Mean Difference Research Articles

Unveiling Resmetirom: A systematic review and meta-analysis on its impact on liver function and safety in non-alcoholic steatohepatitis treatment.

The role of Resmetirom in non-alcoholic steatohepatitis (NASH) represents a promising therapeutic approach in addressing the growing global burden of liver disease. With NASH emerging as a leading cause of liver-related morbidity and mortality worldwide, there is an urgent need for effective treatments. Resmetirom, a selective thyroid hormone receptor-β agonist, offers potential benefits in improving liver histology and metabolic parameters in patients with NASH. This review examines the current evidence surrounding Resmetirom's role in NASH management. A systematic review and meta-analysis was done by searching in Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, MEDLINE (including MEDLINE InProcess) (OvidSP), Web of Science, Embase (OvidSP), and Scopus databases. ROB2 Cochrane tool was used for assessing risk of bias in randomized controlled trials (RCTs). In the analysis, we used RevMan Cochrane software. The study showed that patients who were treated with Resmetirom had significantly lower low-density lipoprotein-cholesterol (LDL-C) levels (mean difference [MD] -10.45; 95% confidence interval [CI] -15.86 to -5.83; P < 0.001) and alanine aminotransferase (ALT) levels (MD -7.18; 95% CI -12.67 to -1.68; P = 0.01) as compared with those in the placebo group. The risk of adverse events including diarrhea [risk ratio (RR)1.81; 95% CI 1.40 to 2.35; P < 0.001] and nausea (RR 1.72; 95% CI 1.31 to 2.27; P < 0.001) was significantly increased for the Resmetirom group as compared with the placebo group. Resmetirom presents a promising therapeutic option for NASH, offering potential benefits in reducing liver fat content and improving histological outcomes. The encouraging results from clinical trials suggest that Resmetirom may address an unmet need in NASH management, providing hope for patients with this progressive liver disease. Further research and long-term studies are warranted to validate its efficacy and safety profile in larger patient populations.

Longitudinal outcomes after financial toxicity and health-related social risks screening and referral.

17 Background: Financial toxicity (FT) is associated with delayed/omitted care, reduced quality of life, and worse mortality. Routine screening for FT and health-related social risks (HRSR) is recommended during clinical care, but there is limited longitudinal evidence on outcomes after patients screen positive and are referred for assistance. Methods: FT and HRSR screening for patients with breast, gynecologic, gastrointestinal, or thoracic cancers was implemented at an urban comprehensive cancer center. Screening included the Comprehensive Score for Financial Toxicity (COST) tool (0-44, lower scores=worse FT) and a HRSR checklist to identify food, housing, and transportation insecurity. COST score ≤16-20 or reported HRSR was a “positive” screen and counseling referral was offered: patients could accept the referral by identifying their current concerns. Analysis sample was limited to receiving chemotherapy, radiotherapy, or surgery 120 days prior to baseline survey and had a follow-up survey 4-12 months later. Data were collected 10/2022-12/2023. Results: 2196 patients met inclusion criteria, median time between surveys was 5.5 months (IQR 4.4, 6.9). 20% (n=438) screened positive and accepted referral; 11% (n=246) screened positive and declined referral; the remaining 69% (n=1512) screened negative. Sociodemographic factors of age (median 58 vs 62, p&lt;.001), sex (82% vs 74% female, p =.015), and race (31% vs 17% racial/ethnic minority, p&lt;.001) were associated with accepting vs declining referral. Those who accepted referral had lower COST scores (median 10 vs 19) and more HRSR (39% vs 20% housing; 32% vs 18% food; 37% vs 17% transportation) at baseline (all p≤.001). At follow-up, both cohorts had COST decrease, indicating worsened FT [mean difference (95% CI): accepted referral -2.0 (-2.8, -1.2) vs declined referral -2.8 (-4.0, 1.5)]. Across all collected HRSR, those who accepted referral had small benefits in previously reported HRSR, however were more likely to have newly designated HRSR (Table shows changes). Conclusions: Screening for FT and HRSR identified one-third of patients on recent cancer treatment with financial or social needs. Those who accepted financial assistance referral had significantly higher FT and more reported HRSR. Although referral did appear to have some benefit on initial needs, new HRSR were identified at follow-up. Future work will focus on optimizing available assistance to meet ongoing patient needs during and after cancer treatment. Accepted Referraln = 438 (%) Declined Referraln = 246 (%) Housing Resolved need 67 (15) 31 (13) New need 54 (12) 15 (6.1) Stable unmet need 102 (23) 18 (7.3) Stable no need 215 (49) 182 (74) Food Resolved need 64 (15) 31 (13) New need 69 (16) 16 (6.5) Stable unmet need 77 (18) 14 (5.7) Stable no need 228 (52) 185 (75) Transportation Resolved need 73 (17) 34 (14) New need 56 (13) 20 (8.1) Stable unmet need 87 (20) 8 (3.3) Stable no need 222 (51) 184 (75)

Neonatal outcomes after in utero exposure to antipsychotics: a systematic review and meta-analysis.

