Impact of tranexamic acid use in total hip replacement patients: A systematic review and meta-analysis.

Purpose: Tranexamic acid (TXA) dose in the context of primary complete hip replacements (THA) is still a hot debate about the best way to administer TXA. The need to select the most efficient and secure TXA dosing regimen, taking into account elements like perioperative bleeding, postoperative complications, and patient outcomes, has been emphasized by numerous studies. Improving clinical procedures and the general efficacy and safety of employing TXA in THA surgeries requires addressing this ongoing debate. Methods: For this systematic review, We looked at the safety and efficacy of administering TXA intravenously (iTXA) and topically (tTXA) during THA. A thorough search turned up ten randomized controlled trials with 1295 individuals. Parameters evaluated included blood loss, Hb level on the day following surgery, transfusion rates, and drainage volume. Results: Strategies had comparable impacts on deep vein thrombosis occurrences and wound complications. iTXA produced considerably less intraoperative blood loss (WMD = -12.687), concealed blood loss (WMD = 14.276), and the greatest hemoglobin drop (WMD = -0.400) when compared to tTXA. Conclusion: Both administration techniques were secure and efficient in primary THA, although iTXA showed superior results in lowering blood loss and Hb decline.

Epidemiological Study in Antiviral Innate Immunity.

This chapter summarizes the epidemiological study design of natural immune epidemiology studies based on recent COVID-19-related research. The epidemiological studies on antiviral innate immunity have mainly included randomized controlled trials (RCTs) and observational studies. Importantly, this chapter will discuss how to use these methodologies to answer an epidemiological question of natural immunity in the viral infection process based on previous studies. An observational case- or cohort-based study of antiviral innate immunity may support this theoretical hypothesis but is not appropriate for clinical practice or treatment. RCTs are the gold standard for epidemiological studies and occupy a greater role in the hierarchy of evidence.

The effectiveness of psychotherapies in reducing further suicide attempts: a systematic review with meta-analysis of randomized controlled trials

There is little evidence on the effectiveness of psychotherapeutic interventions in reducing new suicide attempts. This article aims to evaluate the effectiveness of psychotherapeutic interventions in reducing suicide attempts among patients with a history of previous attempts. We selected 17 articles from four databases: PubMed, Cochrane, APA PsycInfo and LILACS, in 2023. Six studies showed statistical differences that favored psychotherapeutic intervention at some point during the follow-up period. These psychotherapies addressed: problem-solving, hope induction, skills training. When comparing psychotherapy with usual care, a meta-analysis revealed an odds ratio of 0.41 (95 % CI, 0.17-0.99, p = .05) in the analysis up to 12 months of follow-up, and an odds ratio of 0.48 (95 % CI, 0.30-0.78, p < .001) after 12 months of follow-up. The results indicate the efficacy of these interventions in reducing additional suicide attempts, but they should be analyzed with caution, given the heterogeneity of the sample, treatments, and comparators. This review supports the development of prevention strategies indicated for patients who have attempted suicide.

Hay poca evidencia sobre la eficacia de las psicoterapias para reducir los nuevos intentos de suicidio. Este artículo tiene como objetivo evaluar la efectividad de las intervenciones psicoterapéuticas en la reducción de los intentos de suicidio entre pacientes con intentos previos. Se seleccionaron 17 artículos de cuatro bases de datos: PubMed, Cochrane, APA PsycInfo y LILACS. Seis estudios mostraron diferencias estadísticas que favorecieron la intervención psicoterapéutica en algún momento durante el período de seguimiento. Estas psicoterapias abordaron: resolución de problemas, inducción de esperanza y entrenamiento de habilidades. Al comparar la psicoterapia con el tratamiento habitual, el metanálisis reveló un odds ratio de 0.41 (IC del 95 %, 0.17 a 0.99, p = .05) en el análisis hasta los 12 meses de seguimiento, y un odds ratio de 0.48 (IC del 95 %, 0.30 a 0.78, p < .001) después de 12 meses de seguimiento. Los resultados apuntan a la eficacia de estas intervenciones para reducir los intentos de suicidio adicionales, pero deben analizarse con cautela, dada la heterogeneidad de la muestra, los tratamientos y los comparadores. Esta revisión apoya el desarrollo de estrategias de prevención indicadas para pacientes que han intentado suicidarse.

