bluuebunny/crossref_metadata_2025 huggingface dataset:
Tapering of biological treatment in autoinflammatory diseases: a scoping review
Authors: Welzel Tatjana , Oefelein Lea , Twilt Marinka , Pfister Marc , Kuemmerle-Deschner Jasmin B. , Benseler Susanne M.
Published: August 2022

Background

Biological treatment and treat-to-target approaches guide the achievement of inactive disease and clinical remission in Autoinflammatory Diseases (AID). However, there is limited evidence addressing optimal tapering strategies and/or discontinuation of biological treatment in AID. This study evaluates available evidence of tapering biological treatment and explores key factors for successful tapering.

Methods

A systematic literature search was conducted in Embase, MEDLINE, Cochrane Database of Systematic Reviews and Cochrane Central Register of Controlled Trials using the OVID platform (1990-08/2020). Bibliographic search of relevant reviews was also performed. Studies/case series (n ≥ 5) in AID patients aged ≤ 18 years with biological treatment providing information on tapering/treatment discontinuation were included. After quality assessment aggregated data were extracted and synthesized. Tapering strategies were explored.

Results

A total of 6035 records were identified. Four papers were deemed high quality, all focused on systemic juvenile idiopathic arthritis (sJIA) (1 open-label randomized trial, 2 prospective, 1 retrospective observational study). Biological treatment included anakinra (n = 2), canakinumab (n = 1) and tocilizumab (n = 1). Strategies in anakinra tapering included alternate-day regimen. Canakinumab tapering was performed randomized for dose reduction or interval prolongation, whereas tocilizumab was tapered by interval prolongation. Key factors identified included early start of biological treatment and sustained inactive disease.

Conclusion

Tapering of biological treatment after sustained inactive disease should be considered. Guidance for optimal strategies is limited. Future studies may leverage therapeutic drug monitoring in combination with pharmacometric modelling to further enhance personalized “taper-to-target” strategies respecting individual patients and diseases aspects.
Synchrotron tomography applications in agriculture and food sciences research: a review
Authors: Indore Navnath S. , Karunakaran Chithra , Jayas Digvir S.
Published: August 2022

Synchrotron imaging is widely used for research in many scientific disciplines. This article introduces the characteristics of synchrotron X-ray imaging and its applications in agriculture and food science research. The agriculture and food sector are a vast area that comprises of plants, seeds, animals, food and their products; soils with thriving microbial communities; and natural resources such as water, fertilizers, and organic matter. These entities have unique internal features, structures and compositions which differentiate them from each other in varieties, species, grades, and types. The use of a bright and tuneable monochromatic source of synchrotron imaging techniques enables researchers to study the internal features and compositions of plants, seeds, soil and food in a quick and non-destructive way to enhance their use, conservation and productivity. Synchrotron’s different X-ray imaging techniques offer a wide domain of applications, which make them perfect to enhance the understanding of structures of raw and processed food products to promote food safety and security. Therefore, this paper summarizes the results of major experiments carried out with seeds, plants, soil, food and relevant areas of agricultural sciences with more emphasis on two synchrotron X-ray imaging techniques: absorption and phase-contrast imaging and computed tomography.
A method of two-dimensional correlation spectroscopy combined with residual neural network for comparison and differentiation of medicinal plants raw materials superior to traditional machine learning: a case study on Eucommia ulmoides leaves
Authors: Li Lian , Li Zhi Min , Wang Yuan Zhong
Published: August 2022

Background

Eucommia ulmoides leaf (EUL), as a medicine and food homology plant, is a high-quality industrial raw material with great development potential for a valuable economic crop. There are many factors affecting the quality of EULs, such as different drying methods and regions. Therefore, quality and safety have received worldwide attention, and there is a trend to identify medicinal plants with artificial intelligence technology. In this study, we attempted to evaluate the comparison and differentiation for different drying methods and geographical traceability of EULs. As a superior strategy, the two-dimensional correlation spectroscopy (2DCOS) was used to directly combined with residual neural network (ResNet) based on Fourier transform near-infrared spectroscopy.

