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Background In duodenoscopy, during endoscopic retrograde cholangiopancreatography (ERCP), a backward-oblique angle duodenoscope (BOAD) is generally used. In Japan, 15° BOAD are mainly used, but in Western countries, 5° BOAD are mostly used. In bile duct cannulation associated with ERCP, a catheter for contrast imaging is used in Japan, but wire-guided cannulation (WGC) using a papillotome is standard in Western countries. We conducted a randomized controlled multicenter trial to evaluate the contributions of different duodenoscopes using WGC to selective common bile duct cannulation. Methods Subjects comprised 179 consecutive patients who underwent ERCP. Patients were randomized into the 15° BOAD group (15° group, n  = 90) or the 5° BOAD group (5° group, n  = 89). Results The duodenal papilla could not be accessed endoscopically in two cases from each group. Success rates for bile duct cannulation by WGC without bow-up for the 15° and 5° groups were 85.6 and 56.2%, respectively ( P  < 0.01). Success rates for bile duct cannulation by WGC with bow-up for the 15° and 5° groups were 88.9 and 78.7%, respectively. Total rates of bile duct cannulation for the 15° and 5° groups were 94.4 and 92.1%, respectively. As for accidents, incidences of acute pancreatitis for the 15° and 5° groups were 5.6 and 9.0%, respectively, with no significant difference seen. Conclusions With 15° BOAD, bile duct cannulation was favorable without papillotome bow-up. With 5° BOAD, the success rate of WGC may be improved by adjusting the angle based on papillotome bow-up.

Objectives The aim of this study was to evaluate the effectiveness of individual placement and support (IPS) for people struggling with work participation due to moderate-to-severe mental illness. The study was conducted in Norway, a setting characterized by a comprehensive welfare system and strong employment protection legislation. Methods A randomized controlled multicenter trial including 410 participants was conducted. The intervention group received IPS according to the IPS manual. The control group received high-quality usual care. The main outcome was competitive employment at 12- and 18-months follow-up, based on objective registry data. Changes in mental health and health-related quality of life were secondary outcomes. Results At 12-months follow-up, 36.6% of participants in the IPS group and 27.1% of participants in the control group were in competitive employment, while the difference was slightly higher (37.4% versus 27.1%) at 18-months follow-up. Furthermore, IPS yielded positive effects on all the secondary outcomes compared to the control group (all P<0.05). Conclusions The IPS model of supported employment was superior to high-quality usual care on both vocational and non-vocational outcomes for people with moderate-to-severe mental illness, even in a policy context characterized by high job security and a comprehensive welfare system.

Background Chronic pain imposes a substantial burden on individuals and society. Cognitive behavioral therapy for chronic pain (CBT-CP) has proven effective internationally, but randomized evidence in Japan is scarce. The first Japanese trial was a single-center, 16-session videoconference program that prioritized pain intensity. In contrast, this multicenter trial tests a brief, face-to-face, individualized CBT-CP program with quality of life (QoL) as the primary outcome. Methods This open-label, randomized, parallel-group superiority trial enrolls 60 adults aged 20–80 years with chronic pain persisting ≥ 3 months and EQ-5D-5L scores ≤ 0.80, indicating reduced QoL. Participants are randomized 1:1 to treatment as usual (TAU) plus an eight-session CBT-CP program or to a waitlist control receiving TAU only. The manualized intervention includes psycho-education, relaxation, activity pacing, and cognitive restructuring, delivered weekly face-to-face, with the goal of completing eight sessions within 14 weeks. If necessary, sessions may extend beyond the 15th week; however, the post-assessment is always conducted at 15 ± 2 weeks irrespective of intervention timing. Therapists meet prespecified eligibility criteria and receive structured training, supervision, and fidelity monitoring. The primary outcome is QoL (EQ-5D-5L) at 15 ± 2 weeks. Secondary outcomes include pain intensity, disability, depressive symptoms, catastrophizing, fear of movement, pain self-efficacy, and health-related QoL assessed by the SF-12. These outcomes, together with prognostic risk and somatic symptom burden, will also be examined as potential mediators or moderators. The intervention group undergoes a 27 ± 2-week follow-up to explore mid-term durability in a single-arm pre/post analysis. Analyses follow the intent-to-treat principle using linear mixed models, with effect sizes and confidence intervals reported; multiplicity will be considered in interpreting secondary outcomes. Blinding of participants and therapists is not feasible. Discussion This trial will clarify the added value of a brief, fidelity-assured, face-to-face CBT-CP program in Japan, where implementation remains limited. Findings are expected to guide clinical adoption, workforce training, and dissemination, while also generating hypotheses about for whom and through which processes CBT-CP may confer benefit. Trial registration University Hospital Medical Information Network Clinical Trials Registry, UMIN000042798. Registered on 21 December 2020, https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048858 .

