Low grade, indolent lymphomas of the head and neck: Comparative toxicity of standard versus very low dose radiation therapy.

National Comprehensive Cancer Network guidelines recommend radiation therapy (RT) for localized indolent non-Hodgkin lymphomas (iNHL). Many referring physicians avoid RT to the head and neck (HN) due to fears of toxicity. Very low-dose radiation (4 Gy) for select patients produces sustained local control and recently gained popularity. We compared early and late toxicities of standard 24-30 Gy to 4 Gy in patients with HN iNHL. We retrospectively analyzed 266 consecutive patients with HN iNHL receiving RT from 1994 to 2017. Patient characteristics, outcomes, and toxicities were collected from medical records. Early (≤2 months post-RT) and late (>2 months post-RT) toxicities were graded per Common Terminology Criteria for Adverse Events version 4. Grades 1-2 were defined as "low-grade" and 3-4 "high-grade." Toxicity incidence was compared between 4 and >4 Gy, grouped by treated site (orbit, nonorbital head, neck, skin) and early versus late. Median follow-up was 23 months (2-145) and 68 months (2-256) for 4Gy and >4 Gy cohorts, respectively. Median dose for the >4 Gy cohort was 30 Gy (10.5-54 Gy). Early and late toxicity incidences were lower in the 4 Gy cohort compared to >4 Gy across all RT-sites: early toxicity, orbit, 42% versus 96%; nonorbital head, 24% versus 96%; neck, 22% versus 94%; skin, 31% versus 87%; late toxicity, orbit, 20% versus 71%; nonorbital head, 6% versus 66%; neck, 6% versus 57%; skin, 0% versus 46% (4 Gy vs. >4 Gy, respectively). Toxicities among both cohorts were largely low-grade. High-grade early and late toxicities did not occur in the 4 Gy cohort. There was 1 high-grade early toxicity (Grade 3 dry mouth) and 17 high-grade late toxicities (Grade 3 cataracts) in the >4 Gy cohort. RT to HN for iNHL is associated with minimal short- and long-term toxicity and excellent local control among 4 Gy and >4 Gy treatments. In this setting, "toxicity" concerns should not deter oncologists from potentially curative RT. In select patients where toxicity remains a concern, very low dose 4 Gy could be considered.

Effects of choral singing versus health education on cognitive decline and aging: a randomized controlled trial.

We conducted a randomized controlled trial to examine choral singing's effect on cognitive decline in aging. Older Singaporeans who were at high risk of future dementia were recruited: 47 were assigned to choral singing intervention (CSI) and 46 were assigned to health education program (HEP). Participants attended weekly one-hour choral singing or weekly one-hour health education for two years. Change in cognitive function was measured by a composite cognitive test score (CCTS) derived from raw scores of neuropsychological tests; biomarkers included brain magnetic resonance imaging, oxidative damage and immunosenescence. The average age of the participants were 70 years and 73/93 (78.5%) were female. The change of CCTS from baseline to 24 months was 0.05 among participants in the CSI group and -0.1 among participants in the HEP group. The between-group difference (0.15, p=0.042) became smaller (0.12, p=0.09) after adjusting for baseline CCTS. No between-group differences on biomarkers were observed. Our data support the role of choral singing in improving cognitive health in aging. The beneficial effect is at least comparable than that of health education in preventing cognitive decline in a community of elderly people. Biological mechanisms underlying the observed efficacy should be further studied.

Adolescent mental health education InSciEd Out: a case study of an alternative middle school population.

BACKGROUND: Mental illness contributes substantially to global disease burden, particularly when illness onset occurs during youth and help-seeking is delayed and/or limited. Yet, few mental health promotion interventions target youth, particularly those with or at high risk of developing mental illness ("at-risk" youth). Community-based translational research has the capacity to identify and intervene upon barriers to positive health outcomes. This is especially important for integrated care in at-risk youth populations. METHODS: Here the Integrated Science Education Outreach (InSciEd Out) program delivered a novel school-based anti-stigma intervention in mental health to a cohort of seventh and eighth grade at-risk students. These students were assessed for changes in mental health knowledge, stigmatization, and help-seeking intentions via a classroom activity, surveys, and teacher interviews. Descriptive statistics and Cohen's d effect sizes were employed to assess pre-post changes. Inferential statistical analyses were also conducted on pilot results to provide a benchmark to inform future studies. RESULTS: Elimination of mental health misconceptions (substance weakness p = 0.00; recovery p = 0.05; prevention p = 0.05; violent p = 0.05) was accompanied by slight gains in mental health literacy (d = 0.18) and small to medium improvements in help-seeking intentions (anxiety d = 0.24; depression d = 0.48; substance d = 0.43; psychosis d = 0.53). Within this particular cohort of students, stigma was exceptionally low at baseline and remained largely unchanged. Teacher narratives revealed positive teacher views of programming, increased student openness to talk about mental illness, and higher peer and self-acceptance of mental health diagnoses and help-seeking. CONCLUSIONS: Curricular-based efforts focused on mental illness in an alternative school setting are feasible and integrated well into general curricula under the InSciEd Out framework. Preliminary data suggest the existence of unique help-seeking barriers in at-risk youth. Increased focus upon community-based programming has potential to bridge gaps in translation, bringing this critical population to clinical care in pursuit of improved mental health for all. Trial registration ClinicalTrials.gov, ID:NCT02680899. Registered 12 February 2016, https://clinicaltrials.gov/ct2/show/NCT02680899.