Results

(1) Each category samples from different regions could be clustered together better than different drying methods through exploratory analysis and hierarchical clustering analysis; (2) A total of 3204 2DCOS images were obtained, synchronous 2DCOS was more suitable for the identification and analysis of EULs compared with asynchronous 2DCOS and integrated 2DCOS; (3) The superior ResNet model about synchronous 2DCOS used to identify different drying method and regions of EULs than the partial least squares discriminant model that the accuracy of train set, test set, and external verification was 100%; (4) The Xinjiang samples was significant differences than others with correlation analysis of 19 climate data and different regions.

Conclusions

This study verifies the superiority of the ResNet model to identify through this example, which provides a practical reference for related research on other medicinal plants or fungus.
Promises and pitfalls in implementation science from the perspective of US-based researchers: learning from a pre-mortem
Authors: Beidas Rinad S. , Dorsey Shannon , Lewis Cara C. , Lyon Aaron R. , Powell Byron J. , Purtle Jonathan , Saldana Lisa , Shelton Rachel C. , Stirman Shannon Wiltsey , Lane-Fall Meghan B.
Published: August 2022

Background

Implementation science is at a sufficiently advanced stage that it is appropriate for the field to reflect on progress thus far in achieving its vision, with a goal of charting a path forward. In this debate, we offer such reflections and report on potential threats that might stymie progress, as well as opportunities to enhance the success and impact of the field, from the perspective of a group of US-based researchers.

Main body

Ten mid-career extramurally funded US-based researchers completed a “pre-mortem” or a group brainstorming exercise that leverages prospective hindsight to imagine that an event has already occurred and to generate an explanation for it — to reduce the likelihood of a poor outcome. We came to consensus on six key themes related to threats and opportunities for the field: (1) insufficient impact, (2) too much emphasis on being a “legitimate science,” (3) re-creation of the evidence-to-practice gap, (4) difficulty balancing accessibility and field coherence, (5) inability to align timelines and priorities with partners, and (6) overly complex implementation strategies and approaches.

Conclusion

We submit this debate piece to generate further discussion with other implementation partners as our field continues to develop and evolve. We hope the key opportunities identified will enhance the future of implementation research in the USA and spark discussion across international groups. We will continue to learn with humility about how best to implement with the goal of achieving equitable population health impact at scale.
Correlation between hematological parameters and PET/CT metabolic parameters in patients with head and neck cancer
Authors: Bojaxhiu Beat , Sinovcic Dubravko , Elicin Olgun , Templeton Arnoud J. , Shelan Mohamed , Wartenberg Jan , Alberts Ian , Rominger Axel , Aebersold Daniel M. , Zaugg Kathrin
Published: August 2022

Background

Systemic inflammation is predictive of the overall survival in cancer patients and is related to the density of immune cells in the tumor microenvironment of cancer, which in turn correlates with 18F -fluorodeoxyglucose (FDG)-positron emission tomography/computed tomography (PET/CT) metabolic parameters (MPs). The density of tumor-infiltrating lymphocytes (TILs) in the microenvironment has the potential to be a biomarker that can be used clinically to optimize patient selection in oropharyngeal head and neck squamous cell carcinoma (HNSCC). There is little to no data regarding the association of systemic inflammation with PET/CT-MPs, especially in HNSCC. This study aimed to evaluate the correlation between markers of host inflammation, namely blood neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR), with the PET/CT-MPs standardized uptake value (SUV), metabolic tumor volume (MTV), and total lesion glycolysis (TLG) of the primary tumor, derived from FDG-PET/CT in patients with nonmetastatic (cM0) HNSCC before treatment. We hypothesized that NLR and PLR at baseline are positively correlated with PET/CT-MPs.

Methods

A retrospective review of consecutive patients with HNSCC with a pretreatment PET/CT was performed. NLR and PLR were computed using complete blood counts measured within 10 days before the start of any treatment. The correlation between NLR and PLR with PET/CT-MPs was evaluated with Spearman's rho test.

Results

Seventy-one patients were analyzed. Overall survival (OS) at 1, 2, and 3 years was 86%, 76%, and 68%. PLR was found to be correlated with MTV (rho = 0.26, P = .03) and TLG (rho = 0.28, P = .02) but not with maximum SUV or mean SUV. There was no correlation between NLR and the analyzed PET/CT-MPs. TLG was associated with worse survival in uni- and multivariable analysis, but no other PET/CT-MPs were associated with either OS or disease-specific survival (DSS). NLR and PLR were associated with OS and DSS on uni- and multivariable analysis.

