Controlled Study Research Articles

The Effect of Platelet-Rich Fibrin (PRF) in Accelerating Periodontal Regeneration: A Randomized Controlled Clinical Trial

ABSTRACT Background: Regeneration of periodontal tissues is an essential component in treating periodontal disease, and there is an increasing focus on biological agents that might improve the healing process. Materials and Methods: The randomized controlled clinical study included a cohort of 60 individuals diagnosed with chronic periodontitis. Each participant was randomly allocated to one of two groups: the experimental group (n = 30), which underwent PRF in combination with traditional open flap debridement (OFD), and the control group (n = 30), which received OFD alone. Clinical criteria such as probing pocket depth (PPD), clinical attachment level (CAL), and bone fill percentage were assessed at baseline and after 6 months. Furthermore, cone-beam computed tomography (CBCT) was used to evaluate bone regrowth radiographically. Results: Following a period of 6 months, the experimental group had a notable decrease in postpartum depression (mean decrease of 4.2 mm) and an increase in central artery ligation (mean increase of 3.5 mm) compared to the control group, which had a mean decrease in postpartum depression of 2.8 mm and a mean increase in central artery ligation of 2.1 mm. The test group had a notably greater proportion of bone fill (45%) in comparison to the control group (30%). Further radiographic study verified enhanced bone regeneration in the areas treated with PRF. Conclusion: The use of Platelet-Rich Fibrin (PRF) in combination with traditional periodontal surgery greatly expedites the process of periodontal regeneration, as shown by notable enhancements in clinical indicators and bone regeneration.

Does adjunctive phototherapy have better outcomes than adjunctive antibiotic therapy for the management of peri-implantitis?

Elsevier's Scopus, Web of Science and Pubmed through Medline identified 431 articles, which were reduced to 206 when duplicates were removed. 8 articles were screened, and 1 excluded after reading the full-text, leaving 7 studies. 6 of these were randomised controlled trials, and 1 a non-randomised controlled clinical trial. Studies selected were either blinded, double-blinded, split-mouth clinical studies, comparative or controlled clinical studies, or randomised controlled trials in humans. There were no limitations on year of publication or language of studies. Most studies had a control of mechanical debridement (MD) with adjuvant antibiotics; 1 was surgical therapy. The test group was MD with adjuvant phototherapy. Exclusions were in vitro reports, animal studies, treatment with sole laser therapy, treatment with no additional antimicrobial therapy alongside MD. Pre-prints, reviews, abstracts, opinion articles, editorials, case reports and case series were also excluded. Data were extracted electronically by a single author and a senior librarian from the 3 databases. Titles and abstracts of articles were screened by the author if they contained Medical Subject Headings either in free terms or with Boolean operators. Full text studies that met the inclusion criteria were included. Data were also searched manually in 6 journals. For missing or conflicting information, the author of the article was contacted for clarification. Data extracted were country of origin of article, study design, sample size, research groups, diagnostic criteria, frequency of intervention, follow-up visits, and outcome of parameters which included clinically: plaque index (PI), probing depth (PD), bleeding on probing (BOP) and radiographically: crestal bone loss (CBL). Additional data on lasers were also collected, although not all studies had complete data on this. RevMan was used for statistical analysis. Inconsistencies were evaluated using I2 value > 50% and Cochrane's Q test, with a P value < 0.05 considered. Standard Mean Differences (SMD) were calculated and Confidence Interval was set at 95%. A random effects model was used for each meta-analysis. PI had no statistical difference, with high heterogeneity. PD had no statistical difference, with no heterogeneity. BOP had a statistically significant difference and a high level of heterogeneity, favouring adjunctive phototherapy. MBL had statistically non-significant differences between control and test groups, and no heterogeneity. The findings from the systematic review differed from the meta-analysis, suggesting that application of adjuvant phototherapy was equally as effective as adjunctive antibiotic therapy in outcomes such as PI, PD, BOP and MBL. The meta-analysis found that implants treated with adjuvant phototherapy had superior outcomes in relation to BOP only.

Influence of Application Timing and Cultivar on Soybean Tolerance and Weed Control from Diflufenican or a Diflufenican-Containing Premixture

Abstract Bayer CropScience anticipates launching several premixtures for use in soybean, targeted at control of Palmer amaranth. One of the premixtures will contain diflufenican (WSSA Group 12), metribuzin (Group 5), and flufenacet (Group 15) (DFF-containing premixture), offering an alternative site of action for soybean producers. Field experiments were conducted in Arkansas and Michigan to evaluate application timings of the DFF-containing premixture for soybean tolerance and weed control and possible cultivar tolerance differences to diflufenican and the DFF-containing premixture. Soybean injury from the 1X and 2X rates of the DFF-containing premixture ranged from 0% to 60% 14 d after planting (DAP), with injury increasing the closer the herbicide was applied to soybean emergence. Excluding the 2X rate applied 3 DAP in Arkansas in 2023, soybean injury was &lt;20% regardless of location, site year, application timing, and rate. For weed control experiments, only a 1X rate of the DFF-containing premixture was applied at the various application timings. Control of five weed species, encompassing broadleaves and grasses, ranged from 81% to 98%, regardless of application timing by 28 DAP. By 42 DAP, weed control ranged from 71% to 97%, with the 14-d preplant application timing typically being the least effective. The DFF-containing premixture and diflufenican alone were applied PRE at 1X and 2X rates for the soybean cultivar study. Soybean metribuzin sensitivity did not affect the degree of crop response, even on a high pH soil, and injury to soybean never exceeded 20%. Overall, the DFF-containing premixture will be a tool that soybean producers can integrate into a season-long herbicide program for use across the United States regardless of the soybean cultivar.