Examining the Efficacy of Control Groups in Achieving Statistical Control: A Critical Look at Randomized Controlled Trials.

The randomized controlled trial (RCT) is widely esteemed as the gold standard of experimental research methodologies, purportedly due to its rigorous approach to achieving statistical control. By systematically assigning participants to either a control group or an experimental group through randomization, RCTs claim to isolate the effects of the intervention from confounding variables. This methodological rigor is believed to be instrumental in ensuring that observed outcomes can be attributed with a high degree of confidence to the experimental treatment rather than to extraneous factors. Random assignment in RCTs is believed to mitigate selection bias and enhance generalizability. However, they necessitate a large sample size and are often constrained by ethical considerations. The repeated measures design represents a sophisticated alternative that provides nuanced statistical control by allowing each participant to serve as their own control. Repeated measures analyses commonly include the paired t-test, Wilcoxen Signed Rank Test, and the Repeated Measures Analysis of Variance (ANOVA). These approaches are particularly advantageous in mitigating the impact of individual variability, an inherent noise source in many research settings. By employing repeated measures, researchers can achieve heightened precision in estimating treatment effects, as each subject's baseline characteristics and responses to experimental conditions are held constant across the various stages of the study. This nuanced control contrasts with the traditional claim within medical science on the "rigorously controlled" nature of RCTs. While RCTs are celebrated for their methodological robustness and capacity to minimize bias through randomization, their application is not always the most efficient or practical for all research questions. Although significant, the methodological strengths of RCTs may be overshadowed by the inherent limitations of their design, including the inability to "control for" an infinite number of confounding variables, ethical considerations, and the challenge of achieving generalizability across varied real-world contexts. In contrast, the often-underutilized repeated measures design offers a valuable alternative by harnessing within-subject comparisons to enhance statistical sensitivity. This design is particularly effective when longitudinal data is paramount or focuses on assessing dynamic changes over time as the result of treatment. It is imperative, however, to acknowledge that repeated measures designs have challenges. Potential issues such as carryover effects, order effects, and the complexity of statistical analysis necessitate careful consideration and robust methodological strategies to ensure valid interpretations of the data. While RCTs remain the gold standard for their claimed methodological rigor and ability to establish causal relationships with high confidence, repeated measures designs offer a complementarily more progressive approach that enhances precision by controlling for individual differences. Both methodologies hold significant merit within the research landscape, and their application should be thoughtfully considered based on the specific research objectives, practical constraints, and the nature of the phenomena under investigation.

Efficacy and safety of traditional Chinese medicine combined with azithromycin sequential therapy for mycoplasma pneumonia among children: a meta-analysis of randomized controlled trials.

Background: Traditional Chinese medicine (TCM) is used to treat mycoplasma pneumonia (MP) in children with favorable treatment outcome in China. In the present study, we evaluated the clinical efficacy of TCM combined with azithromycin (AZM) for the treatment of MP among children, providing high evidence-based reference for clinical treatment. Method: We retrieved eligible randomized controlled trials (RCTs) from CQVIP, CNKI, WanFang, NSTL, PubMed, Embase, and Embase databases from January 2000 to November 2023. Data extraction and quality assessment of the enrolled studies were independently by two reviewers. Review Manager 5.3 was used for meta-analysis. Result: A total of 51 RCTs involving 5,799 children aged 1-14 enrolled. Meta-analysis demonstrated that TCM combined with AZM improved the cure rate (odds ratio [OR] = 2.34, 95% CI: 2.06 to 2.64) and the effective rate (OR = 5.21, 95% CI: 4.22 to 6.43), shorted the disappearance duration of cough (WMD = -1.62, 95% CI: -1.90 to -1.34), the duration of fever (WMD = -1.62, 95% CI: -1.96 to -1.29), and the disappearance time of lung rales (WMD = -1.15, 95% CI: -1.32 to -0.98), improved CRP levels (WMD = -2.06, 95% CI: -2.57 to -1.55), IL-6 levels (WMD = -1.92,95% CI: -2.51 to -1.34), and TNF-α levels (WMD = -1.59, 95% CI: -2.14 to -1.04), and reduced adverse reactions (OR = 0.37, 95% CI: 0.32 to 0.44). Conclusion: TCM combined with AZM in the treatment of MP among children has favorable clinical efficacy and safety.

