Tag: pubmed

J Ocul Pharmacol Ther. 2022 Nov 15. doi: 10.1089/jop.2022.0012. Online ahead of print.

ABSTRACT

Purpose: The purposes of this study were to investigate cytokine changes in the aqueous humor after treatment of acquired immune deficiency syndrome (AIDS) complicated with cytomegalovirus retinitis (CMVR) and to determine whether these changes are useful prognostic indicators. Methods: This study included 12 patients (15 eyes) undergoing treatment for AIDS and CMVR. The patients received intravitreal injections and systemic intravenous treatment with ganciclovir and foscarnet sodium. The aqueous humor of each eye was sampled before treatment and before the third and fifth injections. The samples were tested to determine the concentrations of each of 27 cytokines using the Luminex 200™ liquid phase chip. Results: The concentrations of cytokines interleukin (IL)-1rα (P = 0.002), IL-1b (P = 0.001), IL-8 (P = 0.001), basic fibroblast growth factor (bFGF) (P < 0.001), interferon γ-induced protein 10 (IP-10) (P = 0.001), and tumor necrosis factor (TNF)-α (P = 0.004) in the aqueous humor before the third and fifth injections were significantly lower after than before treatment. The reductions in TNF-α (P = 0.028) and IL-1b (P = 0.028) concentrations after treatment were statistically significant compared with the postoperative visual acuity improvement (≥3 lines and <3 lines). The difference in TNF-α (P = 0.018) level before and after treatment (the difference between before treatment and before the fifth intravitreal injection) was also statistically significant compared with the number of injections (≥6 times and <6 times). Conclusion: The cytokines IL-1rα, IL-1b, IL-8, bFGF, IP-10, and TNF-α may offer new avenues for evaluation of therapeutic effect, and TNF-α and IL-1b may be important cytokines for prognostic evaluation (based on visual acuity and the number of injections) in patients suffering from AIDS and CMVR. Clinical Trial Registration: Number: ChiCTR2200056955.

PMID:36378859 | DOI:10.1089/jop.2022.0012

Neurourol Urodyn. 2022 Nov 15. doi: 10.1002/nau.25091. Online ahead of print.

ABSTRACT

INTRODUCTION: Gender dysphoria affects over 1 million American adults. Vaginoplasty is a critical step in gender affirmation, and many patients have insufficient genital skin for full-depth penile inversion vaginoplasty (PIV). We reviewed the literature for technical considerations addressing this and present our data supporting the use of peritoneal flaps (Davydov technique).

MATERIALS AND METHODS: A comprehensive review of modern literature was conducted. Second, we present a retrospective case review of our experience with PIV, including data from procedures utilizing peritoneal flaps.

RESULTS: We identified 20 original articles, including retrospective and prospective case and cohort studies. Approaches included the application of local soft tissue grafts and flaps, peritoneal flaps, and intestinal segments. Between June 2018 and February 2021, 47 patients at our institution, underwent PIV for the treatment of gender dysphoria. Nineteen of those patients underwent robotic-assisted peritoneal flap procedure in addition to PIV. In this cohort, the mean follow-up was 200.6 ± 124.8 days. Mean neovaginal depth was 13.1 ± 3.0 cm intra-operatively and 11.0 cm at the last follow-up. Twenty-six percent of complications were Clavien Grade 1 or 2; others included wound dehiscence (30.4%), perianal and urethral fistula (13.0%), and neovaginal stenosis (8.7%). The majority of patients reported satisfactory results in terms of sexual function with intact tactile and erogenous sensation. Almost half were able to have penetrative vaginal intercourse at the last follow-up. We did not aim to perform statistical calculations to compare the outcomes of PIV with and without robotic-assisted peritoneal flap augmentation, as the groups were not constructed in that manner. However, it is evident that anatomical and functional results as well as the distribution of postoperative complications seem similar.

CONCLUSION: Vaginoplasty is indicated in a growing population of patients with a wide range of medical histories and anatomic variations. Genitourinary reconstructive surgeons must have several methods to achieve full-depth vaginoplasty in cases of inadequate genital skin. Peritoneal flaps serve as a versatile, safe, and functionally advantageous solution.

PMID:36378843 | DOI:10.1002/nau.25091

Neurourol Urodyn. 2022 Nov 15. doi: 10.1002/nau.25096. Online ahead of print.

ABSTRACT

OBJECTIVE: To evaluate the efficacy of perineal electrical stimulation (ES) on anxiety, depression, incontinence-related quality of life (QoL), and clinical parameters in men with urinary incontinence (UI) after radical prostatectomy (RP).

