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Among the few interventions that exist to decrease weight stigma in exercise settings, none include a long-term follow-up to assess if changes are sustained. The aim of this study was to assess if a weight stigma intervention that showed success in improving fat attitudes among university recreation center professionals had sustained effects after three months, compared to a control group. Participants were 46 university recreation center professionals who took the Fat Attitudes Assessment Toolkit before completing a two-hour self-paced online intervention or control course, after course completion, and at a three-month follow-up. At follow-up, participants in the intervention group showed significant improvement in total fat attitudes, F (2, 88) = 7.94, p <.001, η2p = 0.15 and in fat acceptance, F (2, 88) = 4.25, p =.017, η2p = 0.09. Future studies should further develop interventions and assess results in larger samples and after longer periods of time. [ABSTRACT FROM AUTHOR]

What are the consequences of upward socioeconomic mobility for disenfranchised individuals? This article examines this question in the context of a business training program offered to residents of Brazilian urban slums, known as "favelas." The study employs a randomized controlled trial complemented by quantile regressions, field visits, and interviews. The results show that training improves favela dwellers' economic outcomes, such as by increasing income and participation in entrepreneurship, and some socio-psychological outcomes, such as by improving self-efficacy and optimism. However, these income improvements were accompanied by participants' enhanced experiences of favela stigma, an adverse socio-psychological outcome related to their residential segregation. Both quantitative and qualitative findings demonstrate the multifaceted nature of socioeconomic mobility, through which favela dwellers who prosper economically become more exposed to prejudice from people living outside favelas. The study illustrates, through the "allegory of the favela," the bittersweet process of socioeconomic mobility. This abductive research contributes to the literature by showing that while interventions designed to enfranchise individuals may effectively achieve economic inclusion in terms of income gains, they may simultaneously lead participants into discriminatory systems that further stigmatize people based on the same characteristics of their prior exclusion. [ABSTRACT FROM AUTHOR]

The objective of this 18-month walking intervention was to evaluate the effect on rest–activity rhythm (RAR) for older adults with mild-to-moderate dementia (65.8% female; aged M = 82.4 [SD = 6.5]). The intervention group (n = 44) was intended to walk 30 min, five times per week for 18 months. The control group (n = 35) received sedentary activities or usual care. RAR was measured at baseline to after 18 months and five times in between actigraphy outcome variables (interdaily stability, intradaily variability, relative amplitude, activity 10 most active hours, and activity 5 least active hours). Hierarchical mixed model analyses revealed no significant intervention effects (with or without baseline confounders as covariate) on RAR. However, participants in the intervention group were able to significantly increase their daily life activity (activity 10 most active hours) from the onset of the preceding measurement, b = 0.10, t(239.32) = 2.36, p =.019. More research is warranted to study the effect of regular walks on older persons with dementia whose RAR is worst at baseline. [ABSTRACT FROM AUTHOR]

BACKGROUND: Venous thromboembolism (VTE) is a preventable medical condition which has substantial impact on patient morbidity, mortality, and disability. Unfortunately, adherence to the published best practices for VTE prevention, based on patient centered outcomes research (PCOR), is highly variable across U.S. hospitals, which represents a gap between current evidence and clinical practice leading to adverse patient outcomes. This gap is especially large in the case of traumatic brain injury (TBI), where reluctance to initiate VTE prevention due to concerns for potentially increasing the rates of intracranial bleeding drives poor rates of VTE prophylaxis. This is despite research which has shown early initiation of VTE prophylaxis to be safe in TBI without increased risk of delayed neurosurgical intervention or death. Clinical decision support (CDS) is an indispensable solution to close this practice gap; however, design and implementation barriers hinder CDS adoption and successful scaling across health systems. Clinical practice guidelines (CPGs) informed by PCOR evidence can be deployed using CDS systems to improve the evidence to practice gap. In the Scaling AcceptabLE cDs (SCALED) study, we will implement a VTE prevention CPG within an interoperable CDS system and evaluate both CPG effectiveness (improved clinical outcomes) and CDS implementation. METHODS: The SCALED trial is a hybrid type 2 randomized stepped wedge effectiveness-implementation trial to scale the CDS across 4 heterogeneous healthcare systems. Trial outcomes will be assessed using the RE2-AIM planning and evaluation framework. Efforts will be made to ensure implementation consistency. Nonetheless, it is expected that CDS adoption will vary across each site. To assess these differences, we will evaluate implementation processes across trial sites using the Exploration, Preparation, Implementation, and Sustainment (EPIS) implementation framework (a determinant framework) using mixed-methods. Finally, it is critical that PCOR CPGs are maintained as evidence evolves. To date, an accepted process for evidence maintenance does not exist. We will pilot a Living Guideline process model for the VTE prevention CDS system. DISCUSSION: The stepped wedge hybrid type 2 trial will provide evidence regarding the effectiveness of CDS based on the Berne-Norwood criteria for VTE prevention in patients with TBI. Additionally, it will provide evidence regarding a successful strategy to scale interoperable CDS systems across U.S. healthcare systems, advancing both the fields of implementation science and health informatics. TRIAL REGISTRATION: Clinicaltrials.gov - NCT05628207. Prospectively registered 11/28/2022, https://classic. CLINICALTRIALS: gov/ct2/show/NCT05628207 .

INTRODUCTION: Brace treatment is common to address radiological dysplasia in infants with developmental dysplasia of the hip (DDH); however, it is unclear whether bracing provides significant benefit above careful observation by ultrasound. If observation alone is non-inferior to bracing for radiological dysplasia, unnecessary treatment may be avoided. Therefore, the purpose of this study is to determine whether observation is non-inferior to bracing for infants with radiological dysplasia. METHODS AND ANALYSIS: This will be a multicentre, global, randomised, non-inferiority trial performed under the auspices of a global prospective registry for infants and children diagnosed with DDH. Patients will be included if they present with radiological dysplasia (centred hip, alpha angle 43-60°, percent femoral head coverage greater than 35% measured on ultrasound) of a clinically stable hip under 3 months old. Patients will be excluded if they present with clinical hip instability, have received prior treatment or have known/suspected neuromuscular, collagen, chromosomal or lower-extremity congenital abnormalities or syndromic-associated hip abnormalities. Patients will be enrolled and randomised to undergo observation alone or brace treatment with a Pavlik harness for a minimum of 6 weeks. Follow-up visits will occur at 6 weeks, 1 year and 2 years post-enrolment. The primary outcome will be the norm-referenced acetabular index measured on the 2-year radiograph with a 3° non-inferiority margin. A total of 514 patients will be included.The study is anticipated to start in April 2024 and end in September 2028.The primary outcome will be compared between arms with a mixed-effects model with a random intercept for study centre, and a single covariate for the treatment group. If the lower bound of the 95% CI lies within 3° of the mean, we will treat this as evidence for non-inferiority. ETHICS AND DISSEMINATION: Ethics approval has been obtained from the lead sites ethics board (University of British Columbia, Childrens and Womens Research Ethics Board). Ethics approval will be obtained from the local ethics committees or institutional review boards at each institution prior to patient enrolment. It is intended that the results of this study shall be published in peer-reviewed journals and presented at suitable conferences. TRIAL REGISTRATION NUMBER: NCT05869851.

This randomized experiment on a social media platform in Pakistan measures the impact of two treatments that use ex-ante moderation to control misinformation about the COVID-19 pandemic compared to standard ex-post moderation. One treatment never posts misinformation, while the other rebuts it. We also disseminate official information about the pandemic on the platform. The treatments reduce daily users by 19%. This reduces exposure to official information by 29% more than exposure to misinformation. A conceptual framework posits that this can be explained by the fact that, in this setting, official information is more trusted and disseminated than misinformation.

BACKGROUND: Self-guided web-based interventions have the potential of addressing help-seeking barriers and symptoms common among university students, such as depression and anxiety. Unfortunately, self-guided interventions are also associated with less adherence, implicating motivation as a potential moderator for adherence and improvement for such interventions. Previous studies examining motivation as a moderator or predictor of improvement on web-based interventions have defined and measured motivation variably, producing conflicting results. OBJECTIVE: This secondary analysis of data from a randomized controlled trial aimed to examine constructs of motivation as moderators of improvement for a self-guided 8-week web-based intervention in university students (N=1607). METHODS: Tested moderators included internal motivation, external motivation, and confidence in treatment derived from the Treatment Motivation Questionnaire. The primary outcome was an improvement in depression and anxiety measured by the Depression Anxiety Stress Scale-21. RESULTS: Piecewise linear mixed effects models showed that internal motivation significantly moderated symptom change for the intervention group (t1504=-2.94; P=.003) at average and high (+1 SD) motivation levels (t1507=-2.28; P=.02 and t1507=-4.05; P

Individuals afflicted with advanced kidney dysfunction who require dialysis for medical management exhibit different degrees of native kidney function, called residual kidney function (RKF), ranging from nil to appreciable levels. The primary focus of this manuscript is to delve into the concept of RKF, a pivotal yet under-represented topic in nephrology. To begin, we unpack the definition and intrinsic nature of RKF. We then juxtapose the efficiency of RKF against that of hemodialysis in preserving homeostatic equilibrium and facilitating physiological functions. Given the complex interplay of RKF and overall patient health, we shed light on the extent of its influence on patient outcomes, particularly in those living with advanced kidney dysfunction and on dialysis. This manuscript subsequently presents methodologies and measures to assess RKF, concluding with the potential benefits of targeted interventions aimed at preserving RKF.