Conclusions

In patients with HNSCC before any treatment such as definitive radio (chemo)therapy or oncologic surgery followed by adjuvant RT, baseline PLR correlated with MTV and TLG but not with SUV. NLR was not correlated with any PET/CT-MPs analyzed in our study. Confirmatory studies are needed, and a potential interaction between tumor microenvironment, host inflammation, and FDG-PET/CT measures warrants further investigation.
Comparison of the efficacy of fully endoscopic spine surgery using transforaminal and interlaminar approaches in the treatment of prolapsed lumbar 4/5 disc herniation
Authors: Zhao Quanlai , Xiao Liang , Wu Zhongxuan , Liu Chen , Zhang Yu
Published: August 2022

Background

There is still much controversy about whether transforaminal or interlaminar fully endoscopic spine surgery can better treat lumbar 4/5 disc herniation. Therefore, this study intends to compare the clinical efficacy of fully endoscopic spine surgery through transforaminal and interlaminar approaches in the treatment of lumbar 4/5 disc herniation.

Methods

Seventy-six patients with lumbar 4/5 disc herniation admitted from March 2019 to June 2020 were divided into the transforaminal approach group (endoscopic transforaminal lumbar discectomy, ETLD; 54 cases) and the interlaminar approach group (endoscopic interlaminar lumbar discectomy, EILD; 22 cases) according to different surgical methods. The general clinical data and clinical evaluation scale of the patients were compared.

Results

The post-operative ODI and VAS scores were significantly better in the EILD group (P < 0.05). The VAS and ODI scores of patients with upper-shoulder and sub-axillary types in the EILD group were superior to those in the ETLD group (P < 0.05), while the VAS and ODI scores of patients with the pre-radicular type were better when they underwent ETLD rather than EILD (P < 0.05). Patients with Lee zone III type in the EILD group had better post-operative ODI scores than those in the ETLD group (P < 0.05), but there was no significant difference in VAS scores (P > 0.05). Patients with Lee zone IV type who underwent EILD had better VAS and ODI scores than those who underwent ETLD (P < 0.05).

Conclusions

For patients with a prolapsed intervertebral disc that belongs to the upper-shoulder type, sub-axillary type, or Lee III or IV type, EILD can achieve better outcomes.
Hybrid convergent ablation versus endocardial catheter ablation for atrial fibrillation: a systematic review and meta-analysis of randomised control trials and propensity matched studies
Authors: Eranki Aditya , Wilson-Smith Ashley R. , Williams Michael L. , Flynn Campbell D. , Manganas Con
Published: August 2022

Introduction

Atrial fibrillation (AF) is the most common arrhythmia. Hybrid convergent ablation (HCA) is an emerging procedure for treating longstanding AF with promising results. HCA consists of a subxiphoid, surgical ablation followed by completion endocardial ablation. This meta-analysis of randomized control trials (RCT’s) and propensity score-matched studies aims to examine the efficacy and safety of HCA compared to endocardial catheter ablation (ECA) alone on patients with AF.

Methods

This review was written in accordance with preferred reporting items for systematic reviews and meta-analyses recommendations and guidance. The primary outcome for the analysis was freedom from AF (FFAF) at final follow up. Secondary outcomes were mortality and significant complications such as tamponade, sternotomy, esophageal injury, atrio-esophageal fistulae post procedurally.

Results

Four studies where included, with a total of 233 patients undergoing HCA and 189 patients undergoing ECA only. Pooled analysis demonstrated that HCA cohorts had significantly higher rates of FFAF than ECA cohorts, with an OR of 2.78 (95% CI 1.82–4.24, P < 0.01, I2 = 0). Major post-operative complications were observed in significantly more patients in the HCA group, with an OR of 5.14 (95% CI 1.70–15.54, P < 0.01). There was only one death reported in the HCA cohorts, with no deaths in the ECA cohort.

