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Nevin Manimala Statistics

Effect of Early Treatment of Spasticity After Stroke on Motor Recovery: Protocol for the Baclotox Multicenter, Double-Blind, Double-Dummy Randomized Controlled Trial

JMIR Res Protoc. 2025 May 9;14:e62951. doi: 10.2196/62951.

ABSTRACT

BACKGROUND: Individuals with poststroke hemiplegia often develop spasticity, which increases disability. Antispastic treatments such as baclofen and botulinum toxin are commonly prescribed in poststroke recovery. However, their impact on motor recovery, especially when administered within the first 2 months after stroke, remains unclear.

OBJECTIVE: This study aims to compare the motor recovery effects of botulinum toxin versus oral baclofen. The hypothesis is that botulinum toxin is more supportive of motor recovery than baclofen and enhances functional recovery.

METHODS: The study is a multicenter, controlled phase IV, comparative, prospective, randomized, double-blind, double-dummy, superiority trial to compare the toxin and baclofen, and a noninferiority trial to compare the toxin and the placebo. It focuses on the time course of the Fugl-Meyer Motor Assessment (FMA) as the primary outcome. The main inclusion criterion is patients with a single stroke in the past 2 months. Treatment comprises 1 intramuscular injection at treatment initiation and oral tablets for 4 months. Randomized patients are allocated to 3 arms: botulinum toxin with placebo baclofen, baclofen with placebo botulinum toxin, and placebo baclofen with placebo botulinum toxin. FMA scores are assessed at pretreatment, 1 month, and 3 months later. Spasticity, functional abilities, activities of daily living, pain, and quality of life are also evaluated. Adverse effects are monitored. A positive difference of 13 points in the FMA time course between the botulinum toxin and baclofen groups is considered a relevant effect. The data analysis plan involves linear regression models to compare primary and secondary outcomes, with adjustments for covariates such as age, center, and associated treatments. Subgroup analyses will examine proportional recovery profiles, and missing data in Fugl-Meyer scores will be addressed using imputation methods.

RESULTS: A total of 179 participants were randomized across 18 centers, with inclusions delayed due to the COVID-19 pandemic. As of December 2024, the data manager currently has all the data, and a review of data quality is in progress. No statistical analysis has been conducted so far, and the blind will be lifted after the analysis.

CONCLUSIONS: This study identifies the most suitable spasticity treatment, considering the specificities of the stroke and constraints during the recovery phase. It will provide recommendations for the primary treatment of early spasticity post stroke.

TRIAL REGISTRATION: ClinicalTrials.gov NCT02462317; https://clinicaltrials.gov/study/NCT02462317; European clinical trials (EudraCT) 2010-022881-28; https://www.clinicaltrialsregister.eu/ctr-search/trial/2010-022881-28/FR.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/62951.

PMID:40344664 | DOI:10.2196/62951

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Evaluation of the Impact of Mobile Health App Vitadio in Patients With Type 2 Diabetes: Randomized Controlled Trial

J Med Internet Res. 2025 May 9;27:e68648. doi: 10.2196/68648.

ABSTRACT

BACKGROUND: Effective diabetes management requires a multimodal approach involving lifestyle changes, pharmacological treatment, and continuous patient education. Self-management demands can be overwhelming for patients, leading to lowered motivation, poor adherence, and compromised therapeutic outcomes. In this context, digital health apps are emerging as vital tools to provide personalized support and enhance diabetes management and clinical outcomes.

OBJECTIVE: This study evaluated the impact of the digital health application Vitadio on glycemic control in patients with type 2 diabetes mellitus (T2DM). Secondary objectives included evaluating its effects on cardiometabolic parameters (weight, BMI, waist circumference, blood pressure, and heart rate) and self-reported measures of diabetes distress and self-management.

METHODS: In this 6-month, 2-arm, multicenter, unblinded randomized controlled trial, patients aged 18 years or older diagnosed with T2DM were randomly assigned (1:1) to an intervention group (IG) receiving standard diabetes care reinforced by the digital health app Vitadio or to a control group (CG) provided solely with standard diabetes care. Vitadio provided a mobile-based self-management support tool featuring educational modules, motivational messages, peer support, personalized goal setting, and health monitoring. The personal consultant was available in the app to provide technical support for app-related issues. The primary outcome, assessed in the intention-to-treat population, was a change in glycated hemoglobin (HbA1c) levels at 6 months. Secondary outcomes included changes in cardiometabolic measures and self-reported outcomes. Data were collected in 2 study centers: diabetologist practice in Dessau-Roßlau and the University of Dresden.