Adverse neonatal outcomes following in utero antipsychotic exposure remain unclear. This systematic review and meta-analysis aimed to investigate associations between in utero first- and second-generation antipsychotic exposure and various neonatal outcomes. The primary outcome was small for gestational age. Secondary outcomes included other birth weight-related measures, prematurity and neonatal outcomes. MEDLINE, EMBASE, CENTRAL, ICTRP, and ClinicalTrials.gov were searched for on 8th July 2023. Two reviewers independently selected studies reporting associations between exposure and neonatal outcomes (all designs were eligible, no language or time restriction) and extracted data. ROBINS-I was used for risk of bias assessment. Meta-analyses were performed. Measures of association were odds ratios and mean differences. Thirty-one observational studies were included. Regarding small for gestational age < 10th percentile, meta-analysis was only performed for second-generation antipsychotics and showed no evidence for an association (OR 1.31 [95%CI 0.83; 2.07]; I²=46%; phet=0.13, n = 4 studies). First-generation antipsychotics were associated with an increased risk of small for gestational age < 3rd percentile (OR 1.37 [95%CI 1.02; 1.83]; I²=60%; phet=0.04, n = 5) and a lower mean birthweight (MD -135g [95%CI -203; -66]; I²=53%; phet=0.07, n = 5). Second-generation antipsychotics were associated with large for gestational age > 97th percentile (OR 1.56 [95%CI 1.31; 1.87]; I²=4%; phet=0.37, n = 4) and Apgar score < 7 (OR 1.64 [95%CI 1.09; 2.47]; I²=47%; phet=0.13, n = 4). Both types of antipsychotics were associated with increased risks of preterm birth and neonatal hospitalization. Despite potential confounding in the studies, this systematic review and meta-analysis showed that newborns of mothers using antipsychotics during pregnancy are potentially at risk of adverse neonatal outcomes. Data sources: MEDLINE, EMBASE, CENTRAL, ICTRP, ClinicalTrials.gov. Prospero Registration Number CRD42023401805.

Leveraging non-coding regions to guarantee the accuracy of small-sized panel-based tumor mutational burden estimates.

Accurate estimation of tumor mutational burden (TMB) as a predictor of responsiveness to immune checkpoint inhibitors in gene panel assays requires an adequate panel size. The current calculations of TMB only consider coding regions, while most of gene panel assays interrogate non-coding regions. Leveraging the non-coding regions is a potential solution to address this panel size limitation. However, the impact of including non-coding regions on the accuracy of TMB estimates remains unclear. This study investigated the validity of leveraging non-coding regions to supplement panel size using the OncoGuide NCC Oncopanel System (NOP). The aim of this study was to evaluate test performance against orthogonal assays and the association with responsiveness to immune checkpoint inhibitors was not included in the evaluation. We compared TMB status and values between TMB calculated only from coding regions (NOP-coding) and from both coding and non-coding regions (NOP-overall) using whole exome sequencing (WES) and FoundationOne®CDx (F1CDx) assay. Our findings revealed that NOP-overall significantly improved the overall percent agreement (OPA) with TMB status compared with NOP-coding for both WES (OPA: 96.7% vs. 73.3%, n = 30) and F1CDx (OPA: 90.0% vs. 73.3%). Additionally, the mean difference in TMB values compared with WES was lower for NOP-overall (3.55 [95% CI: 0.98-6.13]) than for NOP-coding (6.22 [95% CI: 3.73-8.70]). These results exemplify the utility of incorporating non-coding regions to maintain accurate TMB estimates in small-sized panels.

Effects of wearable device training on upper limb motor function in patients with stroke: a systematic review and meta-analysis.

