Dixonhelbo1622

A previous cross-sectional study reported that nighttime light is associated with increased occurrence of manic symptoms in bipolar disorder; however, the longitudinal association between nighttime light and subsequent mood episode relapses remains unclear. We determined whether bedroom nighttime light was associated with mood episode relapses in patients with bipolar disorder.

This prospective cohort study included 172 outpatients with bipolar disorder who participated in an Association between the Pathology of Bipolar Disorder and Light Exposure in Daily Life (APPLE) cohort study. A portable photometer was used to measure illuminance in the bedroom from bedtime to rising time during 7 consecutive nights for baseline assessment. Then, the participants were assessed at a 2-year follow-up for mood episode relapses.

Of the 172 participants, 157 (91%) completed the 2-year follow-up, and 39 (22%) experienced manic or hypomanic episodes (with or without mixed features), during that time. ASN007 In the Cox proportional-hazards model, the hazard ratio (HR) for manic/hypomanic episode relapses was significantly higher when the average nighttime illuminance was ≥3lux (n=71) than when it was <3lux (n=101; HR, 2.54; 95% confidence interval (CI), 1.33-4.84). In the multivariable model adjusted for a propensity score in relation to nighttime light, the relationship remained significant (HR, 2.17; 95% CI, 1.04-4.52). The association between nighttime light and depressive episode relapses was not significantly different.

Keeping the bedroom dark at night may prevent hypomanic and manic episodes.

Keeping the bedroom dark at night may prevent hypomanic and manic episodes.Since the release of the ICH E9(R1) (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Addendum on Estimands and Sensitivity Analysis in Clinical Trials to the Guideline on Statistical Principles for Clinical Trials) document in 2019, the estimand framework has become a fundamental part of clinical trial protocols. In parallel, complex innovative designs have gained increased popularity in drug development, in particular in early development phases or in difficult experimental situations. While the estimand framework is relevant to any study in which a treatment effect is estimated, experience is lacking as regards its application to these designs. In a basket trial for example, should a different estimand be specified for each subpopulation of interest, defined, for example, by cancer site? Or can a single estimand focusing on the general population (defined, for example, by the positivity to a certain biomarker) be used? In the case of platform trials, should a different estimand be proposed for each drug investigated? In this work we discuss possible ways of implementing the estimand framework for different types of complex innovative designs. We consider trials that allow adding or selecting experimental treatment arms, modifying the control arm or the standard of care, and selecting or pooling populations. We also address the potentially data-driven, adaptive selection of estimands in an ongoing trial and disentangle certain statistical issues that pertain to estimation rather than to estimands, such as the borrowing of nonconcurrent information. We hope this discussion will facilitate the implementation of the estimand framework and its description in the study protocol when the objectives of the trial require complex innovative designs.

The long-term increase in survival from cutaneous malignant melanoma (CMM) is generally attributed to the decreasing trend in tumour thickness, the single most important prognostic factor.

To determine the relative contribution of decreased tumour thickness to the favourable trend in survival from CMM in Italy.

Eleven local cancer registries covering a population of 8 056 608 (13.4% of the Italian population in 2010) provided records for people with primary CMM registered between 2003 and 2017. Age-standardized 5-year net survival was calculated. Multivariate analysis of 5-year net survival was undertaken by calculating the relative excess risk (RER) of death. The relative contribution of the decrease in tumour thickness to the RER of death was evaluated using a forward stepwise flexible parametric survival model including the available prognostic factors.

Over the study period, tumour thickness was inversely associated with 5-year net survival and multivariate RER in both sexes. The median thickness opulation level in Europe is ill-defined. What does this study add? In Italy, the 5-year net survival from CMM in 2013-2017 improved vs. 2003-2007, especially among male patients and in the two highest tumour thickness categories. Male patients, for the first time, exhibited the same survival as female patients despite having still thicker lesions. The decrease in median tumour thickness accounted for a small part of the improvement. Novel therapies, approved in 2013, are the factor most likely to account for the remaining improvement.

Smoking contributes to the top 3 deadliest cancers, cancers of the lung, colon, and pancreas, which account for nearly 40% of all cancer-related deaths in the United States. Despite historicly low smoking rates, substantial disparities remain among people with mental health conditions and substance use disorders (SUDs).

The study examined the prevalence of smoking among adults from underserved communities who are served at federally qualified health centers through an analysis of the 2014 Health Center Patient Survey. Furthermore, the study assessed associations of smoking with co-occurring mental health conditions and SUDs among adult smokers (n = 1735).