Comparative effectiveness of treatments for recurrent Clostridioides difficile infection: a network meta-analysis of randomized controlled trials.

Background: Clostridioides difficile infection (CDI) is the most common cause of healthcare-associated infectious diarrhea. A major clinical challenge is recurrent CDI (rCDI) without effective standard drug-based therapy. Additionally, a comprehensive comparison of various therapy effectiveness in rCDI patients is still under investigation. Methods: A Bayesian network meta-analysis (NMA) of randomized control trials up to March 2024 was performed to investigate the efficacy of rCDI interventions. Results: Seventeen trials were included, comprising 4,148 CDI patients with ten interventions, including fecal microbiota transplantation (FMT) by lower gastrointestinal (LGI), FMT by upper gastrointestinal (UGI), Autologous FMT (AFMT), vancomycin + FMT, vancomycin, placebo, fidaxomicin, Vowst (SER109), Rebyota (RBX2660), and monoclonal antibody. NMA showed that FMT by LGI had the highest efficacy in treating rCDIs with an odds ratio (95% confidence interval) of 32.33 (4.03, 248.69) compared with placebo. FMT by UGI also showed high efficacy, whereas the efficacy comparison between FMT by LGI and UGI was not statistically significant (ORs) (95% CI), 1.72 (0.65, 5.21). The rankogram and surface under the cumulative ranking curve (SUCRA) also showed FMT by LGI ranked at the top and FMT by UGI ranked second in the curative effect. Conclusion: NMA demonstrates FMT's significant efficacy in rCDI management, regardless of administration route (lower or upper gastrointestinal). Despite its significant benefits, FMT's safety is a concern due to the lack of standardized FDAcompliant manufacturing and oversight. Microbiota-based therapies also exhibit potential. However, limited research mandates further clinical exploration. Antibiotics, in contrast, display comparatively reduced efficacy in rCDI, potentially linked to disruptions in native gut microflora balance. Systematic Review: https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=368435, Identifier CRD42022368435.

Citrus supplementation in subjective cognitive decline: results of a 36-week, randomized, placebo-controlled trial.

BACKGROUND: Developing interventions for older adults with subjective cognitive decline (SCD) has the potential to prevent dementia in this at-risk group. Preclinical models indicate that Citrus-derived phytochemicals could benefit cognition and inflammatory processes, but results from clinical trials are still preliminary. The aim of this study is to determine the effects of long-term supplementation with Citrus peel extract on cognitive performance and inflammation in individuals with SCD. METHODS: Eighty participants were randomly assigned to active treatment (400 mg of Citrus peel extract containing 3.0 mg of naringenin and 0.1 mg of auraptene) or placebo at 1:1 ratio for 36 weeks. The primary endpoint was the change in the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) total score across the 36-week trial period. Other cognitive outcomes included tests and scales evaluating verbal memory, attention, executive and visuospatial functions, and memory concerns. The secondary endpoint was the change of interleukin-8 (IL-8) levels over the 36-week trial period in a subsample of 60 consecutive participants. An Intention-to-treat approach with generalized linear mixed models was used for data analysis. RESULTS: The RBANS total score showed significant improvement in both Citrus peel extract and placebo groups at 36 weeks (p for time < .001, d = 0.36, p time x treatment = .910). Significant time effects were also found in cognitive domains of short- and long-term verbal memory (p < .001) and scales of subjective memory (p < .01), with no significant time x treatment interaction. The largest effect sizes were observed in verbal memory in the placebo group (d = 0.69 in short-term, and d = 0.78 in long-term verbal memory). Increased IL-8 levels were found at 36-week follow-up in both Citrus peel extract and placebo groups (p for time = .010, d = 0.21, p time x treatment = .772). Adverse events were balanced between groups. CONCLUSIONS: In this randomized clinical trial, long-term Citrus peel extract supplementation did not show cognitive benefits over placebo in participants with SCD, possibly due to high placebo response. These findings might have specific implications for designing future nutraceutical trials in individuals experiencing SCD. TRIAL REGISTRATION: The trial has been registered at the United States National Library of Medicine at the National Institutes of Health Registry of Clinical Trials under the code NCT04744922 on February 9th, 2021 ( https://www. CLINICALTRIALS: gov/ct2/show/NCT04744922 ).

