Effect of acidic vaginal pH on the efficacy of dinoprostone (PGE2) vaginal tablet for labor induction in full term pregnant women: a randomized controlled trial.

OBJECTIVES: 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. METHODS: 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). RESULTS: 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). CONCLUSIONS: 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.

Acute Effect of Transcranial Direct Current Stimulation in Pelvic Floor Muscle Function in Young Healthy Women: Initial Findings of a Randomized Controlled Trial.

INTRODUCTION AND HYPOTHESIS: Transcranial direct current stimulation (tDCS) can enhance muscle function in healthy individuals. However, it is unknown if tDCS associated with pelvic floor muscle training (PFMT) can improve pelvic floor muscle function (PFMF) in healthy women. The aim of this study was to investigate the acute effect of a single session of tDCS in PFMF compared with sham-tDCS in healthy women. METHODS: A double-blind, cross-over, randomized clinical trial was conducted with healthy, nulliparous and sexually active women. PFMF was assessed by bidigital palpation (PERFECT scale) and intravaginal pressure by a manometer (Peritron™). Participants randomly underwent two tDCS sessions (active and sham) 7 days apart. The electrode was positioned equal for both protocols, the anode electrode in the supplementary motor area (M1) and the cathode electrode in the right supraorbital frontal cortex (Fp2). The current was applied for 20 min at 2 mA in active stimulation and for 30 s in sham-tDCS. The tDCS applications were associated with verbal instructions to PFMT in a seated position. After each tDCS session PFMF was reevaluated. RESULTS: Twenty young healthy women (aged 23.4 ± 1.7 years; body mass index 21.7 ± 2.2 kg/m2) were included. No difference was observed in power, endurance, and intravaginal pressure of PFMF (p > 0.05). The number of sustained contractions improved from 3.0 (2.0-3.5) to 4.0 (3.0-5.0) after active-tDCS (p = 0.0004) and was superior to sham-tDCS (p = 0.01). CONCLUSION: The number of sustained contractions of PFM improved immediately after a single active-tDCS session, with a difference compared with the post-intervention result of sham-tDCS in healthy young women.

Digital Interventions to Modify Skin Cancer Risk Behaviors in a National Sample of Young Adults: Randomized Controlled Trial.

BACKGROUND: Young adults engage in behaviors that place them at risk for skin cancer. Dissemination of digital health promotion interventions via social media is a potentially promising strategy to modify skin cancer risk behaviors by increasing UV radiation (UVR) protection and skin cancer examinations. OBJECTIVE: This study aimed to compare 3 digital interventions designed to modify UVR exposure, sun protection, and skin cancer detection behaviors among young adults at moderate to high risk of skin cancer. METHODS: This study was a hybrid type II effectiveness-implementation randomized controlled trial of 2 active interventions, a digital skin cancer risk reduction intervention (UV4.me [basic]) compared with an enhanced version (UV4.me2 [enhanced]), and an electronic pamphlet (e-pamphlet). Intervention effects were assessed over the course of a year among 1369 US young adults recruited primarily via Facebook and Instagram. Enhancements to encourage intervention engagement and behavior change included more comprehensive goal-setting activities, ongoing proactive messaging related to previously established mediators (eg, self-efficacy) of UVR exposure and protection, embedded incentives for module completion, and ongoing news and video updates. Primary outcome effects assessed via linear regression were UVR exposure and sun protection and protection habits. Secondary outcome effects assessed via logistic regression were skin self-exams, physician skin exams, sunscreen use, indoor tanning, and sunburn. RESULTS: The active interventions increased sun protection (basic: P=.02; enhanced: P<.001) and habitual sun protection (basic: P=.04; enhanced P=.01) compared with the e-pamphlet. The enhanced intervention increased sun protection more than the basic one. Each active intervention increased sunscreen use at the 3-month follow-up (basic: P=.03; enhanced: P=.01) and skin self-exam at 1 year (basic: P=.04; enhanced: P=.004), compared with the e-pamphlet. Other intervention effects and differences between the Basic and Enhanced Intervention effects were nonsignificant. CONCLUSIONS: The active interventions were effective in improving several skin cancer risk and skin cancer prevention behaviors. Compared with the basic intervention, the enhanced intervention added to the improvement in sun protection but not other behaviors. Future analyses will explore intervention engagement (eg, proportion of content reviewed). TRIAL REGISTRATION: ClinicalTrials.gov NCT03313492; http://clinicaltrials.gov/ct2/show/NCT03313492.