To evaluate the effect of wearable device training on improving upper limb motor function in patients who experienced strokes. The PubMed, Embase, Cochrane Library, Web of Science, MEDLINE, SCOPUS, China National Knowledge Infrastructure, WanFang, and VIP databases were searched for randomized controlled trials (RCTs) that assessed the effectiveness of wearable device training in improving upper limb motor function in patients with stroke. Two investigators independently screened studies by their titles and abstracts and cross-checked, downloaded, and evaluated the results. Disagreements were resolved by a third highly experienced researcher. Risk of bias was evaluated using the Cochrane risk-of-bias tool. This meta-analysis was registered in PROSPERO (registration No. CRD42023421633). This study comprised 508 patients from 14 RCTs. The experimental group assessed various wearable devices, including 3D-printed dynamic orthoses, inertial measurement unit (IMU) sensors, electrical stimulation devices, and virtual reality (VR) devices for virtual interactive training. The control group received traditional rehabilitation therapies, including physical and conventional rehabilitation. The experimental group scored better on the Fugl-Meyer Assessment (FMA-UE) scale (standardized mean difference [SMD] 0.26, 95% confidence interval [CI] 0.07, 0.45) and Box and Block Test (BBT) (SMD 0.43, 95% CI 0.17, 0.69) versus controls. No significant intergroup differences were observed in the Action Research Arm Test (SMD 0.20, 95% CI -0.15, 0.55), motor activity log (mean difference [MD] 0.32, 95% CI -0.54, 0.33), and modified Ashworth scale (MD -0.08, 95% CI -0.81, 0.64). The probability rankings of wearable devices that improved FMA-UE scores in patients with stroke were: orthotic devices, with the highest probability ranking of 0.45, followed by sensor devices at 0.23, electrical stimulation devices at 0.21, and VR devices at 0.11. Wearable device training was found to significantly improve upper limb motor function in patients with stroke, particularly for large-range movements. Improvements in FMA-UE and BBT scores reflected reduced impairment and enhanced manual dexterity, respectively. However, the training had no significant effect on hand movement frequency, fine motor skills, or spasticity. Among the different wearable devices tested, orthoses produced the most effective results.

Efficacy and Safety of Roxadustat for Anemia in Patients Receiving Chemotherapy for Nonmyeloid Malignancies: A Randomized, Open-Label, Active-Controlled Phase III Study.

We evaluated the efficacy and safety of roxadustat, a first-in-class hypoxia-inducible factor prolyl hydroxylase inhibitor, for chemotherapy-induced anemia (CIA) in patients with nonmyeloid malignancies receiving multicycle treatments of chemotherapy. In this open-label, noninferiority phase III study conducted at 44 sites in China, 159 participants age ≥18 years with CIA nonmyeloid malignancy and CIA were randomly assigned (1:1) to oral roxadustat or subcutaneous recombinant human erythropoietin-α (rHuEPO-α) three times a week for 12 weeks. Roxadustat starting dosages were 100, 120, and 150 mg three times a week for participants weighing 40-<50, 50-60, and >60 kg, respectively. rHuEPO-α starting dosage for all participants was 150 IU/kg three times a week. Both roxadustat and rHuEPO-α dosages could be modified. The primary end point was least-squares mean (LSM) change in hemoglobin (Hb) concentration from baseline to the concentration averaged over weeks 9-13. Of the 159 participants randomly assigned, 140 were included in the per-protocol set (roxadustat, n = 78; rHuEPO-α, n = 62). The LSM (95% two-sided CI) change from baseline to weeks 9-13 in Hb concentration was 17.1 (13.58 to 20.71) g/L with roxadustat and 15.4 (11.34 to 19.50) g/L with rHuEPO-α (mean difference [95% CI], 1.7 [-3.39 to 6.84]). The lower bound of the one-sided 97.5% CI for the treatment difference (‒3.4 g/L) was greater than the predefined noninferiority margin of ‒6.6 g/L, establishing noninferiority. Noninferiority was supported by five of six key secondary end points. Rates of adverse events were generally comparable between treatments and consistent with previous findings. Roxadustat was noninferior to rHuEPO-α in treating CIA in participants with nonmyeloid malignancies receiving multicycle treatments of myelosuppressive chemotherapy. The oral formulation of roxadustat may potentially increase compliance.

Is atezolizumab plus bevacizumab as first-line therapy for unresectable hepatocellular carcinoma superior to lenvatinib? a systematic review and meta‑analysis.