Assessment of a Hearing Aid Training Program for Health Care Workers.

The purpose of the present study was to develop and evaluate an in-person hearing aid training program designed for health care workers and personal care aides (PCAs) who care for older adults. Participants were 18 health care workers and PCAs whose clients were older adults. This was a randomized controlled study in which half of the participants were assigned to the experimental group (n = 9) and the other half to a control group (n = 9). The experimental group was administered a hearing aid training program that was developed in this study for health care workers and PCAs. Participants in the control group were trained on a task similar in complexity and administration time to the hearing aid training program. The Practical Hearing Aid Skills Test-Revised Version 2 (PHAST-Rv2) was administered before and immediately after training. A 2 × 2 mixed analysis of variance (ANOVA) was used to compare the pre- and post-training scores between and within the experimental and control groups. Descriptive statistics were used to examine the differences between pre- and post-training scores on each of the administered PHAST-Rv2 tasks. In addition, participants were asked about their experience helping clients with their hearing aids. Mean pre- and post-training PHAST-Rv2 scores for the experimental group were 59.50% and 95.84%, respectively, and 57.66% and 59.96%, respectively, for the control group. Results from a 2 × 2 mixed ANOVA with time point (pre- and post-training) as the within-subject variable and group (experimental and control) as the between-subject variable demonstrated that hearing aid training significantly improved PHAST-Rv2 scores for the experimental group. Post-training, the tasks that the experimental group improved on the most were brushing the microphone port, cleaning the dome, placing the hearing aids in the charger, and inserting the hearing aid into the model ear. No demographic variables were significantly correlated with the participants' improvement on the PHAST-Rv2 post-training score. A hearing aid training program designed specifically for health care workers was shown to be an efficient and effective way to improve how well health care workers can care for and operate a hearing aid.

Evaluation and prediction of relapse risk in stable systemic lupus erythematosus patients after glucocorticoid withdrawal (PRESS): an open-label, multicentre, non-inferiority, randomised controlled study in China

ObjectivesTo explore the relapse rate after glucocorticoid (GC) withdrawal with or without hydroxychloroquine (HCQ) maintenance in sustained clinically inactive systemic lupus erythematosus (SLE).MethodsThe PRESS trial is a multicentre, 33-week, open-label, three-arm, non-inferiority designed, randomised controlled trial. SLE patients with sustained clinically inactive disease who were maintained on low-dose GC plus HCQ therapy were screened and qualified patients were randomly assigned to three groups: drug-free group (both GC and HCQ withdrawal); HCQ group (discontinued GC but maintained HCQ); dual maintenance group (both GC and HCQ continued). The primary endpoint was to compare the proportion of patients experiencing a relapse as defined by the Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus Disease Activity Index flare index by 33 weeks. Two parallel non-inferiority analyses were performed (drug-free group vs dual maintenance group and HCQ group vs dual maintenance group).ResultsFrom 3 November 2016 to 13 August 2021, 333 participants complied with the protocol after randomisation were analysed. The relapse rates in the three groups were 26.1%, 11.2% and 4.7%, respectively. Compared with dual maintenance group, drug-free group failed to achieve non-inferiority significance (relapse rate difference 21.4%; 95% CI 12.3% to 30.5%; Pnon-inferiority=0.238), whereas HCQ group achieved non-inferiority (relapse rate difference 6.5%; 95% CI −0.5% to 13.5%; Pnon-inferiority=0.034). HCQ group also exhibited fewer relapses than drug-free group (p=0.006). Adverse events were similar among all three groups.ConclusionsGC withdrawal may be feasible in sustained clinically inactive SLE patients. HCQ maintenance can exert a protective role in preventing disease relapse after GC withdrawal.Trial registration numberNCT02842814.

Impact of integrating traditional care with the modern healthcare system in reducing tuberculosis diagnosis delays in Ethiopia: a clustered randomized controlled study.