METHODS: Fifty-eight men with UI after RP were randomized into two groups using the random numbers generator as follows: Group 1 received perineal ES (n:29), and Group 2 no treatment (n:29). Perineal ES was performed in lithotomy position via a stimulation device (Enraf Myomed 632) with surface electrodes, 3 days a week, 20 min a day, for a total of 24 sessions for 8 weeks. Men were evaluated in terms of continence rates (primary outcome), incontinence severity (24 h-pad test), incontinence episodes (3-day bladder diary), anxiety-depression (HADS), QoL (IIQ-7), and improvement rates and treatment satisfaction (Likert scale) at the baseline and the end of treatment (8th week).

RESULTS: A statistically significant improvement was found in all parameters except depression in Group 1, in the severity of incontinence and QoL parameters in Group 2 at the 8th week compared to the baseline values (p < 0.05). At the end of treatment; the severity of incontinence, incontinence episodes, QoL, and anxiety were significantly improved in Group 1 compared to Group 2 (p < 0.05). No difference was found between the two groups in terms of depression (p > 0.05). The continence and improvement rates and treatment satisfaction were significantly higher in Group 1 than in Group 2 (p < 0.05).

CONCLUSION: Perineal ES is more effective than no treatment in men with UI after RP as an alternative ES option that is well tolerated and does not produce serious adverse events. Clinical Trial Registration: This study was registered with ClinicalTrials.gov number, NCT05236140.

PMID:36378836 | DOI:10.1002/nau.25096

Am J Respir Crit Care Med. 2022 Nov 15. doi: 10.1164/rccm.202204-0629OC. Online ahead of print.

ABSTRACT

RATIONALE: The respective effects of PEEP and pressure support delivered through the helmet interface in hypoxemic patients need to be better understood.

OBJECTIVES: To assess the respective effects of helmet pressure support (NIV) and continuous positive-airway pressure (CPAP) compared to high-flow nasal oxygen (HFNO) on effort to breathe, lung inflation and gas exchange in hypoxemic patients (PaO2/FiO2≤200).

METHODS: Fifteen patients underwent 1-hour phases (constant FiO2) of HFNO (60 L/min), helmet NIV (PEEP=14 cmH2O, pressure support=12 cmH2O) and CPAP (PEEP=14 cmH2O) in randomized sequence.

MEASUREMENTS: Inspiratory esophageal (ΔPES) and transpulmonary pressure (ΔPL) swings were used as surrogates for inspiratory effort and lung distension, respectively. Tidal volume (VT) and end-expiratory lung volume were assessed with electrical impedance tomography.

MAIN RESULTS: ΔPES was lower during NIV vs. CPAP and HFNO (5[3-9] cmH2O vs. 13[10-19] vs. 10[8-13], p=0.001 and p=0.01). ΔPL was not statistically different between treatments. PaO2/FiO2 ratio was significantly higher during NIV and CPAP vs. HFNO (166[136-215] and 175[158-281] vs. 120[107-149], p=0.002 and p=0.001). NIV and CPAP similarly increased VT vs. HFNO (mean change: 70%[95%CI: 17-122], p=0.02; 93% [95%CI: 30-155], p=0.002) and end-expiratory lung volume (mean change: 198%[95%CI: 67-330], p=0.001; 263%[95%CI: 121-407], p=0.001), mostly due to increased aeration/ventilation in dorsal lung regions. During HFNO, 14/15 patients had pendelluft involving>10% of VT: pendelluft was mitigated by CPAP and further by NIV.

CONCLUSIONS: Compared to HFNO, helmet NIV, but not CPAP, reduced ΔPES. CPAP and NIV similarly increased oxygenation, end-expiratory lung volume and VT, without affecting ΔPL. NIV, and to a lesser extent, CPAP, mitigated pendelluft. Clinical trial registration available at www.

CLINICALTRIALS: gov, ID: NCT04241861.

PMID:36378814 | DOI:10.1164/rccm.202204-0629OC

J Cardiovasc Electrophysiol. 2022 Nov 15. doi: 10.1111/jce.15747. Online ahead of print.

ABSTRACT

BACKGROUND: Implantable cardioverter defibrillators (ICD) are indicated for primary and secondary prevention of sudden cardiac arrest. Despite enhancements in design and technologies, the ICD lead is the most vulnerable component of the ICD system and failure of ICD leads remains a significant clinical problem. A novel, small diameter, lumenless, catheter delivered, defibrillator lead was developed with the aim to improve long term reliability.