BACKGROUND: The primary objective of this randomized controlled trial (RCT) is to establish the effectiveness of time-restricted eating (TRE) compared with the Mediterranean diet for people with bipolar disorder (BD) who have symptoms of sleep disorders or circadian rhythm sleep-wake disruption. This work builds on the growing evidence that TRE has benefits for improving circadian rhythms. TRE and Mediterranean diet guidance will be offered remotely using self-help materials and an app, with coaching support. METHODS: This study is an international RCT to compare the effectiveness of TRE and the Mediterranean diet. Three hundred participants will be recruited primarily via social media. Main inclusion criteria are: receiving treatment for a diagnosis of BD I or II (confirmed via DIAMOND structured diagnostic interview), endorsement of sleep or circadian problems, self-reported eating window of ≥ 12 h, and no current mood episode, acute suicidality, eating disorder, psychosis, alcohol or substance use disorder, or other health conditions that would interfere with or limit the safety of following the dietary guidance. Participants will be asked to complete baseline daily food logging for two weeks and then will be randomly allocated to follow TRE or the Mediterranean diet for 8 weeks, during which time, they will continue to complete daily food logging. Intervention content will be delivered via an app. Symptom severity interviews will be conducted at baseline; mid-intervention (4 weeks after the intervention begins); end of intervention; and at 6, 9, and 15 months post-baseline by phone or videoconference. Self-rated symptom severity and quality of life data will be gathered at those timepoints, as well as at 16 weeks post baseline. To provide a more refined index of whether TRE successfully decreases emotional lability and improves sleep, participants will be asked to complete a sleep diary (core CSD) each morning and complete six mood assessments per day for eight days at baseline and again at mid-intervention. DISCUSSION: The planned research will provide novel and important information on whether TRE is more beneficial than the Mediterranean diet for reducing mood symptoms and improving quality of life in individuals with BD who also experience sleep or circadian problems. TRIAL REGISTRATION: ClinicalTrials.gov ID NCT06188754.

PurposeMetformin use has been associated with a decreased risk of age-related macular degeneration (AMD) progression in observational studies. We aimed to evaluate the efficacy of oral metformin for slowing geographic atrophy (GA) progression.DesignParallel-group, multicenter, randomized phase II clinical trial.ParticipantsParticipants aged ≥ 55 years without diabetes who had GA from atrophic AMD in ≥ 1 eye.MethodsWe enrolled participants across 12 clinical centers and randomized participants in a 1:1 ratio to receive oral metformin (2000 mg daily) or observation for 18 months. Fundus autofluorescence imaging was obtained at baseline and every 6 months.Main outcome measuresThe primary efficacy endpoint was the annualized enlargement rate of the square root-transformed GA area. Secondary endpoints included best-corrected visual acuity (BCVA) and low luminance visual acuity (LLVA) at each visit.ResultsOf 66 enrolled participants, 34 (57 eyes) were randomized to the observation group and 32 (53 eyes) were randomized to the treatment group. The median follow-up duration was 13.9 and 12.6 months in the observation and metformin groups, respectively. The mean ± standard error annualized enlargement rate of square root transformed GA area was 0.35 ± 0.04 mm/year in the observation group and 0.42 ± 0.04 mm/year in the treatment group (risk difference = 0.07 mm/year, 95% confidence interval = -0.05 to 0.18 mm/year; P = 0.26). The mean ± standard error decline in BCVA was 4.8 ± 1.7 letters/year in the observation group and 3.4 ± 1.1 letters/year in the treatment group (P = 0.56). The mean ± standard error decline in LLVA was 7.3 ± 2.5 letters/year in the observation group and 0.8 ± 2.2 letters/year in the treatment group (P = 0.06). Fourteen participants in the metformin group experienced nonserious adverse events related to metformin, with gastrointestinal side effects as the most common. No serious adverse events were attributed to metformin.ConclusionsThe results of this trial as conducted do not support oral metformin having effects on reducing the progression of GA. Additional placebo-controlled trials are needed to explore the role of metformin for AMD, especially for earlier stages of the disease.Financial disclosuresProprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Context: The long duration and high cost of anterior cruciate ligament reconstruction (ACLR) rehabilitation can pose barriers to completing rehabilitation, the latter stages of which progress to demanding sport-specific exercises critical for a safe return to sport. A staged approach shifting in-person physiotherapy sessions to later months of recovery may ensure patients undergo the sport-specific portion of ACLR rehabilitation. Design/Objective: To compare postoperative outcomes of knee function in patients participating in a staged ACLR physiotherapy program to patients participating in usual care physiotherapy through a randomized controlled trial. Methods: One hundred sixty-two patients were randomized to participate in staged (n = 80) or usual care physiotherapy (n = 82) following ACLR and assessed preoperatively and postoperatively at 2 weeks, 6 weeks, 3 months, and 6 months. The staged group completed the ACLR rehabilitation protocol at home for the first 3 months, followed by usual care in- person sessions. The usual care group completed in-person sessions for their entire rehabilitation. Outcome measures included the Lower Extremity Functional Scale, International Knee Documentation Committee Questionnaire, pain, range of motion, strength, and hop testing. Results: There were no statistically significant between-group differences in measures of knee function at 6 months postoperative. Patients in the usual care group reported significantly higher International Knee Documentation Committee scores at 3 months postoperative (mean difference = 5.8; 95% confidence interval, 1.3 to 10.4; P = .01). Conclusion: A staged approach to ACLR rehabilitation does not appear to impede knee function at 6 months postoperative but may result in worse patient reported outcomes at early follow-ups. [ABSTRACT FROM AUTHOR]

INTRODUCTION: As malaria declines, low-density malaria infections (LMIs) represent an increasing proportion of infections and may have negative impacts on child health and cognition, necessitating development of targeted and effective solutions. This trial assesses the health, cognitive and socioeconomic impact of two strategies for detecting and treating LMI in a low transmission setting. METHODS AND ANALYSIS: The study is a 3-arm open-label individually randomised controlled trial enrolling 600 children aged 6 months to 10 years in Bagamoyo district, Tanzania. Children are randomised to one of three arms: active case detection with molecular (ACDm) testing by high volume quantitative PCR (qPCR), passive case detection also with molecular testing (PCDm) and a control of standard PCD using rapid diagnostics tests (RDTs). Over the 2-year trial, ACDm participants receive malaria testing using RDT and qPCR three times annually, and malaria testing by RDT only when presenting with fever. PCDm and PCD participants receive malaria testing by RDT and qPCR or RDT only, respectively, when presenting with fever. RDT or qPCR positive participants with uncomplicated malaria are treated with artemether lumefantrine. The primary outcome is cumulative incidence of all-cause sick visits. Secondary outcomes include fever episodes, clinical failure after fever episodes, adverse events, malaria, non-malarial infection, antibiotic use, anaemia, growth faltering, cognition and attention, school outcomes, immune responses, and socioeconomic effects. Outcomes are assessed through monthly clinical assessments and testing, and baseline and endline neurodevelopmental testing. The trial is expected to provide key evidence and inform policy on health, cognitive and socioeconomic impact of interventions targeting LMI in children. ETHICS AND DISSEMINATION: Study is approved by Tanzania NatHREC and institutional review boards at University of California San Francisco and Ifakara Health Institute. Findings will be reported on ClinicalTrials.gov, in peer-reviewed journals and through stakeholder meetings. TRIAL REGISTRATION NUMBER: NCT05567016.

OBJECTIVE: To study the impact of vigorous vs. moderate exercise on metabolic parameters in polycystic ovary syndrome (PCOS). DESIGN: Randomized controlled trial. SETTING: Unsupervised home-based exercise program. PATIENTS: Patients with PCOS on the basis of the Rotterdam criteria with insulin resistance. INTERVENTIONS: Participants were block randomized to a home-based exercise program of 75 minutes of vigorous exercise or 150 minutes of moderate exercise per week, for 8 weeks total. MAIN OUTCOME MEASURES: Changes in glucose, insulin, and insulin resistance. RESULTS: In total, 36 participants were randomized, of whom 20 completed the study. The percentage changes from baseline at 4 and 8 weeks for fasting glucose, insulin, and homeostatic model assessment for insulin resistance did not significantly differ between the groups, except for the change in the 8-week glucose level, which was more favorable in the moderate arm (8.06% [standard deviation, 6.44%] in the vigorous group compared with -0.32% [standard deviation, 4.91%] in the moderate group). The absolute values of the main outcomes (fasting glucose, insulin, and homeostatic model assessment for insulin resistance) at baseline and 4 and 8 weeks did not significantly differ between trial arms. When assessing the change from baseline at 4 and 8 weeks, overall and within each trial arm, only the 8-week fasting glucose level was significantly greater than the baseline value in the vigorous arm (93.5 [95% confidence interval, 88.7-98.3] vs. 86.8 [95% confidence interval, 81.1-92.4]). CONCLUSIONS: Unsupervised short-term exercise programs may not achieve significant metabolic improvements in patients with PCOS, regardless of vigorous vs. moderate intensity. Future studies should investigate this question in larger sample sizes and longer or structured exercise programs. CLINICAL TRIAL REGISTRATION NUMBER: ClinicalTrials.gov identifier, NCT02303470.

BackgroundHuman papillomavirus (HPV) infections can cause cancers of the cervix, vagina, vulva, penis, anus, and oropharynx. The most recently approved HPV vaccine, Gardasil-9, protects against HPV infection and can prevent HPV-associated invasive cancers. However, Gardasil-9 is one of the most underused vaccines in the US today. Young adults are at risk for HPV infection, but many are not vaccinated. This study uses a randomized controlled trial (RCT) to test an innovative multilevel intervention to increase HPV vaccination rates among young adults. In this paper, we describe the research protocol.MethodsThe study uses a two by three factorial design. A total of 1200 young adults in Texas, age 18-26 years, who have not been previously fully vaccinated against HPV will be randomly assigned to one of six conditions to receive: (1) standard CDC information about HPV vaccination (control); (2) video narratives about HPV vaccination; (3) written narratives about HPV vaccination; or (4-6) enhanced access to HPV vaccine combined with (4) standard CDC information, (5) video narratives, or (6) written narratives. The two primary outcomes are the rate of HPV vaccination initiation by 3-month follow-up and rate of HPV vaccination completion by 9-month follow-ups. We will determine the impact of the individual level intervention (i.e., persuasive narratives through video or written format), the systemic level intervention (i.e., enhanced access to HPV vaccines), and the combination of both levels, on HPV vaccination initiation and completion. We will also use purposive sampling to select participants to take part in semi-structured interviews/focus groups to better understand the mechanisms of the intervention.DiscussionRecruitment and data collection began in March 2022. We expect to complete data collection by March 2026. We expect that narratives, enhanced access, and the combination of both will improve HPV vaccination initiation and completion rates among young adults. If proven successful, these individual- and system-level interventions can be easily disseminated in regions with low HPV vaccination rates to improve HPV vaccination, and ultimately decrease HPV-related cancer burden.Trial registrationNCT05057312.