Cost-utility analysis of provision of e-cigarette starter kits for smoking cessation in emergency departments: An economic evaluation of a randomized controlled trial.

AIMS: To assess the cost-effectiveness of the Cessation of Smoking Trial in Emergency Department (COSTED) intervention compared with signposting to local stop smoking service (SSS) from the National Health Service (NHS) and personal social services (PSS) perspective. DESIGN, SETTING AND PARTICIPANTS: This was a two-group, multi-centre, pragmatic, individually randomized controlled trial set in six Emergency Departments (EDs) in urban and rural areas in the United Kingdom. Adult (≥ 18 years) daily smokers (at least one cigarette or equivalent per day) but not daily e-cigarette users, with carbon monoxide reading ≥ 8 parts per million, attending the ED (n = 972) were included. The intervention consisted of provision of an e-cigarette starter kit plus brief smoking cessation advice and referral to a local SSS. Control was an information card on how to access local SSS. MEASUREMENTS: Intervention costs included costs of training and delivery. Control costs included costs of printing information cards. Costs of smoking cessation and health-care services were estimated based on quantities reported by participants and unit costs extracted from secondary sources. The effects were measured by quality-adjusted life years (QALYs) derived from EQ-5D-5L. Other outcomes were smoking cessation measures. The primary outcome was incremental cost-effectiveness ratio (ICER), which was calculated by dividing the difference in costs by the difference in QALYs between groups. FINDINGS: The mean intervention costs were £48 [standard error (SE) = £0] per participant and the mean control costs were £0.2 (SE = £0) per participant. Using regression estimates, total costs were £31 [95% confidence interval (CI) = -£341 to £283] higher and 6-month QALYs were 0.004 (95% CI = -0.004 to 0.014) higher in the intervention group than in the control group. The ICER was calculated at £7750 (probability of cost-effective at range £20 000-30 000: 72.2-76.5%). CONCLUSIONS: The UK Cessation of Smoking Trial in Emergency Department (COSTED) intervention (provision of an e-cigarette starter kit plus brief smoking cessation advice) was cost-effective compared with signposting to local stop smoking services under the current recommendations of the maximum acceptable thresholds.

The Efficacy of Two Triple Therapy Regimens and One Quadruple Regimen [Omeprazole, Amoxicillin, Metronidazole with Bismuth] in Eradicating Helicobacter Pylori in Patients with Peptic Ulcer: A Randomized Clinical Trial.

BACKGROUND: Helicobacter pylori [H. pylori] infection is the main cause of most PUD; therefore, the eradication of H. pylori is extremely important in the treatment of PUD. There are several recommended treatment regimens suggested to eradicate this organism. AIM: This study compared the efficacy of three anti-Helicobacter pylori regimens in patients with dyspepsia or peptic ulcer disease [PUD]. OBJECTIVE: The objective of this study was to assess the efficacy of three anti-H Pylori treatments in patients based on C14 urease breath test [C-UBT] results, drug compliance, and adverse effects. METHODS: This randomized, open-label clinical trial included 136 H. Pylori-infected patients without prior treatment. Patients were randomly divided into three groups. The OAC group received 20 mg Omeprazole capsules twice a day, two 500 mg Amoxicillin capsules twice a day, and 500 mg Clarithromycin capsules twice a day for 14 days. The OAL group received 20 mg Omeprazole capsules twice a day, two 500 mg Amoxicillin capsules twice a day, and Levofloxacin 500 mg capsules twice a day for 14 days. The OAMB group received 20 mg Omeprazole capsules twice a day, two 500 mg Amoxicillin capsules twice a day, Metronidazole 500mg three times a day, and Bismuth 240 mg twice a day for 14 days. Evaluation for compliance and drug-related adverse effects were assessed at the end of two weeks. H. Pylori eradication was evaluated eight weeks after treatment using the C-UBT. RESULTS: A total of 136 patients participated in this study, and their groups were matched based on age and sex. The results of the C-UBT test showed that the eradication rate of H. Pylori was 82.2%, 91.3%, and 97.3% for the three-drug OAC, OAMB, and OAL treatment regimens, respectively. Moreover, all the regimens showed high compliance among the patients. Only OAC and OAL showed a significant difference in the H. Pylori eradication rate, and no superiority was found between OAMB and OAL or OAC therapies. CONCLUSION: The regime of OAL achieved a satisfactory rate of H. pylori infection eradication with good tolerance in patients with PUD, without any acute side effects. CLINICAL TRIAL REGISTRATION NUMBER: IRCT201605189014N100.