Diagnosis and treatment initiation delays for tuberculosis (TB) are significant challenges in resource-limited settings. These delays can result in poor treatment outcomes, disease transmission, and increased costs. This study aimed to assess the effect of integrating traditional care with modern healthcare systems on reducing TB diagnosis delay. A cluster randomized controlled trial was conducted among TB patients, with 510 participants, 255 individuals were assigned to the intervention group and 255 to the control group. Training in the intervention group was provided for both traditional and modern healthcare providers in three rounds to enhance their knowledge, attitudes, and skills in TB screening and referral. A non-parametric independent sample test was used to compare the baseline and end-line data. The effect size was determined using Cohen's d. To account for individual and cluster-level variations, a mixed-effect parametric survival model was employed. Furthermore, conditional (fixed only) and marginal (random effects) graphs were used to compare between the intervention and control groups. A total of 510 participants were included in the baseline study, with a similar number of participants included in the endline study. In the intervention group, the delay in diagnosis was 4.185 per 1000 person-days post-intervention, compared to 4.608 per 1000 person-days pre-intervention. In the control group, the delay for diagnosis was 4.759 per 1000 person-days pre-intervention and 5.031 per 1000 person-days post-intervention. The median time to diagnosis was 135days. The non-parametric comparison showed that the intervention significantly reduced patient delays in the intervention group compared to the control group (p = 0.006), with a Cohen's d effect size of 0.246. The intervention also significantly reduced diagnosis delay in the intervention group compared to the control group (p = 0.036), with a Cohen's d effect size of 0.187. The diagnosis of TB was accelerated by 1.076 times due to the integration of traditional care with the modern healthcare system in the intervention group compared to the control group (δ: 1.076; 95% CI 1.021, 1.134). The involvement of traditional care providers in TB control programs significantly reduced diagnosis delays in Ethiopia. These findings suggest the need for integrating traditional care with modern healthcare systems for the effective prevention of TB in high-burden countries. Clinical trial registration ClinicalTrials.gov ID: NCT05236452.

Should we restrict food intake during labor? A randomized controlled trial.

To evaluate whether consuming food during labor influences its outcomes. This randomized controlled study included healthy, laboring patients at 37-41weeks of gestation. After epidural anesthesia, patients were randomized into groups of eating at will versus drinking clear fluids only. The primary composite outcome included unplanned cesarean delivery, the need for general anesthesia, asphyxia, postpartum fever, and prolonged postpartum admission (more than 5days). Secondary outcomes included the need for oxytocin, length of the second stage of labor, postpartum analgesia requirements, and early maternal and neonatal outcomes. Sample size analysis indicated that 126 patients needed to be randomized to detect a statistically significance difference between the groups. A total of 129 patients were randomized: 58 to the fluids-only group and 71 to the food group. The groups had similar basic characteristics. The composite outcome of complications attributed to eating during labor and delivery was comparable between groups. Labor progression and the need for oxytocin augmentation were similar in both groups. The groups had comparable fetal heart rate tracings, modes of delivery, maternal and neonatal outcomes, and complications. None of the patients in the study experienced aspiration or an indication for general anesthesia. While our data suggest that eating during labor does not adversely affect labor progression or outcomes, we recommend a cautious approach, allowing patients autonomy while considering individual risk factors. The study has been registered in the primary clinical trial registry on 02/12/2023. ISRCTN trial number ISRCTN11794106, registration number 44513. https://www.isrctn.com/ISRCTN11794106 .

BS SO16 - How to improved quality of life and prevented long term vomiting after laparoscopic sleeve gastrectomy(Vertical and Buttress technique)

Abstract Background The clinical nausea/vomiting and clinical GERD are most common symptom after laparoscopic sleeve gastrectomy for treatment the morbid obesity patients and impaired to quality of life. We observed the other technique, laparoscopic vertical sleeve gastrectomy, is less in clinical nausea/vomiting and quality of life is better tan classical laparoscopic sleeve gastrectomy. Method This retrospective cohort study includes patients morbid obesity who underwent laparoscopic vertical sleeve gastrectomy(50 patients) at King Taksin Memorial Hospital(between January 1st 2023- January 1st 2024, mean and average follow up 7 months). Results The morbid obesity patients who underwent laparoscopic vertical sleeve gastrectomy was female 76%, average age 38.60 +/-9.67 years old, body weight 119.35+/-24.65 kg and BMI 44.48+/-7.0 kg/m2. There was no clinical vomiting and only 13.33 % had clinical GERD symptom(GERDQ score). The average % total weight loss was 23.66+/-10.24 kg, total weight loss was 29.95+/-16.66 kg within 1 year(comparable to other standard technique). There were no perioperative complications, no reoperation and no readmission with improved comorbidity. The total score gastrointestinal quality of life was 81.94%. Conclusion The laparoscopic vertical sleeve gastrectomy had % total weight loss comparable to other standard technique. There was 0% of the patient had clinical vomiting and only 13.33% of the patient had clinical GERD symptom. There were no intraoperative or postoperative complication, reoperation, readmission and improved comorbidity. In this study, laparoscopic vertical sleeve gastrectomy is less in clinical vomiting and GERD symptom and improve the gastrointestinal quality of life. However, the data comparison between laparoscopic vertical sleeve gastrectomy with laparoscopic classical sleeve gastrectomy in nausea/vomiting, gastrointestinal quality of life with long term outcomes and randomized controlled studies are still needed.