Protocol for a pragmatic trial of Cannabidiol (CBD) to improve chronic pain symptoms among United States Veterans.

BACKGROUND: Chronic pain affects over 100 million Americans, with a disproportionately high number being Veterans. Chronic pain is often difficult to treat and responds variably to medications, with many providing minimal relief or having adverse side effects that preclude use. Cannabidiol (CBD) has emerged as a potential treatment for chronic pain, yet research in this area remains limited, with few studies examining CBD's analgesic potential. Because Veterans have a high need for improved pain care, we designed a clinical trial to investigate CBD's effectiveness in managing chronic pain symptoms among Veterans. We aim to determine whether CBD oral solution compared to placebo study medication is associated with greater improvement in the Patient Global Impression of Change (PGIC). METHODS: We designed a randomized, double-blind, placebo-controlled, pragmatic clinical trial with 468 participants. Participants will be randomly assigned in a 1:1 ratio to receive either placebo or a CBD oral solution over a 4-week period. The trial is remote via a smartphone app and by shipping study materials, including study medication, to participants. We will compare the difference in PGIC between the CBD and placebo group after four weeks and impacts on secondary outcomes (e.g., pain severity, pain interference, anxiety, suicide ideation, and sleep disturbance). DISCUSSION: Once complete, this trial will be among the largest to date investigating the efficacy of CBD for chronic pain. Findings from this clinical trial will contribute to a greater knowledge of CBD's analgesic potential and guide further research. Given the relative availability of CBD, our findings will help elucidate the potential of an accessible option for helping to manage chronic pain among Veterans. TRIAL REGISTRATION: This protocol is registered at clinicaltrials.gov under study number NCT06213233.

Electroacupuncture for slow flow/no-reflow phenomenon in patients with acute myocardial infarction undergoing percutaneous coronary intervention: protocol for a pilot randomized controlled trial.

Background: Slow flow/no-reflow (SF-NR) during percutaneous coronary intervention (PCI) is associated with poor prognosis of patients with acute myocardial infarction (AMI). Currently, effective treatment is not available for SF-NR. Electroacupuncture (EA) has shown significant efficacy as an adjuvant therapy for many cardiovascular diseases by improving microcirculation and reducing ischemia-reperfusion injury. However, its effects on SF-NR in the AMI patients during PCI are not clear. This pilot trial aims to determine the efficacy of intraoperative EA in alleviating SF-NR in AMI patients undergoing PCI. Methods: This prospective, single-center, randomized controlled, pilot trial will recruit 60 AMI patients scheduled for PCI at the Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, China. The patients will be randomized in a 1:1 ratio into the EA or the control groups. Patients in the control group will undergo standard PCI. Patients in the EA group will undergo intraoperative electroacupuncture while undergoing standard PCI. Incidence of SF-NR is the primary outcome for this study. This study will also assess secondary outcomes including cardiac biomarkers, inflammatory biomarkers, pain and anxiety scores, electrocardiography parameters, traditional Chinese medicine (TCM) symptom score, and major adverse cardiovascular and cerebrovascular events (MACCE). All the included patients will undergo laboratory tests including routine blood tests, levels of electrolytes, as well as liver and renal function tests. Patients will be followed up for 1 month after the procedure. Discussion: This pilot trial will provide evidence for the potential benefits of intraoperative EA in improving microvascular perfusion and preventing or alleviating SF-NR during PCI in patients with AMI. If proven effective, intraoperative EA will provide a new and effective strategy against SF-NR and provide evidence for subsequent multicenter trials. Clinical Trial Registration: ClinicalTrials.gov, identifier (ChiCTR2300072265). Registered on 8 June 2023.

[Experience with an international study on standard-risk relapsed childhood acute lymphoblastic leukemia (IntReALL SR 2010 study) in Japan].

Many effective new agents for relapsed childhood acute lymphoblastic leukemia (ALL) are now becoming available, and international standard chemotherapy should be developed to optimize use of these agents. Randomized controlled trials (RCTs) are needed to establish a standard treatment, but few have been conducted for relapsed childhood ALL in Japan due to the small patient population. Participation in international RCTs is necessary to access sufficient patients for informative study results, but differences in approved drugs and healthcare systems between countries make this challenging. In 2014, the Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) participated in an international study on standard-risk relapsed childhood ALL (IntReALL SR 2010) involving two RCTs and multiple drugs not approved in Japan, which was addressed by replacing the unapproved drugs with alternative approved drugs with the same or similar efficacy. This article discusses the historical background of treatment development for relapsed childhood ALL, our experience in participating in the IntReALL SR 2010 trial, and prospects for treating relapsed childhood ALL.