The VIPP-SD (Video-feedback Intervention to promote Positive Parenting and Sensitive Discipline) program has been shown to promote positive interactions between parents and children with behavior problems. This study evaluated an adapted version for teachers (VIPP-School) through a parallel-group randomized controlled trial involving 58 teacher–child dyads from kindergarten to second grade. Teacher–child dyads were randomly assigned to VIPP-School (n = 28) or an active control group (n = 30). Intention-to-treat analyses showed improvements in teacher sensitivity (d  = 0.87) and supportive teacher classroom interactions (d  = 0.53) in the VIPP-School condition compared to the control condition. VIPP-School had no significant effect on teachers’ observed sensitive discipline (although changes were in the expected direction), nor on reported child externalizing behavior, overall relationship quality, school happiness or teacher self-efficacy. These findings show that the intervention, originally developed for families, could be effectively applied to early elementary education. The limited number of sessions increases the feasibility of VIPP-School. [ABSTRACT FROM AUTHOR]

Background: The effectiveness and adverse effects of coenzyme Q10 for heart failure remain unclear owing to small sample sizes and variations in the quality of existing studies in literature. Methods: The databases of EMBASE, PubMed, Web of Science, CINAHL databases, Scopus, Cochrane Central Register of Controlled Trials, VIP, Wanfang, and CNKI were searched for randomized controlled trials on the coenzyme Q10-assisted treatment of heart failure. Relevant literature was retrieved, data were extracted, and the risk of bias of the included studies was evaluated by two investigators independently using the Review Manager 5.4 software and the STATA 15 software. Results: In total, 33 studies were included in this meta-analysis, which showed that all-cause mortality [RR = 0.64, 95% CI (0.48, 0.85), P = 0.002; GRADE: moderate quality], hospitalization for heart failure [RR = 0.50, 95% CI (0.37, 0.67), P < 0.00001; GRADE: moderate quality], New York Heart Association classification [MD = − 0.29, 95% CI (− 0.39, − 0.19), P < 0.00001; GRADE: low quality], and brain natriuretic peptide level [MD = − 91.97, 95% CI (− 103.11, − 80.83), P < 0.00001; GRADE: low quality] were lower in the coenzyme Q10 group than in the control group. Meanwhile, left ventricular ejection fraction [MD = 0.51, 95% CI (0.31, 0.71), P < 0.00001; GRADE: low quality] and 6-min walk test result [MD = 31.70, 95% CI (19.96, 43.43), P < 0.00001; GRADE: moderate quality] were better than those in the control group. Conclusions: According to the existing evidence, coenzyme Q10 reduces all-cause mortality, hospitalization for heart failure, New York Heart Association classification, and brain natriuretic peptide level and improves left ventricular ejection fraction and 6-min walk test result in those with heart failure without major adverse effects. Trial registration: This study protocol was registered in the International Prospective Register of Systematic Reviews (PROSPERO, http://www.crd.york.ac.uk/prospero), with the registration number CRD42023493184. [ABSTRACT FROM AUTHOR]

Introduction: Sepsis, a life-threatening syndrome, is often accompanied by tachycardia in spite of hypovolemia and hypotension have been corrected. Recently, relevant studies have shown that sustained tachycardia in sepsis was related to high mortality, and appropriate control of heart rate (HR) could improve prognosis. Ivabradine reduces HR directly without a negative inotropic effect through inhibition of the If ionic current, which is different from the traditional rate control drug (beta-blockers). Methods and analysis: This is a prospective, multicenter, randomized, open label study designed to investigate the effect of heart rate control with ivabradine on hemodynamic in patients with sepsis. Our study will enroll 172 patients with sepsis as defined by The Third International Consensus Definitions for Sepsis and Septic Shock criteria with sinus rate of 95 bpm or higher despite a hemodynamic optimization. Patients will be randomly assigned to standard treatment group (GS) or ivabradine group (GI, standard treatment for sepsis plus enteral ivabradine). Patients in GI will receive ivabradine to maintain HR between 70 and 94 bpm. The primary outcome is the difference of a reduction in HR below 95 bpm and the effect of ivabradine on hemodynamics between GI and GS group within the first 96 h after randomization. The secondary outcomes include organ function measures, the difference in SOFA score, incidence of adverse events, need for organ support, length of ICU stay, and 28-day overall mortality. Discussion: There are limited studies on ivabradine to control heart rate in patients with sepsis. Our study aims to evaluate whether direct sinus node inhibition can improve hemodynamics, as well as its impact on organ function and prognosis in patients with sepsis, so as to provide evidence for the safe usage in clinical practice. Trial registration: ClinicalTrials.gov NCT05882708. Registered on May 11, 2023, https://clinicaltrials.gov/ct2/show/NCT05882708. [ABSTRACT FROM AUTHOR]

Background: Peer support is a promising and significant way for people living with HIV (PLWH) to improve their health outcomes. Matching PLWH with HIV peer volunteers can effectively stimulate and mobilize the function of peer support in health management. We develop the online platform Aspark, which features a precision matching function for PLWH and volunteers. This protocol provides a comprehensive overview of the randomized controlled trial design based on Aspark. Method: A parallel randomized controlled trial using block randomization will be conducted at the Beijing YouAn Home of Loving Care. The intervention group (n = 70) will have access to all 12 features of Aspark, including precise volunteer matching, health management tools, drug interaction queries, and medication reminders. The control group (n = 70) will have access to two features of informational support on Aspark. The outcomes of both groups will be evaluated at baseline and at 3, 6, 9, and 12 months after platform registration. The primary outcome is perceived social support. The secondary outcomes include mental symptoms, quality of life, self-efficacy, medication adherence, and health behaviors. Linear mixed models or generalized linear mixed models will be applied to test the intervention effects. Discussion: The Aspark trial is a randomized controlled trial designed to examine the influence of a mobile health (mHealth) application that integrates peer support and precision matching to strengthen social support for PLWH in China. This trial has the potential to significantly enhance social support for PLWH while also optimizing the delivery of peer support services and fully mobilizing the role of peer support in the overall health management of PLWH. Trial registration: Clinical registration number: ChiCTR2300077454. [ABSTRACT FROM AUTHOR]

Background Objective Search Strategy Selection Criteria and Data Collection Main Results Conclusion The effectiveness and safety of laparoscopic pectopexy (LP) in the treatment of female pelvic organ prolapse (POP) have recently gained significant interest.This study aimed to compare the outcomes and effectiveness of LP and laparoscopic sacrocolpopexy (LSC).A comprehensive literature search was conducted across multiple databases, including PubMed, MEDLINE, Embase, Web of Science, Cochrane Library, Clinical Trials, and CNKI. No language restrictions were applied in the search. The search encompassed the entire period from the inception of the respective databases to April 2023.All randomized controlled trials and comparative studies were included. A cumulative analysis was conducted on 10 studies, accounting for 15% of the overall research pool. The sample sizes of these studies were 760. Two researchers independently evaluated the eligibility of the studies, collected the relevant data, and evaluated their potential bias.Compared with LSC, the average operation time for LP in the simple surgery group was shorter (standardized mean difference [SMD] –2.14, 95% CI –2.68 to −1.60, P < 0.001). The average bleeding volume was lower (SMD –3.17, 95% CI –5.22 to −1.12, P = 0.002), the postoperative indwelling catheterization time was shorter (SMD –0.35, 95% CI –0.67 to −0.02, P = 0.040), and there were fewer total postoperative complications (odds ratio [OR] 0.53, 95% CI 0.30–0.94, P = 0.030). In terms of effectiveness, the LP group had fewer postoperative prolapse recurrences than the LSC group (OR 0.33, 95% CI 0.14–0.77, P = 0.010).LP demonstrates a comparable surgical efficacy to LSC. However, the surgical safety of LP is significantly improved. These findings should be validated by including additional randomized controlled trials. [ABSTRACT FROM AUTHOR]

Background: Prior meta-analyses have evaluated digital interventions for alcohol exclusively and alcohol/tobacco combined. These meta-analyses showed positive outcomes pertaining to alcohol and alcohol/tobacco combined. Yet questions remain pertaining to the effect of digital cognitive-behavioral therapy (CBT) on reducing alcohol and drug use.Objectives: The purpose of the meta-analysis was to determine the mean effect size, relative to control groups, of digital CBT, for posttest reductions in drug and/or alcohol use.Methods: The Preferred Reporting Items for Systematic Reviews and Meta-analyses criteria was used to guide this review and meta-analysis. Electronic databases (APA PsycArticles, Academic Search Complete, APA PsycInfo, CINAHL Complete, ERIC, MEDLINE, Psychology and Behavioral Sciences Collection, Social Sciences Full Text, Social Work Abstracts, SocINDEX), clinicaltrials.gov, reference lists were searched. The protocol was registered in PROSPERO (ID#: CRD42023471492). The CBT interventions included cognitive restructuring.Results: All but one of the effect sizes favored digital CBT (from −0.02 to −1.45). After the removal an outlier, a small, significant, random effects model Hedges’ g summary effect of −0.23 (95% confidence interval: −0.32, −0.14, p < .0001) showed a reduction in substance use at the posttest, favoring digital CBT relative to the control group. A variety of control conditions were used; however, the effects sizes had minimal heterogeneity (k = 17, I2 = 5.34, Q = 16.9, p = .39). The funnel plot and Egger regression test intercept (0.01, p = .99) lacked publication bias.Conclusion: The meta-analytic findings suggest digital CBT is an efficacious treatment for reducing alcohol and drug use overall. [ABSTRACT FROM AUTHOR]