METHODS AND RESULTS: The Lead Evaluation for Defibrillation and Reliability (LEADR) study is a multi-center, single-arm, Bayesian, adaptive design, pre-market interventional pivotal clinical study. Up to 60 study sites from around the world will participate in the study. Patients indicated for a de novo ICD will undergo defibrillation testing at implantation and clinical assessments at baseline, implant, pre-hospital discharge, 3 months, 6 months, and every 6 months thereafter until official study closure. Patients may be participating for a minimum of 18 months to approximately 3 years. Fracture-free survival will be evaluated using a Bayesian statistical method that incorporates both virtual patient data (combination of bench testing to failure with in-vivo use condition data) with clinical patients. The clinical subject sample size will be determined using decision rules for number of subject enrollments and follow-up time based upon the observed number of fractures at certain time points in the study. The adaptive study design will therefore result in a minimum of 500 and a maximum of 900 patients enrolled.

CONCLUSION: The LEADR Clinical Study was designed to efficiently provide evidence for short- and long-term safety and efficacy of a novel lead design using Bayesian methods including a novel virtual patient approach. This article is protected by copyright. All rights reserved.

PMID:36378803 | DOI:10.1111/jce.15747

IEEE Trans Med Imaging. 2022 Nov 15;PP. doi: 10.1109/TMI.2022.3220706. Online ahead of print.

ABSTRACT

Dataset auditing for machine learning (ML) models is a method to evaluate if a given dataset is used in training a model. In a Federated Learning setting where multiple institutions collaboratively train a model with their decentralized private datasets, dataset auditing can facilitate the enforcement of regulations, which provide rules for preserving privacy, but also allow users to revoke authorizations and remove their data from collaboratively trained models. This paper first proposes a set of requirements for a practical dataset auditing method, and then present a novel dataset auditing method called Ensembled Membership Auditing (EMA). Its key idea is to leverage previously proposed Membership Inference Attack methods and to aggregate data-wise membership scores using statistic testing to audit a dataset for a ML model. We have experimentally evaluated the proposed approach with benchmark datasets, as well as 4 X-ray datasets (CBIS-DDSM, COVIDx, Child-XRay, and CXR-NIH) and 3 dermatology datasets (DERM7pt, HAM10000, and PAD-UFES-20). Our results show that EMA meet the requirements substantially better than the previous state-of-the-art method. Our code is at: https://github.com/Hazelsuko07/EMA.

PMID:36378795 | DOI:10.1109/TMI.2022.3220706

Circ Cardiovasc Imaging. 2022 Nov;15(11):e013676. doi: 10.1161/CIRCIMAGING.121.013676. Epub 2022 Nov 15.

ABSTRACT

BACKGROUND: The FUEL trial (Fontan Udenafil Exercise Longitudinal) demonstrated statistical improvements in exercise capacity following 6 months of treatment with udenafil (87.5 mg po BID). The effect of udenafil on echocardiographic measures of single ventricle function in this cohort has not been studied.

METHODS: The 400 enrolled participants were randomized 1:1 to udenafil or placebo. Protocol echocardiograms were obtained at baseline and 26 weeks after initiation of udenafil/placebo. Linear regression compared change from baseline indices of single ventricle systolic, diastolic and global function, atrioventricular valve regurgitation, and mean Fontan fenestration gradient in the udenafil cohort versus placebo, controlling for ventricular morphology (left ventricle versus right ventricle/other) and baseline value.

RESULTS: The udenafil participants (n=191) had significantly improved between baseline and 26 weeks visits compared to placebo participants (n=195) in myocardial performance index (P=0.03, adjusted mean difference [SE] of changes between groups -0.03[0.01]), atrioventricular valve inflow peak E (P=0.009, 3.95 [1.50]), and A velocities (P=0.034, 3.46 [1.62]), and annular Doppler tissue imaging-derived peak e’ velocity (P=0.008, 0.60[0.23]). There were no significant differences in change in single ventricle size, systolic function, atrioventricular valve regurgitation severity, or mean fenestration gradient. Participants with a dominant left ventricle had significantly more favorable baseline values of indices of single ventricle size and function (lower volumes and areas, E/e’ ratio, systolic:diastolic time and atrioventricular valve regurgitation, and higher annular s’ and e’ velocity).

CONCLUSIONS: FUEL participants who received udenafil demonstrated a statistically significant improvement in some global and diastolic echo indices. Although small, the changes in diastolic function suggest improvement in pulmonary venous return and/or augmented ventricular compliance, which may help explain improved exercise performance in that cohort.

REGISTRATION: URL: https://clinicaltrials.gov; Unique Identifier: NCT02741115.