Abstract 4125157: Efficacy of Adding Sodium-Glucose Co-Transporter 2 Inhibitor versus Standard Therapy Alone in Post-Percutaneous Coronary Intervention Patients: A Systematic Review and Meta-Analysis

Background: Recent evidence suggests that sodium-glucose cotransporter-2 inhibitors (SGLT2-i) may improve outcomes in patients with coronary artery disease (CAD) through various physiological pathways. However, their impact on patients who have undergone percutaneous coronary intervention (PCI) is not well established. This meta-analysis aims to evaluate the effectiveness of additive SGLT2 inhibitors versus standard therapy alone in patients with CAD after PCI. Methods: A systematic search was conducted across the Medline, Embase, and Cochrane Library databases for randomized controlled trials (RCTs) and observational studies that compared the addition of SGLT2 inhibitors to standard therapy versus standard therapy alone in patients post-PCI. The outcomes analyzed were Major Adverse Cardiovascular Events (MACE), all-cause death, cardiovascular death, recurrent acute myocardial infarction (AMI), nonfatal stroke, revascularization, and hospitalization for heart failure (HF). Results: A total of 7 studies met the inclusion criteria, encompassing a total of 11,800 individuals (5,004 on SGLT2-i and 6,796 non-SGLT2-i; mean age of 62.7 years; 28% women; 95% diabetic patients). SGLT2 inhibitors significantly reduced the risk of all-cause mortality (RR 0.6, 95% CI: 0.5-0.72, p&lt;0.01), cardiovascular death (RR 0.39, 95% CI: 0.16-0.94, p=0.03) and hospitalization for HF (RR 0.55, 95% CI: 0.4-0.76, p&lt;0.01) compared to standard therapy alone. The occurrence of the composite endpoint (MACE) (RR 0.67, 95% CI: 0.44-1.01, p=0.056), any revascularization (RR 0.93, 95% CI: 0.57-1.53, p=0.784), recurrent AMI (RR 0.70, 95% CI: 0.41-1.18, p=0.176) and stroke (RR 0.94, 95% CI: 0.68-1.30, p=0.717) did not differ significantly between groups. Conclusions: Adding SGLT2 inhibitors to standard therapy significantly improved cardiovascular outcomes in patients with CAD who have undergone PCI, including reduced mortality and hospitalization for HF rates, with similar rates of recurrent AMI, coronary revascularization and stroke. These findings support the consideration of adding SGLT2 inhibitors as part of the therapeutic regimen for post-angioplasty patients, especially those with diabetes.

Abstract 4136355: Investigating Changes in Hazardous and Harmful Drinking Among Young Adults Through Zoom Intervention

Introduction/Background: Hazardous drinking is a major adverse factor for young adults’ health. This study investigates the efficacy of an integrated contingency management and problem-solving Zoom intervention in addressing hazardous and harmful drinking among young adults. Research Questions/Hypothesis: Participants who receive the 8-session integrated Zoom CM-PST intervention will demonstrate a significant reduction in hazardous and harmful drinking behaviors compared to baseline measurements. Goals/Aims: The aims of this study were to evaluate the effectiveness of 8-session integrated Zoom contingency management and problem-solving Zoom intervention in reducing hazardous and harmful drinking reduction and abstinence. Methods/Approach: This pilot randomized controlled trial study employed a single-arm design with post-intervention and follow-up assessments at 12 weeks. The study targeted young adults aged 18-24 in Chicagoland who regularly consume alcohol at least once a week and have alcohol use disorder. Participants completed the Alcohol Use Disorders Identification Test (AUDIT), Drinking Motives Questionnaire-Revised (DMQ-R), and the 90-day Timeline Follow-back (TLFB) at baseline and 12 weeks after the intervention. The Zoom CM-PST intervention was administered to the participants, and a self-reported questionnaire was utilized to evaluate participants’ drinking use, severity, motivation, and hazardous drinking behavior at baseline and at the 12-week follow-up. A paired t-test, correlation, and multiple regressions were performed to investigate changes in hazardous and harmful drinking among 20 young adults aged 18-24. Results: A paired t-test showed that the participant’s level of alcohol use problem and social, coping, and enhancement motivation for alcohol use decreased from pre- to post-intervention. High drinking behaviors accounted for 40% at baseline, while 35% at post-intervention assessment. Over 12 weeks, 45% of participants demonstrated an improvement in hazardous drinking behaviors. Motivation at baseline was a significant factor affecting post-intervention alcohol use problems at 12 weeks. Conclusions: The results showed notable enhancements in alcohol use problem reduction and motivation for alcohol use at 12 weeks. The study provides useful insights into the effectiveness of web-based integrated contingency management and problem-solving Zoom interventions in mitigating hazardous and harmful drinking among young adults.

Synthesis of cefixime loaded PCL/HPMC blend nanoparticles: a controlled release study and in vitro anti-bacterial evaluation

Aim To enhance cefixime’s effectiveness and address drug delivery challenges like concentration at the site, dose, and time, present study investigated the impact of polymer blends on cefixime’s in vitro release profile. Methods Cefixime-loaded nanoparticles were prepared via a modified solvent evaporation method, forming a W/O/W double emulsion. Characterisation included FT-IR, zeta potential, TGA, TEM, and XRD, with in vitro studies and kinetic models used to analyse the release mechanism. Results The PH-4 nanoparticle formulation (80:20 PCL/HPMC, 0.5% PVA) achieved an 81% loading rate, no adverse effects, and a controlled release of 84.66%±2.53 over 30 days. It showed stable physicochemical properties, with in vitro antibacterial tests revealing inhibition zones of 27.4 ± 2.12 mm for E. coli and 17.2 ± 2.23 mm for S. aureus at 12 hours. Conclusion Based on the findings, developed nanoparticulate system containing PCL/HPMC demonstrates its efficacy and safety as a controlled drug delivery method for antibiotics like cefixime.

