Efficacy of Intravesical Nadofaragene Firadenovec for Patients With Bacillus Calmette-Guérin-Unresponsive Nonmuscle-Invasive Bladder Cancer: 5-Year Follow-Up From a Phase 3 Trial.

Purpose: Nadofaragene firadenovec-vncg is a nonreplicating adenoviral vector-based gene therapy for bacillus Calmette-Guérin (BCG)-unresponsive carcinoma in situ (CIS) with/without high-grade Ta/T1. We report outcomes following 5 years of planned follow-up.

Materials And Methods: This open-label phase 3 trial (NCT02773849) enrolled patients with BCG-unresponsive nonmuscle-invasive bladder cancer in 2 cohorts: CIS ± Ta/T1 (CIS; n = 107) and Ta/T1 without CIS (Ta/T1 cohort; n = 50).

Comparison of middle- and bottom-up mass spectrometry in forced degradation studies of bevacizumab and infliximab.

Monoclonal antibodies (mAbs) used as therapeutics need comprehensive characterization for appropriate quality assurance. For analysis, cost-effective methods are of high importance, especially when it comes to biosimilar development which is based on extended physicochemical characterization. The use of forced degradation to study the occurrence of modifications for analysis is well established in drug development and may be used for the evaluation of critical quality attributes (CQAs).

The Role of Magnetic Resonance Imaging of the Temporomandibular Joint to Investigate Tinnitus in Adults with Temporomandibular Joint Disorder: A Comparative Study.

 The prevalence of tinnitus is higher in individuals with temporomandibular joint disorder (TMD) than in the general population. Magnetic resonance imaging (MRI) of the temporomandibular joint (TMJ) is the method of choice for investigation, and it has been hypothesized that specific MRI findings might be observed in TMD with comorbid tinnitus.  To comparatively describe MRI findings in patients with TMD with and without tinnitus, identifying the most common TMJ alterations and determining whether a correlation exists between severity of TMD and tinnitus.

Sleep Disorders in Patients with Temporomandibular Disorders (TMD) in an Adult Population-Based Cross-Sectional Survey in Southern Brazil.

Purpose: To verify the prevalence of sleep disorders in temporomandibular disorders (TMD) subjects in a Brazilian population-based, cross-sectional survey (N = 1,643).

Materials And Methods: Patients were assessed with the Research Diagnostic Criteria for TMD (RDC/TMD) Axes I and II and the Sleep Assessment Questionnaire. Student t test and Pearson chi-square test were used for continuous and categorical data analyses, respectively.

Forced Degradation Testing as Complementary Tool for Biosimilarity Assessment.

Oxidation of monoclonal antibodies (mAbs) can impact their efficacy and may therefore represent critical quality attributes (CQA) that require evaluation. To complement classical CQA, bevacizumab and infliximab were subjected to oxidative stress by HO for 24, 48, or 72 h to probe their oxidation susceptibility. For investigation, a middle-up approach was used utilizing liquid chromatography hyphenated with mass spectrometry (LC-QTOF-MS).

Current Methods of Bruxism Diagnosis: A Short Communication.

Purpose: To assess the current diagnostic methods for sleep bruxism (SB).

Materials And Methods: This review of the literature evaluates all available instrumental and noninstrumental methods of bruxism/SB diagnosis.

Results: SB diagnosis can be performed using self-reports and clinical examination, but these methods have little agreement with polysomnography.

Depression and Somatization in Patients with Temporomandibular Disorders in a Population-Based Cross-Sectional Study in Southern Brazil.

Purpose: To assess the prevalence of depression and somatization in patients with temporomandibular disorders (TMD) in a Brazilian population-based cross-sectional survey.

Materials And Methods: A total of 1,643 subjects were assessed for TMD using the Research Diagnostic Criteria for Temporomandibular Disorders Axes I and II and were assessed for depression and somatization using the Graded Chronic Pain Scale. The data were cross-tabulated for comparison between TMD subjects and controls.

SQ house dust mite sublingual immunotherapy tablet subgroup efficacy and local application site reaction duration.

Background: Allergic rhinitis with or without conjunctivitis (AR/C) is common, necessitating evaluation of SQ house dust mite (HDM) sublingual immunotherapy (SLIT)-tablet efficacy in various subgroups.

Objective: To evaluate 12 SQ-HDM efficacy and safety across subgroups, and the onset, duration, and recurrence of local application site reactions.

Methods: Subgroup (age, sex, race, asthma status, and allergen sensitization) efficacy was assessed using pooled data from 2 previously described trials of daily 12 SQ-HDM vs placebo for AR/C (n = 2,138).

Clinical benefits of treatment with SQ house dust mite sublingual tablet in house dust mite allergic rhinitis.

