OBJECTIVE: The objective was the comparison of an occlusal device (OD), and sleep hygiene and progressive muscle relaxation (SH & PMR) on perceived stress and sleep bruxism activity (burst/episode and episode/hour) in participants with sleep bruxism.
METHODS: Sixty-six participants with self-reported sleep bruxism were selected and randomly allocated into two groups: OD group or SH & PMR group. Assessment of perceived stress and sleep bruxism activity were the primary outcomes. The Perceived Stress Scale-10 (PSS-10 scale) was used to measure perceived stress and bruxism episodes/hour and bursts/episode recorded by electromyography of masseter and temporalis. These outcomes were assessed at baseline, 1 month, 6 months, and 1 year. The paired t-test assessed changes in PSS-10 scores and sleep bruxism activity within the same group over different time points (baseline, 1 month, 6 months, and 1 year). The unpaired t-test compared scores between two groups (OD and SH & PMR) at each time point to evaluate intervention differences. The chi-square test compared gender distribution between both groups.
RESULTS: PSS-10 scores were found to decrease with the OD at 1 month and 6 months compared to baseline and SH & PMR at all subsequent follow-ups. This decrease was not statistically significant (p > 0.05) between the OD and SH & PMR groups at all follow-ups. OD and SH & PMR significantly reduced bruxism episodes/hour and bursts/episode at all follow-ups (p < 0.05). There were no adverse effects related to any intervention.
CONCLUSIONS: The OD and SH & PMR both effectively reduced PSS-10 scores over 6 months and significantly decreased bruxism episodes and bursts per episode. Both methods are safe and effective for managing sleep bruxism and reducing stress.

OBJECTIVE: Many cancer patients wish for complementary and integrative medicine (CIM) consultations led by their oncology physician. Within the KOKON-KTO study, oncology physicians in the intervention group were trained in a blended learning to provide CIM consultations to their cancer patients in addition to distributing a leaflet about CIM websites. Control oncology physicians only distributed the leaflet. The training showed positive effects on the patient-level. As of now, no consistent evidence exists on the long-term effects of such one-time-only CIM consultation during cancer treatment.
METHODS: In the KOKON-KTO follow-up study, cancer patients previously participating in the KOKON-KTO study (intervention group:IG and control group: CG) received, at least 24 months later, a follow-up questionnaire by post, evaluating long-term effects of the KOKON-KTO consultation using the measures provided in the original study (patient-physician communication (EORTC-QLQ-COMU2), satisfaction with cancer treatment (PS-CaTE), CIM disclosure with healthcare provider (HCP), and need for CIM consultation during cancer therapy).
RESULTS: In total, 102 cancer patients participated in the follow-up study (IG n = 62; CG n = 40). The overall reponse rate was around 36% (IG: 48.4%; CG: 23.7%). In the follow-up study, differences between groups had increased and were still shown (EORTC-QLQ-COMU26, 0-100 point scale, ≥10-point-group difference) in some subscales: patient\'s active behavior (in means; IG:73.6 (95% CI, 63.8-83.5); CG:61.1 (95% CI, 52.4-69.8)); clinician-patient relationship (IG:80.9 (95% CI, 71.8-90.0); CG:68.7 (95% CI, 59.3-78.0)). For some outcomes, differences decreased over time (e.g., EORTC-QLQ-COMU26 subscales \"takes into account patient\'s preference\" and \"corrects misunderstandings\"). More patients in the CG used CIM without oncology physicians\' knowledge (IG: 13.7%, CG: 24.0%).
CONCLUSIONS: This study presents first findings that one-time-only CIM consultations may enhance patient-physican relationship and CIM disclosure long-term. To further support cancer patients\' in their wish for CIM consultations, training programs should provide oncology physicians with CIM competencies for different cancer stages including cancer survivors.