Conclusion

HCA is associated with a significantly higher FFAF than ECA, however, it is associated with increased post-procedural complications. There was only one death in the HCA cohort. Large RCT’s comparing the HCA and ECA techniques may further validate these results.
Patients’ and parents’ experiences during wound care of epidermolysis bullosa from a dyadic perspective: a survey study
Authors: Mauritz Petra J. , Bolling Marieke , Duipmans José C. , Hagedoorn Mariët
Published: August 2022

Background

Epidermolysis bullosa is a rare, often severe, genetic disorder characterized by fragility of the skin and mucous membranes. Despite the important role of parents during wound care, an essential factor in adapting to this disease, studies focusing on the parent–child relationship during wound care are scarce. The current study is aimed at addressing this gap.

Methods

A quantitative study among 31 children (n = 21 ≤ 17 years; n = 10 17–25 years) and 34 parents (including 27 parent–child dyads) was conducted to examine the relationship between pain, itch, anxiety, positive and negative feelings, and coping strategies assessed with the newly developed Epidermolysis Bullosa Wound Care List. The majority of the analyses were descriptive and the results were interpreted qualitatively because of the small sample size.

Results

Children and parents both showed significantly more positive (i.e. ‘protected’, ‘proud’, ‘calm’, ‘connected to each other’ and ‘courageous’) than negative feelings (i.e. ‘helpless’, ‘angry’, ‘insecure’, ‘guilty’, ‘gloomy’ and ‘sad’) during wound care, with parents reporting both feelings more than children. The more children experienced pain, the more they were anxious, had negative feelings, were inclined to use distraction, to postpone wound care and to cry. The more parents experienced feelings (either positive or negative), the more likely they sought distraction. With regard to child-parent dyads the results showed that the more children expressed anxiety, the more parents experienced negative feelings. Furthermore, those who reported more negative feelings were more likely to hide their feelings, while those who reported more positive feelings were more inclined to show their feelings. Pain, itch and anxiety in the child were associated with more distraction or postponement of wound care by the parent.

Conclusion

This study underlines the importance of paying attention to the relationship between feelings and coping strategies in child-parent dyads in the management of pain and anxiety during wound care. Further research could provide more insight how these feelings and coping strategies are related to the psychological well-being of both the child and the parent in the short term as well as in the long term.
A case–control study regarding factors associated with digital dermatitis in Norwegian dairy herds
Authors: Ahlén Lina , Holmøy Ingrid Hunter , Nødtvedt Ane , Sogstad Åse Margrethe , Fjeldaas Terje
Published: August 2022

Background

Digital dermatitis (DD) is a contagious bovine foot disease causing painful lesions, lameness, and reduced animal welfare. Previous studies indicate a complex aetiology of the disease. The aim of this study was to compare DD negative and DD positive herds to identify factors associated with DD in Norwegian dairy herds by analysing data obtained in a questionnaire and data recorded in the Norwegian Dairy Herd Recording System (NDHRS). The questionnaire was e-mailed to the owners of all 380 herds recorded with DD in 2019 and to 1530 randomly selected herds with no recordings of DD. Altogether 559 dairy herds were included in the final study population, of which 113 was classified as DD positive (≥ one cow recorded with DD in NDHRS) and 446 as DD negative. When stratified by housing system, the ratio between DD positive and negative herds was 108/281 in free stalls and 5/165 in tie stalls. Multilevel logistic regression was used to model the association between potential risk factors and variables related to the detection and diagnosis of DD, and the outcome in the free-stall population. Geographical area (county) was included in the model as a random effect.

Results

In the final study population 108/113 (96%) of the DD positive herds were housed in free stalls versus 5/113 (4%) in tie stalls. The free-stall herds’ DD status was associated with purchase of cattle during the last 5 years (baseline: 0 animals, OR = 2.30 for category 12–27 animals, OR = 4.34 for 28–52 animals, and OR = 5.39 for  ≥ 53 animals). The DD status was also associated with claw trimming frequency (Baseline: 1 < 2/year, OR = 0.41 for category  < 1/year, and OR = 4.09 for  ≥ 3/year), whether the claw trimming was done by a certified professional trimmer or not (baseline:  ≤ 90% of the cows, OR = 3.98 for category  ≥ 90% of the cows), cleaning of feet in the chute before trimming (baseline: no cleaning, OR = 1.98 for category cleaning), and alley flooring (baseline: slatted floor, OR = 2.36 for category solid floor).