Short-term outcomes of oropharyngeal administration of colostrum in preterm neonates: a double-blind placebo-controlled randomized trial.

Background: The oropharyngeal administration of colostrum (OAC) in neonates has several benefits. Purpose: To investigate the short-term outcomes of OAC in preterm neonates. Methods: We performed this two-arm, double-blind, placebo-controlled randomized trial at a tertiary neonatal center in Iran in 2021-2023. The intervention and control arms received 0.2 mL of their mother's colostrum or distilled water via oropharyngeal administration every 6 h for 3 days starting from birth until 72 h of age. The main study outcomes were neonatal death, the incidence of necrotizing enterocolitis (NEC), sepsis, retinopathy of prematurity (ROP), length of hospital stay, and period to full enteral feeding. A regression analysis was used to adjust for possible confounders. Results: A total of 126 neonates (mean gestational age, 30.05 weeks) were randomized to the intervention and placebo groups (n=63 each) and had a mean ± SD weight of 1247 ± 193 vs 1156 ± 215 g (P=0.013) and 1- and 5-min Apgar scores of 6.35 vs 5.38 (P=0.003) and 7.84 vs 7.13 (P=0.001), respectively. The mortality rate was 12.7% in the intervention group versus 14.3% in the placebo group (P=0.794). The NEC rate was significantly lower in the intervention versus placebo arm (11.1% vs. 28.6%, respectively; P=0.010), as was the clinically suspected sepsis rate (15.9% vs. 39.7%, respectively; P=0.004). The ROP and bronchopulmonary dysplasia rates did not differ significantly between groups after the adjustment for confounders. The mean length of hospital stay was shorter in the intervention group (26.1 vs. 37.32; P=0.023). Moreover, the mean duration of antibiotic therapy and period to full feeding were significantly shorter in the intervention group. Conclusion: OAC could effectively decrease the incidence of complications in preterm infants and facilitate earlier patient discharge.

Effects and mechanisms of supramaximal high-intensity interval training on extrapulmonary manifestations in people with and without chronic obstructive pulmonary disease (COPD-HIIT): study protocol for a multi-centre, randomized controlled trial.

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

Deep transcranial magnetic stimulation for treatment-resistant obsessive-compulsive disorder: A meta-analysis of randomized-controlled trials.

BACKGROUND: Deep transcranial magnetic stimulation (dTMS), an advancement of transcranial magnetic stimulation, was created to reach wider and possibly more profound regions of the brain. At present, there is insufficient high-quality evidence to support the effectiveness and safety of dTMS in treating obsessive-compulsive disorder (OCD). OBJECTIVE: This study used a meta-analysis to evaluate the effectiveness and safety of dTMS for treating OCD. METHODS: Four randomized controlled trials were found by searching PubMed, Embase, Web of Science, and Cochrane Library up to February 2024. The fixed effects meta-analysis model was used for the purpose of data merging in Stata17. The risk ratio (RR) value was used as the measure of effect size to compare response rates and dropout rates between active and sham dTMS. RESULTS: The meta-analysis included four randomized-controlled trials involving 252 patients with treatment-resistant OCD. Active dTMS showed a notably greater rate of response on the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) in comparison to sham dTMS after treatment (Y-BOCS: RR = 3.71, 95% confidence interval [CI] 2.06 to 6.69) and at the one-month follow-up (Y-BOCS: RR = 2.60, 95% CI 1.59 to 4.26). Subgroup analysis revealed that active dTMS with H-coils was more effective than sham dTMS (RR = 3.57, 95%CI 1.93 to 6.60). No serious adverse events were documented in the studies that were included. CONCLUSION: The findings suggest that dTMS demonstrates notable efficacy and safety in treating patients with treatment-resistant OCD compared to sham dTMS, with sustained effectiveness noted throughout the one-month post-treatment period.

The Impact of the American Association of Thoracic Surgery on Clinical Trial Development by Cardiothoracic Surgeons.