Background: Latinx children in the United States experience disparities in asthma control and asthma-related functional outcomes compared to non-Latinx White children, including more school absences, emergency department visits, and hospitalizations for asthma. Stress appears to play a role in asthma control, but interventions designed to address the role of stress in asthma control for Latinx children are limited. Method: The current randomized controlled trial tests the effects of Adapt 2 Asthma (A2A), a family-based coping skills and asthma management intervention tailored to the stressors, strengths, and cultural beliefs of Latinx families, compared to an asthma self-management control arm (the Asthma Plan for Kids; APK). Latinx families of children ages 8 to 14 years old with asthma (target N = 280) are identified and enrolled from primary care clinics and randomly assigned to either A2A or APK. The intervention is delivered by lay health workers trained and receiving ongoing consultation from the study team. The primary outcome is child- and parent-reported asthma control, while secondary outcomes are child's quality of life, lung function, school absences, and emergency department visits, and child and parent coping and family asthma management behaviors. Participants will be assessed at baseline, post-intervention, and at 6- and 12-month follow-up timepoints. Discussion: This study has the potential to provide new evidence regarding the effects of culturally relevant coping and asthma management intervention strategies for Latinx children with asthma. Trial Registration: Clinicaltrials.gov NCT05118282. Registered on 11 November 2021. [ABSTRACT FROM AUTHOR]

Purpose: To investigate the efficacy of high-dose vitamin D supplementation (VDS) plus standard urotherapy (SU) in managing pediatric overactive bladder dry (OAB-dry), specifically in children with (1) vitamin D levels between 20 and 35 ng/mL and (2) heightened baseline symptom severity. Methods: In this secondary analysis of a randomized controlled trial, eligible children (n = 303) were assigned to 8 weeks of VDS + SU group, solifenacin (SOL) + SU group, or SU alone group. The primary outcome was voiding frequency; secondary outcomes included urgency, nocturia, quality of life (QoL), pediatric lower urinary tract symptoms scores, and patient satisfaction. Results: Among 303 participants, 197 (65%) had vitamin D levels between 20 and 35 ng/mL, and 119 (39%) exhibited heightened baseline symptom severity. In both subgroups, VDS + SU resulted in significantly greater improvements in voiding frequency compared to SOL + SU and SU alone. In the vitamin D subgroup (20–35 ng/mL), the median difference in voids/day between VDS + SU and SOL + SU was 2.0 (95% CI, 1.0 to 3.0; P = 0.003) and 3.2 compared to SU alone (P < 0.001). In the heightened symptom subgroup, the median difference was 3.0 (95% CI, 2.0 to 4.0; P < 0.001) vs. SOL + SU and 5.0 (95% CI, 4.0 to 6.0; P < 0.001) vs. SU alone. The VDS + SU group generally outperformed the other groups in various secondary outcome measures. Conclusion: High-dose VDS plus SU has significant therapeutic benefit in children with OAB-dry in those with vitamin D levels between 20 and 35 ng/mL and with more severe symptoms, compared to SOL + SU or SU alone. [ABSTRACT FROM AUTHOR]

Background: Some evidence suggests that fluid resuscitation with lactated Ringer's solution (LR) may have an anti-inflammatory effect on acute pancreatitis (AP) when compared to normal saline (NS) and may be associated with a decrease in severity, but existing single-center randomized controlled trials showed conflicting results. The WATERLAND trial aims to investigate the efficacy and safety of fluid resuscitation using LR compared to NS in patients with AP. Methods: The WATERLAND trial is an international multicenter, open-label, parallel-group, randomized, controlled, superiority trial. Patients will be randomly assigned in a 1:1 ratio to receive LR versus NS-based fluid resuscitation for at least 48 h. The primary outcome will be moderately severe or severe AP, according to the revision of the Atlanta classification. The secondary objectives of the WATERLAND trial are to determine the effect of LR versus NS fluid resuscitation on several efficacy and safety outcomes in patients with AP. A total sample of 720 patients, 360 in the LR group and 360 in the NS group, will achieve 90% power to detect a difference between the group proportions of 10%, assuming that the frequency of moderately severe or severe AP in the LR group will be 17%. A loss to follow-up of 10% of patients is expected, so the total sample size will be 396 patients in each treatment arm (792 patients overall). The test statistic used is the two-sided Z test with pooled variance set at a 0.05 significance level. Discussion: The WATERLAND study aims to improve the early management of AP. Fluid resuscitation is an inexpensive treatment available in any hospital center worldwide. If a better evolution of pancreatitis is demonstrated in one of the treatment arms, it would have important repercussions in the management of this frequent disease. Trial registration: ClinicalTrials.gov, NCT05781243. Registration date on January 4, 2023. EudraCT number 2023–000010-18, first posted March 23, 2023. [ABSTRACT FROM AUTHOR]

Background: Patient education is a crucial strategy for promoting prevention and diabetes self-management since glycemic control achievement involves taking medications, medical nutrition therapy, physical exercise, and behavior changes. However, patient education programs are still barely implemented in low- and middle-income countries. This trial aims to investigate whether a lifestyle education intervention added to physical exercising is superior to sole physical exercising regarding functional capacity, disease-related knowledge, health behaviors, cardiometabolic health parameters, quality of life, depression, and diet quality in individuals with prediabetes or diabetes. Methods: Multicenter double-blinded randomized controlled trial with two parallel arms involving 12-week intervention and 6-month follow-up. The eligible individuals (≥ 18 years, living with prediabetes or diabetes, literate, no clinical decompensation and/or physical and/or mental limitations that contraindicate physical exercising, written physician permission for exercise, no cognitive impairment, no vision limitations for reading, no confirmed diagnosis of unstable coronary disease or heart failure, no pacemaker and/or implantable cardioverter-defibrillator, no complex ventricular arrhythmias, no intermittent claudication, no recent cardiovascular event or cardiac surgery, and no currently enrolled in a structured exercise program) were recruited from two Brazilian cities and randomized to either (1) an Exercise and Lifestyle Education Program (ExLE) or (2) an Exercise Program (Ex), which can be delivered on-site or remotely based on the participants' internet access and technology literacy. The primary outcomes will be changes in functional capacity and disease-related knowledge. The secondary outcomes will involve changes in health behaviors (health literacy, physical activity level, exercise self-efficacy, and medication adherence) and cardiometabolic health parameters (glycemic control, anthropometric measures, and cardiac autonomic control). Program adherence, satisfaction with the program, diabetes-related morbidity, and changes in quality of life, depression, and diet quality will be the tertiary outcomes. Assessments will occur at baseline, post-intervention, and after 6-month follow-up. Discussion: If superior effectiveness of ExLE compared to Ex program to improve the outcomes measures is found, this program could be delivered broadly in the Brazilian health system, especially in the primary care facilities where most individuals living with prediabetes and diabetes in our country are assisted. Trial registration: ClinicalTrials.gov, NCT03914924. Registered on April 16, 2019. [ABSTRACT FROM AUTHOR]

Aim Materials and Methods Results Conclusions Clinical Trial Registration We conducted a multicentre, randomized phase 3 trial in China to evaluate the efficacy and safety of cofrogliptin (HSK7653), a novel long‐acting dipeptidyl peptidase‐4 inhibitor, in patients with drug‐naïve type 2 diabetes (T2D).Patients with inadequately controlled T2D were randomly assigned (1:1:1) to cofrogliptin 10 mg, cofrogliptin 25 mg or placebo, taken orally once every 2 weeks for a 24‐week double‐blind period. Eligible patients then received cofrogliptin 25 mg in a 28‐week open‐label extension. The primary endpoint was the change in glycated haemoglobin (HbA1c) from baseline to week 24.In total, 475 patients (median age: 54.0 years) were randomized and received at least one dose of cofrogliptin 10 mg (n = 158), cofrogliptin 25 mg (n = 158) or placebo (n = 159); 401 patients entered the open‐label extension. At week 24, the least‐squares (LS) mean difference (95% confidence interval [CI]) in HbA1c versus placebo was −0.63% (−0.81, −0.46) with cofrogliptin 10 mg and −0.59% (−0.77, −0.42) with cofrogliptin 25 mg (both p < 0.0001). The LS mean (standard error) change in HbA1c from baseline was maintained at the end of the study in patients given open‐label cofrogliptin 25 mg for an additional 28 weeks: cofrogliptin 10 mg: −0.86% (0.07); cofrogliptin 25 mg: −0.74% (0.07); placebo: −0.89% (0.07). Over the entire study, common adverse events were hyperuricaemia, hyperlipidaemia, hypertriglyceridaemia, increased lipase, upper respiratory tract infection and urinary tract infection. Hypoglycaemic events did not significantly differ between groups.Cofrogliptin provided glycaemic control over 52 weeks and was generally well tolerated in patients with T2D.Registered on Clinicaltrials.gov with the registration number NCT04556851 (https://clinicaltrials.gov/study/NCT04556851). [ABSTRACT FROM AUTHOR]

ABSTRACT Objective Method Results Discussion We examine the small amount of research to date that describes and/or evaluates waitlist interventions as a precursor to treatment for an eating disorder (ED) with the intent to provide recommendations for future research that can further test the efficacy and effectiveness of waitlist interventions.A review of published studies showed the standard of proof about the usefulness of waitlist interventions to be slight, with important gaps in our knowledge. One such gap was whether recovered people with lived experience could provide support to adults waiting for treatment. We briefly present new research evaluating this approach (N = 40), where people waiting for treatment were randomized to waitlist as usual or guided self‐help with a trainee psychologist or a person with lived experience.Eight published studies across 10 different programs are described; N = 7 addressed waitlists for children and adolescents, and only three were randomized controlled trials. Our new research did not support the involvement of people with lived experience at this stage of the treatment journey.The results suggest some promise of waitlist interventions. Parents waiting for family‐based treatment were able to improve weight and nutritional health in their children and experienced improved self‐efficacy with respect to managing the ED. Provision of a waitlist intervention to adults may increase the probability of later engagement in treatment. It is still not possible to conclude whether waitlist interventions improve outcomes over treatment compared to those who did not receive such an intervention. We make five recommendations for future research. [ABSTRACT FROM AUTHOR]