BACKGROUND: Statins are widely used for treating patients with ischemic stroke at risk of secondary cerebrovascular events. It is unknown whether Asian populations benefit from more intensive statin-based therapy for stroke recurrence. Therefore, in the present study we evaluated the effectiveness and safety of high-dose and moderate-dose statins for patients who had experienced mild ischemic stroke during the acute period.
RESULTS: This multicenter prospective study included patients with mild ischemic stroke who presented within 72 hours of symptom onset. The outcomes of patients in the high-intensity and moderate-intensity statin treatment groups were compared, with the main efficacy outcome being stroke recurrence and the primary safety end point being intracranial hemorrhage. The propensity score matching method was employed to control for imbalances in baseline variables. Subgroup analyses were conducted to evaluate group differences. In total, the data of 2950 patients were analyzed at 3 months, and the data of 2764 patients were analyzed at 12 months due to loss to follow-up. According to the multivariable Cox analyses adjusted for potential confounders, stroke recurrence occurred similarly in the high-intensity statin and moderate-intensity statin groups (3 months: adjusted hazard ratio [HR], 1.12 [95% CI, 0.85-1.49]; P=0.424; 12 months: adjusted HR, 1.08 [95% CI, 0.86-1.34]; P=0.519). High-intensity statin therapy was associated with an increased risk of intracranial hemorrhage (3 months: adjusted HR, 1.81 [95% CI, 1.00-3.25]; P=0.048; 12 months: adjusted HR, 1.86 [95% CI, 1.10-3.16]; P=0.021). The results from the propensity score-matched analyses were consistent with those from the Cox proportional hazards analysis.
CONCLUSIONS: Compared with moderate-intensity statin therapy, high-dose statin therapy may not decrease the risk of mild, noncardiogenic ischemic stroke recurrence but may increase the risk of intracranial hemorrhage.
BACKGROUND: URL: www.chictr.org.cn/. Unique Identifier: ChiCTR1900025214.

OBJECTIVE: The clinical efficacy and safety of a novel left atrial appendage (LAA) occluder of the SeaLA closure system in patients with nonvalvular atrial fibrillation (NVAF) were reported.
BACKGROUND: Patients with NVAF are at a higher risk of stroke compared to healthy individuals. Left atrial appendage closure (LAAC) has emerged as a prominent strategy for reducing the risk of thrombosis in individuals with NVAF.
METHODS: A prospective, multicenter study was conducted in NVAF patients with a high risk of stroke.
RESULTS: The LAAC was successfully performed in 163 patients. The mean age was 66.93 ± 7.92 years, with a mean preoperative CHA2DS2-VASc score of 4.17 ± 1.48. One patient with residual flow >3 mm was observed at the 6-month follow-up, confirmed by TEE. During the follow-up, 2 severe pericardiac effusions were noted, and 2 ischemic strokes were observed. Four device-related thromboses were resolved after anticoagulation treatment. There was no device embolism.
CONCLUSIONS: The LAAC with the SeaLA device demonstrates encouraging feasibility, safety, and efficacy outcomes.

OBJECTIVE: To analyze the impact of prior therapies on outcomes with selinexor, bortezomib, and dexamethasone (SVd) versus bortezomib and dexamethasone (Vd) in 402 patients with relapsed/refractory multiple myeloma (RRMM) in the phase 3 BOSTON trial.
METHODS: Post hoc analysis of progression-free survival (PFS), overall survival (OS), and safety for lenalidomide-refractory, proteasome inhibitor (PI)-naïve, bortezomib-naïve, and one prior line of therapy (1LOT) patient subgroups.
RESULTS: At a median follow-up of over 28 months, clinically meaningful improvements in PFS were noted across all groups with SVd. The median SVd PFS was longer in all subgroups (lenalidomide-refractory: 10.2 vs. 7.1 months, PI-naïve: 29.5 vs. 9.7; bortezomib-naïve: 29.5 vs. 9.7; 1LOT: 21.0 vs. 10.7; p < .05). The lenalidomide-refractory subgroup had longer OS with SVd (26.7 vs. 18.6 months; HR 0.53; p = .015). In all subgroups, overall response and ≥very good partial response rates were higher with SVd. The manageable safety profile of SVd was similar to the overall patient population.
CONCLUSIONS: With over 2 years of follow-up, these clinically meaningful outcomes further support the use of SVd in patients who are lenalidomide-refractory, PI-naïve, bortezomib-naïve, or who received 1LOT (including a monoclonal antibody) and underscore the observed synergy between selinexor and bortezomib.