PMID:36378780 | DOI:10.1161/CIRCIMAGING.121.013676

Genet Epidemiol. 2022 Nov 15. doi: 10.1002/gepi.22507. Online ahead of print.

ABSTRACT

The clustering of proteins is of interest in cancer cell biology. This article proposes a hierarchical Bayesian model for protein (variable) clustering hinging on correlation structure. Starting from a multivariate normal likelihood, we enforce the clustering through prior modeling using angle-based unconstrained reparameterization of correlations and assume a truncated Poisson distribution (to penalize a large number of clusters) as prior on the number of clusters. The posterior distributions of the parameters are not in explicit form and we use a reversible jump Markov chain Monte Carlo based technique is used to simulate the parameters from the posteriors. The end products of the proposed method are estimated cluster configuration of the proteins (variables) along with the number of clusters. The Bayesian method is flexible enough to cluster the proteins as well as estimate the number of clusters. The performance of the proposed method has been substantiated with extensive simulation studies and one protein expression data with a hereditary disposition in breast cancer where the proteins are coming from different pathways.

PMID:36378773 | DOI:10.1002/gepi.22507

Circ Cardiovasc Qual Outcomes. 2022 Nov;15(11):e009333. doi: 10.1161/CIRCOUTCOMES.122.009333. Epub 2022 Nov 15.

ABSTRACT

BACKGROUND: Cardiovascular disease is the leading cause of death in the United States; however, women and rural residents face notable health disparities compared with male and urban counterparts. Community-engaged programs hold promise to help address disparities through health behavior change and maintenance, the latter of which is critical to achieving clinical improvements and public health impact.

METHODS: A cluster-randomized controlled trial of Strong Hearts, Healthy Communities-2.0 conducted in medically underserved rural communities examined health outcomes and maintenance among women aged ≥40 years, who had a body mass index >30 or body mass index 25 to 30 and also sedentary. The multilevel intervention provided 24 weeks of twice-weekly classes with strength training, aerobic exercise, and skill-based nutrition education (individual and social levels), and civic engagement components related to healthy food and physical activity environments (community, environment, and policy levels). The primary outcome was change in weight; additional clinical and functional fitness measures were secondary outcomes. Mixed linear models were used to compare between-group changes at intervention end (24 weeks); subgroup analyses among women aged ≥60 years were also conducted. Following a 24-week no-contact period, data were collected among intervention participants only to evaluate maintenance.

RESULTS: Five communities were randomized to the intervention and 6 to the control (87 and 95 women, respectively). Significant improvements were observed for intervention versus controls in body weight (mean difference: -3.15 kg [95% CI, -4.98 to -1.32]; P=0.008) and several secondary clinical (eg, waist circumference: -3.02 cm [-5.31 to -0.73], P=0.010; systolic blood pressure: -6.64 mmHg [-12.67 to -0.62], P=0.031; percent body fat: -2.32% [-3.40 to -1.24]; P<0.001) and functional fitness outcomes; results were similar for women aged ≥60 years. The within-group analysis strongly suggests maintenance or further improvement in outcomes at 48 weeks.

CONCLUSIONS: This cardiovascular disease prevention intervention demonstrated significant, clinically meaningful improvements and maintenance among rural, at-risk older women.

REGISTRATION: URL: https://www.

CLINICALTRIALS: gov; Unique identifier: NCT03059472.

PMID:36378768 | DOI:10.1161/CIRCOUTCOMES.122.009333

Am J Community Psychol. 2022 Nov 15. doi: 10.1002/ajcp.12633. Online ahead of print.

ABSTRACT

This study fills a methodological gap in racial justice research by assessing the utility and validity of the Black Community Activism Orientation Scale (BCAOS) in a racially and ethnically diverse sample of college-going young adults (N = 624, M = 19.4 years, SD = 1.89) from 10 colleges in the United States. Confirmatory factor analysis was conducted to estimate the goodness of fit of the proposed three-factor model and assess the validity of the BCAOS. Findings from the confirmatory factor analysis provide statistical support for use of the BCAOS as a measure of racial justice activism in support of Black communities among racially and ethnically diverse college-going young adults. Findings from the study also suggest that White college students and men are less oriented toward racial justice activism than women and racially marginalized students. Convergent and discriminant validity were established through bivariate correlations of the BCAOS factors with other civic development measures. As more and more young people consider the importance of standing against racial oppression, the BCAOS has utility as an assessment instrument in future racial justice research, education, intervention, and youth programming efforts.

PMID:36378747 | DOI:10.1002/ajcp.12633