Background: Caregiver stress can pose serious health and psychological concerns, highlighting the importance of timely interventions for family caregivers of people with dementia. Single-session mindfulness-based interventions could be a promising yet under-researched approach to enhancing their mental well-being within their unpredictable, time-constrained contexts. This trial will evaluate the effectiveness and feasibility of a blended mindfulness-based intervention consisting of a single session and app-based follow-up in reducing caregiver stress. Methods/Design: The study is a single-blinded randomized controlled trial with two arms (intervention versus an education session on dementia care) and assessments at baseline, 8 weeks, and 6 months. The eligibility criteria include: family caregivers aged 18 years or older; providing care for an individual with a confirmed medical diagnosis of dementia for at least 3 months prior to recruitment, with a minimum of 4 hours of daily contact; and exhibiting a high level of caregiver stress. The intervention comprises a 90-minute group-based session with various mindfulness practices and psychoeducation. Participants will receive a self-practice toolkit to guide their practice over a duration of 8 weeks. Sharing activities will be implemented through an online social media platform. The primary outcome is perceived caregiving stress. The secondary outcomes include depressive symptoms, positive aspects of caregiving, dyadic relationship, trait mindfulness, and neuropsychiatric symptoms of care recipients. The feasibility outcomes include eligibility and enrollment, attendance, adherence to self-practice, and retention, assessed using mixed methods. Discussion: The study will contribute to the evidence base by investigating whether a single-session mindfulness intervention is effective and feasible for reducing caregiver stress among family caregivers of people with dementia. Trial registration: ClinicalTrials.gov, NCT06346223. Registered on April 3, 2024. [ABSTRACT FROM AUTHOR]

In this triple-blind, randomized clinical trial, 60 menopausal women between the ages of 45 and 65 were randomized to receive 78% dark chocolate (12 g/day) or milk chocolate (12 g/day) for eight weeks. The primary outcome was depression scores. Secondary outcomes included sleep quality and anthropometric indices. ANCOVA with baseline adjustment showed that the mean depression score after the intervention in the group receiving dark chocolate was significantly reduced compared to the milk chocolate group (mean difference: -2.3; 95% confidence interval: -3.9 to -0.8; p = 0.003; Cohen's d = -0.54). However, no statistically significant difference in the overall sleep quality score and its subdomains was observed between the two groups after the intervention (p > 0.05). Furthermore, after the intervention, there was no statistically significant difference between the two groups in terms of anthropometric indices, including weight (p = 0.075), BMI (p = 0.137), waist circumference (p = 0.463), and hip circumference (p = 0.114). The study suggests that consuming 78% dark chocolate for eight weeks may contribute to improvements in depression scores, but it does not appear to improve sleep quality or anthropometric indices. Trial registration: IRCT20220926056046N1; December 2022. [ABSTRACT FROM AUTHOR]

Background: Rotator cuff tears (RCT) are a common musculoskeletal condition, especially in the aging population. The prevalence of rotator cuff tears varies based on factors like age, occupation, and activity level. In the general population, the prevalence of rotator cuff tears is estimated to be around 20 to 25%. Rotator cuff tears (RCT) have an impact in patients' pain level, shoulder function, sleep disturbance, and quality of life. Primary tendon surgery is in mostly cases necessary. This study aimed to examine if treatment of rotator cuff lesions with implantation of micro-fragmented adipose tissue can improve patients' reported pain and function compared to conventional surgery. Methods: The study is a prospective superiority parallel-group single-center randomized controlled trial including 30 patients between 40 and 69 years of age in Denmark. Patients will be allocated 1:1 ratio to reconstruction of the supraspinatus tendon with an injection of micro-fragmented adipose tissue into the related muscle (stem cell treatment) or the standard of care (SOC), which is conventional surgery. Patients, project assistants, physicians, and outcome adjudicators are not blinded to randomization due to practical constraints. The radiologist and the statistician performing the analysis will be blinded. The primary outcome will be the Oxford shoulder score at 12 months post-surgery. Discussion: This study will assess whether adding micro-fragmented adipose tissue therapy to conventional rotator cuff tear treatment can enhance recovery, accelerate return to daily activities, and improve functional outcomes. The research will also determine if this minimally invasive procedure could be standardized for routine patient care. Trial registration: ClinicalTrials.gov NCT06505135. Registered on July 10, 2024. [ABSTRACT FROM AUTHOR]

ABSTRACT Background and Aim Methods Results Conclusions Clinical practice guidelines suggest access flap surgery for managing deep residual pockets after steps 1 and 2 of periodontal therapy. Papilla‐preservation flap surgery (PPFS) is the least invasive approach to access and instrument biofilm‐contaminated root surfaces. Endoscopic‐assisted subgingival debridement (EASD) may enhance the outcomes of repeated instrumentation and provide a minimally invasive non‐surgical alternative.This was a single‐blind, controlled, randomized, parallel‐group, non‐inferiority 12‐month trial comparing EASD with PPFS. Male and female adults with generalized stage III periodontitis and persistent periodontal pockets associated with an intrabony defect after steps 1 and 2 of periodontal therapy were recruited at Prince Philip Dental Hospital. Inter‐group differences in clinical attachment level (CAL) changes at 12 months were the primary outcome. Secondary outcomes included pocket resolution (no pocket > 5 mm and no pocket > 4 with bleeding on probing), radiographic bone changes, treatment time, early wound healing and quality‐of‐life measurements.Sixty‐two subjects (30 EASD and 32 PPFS) were included in the intention‐to‐treat analysis. CAL gains were 2.0 ± 1.0 and 1.8 ± 1.0 mm for test and controls, respectively. The 95% CI of the inter‐group difference was −0.3 to 0.8 mm and within the stipulated 1‐mm non‐inferiority margin. No inter‐group differences were observed (i) in pocket resolution, which was achieved in more than 87% of cases for all groups/time points, and (ii) in radiographic bone healing. The treatment time was significantly shorter for EASD than for PPFS. Better early wound healing index scores were observed for EASD. No inter‐group differences in pain, quality of life or safety were detected.EASD was not inferior to PPFS for managing residual pockets associated with intrabony defects. The observed outcome profile supports additional developments and studies to validate EASD as an alternative to surgery for isolated persistent pockets (ChiCTR‐INR‐16008407). [ABSTRACT FROM AUTHOR]

Background: A substantial amount of research has explored the intricate relationship between exercise and sleep quality, consistently confirming that exercise can effectively enhance sleep quality. Nevertheless, previous studies have yet to conclusively determine which specific exercise program is most efficacious in improving sleep quality. To address this gap, the present study systematically evaluated the differential effects of various types of exercise, as well as exercise dosages (including duration, intervention period, frequency, and intensity), on sleep outcomes using a network meta-analysis approach. This endeavor aims to provide evidence-based support for the development of scientifically effective exercise programs tailored to improve sleep quality. Methods: Through the Web of Science, PubMed, Cochrane Library, Embase, and Scopus databases, we conducted a search for randomized controlled trials investigating the effects of exercise interventions on sleep, with a search cutoff date of April 30, 2024. We rigorously selected the literature according to the PICOS principle, and two independent researchers extracted the data. We would like to change this passage to: Bias risk assessment was conducted using the RevMan 5.4 software, and traditional meta-analysis and network meta-analysis were performed using Stata 17.0 software to generate forest plots, network evidence plots, and funnel plots. Furthermore, we adopted the surface under the cumulative ranking curve (SUCRA) to evaluate and rank the intervention effects of different exercise types and dosages on sleep quality. To verify the robustness of our study results, we performed a sensitivity analysis using the leave-one-out method. Results: The study strictly adhered to the PRISMA guidelines and included 58 RCT papers with a total of 5,008 participants. The network meta-analysis revealed significant variations in the impact of exercise frequency on sleep outcomes when compared to the control group. Interventions of 1-2 times per week [SMD = -0.85, 95% CI (-1.43, -0.26)], 3 times per week [SMD = -0.45, 95% CI (-0.80, -0.11)], and 4 times per week [SMD = -1.09, 95% CI (-1.92, -0.26)] demonstrated the most notable effects. Interventions lasting =30 min and 60-65 min were significantly more effective than the control group, with =30 min proving significantly more effective than 40-55 min [SMD = 0.75, 95% CI (0.01, 1.49)]. Interventions lasting 9-10 weeks [SMD = -1.40, 95% CI (-2.37, -0.44)], 12-16 weeks [SMD = -0.55, 95% CI (-0.90, -0.20)], and = 24 weeks [SMD = -0.71, 95% CI (-1.31, -0.10)] were all significantly more effective than the control group. Additionally, the 9-10 weeks intervention period was found to be significantly more effective than the 6-8 weeks period [SMD = -1.21, 95% CI (-2.37, -0.04)]. Furthermore, interventions of moderate intensity [SMD = -1.06, 95% CI (-1.52, -0.61)] and high intensity [SMD = -1.48, 95% CI (-2.55, -0.40)] exercise interventions yielded significantly greater benefits compared to the control group. Specifically, high intensity interventions [SMD = -1.97, 95% CI (-3.37, -0.56)] and moderate intensity [SMD = -1.55, 95% CI (-2.57, -0.54)] exercise interventions were found to be significantly more effective than moderate-high intensity interventions. In terms of exercise types, aerobic exercise [SMD = -0.56, 95% CI (-0.86, -0.27)], traditional Chinese exercises [SMD = -0.57, 95% CI (-0.97, -0.18)], and combined exercise [SMD = -0.99, 95% CI (-1.66, -0.32)] interventions all produced significant improvements compared to the control group. The study determined that the most effective combination of exercise prescription elements for enhancing sleep quality includes a frequency of 4 times per week (SUCRA = 84.7), a duration of =30 min (SUCRA = 92.2), a period of 9-10 weeks (SUCRA = 89.9), and high-intensity (SUCRA = 92.9) combined exercise (SUCRA = 82.7). Conclusion: The current evidence indicates that combined exercise with a frequency of 4 times per week, a duration of =30 min, a period of 9-10 weeks, and high intensity is most effective for improving sleep quality. Nevertheless, due to the limited number of studies included, further research is needed to enhance the reliability of the findings. [ABSTRACT FROM AUTHOR]