Motivational Variables as Moderating Effects of a Web-Based Mental Health Program for University Students: Secondary Analysis of a Randomized Controlled Trial.

BACKGROUND: Self-guided web-based interventions have the potential of addressing help-seeking barriers and symptoms common among university students, such as depression and anxiety. Unfortunately, self-guided interventions are also associated with less adherence, implicating motivation as a potential moderator for adherence and improvement for such interventions. Previous studies examining motivation as a moderator or predictor of improvement on web-based interventions have defined and measured motivation variably, producing conflicting results. OBJECTIVE: This secondary analysis of data from a randomized controlled trial aimed to examine constructs of motivation as moderators of improvement for a self-guided 8-week web-based intervention in university students (N=1607). METHODS: Tested moderators included internal motivation, external motivation, and confidence in treatment derived from the Treatment Motivation Questionnaire. The primary outcome was an improvement in depression and anxiety measured by the Depression Anxiety Stress Scale-21. RESULTS: Piecewise linear mixed effects models showed that internal motivation significantly moderated symptom change for the intervention group (t1504=-2.94; P=.003) at average and high (+1 SD) motivation levels (t1507=-2.28; P=.02 and t1507=-4.05; P<.001, respectively). Significant results remained even after controlling for baseline severity. The results showed that confidence in treatment did not significantly moderate symptom change for the intervention group (t1504=1.44; P=.15). In this sample, only internal motivation was positively correlated with service initiation, intervention adherence, and intervention satisfaction. CONCLUSIONS: The combination of a web-based intervention and high or moderate internal motivation resulted in greater improvement in the total Depression Anxiety Stress Scale-21 score. These findings highlight the importance of conceptually differentiating motivation-related constructs when examining moderators of improvement. The results suggest that the combination of a web-based intervention and high or moderate internal motivation results in greater improvement. These findings highlight the importance of conceptually differentiating motivation-related constructs when examining moderators of improvement. To better understand the moderating role of internal motivation, future research is encouraged to replicate these findings in diverse samples as well as to examine related constructs such as baseline severity and adherence. Understanding these characteristics informs treatment strategies to maximize adherence and improvement when developing web-based interventions as well as allows services to be targeted to individuals likely to benefit from such interventions. TRIAL REGISTRATION: ClinicalTrials.gov NCT04361045; https://clinicaltrials.gov/study/NCT04361045.

Cerina: cognitive-behavioural therapy-based mobile application for managing GAD symptoms among Ulster University Students in Northern Ireland - a protocol for a pilot feasibility randomised controlled trial.

INTRODUCTION: University students are one of the most vulnerable populations for anxiety disorders worldwide. In Northern Ireland, anxiety disorders appear to be more common among the university student population due to the population demographics across the region. Despite the need, these students show less inclination to access the widely available on-campus well-being services and other external professional services. Digital cognitive-behavioural therapy (CBT) aims to bridge this gap between the need for psychological help and access to it. However, challenges such as limited reach, low adoption, implementation barriers and poor long-term maintenance are mainstay issues resulting in reduced uptake of digital CBT. As a result, the potential impact of digital CBT is currently restricted. The proposed intervention 'Cerina' is a scalable CBT-based mobile app with an interactive user interface that can be implemented in university settings if found to be feasible and effective. METHODS AND ANALYSIS: The study is a single-blind pilot feasibility randomised controlled trial aiming to test the feasibility and preliminary effects of Cerina in reducing Generalised Anxiety Disorder (GAD) symptoms. Participants are 90 Ulster University students aged 18 and above with self-reported GAD symptoms. They will be allocated to two conditions: treatment (ie, access to Cerina for 6 weeks) and a wait-list control group (ie, optional on-campus well-being services for 6 weeks). Participants in the wait-list will access Cerina 6 weeks after their randomisation and participants in both conditions will be assessed at baseline, at 3 (mid-assessment) and 6 weeks (postassessment). The primary outcome is the feasibility of Cerina (ie, adherence to the intervention, its usability and the potential to deliver a full trial in the future). The secondary outcomes include generalised anxiety, depression, worry and quality of life. Additionally, participants in both conditions will be invited to semistructured interviews for process evaluation. ETHICS AND DISSEMINATION: Ethical approval for the study has been granted by the Ulster University Research Ethics Committee (ID: FCPSY-22-084). The results of the study will be disseminated through publications in scientific articles and presentations at relevant conferences and/or public events. TRIAL REGISTRATION NUMBER: NCT06146530.