OBJECTIVE: Clinical trials play a critical role in the rapidly evolving field of cardiothoracic surgery and the American Association of Thoracic Surgery (AATS) Clinical Trials Methods Course has provided a biannual symposium led by preeminent surgeons with vast experience in planning, conducting and analyzing surgical clinical trials. This study hypothesizes that participation in the course is associated with future success in clinical trial leadership. METHODS: A list of course attendees (2014-2022) was queried in "ClinicalTrials.gov", a database of clinical trials funded by the United States Health and Human Services and the National Institutes of Health. The type of clinical trial and publications from the trial were collected. Demographic information about the participants were collected from faculty pages. RESULTS: A total of 107 participants from various professional backgrounds attended the AATS Clinical Trials course and led 91 clinical trials. The average time to starting a clinical trial after attending the workshop was 3.04 years for participants who had not already been involved with a trial. Of the 107 participants, 36 (36/107; 33.6%) were either the principal investigator or a sub-investigator for 91 clinical trials. CONCLUSIONS: The AATS Clinical Trials course provides participants the tools for successfully leading surgical clinical trials. Although participation has been limited, those who attend the course and lead a clinical trial do so within approximately 3 years. The Clinical Trials course provides an excellent return on investment and the AATS should continue sponsorship of this program as it supports the develop of future leaders in cardiothoracic surgery.

Hydraulic sinus floor elevation using advanced platelet-rich fibrin: A randomized clinical trial with two-dimensional radiographic results.

PURPOSE: To assess the radiographic outcomes, complications, and implant survival rates of advanced platelet-rich fibrin versus xenografts in hydraulic sinus floor elevation. METHODS: In this randomized trial, 40 patients with 46 implants were divided into two groups: a test group (advanced platelet-rich fibrin alone) and a control group (xenograft alone). The key outcome measures included bone regeneration, implant survival, and complications. RESULTS: Both groups achieved 100% implant survival. One case of maxillary sinus infection occurred in the control group after surgery. There was no significant difference in bone regeneration between the two groups at 6 months post-surgery and 12 months post-load (P > 0.05). The residual bone height and sinus width at the apex of the implant were significant negative predictors of bone regeneration (P < 0.05), whereas the presence of adjacent teeth was a significant positive predictor (P < 0.05). CONCLUSIONS: Both advanced platelet-rich fibrin and xenografts effectively enhanced bone growth at sinus floor elevation, achieving high implant survival rates over one year. Advanced platelet-rich fibrin alone may be a viable xenograft alternative, necessitating further long-term studies to confirm its efficacy. The study was registered in the Chinese Clinical Trial Registry (http://www.chictr.org.cn/) with the registration number ChiCTR2100042060. This clinical trial was not registered before participant recruitment or randomization.

Participant Experiences from a Randomized Controlled Trial of Heated Yoga for Depression.

Despite decades of research on yoga and depression, subjective experiences of participants in these studies have rarely been reported, and never in individuals receiving heated yoga for depression. We examined patient-reported qualitative findings from an 8-week randomized controlled trial of heated yoga for depression. Eighty medically healthy participants with moderate-to-severe depression were randomized to 8 weeks of at least twice-weekly heated yoga classes, derived from Bikram yoga, or a waitlist control. Fifty-seven participants received a clinician-administered exit interview at intervention completion/study withdrawal. The exit interview assessed: (1) how participants felt immediately following the heated yoga sessions (acute effects), (2) what they liked or found helpful about heated yoga over the 8-week intervention (positive effects), and (3) what they disliked/did not find helpful over the 8-week intervention (negative effects). Qualitative data were analyzed using thematic analysis. Acute improvements in depressive symptoms (i.e., immediately following yoga) were the most commonly reported (n = 44, 77.2%), followed by overall positive effects on depressive symptoms (i.e., over the course of the 8-week intervention; n = 33, 57.9%), including improvements in sleep (n = 10, 17.5%), energy (n = 13, 22.8%), mood (n = 18, 31.6%), motivation (n = 2, 3.5%), and concentration/decision-making (n = 5, 8.8%). Overall negative effects (i.e., over the course of the 8-week intervention) included dislike of various aspects of the intervention (n = 19, 33.3%), such as instruction (n = 7, 12.3%), difficulty (n = 7, 12.3%), repetitiveness (n = 3, 5.3%), class length (n = 2, 3.5%), and boredom (n = 7, 12.3%). Most participants reported both overall positive and negative effects (n = 37, 64.9%). Of the rest, 19 (33.3%) reported only overall positive effects, and 1 (1.8%) reported only overall negative effects. Most participant experiences were positive. Negative effects were less common and primarily involved dislike of different aspects of the heated yoga. The findings support strong acceptability and subjective improvement in depressive symptoms in depressed individuals.