This meta-analysis was dedicated to evaluating the effectiveness and safety of Atezolizumab plus Bevacizumab (Atez/Bev) and Lenvatinib (LEN) as first-line systematic therapy for unresectable hepatocellular carcinoma (u-HCC). The prospective protocol for this study was registered with the PROSPERO (Registration number: CRD42022356874). Literature searches were conducted in PubMed, EMBASE database Cochrane Library, and Web Science to determine all clinical controlled studies that reported Atez/Bev and LEN for treating u-HCC. We. evaluated as primary end-point overall survival (OS) and progression-free survival (PFS), as well as other outcomes such as tumor response and adverse events (AEs).Quality assessment and data extraction of studies were conducted independently by three reviewers. Mean difference (MD) and odds ratio (OR) with 95% confidence interval (CI) were calculated using a fixed-effects or random-effects model. The meta-analysis was performed with RevMan 5.3 software. 12 retrospective cohort studies (RCSs) involving a total of 4948 patients were finally included. The results showed that compared with LEN, Atez/Bev can improve the patient's PFS (HR = 0.80, 95% CI: 0.72 ~ 0.88; p < 0.0001) and reduce the rate of overall AEs (OR = 0.46 95% CI: 0.38 ~ 0.55, p < 0.00001) and grade ≥ 3 AEs (OR = 0.43; 95% CI: 0.36 ~ 0.51, p < 0.00001), while there is no difference between OS and treatment responses rate (objective response rate, disease control rate, complete response, partial response, progressive disease, and stable disease) between two groups. In addition, the subgroup analysis shows that Atez/Bev can promote the OS of patients with viral hepatitis. (HR = 0.79, 95% CI: 0.67 ~ 0.95; p = 0.01), while LEN has an advantage in improving OS in patients with Child-Pugh grade B liver function (HR = 1.98, 95% CI: 1.50 ~ 2.63; p < 0.00001). Current evidence shows that compared with LEN, Atez/Bev has more advantages in PFS and safety in treating u-HCC and can improve the OS of patients with viral. LEN has advantages in improving the OS of patients with grade B liver function. However, more multicenter randomized controlled experiments are needed in the future to verify our results.

Changes in memory and cognition during the SARS-CoV-2 human challenge study

Patient-reported outcomes and cross-sectional evidence show an association between COVID-19 and persistent cognitive problems. The causal basis, longevity and domain specificity of this association is unclear due to population variability in baseline cognitive abilities, vulnerabilities, virus variants, vaccination status and treatment. Thirty-four young, healthy, seronegative volunteers were inoculated with Wildtype SARS-CoV-2 under prospectively controlled conditions. Volunteers completed daily physiological measurements and computerised cognitive tasks during quarantine and follow-up at 30, 90, 180, 270, and 360 days. Linear modelling examined differences between 'infected' and 'inoculated but uninfected' individuals. The main cognitive endpoint was the baseline corrected global cognitive composite score across the battery of tasks administered to the volunteers. Exploratory cognitive endpoints included baseline corrected scores from individual tasks. The study was registered on ClinicalTrials.gov with the identifier NCT04865237 and took place between March 2021 and July2022. Eighteen volunteers developed infection by qPCR criteria of sustained viral load, one without symptoms and the remainder with mild illness. Infected volunteers showed statistically lower baseline-corrected global composite cognitive scores than uninfected volunteers, both acutely and during follow up (mean difference over all time points=-0.8631, 95% CI=-1.3613,-0.3766) with significant main effect of group in repeated measures ANOVA (F (1,34)=7.58, p=0.009). Sensitivity analysis replicated this cross-group difference after controlling for community upper respiratory tract infection, task-learning, remdesivir treatment, baseline reference and model structure. Memory and executive function tasks showed the largest between-group differences. No volunteers reported persistent subjective cognitive symptoms. These results support larger cross sectional findings indicating that mild Wildtype SARS-CoV-2 infection can be followed by small changes in cognition and memory that persist for at least a year. The mechanistic basis and clinical implications of these small changes remain unclear. This study was funded through the UK Vaccine Taskforce of the Department for Business, Energy and Industrial Strategy (BEIS) of Her Majesty's Government. WT was funded by the EPSRC through the CDT for Neurotechnology Imperial College London.

The evaluation of rotational lateral ankle laxity in gravity stress position by ultrasonography: normative value in uninjured ankles

BackgroundThe evaluation of lateral ankle laxity remains challenging when diagnosing chronic lateral ankle instability (CLAI). Several studies have reported that internal rotation of the talus as an indicator of rotational lateral ankle laxity (RLAL) increases in patients with CLAI. However, there is no established method for detecting and evaluating the RLAL. This study aimed to report a novel method for evaluating the RLAL in the gravity stress position by measuring the talofibular distance (TFD) using ultrasonography (US) and show the normative value of the TFD.MethodsThe TFDs in the subjects with healthy ankles were prospectively measured 10 mm distal to the ankle joint in the neutral ankle position and gravity stress position using US. The differences in the TFD between the two ankle positions were evaluated. The differences in the TFD by gender and ankle laterality were also evaluated.ResultsA total of 52 healthy ankles of 28 subjects (mean age, 24.0 ± 1.6; male/female, 12/16) were finally included. There was a significant difference in the TFD between the neutral ankle position (6.9 ± 0.9 mm) and gravity stress position (9.0 ± 0.9 mm) (p < 0.001). The mean difference in the TFD between the two ankle positions was 2.1 ± 0.6 mm. There were no significant differences in the TFD by gender and ankle laterality.ConclusionsThe present study reported a novel US method for evaluating RLAL by applying gravity stress and the normative value of the TFD.

Understanding Insulin Resistance in NAFLD: A Systematic Review and Meta-Analysis Focused on HOMA-IR in South Asians.