Graded Exposure Therapy for Fear Avoidance Behaviour After Concussion (GET FAB): protocol for a multisite Canadian randomised controlled trial.

INTRODUCTION: Persistent symptoms after mild traumatic brain injury (mTBI) negatively affect daily functioning and quality of life. Fear avoidance behaviour, a coping style in which people avoid or escape from activities or situations that they expect will exacerbate their symptoms, maybe a particularly potent and modifiable risk factor for chronic disability after mTBI. This study will evaluate the efficacy of graded exposure therapy (GET) for reducing persistent symptoms following mTBI, with two primary aims: (1) To determine whether GET is more effective than usual care; (2) to identify for whom GET is the most effective treatment option, by evaluating whether baseline fear avoidance moderates differences between GET and an active comparator (prescribed aerobic exercise). Our findings will guide evidence-based care after mTBI and enable better matching of mTBI patients to treatments. METHODS AND ANALYSIS: We will conduct a multisite randomised controlled trial with three arms. Participants (n=220) will be recruited from concussion clinics and emergency departments in three Canadian provinces and randomly assigned (1:2:2 ratio) to receive enhanced usual care, GET or prescribed aerobic exercise. The outcome assessment will occur remotely 14-18 weeks following baseline assessment, after completing the 12-week treatment phase. The primary outcome will be symptom severity (Rivermead Post-concussion Symptoms Questionnaire). ETHICS AND DISSEMINATION: Informed consent will be obtained from all participants. All study procedures were approved by the local research ethics boards (University of British Columbia Clinical Research Ethics Board, University of Calgary Conjoint Health Research Ethics Board, University Health Network Research Ethics Board-Panel D). Operational approvals were obtained for Vancouver Coastal Health Research Institute and Provincial Health Services Authority. If GET proves effective, we will disseminate the GET treatment manual and present instructional workshops for clinicians. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov #NCT05365776.

Effectiveness of a mobile application for independent computerized cognitive training in patients with mild cognitive impairment: study protocol for the NeNaE Study, a randomized controlled trial.

BACKGROUND: Mild cognitive impairment (MCI) involves cognitive decline beyond typical age-related changes, but without significant daily activity disruption. It can encompass various cognitive domains as the causes of MCI are diverse. MCI as well as frequent comorbid neuropsychiatric conditions like depression and anxiety affect individuals' quality of life. Early interventions are essential, and computerized cognitive training (cCT) is an established treatment method. This paper presents the protocol for the NeuroNation MED Effectiveness Study, evaluating the self-administered mobile cCT intervention ("NeuroNation MED") in individuals with MCI to assess training effects on cognitive domains, health competence, neuropsychiatric symptoms, psychological well-being, and the general application usability. METHODS: This study protocol presents a single-blinded multicenter randomized controlled trial that will be carried out in six study centers in Germany and Luxembourg. We included adults with MCI (existing F06.7 ICD-10-GM diagnosis and TICS ≥ 21 and ≤ 32). The intervention group will use a mobile, multi-domain cCT ("NeuroNation MED") for 12 weeks. Meanwhile, the wait list control group will receive standard medical care or no care. The eligibility of volunteers will be determined through a telephone screening. After completion of the baseline examination, patients will be randomly assigned to one of the experimental conditions in a 2:1 ratio. In total, 286 participants will be included in this study. The primary outcome is the change of cognitive performance measured by the index score of the screening module of the Neuropsychological Assessment Battery. Secondary outcomes are changes in the Cognitive Failures Questionnaire, Hospital Anxiety and Depression Scale, Health-49, Health Literacy Questionnaire, among others. All of the primary and secondary outcomes will be assessed at baseline and after the 12-week post-allocation period. Furthermore, the intervention group will undergo an assessment of the System Usability Scale, and the training data of the NeuroNation MED application will be analyzed. DISCUSSION: This study aims to assess the effectiveness of a mobile self-administered cCT in enhancing cognitive abilities among individuals diagnosed with MCI. Should the findings confirm the effectiveness of the NeuroNation MED app, it may confer possible benefits for the care management of patients with MCI, owing to the accessibility, cost-effectiveness, and home-based setting it provides. Specifically, the cCT program could provide patients with personalized cognitive training, educational resources, and relaxation techniques, enabling participants to independently engage in cognitive training sessions at home without further supervision. TRIAL REGISTRATION: German Clinical Trials Register DRKS00025133. Registered on November 5, 2021.