A Service-Learning Program to Prevent Online Hate Speech Perpetration Among Secondary Education Students: A Pilot Study.

The evolution and rapid expansion of online hate speech perpetration (OHSP) behaviors among adolescents toward different groups contrast with the lack of theory-based and empirically evaluated programs targeting this phenomenon. This study, developed by the Spanish Volunteering Platform, contributes to reversing this situation by investigating the impact of a service-learning program to prevent OHSP among students in secondary education. To do so, a cluster-randomized research design was adopted with a sample of secondary school students (n = 60) from two public schools. After the random assignment of each class group to either the intervention or control condition, the service-learning program previously designed was implemented for 3 months. Regression results in model 7 with all predictors and controls yield a significant effect on the variable experimental group = 0.803, p < .05, and gender = 0.987, p < .05, explaining 45.9% of the variance. The effect size for this intervention was 0.42. From a theoretical perspective, participants are moving in the right direction to reduce and/or prevent OHSP behaviors, which demonstrates the theoretical utility of the theory of planned behavior in hate speech research. Finally, several recommendations are made to improve the impact of future replications or adaptations of this program.

Population-level effects on crime of recovering firearms from armed prohibited persons: intention-to-treat analysis of a pragmatic cluster-randomised trial in California cities.

BACKGROUND: Too little is known about the effectiveness of efforts to prevent firearm violence. We evaluated California's Armed and Prohibited Persons System (APPS), which identifies legal purchasers of firearms who have become prohibited persons and seeks to recover all firearms and ammunition to which they have access. DESIGN AND METHODS: This cluster-randomised pragmatic trial was made possible by APPS's expansion from a small pilot to a continuing statewide programme. We included 363 California cities, allocated to early (n=187) or later (n=176) intervention in blocks stratified by region within the state, and within region by population and violent crime rate. The study period began 1 February 2015; region-specific end dates ranged from 1 May 2015 to 1 February 2016. Analysis was on an intention-to-treat, difference-in-difference basis using generalised linear mixed models and generalised estimating equations with robust SEs. The population-level primary outcome measures were monthly city-level counts of firearm-related homicides, robberies and aggravated assaults. The primary model was adjusted for stratification variables; city-level population, population density, socioeconomic status and firearm purchasing; year; and month. FINDINGS: Allocation groups were well balanced on baseline characteristics and implementation measures. In adjusted models, allocation to early intervention was not associated with statistically significant differences in any primary outcome measure; these findings were robust to multiple sensitivity analyses. There was some heterogeneity across regions. CONCLUSIONS: The APPS intervention directly affects a very small percentage of the population, limiting its potential for population-level effects. Individual-level analyses may provide a better estimate of the intervention's effectiveness. TRIAL REGISTRATION NUMBER: NCT02318732.

Multicentre, randomized, double-blind, prospective study on the effects of ImmunoAdSorptiOn on cardiac function in patients with Dilated CardioMyopathy (IASO-DCM): Rationale and design.

AIMS: Pilot studies indicate that immunoadsorption with subsequent IgG substitution (IA/IgG) induces beneficial effects in patients with dilated cardiomyopathy (DCM) and heart failure. This placebo-controlled study investigates whether IA/IgG treatment enhances left ventricular (LV) systolic function as compared to a control group receiving pseudo-treatment. METHODS: This multicentre, randomized, double-blind, parallel-group trial aims to include 200 patients with heart failure due to DCM (LV ejection fraction [LVEF] <40%) on optimized guideline-directed heart failure medication. Participants are randomly assigned in a 1:1 ratio to IA/IgG using protein-A columns, or to pseudo-immunoadsorption followed by an intravenous infusion without IgG. Follow-up visits take place by telephone after 1 and 3 months and at the study centres after 6, 12 and 24 months. The primary efficacy endpoint is the change in LVEF from baseline to 6 months determined by contrast echocardiography, analysed at a core lab. In addition, LV end-diastolic and end-systolic volumes will be analysed as secondary endpoints over the entire study period to assess whether IA/IgG affects LV remodelling. As main secondary outcome, a composite of all-cause death, cardiac resuscitation, hospitalization for heart failure, and need for cardiac surgery to improve myocardial pump function will be evaluated after 24 months. In addition, exploratory outcomes as well as safety endpoints related to the treatment will be assessed throughout the whole study period. CONCLUSION: IASO-DCM is a randomized study which will provide comprehensive insights into the effects of immunoadsorption with subsequent IgG substitution in patients with DCM.