Conclusions

Digital dermatitis was far more frequent in Norwegian dairy herds housed in free stalls versus those housed in tie stalls. In the free-stall herds purchase of cattle, increasing trimming frequency, use of certified professional trimmer, cleaning of the feet in the chute, and solid flooring in the alleys were associated with increased odds of recorded DD.
Neural network methods for diagnosing patient conditions from cardiopulmonary exercise testing data
Authors: Brown Donald E. , Sharma Suchetha , Jablonski James A. , Weltman Arthur
Published: August 2022

Background

Cardiopulmonary exercise testing (CPET) provides a reliable and reproducible approach to measuring fitness in patients and diagnosing their health problems. However, the data from CPET consist of multiple time series that require training to interpret. Part of this training teaches the use of flow charts or nested decision trees to interpret the CPET results. This paper investigates the use of two machine learning techniques using neural networks to predict patient health conditions with CPET data in contrast to flow charts. The data for this investigation comes from a small sample of patients with known health problems and who had CPET results. The small size of the sample data also allows us to investigate the use and performance of deep learning neural networks on health care problems with limited amounts of labeled training and testing data.

Methods

This paper compares the current standard for interpreting and classifying CPET data, flowcharts, to neural network techniques, autoencoders and convolutional neural networks (CNN). The study also investigated the performance of principal component analysis (PCA) with logistic regression to provide an additional baseline of comparison to the neural network techniques.

Results

The patients in the sample had two primary diagnoses: heart failure and metabolic syndrome. All model-based testing was done with 5-fold cross-validation and metrics of precision, recall, F1 score, and accuracy. As a baseline for comparison to our models, the highest performing flow chart method achieved an accuracy of 77%. Both PCA regression and CNN achieved an average accuracy of 90% and outperformed the flow chart methods on all metrics. The autoencoder with logistic regression performed the best on each of the metrics and had an average accuracy of 94%.

Conclusions

This study suggests that machine learning and neural network techniques, in particular, can provide higher levels of accuracy with CPET data than traditional flowchart methods. Further, the CNN performed well with a small data set showing that these techniques can be designed to perform well on small data problems that are often found in health care and the life sciences. Further testing with larger data sets is needed to continue evaluating the use of machine learning to interpret CPET data.
Novel mutations of the ABCA12, KRT1 and ST14 genes in three unrelated newborns showing congenital ichthyosis
Authors: Serra Gregorio , Memo Luigi , Cavicchioli Paola , Cutrone Mario , Giuffrè Mario , La Torre Maria Laura , Schierz Ingrid Anne Mandy , Corsello Giovanni
Published: August 2022

Background

Congenital ichthyosis (CI) is a heterogeneous group of genetic disorders characterized by generalized dry skin, scaling and hyperkeratosis, often associated to erythroderma. They are rare diseases, with overall incidence of 6.7 in 100,000. Clinical manifestations are due to mutations in genes mostly involved in skin barrier formation. Based on clinical presentation, CI is distinguished in non-syndromic and syndromic forms. To date, mutations of more than 50 genes have been associated to different types of CI.

Cases presentation

We report on three Italian unrelated newborns showing clinical signs compatible with different forms of CI of variable severity, namely Harlequin ichtyosis (HI), epidermolytic ichtyosis (EI) and autosomal recessive ichtyosis with hypotrichosis (ARIH). Target next generation sequencing (NGS) analysis identified three novel mutations of theABCA12,KRT1andST14genes, respectively associated to such congenital ichtyoses, not reported in literature. Genomic investigation allowed to provide the more appropriate management to each patient, based on an individualized approach.

Conclusions

Our report highlights the wide genetic heterogeneity and phenotypic variability of CI. It expands the current knowledge on such diseases, widening their genomic database, and providing a better clinical characterization. Furthermore, it underlines the clinical relevance of NGS, which is essential to address the management of patients. Indeed, it may guide towards the most adequate approach, preventing clinical obstinacy for subjects with more severe forms and unfavorable outcomes (together with the support, in such situations, of bioethicists included within the multidisciplinary care team), as well as reassuring families in those with milder course and favorable evolution.
Study protocol and methods for Easing Pelvic Pain Interventions Clinical Research Program (EPPIC): a randomized clinical trial of brief, low-intensity, transdiagnostic cognitive behavioral therapy vs education/support for urologic chronic pelvic pain syndrome (UCPPS)
Authors: Lackner Jeffrey M. , Jaccard James , Quigley Brian M. , Ablove Tova S. , Danforth Teresa L. , Firth Rebecca S. , Gudleski Gregory D. , Krasner Susan S. , Radziwon Christopher D. , Vargovich Alison M. , Clemens J. Quentin , Naliboff Bruce D.
Published: August 2022