Single-dose fluoroquinolone therapy of acute uncomplicated urinary tract infection in women: results from a randomized, double-blind, multicenter trial comparing single-dose to 3-day fluoroquinolone regimens.

OBJECTIVES: To compare the efficacy and safety of single-dose and 3-day fluoroquinolone treatment of uncomplicated urinary tract infection (UTI). METHODS: Adult women with acute uncomplicated UTI were randomized to receive either a single dose of gatifloxacin (400 mg), 3 days of gatifloxacin (200 mg daily), or 3 days of ciprofloxacin (100 mg twice daily). Patients were assessed at four points during the study: before treatment (within 48 hours before the initiation of the study medication), at the end of treatment (by telephone contact on day 3), and twice after treatment completion (5 to 9 days after treatment [test-of-cure visit] and 29 to 42 days after treatment [only patients with a bacteriologic response of eradication at the test-of-cure visit]). RESULTS: The bacterial eradication rate for the single-dose gatifloxacin, 3-day gatifloxacin, and 3-day ciprofloxacin groups was 90%, 95%, and 89%, respectively; the clinical efficacy rate was 93%, 95%, and 93%, respectively, for microbiologically assessable patients at the test-of-cure visit. Eradication of the most common uropathogens, including Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis, was achieved with gatifloxacin and ciprofloxacin. Single-dose gatifloxacin was equivalent to 3-day ciprofloxacin in both microbiologic and clinical efficacy. CONCLUSIONS: Single-dose and 3-day gatifloxacin were microbiologically and clinically equivalent to 3-day ciprofloxacin for the treatment of acute UTI among women. Single-dose gatifloxacin may offer advantages over 3-day fluoroquinolone therapy for uncomplicated UTI by decreasing secondary use of medical resources and improving patient compliance.

A randomized, double-blind, multicenter comparison of gatifloxacin versus ciprofloxacin in the treatment of complicated urinary tract infection and pyelonephritis.

BACKGROUND: Gatifloxacin is a fluoroquinolone antibiotic with a broad spectrum of in vitro and in vivo activity against the gram-negative and gram-positive pathogens frequently implicated in urinary tract infections (UTIs). OBJECTIVE: This study compared the clinical and bacteriologic efficacy and tolerability of gatifloxacin versus ciprofloxacin in adult patients with complicated UTIs or pyelonephritis. METHODS: In this double-blind, multicenter, randomized, comparative study, patients were treated with either gatifloxacin 400 mg once daily or ciprofloxacin 500 mg twice daily for 7 to 10 days. Bacteriologic eradication (by quantitative urine culture) and clinical efficacy rates were assessed at a test-of-cure visit (5 to 9 days and 4 to 11 days posttreatment, respectively) and at an extended follow-up visit (29-42 days and 25-50 days posttreatment, respectively). RESULTS: A total of 372 adults were randomized to treatment, 189 to gatifloxacin and 183 to ciprofloxacin. The most commonly isolated pretreatment pathogens (n = 292) were Escherichia coli (53%) and Klebsiella pneumoniae (13%). Pathogen eradication rates for complicated UTIs were 92% and 83% with gatifloxacin and ciprofloxacin, respectively (95% CI, -4.1% to 24.5%); for pyelonephritis, the respective rates were 92% and 85% (95% CI, -20% to 37%). Clinical response rates of >90% were observed in both treatment groups among patients with complicated UTIs as well as those with pyelonephritis. Sustained eradication rates were 76% (64/84) with gatifloxacin and 66% (52/79) with ciprofloxacin. Both drugs were well tolerated, with the most common adverse events in both treatment groups being nausea, dizziness, diarrhea, and vomiting. CONCLUSIONS: Gatifloxacin is comparable to ciprofloxacin based on clinical efficacy and bacteriologic eradication rates for the treatment of complicated UTIs or pyelonephri- tis and is associated with a low incidence of clinically significant adverse events.