The effect of Phytopaj ) Ferula assa-foetida L. oleo gum resin and tragacanth( in patients with COVID-19: A randomized clinical trial.

Objective: Exogenous hydrogen sulfide (H2S) has a positive effect on respiratory diseases. Oleo-gum of Ferula assa-foetida contains this compound. This study assessed the effects of Ferula assa-foetida L. oleo gum resin and tragacanth (Phytopaj) on patients with COVID-19. Materials and Methods: A randomized, single-blinded, controlled trial (RCT) phase 2 was conducted in Mashhad on hospitalized COVID-19 patients. In this RCT, 122 patients were randomly assigned to either receive a 14-day oral phytopaj plus ordinary treatment or ordinary treatment only. Changes in peripheral blood lymphocyte count (LC) and blood oxygen saturation (PO2) were the endpoints. Results: Mean±SD of PO2 in Phytopaj comparison ordinary treatment before intervention was 91.86±4.62 and 91.41±9.18, after the intervention it was 93.22±4.26 and 91.91±5.92 mmHg; before intervention, mean±SD of peripheral blood lymphocyte count was 1015.90±500.55, and 1104.28±543.61, and after intervention, it was 1652.27±921.38 and 1326.12±719.28/µL respectively. Conclusion: Phyopaj is most useful in moderate stages of Covid19, and it is not recommended for elderly patients and patients with comorbidity until more insight is gained.

Short- and long-term effects of imatinib in hospitalised COVID-19 patients: A randomised trial.

OBJECTIVES: We studied the short- and long-term effects of imatinib in hospitalised COVID-19 patients. METHODS: Participants were randomised to receive standard of care (SoC) or SoC with imatinib. Imatinib dosage was 400mg daily until discharge (max 14 days). Primary outcomes were mortality at 30 days and 1 year. Secondary outcomes included recovery, quality of life and long COVID symptoms at 1 year. We also performed a systematic review and meta-analysis of randomised trials studying imatinib for 30-day mortality in hospitalised COVID-19 patients. RESULTS: We randomised 156 patients (73 in SoC and 83 in imatinib). Among patients on imatinib, 7.2% had died at 30 days and 13.3% at 1 year and in SoC 4.1% and 8.2% (adjusted HR 1.35, 95% CI 0.47-3.90). At 1-year, self-reported recovery occurred in 79.0% in imatinib and in 88.5% in SoC (RR 0.91, 0.78-1.06). We found no convincing difference in quality of life or symptoms. Fatigue (24%) and sleep issues (20%) frequently bothered patients at one year. In the meta-analysis, imatinib was associated with a mortality risk ratio of 0.73 (0.32-1.63; low certainty evidence). CONCLUSIONS: The evidence raises doubts regarding benefit of imatinib in reducing mortality, improving recovery and preventing long COVID symptoms in hospitalised COVID-19 patients.

Clinical trial designs to assess treatment effects on glomerular filtration rate decline.

Glomerular filtration rate (GFR) decline is used as surrogate endpoint for kidney failure. Interventions that reduce chronic kidney disease (CKD) progression often exert acute GFR reductions which differ from their long-term benefits and complicate the estimation of long-term benefit. Here, we assessed the utility of two alternative trial designs (wash-out design and active run-in randomized withdrawal design) that attempt to exclude the impact of acute effects. Post-hoc analyses of two clinical trials that characterized the effect of an intervention with acute reductions in GFR were conducted. The two trials included a wash-out period (EMPAREG-Outcome testing empagliflozin vs placebo) or an active run-in period with a randomized withdrawal (SONAR testing atrasentan vs placebo). We compared the drug effect on GFR decline calculated from the first on-treatment visit to the end-of-treatment (chronic effect in a standard randomized trial design) with GFR change calculated from randomization to end-of-wash-out, or GFR change from treatment specific baseline GFR values (GFR at start-of-run-in for placebo and end-of-run-in for atrasentan) until end-of-treatment. The effect of empagliflozin versus placebo on chronic GFR slope was 1.72 (95% confidence interval 1.49-1.94) mL/min/1.73m2 /year, similar to total GFR decline from baseline to the end of wash-out period using a linear mixed model 1.64 (1.44-1.85) mL/min/1.73m2 /year). The effect of atrasentan versus placebo on chronic GFR slope was 0.72 (0.32-1.11) mL/min/1.73m2 /year, similar to total slope from a single slope model when estimated from treatment specific baseline GFR values 0.77 (0.39-1.14) mL/min/1.73m2 /year). Statistical power of the two designs outperformed the standard randomized design. Thus, wash-out and active-run-in randomized-withdrawal trial designs are appropriate models to compute treatment effects on GFR decline.

