Search

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]

An increase in visceral fat is associated with an increase in insulin resistance, so reducing body fat mass through exercise may help alleviate type 2 diabetes mellitus (T2DM). The current meta-analysis evaluated the effect of changes in body fat via an intervention of regular exercise on hemoglobin A1c (HbA1c) in patients with T2DM. The inclusion criteria were randomized controlled trials involving adults with T2DM, intervention involving exercise alone, an overall duration of intervention ≥12 weeks, and reporting HbA1c and body fat mass. The mean differences (MDs) were defined as the MD between the exercise group and the control group, and the MDs in HbA1c (in percentage) and body fat mass (in kilograms) were calculated. All MDs in HbA1c were pooled as overall effects. A meta-regression analysis was performed to evaluate the relationship between the MD in the body fat mass (in kilograms) and the MD in HbA1c. Twenty studies (1,134 subjects) were analyzed. The pooled MD in HbA1c (in percentage) decreased significantly (−0.4; 95% confidence interval [−0.5, −0.3]) but contained significant heterogeneity (Q = 52.7, p <.01; I2 = 41.6%). A meta-regression analysis showed that a decrease in the MD in body fat mass was significantly associated with a decrease in the MD in HbA1c (R2 = 80.0%) and heterogeneity decreased (Q = 27.3, p =.61; I2 = 11.9%), and a reduction in body fat mass of 1 kg was estimated to decrease the HbA1c (%) by approximately 0.2. The current study suggested that a decrease in HbA1c due to regular exercise depends on a reduction in body fat mass in patients with T2DM. [ABSTRACT FROM AUTHOR]

Aim Methods Results Conclusion This study aimed to develop and evaluate the efficacy and safety of Supine Daoyin, a TCM PR technique, in hospitalized patients with AECOPD.This is a multicenter, prospective, randomized, controlled trial involving AECOPD inpatients recruited from April 2021 to December 2023 in five tertiary hospitals in China. Participants were randomly assigned to 14 days of Supine Daoyin group or control group and evaluated at days 3, 7, and 14 (posttreatment). The primary outcomes were LOS and CCQ and secondary outcomes were 6MWD, 30‐STS, BI, Borg CR10, time on mechanical ventilation, SGRQ, mCOPD‐PRO, and mESQ‐COPD.Out of 369 participants screened, 228 were randomly assigned (Supine Daoyin group: n = 114; control group: n = 114). For primary outcomes, there was no significant between‐group difference in LOS (p > 0.05), but for CCQ the Supine Daoyin was superior to control at days 7 (p < 0.01) and 14 (p < 0.01). For secondary outcomes, Supine Daoyin groups showed robust and superior improvements in 6MWD, 30‐STS, BI, Borg CR10, SGRQ, mCOPD‐PRO, and mESQ‐COPD (all p < 0.05), but for time on mechanical ventilation there was no significant difference in two groups (p > 0.05).Supine Daoyin, a novel TCM PR technique, demonstrates safety and efficacy for AECOPD inpatients, yielding clinically meaningful improvements in health status, exercise capacity, and quality of life. This study offers a viable PR option for AECOPD patients with severe symptoms and limited mobility. [ABSTRACT FROM AUTHOR]

Objectives Design Methods Results Conclusions Behaviour change theories have extensively been used in health behaviour change interventions and their programme theories. However, they are rarely evaluated in randomized field studies. The Let's Move It intervention targeted various psychosocial constructs to increase adolescents' physical activity. A theory‐based process evaluation aiming to illuminate the trial findings as well as to test the programme theory used is conducted. Specifically, we investigate whether the intervention influenced the theorized determinants of change immediately post‐intervention and after 1 year, and whether these determinants were associated with changes in physical activity.A cluster‐randomized controlled trial (n = 1166).We measured theorized determinants with self‐report, and physical activity (PA) with accelerometry and self‐report. The effects are evaluated with repeated measures ANOVA and regression models.No changes were detected in most theorized determinants but intervention arm reported higher enactment of behaviour change techniques used during intervention immediately post‐intervention and lower descriptive norms for PA throughout. Autonomous motivation was associated with PA immediately post‐intervention.The lack of intervention effects may be due to many factors, for example insensitive measures, ceiling effects. However, reporting these null effects advances understanding of behaviour change processes. We introduce methodologic possibilities for future intervention programme theory evaluation efforts. [ABSTRACT FROM AUTHOR]

Background Methods Results Conclusion Intranasal corticosteroids were recommended as first‐line drugs for the treatment of allergic rhinitis (AR) children. A variety of corticosteroids were available for clinical choice; however, which could relieve the clinical symptoms of patients to the greatest extent was currently unknown. Thus, we performed a network meta‐analysis (NMA) to systematically evaluate the effectiveness and safety of different corticosteroids in treating children with AR, which might provide a basis for more rational clinical treatment decisions.Seven electronic databases were searched, and the retrieval time range was the time from their inception to November 2023. The literature screening, data extraction, and assessment of the risk of bias of included studies were completed independently by two reviewers. A frequentist NMA was performed with Stata17.0 software.A total of 43 RCTs covering 10,897 participants were included. In the improvement of reflective total nasal symptom score (rTNSS) and instantaneous total nasal symptom score (iTNSS), fluticasone furoate nasal spray (FFNS) and beclomethasone dipropionate (BDP) nasal aerosol presented the best efficacy. Regarding the incidence of adverse reactions, mometasone furoate aqueous nasal spray (MFANS) and BDP showed a good safety profile. In terms of the influence of cortisol (urinary free cortisol, plasma cortisol) and growth, no significant difference was observed between the different groups.The results showed that BDP nasal aerosol and FFNS had best efficacy; MFANS and BDP had the best safety profile. However, this conclusion was less convincing because of the limited numbers of patients/controls and study quality. [ABSTRACT FROM AUTHOR]

Background: Maintenance of physical function, mobility, and independent living are important goals for older adults. However, concerns about falling (CaF) play a central role in the vicious cycle of CaF, inflammation, loss of muscle mass, and decreasing physical function ultimately resulting in negative health outcomes. CaF, like other states of chronic stress and anxiety, can be considered as enduring adverse stimuli affecting the stress systems and the inflammatory system. Therefore, the aim of this study is to investigate whether a reduction of CaF leads to a reduction of stress and therefore possibly reduces chronic low-grade inflammation. Understanding the role and directionality of the effects of inflammation on CaF increases our understanding of age-related loss of mobility and physical function. Methods: In this study, community-dwelling older adults, aged 70 years and older, will be randomly assigned to either a 4-month, multi-component intervention with exercise training and cognitive-behavioral components or to a sham control group with light stretching exercises, cognitive training, and educational health lectures. For the operationalization of specific CaF, the Falls Efficacy Scale—International will be used. Stress and related psychological symptoms will be monitored using established self-reports and by measuring salivary cortisol. Concentrations of C-reactive protein, interleukin 6, interleukin 10, and tumor-necrosis-factor-alpha, as well as gene expression of selected inflammatory transcripts, will be used as surrogate parameters of the inflammatory status at baseline, after the 4-month intervention and 8-month follow-up. Discussion: This study will be the first to test whether CaF are related with stress system activity or reactivity or with markers of inflammation in the context of a multi-component intervention with exercise training and cognitive-behavioral components addressing CaF. The reduction of specific CaF or general psychological symptoms should reverse alterations in stress systems, and / or slow down low-grade inflammation. Changes in activity, as well as psychological and biological pathways leading from CaF to muscle loss will be measured, to disentangle the individual contribution to sarcopenia, and to provide an additional pathway to break or slow-down the vicious cycle of CaF and sarcopenia. Trial registration: German Clinical Trials Register (DRKS): DRKS00029171. Registered 22 July 2022. [ABSTRACT FROM AUTHOR]

Background: The rate of vitamin D deficiency (VDD) in critically ill children worldwide has been estimated at 50%. These children are at risk of multiple organ dysfunction, chronic morbidity, and decreased health related quality of life (HRQL). Pediatric and adult ICU clinical trials suggest that VDD is associated with worse clinical outcomes, although data from supplementation trials are limited and inconclusive. Our group's phase II multicenter dose evaluation pilot study established the efficacy and safety of an enteral weight-based cholecalciferol loading dose to rapidly restore vitamin D levels in critically ill children. Methods: Our aim is to evaluate the impact of this dosing regimen on clinical outcomes. VITdALIZE-KIDS is a pragmatic, phase III, multicenter, double-blind RCT aiming to randomize 766 critically ill children from Canadian PICUs. Participants are randomized using a 1:1 scheme to receive a single dose at enrollment of enteral cholecalciferol (10,000 IU/kg, max 400,000 IU) or placebo. Eligibility criteria include critically ill children aged newborn (> 37 weeks corrected gestational age) to < 18 years who have blood total 25-hydroxyvitamin D < 50 nmol/L. The primary objective is to determine if rapid normalization of vitamin D status improves HRQL at 28 days following enrollment. The secondary objective is to evaluate the impact of rapid normalization of vitamin D status on multiple organ dysfunction. The study includes additional tertiary outcomes including functional status, HRQL and mortality at hospital discharge and 90 days, PICU and hospital length of stay, and adverse events related to vitamin D toxicity. Additionally, we are performing comprehensive vitamin D speciation and non-targeted metabolite profiling as part of a sub-study for the first 100 participants from whom an enrollment and at least one post-intervention blood and urine sample were obtained. Discussion: The VITdALIZE-KIDS trial is the first phase III, multicenter trial to evaluate whether rapid normalization of vitamin D status could represent a simple, inexpensive, and safe means of improving outcomes following pediatric critical illness. Recruitment was initiated in June 2019 and is expected to continue to March 2026. Trial registration: Clinicaltrials.gov, NCT03742505. Study first submitted on November 12, 2018 https://clinicaltrials.gov/study/NCT03742505 [ABSTRACT FROM AUTHOR]