RESULTS: Between November 2022 and June 2023, a total of 276 patients were screened for eligibility, with 149 randomized to in intervention group (IG; n=73) and a control group (CG; n=76). The majority of participants were male (91/149, 61%). The dropout rate at month 6 was 19% (121/149). While both groups achieved significant HbA1c reduction at 6 months (IG: mean -0.8, SD 0.9%, P<.001; CG: mean -0.3, SD 0.7%, P=.001), the primary confirmatory analysis revealed statistically significant advantage of the IG (adjusted mean difference: -0.53%, SD 0.15, 95% CI -0.24 to -0.82; P<.001; effect size [Cohen d]=0.67, 95% CI 0.33-1). Significant between-group differences in favor of the IG were also observed for weight loss (P=.002), BMI (P=.001) and systolic blood pressure (P<.03). In addition, Vitadio users experienced greater reduction in diabetes-related distress (P<.03) and obtained more pronounced improvements in self-care practices in the areas of general diet (P<.001), specific diet (P<.03), and exercise (P<.03).

CONCLUSIONS: This trial provides evidence for the superior efficacy of Vitadio in lowering the HbA1c levels in T2DM patients compared to standard care. In addition, Vitadio contributed to improvements in cardiometabolic health, reduced diabetes-related distress, and enhanced self-management, highlighting its potential as an accessible digital tool for comprehensive diabetes management.

TRIAL REGISTRATION: German Clinical Trials Registry DRKS00027405; https://drks.de/search/de/trial/DRKS00027405.

PMID:40344662 | DOI:10.2196/68648

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Nevin Manimala Statistics

The Effect of Socioeconomic Status and Social Deprivation on Outcomes Following Reverse Shoulder Arthroplasty: Data From an Urban Academic Center

J Am Acad Orthop Surg. 2025 May 6. doi: 10.5435/JAAOS-D-24-01352. Online ahead of print.

ABSTRACT

PURPOSE: Rotator cuff tear arthropathy (CTA) and glenohumeral osteoarthritis pose notable financial and symptomatic burdens on the aging population. This study aims to determine how social determinants of health affect patient-reported outcomes following reverse total shoulder arthroplasty (rTSA), the surgical treatment for cuff tear arthropathy and glenohumeral osteoarthritis.

METHODS: A single-center retrospective review was conducted for patients who underwent rTSA between 2017 and 2022. Zip codes were used to determine income levels, as defined by the U.S. Department of Housing and Urban Development (HUD) and the Federal Reserve (FED). Social disadvantage was quantified using Social Deprivation Index (SDI). The American Shoulder and Elbow Score (ASES) was obtained by chart review or calls at a minimum 2-year follow-up. Statistical analysis was notable done using analysis of variance, Kruskal-Wallis, and Pearson chi-square tests.

RESULTS: A total of 121 patients met inclusion criteria. Of those included, 101 patients (83%) had 2-year ASES scores. Patients were divided into three cohorts based on HUD income status, FED income status, and SDI score. A difference was observed in 2-year ASES scores when stratified by HUD subgroups (P = 0.011); however, no difference was observed in 2-year ASES scores between FED or SDI subgroups. Analysis yielded no differences in pain scores, range of motion, total length of hospital stay, complications, or revision rates between all subgroups (all, P > 0.05).

DISCUSSION: The results of this study yielded no notable difference in postoperative ASES scores between FED classes or SDI subgroups. Although a difference was observed in ASES scores between HUD classes, it may be clinically negligible. Contrary to previous literature, socioeconomic status and social deprivation did not affect postoperative outcomes within our patient population.

CONCLUSION: Social determinants of health did not affect outcomes of patients undergoing a rTSA within the first 2 years after surgery.

LEVEL OF EVIDENCE: III.

PMID:40344656 | DOI:10.5435/JAAOS-D-24-01352

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Examining the Relationship Between Relative Value Units and Patient-reported Outcomes: Implications for Value-based Care

J Am Acad Orthop Surg. 2025 May 6. doi: 10.5435/JAAOS-D-24-01297. Online ahead of print.

ABSTRACT

INTRODUCTION: Compensation based on work relative value unit (wRVU) production is common among orthopaedic surgeons. With increased adoption of value-based payments, a greater portion of surgeon compensation will be linked to quality and outcome measures-including patient-reported outcomes. Therefore, we aimed to evaluate the relationship between wRVUs and changes in Patient-reported Outcomes Measurement Information System-Physical Function (PROMIS-PF) scores to assess whether wRVUs could serve as a marker of patient-reported functional improvements.

METHODS: A retrospective review of 2,996 orthopaedic surgeries at a single institution was done. Patient characteristics, total wRVUs billed by the surgeon for the case, operating room (OR) time, and change in PROMIS-PF scores from baseline to 6 months postoperatively were compared across subspecialties. Pearson correlation and multivariable linear regression were used to assess the relationship between wRVUs, OR time, and PROMIS-PF change.