Abstract 4120716: Aspirin plus clopidogrel versus aspirin alone in patients with mild-to-moderate stroke: A systematic review and meta-analysis

Background: Studies have shown that dual antiplatelet therapy (DAPT) is superior to aspirin monotherapy in patients with minor stroke or transient ischemic attacks. However, there is limited evidence regarding the efficacy and safety of DAPT in mild-to-moderate stroke. Aims: We conducted a systematic review and meta-analysis to evaluate whether DAPT is superior to single antiplatelet among patients with mild to moderate ischemic stroke. Methods: PubMed/MEDLINE, Embase, the Cochrane Library, and ClinicalTrials.gov were searched from inception till March 2024 for published randomized controlled trials (RCTs) and observational studies that compared aspirin plus clopidogrel versus aspirin monotherapy in patients with mild-to-moderate stroke. R version 4.3.2 was used to calculate risk ratios (RRs) with 95% confidence intervals (95% CIs). Results: A total of 4 studies reporting data for 15,173 patients were included. DAPT was associated with a reduced risk of early neurological deterioration (END) (RR: 0.55, 95% CI: 0.28 to 1.05, p = 0.07 Figure 1A) and recurrent ischemic stroke (RR: 0.65, 95% CI: 0.41 to 1.04, p = 0.07 Figure 1B) without reaching statistical significance. The risk of recurrent hemorrhagic stroke (RR: 0.94, 95% CI: 0.47 to 1.86, p = 0.86 Figure 2A), all-cause death (RR: 0.75, 95% CI: 0.52 to 1.08 Figure 2B), or myocardial infarction (RR: 0.83, 95% CI: 0.45 to 1.54 Figure 2C) was comparable across the two groups. DAPT was not associated with an increased risk of any bleeding event (RR: 0.70, 95% CI: 0.36 to 1.36 Figure 2D). Conclusion: DAPT possibly reduces the risk of END and recurrent ischemic stroke as compared to aspirin monotherapy in mild or moderate stroke without increasing the risk of bleeding events.

Vancomycin-induced acute kidney injury in rats: beneficial effects deriving from the co-administration of tadalafil or vitamin C

Background: Vancomycin (VAN) is widely employed in clinical settings for the treatment of severe infections attributable to multi-resistant bacteria, with a notable emphasis on Gram-positive strains. However, its therapeutic usage is significantly hampered by the potential for acute kidney injury (AKI); specifically, the nephrotoxic effects it can exert. In controlled experimental studies, the intraperitoneal (i.p.) administration of VAN at a dose of 400 mg/kg/day over a consecutive seven-day period has been shown to induce considerable AKI in rats. In addressing this concern, vitamin C (VC), recognized traditionally for its antioxidant properties, has been utilized to mitigate various forms of organ damage and inflammatory responses, primarily by diminishing oxidative stress and attenuating inflammation. Concurrently, tadalafil (TAD), a phosphodiesterase type-5 inhibitor commonly associated with the treatment of erectile dysfunction, is also noted for its beneficial anti-inflammatory and antioxidant effects, alongside vasodilatory properties. Aim: This study was designed in order to investigate the protective capabilities of TAD or VC against the VAN-induced nephrotoxic effects in a rat model of AKI. Methodology: A total of 24 male albino Wistar rats were allocated into four distinct groups for the purpose of comparative analysis. Following treatment, both kidney and blood samples were obtained for further evaluation. The study randomized the rats into four categories: group 1 served as the control group, group 2 received VAN at a dosage of 400 mg/kg (via an i.p. injection on a daily basis), group 3 was administered VAN (400 mg/kg; i.p., daily) in conjunction with TAD at a dose of 5 mg/kg daily, and group 4 was given VAN (400 mg/kg; i.p., daily) alongside VC at a dosage of 200 mg/kg daily. Results: Evaluations included the measurement of renal function indicators such as the serum levels of urea, of creatinine, and the creatinine clearance. Additionally, the analysis involved the assessment of antioxidant markers in renal tissue homogenates, including malondialdehyde (MDA), glutathione, and superoxide dismutase. To further elucidate the inflammatory response, indices such as the levels of the tumor necrosis factor-alpha, the interleukins (IL)-1β and IL-6, and the nuclear factor-κB were evaluated within the renal tissue homogenate samples of the studied rats. The administration of VAN resulted in a marked elevation of renal biomarkers and inflammatory indices, alongside a significant reduction in antioxidant levels, with an exception for MDA (which exhibited increased levels); these changes reached statistical significance (p&lt;0.05) when measured against the control group. In contrast, the supplementation with TAD or VC was effective in significantly lowering the serum levels of both renal and inflammatory indicators when compared to the group treated solely with VAN. Furthermore, antioxidant measurements improved, alongside a reduction in MDA levels, thereby demonstrating significant differences (p&lt;0.05). Conclusion: The findings of this study reveal that both TAD and VC provide a degree of renal protection against the VAN-induced damage by enhancing kidney function markers and, concurrently, lessening oxidative stress and inflammatory responses associated with nephrotoxicity.