Background: Rotator cuff calcific tendinitis (RCCT) is a common shoulder disease whose main symptoms include shoulder pain, limited mobility, and calcification deposits in the shoulder. Traditional treatment methods have certain limitations, so finding new treatment methods has become the focus of research. Extracorporeal shock wave (ESW) and platelet-rich plasma (PRP) treatments have attracted much attention due to their non-invasive and tissue repair-promoting properties; however, the efficacy of their combined treatment in RCCT remains unclear. Methods: This study is designed as a single-center, assessment-blind, randomized controlled clinical trial with three parallel groups. Sixty subjects will be recruited and randomly divided into the ESW group, PRP group, and ESW combined with PRP group, in a 1:1:1 ratio. The entire intervention period is 4 weeks, and the follow-up period is 4 weeks. Outcomes will be measured at baseline (T0), after 1 week of intervention (T1), after 2 weeks of intervention (T2), after 4 weeks of intervention (T3), and after an additional 4 weeks of follow-up period (T4). The primary endpoint is the VAS score. Secondary endpoints are ASES, CMS, UCLA, and the location and size of calcified areas. Discussion: This study aims to evaluate the efficacy of ESW therapy combined with PRP in treating RCCT. We compare the effects of single and combined treatments to explore their impact on disease symptoms, functional improvement, and calcification regression. This provides a scientific basis for identifying more effective treatment options. Trial registration: ClinicalTrials.gov NCT06372600. Registered on April 17, 2024; version 1. [ABSTRACT FROM AUTHOR]

Excessive sugar intake poses a significant risk factor for non-communicable diseases. A positive healthy eating (PHE) intervention was developed to promote low-sugar dietary practices in families. The PHE intervention capitalized on positive psychological constructs to overcome barriers to health behavior change by helping families associate feelings of joy, gratitude, and savoring with healthy eating. In a cluster randomized controlled trial, 1983 participants from 1467 families were recruited in Hong Kong. PHE included a core and booster session. Data were collected at pre-intervention, post-intervention, and at 1-month and 3-month follow-up. Compared to the control, PHE showed greater increase in intention to change at post-intervention, engagement in low-sugar dietary practices individually and with family members at 3-month follow-up, and greater reduction in sugar-sweetened beverage intake at 1-month and 3-month follow-up. Intentions to change mediated PHE's effects on low-sugar dietary practices. Focus group interviews revealed the behavior-change process and family quality of life. [ABSTRACT FROM AUTHOR]

Background: Multiple Sclerosis (MS) is a chronic inflammatory neurodegenerative disease with diverse symptomatology, significantly impacting patients' quality of life (QoL). While pharmacological therapies focus primarily on reducing inflammation and relapse rates, non-pharmacological interventions, including digital health applications, have shown promise in improving QoL among persons with MS (PwMS). Pilot studies had shown the feasibility and acceptability of levidex, a digital health application based on cognitive behavioral therapy (CBT) principles, a broad set of behavior change techniques, and relevant lifestyle-change advice. This randomized controlled trial aimed to examine the effects of levidex on MS-related QoL over 6 months. Methods: Participants who were diagnosed with MS for at least one year were recruited via the internet in Germany, using a secure survey software platform, and were randomly assigned to the intervention group (IG), in which they received standard care + levidex, or an active control group (CG), in which they received standard care and were offered web-adapted material on the topic of lifestyle change from the German Multiple Sclerosis Society (DMSG). The primary outcome was MS-related QoL after 6 months, measured by the Hamburg Quality of Life Questionnaire in MS (HAQUAMS); secondary outcomes included QoL subscales, sick days, and health behavior, among others. Analyses of Covariance (ANCOVA) were used to examine intervention effects at 6 months. Participants were recruited between November 2020 and February 2022. Results: A total of 421 adult participants (mean age: 47.5, 78.1% women) were included and randomized (IG, n = 195, CG, n = 226). After 6 months, the IG exhibited significantly higher MS-related QoL, compared to the CG (total score HAQUAMS, adjusted group mean difference = -0.14, 95% CI: [-0.22, -0.06], p = 0.001; Cohen's d = 0.23), with significant effects also observed on the cognitive and mood subscales. At 6 months, IG participants also reported significantly fewer sick days (median = 2 days in IG vs. 6 days in CG; W = 3939, p = 0.012) and significantly higher levels of daily activities, as measured by the Frenchay Activity Index, adjusted group mean difference = 1.37, 95% CI = [0.33, 2.40], p = 0.010; Cohen's d = 0.16. Safety analyses showed no adverse events and good satisfaction. Conclusions: Compared to the control group, levidex facilitated clinically relevant improvements in MS-related QoL, reduced sick days, and enhanced activity in PwMS over 6 months. These findings suggest that levidex can serve as an effective non-pharmacological adjunctive treatment element to standard care and could help improve QoL among PwMS. Trial registration: Registered on 22.09.2020 at the German Clinical Trials Register DRKS00023023. [ABSTRACT FROM AUTHOR]

Background and aims Design, setting and participants Intervention and comparator Measurements Conclusion Signficant inequalities in tobacco smoking exist, with higher smoking rates among people from low‐socio‐economic status (low‐SES) populations. Tailored technology‐based programs for low‐SES smoking populations have the potential for high reach, but require effectiveness data from large‐scale trials. This trial among Australians who smoke from a low‐SES background will determine the effectiveness and cost‐effectiveness of tailored text‐message (TTM) support compared with standard Quitline (SQL) telephone support service.This is a two‐arm, parallel group, randomized, non‐inferiority trial with allocation concealment and blinded outcome assessment in an Australian population within the greater Sydney region in New South Wales. Participants are adults who smoke daily (n = 1246), are interested in quitting and currently receiving a government pension or allowance, and will be recruited via advertisements.Participants will be randomized (1:1 ratio) to receive either 12 months of TTM quit support or enrolment in SQL telephone support.Assessments will be completed at baseline (telephone interview), within 1 month (check‐in call), at 3 months (on‐line questionnaire) and 12 months (telephone interview) post‐randomization. The primary outcome will be 6‐month continuous abstinence verified by carbon monoxide breath test at 12‐month follow‐up. The study will test whether TTM is non‐inferior to SQL by a non‐inferiority margin of 2%, i.e. the quit rate in the TTM group will be no worse than 2% less than the quit rate in the SQL group. Secondary outcomes will include self‐reported continuous and point prevalence abstinence and acceptability and cost‐effectiveness of TTM versus SQL.Should the tailored text‐message support prove non‐inferior and more cost‐effective than Quitline for this population, this will provide an opportunity for the upscaling of an effective, inexpensive and tailored quit support service. The trial findings will inform cessation treatment policy for priority populations in Australia and globally. [ABSTRACT FROM AUTHOR]

Age at first onset of depression as a clinical factor affecting cognitive improvement in late life depression was investigated. This is a secondary analysis of an eight-week randomized controlled trial involving 452 elderly patients treated by vortioxetine, duloxetine or placebo (1:1:1). Patients were subcategorized into early-onset (LLD-EO) and late-onset (LLD-LO) groups divided by onset age of 50. Cognitive performance was assessed by composite score of Digit Symbol Substitution Test (DSST) and the Rey Auditory Verbal Learning Test (RAVLT) tasks, while depressive symptoms were assessed by Montgomery–Åsberg Depression Rating Scale (MADRS). Vortioxetine and duloxetine exhibited advantages versus placebo in improving cognitive performance in the LLD-LO group, yet not in the LLD-EO group after eight weeks. Patients in the LLD-EO group showed overall advantage to placebo in depressive symptoms before endpoint (week 8) of treatment, while patients in the LLO-LO group showed no advantage until endpoint. Path analysis suggested a direct effect of vortioxetine (B = 0.656, p =.036) and duloxetine (B = 0.726, p =.028) on improving cognition in the LLD-LO group, yet in all-patients treated set both medications improved cognition indirectly through changes of depressive symptoms. Reliability of clinical history could raise caution as it was collected by subjective recall of patients. Age at first onset might affect cognitive improvement as well as change in depressive symptoms and its mediation towards cognitive improvement in late life depression treated with vortioxetine and duloxetine. • Vortioxetine and Duloxetine improved cognitive performance of elderly depressed patients with first onset after 50. • Patients with first depressive onset before 50 showed earlier symptomatic change than those with first onset after 50. • Vortioxetine and duloxetine showed direct treatment effect on improving cognition in patients with first episode after 50. [ABSTRACT FROM AUTHOR]

Background: Liver cancer (LC) screening, such as AFP test and abdominal ultrasound, is an effective way to prevent LC, one of the most common cancers worldwide. Despite the proven screening benefits, screening participation among high-risk populations for LC remains low. This suggests that targeted, systematic, and effective interventions should be provided to improve knowledge and awareness related to LC screening, enhance screening intentions, and thereby promote screening behaviors. Telephone is people's main medium of daily communication and mHealth-based programs offer a potential and effective solution for promoting health behaviors. The purpose of this study is to develop and implement a mHealth (WeChat app) based intervention guided by Fogg's Behavior Model (FBM) to augment the knowledge of LC prevention among people at risk of LC and enhance their motivation for screening, and to validate its effectiveness in improving LC screening. Methods: We propose a two-arm, single-blind randomized controlled trial with 82 at-risk individuals of LC, delivering a 6-month mHealth-based intervention program with optional health counseling. Recruitment will be through tertiary hospitals and community organizations in 4 districts in Heng Yang. In total, 82 individuals at high risk for HCC will be randomized 1:1 to intervention or control (usual care) groups. The intervention group will receive intervention, whose contents are based on the FBM model, via multiple forms of media including PowerPoint presentation, multimedia video, health information booklet and screening message, which is delivered in the WeChat Applet. Control dyads will be provided with usual health education. Outcomes will be assessed at baseline and post-intervention. Discussion: The findings of this study will provide evidence of the benefits of utilizing mHealth-based approaches in intervention development to enhance the effectiveness of screening adherence for high-risk people of LC. Further, the findings would provide reference to the potential incorporation of the targeted intervention in local community organizations. Trial registration: Chinese Clinical Trial Registry (ChiCTR2400080530) Date registered: 31/1/2024. [ABSTRACT FROM AUTHOR]