The Effect of Gua Sha Therapy on Pain in Parkinson's Disease: a Randomized Controlled Trial.

Purpose: Pain is a common yet undertreated symptom of Parkinson's disease (PD). This study investigated the effect of Gua Sha therapy on pain in patients with PD. Patients and Methods: A total of 56 PD patients with pain were randomized into either the experimental group (n=28), receiving 12 sessions of Gua Sha therapy, or the control group (n=28) without additional treatment. Participants underwent assessment at baseline, after the twelfth invention, and at the 2-month follow-up timepoints. The primary outcome was KPPS and VAS. Secondary outcomes included UPDRS I-III, PDSS-2, HADS, PDQ-39, and blood biomarkers (5-HT, IL-8, IL-10). Results: The experimental group reported a significant improvement in pain severity, motor functions, affective disorder, and sleep quality (P < 0.05). Furthermore, increasing trends in both 5-HT and IL-10, as well as decreasing trends in IL-8 were observed. No serious adverse events occurred. Conclusion: The preliminary findings suggest that Gua Sha therapy may be effective and safe for alleviating pain and improving other disease-related symptoms in PD patients.

Taking the edge off: a feasibility randomized controlled trial of an online mindfulness-based intervention to reduce suspiciousness/paranoia in high positive schizotypy.

Positive schizotypy can uniquely predict the development of psychosis with suspiciousness/paranoia having emerged as a key risk factor, pointing to significant worth in reducing this aspect in individuals with high positive schizotypy. Reduced paranoia in the general population following brief online mindfulness training has been previously reported. This study investigated the feasibility of a 40-day online mindfulness-based intervention (MBI) (n = 12) in the individuals with high positive schizotypy characterized by high suspiciousness/paranoia and to estimate its effect on paranoia as compared with an active control condition using reflective journaling (n = 12). The outcome measures were self-reported trait and VR-induced state paranoia, completed at baseline, after 10 days and post-intervention. The feasibility criteria included retention, adherence, engagement, and acceptability. There was 100% retention, excellent adherence to content and engagement, with an average MBI session completion rate of 91%. Acceptability, indexed by a self-rated motivation to continue practice post-intervention, was also high. No MBI effect on trait paranoia was observed; however, the MBI group showed a reduction in the VR-induced state paranoia with a medium-to-large effect (d = 0.63). The findings support conducting larger-scale randomized controlled trials to evaluate the effects of online MBIs on reducing suspiciousness/paranoia to mitigate psychosis risk in individuals with high positive schizotypy. Clinical Trial Registration:https://www.isrctn.com/, identifier ISRCTN78697391.

Optimizing Blood Pressure Management in Type 2 Diabetes: A Comparative Investigation of One-Time Versus Periodic Lifestyle Modification Counseling.

