacterial colonization.