Abstract 4136346: A Comparative Analysis of Esophageal Cooling for Preventing Esophageal Injury Post Atrial Fibrillation Catheter Ablation: A Systematic Review and Meta-analysis

Introduction: Thermal injury following atrial fibrillation catheter ablation is a rare but fatal complication. We aim to assess the safety profile of different forms of esophageal cooling methods versus standards of care. Methods: We searched PubMed, Cochrane Library, Scopus, and Web of Science databases for randomized controlled trials and cohort studies comparing esophageal cooling to Luminal esophageal temperature (LET) monitoring regarding esophageal thermal lesions (ETL) post atrial fibrillation ablation. Case reports, case series, reviews, conference abstracts and animal studies were excluded. Review manager software (version 5.4) was used to perform the meta-analysis. Results: We included 10 studies with 25662 patients in total: 14515 patients in the esophageal cooling group and 11147 patients in the LET group. Overall esophageal lesion analysis demonstrated no statistically significant difference between the esophageal cooling group and LET (RR = 0.72, 95% CI = 0.35 to 1.49, p-value = 0.38). Subgroup analysis showed no statistically significant difference for mild/moderate lesions (RR = 1.52, 95% CI = 0.80 to 2.90, p-value = 0.20). However, the subgroup analysis showed a statistically significant association between esophageal cooling and decreased severity of esophageal lesions compared with LET (RR = 0.29, 95% CI = 0.12 to 0.71, p-value = 0.007). Regarding AF recurrence, the pooled analysis showed no statistically significant difference between esophageal cooling group and LET (RR = 1.24, 95% CI = 0.95 to 1.61, p-value = 0.11). Conclusion: In patients undergoing AF catheter ablation, the implementation of esophageal cooling showed statistical significance in decreasing the severity of esophageal lesions compared to the LET group. Also, esophageal cooling demonstrated non-inferiority in AF recurrence compared to LET. Future research should focus on assessing the long-term effects of esophageal cooling during AF catheter ablation.

Abstract 4136403: Impact of Coronary Artery Calcium Scores on Cardiovascular Risk and Preventive Therapies: A Systematic Review and Meta-Analysis

Introduction: Coronary artery calcium (CAC) serves as a key marker of atherosclerosis and is widely utilized in the noninvasive evaluation of coronary artery disease. We aim to compare cardiovascular risk outcomes and the likelihood of initiating or continuing pharmacological and lifestyle preventive therapies in asymptomatic and symptomatic patients with a CAC score greater than zero and those with a CAC score of zero with no established diagnosis of coronary artery disease. Methods: We performed systematic searches of PubMed, Scopus, Google Scholar, Cochrane Central, and ClinicalTrials.gov from inception to May 2024. Our search focused on randomized controlled trials and observational studies comparing outcomes between patients with a CAC score greater than zero and those with a CAC score of zero. Results: We included 53 observational studies, incorporating data from 210,672 asymptomatic and 32,477 symptomatic patients. Over a mean follow-up duration of 8.6 years, we observed that a CAC score greater than zero significantly correlated with an elevated risk of major adverse cardiovascular events (MACE) (OR: 5.58; 95% CI: 4.05–7.69; P &lt; 0.00001). This association extended to all-cause mortality (OR: 3.90; 95% CI: 2.78–5.48; P &lt; 0.00001), myocardial infarction (OR: 4.01; 95% CI: 3.45–4.65; P &lt; 0.00001), and the need for revascularization (OR: 11.90; 95% CI: 6.82–20.78; P &lt; 0.00001). Patients with a CAC score greater than zero were more likely to commence and continue aspirin therapy (OR: 2.45; 95% CI: 1.56–3.83; P &lt; 0.0001 for initiation and OR: 1.71; 95% CI: 1.31–2.23; P &lt; 0.0001 for continuation). Similar trends were noted for lipid-lowering medications (OR: 2.44; 95% CI: 1.57–3.79; P &lt; 0.0001 for initiation and OR: 2.48; 95% CI: 1.53–4.01; P = 0.0002 for continuation), as well as the initiation of blood pressure medications (OR: 1.94; 95% CI: 1.61–2.33; P &lt; 0.00001). Furthermore, a CAC score greater than zero was linked to increased adoption of lifestyle modifications, including enhanced physical activity (OR: 1.84; 95% CI: 1.41–2.41; P &lt; 0.00001) and dietary changes (OR: 1.94; 95% CI: 1.52–2.49; P &lt; 0.00001). Conclusion: Patients with elevated CAC scores are more likely to initiate and continue preventive pharmacological therapies and adopt beneficial lifestyle modifications. These findings underscore the importance of CAC scoring in guiding the management and prevention of cardiovascular disease in both asymptomatic and symptomatic populations.