Urinary incontinence (UI) is a common condition during pregnancy, significantly impacting the physical and mental well-being as well as quality of life. With advancements in mobile health technology, mobile apps provide innovative approaches for managing UI. Although small-scale studies have demonstrated their efficacy in alleviating maternal UI symptoms, there is a notable lack of large-scale, multicenter trials to validate these findings. This multicenter randomized controlled trial evaluated the effectiveness of a mobile app (\"Urinary Incontinence for Women\") for self-management of UI among pregnant women. A total of 295 participants were recruited from obstetric clinics at 5 hospitals and randomized to either a 12-week mobile app-based intervention group (n=148) or a standard care group (n=147). The primary outcome was UI symptom severity, with secondary outcomes of the impact of UI on quality of life and self-efficacy in pelvic floor muscle training (PFMT). Assessments were conducted at baseline, postintervention (12 weeks), and 6-8 weeks postpartum via electronic questionnaires. Generalized estimating equation modeling was used to evaluate the intervention effects. Subgroup analyses were performed to examine intervention effects across different baseline characteristics. A total of 267 participants (267/295, 90.5%) completed all assessments. The intervention group showed significantly improved UI symptom severity compared with controls postintervention (β=-.97, 95% CI -1.85 to -0.08; P=.03), with further improvement at 6-8 weeks postpartum (β=-1.93, 95% CI -2.70 to -1.17; P<.001). The impact of UI on quality of life also improved in the intervention group postintervention (β=-1.05, 95% CI -1.95 to -0.15; P=.048) and at 6-8 weeks postpartum (β=-1.72, 95% CI -2.46 to -0.98; P<.001). No significant between-group difference was observed in PFMT self-efficacy (β=1.49, 95% CI -2.93 to 5.90; P=.51), which decreased significantly from postintervention to 6-8 weeks postpartum (β=-4.66, 95% CI -8.11 to -1.22; P=.008). Subgroup analyses revealed significant interactions between intervention effects and education level, PFMT performing before enrollment, history of vaginal delivery, and baseline UI symptoms. The \"Urinary Incontinence for Women\" app-based self-management strategies significantly improved UI symptom severity and quality of life in pregnant and postpartum women, with pronounced effects in certain subgroups based on education level and baseline UI status. While PFMT self-efficacy was not enhanced, the app's benefits underscore the clinical relevance of personalized UI management.

Background Neurosyphilis may cause irreversible neurological sequelae. First-line treatment consists of penicillin G, with ceftriaxone being an alternative treatment in patients allergic to penicillin. The lack of clinical data comparing the efficacy of these two drugs indicated the need for comparative clinical trials to improve national treatment guidelines in China. Methods/design In this multicenter randomized controlled clinical trial, 290 patients newly diagnosed with neurosyphilis will be randomized 1:1 to treatment with aqueous crystalline penicillin G (ACPG) or ceftriaxone. Patients will be treated with standard regimens of ACPG or ceftriaxone according to Chinese National Guidelines and will be followed up for 12 months. All clinical parameters will be assessed at baseline and at follow-up 3, 6, 9, and 12 months later. The primary outcomes will include cerebrospinal fluid (CSF) white blood cell (WBC) count, serological efficacy, and clinical efficacy. The secondary outcomes will include CSF protein concentrations, Mini-Mental State Examination (MMSE) scores, imaging results, recurrence, and time to recovery from neurosyphilis. Adverse events will be monitored and recorded during the trial. Discussion This trial will provide clinical data to determine whether ceftriaxone is non inferior to ACPG in treating neurosyphilis and will provide evidence for the improvement of treatment guidelines. Trial registration Chinese Clinical Trial Registry ChiCTR2100047164. Registered on 9 June 2021 and updated on 23 November 2021.

Background Acute ST-elevation myocardial infarction (STEMI) is associated with a high incidence of complications as well as a considerable hospitalization rate and economic burden. Preliminary evidence suggests that remote ischemic conditioning (RIC) is a promising non-invasive intervention that may effectively and safely reduce myocardial infarct size, subsequent cardiac events and complications, and mortality. However, RIC’s cardio-protective effect remains under debate, especially for single timepoint RIC programs. Adequately powered large-scale randomized controlled trials investigating clinical outcomes are thus needed to clarify the role of full disease cycle RIC programs. Methods The intelligent “Internet Plus”-based full disease cycle remote ischemic conditioning (i-RIC) trial is a pragmatic, multicenter, randomized controlled, parallel group, clinical trial. The term, intelligent “Internet Plus”-based full disease cycle, refers to smart devices aided automatic and real-time monitoring of remote ischemic pre-, per- or post-conditioning intervention for patients with STEMI undergoing percutaneous coronary intervention (PCI). Based on this perspective, 4700 STEMI patients from five hospitals in China will be randomized to a control and an intervention group. The control group will receive PCI and usual care, including pharmacotherapy, before and after PCI. The intervention group will receive pre-, per-, and post-operative RIC combined with long-term i-RIC over a one-month period in addition. A smartphone application, an automated cuff inflation/deflation device and “Internet Plus”-based administration will be used in the long-term phase. The primary outcome is the combined cardiac death or hospitalization for heart failure rate. Secondary outcomes include clinical and functional outcomes: major adverse cardiac and cerebrovascular events rate, all-cause mortality, myocardial reinfarction rate, readmission rate for heart failure and ischemic stroke rate, unplanned revascularization rate, plasma concentration of myocardial infarction-related key biomarkers, infarct size, cardiac function, cardiopulmonary endurance, health-related quality of life, total hospital length of stay, total medical cost, and compliance with treatment regime. Discussion The i-RIC trial is designed to test the hypothesis that clinical and functional outcomes can be improved with the i-RIC program in STEMI patients undergoing PCI. The concept of RIC is expected to be enhanced with this intelligent “Internet Plus”-based program focusing on the full disease cycle. If the i-RIC program results in superior improvement in primary and secondary outcomes, it will offer an innovative treatment option for STEMI patients and form the basis of future recommendations. Clinical Trial Registration Chinese Clinical Trial Registry ( http://www.chictr.org.cn ): ChiCTR2000031550, 04 April 2020.