RESULTS: Statistically significant differences in average wRVUs, OR times, and PROMIS-PF scores were observed across subspecialties. A strong positive correlation between wRVUs and OR time existed (r = 0.732, P < 0.001) that explained approximately 54% of OR-time variability. A weak positive correlation between wRVUs and change in PROMIS-PF scores was observed (r = 0.058, P = 0.002) that explained <1% of the variation. Each 1-point increase in wRVU was associated with a 3-minute increase in surgical duration (β = 3.04, P < 0.001) after controlling for demographics, comorbidities, and subspecialty, accounting for approximately 63% of OR-time variation. Each 1-point increase in wRVU was independently associated with a 0.02-point increase in PROMIS-PF change (β = 0.02, P = 0.036), explaining approximately 7% of the variation.

CONCLUSION: Across orthopaedic subspecialties, notable variability in both wRVUs and physical function improvements at 6 months postoperatively exists. Although highly correlated with surgical time, wRVUs show little association with functional improvement across subspecialties. As the transition toward value-based payment models continues, measurement of and compensation for work complexity and functional outcomes must remain separate and distinct.

PMID:40344652 | DOI:10.5435/JAAOS-D-24-01297

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Nevin Manimala Statistics

Incidence trends of primary cutaneous B- and T-cell lymphoma before and after the COVID-19 pandemic

J Dtsch Dermatol Ges. 2025 May 9. doi: 10.1111/ddg.15730. Online ahead of print.

NO ABSTRACT

PMID:40344645 | DOI:10.1111/ddg.15730

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Nevin Manimala Statistics

MAMDC2-AS1 Induces Cuproptosis in Relapsed and Refractory Multiple Myeloma

Cancer Rep (Hoboken). 2025 May;8(5):e70216. doi: 10.1002/cnr2.70216.

ABSTRACT

BACKGROUND: Multiple myeloma is a malignant disorder involving the uncontrolled proliferation of plasma cells in the bone marrow. Prognosis remains poor for individuals with relapsed and refractory multiple myeloma (RRMM), and the underlying mechanisms are yet to be fully understood.

METHODS: We collected bone marrow RNA-Seq data from a total of 557 patients with MM from the GEO database (GSE24080) for further analysis, dividing them into relapsed/refractory and control groups. Additionally, we collected bone marrow samples from 57 MM patients to validate the performed RNA-Seq data analysis.

RESULTS: RNA-Seq analysis of patients with RRMM revealed a significant upregulation of genes associated with cuproptosis. Using the LASSO Cox regression method, several long noncoding RNAs (lncRNAs) were identified that influence copper-induced cell death. Based on these lncRNAs, patients were stratified into high-risk and low-risk groups. The high-risk group exhibited a significantly worse overall survival (OS) compared to the low-risk group, with a p-value of less than 0.001. Our statistical analysis, incorporating LASSO Cox regression, indicated that among these lncRNAs, MAMDC2-AS1 was particularly noteworthy due to its strong correlation with OS (p-value < 0.01). Further validation using qPCR and survival analysis established MAMDC2-AS1 as a strong predictor of prognosis in MM. This finding suggests that MAMDC2-AS1 can serve as a potential independent biomarker for RRMM. The qPCR data validated the RNA-Seq findings and uncovered the significance of MAMDC2-AS1 in the prognosis of this disease.

CONCLUSION: MAMDC2-AS1 plays a significant role in RRMM. Promisingly, Bortezomib, Bosutinib, Crizotinib, and DMOG have demonstrated promising efficacy in addressing advanced cases.

PMID:40344606 | DOI:10.1002/cnr2.70216

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Use of saline-soaked bacterial culture swabs increases bacterial recovery in dogs with superficial bacterial folliculitis

Vet Dermatol. 2025 May 9. doi: 10.1111/vde.13355. Online ahead of print.

ABSTRACT

BACKGROUND: Canine superficial bacterial folliculitis (SBF) is a common recurrent condition with a growing requirement for culture and susceptibility as a consequence of increased antimicrobial resistance and antimicrobial stewardship. Different opinions persist about the ideal technique for culture sample acquisition, which varies with lesion characteristics.

OBJECTIVE: To determine if a difference exists in the recovered quantity of bacteria acquired when sampling nonexudative clinical lesions of SBF (crusts and epidermal collarettes) between a dry culture swab and a saline-moistened culture swab.

ANIMALS: Nine dogs with crusts or epidermal collarettes and cytological findings consistent with SBF were recruited.