Treatment with SQ (standardised quality) house dust mite sublingual tablet for 1 year resulted in a decreased probability of having an allergic rhinitis (AR) exacerbation day (from 11% [placebo] to 5% [SQ house dust mite sublingual tablet]) and an increased probability of having a mild AR day (from 16% [placebo] to 34% [SQ house dust mite sublingual tablet]).

Efficacy of house dust mite sublingual immunotherapy tablet in North American adolescents and adults in a randomized, placebo-controlled trial.

Background: The house dust mite (HDM) sublingual immunotherapy (SLIT) tablet (MK-8237; Merck & Co, Kenilworth, NJ/ALK-Abelló, Hørsholm, Denmark) has demonstrated beneficial effects on allergic rhinoconjunctivitis and asthma outcomes in European trials.

Objective: This is the first trial to assess the efficacy/safety of HDM SLIT-tablets in North American subjects with HDM-induced allergic rhinitis with or without conjunctivitis (AR/C).

Methods: In this double-blind, multicenter trial (NCT01700192) 1482 subjects (aged ≥12 years) with HDM-induced AR/C with or without asthma were randomized to a daily SQ HDM SLIT-tablet (12 SQ-HDM dose) or placebo for up to approximately 52 weeks.

SQ house dust mite (HDM) SLIT-tablet provides clinical improvement in HDM-induced allergic rhinitis.

House dust mite (HDM) allergy represents a highly prevalent inhalant allergy, and exposure to HDM allergens results in allergic rhinitis with persistent symptoms that may not be adequately controlled with available allergy pharmacotherapy. Allergy immunotherapy constitutes a complementary treatment option targeting the underlying immunological mechanisms of allergic disease and represents the only treatment with a potential for disease modification and long-term efficacy. As traditional allergy immunotherapy delivered by subcutaneous injection of specific HDM allergens involves a time-consuming treatment regimen and a risk of systemic adverse reactions, sublingually administered allergy immunotherapy (SLIT) has been investigated as a more convenient treatment option with similar levels of efficacy and an improved safety profile that allows for at-home daily administration.

Effective treatment of house dust mite-induced allergic rhinitis with 2 doses of the SQ HDM SLIT-tablet: Results from a randomized, double-blind, placebo-controlled phase III trial.

Background: The SQ HDM SLIT-tablet (ALK) has been developed for treatment of house dust mite (HDM)-induced respiratory allergic disease.

Objective: This trial investigated the efficacy and safety of the SQ HDM SLIT-tablet in adults with moderate-to-severe HDM-induced allergic rhinitis (AR).

Methods: The trial was a randomized, double-blind, placebo-controlled phase III trial conducted in 12 European countries including 992 adults with moderate-to-severe HDM-induced AR despite treatment with pharmacotherapy.

Analysis of the effects of a mandibular advancement device on sleep bruxism using polysomnography, the BiteStrip, the sleep assessment questionnaire, and occlusal force.

Purpose: This before and after study evaluated the effects of a mandibular advancement device (MAD) on sleep bruxism (SB) activity and its associated signs and symptoms.

Materials And Methods: Nineteen young adults (39.9 ± 12.

Effects of the bite splint 15-day treatment termination in patients with temporomandibular disorder with a clinical history of sleep bruxism: a longitudinal single-cohort study.

Objective: The aim of this study was to assess the effects of bite splint (BS) treatment termination in patients treated for temporomandibular disorder (TMD) and sleep bruxism (SB).

Study Design: This longitudinal single-cohort study assessed 30 patients (29.5 ± 7.

Comparative study of bactericidal activities, postantibiotic effects, and effects of bacterial virulence of penicillin G and six macrolides against Streptococcus pneumoniae.

In this report, we present MIC, bactericidal activity, postantibiotic effect (PAE), and in vivo infectivity data for postantibiotic-phase pneumococci. We compared and evaluated penicillin G and six macrolides, erythromycin, azithromycin, clarithromycin, dirithromycin, roxithromycin, and spiramycin, against 10 strains of pneumococci with various levels of susceptibility to penicillin. All of the agents, except azithromycin, exhibited a bactericidal effect (a > or = 3 log10 decrease in the number of CFU per milliliter) after 4 h of exposure to a concentration equal to 10 times the MIC, displaying the following hierarchy: spiramycin = penicillin G = erythromycin = dirithromycin = clarithromycin = roxithromycin > azithromycin.

Cisapride for intractable constipation in children: observations from an open trial.

Twelve patients with chronic constipation refractory to the vigorous use of emollients, enemas, and/or laxatives were chosen for study of the investigational prokinetic agent, Cisapride. The patients included 8 boys and 4 girls with diagnoses of functional constipation. Ages ranged from 2 to 13 years; duration of symptoms before Cisapride use ranged from 1.

The Myopter viewer: an instrument for treating and preventing myopia.

A new instrument has been developed for utilization in attempts at myopia therapy and control. The inventor discusses instrument design and treatment procedures, and suggests an explanation for the movement of juvenile eyes from hypermetropia into myopia.