Background Type 2 diabetes mellitus (T2DM) often coexists with hypertension, significantly increasing cardiovascular risks. Lifestyle modification counseling has shown promise in managing T2DM and its comorbidities. However, the optimal frequency and structure of counseling for blood pressure control remain uncertain. Our study examines the best approach for managing blood pressure in T2DM patients by comparing the outcomes of two counseling strategies: a single session and periodic counseling over time. Methodology A total of 110 diabetic patients were enrolled, with 52 patients in each group after loss to follow-up. A randomized controlled trial compared one-time counseling (control) to six months of periodic counseling (intervention) on lifestyle modification. A weighing machine, stadiometer, 24-hour dietary recall, food frequency questionnaire, biochemical blood sugar level analysis, and telephonic follow-up were the essential tools used. The data were analyzed using SPSS version 24.0 (IBM Corp., Armonk, NY, USA), employing descriptive statistics, including frequencies, percentages, graphs, mean, and standard deviation. Statistical significance at the 5% level was tested using probability (p) calculations. The Kolmogorov-Smirnov test confirmed normal distribution (p > 0.05). Parametric tests, specifically independent t-tests, were used for between-group comparisons of continuous variables, while categorical variables were analyzed using the chi-square test or Fisher's exact test. Intragroup comparisons over time employed repeated-measures analysis of variance for continuous variables. Changes within groups after six months were assessed using paired t-tests. All statistical analyses adhered to a significance level of p < 0.05. Results The gender distribution at baseline was similar between the control (55.8% male, 44.2% female) and intervention (46.2% male, 53.8% female) groups, with no significant differences (p = 0.327). The mean weight was 66.67 ± 11.51 kg in the control group and 67.14 ± 11.19 kg in the intervention group (p = 0.835), and the body mass index was 25.61 ± 4.09 kg/m² and 26.29 ± 6.01 kg/m², respectively (p = 0.503). Clinical parameters such as fasting blood sugar, postprandial blood sugar, glycosylated hemoglobin, and blood pressure showed no significant differences between the control and intervention groups at baseline (p > 0.05). After six months, the intervention group exhibited a trend toward lower blood pressure compared to the control group, but the differences were not statistically significant. The mean systolic blood pressure was 132.15 ± 14.867 mmHg in the control group and 129.15 ± 9.123 mmHg in the intervention group (p = 0.218). Changes in blood pressure over the six-month period showed significant decreases within the intervention group, while changes in the control group did not reach statistical significance. The mean difference in systolic blood pressure in the intervention group was 5.54 ± 9.77 mmHg (p = 0.0001), indicating a notable reduction, while the control group had a smaller and statistically insignificant increase of 2.308 ± 9.388 mmHg (p = 0.082). Conclusions This study addresses a significant gap in the literature by comparing the efficacy of one-time vs. periodic counseling in T2DM management. While periodic counseling shows promise in improving diastolic blood pressure, further research is needed to understand its nuanced effects and optimize lifestyle interventions for T2DM patients.

Reducing parenting stress in Chinese parents of children with learning disabilities with a mindful parenting program: A randomized controlled trial.

BACKGROUND: Parents raising children with Learning Disabilities (LDs) often face multiple challenges and high levels of parenting stress, especially in societies with intense academic competitions. Mindful parenting (MP) is an emerging approach that brings mindful awareness to parent-child interactions and is found effective in reducing parenting stress in various parent populations. AIMS: This study examined the effectivenesss of an 8-week online MP program on Chinese parents of children with LDs. METHODS AND PROCEDURES: A MP program was adapted and implemented in an online format with 69 parents of children with LDs. A randomized controlled trial design was used to examine the efficacy of the mindful parenting group compared with a wait-list control group. Parenting stress, mindful parenting and self-compassion were assessed pre- and post-intervention. OUTCOMES AND RESULTS: Compared with the wait-list control group, the MP group participants showed decreased parenting stress (d = 0.62, p < 0.05), improved mindful parenting (d = 0.63, p < 0.05), and increased self-compassion (d = 0.61, p < 0.05). CONCLUSIONS AND IMPLICATIONS: These findings support the effectiveness of an online MP intervention in reducing parenting stress and increasing mindful parenting and self-compassion among Chinese parents of children with LDs. The behavioral and intrapersonal aspects of MP are more amenable to improvement, whereas the attitudinal and interpersonal aspects, particularly non-judgmental acceptance and compassion towards the child, are resistant to change. Future studies should explore strategies to enhance these attitudinal aspects and interpersonal processes of MP.

Efficacy of Cerebellar Transcranial Magnetic Stimulation in Treating Essential Tremor: A Randomized, Sham-Controlled Trial.

BACKGROUND AND PURPOSE: Repetitive transcranial magnetic stimulation (rTMS) of the cerebellar hemisphere represents a new option in treating essential tremor (ET) patients. We aimed to determine the efficacy of cerebellar rTMS in treating ET using different protocols regarding the number of sessions, exposure duration, and follow-up duration. METHODS: A randomized sham-controlled trial was conducted, in which 45 recruit patients were randomly allocated to 2 groups. The first (active group) comprised 23 patients who were exposed to 12 sessions of active rTMS with 900 pulses of 1-Hz rTMS at 90% of the resting motor threshold daily on each side of the cerebellar hemispheres over 4 weeks. The second group (sham group) comprised 22 patients who were exposed to 12 sessions of sham rTMS. Both groups were reassessed at baseline and after 1 day, 1 month, 2 months, and 3 months using the Fahn-Tolosa-Marin tremor-rating scale (FTM). RESULTS: Demographic characteristics did no differ between the two groups. There were significant reductions both in FTM subscores A and B and in the FTM total score in the active-rTMS group during the period of assessment and after 3 months (p=0.031 and 0.011, respectively). However, subscore C did not change significantly from baseline when assessed at 2 and 3 months (p=0.073 and 0.236, respectively). Furthermore, the global assessment score was significantly higher in the active-rTMS group (p>0.001). CONCLUSIONS: Low-frequency rTMS over the cerebellar cortex for 1 month showed relative safety and long-lasting efficacy in patients with ET. Further large-sample clinical trials are needed that include different sites of stimulation and longer follow-ups.