Probiotics, known for regulating gut microbiota, may aid those with overweight or obesity, but their mechanisms require more research. This study involved 75 overweight or obese young adults, randomly assigned to either a Bifidobacterium breve BBr60 (BBr60) group or a placebo group. Both groups received diet guidance and took either BBr60 (1 × 1010 CFU/day) or a placebo for 12 weeks. Researchers analyzed body composition, serum glucose, lipids, liver and kidney function, comprehensive metabolome, and intestinal homeostasis before and after the intervention. After 12 weeks, BBr60 significantly reduced weight and BMI compared to pretreatment levels and outperformed the placebo. The BBr60 group also showed improved blood biochemistry, with notably lower fasting blood glucose (FBG) levels than the placebo group (p < 0.05). Additionally, BBr60 influenced vital serum and fecal metabolites related to three amino acid metabolic pathways and regulated the bacteria Dialister, Klebsiella, and Bacteroides, which correlated strongly with serum metabolites. These findings indicate that BBr60 can safely and effectively regulate BMI, body weight, serum glucose, lipids, and liver function markers, which may involve BBr60's impact on key gut bacteria, which influence metabolites related to the valine, leucine, and isoleucine biosynthesis; glycine, serine, and threonine metabolism; and alanine, aspartate, and glutamate metabolism. [ABSTRACT FROM AUTHOR]

The aim of this study was to investigate whether a reduction in accelerometer-measured sedentary behavior (SB) improves blood lipids in inactive adults with metabolic syndrome (MetS). Sixty-four participants were randomly assigned into intervention (INT, n = 33) and control (CONT, n = 31) groups. The INT group was instructed to reduce SB by 1 h/day without increasing formal exercise, whereas the CONT group was advised to maintain usual SB habits. SB and physical activity (PA) were measured with accelerometers throughout the intervention. Plasma lipid concentrations and dietary intake by food diaries were assessed at baseline and at the end of the intervention. High-density lipoprotein percentage of total cholesterol decreased during the intervention similarly in both groups (p = 0.047). Other blood lipids did not change from baseline to six months in either group. The CONT group had a statistically significant reduction in the intake of saturated fatty acids compared to the INT group (p = 0.03). Intervention resulting in a 40-minute reduction in daily SB and 20-minute increase in habitual MVPA seems to not be effective in improving blood lipids in adults with MetS. Reducing SB together with a higher volume and/or intensity of PA and proper nutrition may be needed to reduce the risk of cardiometabolic diseases. Trial registration. This study is registered at ClinicalTrials.gov (NCT03101228, 05/04/2017). https://www.clinicaltrials.gov/ct2/show/NCT03101228?term=NCT03101228&draw=2&rank=1. [ABSTRACT FROM AUTHOR]

Background: Young adult suicidality is worldwide a prevalent mental health problem and the number one cause of death, with devastating consequences for individuals and their families, and substantial economic costs. However, psychological and pharmacological treatments currently recommended in guidelines for treatment of high-risk youth for fatal suicide have limited effect. In line with the World Health Organization's (WHO) recommendation to involve the family in treatment of these youth, attachment-based family therapy (ABFT) was developed, a 16-week attachment and emotion-focused treatment, implemented in mental health care settings across various European countries in the past years, and becoming increasingly popular among therapists. However, the (cost-)effectiveness of ABFT has not been studied in emerging adults. In the proposed pragmatic randomized controlled trial (RCT), we aim to evaluate the effectiveness and cost-effectiveness of ABFT compared to treatment as usual (TAU) on suicidality, as delivered in daily practice. Methods: This pragmatic multicenter study in the Netherlands and Belgium includes 13 participating sites. Participants are suicidal young adults (≥ 31 SIQ-JR score) between 16 and 30 years old who seek mental health treatment (n = 142) and their caregivers. The primary outcome is suicidality (SIQ-JR), with assessments at baseline, post-intervention (5 months after baseline), 3, 6, and 12 months after intervention. We predict that, compared to TAU, ABFT will lead to a stronger reduction in suicidality and will be more cost-effective, over the course of all time points. We also expect stronger decreases in depressive symptoms, given that suicidality is very common in individuals with depressive disorder, as well as more improvement in family functioning, autonomy, entrapment, and young adult attachment, in the ABFT condition. Discussion: This study can contribute to improving the care for suicidal youngsters with high mortality risk. Treatment of suicidal emerging adults is understudied. The results will inform clinical guidelines and policy makers and improve treatment of suicidal emerging adults. Trial registration: This trial is registered on ClinicalTrials.gov (NCT05965622, first posted on July 28, 2023). [ABSTRACT FROM AUTHOR]

Background: Management of rheumatoid arthritis (RA) relies on symptoms reported by patients during infrequent outpatient clinic visits. These reports are often incomplete and inaccurate due to poor recall, leading to suboptimal treatment decisions and outcomes. Asking people to track symptoms in-between visits and integrating the data into clinical pathways may improve this. However, knowledge on how to implement this into practice and its impact on services and outcomes remains scarce in RA. Therefore, we evaluate the comparative effectiveness and cost-effectiveness of integrated symptom tracking in people with RA over and above usual care, while generating insights on factors for successful implementation. Methods: In this superiority stepped wedge cluster-randomized controlled trial with continuous recruitment short exposure design, 16 rheumatology outpatient departments (clusters) recruit a total of 732 people with active RA. They initially offer clinic visits according to standard of care before switching in pairs to visits with integrated symptom tracking. Clusters switch in randomized order every 3 weeks. Integrated symptom tracking consists of (1) a mobile app for patients to track their symptoms daily and other RA aspects weekly/monthly, and (2) an interactive dashboard visualizing the app data, which healthcare professionals access from their electronic health record system. Clinic visits happen according to usual practice, with tracked symptom data only reviewed during visits. Our primary outcome is a difference in marginal mean disease activity score at 12 ± 3 months between standard of care and integrated symptom tracking, after accounting for baseline values, cluster, and other covariates. Secondary outcomes include patient-reported disease activity, quality of life and quality-adjusted life-years, medication/resource use, consultation and decision-making experience, self-management, and illness perception. We also conduct interviews and observations as part of a parallel process evaluation to gather information on implementation. Discussion: Our trial will generate high-quality evidence of comparative and cost-effectiveness of integrated symptom tracking compared to standard of care in people with RA, with our process evaluation delivering knowledge on successful implementation. This optimizes the chances of integrated symptom tracking being adopted more widely if we find it is (cost-) effective. Trial registration: Registered 4-Jun-2024 on https://www.isrctn.com/, ISRCTN51539448. Trial open science framework repository: https://osf.io/sj9ha/. [ABSTRACT FROM AUTHOR]

Background : Overuse and misuse of antibiotics is one of the driving factors of antimicrobial resistance, a growing global health threat. The use of antibiotics is particularly high in children. Even though the implementation of antibiotic stewardship programs (ASP) in pediatrics has been shown to reduce antibiotic use, this implementation has been limited to large university hospitals in Germany. Telemedicine applications might be an effective approach to implement ASP in non-university settings. Methods: This protocol details the TeleKasper study (Telemedical Competence Network “Antibiotic Stewardship in Pediatrics”). Tele-Kasper is a stepped-wedge cluster-randomized trial that will be conducted across non-university children’s hospitals in Germany. The intervention consists of a telemedical consultation service in the form of a network in different German areas, using an app as a communication tool. The primary outcome will be a 20% reduction in overall antibiotic consumption measured using defined daily doses per 100 patient days. Discussion: The TeleKasper study aims to implement and evaluate a prototype for a nationwide antibiotic stewardship program by telemedical means in pediatric departments in non-university hospitals in Germany to promote rational antibiotic use and improve medical care for infections. Trial registration: German Clinical Trials Register (DRKS) DRKS00028534. Registered on 22nd of April 2022. [ABSTRACT FROM AUTHOR]

Background: Neoadjuvant chemotherapy (NAC) for breast cancer enables pathological complete response (pCR) in patients initially diagnosed with axillary lymph node metastases, potentially obviating the need for axillary lymph node dissection (ALND). Current targeted axillary dissection (TAD) techniques, guided by traditional tissue markers placed prior to NAC, face challenges such as marker loss and high costs. Carbon nanoparticle suspension injection (CNSI) offers a stable and reliable alternative for marking, which could enhance the TAD procedure. This study aims to evaluate the feasibility and accuracy of different TAD strategies using CNSIs and to explore their clinical utility in locally advanced breast cancer. Methods: This prospective, multicenter, randomized controlled trial will enroll 126 biopsy-proven breast cancer patients with suspicious axillary lymph node metastases (cN1-2a) who achieve ycN0 status following NAC. Participants will be randomized in a 1:1:1 ratio to undergo TAD guided by: [1] conventional tissue clips (CG-TAD); [2] CNSI lymph node marking (CN-LNM); or [3] peritumoral CNSI mapping (PCN-MAP). Primary endpoints include retrieval rate of marked lymph nodes, number of sentinel and marked lymph nodes, concordance rates, and complication rates. Secondary endpoints encompass regional and distant recurrence rates, survival outcomes, surgical duration, postoperative complications, quality of life scores, and margin status in breast-conserving surgery. Statistical analyses will adhere strictly to the CONSORT guidelines. Discussion: This study aims to evaluate the feasibility and accuracy of CNSI for targeted axillary dissection in breast cancer patients following neoadjuvant chemotherapy and to explore its clinical significance in reducing surgical complications and costs, as well as improving surgical precision. Trial registration: Clinicaltrials.gov, NCT04744506, Registered 27 December 2020, Updated 24 September 2024. Protocol Version Ver 1.2, 17/9/2024. [ABSTRACT FROM AUTHOR]

RCTs in primary schools in rural China show frequent personalized teacher feedback improves exam scores for Grade 3 (age 9), including those ‘left behind’ by migrating parents. Two terms of biweekly feedback increase math and language scores by 0.15 standard deviations, with an RCT texting results to parents giving 0.26 sd extra math improvement for the left-behind. Some math improvements maintain even 30 months later. Direct costs are under $5/student. Yet identical feedback produces nothing for Grade 5. Information feedback interventions thus have excellent potential, but their fall in impact with age suggests efforts must begin early. [ABSTRACT FROM AUTHOR]