Background: In locally advanced rectal cancer (LARC), optimizing neoadjuvant strategies, including the addition of concurrent chemotherapy and dose escalation of radiotherapy, is essential to improve tumor regression and subsequent implementation of anal preservation strategies. Currently, dose escalation studies in rectal cancer have focused on the primary lesions. However, a common source of recurrence in LARC is the metastasis of cancer cells to the proximal lymph nodes. In our trial, we implement simultaneous integrated boost (SIB) to both primary lesions and positive lymph nodes in the experimental group based on magnetic resonance-guided adaptive radiotherapy (MRgART), which allows for more precise (and consequently intense) targeting while sparing neighboring healthy tissue. The objective of this study is to evaluate the efficacy and safety of MRgART dose escalation to both primary lesions and positive lymph nodes, in comparison with the conventional radiotherapy of long-course concurrent chemoradiotherapy (LCCRT) group, in the neoadjuvant treatment of LARC. Methods: This is a multi-center, randomized, controlled phase III trial (NCT06246344). 128 patients with LARC (cT3-4/N+) will be enrolled. During LCCRT, patients will be randomized to receive either MRgART with SIB (60–65 Gy in 25–28 fractions to primary lesions and positive lymph nodes; 50–50.4 Gy in 25–28 fractions to the pelvis) or intensity-modulated radiotherapy (50–50.4 Gy in 25–28 fractions). Both groups will receive concurrent chemotherapy with capecitabine and consolidation chemotherapy of either two cycles of CAPEOX or three cycles of FOLFOX between radiotherapy and surgery. The primary endpoints are pathological complete response (pCR) rate and surgical difficulty, while the secondary endpoints are clinical complete response (cCR) rate, 3-year and 5-year disease-free survival (DFS) and overall survival (OS) rates, acute and late toxicity and quality of life. Discussion: Since dose escalation of both primary lesions and positive nodes in LARC is rare, we propose conducting a phase III trial to evaluate the efficacy and safety of SIB for both primary lesions and positive nodes in LARC based on MRgART. Trial registration: The study was registered at ClinicalTrials.gov with the Identifier: NCT06246344 (Registered 7th Feb 2024). [ABSTRACT FROM AUTHOR]

Background: Individuals with high blood pressure in India often miss essential follow-up visits. Missed visits contribute to gaps across the hypertension care continuum and preventable cardiovascular disease. Widespread misconceptions around hypertension care and treatment may contribute to low follow-up attendance rates, but to date, there is limited evidence of the effect of interventions to debunk such misconceptions on health-seeking behavior. We conducted a randomized controlled trial to measure whether combining information debunking commonly-held misconceptions with a standard reminder reduces missed follow-up visits among individuals with high blood pressure and investigated whether any observed effect was moderated through belief change. Methods: We recruited 388 patients with uncontrolled blood pressure from the outpatient wards of two public sub-district hospitals in Punjab, India. Participants randomly assigned to the intervention arm received two WhatsApp messages, sent 3 and 1 days before their physician-requested follow-up visit. The WhatsApp message began with a standard reminder, reminding participants of their upcoming follow-up visit and its purpose. Following the standard reminder, we included brief debunking statements aimed at acknowledging and correcting common misconceptions and misbeliefs about hypertension care seeking and treatment. Participants in the control group received usual care and did not receive any messages. Results: We did not find evidence that the enhanced WhatsApp reminders improved follow-up visit attendance (Main effect: 2.2 percentage points, p-value = 0.603), which remained low across both treatment (21.8%, 95% CI: 15.7%, 27.9%) and control groups (19.6%, 95% CI: 14.2%, 25.0%). Participants had widespread misconceptions about hypertension care but our debunking messages did not successfully correct these beliefs (p-value = 0.187). Conclusions: This study re-affirms the challenge of continuity of care for chronic diseases in India and suggests that simple phone-based health communication methods may not suffice for changing prevalent misconceptions and improving health-seeking behavior. Trial registration: The trial began on July 18th. We registered the trial on July 18th (before recruitment began), including the main outcomes, on the German Clinical Trial Register [Identifier: DRKS00029712] and published a pre-analysis plan in the Open Science Framework [osf.io/67g35]. [ABSTRACT FROM AUTHOR]

Background: Individuals with high blood pressure in India often miss essential follow-up visits. Missed visits contribute to gaps across the hypertension care continuum and preventable cardiovascular disease. Widespread misconceptions around hypertension care and treatment may contribute to low follow-up attendance rates, but to date, there is limited evidence of the effect of interventions to debunk such misconceptions on health-seeking behavior. We conducted a randomized controlled trial to measure whether combining information debunking commonly-held misconceptions with a standard reminder reduces missed follow-up visits among individuals with high blood pressure and investigated whether any observed effect was moderated through belief change. Methods: We recruited 388 patients with uncontrolled blood pressure from the outpatient wards of two public sub-district hospitals in Punjab, India. Participants randomly assigned to the intervention arm received two WhatsApp messages, sent 3 and 1 days before their physician-requested follow-up visit. The WhatsApp message began with a standard reminder, reminding participants of their upcoming follow-up visit and its purpose. Following the standard reminder, we included brief debunking statements aimed at acknowledging and correcting common misconceptions and misbeliefs about hypertension care seeking and treatment. Participants in the control group received usual care and did not receive any messages. Results: We did not find evidence that the enhanced WhatsApp reminders improved follow-up visit attendance (Main effect: 2.2 percentage points, p-value = 0.603), which remained low across both treatment (21.8%, 95% CI: 15.7%, 27.9%) and control groups (19.6%, 95% CI: 14.2%, 25.0%). Participants had widespread misconceptions about hypertension care but our debunking messages did not successfully correct these beliefs (p-value = 0.187). Conclusions: This study re-affirms the challenge of continuity of care for chronic diseases in India and suggests that simple phone-based health communication methods may not suffice for changing prevalent misconceptions and improving health-seeking behavior. Trial registration: The trial began on July 18th. We registered the trial on July 18th (before recruitment began), including the main outcomes, on the German Clinical Trial Register [Identifier: DRKS00029712] and published a pre-analysis plan in the Open Science Framework [osf.io/67g35]. [ABSTRACT FROM AUTHOR]

A meta-analysis including all relevant randomized controlled trials was conducted to compare soft bandage, splint and cast as the treatment of torus fracture. PubMed, Scopus, and Web of Science databases were searched in January 2023. Two comparisons were made: (1) splint versus cast, and (2) bandage versus rigid immobilization (i.e. splint or cast). Main outcomes were pain, clinical healing of the fracture and return to activities. Secondary outcomes were adverse events (skin issues, problems with cast/splint/bandage) and patient/parental satisfaction. Seven studies with 1550 patients were included. Splint was associated with higher pain scores at 3 days compared to cast (Mean difference [MD] 1.00, CI 0.06–1.94) and at 1 week (MD 1.46, CI 0.84–2.08, moderate-certainty evidence), but faster return to activities (at 3 weeks RR 1.77, CI 1.09–2.88, at 4 weeks RR 1.44, CI 1.11–1.82, moderate-certainty evidence). All torus fractures heal clinically within 3–4 weeks (low-certainty evidence). Bandage may lead to slightly higher pain score (MD 0.35, CI 0.04–0.66, moderate-certainty evidence) at first day after treatment compared to rigid immobilization, but no evidence of a difference was found in later time points. In conclusion, soft bandage or removable wrist splint seem to be optimal first-line treatment of distal forearm torus fracture. [ABSTRACT FROM AUTHOR]

Background: Tai Chi (TC) holds a unique and valued place in promoting the physical and mental health of college students. Its significance is underscored by its incorporation as a compulsory physical education course in every university in China. TC, with its rich tradition, places a strong emphasis on posture control as a core sports ability. However, the students in Tai Chi Elective Course (TCEC) have very poor posture control ability. This study protocol investigates the potential of Tan Tui (TT) to address these issues, as TT is a fundamental skill for beginners of traditional Chinese martial arts and has a track record of enhancing lower limb strength and balance, making it a promising choice for improving posture control in TCEC. Methods/design: To investigate the impact of different intensities of TT exercises on posture control in TCEC students, we have designed a randomized, double-blind, parallel-controlled trial. Seventy-six students in the TCEC will be randomly divided into low-intensity Tan Tui (LTT), medium-intensity Tan Tui (MTT), and high-intensity Tan Tui exercises group (HTT) and control group (CON), each with 19 people. The LTT group, MTT group, and HTT group will be given different intensity of TT exercises, and the CON group will be given regular TCEC. The intervention period will be 6 weeks (2 times a week, 20 min each time). At baseline (before), 4 weeks of intervention (middle), and 6 weeks of intervention (after), the Unipedal Stance Test (UST), the Star Excursion Balance Test (SEBT), 60°/s angular velocity knee joint flexion and extension relative peak torque (RPT), and knee joint position perception (KJPP) will be evaluated. Discussion: This is the first randomized controlled trial protocol from the perspective of training intensity to evaluate the effect of different intensity of TT exercises on posture control of students in TCEC. Should our research reveal a significant intervention effect, the results will offer preliminary, higher-quality evidence supporting the positive impact of varying intensities of Tan Tui exercises on posture control in TCEC students. Trial registration: Chinese Clinical Trial Registry ChiCTR2000039109. Registered on October 17, 2020. [ABSTRACT FROM AUTHOR]

Background: Approximately onethird of cancer survivors encounter challenges reintegrating into the workforce, often experiencing involuntary unemployment and/or partial or full work disability following diagnosis and treatment. Returning to paid employment presents evident challenges due to uncertainties regarding work ability, perceived employer discrimination, and a lack of support, thereby risking social exclusion. However, interventions addressing return to paid employment among unemployed and/or work-disabled cancer survivors are scarce. Here, we describe the protocol of a randomized controlled trial (RCT), including a process and economic evaluation, evaluating the effectiveness and cost-effectiveness of the PLACES (unemPLoyed cAnCEr survivors Support) intervention aimed at supporting unemployed and/or work-disabled cancer survivors returning to paid employment. Methods: A two-armed RCT with a 12-month follow-up period will be conducted. Eligible participants: (1) are of working age (18–65 years), (2) are diagnosed with cancer between 6 months and 10 years ago, (3) are unemployed and/or partially or fully work-disabled, (4) have completed cancer treatment, and (5) are seeking paid employment and are motivated to initiate work immediately. Participants will primarily be identified through the Dutch Social Security Agency and the Netherlands Cancer Registry and recruited via healthcare professionals. Participants randomly allocated to the intervention group (n = 82) will receive the PLACES intervention: a tailored supported employment intervention based on the principles of Individual Placement and Support (IPS). This includes support in seeking, returning to, and maintaining paid employment. Participants allocated to the control group (n = 82) will receive care as usual. All participants will be asked to complete questionnaires, at baseline (T0), and after 3 (T1), 6 (T2), and 12 (T3) months of follow-up. The primary outcome is paid employment [yes/no]. Secondary outcomes are time until paid employment, change in working hours, work ability, quality of (working) life, and self-efficacy regarding return to work. Additionally, process and economic evaluations will be conducted. Discussion: We hypothesize that the PLACES intervention will be effective in obtaining paid employment, enhancing work ability, and improving quality of life. In addition, we expect the intervention to be cost-effective. If proven effective and cost-effective, actions should be taken to implement the intervention in usual care. Trial registration: NCT06028048. [ABSTRACT FROM AUTHOR]