MATERIALS AND METHODS: Each clinical lesion was divided into two halves. One half of the lesion was sampled with a dry cotton sterile swab, while the other half was sampled with a sterile swab saturated with sterile saline. Each lesion was sampled with the culture swab by rolling it over the corresponding half four times. Aerobic quantitative cultures were then performed to determine the number of Staphylococcus-type colonies present.

RESULTS: A total of 19 lesions (13 crusts and six epidermal collarettes) were evaluated. Dry culture swab identified a mean staphylococcal bacterial count of 3.83 Log10 colony-forming units (cfu)/mL (standard deviation [SD] = 0.70). The saline-soaked culture swab revealed a median bacterial count of 4.41 Log10 cfu/mL (SD = 0.77). There was a statistically significant difference between the sample collection methods (p = 0.002).

CONCLUSIONS AND CLINICAL RELEVANCE: Sterile saline-soaked swabs are more likely than dry swabs to result in increased recovery of bacteria from nonexudative lesions.

PMID:40344589 | DOI:10.1111/vde.13355

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Capturing Excited State Proton Transfer Dynamics with Reactive Machine Learning Potentials

J Phys Chem Lett. 2025 May 9:4900-4906. doi: 10.1021/acs.jpclett.5c00688. Online ahead of print.

ABSTRACT

Excited state proton transfer is a fundamental process in photochemistry, playing a crucial role in fluorescence sensing, bioimaging, and optoelectronic applications. However, fully resolving its dynamics remains challenging due to the prohibitive computational cost of ab initio simulations and the need for ultrafast experimental techniques with high temporal resolution. Here, we tackle this challenge by using machine learning-driven excited state molecular dynamics simulations. We propose an active learning framework powered by enhanced sampling techniques for constructing a high-quality training set for excited state machine learning potentials, which we then use to map the reaction free energy landscape and capture the photorelaxation dynamics. Using 10-hydroxybenzo[h]quinoline as a test case, our simulations reveal a barrierless excited state proton transfer occurring within ∼50 fs, accompanied by a significant red shift in the emission energy (∼1 eV), in agreement with experimental findings. Furthermore, our results highlight a strong coupling between proton transfer and charge redistribution, which facilitates the rapid tautomerization process. These findings showcase the power of machine learning-driven molecular dynamics in accurately capturing photochemical dynamics while enabling large-scale statistical sampling.

PMID:40344586 | DOI:10.1021/acs.jpclett.5c00688

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An analysis of adolescent leisure activity structure based on subjective well-being: Focusing on social network analysis

PLoS One. 2025 May 9;20(5):e0322956. doi: 10.1371/journal.pone.0322956. eCollection 2025.

ABSTRACT

This study examines how adolescent leisure activity networks relate to subjective well-being (SWB) using Statistics Korea’s 2019 Time Use Survey. The analysis includes 241 high-SWB and 241 low-SWB adolescents, assessing network density, inclusiveness, average distance, isolated nodes, degree centrality, and cohesion through NetMiner 4.0, with descriptive statistics processed in SPSS ver. 25.0. The results show clear differences in leisure activity networks. High-SWB adolescents engaged in more social activities and sports, while low-SWB adolescents participated in fewer, more solitary activities. High-SWB networks were diverse and well-connected, whereas low-SWB networks were more fragmented. Screen-based activities also played different roles: supporting social connections in high-SWB adolescents but reinforcing isolation in low-SWB adolescents. This study visually highlights that leisure participation varies by SWB level. The findings suggest that promoting diverse and interactive leisure activities can improve adolescent well-being, offering insights for policy and intervention programs.

PMID:40344567 | DOI:10.1371/journal.pone.0322956

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Cognitive traces of life kinetic exercise in puberty sedentary subjects

PLoS One. 2025 May 9;20(5):e0322778. doi: 10.1371/journal.pone.0322778. eCollection 2025.

ABSTRACT

In this study, it was aimed to reveal the effect of regular life kinetic exercises on the concepts of motivation and imagery in sports in puberty period individuals. In the study in which “pre-test-post-test control group design” was used, 44 students (experiment = 22, control = 22) who were continuing their education in a state secondary school and selected by appropriate sampling method participated. The “Personal Information Form”, “Motivation Scale in Sport” and “Imagery Inventory in Sport” were used as data collection tools. The collected data were analysed using repeated measures analysis of variance. When the results were analysed, it was determined that there were statistically significant differences in the pre-test and post-test mean scores of motivation and imagery in sport. As a result, it can be stated that the life kinetic exercise protocol applied for 8 weeks in sedentary individuals positively predicted motivation and imagery parameters in sports. This result indicates that the related psychological phenomena, which are as important as sport performance in sports, can be positively affected by cognitive and motoric exercise combinations.

PMID:40344562 | DOI:10.1371/journal.pone.0322778