Aggressive hydration with lactated Ringer's solution versus plasma solution for the prevention of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (ALPS study): protocol for a multicentre, double-blind, randomised controlled trial.

INTRODUCTION: Endoscopic retrograde cholangiopancreatography (ERCP) plays an indispensable role in treating pancreato-biliary diseases but carries a risk of post-ERCP pancreatitis (PEP). Despite advances in the prevention strategies, prevention of PEP remains imperfect, necessitating more refined hydration methods. This study investigates the effectiveness of lactated Ringer's solution versus plasma solution in preventing PEP. METHOD AND ANALYSIS: This multicentre, double-blind, randomised controlled trial, will be initiated by the investigator-sponsor, and conducted in three tertiary centres in South Korea. The aim of this study is to assess the effectiveness of hydration in preventing PEP in patients with naïve papillae. It will target patients with naïve papillae, focusing on those at medium to high risk of PEP. Patients aged ≤18 years and those with serious comorbidities, acute/chronic pancreatitis and various other medical conditions will be excluded. Eligible participants will be randomly assigned into two arms in equal numbers: (1) PEP prevention using lactated Ringer's solution and (2) PEP prevention using plasma solution. The primary outcome of this study will be the occurrence of PEP, and secondary outcomes will be additional risk factors and potential adverse events related to ERCP. With a total enrolment of 844 patients, the study will be able to detect significant differences between the intervention arms. ETHICS AND DISSEMINATION: Ethical approval is obtained from each institution (Asan Medical Centre, 2023-0382; Seoul National University Hospital, H-2302-05-1404; Samsung Medical Centre, SMC 2023-02-001-009). All participants provided informed consent following clear explanation of the study procedures. The results of the study will be disseminated in peer-reviewed journals and research conferences. TRIAL REGISTRATION NUMBER: NCT05832047. PROTOCOL VERSION: Ver 4.1 (2023).

Comparison of the efficacy and safety of vertebroplasty with different pedicle approaches for osteoporotic vertebral.

OBJECTIVE: To compare the efficacy and safety of vertebroplasty through different pedicle approaches in the treatment of osteoporotic vertebral compression fracture osteoporotic vertebral compression fractures (OVCF) by network meta-analysis. METHODS: Pubmed, Embase, Cochrane Library, Web of Science. Database for literature retrieval, retrieval time from the establishment of the database to April 2023, the randomized controlled trials of unilateral vertebroplasty (UVP), bilateral vertebroplasty (BVP), unilateral kyphoplasty (UKP), bilateral kyphoplasty (BKP), curved vertebroplasty (CVP) and curved kyphoplasty (CKP) were screened, evaluated and the data were extracted and included in the analysis. STATA 15.0 and ReMan 5.3 were used for data analysis. This study was registered in the National Institute for Health Research (NIHR) with the registration number CRD42023405181. RESULTS: This study included 16 articles with a total of 1712 patients. The order of visual analogue scale (VAS) improvement from good to bad is CVP > BVP > UVP > CKP > BKP > UKP. The order of kyphotic angles improvement from good to bad is CKP > UKP > UKP > UVP > BVP > CVP. The order of bone cement injection from less to more is UVP > CVP > UKP > CKP > BVP > BKP. The order of bone cement leakage rate from less to more is CKP > CVP > UKP > BKP > UVP > BVP. The order of X-ray exposure time from less to more is CKP > CVP > UVP > BVP > UKP > BKP. The order of operation time from less to more is CVP > UVP > UKP > CKP > BVP > BKP. CONCLUSION: For patients with kyphotic angles, kyphoplasty has unique advantages in improving kyphotic angles. But generally speaking, curved approach can optimize the distribution of bone cement through unilateral approach to achieve the orthopedic effect of bilateral approach, which is a minimally invasive technique with better curative effect and higher safety in the treatment of OVCF.