Background: A recent meta-analysis concluded that outpatient appendectomy appears feasible and safe, but there is a lack of high-quality evidence and a randomized trial is needed. The aim of this trial is to demonstrate that outpatient appendectomy is non-inferior to conventional inpatient appendectomy in terms of overall morbi-mortality on the 30th postoperative day (D30). Methods: SAMBA is a prospective, randomized, controlled, multicenter non-inferiority trial. We will include 1400 patients admitted to 15 French hospitals between January 2023 and June 2025. Inclusion criteria are patients aged between 15 and 74 years presenting acute uncomplicated appendicitis suitable to be operated by laparoscopy. Patients will be randomized to receive outpatient care (day-surgery) or conventional inpatient care with overnight hospitalization in the surgery department. The primary outcome is postoperative morbi-mortality at D30. Secondary outcomes include time from diagnosis to appendectomy, length of total hospital stay, re-hospitalization, interventional radiology, re-interventions until D30, conversion from outpatient to inpatient, and quality of life and patient satisfaction using validated questionnaires. Discussion: The SAMBA trial tests the hypothesis that outpatient surgery (i.e., without an overnight hospital stay) of uncomplicated acute appendicitis is a feasible and reliable procedure in establishments with a technical platform able to support this management strategy. Trial registration: ClinicalTrials.gov NCT05691348. Registered on 20 January 2023. [ABSTRACT FROM AUTHOR]

Background: Tai Chi (TC) holds a unique and valued place in promoting the physical and mental health of college students. Its significance is underscored by its incorporation as a compulsory physical education course in every university in China. TC, with its rich tradition, places a strong emphasis on posture control as a core sports ability. However, the students in Tai Chi Elective Course (TCEC) have very poor posture control ability. This study protocol investigates the potential of Tan Tui (TT) to address these issues, as TT is a fundamental skill for beginners of traditional Chinese martial arts and has a track record of enhancing lower limb strength and balance, making it a promising choice for improving posture control in TCEC. Methods/design: To investigate the impact of different intensities of TT exercises on posture control in TCEC students, we have designed a randomized, double-blind, parallel-controlled trial. Seventy-six students in the TCEC will be randomly divided into low-intensity Tan Tui (LTT), medium-intensity Tan Tui (MTT), and high-intensity Tan Tui exercises group (HTT) and control group (CON), each with 19 people. The LTT group, MTT group, and HTT group will be given different intensity of TT exercises, and the CON group will be given regular TCEC. The intervention period will be 6 weeks (2 times a week, 20 min each time). At baseline (before), 4 weeks of intervention (middle), and 6 weeks of intervention (after), the Unipedal Stance Test (UST), the Star Excursion Balance Test (SEBT), 60°/s angular velocity knee joint flexion and extension relative peak torque (RPT), and knee joint position perception (KJPP) will be evaluated. Discussion: This is the first randomized controlled trial protocol from the perspective of training intensity to evaluate the effect of different intensity of TT exercises on posture control of students in TCEC. Should our research reveal a significant intervention effect, the results will offer preliminary, higher-quality evidence supporting the positive impact of varying intensities of Tan Tui exercises on posture control in TCEC students. Trial registration: Chinese Clinical Trial Registry ChiCTR2000039109. Registered on October 17, 2020. [ABSTRACT FROM AUTHOR]

PurposeMethodsResultsConclusionsTo compare the long-term outcomes of mucosal-sparing mechanical endoscopic dacryocystorhinostomy (MMED) for primary acquired nasolacrimal duct obstruction (PANDO) with or without silicone intubation.An 11-year follow-up study of the Silicone intubation in Endoscopic Dacryocystorhinostomy (SEND) randomized controlled trial (RCT) was conducted at a university-affiliated dacryology clinic from December 2019 to March 2023. Questionnaires on symptoms, anterior segment examination, endoscopic examination with functional endoscopic dye test (FEDT) and FICI grading, and ostial size measurements using Image J software were performed by a masked ophthalmologist. The primary outcome was surgical success, defined by Munk’s score ≤1 and a positive fluorescein endoscopic dye test. Secondary outcomes included risk factors for failure and outcomes of revision surgeries.Fifty-three of the original 118 patients were evaluated at 155 ± 21 (136–218) months postoperatively. Seventy-seven percent (46/60) ostia remained successful, including 70% (19/27) of unstented and 82% (27/33) of stented ostia (p = .3). Stented ostia had larger size (p = .003), but this did not confer higher success (p = .14). Successful ostia had higher FICI scores and better ostial dynamicity (p < .05). Ostium movement was the only parameter associated with surgical success on multivariate analysis (OR 13.1, p = .01). Four (1 stented) underwent revision MMED, intraoperative mitomycin-C, and 12-week intubation. All revision ostia were functional after 141 ± 43 months.Surgical success of MMED after 11-years was 77%, a notable reduction compared to 96% success at 1-year. Statistical advantage of silicone intubation for primary MMED was not demonstrated, though clinically, stented ostia had a higher success (82% vs 70%). The presence of a dynamic internal common opening was highly associated with long-term surgical success. [ABSTRACT FROM AUTHOR]

Background: Patients with psoriatic arthritis (PsA) often suffer from anxiety disorders. While upadacitinib has shown effectiveness in reducing various disease activity indicators in active PsA, its impact on anxiety disorders in PsA patients needs further investigation. Methods: In this 12-week randomized, open-label, controlled trial, PsA patients with coexisting anxiety were randomly assigned to either the upadacitinib group or the adalimumab group in a 1:1 ratio. The upadacitinib group received a daily dose of 15 mg, while the adalimumab group received 40 mg every 2 weeks. The primary outcome measured the change in Hospital Anxiety Self-Assessment Scale (HADS-A) total scores after the 12-week intervention. Secondary outcomes included changes in the Health Assessment Questionnaire-Disability Index (HAQ-DI), the percentage of participants meeting the ACR20 criteria compared to baseline after 12 weeks, and the percentage of participants achieving a grade 0 or 1 in the psoriasis static Investigator's overall assessment (sPGA) at week 12 with an improvement of at least 2 points from baseline (sPGA 0/1). One-way analysis of variance (ANOVA) was used to compare the means of normally distributed variables between the upadacitinib and adalimumab groups. Discussion: The impact of upadacitinib on anxiety in PsA patients remains uncertain. This 12-week open randomized controlled trial aims to provide insights into disease progression and underscore the importance of addressing PsA-related anxiety during treatment. Trial registration: ChiCTR2400079755. Registered on January 11, 2024, with ChiCTR. https://www.chictr.org.cn/showproj.html?proj=216538 [ABSTRACT FROM AUTHOR]

Background: Higher cruciferous vegetable intake is associated with lower cardiovascular disease risk in observational studies. The pathways involved remain uncertain. We aimed to determine whether cruciferous vegetable intake (active) lowers 24-h brachial systolic blood pressure (SBP; primary outcome) compared to root and squash vegetables (control) in Australian adults with mildly elevated BP (SBP 120–160 mmHg inclusive). Methods: In this randomized, controlled, crossover trial, participants completed two 2-week dietary interventions separated by a 2-week washout. Cruciferous vegetables were compared to root and squash vegetables (~ 300 g/day) consumed with lunch and dinner meals. Participants were blinded to which interventions were the active and control. Adherence was assessed using food diaries and biomarkers (S-methyl cysteine sulfoxide (SMCSO, active) and carotenoids (control)). Twenty-four-hour brachial ambulatory SBP and secondary outcomes were assessed pre- and post each intervention. Differences were tested using linear mixed effects regression. Results: Eighteen participants were recruited (median (IQR) age: 68 (66–70); female: n = 16/18; mean ± SD clinic SBP: 135.9 ± 10.0 mmHg). For both interventions, 72% participants had 100% adherence (IQR: 96.4–100%). SMCSO and carotenoids were significantly different between interventions (mean difference active vs. control SMCSO: 22.93 mg/mL, 95%CI 15.62, 30.23, P < 0.0001; carotenoids: − 0.974 mg/mL, 95%CI − 1.525, − 0.423, P = 0.001). Twenty-four-hour brachial SBP was significantly reduced following the active vs. control (mean difference − 2.5 mmHg, 95%CI − 4.2, − 0.9, P = 0.002; active pre: 126.8 ± 12.6 mmHg, post: 124.4 ± 11.8 mmHg; control pre: 125.5 ± 12.1 mmHg, post: 124.8 ± 13.1 mmHg, n = 17), driven by daytime SBP (mean difference − 3.6 mmHg, 95%CI − 5.4, − 1.7, P < 0.001). Serum triglycerides were significantly lower following the active vs. control (mean difference − 0.2 mmol/L, 95%CI − 0.4, − 0.0, P = 0.047). Conclusions: Increased intake of cruciferous vegetables resulted in reduced SBP compared to root and squash vegetables. Future research is needed to determine whether targeted recommendations for increasing cruciferous vegetable intake benefits population health. Trial registration: Clinical trial registry ACTRN12619001294145. https://www.anzctr.org.au [ABSTRACT FROM AUTHOR]