Background: Coronary artery bypass grafting is associated with a high occurrence of postoperative cardiopulmonary complications. Preliminary evidence suggested that enhanced recovery after surgery can effectively reduce the occurrence of postoperative cardiopulmonary complications. However, enhanced recovery after surgery with systematic integration of cardiopulmonary rehabilitation (ERAS-CaRe) into for Coronary artery bypass grafting has not been evaluated so far. We thus design the ERAS-CaRe randomized-controlled trial to evaluate possible superiority of embedding cardiopulmonary rehabilitation in ERAS over ERAS alone as well as to investigate effects of differential timing of cardiopulmonary rehabilitation within enhanced recovery after surgery (pre-, post-, perio-operative) on post-operative cardiopulmonary complications following Coronary artery bypass grafting surgery. Methods: ERAS-CaRe is a pragmatic, randomized-controlled, parallel four-arm, clinical trial. Three hundred sixty patients scheduled for Coronary artery bypass grafting in two Chinese hospitals will be grouped randomly into (i) Standard enhanced recovery after surgery or (ii) pre-operative ERAS-CaRe or (iii) post-operative ERAS-CaRe or (iv) perio-operative ERAS-CaRe. Primary outcome is the occurrence of cardiopulmonary complications at 10 days after Coronary artery bypass grafting. Secondary outcomes include the occurrence of other individual complications including cardiac, pulmonary, stroke, acute kidney injury, gastrointestinal event, ICU delirium rate, reintubation rate, early drainage tube removal rate, unplanned revascularization rate, all-cause mortality, ICU readmission rate, plasma concentration of myocardial infarction-related key biomarkers etc. Discussion: The trial is designed to evaluate the hypothesis that a cardiopulmonary rehabilitation based enhanced recovery after surgery program reduces the occurrence of cardiopulmonary complications following Coronary artery bypass grafting and to determine optimal timing of cardiopulmonary rehabilitation within enhanced recovery after surgery. The project will contribute to increasing the currently limited knowledge base in the field as well as devising clinical recommendations. Trial registration: The trial was registered at the Chinese Clinical Trials Registry on 25 August 2023 (ChiCTR2300075125; date recorded: 25/8/2023, https://www.chictr.org.cn/). [ABSTRACT FROM AUTHOR]

Background: Drug-dependent insomnia refers to insomnia patients taking sedatives and sleeping pills regularly for a long period. Auricular acupressure (AA) has attracted growing attention as a complementary treatment for insomnia. Nevertheless, there is a lack of rigorous studies evaluating AA specifically for estazolam-dependent insomnia. Our proposed trial aims to assess the therapeutic effect of AA on estazolam-dependent insomnia. Methods: This study is a randomized, single-blinded, three-arm controlled trial. No less than 108 participants will be randomized into one of three groups: AA group, sham auricular acupressure (SAA) group, and conventional dosage reduction group. All treatments will be administered for 4 weeks, with a follow-up period of 1 month. The primary clinical outcomes will be estazolam dosing and reduction rates, serum gamma-aminobutyric acid (GABA) and cortisol (CORT) levels. Secondary outcomes will concern the Pittsburgh sleep quality index (PSQI) and Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ). Both intention-to-treat and per-protocol analyses will be performed, with the significance level determined as 5%. Discussion: The study results will provide evidence on the efficacy and safety of AA in managing estazolam-dependent insomnia by analyzing its immediate effect, time-effect relationship, and reduction of estazolam use. Trial Registration: Clinicaltrials.gov (identification number: NCT06258226; Registered 5 February 2024, https://clinicaltrials.gov/ct2/show/NCT06258226). [ABSTRACT FROM AUTHOR]

Background : Vancomycin is a commonly prescribed antibiotic to treat serious Gram-positive infections in children. The efficacy of vancomycin is known to be directly related to the pharmacokinetic/pharmacodynamic (PK/PD) index of the area under the concentration–time curve (AUC) divided by the minimal inhibitory concentration (MIC) of the pathogen. In most countries, steady-state plasma concentrations are used as a surrogate parameter for this target AUC/MIC, but this practice has some drawbacks. Hence, AUC-based dosing using model-informed precision dosing (MIPD) tools has been proposed for increasing the target attainment rate and reducing vancomycin-related nephrotoxicity. Solid scientific evidence for these claimed benefits is lacking in children. This randomized controlled trial aims to investigate the large-scale utility of MIPD dosing of vancomycin in critically ill children. Methods: Participants from 14 neonatal intensive care, pediatric intensive care, and pediatric hemo-oncology ward units from 7 hospitals are randomly allocated to the intervention or standard-of-care comparator group. In the intervention group, a MIPD dosing calculator is used for AUC-based dosing, in combination with extra sampling for therapeutic drug monitoring in the first hours of treatment, as compared to standard-of-care. An AUC24h between 400 and 600 is targeted, assuming an MIC of 1 mg/L. Patients in the comparator group receive standard-of-care dosing and monitoring according to institutional guidelines. The primary endpoint is the proportion of patients reaching the target AUC24h/MIC of 400–600 between 24 and 48 h after the start of vancomycin treatment. Secondary endpoints are the proportion of patients with (worsening) acute kidney injury during vancomycin treatment, the proportion of patients reaching target AUC24h/MIC of 400–600 between 48 and 72 h after the start of vancomycin treatment, time to clinical cure, ward unit length-of-stay, hospital length-of-stay, and 30-day all-cause mortality. Discussion: This trial will clarify the propagated benefits and provide new insights into how to optimally monitor vancomycin treatment in critically ill children. Trial registration: Eudract number: 2019–004538-40. Registered on 2020–09-08 ClinicalTrials.gov NCT046666948. Registered on 2020–11-28 [ABSTRACT FROM AUTHOR]

Background: Currently, most elderly chronic heart failure (CHF) patients go home for rehabilitation after certain treatment in hospitals. However, the results of their rehabilitation at home are not satisfactory. According to studies, dyadic treatments can increase the efficiency of home rehabilitation, enhance both partners' quality of life, lessen the caregiver's load of care, and alleviate the strain of medical resources. Thus, the aim of our research is to design a study protocol that included elderly CHF patients and their informal caregivers as an intervention unit and to explore the impact of the protocol on their health and physical outcomes. Methods: This is a prospective randomized controlled trial conducted in a triple-A hospital. In total, 80 elderly CHF patients and informal caregivers (80 dyads) will be recruited with informed consent. Based on the randomized numbers, they are divided into a control group (40 dyads) and an intervention group (40 dyads), subjects in the control group will receive usual care, and subjects in the intervention group will receive a home-based disease management program based on the Theory of Dyadic Illness Management on the basis of the control group. The duration of the intervention is 3 months, and the follow-up is 6 months. Data is collected at enrolment, 3 months after the intervention, and 3 months after the end of the intervention. The primary outcome is patients' quality of life and readmission. Secondary outcomes include patients' self-management behaviors, anxiety, and depression and caregivers' quality of life and care burden. Discussion: This study focuses on whether this home-based disease management program can improve the quality of life of elderly patients with CHF, reduce the readmission rate, enhance their self-management capacity, reduce negative emotions, and reduce the burden of informal caregivers. It can provide a new perspective on home management and cardiac rehabilitation of heart failure disease in the elderly, as well as alleviate problems such as the burden of healthcare resources. Trial registration: Chinese Clinical Trials Registry ChiCRT2300068026. Registered on 3 February 2023, manuscript Version: 1.0, https://www.chictr.org.cn/. [ABSTRACT FROM AUTHOR]

Background: Beyond being a pulmonary disease, chronic obstructive pulmonary disease (COPD) presents with extrapulmonary manifestations including reduced cognitive, cardiovascular, and muscle function. While exercise training is the cornerstone in the non-pharmacological treatment of COPD, there is a need for new exercise training methods due to suboptimal adaptations when following traditional exercise guidelines, often applying moderate-intensity continuous training (MICT). In people with COPD, short-duration high-intensity interval training (HIIT) holds the potential to induce a more optimal stimulus for training adaptations while circumventing the ventilatory burden often associated with MICT in people with COPD. We aim to determine the effects of supramaximal HIIT and MICT on extrapulmonary manifestations in people with COPD compared to matched healthy controls. Methods: COPD-HIIT is a prospective, multi-centre, randomized, controlled trial with blinded assessors and data analysts, employing a parallel-group designed trial. In phase 1, we will investigate the effects and mechanisms of a 12-week intervention of supramaximal HIIT compared to MICT in people with COPD (n = 92) and matched healthy controls (n = 70). Participants will perform watt-based cycling two to three times weekly. In phase 2, we will determine how exercise training and inflammation impact the trajectories of neurodegeneration, in people with COPD, over 24 months. In addition to the 92 participants with COPD performing HIIT or MICT, a usual care group (n = 46) is included in phase 2. In both phases, the primary outcomes are a change from baseline in cognitive function, cardiorespiratory fitness, and muscle power. Key secondary outcomes include change from baseline exercise tolerance, brain structure, and function measured by MRI, neuroinflammation measured by PET/CT, systemic inflammation, and intramuscular adaptations. Feasibility of the interventions will be comprehensively investigated. Discussion: The COPD-HIIT trial will determine the effects of supramaximal HIIT compared to MICT in people with COPD and healthy controls. We will provide evidence for a novel exercise modality that might overcome the barriers associated with MICT in people with COPD. We will also shed light on the impact of exercise at different intensities to reduce neurodegeneration. The goal of the COPD-HIIT trial is to improve the treatment of extrapulmonary manifestations of the disease. Trial registration: Clinicaltrials.gov: NCT06068322. Prospectively registered on 2023-09-28. [ABSTRACT FROM AUTHOR]