Randomized Controlled Trial to Evaluate the Efficacy of Positive Mental Health Program for Adults: Study Protocol.

AIM: To evaluate the effectiveness of a positive mental health program for adults (PMHP) in the community. BACKGROUND: Positive mental health (PMH) can be seen as a construct represented by six factors (personal satisfaction, prosocial attitude, self-control, autonomy, problem resolution, and self-actualization, and interpersonal relationship skills) according to the Multifactorial Model for PMH. Although there are several interventions in promoting mental health, research on effective promotion of PMH for adults in the community with structured and validated programs of PMH is scarce. METHODS: This study protocol describes a randomized controlled trial (RCT) following a wait-list control design, aimed at evaluating the effectiveness of a PMHP in the community. This study was approved in June 2019 by the Ethics Committee. Participants will be recruited from the school community of teachers. Participants aged ≥ 18 years. The participants will be randomized 1:1 to either (a) an intervention group, which will integrate the PMHP, or (b) the standby control group. Three assessment moments for both groups will take place initial, after the intervention, and a follow-up of 3-6 months. The evaluation instruments will include a sociodemographic questionnaire, a PMH questionnaire, and a psychological vulnerability scale. CONCLUSION: The current study provides an innovative approach to PMH. Further, the study may demonstrate new interventions in PMH in the community, based on a program with systematized guidelines and sessions structured according to individual needs. It is expected that at the end of the program, the experimental group will increase the level of PMH. RELEVANCE TO CLINICAL PRACTICE: To allow future official implementation of the PMH program and the replication of the study in other professional groups as a promotion tool. NO PATIENT OR PUBLIC CONTRIBUTION: There was no funding to remunerate a participant for this study. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT04600401. Registered on May 15, 2020.

Incidence of aortic valve reintervention in patients with aortic stenosis undergoing transcatheter aortic valve implantation versus surgical aortic valve replacement: a systematic review and updated meta-analysis of randomized studies.

INTRODUCTION: Transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) are established interventions for alleviating symptoms and enhancing survival in individuals with severe aortic stenosis (AS). However, the long-term outcomes and incidence of reintervention associated with TAVI and SAVR remain uncertain. METHODS: We conducted a systematic review and meta-analysis to compare the incidence of reintervention in TAVI versus SAVR. PubMed, Embase, and Cochrane databases were searched for randomized controlled trials (RCTs). Risk ratios (RR) and 95% confidence intervals (CI) were pooled with a random-effects model. A p-value < 0.05 was considered statistically significant. RESULTS: Nine RCTs were included, with 5144 (50.9%) patients randomized to TAVI. Compared with SAVR, TAVI increased reinterventions (RR 1.89; 95% CI 1.29-2.76; p < 0.01) and the need for pacemakers (RR 1.91; 95% CI 1.49-2.45; p < 0.01). In addition, TAVI significantly reduced the incidence of new-onset atrial fibrillation (RR 0.43; 95% CI 0.32- 0.59; p < 0.01). There were no significant differences in all-cause mortality (RR 1.04; 95% CI 0.92-1.16; p = 0.55), cardiovascular mortality (RR 1.04; 95% CI 0.94-1.17; p = 0.44), stroke (RR 0.97; 95% CI 0.80-1.17; p = 0.76), endocarditis (RR 0.96; 95% CI 0.70-1.33; p = 0.82), and myocardial infarction (RR 1.06; 95% CI 0.79-1.41; p = 0.72) between groups. CONCLUSIONS: In patients with severe AS, TAVI significantly increased the incidence of reinterventions and the need for pacemakers as compared with SAVR.