Background: Opioid-related fatalities are a leading cause of death in Ohio and nationally, with an increasing number of overdoses attributable to fentanyl. Rapid fentanyl test strips can identify fentanyl and some fentanyl analogs in urine samples and are increasingly being used to check illicit drugs for fentanyl before they are used. Fentanyl test strips are a promising harm reduction strategy; however, little is known about the real-world acceptability and impact of fentanyl test strip use. This study investigates fentanyl test strip distribution and education as a harm reduction strategy to prevent overdoses among people who use drugs. Methods: The research team will recruit 2400 individuals ≥ 18 years with self-reported use of illicit drugs or drugs purchased on the street within the past 6 months. Recruitment will occur at opioid overdose education and naloxone distribution programs in 16 urban and 12 rural Ohio counties. Participating sites will be randomized at the county level to the intervention or non-intervention study arm. A brief fentanyl test strip educational intervention and fentanyl test strips will be provided to participants recruited from sites in the intervention arm. These participants will be eligible to receive additional fentanyl test strips for 2 years post-enrollment. Participants recruited from sites in the non-intervention arm will not receive fentanyl test strip education or fentanyl test strips. All participants will be followed for 2 years post-enrollment using biweekly, quarterly, and 6-month surveys. Primary outcomes include (1) identification of perceived barriers and facilitating factors associated with incorporating fentanyl test strip education and distribution into opioid overdose education and naloxone distribution programs; (2) differences in knowledge and self-efficacy regarding how to test drugs for fentanyl and strategies for reducing overdose risk between the intervention and non-intervention groups; and (3) differences in non-fatal and fatal overdose rates between the intervention and non-intervention groups. Discussion: Findings from this cluster randomized controlled trial will contribute valuable information about the feasibility, acceptability, and impact of integrating fentanyl test strip drug checking in rural and urban communities in Ohio and help guide future overdose prevention interventions. Trial registration: ClinicalTrials.gov NCT05463341. Registered on July 19, 2022. https://clinicaltrials.gov/study/NCT05463341 [ABSTRACT FROM AUTHOR]

Background: The progressive aging of the population has meant the increase in elderly patients requiring an urgent surgery. Older adults, especially those with frailty, have a higher risk for complications, functional and cognitive decline after urgent surgery. These patients have their functional and physiological reserve reduced which makes them more vulnerable to the effects of being bedridden. The consequences are at multiple levels emphasizing the functional loss or cognitive impairment, longer stays, mortality and institutionalization, delirium, poor quality of life and increased use of resources related to health. We aim to determine whether postoperative physical rehabilitation can prevent functional and cognitive decline and modify the posterior trajectory. Methods/design: This study is a randomized clinical trial, simple blinded, conducted in the Department of Surgery of a tertiary public hospital in Navarra (Hospital Universitario de Navarra), Spain. Patients > = 70 years old undergoing urgent abdominal surgery who meet inclusion criteria will be randomly assigned to the intervention or control group. The intervention will consist of a multicomponent physical training programme, which will include progressive and supervised endurance, resistance and balance training for 4 weeks, twice weekly sessions with a total of 8 sessions, and the group control will receive the usual care. The primary outcome measure is the change in functional (SPPB) and cognitive status (Mini-Mental State Examination) and the change of quality of life (EuroQol-5D-VAS) during the study period. The secondary outcomes are postoperative complications, length of stay, delirium, mortality, use of health resources, functional status (Barthel Index and handgrip strength tests), cost per quality-adjusted life year and mininutritional assessment. The data for both the intervention group and the control group will be obtained at four different times: the initial visit during hospital admission and at months 1, 3 and 6 months after hospital discharge. Discussion: If our hypothesis is correct, this project could show that individualized and progressive exercise programme provides effective therapy for improving the functional capacity and achieve a better functional, cognitive and quality of life recovery. This measure, without entailing a significant expense for the administration, probably has an important repercussion both in the short- and long-term recovery, improving care and functional parameters and could determine a lower subsequent need for health resources. To verify this, we will carry out a cost-effectiveness study. The clinical impact of this trial can be significant if we help to modify the traditional management of the elderly patients from an illness model to a more person-centred and functionally oriented perspective. Moreover, the prescription of individualized exercise can be routinely included in the clinical practice of these patients. Trial registration: ClinicalTrials.gov Identifier: NCT05290532. Version 1. Registered on March 13, 2022. [ABSTRACT FROM AUTHOR]

Background: Potentially curative therapy for locally advanced gastric cancer consists of gastrectomy, usually in combination with perioperative chemotherapy. An oncological resection includes a radical (R0) gastrectomy and modified D2 lymphadenectomy; generally, a total omentectomy is also performed, to ensure the removal of possible microscopic disease. However, the omentum functions as a regulator of regional immune responses to prevent infections and prevents adhesions which could lead to bowel obstructions. Evidence supporting a survival benefit of routine complete omentectomy during gastrectomy is lacking. Methods: OMEGA is a randomized controlled, open, parallel, non-inferiority, multicenter trial. Eligible patients are operable (ASA < 4) and have resectable (≦ cT4aN3bM0) primary gastric cancer. Patients will be 1:1 randomized between (sub)total gastrectomy with omentum preservation distal of the gastroepiploic vessels versus complete omentectomy. For a power of 80%, the target sample size is 654 patients. The primary objective is to investigate whether omentum preservation in gastrectomy for cancer is non-inferior to complete omentectomy in terms of 3-year overall survival. Secondary endpoints include intra- and postoperative outcomes, such as blood loss, operative time, hospital stay, readmission rate, quality of life, disease-free survival, and cost-effectiveness. Discussion: The OMEGA trial investigates if omentum preservation during gastrectomy for gastric cancer is non-inferior to complete omentectomy in terms of 3-year overall survival, with non-inferiority being determined based on results from both the intention-to-treat and the per-protocol analyses. The OMEGA trial will elucidate whether routine complete omentectomy could be omitted, potentially reducing overtreatment. Trial registration: ClinicalTrials.gov NCT05180864. Registered on 6th January 2022. [ABSTRACT FROM AUTHOR]

Background: Individuals with spinal cord injury (SCI) often suffer from neuropathic pain which is often disabling and negatively affects function, participation, and quality of life (QoL). Pharmacological treatments lack efficacy in neuropathic pain reduction hence studying alternatives to drug treatment is necessary. Preclinical evidence of various aerobic exercises has shown positive effects on neuropathic pain but scientific studies investigating its effect in the SCI human population are limited. Methodology: This study is a double-blind, parallel, two-group, randomized controlled trial with an interventional study design that aims to evaluate the effectiveness of aerobic exercise program on neuropathic pain and quality of life (QoL) in individuals with chronic paraplegia. Thirty individuals with chronic paraplegia with the neurological level of injury from T2 to L2 will be recruited from the rehabilitation department at a super specialty hospital based on the inclusion criteria. Using a 1:1 allocation ratio, the participants will be randomly assigned to one of the two groups. The intervention group will perform high-intensity interval training (HIIT) aerobic exercise using an arm ergometer based on their peak heart rate, and the control group will perform free-hand arm aerobic exercise. In both groups, the intervention will be delivered as 30-min sessions, four times a week for 6 weeks. Outcome measures: International Spinal Cord Injury Pain Basic Data Set Version 3.0 will be used for diagnosing and assessing neuropathic pain and its interference with day-to-day activities, mood, and sleep. The International Spinal Cord Society (ISCoS) QoL basic data set will be used to assess QoL, and 6-min push test distance will be used to assess peak heart rate and aerobic capacity. Discussion: The effectiveness of the aerobic exercise program will be assessed based on the changes in neuropathic pain score and its interference with day-to-day activities, mood, sleep, QoL, and aerobic capacity after 3 weeks mid-intervention and after 6 weeks post-intervention. The trial will provide new knowledge about the effectiveness of the aerobic exercise program in improving neuropathic pain and QoL in individuals with chronic paraplegia. Trial registration: Clinical Trials Registry-India CTRI/2023/08/056257. Registered on 8 August 2023. [ABSTRACT FROM AUTHOR]

A single-blind, randomized controlled trial comparing oxycodone and fentanyl for patient-controlled intravenous analgesia (PCIA) after laparoscopic hysteromyomectomy found comparable pain relief between the two groups. The study included 60 participants, with NRS scores for pain at rest and when moving showing no significant differences between oxycodone and fentanyl groups at various time points postoperatively. Self-rating depression scale scores were also similar between the groups at 48 h. However, patients' satisfaction with PCIA was higher in the oxycodone group, with 73.3% reporting being very satisfied compared to 36.7% in the fentanyl group. Additionally, the oxycodone group had fewer incidences of headaches within 48 h postoperatively compared to the fentanyl group. These findings suggest that oxycodone may offer comparable pain relief, higher patient satisfaction, and fewer headaches for patients undergoing laparoscopic hysteromyomectomy compared to fentanyl, making it a suitable option for postoperative pain management in this population. Clinical trial registration number The study was registered with CHICTR.org, ChiCTR2100051924. [ABSTRACT FROM AUTHOR]

Aim Methods Results Conclusions To measure the effectiveness and sustainability of the Juniper UK digital weight‐loss service (DWLS), which delivers 6 months of personalized, proactive lifestyle coaching supplemented with tirzepatide to patients through a multidisciplinary team (MDT).An observer‐blinded randomized controlled trial (RCT) will be conducted on a cohort of non‐diabetic patients of the Juniper DWLS in the UK. Participants in both the intervention and control groups will receive weekly subcutaneous injections of 2.5 mg tirzepatide for 4 weeks, uptitrating the dose to 5.0 mg from weeks 5 to 8, and by 2.5 mg every 4 weeks until reaching 15 mg in week 21, which they will maintain until the end of the intervention period at 6 months, when participants will be taken off the medication. The intervention group will receive personalized weeklylifestyle coaching with a focus on protein intake and resistance training for 6 months. Participants in the control group will attend a diet and exercise group counselling session at programme inception and will be sent a summary of the session's content at months 2 and 4. Aside from these events, health coaches will only interact with control group participants on a reactive basis. From month 6 to month 12, participants from both groups will no longer have access to their MDTs. The trial's co‐primary endpoints include weight loss, fat‐free to fat‐mass ratio and composite strength measures at 12 months (6 months following the end of treatment), compared with baseline. Secondary endpoints include percentage change in weight, fat‐free to fat‐mass ratio, and composite strength from baseline to 6 months, side effect incidence, and change in cardiometabolic risk factors at 12 months. Quality of life and programme engagement represent the study's exploratory endpoints.A total of 688 participants enrolled in the study, with a mean age of 44.6 (± 11.4) years and a mean body mass index of 34.8 (± 7.5) kg/m2; 81.0% of participants are women, and 72.8% are of White ethnicity. More than three‐quarters of participants have at least one co‐morbidity, with dyslipidaemia (42.4%), hypertension (35.3%) and high cholesterol (31.8%) being the most prevalent conditions.This RCT will be the first to assess the effectiveness and sustainability of a real‐world intensive, multidisciplinary DWLS, and it should highlight the potential of such a service for long‐term obesity treatment compared with programmes that deliver standard health counselling. [ABSTRACT FROM AUTHOR]