Abstract 4137687: Rotational atherectomy combined with cutting balloon before stent implantation for patients with severely calcified coronary lesions: A meta analysis

Background: Rotational atherectomy (RA) has been proven to treat coronary artery calcification (CAC) during percutaneous coronary intervention (PCI). Cutting balloons (CBs) are modified balloons (MB). Purpose: We aim to assess the safety and efficacy of RA followed by CB angioplasty (ROTACUT) before stent placement in CAC. Methods: We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) and observational studies, which were retrieved by systematically searching PubMed, Web of Science, Scopus, and Cochrane through January 2024. We used Stata version 17 to pool dichotomous data using risk ratio (RR) and continuous data using mean difference (MD), with a 95% confidence interval (CI). Results: We included eight studies with a total of 846 patients. There was no significant difference between ROTACUT and RA + bare balloons in major adverse cardiovascular events (MACE) (RR: 0.60 with 95% CI [0.31, 1.16], P= 0.13), the incidence of cardiac death (RR: 1.32 with 95% CI [0.42, 4.14], P= 0.64), the incidence of target vessel revascularization (TVR) (RR: 1.89 with 95% CI [0.40, 8.84], P= 0.42), the incidence of target lesion revascularization (TLR) (RR: 0.83 with 95% CI [0.39, 1.79], P= 0.64), procedural duration (MD: 0.78 with 95% CI [-4.68, 6.24], P = 0.78), incidence of stent thrombosis (RR: 0.81 with 95% CI [0.22, 2.95], P= 0.75), and the incidence of any procedure-related complications (RR: 0.86 with 95% CI [0.42, 1.75], P= 0.68). Conclusion: ROTACUT and RA + bare balloons demonstrated similar efficacy and safety profiles in terms of MACE, cardiac death, TVR, TLR, procedural duration, stent thrombosis, and all safety outcomes.

Impact of remote social interaction during the COVID-19 pandemic on the cognitive and psychological status of older adults with and without cognitive impairment: A randomized controlled study.

Social isolation and loneliness have both been associated with psychological health and cognitive decline in older adults. This study investigated the impact of social interaction through remote communication technologies during the COVID-19 pandemic on the cognitive and psychological status of older adults with and without cognitive impairment. Participants were recruited from Boston (USA) and Chieti (Italy). The study used a randomized single-blinded controlled crossover design with an intervention (remote social conversations with research staff over 20-minute video or telephone calls three times per week) and a passive control condition, each one of 4-weeks duration. The primary outcome was a composite cognitive score change from baseline to week 4. Secondary outcomes included scales for mood, anxiety, and loneliness. Out of 196 participants recruited from April 2020 to April 2021, 17% dropped out. Based on the blind MoCA, 52% had cognitive impairment, and 25% were at risk of social isolation according to the Lubben social network scale. We observed that larger social networks were linked to better cognitive status and lower depression and anxiety levels, while loneliness was directly associated to depression severity. Older adults with cognitive impairment exhibited higher levels of depression and anxiety and were at greater risk for social isolation. In terms of the intervention, 91% preferred telephone over video calls. The intervention did not lead to improvements in cognitive or psychological scores. More work is needed to assess the utility of this intervention for the support of a heterogenous cross-cultural sample of older adults at-risk for social isolation, including individuals with cognitive impairment. Future research should explore longer intervention periods, categorize participants by call type, and target those meeting social isolation criteria. ClinicalTrials.gov NCT04480112.

How do patients and healthcare professionals experience foot examinations in diabetes care? - A randomised controlled study of digital foot examinations versus traditional foot examinations.

Digital solutions in healthcare can facilitate and improve care. However, the experiences and the usefulness of using either digital foot examinations or traditional foot examinations need to be evaluated. The aims of the study were to evaluate: 1) The differences in patient experiences, having their foot examined supported by the Clinical Decision Support System as compared with having their foot examined in traditional practice, 2) How healthcare professionals, by using the digital tool, experienced the routine compared with performing the foot examination as in traditional practice. Of a total of 141 patients, 100 patients with diabetes were single-blind digitally randomised to one of two parallel arms: having their foot examined by a healthcare professional using a digital tool (n = 47) or having their foot examined as in traditional practice (n = 53) at the Department of Prosthetics and Orthotics at Sahlgrenska University Hospital, Gothenburg, Sweden. Patients filled in a modified version of the National Patient Survey and the Orthotics and Prosthetics Users' Survey at study end. Two healthcare professionals, working at a Department of Prosthetics and Orthotics, answered surveys regarding the interaction between the patient and the certified prosthetist and orthotist. Patients, aged 66 ± 13 years, perceived a high level of satisfaction with the service at the department, regardless of the method used. No significant differences between groups were found when evaluated by 27 questions in the National Patient Survey or by the Orthotics and Prosthetics Users' Survey, with scores of 67.17 ± 12.18 vs. 66.35 ± 16.52 (p = 0.78) for the intervention and control group respectively. For the same patient that healthcare professionals foot examined, the risk class was fully obtained when the risk to develop foot ulcers was assessed by using the digital tool, whereas only 2% of the patients were classified when foot assessed in traditional practice. Regardless of the method used for the foot examination, patients perceived a high level of satisfaction with the services at the Department of Prosthetics and Orthotics. All the patients were risk classified in the intervention group. The healthcare professionals found that, by using the Clinical Decision Support System, the foot examination was structured and followed clinical guidelines. Furthermore, the documentation in the electronic health record was thorough, even though further improvements, such as integration with co-existing health record systems, were requested. Clinical Trials NCT03088566 , Registered 23 March 2017.