Background

Urologic chronic pelvic pain syndrome (UCPPS) encompasses several common, costly, diagnoses including interstitial cystitis/bladder pain syndrome and chronic prostatitis/chronic pelvic pain syndrome that are poorly understood and inadequately treated with conventional medical therapies. Behavioral strategies, recommended as a first-line treatment for managing symptoms, are largely inaccessible, time and labor intensive, and technically complex. The Easing Pelvic Pain Interventions Clinical Research Program (EPPIC) is a clinical trial examining the efficacy of low-intensity cognitive behavioral therapy (Minimal Contact CBT or MC-CBT) for UCPPS and its durability 3 and 6 months post treatment. Additional aims include characterizing the operative processes (e.g., cognitive distancing, context sensitivity, coping flexibility, repetitive negative thought) that drive MC-CBT-induced symptom relief and pre-treatment patient variables that moderate differential response.

Methods

UCPPS patients (240) ages 18–70 years, any gender, ethnicity, and race, will be randomized to 4-session MC-CBT or a credible, non-specific education comparator (EDU) that controls for the generic effects from simply going to treatment. Efficacy assessments will be administered at pre-treatment, 2 weeks, and 3 and 6 months post treatment-week acute phase. A novel statistical approach applied to micro-analytic mediator assessment schedule will permit the specification of the most effective CBT component(s) that drive symptom relief.

Discussion

Empirical validation of a low-intensity self-management therapy transdiagnostic in scope has the potential to improve the health of chronic pelvic pain patients refractory to medical therapies, reduce social and economic costs, conserve health care resources, as well as inform evidence-based practice guidelines. Identification of change mechanisms and moderators of treatment effects can provide proactive patient-treatment matching fundamental to goals of personalized medicine.

Trial Registration

Clinicaltrials.gov NCT05127616. Registered on 9/19/21.
Study protocol for a parallel-group randomized controlled multi-center trial evaluating the additional effect of continuous ultrasound bladder monitoring in urotherapy for children with functional daytime urinary incontinence (SENS-U trial)
Authors: de Wall L. L. , Nieuwhof-Leppink A. J. , van de Wetering E. H. M. , Leijn E. , Trompetter M. , de Kort L. M. O. , Feitz W. F. , Schappin R.
Published: August 2022

Background

Lower urinary tract dysfunction or functional urinary incontinence is a common condition with a prevalence up to 21% between 6 and 8 year-old children. It is associated with an impaired quality of life, lower self-esteem, and social stigmatization. Urotherapy is the first treatment of choice for functional daytime urinary incontinence (DUI) in children. Alarm therapy can be a part of urotherapy as it provides the child adequate feedback on wetting accidents. Current alarm systems notify either at a set interval or give a notification when wetting has already occurred to prompt the child to go to the toilet. These alarms do not teach the child the interpretation of the bladder sensation preceding wetting accidents. A new wearable bladder sensor, the SENS-U, recently became available. This is a relative small, wireless ultrasonic sensor, which continuously monitors bladder filling. The SENS-U is able to provide an alarm at the exact moment voiding is warranted. It facilitates the child to learn the sensation of bladder filling preceding voiding in an easier way, increasing the learning curve throughout treatment. Its additional effect in urotherapy on continence and cost-effectiveness is to be determined.

Methods/design

This is a multi-center clinical superiority parallel-group randomized controlled trial including a total of 480 children. Participants between 6 and 16 years of age with functional DUI in which urotherapy is offered as the next treatment of choice are eligible. Four centers, two academic hospitals, and two general care (peripheral) centers are participating. Participants will be randomized at a 1:1:1 ratio into three groups: urotherapy (care as usual), urotherapy with the SENS-U added for 3 consecutive weeks throughout the training, or urotherapy with a SHAM device for 3 weeks. The primary outcome is number of wetting accidents per week after 3 months of training, compared between the SENS-U and the SHAM device. The magnitude of the placebo effect will be assessed by comparing the results of the SHAM group versus the control (care as usual) group.