Non-alcoholic fatty liver disease (NAFLD), a metabolic condition, is becoming increasingly common in South Asia. While its clinical diagnosis primarily relies on sonography and altered hepatic biomarkers, the significance of non-hepatic indicators, such as Homeostasis Model Assessment of Insulin Resistance (HOMA-IR), in relation to NAFLD requires further examination in the South Asian population due to ethnic differences in these markers. This study examined the relationship between insulin resistance, quantified using the Homeostasis Model Assessment of Insulin Resistance (HOMA-IR), and NAFLD, along with other non-hepatic biomarkers. A thorough literature review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. We searched the PubMed, Embase, and Google Scholar databases, yielding 287 articles. After applying the selection criteria and screening, 22 studies were selected for inclusion in the analysis. We extracted and meta-analyzed the data on HOMA-IR in patients with NAFLD, along with other relevant parameters. The Newcastle-Ottawa Scale (NOS) was used to assess the quality of observational studies, whereas the RoB 2.0 tool was employed for randomized controlled trials (RCTs). The systematic review uncovered that individuals with NAFLD demonstrated statistically significant elevations in HOMA-IR levels, with a weighted mean difference (WMD) of 1.28 (95% confidence interval (CI): 1.00-1.58, I² = 98%, p < 0.0001) when compared to healthy subjects. Additionally, NAFLD patients showed markedly higher fasting blood glucose (FBG) levels, with a combined mean difference of 15.64 mg/dL (95% CI: 11.03-20.25, I² = 92%, p < 0.0001). The analysis also revealed increased triglyceride levels in NAFLD patients, with a pooled mean difference of 42.49 mg/dL (95% CI: 29.07-55.91, I² = 97%, p < 0.0001), and elevated C-reactive protein (CRP) levels, with a pooled mean difference of 2.17 mg/L (95% CI: 2.01-2.33, I² = 23%, p < 0.0001). Interestingly, subgroup analysis indicated that obese NAFLD patients exhibited significantly higher HOMA-IR levels than their non-obese counterparts, with a weighted mean difference of 5.85 (95% CI: 4.88-6.81, I² = 0%, p < 0.0001). Variations in study methodology, diagnostic techniques, and subject demographics were identified as sources of heterogeneity. The analysis found little evidence of publication bias, which lends credibility to the results. In South Asian populations, higher HOMA-IR, triglyceride-glucose (TyG) index, and CRP levels are associated with an increased risk of NAFLD. To improve the understanding and treatment of NAFLD in this specific demographic group, it is necessary to establish uniform diagnostic criteria and conduct additional studies, particularly RCTs.

Eversion Force Control and Neural Drive to the Peroneus Muscles in Male Collegiate Soccer Athletes With and Without Perceived Ankle Instability

OBJECTIVE: To investigate whether individuals with perceived ankle instability (PAI) exhibited lower force control capacity and higher neural drive variability during ankle eversion force control tests compared to individuals without PAI. DESIGN: Cross-sectional case-control study. METHODS: We included male collegiate soccer athletes with ( n = 16) and without PAI ( n = 11). Force steadiness and accuracy tests were performed at 10%, 30%, and 50% of maximal voluntary contraction. Neural drive to the peroneal muscles was calculated using high-density surface electromyography. We analyzed force error, force complexity, and force and neural drive variability. RESULTS: Eversion strength was higher in the PAI group (0.36 ± 0.1 N m/kg) ( P = .03). Force error (mean difference [MD], 0.05; 95% confidence interval [CI]: −0.31, 0.21), force complexity (approximate entropy) (MD, 0.08; 95% CI: − 0.34, 0.50), force (MD, 0.20; 95% CI: −1.77, 1.36), and neural drive (MD, 1.75; 95% CI: −2.48, 5.91) variability at 10% maximal voluntary contraction did not differ between groups ( P&gt;.05). There were no significant differences between groups in other intensities and variables ( P&gt;.05). CONCLUSION: Eversion force control and neural drive to the peroneal muscles in male collegiate soccer athletes with PAI did not differ from those in athletes without PAI. JOSPT Open 2024;2(4):1-7. Epub 15 July 2024. doi:10.2519/josptopen.2024.0360

Laparoscopic Versus Open Closure of Duodenal Perforations: A Retrospective Comparative Study in a Rural Hospital, Andhra Pradesh, India