Background Methods Results Conclusions BK polyomavirus‐associated nephropathy (BKPyVAN) is an important cause of allograft dysfunction and failure in kidney transplant recipients (KTRs) and there are no proven effective treatments. Case reports and in vitro data support the potential activity of cidofovir against BK polyomavirus (BKPyV).We report the results of a phase I/II, double‐blind, placebo‐controlled randomized dose‐escalation trial of cidofovir in KTRs with biopsy‐confirmed BKPyVAN and estimated glomerular filtration rate ≥30 mL/min. Intravenous cidofovir (0.25 mg/kg/dose or 0.5 mg/kg/dose) or placebo was administered on days 0, 7, 21, and 35, with final follow‐up through day 49.The trial was prematurely discontinued due to slow accrual after 22 KTRs had completed the study. Cidofovir was safe and tolerated at the doses and duration studied. The proportion of subjects with any adverse event (AE) was similar between groups (9/14 [64%] in the combined cidofovir dose groups and 6/8 [75%] in the placebo group); 84% of AEs were mild. BKPyV DNAemia reduction by day 49 was similar between groups (>1 log10 reduction in (2/9 [22.2%] of 0.25 mg/kg group, 1/5 [20%] of 0.5 mg/kg group, and 2/8 [25%] of placebo group).These preliminary results indicate that low‐dose cidofovir was safe and tolerated but had no significant BKPyV‐specific antiviral effect in KTRs with BKPyVAN. [ABSTRACT FROM AUTHOR]

Objective Methods Results Conclusion ClinicalTrials The present study examined the effects of a nurse‐led family empowerment program on the quality of life of Palestinian pregnant adolescents.This was a randomized controlled trial with a two‐group pre−/post‐test design. The sample consisted of 58 pregnant adolescents recruited from six governmental primary health care clinics in Palestine. Participants were randomly allocated in equal numbers to either the control group (n = 29), which received routine care, or the experimental group (n = 29), which received both routine care and the study program. Data collection instruments included a demographic form and the WHO Quality of Life‐BREF (WHOQoL‐BREF). Data were collected twice: at 32 or 33 weeks' gestation to establish a baseline and at 36 or 37 weeks' gestation post‐test. Statistical analyses were performed and included descriptive statistics, chi‐square and t‐tests.The study findings indicated a significant increase in the mean quality of life scores of the experimental group in the post‐test compared to the pre‐test (P < 0.001). Additionally, pregnant adolescents in the experimental group demonstrated significantly higher post‐test QoL scores than those in the control group (P < 0.001).The nurse‐led family empowerment program emerges as a viable and efficacious alternative intervention for improving the quality of life among Palestinian pregnant adolescents.The study was registered with the NIH U.S. National Library of Medicine ClinicalTrials.gov on 01/09/2021 with the registration code NCT05031130. It can be accessed via this link: https://classic.clinicaltrials.gov/ct2/show/NCT05031130. [ABSTRACT FROM AUTHOR]

Disruptive behavior disorders [including conduct disorder (CD) and oppositional defiant disorder (ODD)] are common childhood and adolescent psychiatric conditions often linked to altered arousal. The recommended first-line treatment is multi-modal therapy and includes psychosocial and behavioral interventions. Their modest effect sizes along with clinically and biologically heterogeneous phenotypes emphasize the need for innovative personalized treatment targeting impaired functions such as arousal dysregulation. A total of 37 children aged 8–14 years diagnosed with ODD/CD were randomized to 20 sessions of individualized arousal biofeedback using skin conductance levels (SCL-BF) or active treatment as usual (TAU) including psychoeducation and cognitive–behavioral elements. The primary outcome was the change in parents´ ratings of aggressive behavior measured by the Modified Overt Aggression Scale. Secondary outcome measures were subscales from the Child Behavior Checklist, the Inventory of Callous-Unemotional traits, and the Reactive-Proactive Aggression Questionnaire. The SCL-BF treatment was neither superior nor inferior to the active TAU. Both groups showed reduced aggression after treatment with small effects for the primary outcome and large effects for some secondary outcomes. Importantly, successful learning of SCL self-regulation was related to reduced aggression at post-assessment. Individualized SCL-BF was not inferior to active TAU for any treatment outcome with improvements in aggression. Further, participants were on average able to self-regulate their SCL, and those who best learned self-regulation showed the highest clinical improvement, pointing to specificity of SCL-BF regulation for improving aggression. Further studies with larger samples and improved methods, for example by developing BF for mobile use in ecologically more valid settings are warranted. [ABSTRACT FROM AUTHOR]

Background: Appendicitis is the commonest paediatric surgical emergency. Adult studies suggest non‐operative management (NOM) may have a place in care. There have been no adequately powered randomized controlled trials in children. Objective: to determine the safety and efficacy of NOM for paediatric simple appendicitis. Methods: A non‐inferiority randomized controlled trial was conducted comparing operative (OM) to NOM of SA in children aged five‐15 years. Primary outcome was treatment success (no unplanned or unnecessary operation, or complication) at 30 days and 12 months, with a non‐inferiority margin of 15%. (anzctr.org.au: ACTRN12616000788471). Results: From 11 June 2016 to 30 November 2020, 222 children were randomized: 94 (42.34%) to OM and 128 (57.66%) to NOM. Non‐inferiority of NOM was not demonstrated at either time point, with 45.67% of NOM patients subsequently undergoing operation. There was no significant difference in complications. Conclusions: While noninferiority was not shown, NOM was safe, with no difference in adverse outcomes between the two groups. Further research to refine the place of NOM of simple appendicitis in children is required, including nuanced patient selection, longer term evaluation, the place of choice, and the acceptability of the treatment for children and their carers. [ABSTRACT FROM AUTHOR]

Introduction and Hypothesis: Despite the high prevalence of fecal incontinence, existing treatment options may be inadequate. Drugs that enhance the tone of the anal sphincter complex could potentially be an effective pharmacological approach. This study investigated the effect of the tricyclic antidepressant imipramine on anal sphincter tone in healthy women, employing anal acoustic reflectometry as the evaluating method. Methods: In a double-blind, randomized, placebo-controlled crossover study, 16 healthy female volunteers were randomized to one of two treatment sequences. The participants attended two study visits separated by at least 7 days' washout. At each visit, they received a single dose of 50 mg imipramine or matching placebo, in alternating order. We assessed the anal opening pressure under the resting state and during voluntary squeezing of the pelvic floor. Measurements were performed pre-dose and 1 h after drug administration, corresponding to the estimated time of peak plasma concentration of imipramine. Results: All participants completed the study. In total, 44% of the participants reported at least one adverse effect, primarily anticholinergic. Compared with placebo, imipramine increased anal opening pressure by 15.2 cmH2O (95% confidence interval [CI] 2.0–28.2 cmH2O, p = 0.03) in the resting state and 15.1 (95% CI 4.2–26.0 cmH2O, p = 0.01) cmH2O during squeezing. Conclusions: The findings indicate that imipramine increases anal sphincter tone in healthy women. However, further research is required to evaluate its clinical impact on individuals with fecal incontinence. This research also demonstrates the effectiveness of using anal acoustic reflectometry for assessing pharmacological effects on anal sphincter function. [ABSTRACT FROM AUTHOR]

Introduction and Hypothesis: Pelvic floor muscle training (PFMT) is effective at improving urinary incontinence (UI) symptoms; however, patients often cannot properly contract their pelvic floor muscles. We hypothesized that contraction of the gluteal muscles alone would have the same effect as PFMT on improving UI symptoms. The aim of this study was to compare the effectiveness of gluteal muscles contraction alone with that of conventional PFMT at home for reducing UI symptoms in women. Methods: Sixty women 30–59 years in age who had stress urinary incontinence (SUI) were randomly assigned to the gluteal muscles training (GMT) group or the PFMT group. The participants in each group performed 3 min of training twice/day using a leaflet unsupervised at home during the 12-week intervention period. Three self-administered UI symptom measures (UI episodes/week, 1-h pad test, and the International Consultation of Incontinence Questionnaire-Short Form score) were compared before the observation period (baseline) and at the 6th or 12th week of the intervention period. Results: Fifty women who completed the 12-week intervention period were analyzed. After the 12-week intervention period, the three UI symptom outcome measures significantly decreased compared with baseline in both groups (α < 0.05). The rate of improvement in UI symptoms (decrease of at least 50% in UI episodes/week and in the 1-h pad test compared with baseline) was 65.2% in the GMT group and 63.0% in the PFMT group, with no significant differences between the two groups (p = 0.898). Conclusions: In unsupervised training using a leaflet at home, contraction of the gluteal muscles alone was shown to be as effective as conventional PFMT in reducing UI symptoms in women with SUI. [ABSTRACT FROM AUTHOR]

The results of a prospective, multi-institutional randomized trial developed to assess the equality of sublobar resection versus standard lobectomy were first published in 1995. They concluded that, compared with lobectomy, sublobar resections did not show any significant improvement either in terms of postoperative morbidity and mortality nor in terms of late post-resectional cardiorespiratory function. Moreover, due to the higher mortality and local recurrence rate related to sublobar resection, lobectomy had to be judged as the best surgical option for patients diagnosed with peripheral early-stage non-small-cell lung cancer. Since then, lobectomy has been considered the best surgical option for fit patients suffering from early-stage non-small cell lung cancer. In 2022 and 2023, three non-inferiority randomized trials were published, comparing lobectomy with the sublobar resection in T1a N0 patients whose tumors were up to 2 cm in size. Although presenting some important differences, all three trials met their primary endpoints, disclosing the non-inferiority of sublobar resections in terms of overall and disease-free survival. This narrative review aims to compare the newly published results of these trials as well as to report results from recent non-randomized studies on this topic. [ABSTRACT FROM AUTHOR]

