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BACKGROUND: During the COVID-19 pandemic, American Society for Testing and Materials level 3 and level 2 medical face masks (MFMs) have been used for most health care workers and even for the first responders owing to a shortage of N95 respirators. However, the MFMs lack effective peripheral seal, leading to concerns about their adequacy to block aerosol exposure for proper protection. The purpose of this study was to evaluate the peripheral seal of level 3 and level 2 MFMs with a 3-dimensional (3D-) printed custom frame. METHODS: Level 3 and level 2 MFMs were tested on 10 participants with and without a 3D-printed custom frame; the efficiency of mask peripheral seal was determined by means of quantitative fit testing using a PortaCount Fit Tester based on ambient aerosol condensation nuclei counter protocol. RESULTS: The 3D-printed custom frame significantly improved the peripheral seal of both level 3 and level 2 MFMs compared with the masks alone (P < .001). In addition, both level 3 and level 2 MFMs with the 3D-printed custom frame met the quantitative fit testing standard specified for N95 respirators. PRACTICAL IMPLICATIONS: The 3D-printed custom frame over level 3 and level 2 MFMs can offer enhanced peripheral reduction of aerosols when using collapsible masks. With the shortage of N95 respirators, using the 3D-printed custom frame over a level 3 or level 2 MFM is considered a practical alternative to dental professionals.

To improve room temperature stability and oral bioavailability of mavatrep (JNJ-39439335, a transient receptor potential vanilloid subtype-1 antagonist), various formulations were initially developed and evaluated in 2 phase 1 open-label, randomized, 3-way crossover studies in healthy participants. Study 1 evaluated 2 new overencapsulated tablet formulations (formulations B and C) relative to an overencapsulated early tablet formulation (formulation A), using mavatrep HCl salt form. Because these tablets were still not room-temperature stable, in study 2: two free-base solid dispersion amorphous formulations (formulations D and E) were evaluated relative to the best encapsulated formulation from study 1 (formulation C) and also food effect. Both studies had screening (∼4 weeks), treatment (study 1: n = 18, 6-sequenced; formulations B and C [2 × 25 mg] versus A [2 × 25 mg]; study 2, part 1: n = 24, formulations D and E [2 × 12.5 mg] versus C [1 × 25 mg]; study 2, part 2: n = 16, best formulation from part 1 fed versus fasted, 2 × 12.5 mg) with a 21-day washout period and a follow-up. Mavatrep exhibited consistent pharmacokinetics across formulations. Following rapid absorption (median tmax , 1.5-6.5 hours), plasma concentrations declined multiexponentially (mean t1/2 , 67-104 hours). The new encapsulated tablet formulation (formulation C, capsule filler: poloxamer 407) was the best formulation (Cmax and AUC values 2-3-fold > than the other 2) from study 1. Using this as a reference in study 2, part 1, only small (

Background Uncooperative pediatric mask induction is linked to perioperative anxiety. Although some risk factors for uncooperative inductions have been reported, there are no large cohort studies that identify intrinsic patient characteristics associated with cooperation. Aim The primary aim was to identify patient characteristics associated with cooperative mask inductions. The secondary aim was to determine whether preoperative interventions were associated with increased cooperation. Methods This retrospective cohort study included patients 2-11 years old and ASA class I-IV who underwent mask induction. Our primary outcome of interest was cooperation with mask induction, which was correlated against the Induction Compliance Checklist. The variables analyzed for association with cooperation were age, sex, ASA class, class of surgery, preferred language, and race. Interventions examined for association with induction cooperation included premedication with midazolam, exposure to distraction technology, parental presence, and the presence of a Child Life Specialist. Multivariate mixed-effects logistic regression was used to assess the relationship between patient characteristics and cooperation. A separate multivariate mixed-effects logistic regression was used to examine the association between preoperative interventions and cooperation. Results 9692 patients underwent 23 474 procedures during the study period. 3372 patients undergoing 5980 procedures met inclusion criteria. The only patient characteristic associated with increased cooperation was age (OR 1.20, p-value 0.03). Involvement of Child Life Specialists was associated with increased cooperation (OR 4.44, p-value = 0.048) while parental/guardian presence was associated with decreased cooperation (OR 0.38, p-value = 0.002). Conclusion In this cohort, increasing age was the only patient characteristic found to be associated with increased cooperation with mask induction. Preoperative intervention by a Child Life Specialists was the sole intervention associated with improved cooperation.

This single-center, double-blind, placebo-controlled, sequential-group phase 1 study evaluated the safety, tolerability, and pharmacokinetics (PK) of mavatrep (JNJ-39439335), a transient receptor potential vanilloid 1 antagonist, in healthy Japanese and caucasian subjects. In part 1, a single-ascending-dose study, 50 subjects (25 each healthy Japanese and caucasians) were enrolled and received a single oral dose of 10, 25, or 50 mg mavatrep. Caucasian subjects were matched to Japanese subjects with respect to age (±5 years) and body mass index (±5 kg/m2 ). In part 2, a multiple-ascending-dose study, 36 Japanese subjects were enrolled and received once-daily oral doses of 10, 25, or 50 mg of mavatrep for 21 days. The single-dose PK of mavatrep and its metabolites was similar in the Japanese and caucasian subjects after adjustment of body weight. Following multiple dosing in Japanese subjects, a steady-state condition was reached in approximately 14 days. M2 and M3 are major circulating metabolites with mean exposure > 10% of mavatrep. Nonrenal clearance was the major route of elimination for mavatrep, M2, and M3. Mavatrep exhibited a long half-life, ranging from 68 to 101 and 82-130 hours for Japanese and caucasian subjects, respectively. After single and multiple dosing, mavatrep was well tolerated. The most common adverse events observed were thermohypoesthesia, feeling cold, chills, and feeling hot. Mavatrep and its metabolites exhibited similar PK profiles after single ascending doses in healthy Japanese and caucasian men.

Introduction The office-based endovascular facility has increased in number recently due in part to expedient patient experience. This study analyzed treatment outcomes of procedures performed in our office-based endovascular suite. Methods Treatment outcomes of 5134 consecutive procedures performed in our office-based endovascular suites from 2006 to 2013 were analyzed. Five sequential groups (group I–V) of 1000 consecutive interventions were compared with regard to technical success and treatment outcomes. Results Our patients included 2856 (56%) females and 2267 (44%) males. Procedures performed included diagnostic arteriogram, arterial interventions, venous interventions, dialysis access interventions, and venous catheter management, which were 1024 (19.9%), 1568 (30.6%), and 3073 (60.0%), 621(12.1%), and 354 (6.9%), respectively. The complication rates for group I, II, III, IV, and V were 3%, 1.5%, 1%, 1.1%, and 0.7%, respectively. The complication rate was higher in group I when compared to each of the remaining four groups ( p Conclusions Endovascular procedure can be performed safely in an office-based facility with excellent outcomes. Lessons learned in establishing office-based endovascular suites with efforts to reduce procedural complications and optimize quality patient care are discussed.

This article examines and compares the extent of microleakage after 24 hours in freshly extracted teeth using three newer or "third generation" dentin bonding agents. Gluma/Pekalux and Scotchbond 2/Silux were more effective in preventing microleakage in cementum/dentin margins than was Universal Bond/Prisma Micro-fine.