Abstract Introduction: Evidence on the outcomes of laparoscopic surgeries, especially in emergency conditions such as peptic ulcer, remains unknown. A retrospective study was conducted in a rural surgical unit in Andhra Pradesh to compare morbidity, mortality, and duration of hospital admission in patients undergoing laparoscopic (Group L) and open (Group O) closure of duodenal perforations. Methods: Retrospective data of adult patients with peptic ulcer perforation treated by surgical approach during January 2012 and December 2017 were scrutinized. Pre- and postoperative records were abstracted for clinical conditions. Mortality was compared between the two groups with appropriate statistical tests. Results: A total of 120 patients, 60 in each group, were recruited for the study. The preoperative clinical characteristics of the two groups were similar. The mean duration of surgery was significantly higher in Group L (212.8 ± 29 min) compared to Group O (107 ± 16 min) (P &lt; 0.001). Wound discharge (n = 3, 5%) and postoperative leak (n = 2, 3.3%) were the only complications noted in the L group. Several complications were noted in the O group including wound discharge (n = 51, 85%), wound dehiscence (n = 12, 20.0%), postoperative leak (n = 8, 13.3%), pneumonia (n = 1, 1.7%), and need for ventilation (n = 6, 10.0%). Three (5%) patients died in the hospital in Group O while none died in Group L. The average duration of hospital admission was 7.1 days (standard deviation [SD] =1.0 days) for Group L and 11.7 days (SD = 2.2 days) for Group O (mean difference: 4.6 days; 95% confidence interval: 4.6–5.2 days). Conclusion: Laparoscopic correction of duodenal ulcer perforation is both feasible and effective in reducing morbidity and mortality and overall treatment duration at peripheral centers.

Ranolazine Effects on Exercise Tolerance and Angina Frequency in Taiwanese Stable Angina: A Bridging Study of the CARISA Randomized Trial

The effectiveness of Ranolazine on chronic angina had been proved and launched in the United States. This study aimed to determine whether add-on Ranolazine could also be effective in Taiwanese population with persisting angina symptoms despite taking conventional antianginal agents. This is a multi-center, randomized, parallel, double-blind comparative study. The endpoint is to compare the change from the baseline of the exercise treadmill test (ETT) performing duration between add-on ranolazine and placebo at week 12. 46 patients were evaluable for the efficacy and safety endpoints. The mean change from baseline in ETT duration at week 12 was increased in the treatment and control group, and their mean difference was 20.8s. All data in the Taiwanese population was like those in the CARISA study (24.0s). The safety evaluation revealed that patients were tolerable to the add-on ranolazine therapy. The AE incidence for both ranolazine and placebo was 34.8%. The data were comparable to the past studies despite the limited statistical power. The add-on ranolazine therapy shows the potential to raise the exercise performance and tolerance of patients with chronic angina.

Pilot Study: Single-depth Superficial Ultrasound with Subdermal Injections of Diluted Calcium Hydroxylapatite for Improving Lower Face Skin Quality.

The lower face can be challenging to treat. We assessed the effectiveness of combining single-depth superficial microfocused ultrasound with visualization (MFU-V, Ultherapy; Merz North America, Inc. Raleigh, N.C.) and subdermal injections of diluted calcium hydroxylapatite (CaHA, Radiesse; Merz North America, Inc. Raleigh, N.C.) in a single session for improving skin quality in the lower face. This study enrolled women with moderate-to-severe fine lines and skin unevenness on the lower face who desired nonsurgical intervention. Single-depth MFU-V treatment (10 MHz/1.5 mm) was followed by subdermal injections of diluted (1:1) CaHA. Subjects were followed up for 24 weeks posttreatment. Objective skin quality assessments (Rv: wrinkle depth; R3z: skin unevenness) were performed using LifeViz Micro (QuantifiCare, Sophia Antipolis, France). Subjective assessments included the modified Fitzpatrick Wrinkle Scale visual analog scale, Global Aesthetic Improvement Scale, and global satisfaction scale. Twelve subjects completed the study. The mean Rv value, mean R3z value, and mean modified Fitzpatrick Wrinkle Scale visual analog scale score improved significantly from baseline to week 24 (mean differences: -0.0321 mm, -0.0684 mm, -1.1667; all P < 0.001). All subjects were rated by the investigators as having demonstrated improvement in their overall aesthetic appearance as early as week 4. All subjects were "very satisfied" or "satisfied" with their treatment from week 12 onwards. No unexpected adverse events were reported. Combination treatment with single-depth superficial MFU-V and diluted CaHA in a single session significantly improved lower facial skin quality, as assessed by both objective and subjective outcome measures.

Geometric Changes in Mitral Valve Apparatus during Long-term Cardiac Resynchronization Therapy as Assessed with Cardiac CT.