Background: In susceptible hosts, SARS-CoV2-induced hyperinflammation accounts for an increased mortality. The search of adjuvant immunomodulatory therapies has been ongoing ever since the pandemic outbreak. Aim: Our purpose was to evaluate the efficacy of cyclosporin A (CsA) as an add-on therapy to the standard of care (SoC) in patients with severe COVID-19 pneumonia. Methods: We conducted a randomized clinical trial in patients admitted to eight Spanish tertiary hospitals. Patients were stratified into two severity categories and randomized in a 1:1 ratio to receive a corticosteroid-based standard therapy with or without CsA. The primary endpoint was FiO2 recovery by Day 12 without relapses. Results: 109 patients were included and randomized, and 98 of them considered for the mITT population (51 assigned to the CsA + SoC group and 47 to the SoC group). A total of 35 (68.6%) patients from the CsA + SoC group and 32 (71.1%) patients from the SoC group reached the primary endpoint in the mITT analysis. No differences were found after stratification into age groups, in the severity level at admission, or in a combination of both. Overall, the time to FiO2 normalization was 7.4 days vs. 7.9 days in the experimental and control groups, respectively. Global mortality was 8.2%. Severe adverse events were uncommon and equally distributed between arms. Conclusion: The addition of CsA did not show differences over a corticosteroid-based treatment in the clinical course of the included patients. A better identification of candidates who will benefit from receiving immunomodulatory drugs is necessary in future studies. [ABSTRACT FROM AUTHOR]

Background/Objectives: In osteopathy, it becomes necessary to produce high-quality evidence to demonstrate its effectiveness. The aim of this meta-research study is to assess the reporting quality of RCTs published in the osteopathic field. Methods: The protocol was preliminarily registered on the "Open Science Framework (OSF)" website. For reporting, we considered the PRISMA 2020 checklist. We included all the RCTs, published between 2011 and 2023, investigating the effectiveness of Osteopathic Manipulative Treatment (OMT) in any possible condition. The search process was conducted on four major biomedical databases including PubMed, Central, Scopus and Embase. A data extraction form was implemented to collect all relevant information. The completeness of reporting was calculated as the percentage of adherence to the CONSORT checklist; the Cochrane ROB 2 tool was considered to assess the risk of bias (RoB) in the following five major domains: randomization (D1), interventions (D2), missing data (D3), outcome measurement (D4), selective reporting (D5). Results: A total of 131 studies were included and the overall adherence was 57%, with the worst section being "other information" (42%). Studies with a lower RoB showed higher adherence to the CONSORT. The "results" section presented the highest differences as follows: D1 (−36.7%), D2 (−27.2%), D3 (−21.5%) and D5 (−25.5%). Significant correlations were also found between the preliminary protocol registration, higher journal quartile, publication in hybrid journals and the completeness of reporting (β: 19.22, CI: 14.45–24.00, p < 0.001; β: 5.41; CI: 2.80–8.02, p ≤ 0.001; β: 5.64, CI: 1.06–10.23, p = 0.016, respectively). Conclusions: The adherence to the CONSORT checklist in osteopathic RCTs is lacking. An association was found between a lower completeness of reporting and a higher RoB, a good journal ranking, publication in hybrid journals and a prospective protocol registration. Journals and authors should adopt all the strategies to adhere to reporting guidelines to guarantee generalization of the results arising from RCTs. [ABSTRACT FROM AUTHOR]

Background: Thyroid disorders, including hypothyroidism, hyperthyroidism, and autoimmune thyroid diseases (AITDs) such as Hashimoto's thyroiditis and Graves' disease, are prevalent endocrine disorders with significant global health impacts. Emerging evidence suggests that vitamin D, known for its role in bone health and calcium metabolism, may also influence immune function and thyroid health. Objective: This study aimed to evaluate the efficacy of vitamin D supplementation in improving thyroid function and reducing autoimmune activity in individuals with thyroid disorders. Methods: This double-blind, randomized controlled trial (RCT) involved 200 participants diagnosed with thyroid disorders, including hypothyroidism, hyperthyroidism, and AITDs. Participants were randomly assigned to receive either vitamin D supplementation (50,000 IU/week for 8 weeks, followed by 2,000 IU/day for 10 months) or a placebo for 12 months. Primary outcomes included changes in serum 25-hydroxyvitamin D [25(OH)D] levels, thyroid function tests (TSH, Free T4, Free T3), and thyroid autoantibodies (anti-TPO, antiTG). Secondary outcomes included improvements in clinical symptoms and quality of life. Data were analyzed using SPSS version 25.0. Results: Participants in the intervention group exhibited a significant increase in serum 25(OH)D levels (from 18.5 ± 4.3 ng/mL to 35.2 ± 6.2 ng/mL, p < 0.001). This increase was associated with significant reductions in TSH levels (-1.2 ± 0.8 mIU/L, p < 0.001) and thyroid autoantibodies (anti-TPO: -30 ± 12 IU/mL, p < 0.001; anti-TG: -25 ± 10 IU/mL, p < 0.001). Improvements in Free T4 and Free T3 levels were also observed in the intervention group (p < 0.001). The control group showed no significant changes in these parameters. Participants in the intervention group reported greater improvement in clinical symptoms and quality of life. Conclusion: Vitamin D supplementation significantly improves thyroid function and reduces autoimmune activity in individuals with thyroid disorders, particularly those with hypothyroidism and AITDs. These findings suggest that vitamin D may serve as an effective adjunctive therapy in managing thyroid disorders. Further research is needed to confirm these results and explore the long-term benefits of vitamin D supplementation in this population. [ABSTRACT FROM AUTHOR]

Chronic low back pain (CLBP) is a prevalent musculoskeletal disorder that significantly impairs daily functioning and quality of life. Exercise therapy, particularly core stabilization exercises and Back School programs, are commonly used interventions for CLBP management. This study aims to compare the effectiveness of these two exercise programs in reducing pain, improving functional disability, and enhancing lumbar spine range of motion in patients with CLBP. Methods: This randomized controlled trial included 40 participants with CLBP, aged 35 to 60 years, from the physiotherapy outpatient department of Deccan Hospital, Hyderabad. Participants were randomly assigned to Group A (Back School program) or Group B (core stabilization exercises), with 20 participants in each group. Both interventions were administered four times a week over a 4-week period. Outcome measures, including the Visual Analogue Scale (VAS), Roland-Morris Disability Questionnaire (RMDQ), and lumbar spine range of motion (TROM), were assessed at baseline and post-intervention. Data analysis included paired and independent t-tests, with significance set at p≤0.05. Results: Both groups showed significant improvements in all outcome measures. Group A's mean VAS score decreased from 7.4 to 5.52, RMDQ score from 16.65 to 9.45, and TROM increased from 1.585 degrees to 2.09 degrees. Group B demonstrated greater improvements, with VAS decreasing from 7.2 to 2.4, RMDQ from 16.6 to 6.75, and TROM increasing from 1.53 degrees to 2.51 degrees. Group B's improvements were significantly greater across all measures (p < 0.0001). Conclusion: Core stabilization exercises resulted in superior outcomes compared to the Back School program, suggesting they may be a more effective intervention for managing CLBP. These findings support the use of core stabilization exercises as a primary therapeutic approach in CLBP management. [ABSTRACT FROM AUTHOR]

Background: Antibiotic-associated diarrhea (AAD) is a prevalent adverse effect of antibiotic therapy, disrupting the gut microbiota and leading to gastrointestinal complications. Probiotics have been suggested as a preventive measure against AAD, but comprehensive clinical trials are needed to confirm their efficacy and elucidate the underlying microbiological mechanisms. Objective: This study aimed to evaluate the efficacy of a multi-strain probiotic formulation in preventing AAD in adult patients undergoing antibiotic therapy, focusing on the impact on gut microbiota composition and immune response. Methods: A double-blind, placebo-controlled randomized trial was conducted over 12 months in a tertiary care hospital in North India. Two hundred adult patients receiving antibiotic therapy were randomly assigned to receive either a multi-strain probiotic formulation (Lactobacillus rhamnosus GG, Bifidobacterium lactis, and Saccharomyces boulardii) or a placebo. The primary outcome was the incidence of AAD during and up to 4 weeks’ post-antibiotic therapy. Secondary outcomes included changes in gut microbiota composition, assessed through 16S rRNA sequencing, and immune response, measured by fecal IgA and cytokine levels. Stool samples were collected at baseline, end of therapy, and 4 weeks’ post-therapy. Statistical analysis compared incidence rates, microbiota changes, and immune markers between groups. Results: The probiotic group exhibited a significantly lower incidence of AAD (15%) compared to the placebo group (35%) (p < 0.05). The probiotic group also maintained higher levels of beneficial bacteria (Lactobacillus and Bifidobacterium) and lower levels of pathogenic bacteria (Clostridioides difficile). Immune response markers indicated a significant increase in fecal IgA levels and a favorable cytokine profile (IL-10 and TNF-α) in the probiotic group compared to the placebo group. Discussion: The findings demonstrate that multi-strain probiotics significantly reduce the incidence of AAD by preserving gut microbiota balance and enhancing immune function. This study supports existing literature, such as McFarland (2006) and Snydman (2008), and provides detailed microbiological and immunological insights into probiotic action. Our results align with other randomized controlled trials and highlight the importance of probiotics in clinical practice to prevent AAD. Conclusion: Probiotics, particularly multi-strain formulations, are effective in preventing AAD by maintaining gut microbiota integrity and boosting immune responses. These findings advocate for the use of probiotics as a complementary therapy during antibiotic treatment to mitigate adverse gastrointestinal effects. Further research should explore personalized probiotic therapies based on individual microbiota profiles. [ABSTRACT FROM AUTHOR]