Aims Materials and Methods Results Conclusions To evaluate the efficacy and safety of add‐on dapagliflozin in patients with type 2 diabetes mellitus (T2D) who had inadequate glycaemic control with metformin and linagliptin.A total of 235 patients with inadequate response to metformin (≥1000 mg/day) plus linagliptin (5 mg/day) were randomized to receive either dapagliflozin/linagliptin fixed‐dose combination (FDC [AJU‐A51]) 10/5 mg/day (n = 117) or linagliptin 5 mg plus placebo (n = 118) for 24 weeks. After the main treatment period, patients who received linagliptin plus placebo were treated with AJU‐A51 for an additional 28 weeks. Change in glycated haemoglobin (HbA1c) from baseline to Week 24 was the primary endpoint.AJU‐A51 significantly reduced HbA1c levels (from 7.93% ± 0.82% to 7.11% ± 0.61%) compared with linagliptin plus placebo (from 7.80% ± 0.71% to 7.87% ± 0.94%), with a least squares mean difference of −0.88% (95% confidence interval −1.07 to −0.68; p < 0.0001) at 24 weeks. The AJU‐A51 group had a significantly higher proportion of patients who achieved HbA1c <7.0% at Week 24 than the control group (44.8% vs. 18.6%; p < 0.001). The AJU‐A51 group maintained glycaemic efficacy up to 52 weeks, whereas the control group showed a substantial reduction in HbA1c after switching to AJU‐A51 in the extension study period. Both groups had similar incidence of treatment‐emergent and serious adverse events, and no cases of symptomatic hypoglycaemia were reported.Dapagliflozin and linagliptin FDC (AJU‐A51) showed potent glucose‐lowering effects, with good tolerability, in patients with T2D who had poor glycaemic control on metformin and linagliptin (ClinicalTrials.gov [NCT06329674]). [ABSTRACT FROM AUTHOR]

Objectives: The purpose of this systematic review of randomized controlled trials (RCTs) was to evaluate the effectiveness, safety, and tolerability of psilocybin in adult patients with major depressive disorder (MDD). Methods: A systematic search (up to September 14, 2023) was conducted for RCTs that examined the efficacy, safety, and tolerability of psilocybin in physically healthy adult patients with MDD. Three independent researchers extracted data from publications where the primary outcome was a change in depressive symptoms, and key secondary outcomes were changes in anxiety symptoms and suicidal ideation, discontinuation rates for any reason, and adverse drug reactions (ADRs). Results: Five RCTs with 472 adult patients with MDD on psilocybin (n = 274) and controls (n = 198) were included. Two of the five RCTs (40%) reported mixed results, while the other three (60%) found that psilocybin had a beneficial effect on MDD treatment. Four RCTs (80%) assessing the anxiolytic effects of psilocybin for treating MDD found that psilocybin was significantly more effective than the control group in improving anxiety symptoms. Psilocybin was more effective than the control group in improving suicidal ideation in one out of five RCTs. Discontinuation rates were similar for any reason between the psilocybin group (2-13%) and the control group (4-21%) (P > 0.05). Four RCTs (80%) reported ADRs in detail. The most common ADR in both groups was headache. Conclusion: Psilocybin was effective in improving depressive symptoms in over half of the included studies and reduced anxiety symptoms in patients with MDD. The long-term efficacy and safety of psilocybin for MDD treatment needs to be further investigated in large RCTs. [ABSTRACT FROM AUTHOR]

Background: Demonstrating the positive effects of Nigella sativa supplementation (Nigella spp) on Allergic Rhinitis (AR) treatment is challenging. To investigate the role of Nigella spp in managing AR, a comprehensive review through systematic reviews and meta-analyses was conducted. Purpose: To carry out a meta-analysis of clinical trials that used Nigella spp in treating AR based on current data. Study Design: A meta-analysis of randomized controlled trials (RCTs) was performed. Methods: Various databases, including PubMed, Web of Science, Embase, Science Direct, Springer Link and the Cochrane Library, were searched until October 2023 to obtain RCTs assessing impact of Nigella spp in the control of AR. The current meta-analysis was carried out with a random-effects model. Results: There were 8 studies enrolled, and our meta-analysis findings revealed that, relative to the control group, observation group exhibited the markedly increased total effective rate for allergic rhinitis treatment (odds ratio [OR] = 4.24, 95% confidence interval [CI] (2.57, 7.27), and p < 0.00001); three studies showed that the effect of Nigella spp for nasal symptoms treatment among patients with allergic rhinitis was superior in observation group to control group [mean difference = -2.60, 95% CI (-2.82, -2.38), p < 0.00001]; adverse effects occurred in five studies, all of which were transient, did not require medical intervention, and were not statistically significant between the two groups [OR = 1.01, 95% CI (0.59, 1.73), p = 0.98]. Conclusion: The observation group demonstrated relative safety and had an enhanced effect on allergic rhinitis treatment and total nasal symptom improvement than the control group. The inclusion of fewer studies and the lower quality of trial design might affect the stability of the results. However, the evidence-based findings that Nigella spp for allergic rhinitis treatment is more accurate should be validated in future large-scale, multicenter, and welldesigned RCTs. [ABSTRACT FROM AUTHOR]

Background: This study aims to investigate the short-term effects and safety of adjunct Suxiao Jiuxin Pills (SJPs) on conventional therapy in chronic coronary syndrome (CCS) patients who are intolerant to the adverse effects of long-acting nitrates. Methods: This was a multicenter, randomized, double-blind, placebo-controlled trial. A total of 174 CCS participants from eight clinical study centers in China were included in the modified intention-to-treat analyses. Participants with CCS and intolerance to the adverse effects of long-acting nitrates were recruited and randomized to either the SJPs or the placebo group for a duration of 4 weeks. Results: Compared to the placebo group, the SJPs group showed a significant improvement in the efficacy rate after 4 weeks (OR = 2.43, 95% CI = 1.32 to 4.47, P = 0.004). Besides, individuals without a history of alcohol consumption showed a greater improvement in the SAQ summary score compared to those with a history of alcohol consumption. Conclusion: Adjunctive SJPs enhance the effectiveness of short-term conventional anti-angina treatment for patients with CCS who experience intolerance to long-acting nitrates, without significant adverse effects during application. Trial registration: Chinese Clinical Trials Registry Platform, ChiCTR2100050066. Registered 16 August 2021, https://www.chictr.org.cn/showproj.html?proj=131470. [ABSTRACT FROM AUTHOR]

Purpose: The purpose of this study was to systematically review the available level I evidence regarding the impact of tranexamic acid (TXA) on early postoperative outcomes in patients undergoing anatomic total shoulder arthroplasty (TSA) and reverse total shoulder arthroplasty (RTSA). Methods: A systematic review of the literature through April 2023 was performed to identify level I RCTs examining the use of TXA at the time of primary TSA or RTSA. Results: Among 5 included studies, a total of 435 patients (219 TXA, 216 control) were identified. Superior hematologic outcomes were observed among the TXA cohort, including lower 24-hour drain output (MD −112.70 mL: p < 0.001), lower pre- to postoperative change in hemoglobin (MD: −0.68 g/dL, p < 0.001), and less total perioperative blood loss (MD: −249.56 mL, p < 0.001). Postoperative Visual Analog Scale for pain (VAS-pain) scores were lower in the TXA group, but not significantly (MD: −0.46, p = 0.17). Postoperative blood transfusion was required in 3/219 TXA patients (1.4%) and 7/216 control patients (3.2%) (RR: 0.40, p = 0.16). Conclusion: Perioperative TXA reduces drain output and total blood loss without increasing the risk of adverse events. TXA was not shown to decrease postoperative transfusion rates when compared to placebo controls. Level of Evidence: Level I, meta-analysis. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effectiveness of a sexual rehabilitation program, SEXHAB, in improving sexual functioning, reducing sexual distress, and enhancing marital satisfaction for women after gynecological cancer treatment. Methods: This is a randomized controlled trial that included 150 women newly diagnosed with gynecological cancer from three public hospitals in Hong Kong. Participants were randomly assigned to the intervention group (n = 78) to receive the SEXHAB or to an attention control group (n = 72) to receive attention. The SEXHAB comprises four individual‐ or couple‐based sessions with three major components: information provision, cognitive‐behavioral therapy and counseling using motivational interviewing skills. The outcomes were measured at baseline (T0), upon completion of the program (T1) and 12‐month post‐treatment (T2). Semi‐structured interviews were also conducted with the SEXHAB group participants to explore their experiences with and opinions toward the program. Results: At both follow‐ups, there were no statistically significant differences between groups in improving sexual functioning, sexual distress and marital satisfaction. Nevertheless, participants in the SEXHAB group reported their partners having significantly greater sexual interest at T1 (76% vs. 52%, rate ratio: 1.46, 95% CI: 1.07 to 1.99, p = 0.024) and T2 (74% vs. 48%, rate ratio: 1.55, 95% CI: 1.11 to 2.10, p = 0.014). From the qualitative interviews, the interviewees who resumed sexual activity reported positive experiences in rebuilding sexuality and intimacy. Conclusions: Despite the quantitative results are negative, the qualitative findings suggest potential benefits of the SEXHAB for women resuming sexual activities after treatment for gynecological cancer. Further studies with longer intervention period and follow‐ups are needed to confirm the intervention effects. [ABSTRACT FROM AUTHOR]

Background: Many individuals with progressive multiple sclerosis (PMS) are challenged by reduced manual dexterity and limited rehabilitation options. Transcranial direct current stimulation (tDCS) during motor training can improve rehabilitation outcomes. We developed a protocol for remotely supervising tDCS to deliver sessions of stimulation paired with training at home. Objective: This study evaluated the effectiveness of at-home tDCS paired with manual dexterity training for individuals with PMS. Methods: Sixty-five right-hand dominant participants with PMS and hand impairment were randomized to receive either active or sham M1-SO tDCS paired with manual dexterity training over 4 weeks. Clinical outcomes were measured by the changes in Nine-Hole Peg Test (9-HPT) and Dellon-Modified-Moberg-Pick-Up Test (DMMPUT). Results: The intervention had high rates of adherence and completion (98% of participants completed at least 18 of 20 sessions). The active tDCS group demonstrated significant improvement for the left hand compared with baseline in 9-HPT (−5.85 ± 6.19 vs −4.23 ± 4.34, p = 0.049) and DMMPUT (−10.62 ± 8.46 vs −8.97 ± 6.18, p = 0.049). The active tDCS group reported improvements in multiple sclerosis (MS)-related quality of life (mean increase: 5.93 ± 13.04 vs −0.05 ± −8.27; p = 0.04). Conclusion: At-home tDCS paired with manual dexterity training is effective for individuals with PMS, with M1-SO tDCS enhancing training outcomes and offering a promising intervention for improving and preserving hand dexterity. [ABSTRACT FROM AUTHOR]