The current recommendation for treating Lassa fever with ribavirin is supported only by weak evidence. Given the persistent effects in areas with endemic transmission and epidemic potential, there is an urgent need to reassess ribavirin and investigate other potential therapeutic candidates; however, a robust clinical trial method adapted to Lassa fever epidemiology has not yet been established. We propose an adaptive phase II/III multicenter randomized controlled platform trial that uses a superiority framework with an equal allocation ratio and accounts for challenges selecting the primary end point and estimating the target sample size by using an interim analysis.

The aim of the present study was to compare the effectiveness of AI-assisted training and conventional human training in clinical practice. This was a multicenter, randomized, controlled clinical trial conducted in five national-level residency training hospitals. Residents from five hospitals participated, divided into three groups: conventional training (Group A), conventional plus specialty training (Group B), and conventional plus AI-assisted training (Group C). The content of the training was ultrasound diagnosis of thyroid nodules. The training lasted for 18 months, and the three groups of participants were phase-tested every 3 months to compare the effect of the training. The diagnostic accuracy of all three groups gradually increased with increasing training time. Among the three groups, groups B and C had higher accuracy than group A ( P  < .001), and there was no significant difference between groups B and C ( P  = .64). Over the training period, diagnostic confidence increased in all groups. Negative activating emotions decreased significantly over time in all groups (95% CI, − 0.81 to − 0.37; P  < .001), while positive activating emotions increased significantly (95% CI, 0.18 to 0.53; P  < .001). Current research shows that all three approaches are viable for training radiology residents. Furthermore, the AI-assisted approach had no negative emotional impact on the trainees, suggesting that integrating AI into radiology training programs could provide a reliable and effective means of achieving the educational goals of medical education.

Background Lumbrokinase has been widely used for patients with acute ischemic stroke (AIS) in China; however, because rigorously designed studies are lacking, safety and efficacy of lumbrokinase in the treatment of acute ischemic stroke remains largely unknown. In this multicenter, randomized, and controlled trial, we aim to compare lumbrokinase plus aspirin versus aspirin alone in patients with acute ischemic stroke. Methods A total of 220 eligible participants will be randomized to either the intervention or control group with a 1:1 ratio. These participants must be diagnosed with acute ischemic stroke for the first time, whose symptoms appear within 72 h. Their NIHSS score must be greater than 5 and less than 15, and their age must be between 35 and 85 years old. They must have not received intravenous thrombolysis, arterial thrombolysis, or intravascular intervention. Participants in the intervention group will be treated with lumbrokinase plus aspirin for the first 90 days. Participants in the control group will use placebo plus aspirin for the first 90 days. Then, all participants will be treated with aspirin only and followed up for another 90 days (180-day follow-up). The primary outcome is the modified Rankin Scale (mRS) score. The secondary outcomes are National Institutes of Health Stroke Scale (NIHSS) score, Activity of Daily Living (ADL) Scale score, coagulation function, and serum hypersensitive C-reactive protein. The exploratory outcomes are fasting lipid panel, recurrence rate, the occurrence of cardiovascular and cerebrovascular events, and the mortality rate. Safety evaluations include liver function and kidney function, serum fibrinogen, adverse events, serious adverse events, and bleeding events. Adherence of participants will also be assessed. Discussion This trial will investigate the efficacy and safety of lumbrokinase plus aspirin as compared to aspirin alone in the treatment of acute ischemic stroke. Trial registration Chinese Clinical Trial Registry, ChiCTR2000032952. Registered on May 16, 2020.

We developed an internet e-learning system in order to improve the ability of endoscopists to diagnose gastric cancer at an early stage. The efficacy of this system at expanding knowledge and providing invaluable experience regarding the endoscopic detection of early gastric cancer was demonstrated through an international multicenter randomized controlled trial. However, the contents of the system have not yet been fully described in the literature. Accordingly, we herein introduce the contents and their principles, which comprise three main subjects: technique, knowledge, and experience. Since all the e-learning contents and principles are based on conventional white-light endoscopy alone, which is commonly available throughout the world, they should provide a good reference point for any endoscopist who wishes to devise learning materials and guidelines for improving their own clinical practice.