BACKGROUND: Cardiovascular disease is the leading cause of death among patients with Duchenne muscular dystrophy (DMD). Identifying patients at risk of early death could allow for increased monitoring and more intensive therapy. Measures that associate with death could serve as surrogate outcomes in clinical trials.
RESULTS: Duchenne muscular dystrophy subjects prospectively enrolled in observational studies were included. Models using generalized least squares were used to assess the difference of cardiac magnetic resonance measurements between deceased and alive subjects. A total of 63 participants underwent multiple cardiac magnetic resonance imaging and were included in the analyses. Twelve subjects (19.1%) died over a median follow-up of 5 years (interquartile range, 3.1-7.0). Rate of decline in left ventricular ejection fraction was faster in deceased than alive subjects (P<0.0001). Rate of increase in indexed left ventricular end-diastolic (P=0.0132) and systolic (P<0.0001) volumes were higher in deceased subjects. Faster worsening in midcircumferential strain was seen in deceased subjects (P=0.049) while no difference in global circumferential strain was seen. The rate of increase in late gadolinium enhancement, base T1, and mid T1 did not differ between groups.
CONCLUSIONS: Duchenne muscular dystrophy death is associated with the rate of change in left ventricular ejection fraction, midcircumferential strain, and ventricular volumes. Aggressive medical therapy to decrease the rate of progression may improve the mortality rate in this population. A decrease in the rate of progression may serve as a valid surrogate outcome for therapeutic trials.

UNASSIGNED: The objective was to develop an innovative method of training emergency medicine (EM) resident physicians to perform the head impulse test (HIT) component of the HINTS (head impulse test, nystagmus, test of skew) examination using video-oculography (VOG) device feedback.
UNASSIGNED: Using principles from motor learning theory and Ericsson\'s framework for expertise, we developed a training innovation utilizing VOG device feedback to teach the degree (10°-20°) and velocity (>100°/s) of head turn required for the HIT. We assessed the technical ability of participants to perform the HIT using the VOG device, without feedback, to count the number of successful HITs out of 20 attempts before, immediately after, and 2 weeks after the training innovation. Participants rated their confidence on a 1 to 5 Likert scale before and 2 weeks after training.
UNASSIGNED: Most participants (11 of 14, 78%) were unable to perform even one successful HIT in 20 attempts before training despite brief verbal and visual instruction regarding the head turn parameters. However, most participants achieved more than one success, in fact, all with at least five successes, immediately after training (13 of 14, 93%) and again 2 weeks after training (nine of 11, 82%). The median (interquartile range) number of successful HITs was 0 (0, mean 0.79) during baseline testing, 7.5 (5.8) immediately after training, and 10 (8.0) 2 weeks after training (p < 0.01, Kruskal-Wallis). The median confidence rating increased from 1.5 (1) before baseline testing to 3 (1.5) after follow-up testing (p = 0.02, Mann-Whitney U).
UNASSIGNED: Prior to motor training, most participants failed to properly perform the HIT. Feedback training with VOG devices may facilitate development of the skills required to properly perform the HIT. Further study is needed to assess the ability to train the interpretive aspect of the HIT and other components of the HINTS examination.