Purpose To assess long-term geometric changes of the mitral valve apparatus using cardiac CT in individuals who underwent cardiac resynchronization therapy (CRT). Materials and Methods Participants from a randomized controlled trial with cardiac CT examinations before CRT implantation and at 6 months follow-up (Clinicaltrials.gov identifier NCT01323686) were invited to undergo an additional long-term follow-up cardiac CT examination. The geometry of the mitral valve apparatus, including mitral valve annulus area, A2 leaflet angle, tenting height, and interpapillary muscle distances, were assessed. Geometric changes at the long-term follow-up examination were reported as mean differences (95% CI), and the Pearson correlation test was used to assess correlation between statistically significant geometric changes and left ventricular (LV) volumes and function. Results Thirty participants (mean age, 68 years ± 9 [SD]; 25 male participants) underwent cardiac CT imaging after a median long-term follow-up of 9.0 years (IQR, 8.4-9.4). There were reductions in end-systolic A2 leaflet angle (-4° [95% CI: -7, -2]), end-systolic tenting height (-1 mm [95% CI: -2, -1]), and end-systolic and end-diastolic interpapillary muscle distances (-4 mm [95% CI: -6, -2]) compared with pre-CRT implantation values. The mitral valve annulus area remained unchanged. LV end-diastolic and end-systolic volumes decreased (-68 mL [95% CI: -99, -37] and -67 mL [95% CI: -96, -39], respectively), and LV ejection fraction increased (13% [95% CI: 7, 19]) at the long-term follow-up examination. Changes in interpapillary muscle distances showed moderate to strong correlations with LV volumes (r = 0.42-0.72; P < .05), while A2 leaflet angle and tenting height were not correlated to LV volumes or function. Conclusion Among the various geometric changes in the mitral valve apparatus after long-term CRT, the reduction in interpapillary muscle distances correlated with LV volumes while the reduced A2 leaflet angle and tenting height did not correlate with LV volumes. Keywords: Mitral Valve Apparatus, Cardiac Resynchronization Therapy, Cardiac CT Supplemental material is available for this article. © RSNA, 2024.

Implementing a Streamlined Hypoglossal Nerve Stimulator Pathway: Cost, Time to Surgery, and Outcomes.

To evaluate the costs, time to surgery, and clinical outcomes associated with implementing a streamlined hypoglossal nerve stimulator (HGNS) implantation pathway. Retrospective cohort study. Single tertiary care center in the United States from 2016 to 2023. Patients with a lack of complete concentric collapse of the velum during volitional snore on in-office laryngoscopy qualified for the streamlined HGNS pathway. This pathway consisted of confirmatory drug-induced sleep endoscopy (DISE) followed immediately by HGNS implantation during the same surgical encounter. Outcomes were compared to patients in the traditional pathway (standalone DISE followed by HGNS implantation on a later date). A total of 68 patients (13 streamlined, 55 traditional) with obstructive sleep apnea who underwent HGNS implantation were included. Patients were predominately male (70.6%) and White (95.6%) and had a mean (SD) age of 63.5 (10.0) years. The streamlined pathway was associated with a significant reduction in both hospital costs (mean difference $9258, 95% confidence interval [CI]: 3690-14,825; P = .002) and time to surgery (mean decrease of 3.82 months, 95% CI: 0.83-6.80 months; P = .013) compared to the traditional pathway. Patients in both groups had reduction in apnea-hypopnea index and Epworth Sleepiness Scale score, with no significant differences in comparisons between groups. In select patients, the streamlined HGNS pathway may expedite time to surgery and reduce hospital costs with comparable clinical outcomes to a traditional 2-stage pathway. Further research is warranted to validate patient selection and better understand longitudinal outcomes.

Comparison of TC-325 Hemostatic Powder with Standard Endoscopic Treatments for Malignancy-Related Upper Gastrointestinal Bleeding: Meta-Analysis of Randomized Controlled Trials.

TC-325 powder has been successfully used in the management of malignancy-related upper gastrointestinal bleeding (UGIB) with favorable results. We conducted a meta-analysis of randomized controlled trials (RCTs) comparing TC-325 hemostatic powder with standard endoscopic treatments in the management of malignancy-related UGIB. Several databases were reviewed from inception to May 02, 2024 to identify RCTs comparing TC-325 and standard endoscopic treatments for the management of malignancy-related UGIB. Our outcomes of interest were immediate hemostasis, 30-day rebleeding, length of hospital stay, need for surgery, need for angiographic embolization, and all-cause mortality. We calculated pooled risk ratio (RR) with 95% confidence intervals (CI) for categorical variables and mean difference (MD) with 95% CI for continuous variables. We used a random effect model to analyze the data and heterogeneity was assessed by I2 statistic. Four RCTs with 227 patients were included. We found that, the rate of immediate hemostasis was significantly higher in the TC-325 group compared to the standard therapy group, RR (95% CI): 1.48 (1.26, 1.74). There was no significant difference in 30-day rebleeding between the groups RR (95% CI): 0.52 (0.15, 1.76). We found no significant difference in other outcomes between groups such as the need for angiographic embolization, all-cause mortality, length of hospital stay, and need for surgery. We found that, TC-325 hemostatic powder was superior to standard endoscopic treatments in achieving immediate hemostasis in patients with malignancy-related UGIB.