There is controversial evidence that acidification of vaginal pH may increase the efficacy of vaginal prostaglandins in labor induction, with research being mainly focused on misoprostol. This study aims to evaluate the impact of this intervention on the progress of labor induction with dinoprostone (PGE2) vaginal tablet. This double-blind, parallel-group, randomized study was conducted between October 2021 and December 2022 at Alexandra General Hospital, Athens, Greece. A total of 230 women with singleton, full term pregnancy that were scheduled for labor induction were randomly divided into two groups: Group A, who received acidic vaginal wash (5 % acetic acid) and Group B, who received a normal saline vaginal wash. Afterwards, participants received a vaginal tablet of 3 mg dinoprostone every 6 h (maximum two doses). There were no statistically significant differences in mode of delivery, duration of different labor stages, Bishop score changes and possible complications. Participants in the acidification group needed less often labor augmentation with oxytocin and epidural anesthesia (p=0.03). Vaginal acidification seems to have no effect on the efficacy of the dinoprostone vaginal tablet. Even though it may reduce the need for oxytocin augmentation, there is no apparent benefit on clinical outcomes, such as reduction in cesarean section rates or shorter labor duration. Future research is necessary in order to validate these findings. [ABSTRACT FROM AUTHOR]

Objective: This study was conducted as a randomized controlled trial to evaluate the technology‐based parent school program. Design: The study was conducted in the well‐child care outpatient clinic of a hospital in Turkey. Data were collected between October 31, 2022 and February 17, 2023. The parent school was prepared based on Meleis' transition theory. Sample: Forty‐eight parents participated in the study. Parents in the intervention group participated in a 10‐week parent school program (five website modules, five online interactive group trainings, and counseling). Measures: Data were collected before the program, after the program, and 1 month after the program. Results: There were increases in the mean scores of the "Parent Skill Assessment Form" and "Skills Assessment Form for the Toddler Development" items in the intervention group compared to the control group. The difference between the groups in the mean scores of the Self‐Efficacy for Parenting Task Index Toddler Scale (1–3 years) was not statistically significant. However, the difference between the times was statistically significant. Conclusion: It was concluded that the technology‐based parent school training program could guide parents with children aged 1–3 years on child‐rearing. Trial registration: It was registered at ClinicalTrials.gov in May 2022 (NCT05370989). [ABSTRACT FROM AUTHOR]

Aims: The aim of this work was to measure the impact of P2P (i.e. peer‐to‐peer), a peer‐led smoking prevention intervention, on daily smoking prevalence of adolescents over 2 school years. Design: A cluster‐randomized controlled trial was performed over a 16‐month follow‐up (trial status: closed to follow‐up). P2P was implemented 1–3 and 13–15 months after baseline. Assessments took place at baseline and 4, 10 and 16 months after baseline. The research team, assessors and adolescents were blinded to the study‐arm assignment only at baseline. Setting: Fifteen vocational high schools in France were randomized into two clusters, using a 1:1 allocation ratio per French department (n intervention = 7, n control = 8). Participants: Participants comprised a sample of 2010 students in year 11 (i.e. 15–16 years) in vocational high schools. A total of 437 students could not be assessed at baseline (absent or left school), yielding a total sample of 1573 students (n intervention = 749, n control = 824). Intervention and comparator: The P2P programme trained voluntary students to become peer educators and design smoking prevention actions for their schoolmates in the intervention group (n = 945 students), compared with a passive control group (n = 1065 students). Measurements The primary outcome was change from baseline in the prevalence of self‐reported daily smoking (i.e. at least one cigarette per day) at 16 months. Findings The 'time × group' interaction indicated that, compared with the control group, the intervention group had statistically significantly fewer daily smokers after 16 months [odds ratio (OR) = 0.33, 95% confidence interval (CI) = 0.20, 0.53]. Similarly, compared with the control group, the intervention group had statistically significantly fewer daily smokers after 4 months (OR = 0.50, 95% CI = 0.30, 0.82) and 10 months (OR = 0.60, 95% CI = 0.37, 0.98). No adverse events of P2P2 were reported. Conclusions: A cluster‐randomized trial found evidence that the peer‐led P2P (peer‐to‐peer) smoking prevention intervention reduced the uptake of daily smoking among high school students in France over 16 months. [ABSTRACT FROM AUTHOR]

Background: Infertility is a prevalent global condition, and emerging reproductive technologies may enhance its evaluation and treatment. Understanding the current features of randomized clinical trials in infertility is crucial for improving study design and ensuring the translation of results for patient benefits. Objectives: To investigate the primary characteristics of randomized clinical trials related to infertility and areas where require improvement. Materials and methods: We conducted a search on the International Clinical Trials Registry platform for eligible infertility trials between 2003 and 2022. The distribution ratio of various characteristics uploaded by infertility‐related studies on the platform was analyzed and compared according to sex and registration year. Results: Out of the total trials, 85.3% (1,906) included only women, 8.6% (192) included only men, and 6.1% (136) included couples. The majority of retrieved trials followed a parallel arm design (91.0%) and were non‐industry‐funded (92.2%), with a median planned sample size of 131 patients (interquartile range 75–270). Among these trials, 54.5% (1,217) were conducted in Asia. The most common primary purpose of infertility‐related trials was treatment (88.8%), with over half of the investigated interventions focusing on medication (57.9%). Discussion: Asia is the leading region for research, and the drug therapy is still widely used and updated. However, support care for infertile couples has also received some preference. Areas that require improvement and promotion include addressing male infertility and focusing on underserved regions like Africa. The results also highlight deficiencies in trial registration and masking methods, emphasizing the need for better regulation and facilitation of infertility trials in the post‐COVID‐19 era. Conclusion: Based on the current status of infertility RCT studies, greater attention should be paid to infertile men and populations in underdeveloped regions like Africa in future studies, together with a standardized registration and implementation procedures. [ABSTRACT FROM AUTHOR]

Objectives: Designing cancer screening trials for multi-cancer early detection (MCED) tests presents a significant methodology challenge, as natural histories of cell-free DNA-shedding cancers are not yet known. A microsimulation model was developed to project the performance and utility of an MCED test in cancer screening trials. Methods: Individual natural history of preclinical progression through cancer stages for 23 cancer classes was simulated by a stage-transition model under a broad range of cancer latency parameters. Cancer incidences and stage distributions at clinical presentation in simulated trials were set to match the data from Surveillance, Epidemiology, and End Results program. One or multiple rounds of annual screening using a targeted methylation-based MCED test (Galleri Ⓡ) was conducted to detect preclinical cancers. Mortality benefit of early detection was simulated by a stage-shift model. Results: In simulated trials, accounting for healthy volunteer effect and varying test sensitivity, positive predictive value in the prevalence screening round reached 48% to 61% in 6 natural history scenarios. After 3 rounds of annual screening, the cumulative proportions of stage I/II cancers increased by approximately 9% to 14%, the incidence of stage IV cancers was reduced by 37% to 46%, the reduction of stages III and IV cancer incidences was 9% to 24%, and the reduction of mortality reached 13% to 16%. Greater reductions of late-stage cancers and cancer mortality were achieved by five rounds of MCED screening. Conclusions: Simulation results guide trial design and suggest that adding this MCED test to routine screening in the United States may shift cancer detection to earlier stages, and potentially save lives. [ABSTRACT FROM AUTHOR]

The COVID-19 pandemic led to a proliferation of remote-proctored (or "at-home") assessments. The lack of standardized setting, device, or in-person proctor during at-home testing makes it markedly distinct from testing at a test center. Comparability studies of at-home and test center scores are important in understanding whether these distinctions impact test scores. This study found no significant differences in at-home versus test center test scores on a large-scale admissions test using either a randomized controlled trial or an observational study after adjusting for differences in sample composition along baseline characteristics. [ABSTRACT FROM AUTHOR]

Exercise interventions show promise in the treatment of anxiety disorders, but effects on health-related quality of life (HR-QoL), work ability, and sick leave are little studied. We investigated these outcomes in a 12-week randomized controlled trial with a 1-year follow-up. Patients aged 18–65 (n = 222) with anxiety disorders from primary care centers in Gothenburg were randomized to a control group or one of two 12-week exercise intervention groups (low-intensity, [LI] and moderate/high-intensity, [HI]); 148 were evaluated at 12-weeks and 113 completed the 1-year follow-up. The EuroQol 5D (EQ5D; index and the visual analogue scale [VAS]), work ability score (WAS), presenteeism, and self-reported sick leave were assessed at baseline, 12 weeks, and 1 year. Improvements were defined by binary cut-offs for each scale. Binary logistic regression with odds ratios (OR) and 95 % confidence intervals (CI) were reported. There were improved scores for EQ5D and WAS in the HI group compared to controls after 12 weeks (EQ5D index: 4.74 [1.91–11.7], EQ5D-VAS 4.00, [1.65–9.72], WAS 3.41 [1.24–7.37]) and 1 year (EQ5D index: 3.05 [1.05–8.81], EQ5D-VAS 3.20 [1.16–8.84], WAS 5.50 [1.85–16.3]). Post-hoc analysis showed higher ORs in participants on antidepressants (n = 75) (12-week EQ5D index: OR 9.95 [2.85–34.8]) and significant improvements in EQ5D scores for both intervention groups after 1 year. There were no between-group differences for presenteeism or sick leave. Discontinuation was high, mostly early after randomization (n = 74), as is common for anxiety interventions. HI Exercise improves HR-QoL and work ability in anxiety patients, especially when combined with antidepressants. • High-intensity exercise improves health-related quality of life and work ability with long-lasting effects after 1 year. • There were trends suggesting a dose-response effect of exercise on health-related quality of life and work ability. • Exercise effects are greater in patients with antidepressant medication. • There were no between-group differences for presenteeism or sick leave. [ABSTRACT FROM AUTHOR]

Pain often occurs after root canal treatment due to unavoidable mechanical or chemical damage. The purpose of the present study was to investigate the efficacy of a nickel-titanium (NiTi) device combined with ultrasonic irrigation and multiple antibiotic creams in the treatment of periapical inflammation of deciduous teeth, so as to improve the understanding of root canal treatment and optimize clinical practice. Evaluation of efficacy was conducted using X-rays and the Visual Analog Scale. This treatment significantly reduced pain and also improved patient compliance and treatment outcomes. The findings of the present study may have scientific and clinical significance for optimizing root canal treatment in pediatric dentistry and requires further in-depth research in clinical practice. These outcomes may provide potential new ideas and directions for improving patients' quality of life and the efficacy of clinical treatment and have further impacts on future related research and medical practice. [ABSTRACT FROM AUTHOR]