The prevalence of smoking among health center patients was 28.1%. Among current smokers, 59.1% had depression and 45.4% had generalized anxiety. Non-Hispanic Black smokers had more than 2 times the odds of reporting SUDs (adjusted odds ratio [aOR], 2.13; 95% confidence interval [CI], 1.06-4.30). Individuals at or below 100% of the federal poverty levelts supporting cancer prevention care to address challenges confronted by vulnerable populations.This paper develops Bayesian sample size formulae for experiments comparing two groups, where relevant preexperimental information from multiple sources can be incorporated in a robust prior to support both the design and analysis. We use commensurate predictive priors for borrowing of information and further place Gamma mixture priors on the precisions to account for preliminary belief about the pairwise (in)commensurability between parameters that underpin the historical and new experiments. Averaged over the probability space of the new experimental data, appropriate sample sizes are found according to criteria that control certain aspects of the posterior distribution, such as the coverage probability or length of a defined density region. Our Bayesian methodology can be applied to circumstances that compare two normal means, proportions, or event times. When nuisance parameters (such as variance) in the new experiment are unknown, a prior distribution can further be specified based on preexperimental data. Exact solutions are available based on most of the criteria considered for Bayesian sample size determination, while a search procedure is described in cases for which there are no closed-form expressions. We illustrate the application of our sample size formulae in the design of clinical trials, where pretrial information is available to be leveraged. Hypothetical data examples, motivated by a rare-disease trial with an elicited expert prior opinion, and a comprehensive performance evaluation of the proposed methodology are presented.

Patients with advanced tumors often suffer from spinal metastatic tumor pain. The current drugs are less effective and have side effects. The objective was to explore the efficacy of iodine-125 particle implantation in the treatment of bone metastatic tumor pain.

In a retrospective study, a total of 27 patients with bone metastatic tumors who could not receive surgery or radiotherapy and chemotherapy were analyzed. All patients received conventional treatment, with the visual analog scale (VAS) of >3 points, and the daily onset pain of >3 times. All patients received CT-guided iodine-125 particle implantation to treat local painful lesions. VAS scores were recorded before treatment (T0) and 1 day (T1), 7 days (T2), 30 days (T3), 90 days (T4), and 180 days (T5) after treatment. Kaplan-Meier analytical method was used to calculate the local control rate (LCR) and survival rate (SR).

All patients successfully completed the CT-guided iodine-125 particle implantation. There was no significant difference in VAS scores before and 1 day after surgery. However, compared with pre-operation, the VAS scores decreased at 7, 30, 90, and 180 days after surgery. The postoperative follow-up was 6-38 months, with a median of 16 months; the LCR at 1, 2, and 3 years after the follow-up were 87%, 51%, and 21%, respectively, and the SR was 84%, 43%, and 16%, respectively. Moreover, no serious adverse reactions were observed.

Iodine-125 particle implantation was effective in the treatment of bone metastatic tumor pain without serious complications, and hence, can be used clinically.

Iodine-125 particle implantation was effective in the treatment of bone metastatic tumor pain without serious complications, and hence, can be used clinically.

Acute Intestinal ischemia (AII) may involve the small and/or large bowel after any process affecting intestinal blood flow. COVID-19-related gastrointestinal manifestations, including AII, have been attributed to pharmacologic effects, metabolic disorders in ICU patients and other opportunistic colonic pathogens. AII in COVID-19 patients may be due also to "viral enteropathy" and SARS-CoV-2-induced small vessel thrombosis. A critical appraisal of personal experience regarding COVID-19 and AII was carried out comparing this with a systematic literature review of published series.

A retrospective observational clinical cohort study and a systematic literature review including only COVID-19 positive patients with acute arterial or venous intestinal ischemia were performed. The primary endpoint of the study was the mortality rate. Secondary endpoints were occurrence of major complications and length of hospital stay.

Patient mean age was 62.9±14.9, with a prevalence of male gender (23 male, 72% vs. 9 femalroving and fastening the use of anticoagulants and trigger an extended indication for early abdominal CECT in patients with suggestive symptoms or biochemical markers of intestinal ischemia.

Our literature review showed how intestinal ischemia in patients with SARS-CoV-2 has been reported all over the world. The majority of the patients have a high CCI with multiple comorbidities, above all hypertension and cardiovascular disease. GI symptoms were not always present at the admission. A high level of suspicion for intestinal ischemia should be maintained in COVID-19 patients presenting with GI symptoms or with incremental abdominal pain. Nevertheless, a prompt thromboelastogram and laboratory test may confirm the need of improving and fastening the use of anticoagulants and trigger an extended indication for early abdominal CECT in patients with suggestive symptoms or biochemical markers of intestinal ischemia.