Depression, anxiety and insomnia among isolated covid-19 patients: tele occupational therapy intervention vs. conventional one: a comparative study.

COVID-19 is known to cause psychological problems. Psychological rehabilitation can be performed to reduce anxiety, depression, and insomnia. Facing patients with infectious diseases can be difficult for medical staff. Therefore, this study compared the effects of psychiatric tele-rehabilitation (TR) and conventional psychiatric rehabilitation (CR) in isolated patients with COVID-19. This randomized controlled study, conducted at a single community-based hospital, included 40 patients (24 in the psychiatric tele-rehabilitation group [TRG] and 16 in the conventional psychiatric rehabilitation group [CRG]) with COVID-19 were recruited from November 18, 2021, to April 7, 2022. Psychiatric rehabilitation is an occupation-based intervention in which patients perform meaningful activities and tasks. Patients in the TRG selected activities, received counseling, and underwent monitoring over the phone, while those in the CRG participated in face-to-face sessions. The interventions were conducted for 50min each day during an isolation period of 7 days in both groups, and all participants received the interventions individually. The primary outcome was anxiety assessed using the Visual Analog Scale (VAS) and the Zung Self-Rating Anxiety Scale (SAS). Secondary outcomes include the Visual Analog Scale (VAS) and the Patient Health Questionnaire-9 (PHQ-9) to evaluate depression, the Multidimensional State Boredom Scale-8 (MSBS-8) to assess boredom. The Korean version of the Insomnia Severity Index (ISI-K) was used to assess the quality of sleep, and the World Health Organization Quality of Life Assessment Instrument-BRIEF (WHOQOL-BREF) was used to evaluate quality of life. Questionnaires were administered at admission, discharge, and at the 6-month follow-up. In the time × group analysis, the SAS total score (p = .033) and the VAS score for depression (p = .012) in the CRG were significantly lower than those in the TRG at the time of discharge. The VAS score for anxiety (p = .007), total SAS score (p = .050), and VAS score for depression (p = .003) in the CRG were also significantly lower than those in the TRG at the 6-month follow-up. The PHQ-9, MSBS-8, ISI-K, and WHOQOL-BREF scores showed no significant interactions in the time × group analysis. TR was effective in reducing anxiety and improving quality of life during hospitalization, but had no remained effects after discharge. Otherwise, CR was more effective than TR for anxiety and depression during hospitalization and had remained effects at 6-month follow-up. However, considering the characteristics of infectious conditions that involve risk in contact, TR will still play an important role, and efforts will be needed to improve the effect that remained. The trial was registered with the Korea Clinical Trials Registry (KCT0006714, Date of registration 08/11/2021).

Abstract 4127513: Cardiopulmonary long-term effects 6, 18 and 30 months after severe covid-19 infection

Background: SARS-CoV-2 infection affects the cardiopulmonary system in both the acute and long-term phase. This study aimed to comprehensively assess symptoms and potential long-term impairments 6, 18 and 30 months in patients previously hospitalized for severe Covid-19 infection. Methods: This prospective registry included patients hospitalized for PCR-confirmed Covid-19 infection. Approximately 6 months post-discharge, follow-up examination included patient history, clinical examination, echocardiography, electrocardiogram, cardiac magnetic resonance imaging (cMRI), chest computed tomography (CT) scan, pulmonary function test (PFT), six-minute walk test (6MWT) and a comprehensive laboratory panel. Patients with pathologic findings during the first visit underwent a second (at 18 months) and third (at 30 months) follow-up examination. Those without pathologic findings or who refused further medical examinations were contacted via phone to inquire about symptoms. Results: Between July 2020 and April 2022, 200 patients (91% general ward, 9% intensive care unit) were recruited. Due to dropouts, the second visit was conducted in 170 patients, and the third visit in 139 (74 in person, 65 via telephone). Long Covid criteria were fulfilled by 73% at 6 months, 52% at 18 months and 49% at 30 months post-discharge, with fatigue being the most common symptom (Figure 1). Echocardiography at 6 months showed impaired left ventricular function in 15 patients, with normalization in 80% at 18 months and further 66% at 30 months (Figure 2). cMRI revealed pericardial effusions in 28 patients at 6 months, which resolved in 47% at 18 months and in further 60% at 30 months. Signs of peri- or myocarditis were present in 7 patients at 6 months and were resolved in all 4 patients who attended control studies at 18 months. Chest CT scans at 6 months identified post-infectious residues in 41 patients, with full recovery in 20% at 18 months without further normalization after 30 months. The length of in-hospital stay was identified as a significant predictor for persisting Long Covid 6 months after discharge (95% CI: 1.005 - 1.12, p=0.03). Conclusion: While the prevalence of Long Covid decreased over time, a significant symptom burden persisted at 6, 18 and even 30 months after severe Covid-19 infection. Structural and functional abnormalities were less frequent compared to reported symptoms, posing a challenge in substantiating the causes of these symptoms.