Influence of aerobic exercise on functional capacity and maximal oxygen uptake in patients with Parkinson's disease: a systematic review and meta-analysis.

to determine the effects of aerobic training in randomized controlled clinical trials on functional capacity, motor symptoms, and oxygen consumption in individuals with PD through a systematic literature review and meta-analysis. PUBMED, Web of Science, CINAHL, SciELO, and Medline databases were searched to identify published studies until September 2023. Randomized controlled clinical trials that evaluated the long-term effect of aerobic exercise in individuals with PD were included. Two independent reviewers extracted the data, assessed the risk of bias and the Grading of Recommendation Assessment, Development, and Evaluation (GRADE). In case of disagreement, a third reviewer was consulted. 13 studies were included in the systematic review and the number of participants was 588 with an average age of 66.2 years (57 to 73 years). The study's exercise intervention lasted between 6 to 70 weeks, with most studies lasting 10-12 weeks, with three sessions/week and an average duration of 47 minutes/session. The meta-analysis revealed that aerobic exercise is effective in enhancing maximal oxygen uptake (SMD 0.42 [CI95% = 0.18, 0.66; p = 0.0007]) and functional capacity (SMD 0.48 [CI95% = 0.24-0.71; p < 0.0001]). In addition, aerobic exercise can reduce the UPDRS III (mean difference -2.48 [CI95% = -3.16, -1.81; p < 0.00001]) score in individuals with PD. Aerobic exercise training conducted 2 to 3 times a week, with different intensities (low to high) can be an effective intervention for enhancing functional capacity, maximizing oxygen uptake, and reducing the UPDRS scores in individuals with Parkinson's disease (PD).

Effectiveness of Polyhexamethylene biguanide Liquid for Chronic Wound Washing

Background: Chronic wounds occur due to a failure in the wound healing process and are currently one of the health problems that require proper management. Some types of chronic wounds include venous leg ulcer (VLU), diabetic foot ulcer (DFU). The use of wound washes is one of the factors that play an important role in chronic wound healing. Purpose: Effectiveness of Polyhexamethylene biguanide in cleaning wounds from old dressing residue and reducing bacterial counts. Methods: Quasi experiment without control group to 30 samples using Polyhexamethylene biguanide with BWAT wound assessment instrument (Bates Jensen Wound Assessment Tool), data processing using SPSS program with Wilcoxon test. Results: 17 (40%) were late elderly (56-65 years), 3 (20%) were early elderly (46-55 years), and 10 (20%) were seniors (&gt; 65 years). The bivariate Wilcoxon test shows that Polyhexamethylene biguanide wound cleansing liquid significantly changes mean values before and after wound care. Before wound care, the mean value was 34.65 ± 14.15, and after treatment, it was 7.87 ± 3.16. The mean difference is -5.14 (-12.24 to 2.56) with a 95% confidence interval, and the p value is 0.031. Conclusion: Polyhexamethylene biguanide was shown to be effective as a wound wash to support the healing process of chronic wounds. Suggestions based on the results of this study can be used for efficient chronic wound washing for patients.

Association of Refractive Errors with Axial Length and Anterior Chamber Depth in Different Age Groups

Purpose: To determine association of refractive errors with axial length and anterior chamber depth in different age groups. Study Design: Cross-sectional study. Place and Duration of Study: Ophthalmology Department of Dow University Hospital (Ojha campus),Dow International Medical College, Dow University of Health Sciences, Karachi, Pakistan from October 2020 to December 2020. Methods: Eighty-three individuals of different age groups ranging from 11-80 years were included in the study.Ocular measurements including refractive error, axial length, and anterior chamber depth were determined in all participants. The association of refractive error with anterior chamber depth and axial length was tested by using two independent sample t test, Mann-Whitney U test and ANOVA. Results: Among 83 individuals, males were 42.2% (n=35) and females were 57.8% (n=48). Most common type of refractive error was astigmatism which was found in 48.2% (n=40) participants. The overall average depth of anterior chamber (mm) and average axial length (mm) were 3.11±0.39 and 23.27±0.87 respectively. Mean differences in anterior chamber depth were statistically significant among different age groups . Statistically significant differences in mean axial length were found among different refractive errors . Conclusion: These results show a significant relation of different refractive errors with axial length and anterior chamber depth and it can be helpfulin explaining the risk factors of different ocular diseases as well asit can also be helpful in clinical and diagnostic purposes in ophthalmology.