OBJECTIVE: A higher risk of cancer among patients with heart failure (HF) has been suggested in recent community-based studies. This study aimed to investigate the impact of HF during hospitalization with acute coronary syndrome (ACS) on the long-term cancer risk.
RESULTS: The study included 572 patients admitted with ACS to three Italian hospitals, discharged cancer-free, and prospectively followed for 24 years or until death. All but three patients completed the follow-up, which represented 6440 person-years (mean age: 66 ± 12 years; 70% males). Baseline HF was diagnosed in 192 (34%) patients. A total of 129 (23%) patients developed cancer (103 without HF and 26 with HF), and 107 (19%) patients died due to it (81 without HF and 26 with HF). The incidence rates for cancer onset and cancer death were not different according to HF status. Cox regression analysis revealed no association between HF or left ventricular ejection fraction (LVEF) and cancer risk. In addition, no difference in cancer risk was observed among patients with HF with preserved ejection fraction, HF with mildly reduced ejection fraction, and HF with reduced ejection fraction. In competing risk regression analysis, the risk of cancer onset associated with HF was sub-hazard ratio (SHR) 0.47 [95% confidence interval (CI): 0.30-0.72; P = 0.001] and SHR 1.02 (95% CI: 1.01-1.04; P = 0.002) with LVEF. Results were the same in the adjusted model. Yet the fully adjusted model showed an attenuated association between cancer death and HF (SHR: 0.63; 95% CI: 0.37-1.05; P = 0.08) and LVEF (SHR: 1.02; 95% CI: 0.99-1.06; P = 0.08). Consistent results were obtained after using propensity score matching analysis that created 192 pairs. A negative interaction between age and HF and a positive interaction between age and LVEF for cancer risk have also been found.
CONCLUSIONS: An inverse association between baseline HF and long-term cancer risk has been observed among the ABC Study on heart disease patients who were followed for 24 years after ACS.

BACKGROUND: A healthy lifestyle is an important factor for preventing heart failure. However, the association between outdoor light exposure time and heart failure is still unknown. The aim of this study was to examine the association between outdoor light exposure time and the incidence of heart failure.
RESULTS: This cohort study included participants from the UK Biobank recruited from 2006 to 2010 who were 40 to 70 years of age and free of heart failure at baseline. The mean follow-up time was 12.61 years. The outdoor light exposure time was self-reported at baseline. A restricted cubic spline was performed to examine the potential nonlinear relationship between outdoor light exposure and the incidence of heart failure. Cox proportional hazard models were used to estimate the hazard ratios (HRs) and 95% CIs. During a mean follow-up of 12.61 years, 13 789 participants were first diagnosed with heart failure. There was a nonlinear (J-shaped) trend between outdoor light time and heart failure risk. Cox proportional hazard regression models showed that, compared with participants who received an average of 1.0 to 2.5 hours of outdoor light per day, those with <1.0 hours or >2.5 hours had a higher risk of heart failure after the model was adjusted for age and sex (<1.0 hours: HR, 1.27 [95% CI, 1.18-1.36]; >2.5 hours: HR, 1.11 [95% CI, 1.07-1.15]). These associations were still significant in the fully adjusted models (<1.0 hours: HR, 1.10 [95% CI, 1.03-1.18]; >2.5 hours: HR, 1.07 [95% CI, 1.03-1.11]).
CONCLUSIONS: We found a J-shaped association between outdoor light exposure time and the risk of incident heart failure, suggesting that moderate exposure to outdoor light may be a prevention strategy for heart failure.

OBJECTIVE: Many congenital hydronephroses spontaneously resolve. This study evaluated a long-term follow-up of more than 4 years of patients with congenital hydronephrosis at a single center.
METHODS: In total, 215 patients (286 kidneys) with congenital hydronephrosis were included. Hydronephrosis outcomes (resolution, improvement, and persistence) and time-to-outcome were evaluated.
RESULTS: Fourteen patients underwent early surgical intervention until the age of 2 years. A total of 189 congenital hydronephrosis cases (66%) showed resolution at a median of 16 months (interquartile range: 7-21 months) and 169 (80%) of 210 kidneys with grade I to II hydronephrosis showed resolution at a median of 14 months (interquartile range: 6-23 months). Of 76 kidneys with grade III to IV hydronephrosis, 24 (32%) showed resolution at a median of 29 months (interquartile range: 24-41 months), and 56 (74%) showed improvement to grade II or less at a median of 12 months (interquartile range: 5-23 months). Of the 76 kidneys with grade III to IV hydronephrosis, five required delayed pyeloplasty at a median of 66 months (interquartile range: 42-89 months). One patient was asymptomatic, with a marked worsening of hydronephrosis and decreased renal function 6 years after the resolution of hydronephrosis.
CONCLUSIONS: None of the patients with grade I to II hydronephrosis required surgical treatment, and a shorter follow-up may be sufficient. Grade III to IV severe hydronephrosis should be considered for a longer and more careful follow-up, given the possibility of asymptomatic exacerbation of hydronephrosis.