Discussion

To our knowledge, this is the first trial studying not only the effect but also the cost-effectiveness of alarm interventions as commonly added in urotherapy.

Trial registration

ISRCTN44345202. Registered on March 2022
Fostering shared decision-making about prostate cancer screening among African American men patients and their primary care providers: a randomized behavioral clinical trial
Authors: Echeverri Margarita , Felder Kyazia , Anderson David , Apantaku Elora , Leung Patrick , Hoff Clare , Dennar Princess
Published: August 2022

Background

Prostate cancer is the third most prevalent cancer in the American population. Furthermore, the prognosis is worse in African American as there is increased morbidity and mortality associated with it.

Purpose

The purpose of this study is to evaluate the effectiveness of a new online method to educate the patient population regarding prostate cancer risk, diagnosis, treatments, and their decisions about whether to be screened for the early detection of prostate cancer.

Methods

Two hundred Black male patients are recruited from different clinical sites and randomized to either the control arm (usual care) or the intervention arm (educational program). We will compare the effectiveness of the intervention to see if patients are discussing the need of getting a prostate-specific antigen (PSA) test, and the possible benefits and harms that may result of having or not having the test, with their primary care providers.

Discussion

Shared decision-making (SDM) is the current standard in most cancer-screening guidelines and also a standard of person-centered care. However, there is a lack of evidence-based approaches to improve decision quality in clinical settings and an increased ambiguity of applying SDM for PSA-based screening among Black men in primary care. Our proposal to evaluate a decisional-aid intervention and measure the actual application of SDM during clinical encounters has a high potential to advance the translation path of implementing shared decision-making in clinical settings and provide evidence of the applicability of the guideline in general.

Innovation and overall impact

Given the 2018 USPSTF updated guidelines recommending shared decision-making about PSA-based screening, the increased risk of prostate cancer mortality in Black men, the challenges of evidence-based decision-making due to the underrepresentation of Blacks in major randomized clinical trials, and implicit racial bias among primary care providers, the time is ripe for interventions to improve shared decision-making about prostate cancer screening in Black men. In this study, we address communication and knowledge gaps between Black men and their primary care providers. The intervention, if proven effective, can be readily scaled across primary care practices across the U.S. and may be adapted to other types of cancer where guidelines have included shared decision-making as well. Early detection of prostate cancer may decrease mortality and morbidity in the long term.
Effectiveness of promotion and support for physical activity maintenance post total hip arthroplasty—study protocol for a pragmatic, assessor-blinded, randomized controlled trial (the PANORAMA trial)
Authors: Bieler Theresa , Magnusson S. Peter , Siersma Volkert , Rinaldo Mie , Schmiegelow Morten Torrild , Beck Torben , Krifa Anne-Mette , Kjær Birgitte Hougs , Palm Henrik , Midtgaard Julie
Published: August 2022

Background

Total hip arthroplasty is considered an efficacious procedure for relieving pain and disability, but despite that objectively measured physical activity level remains unchanged compared to pre-surgery and is still considerably lower than that of a healthy age- and sex-matched population 6–12 months post-surgery. Since there is a graded relationship between physical activity level and functional performance, increasing physical activity may enhance the outcome of the procedure. This study aims to investigate whether promotion and support of physical activity initiated 3 months after total hip arthroplasty complementary to usual rehabilitation care can increase objective measured physical activity 6 months post-surgery.

Methods

The trial is designed as a pragmatic, parallel group, two-arm, assessor-blinded, superiority, randomized (1:1), controlled trial with post intervention follow-up 6 and 12 months after total hip arthroplasty. Home-dwelling, independent, and self-reliant patients with hip osteoarthritis are provisionally enrolled prior to surgery and re-screened about 2–3 months post-surgery to confirm eligibility. Baseline assessment is conducted 3 months post-surgery. Subsequently, patients (n=200) are randomized to either a 3-month, multimodal physical activity promotion/education intervention or control (no further attention). The intervention consists of face-to-face and telephone counselling, patient education material, pedometer, and step-counting journal. The primary outcome is objectively measured physical activity, specifically the proportion of patients that complete on average ≥8000 steps per day 6 months post-surgery. Secondary outcomes include core outcomes (i.e., physical function, pain, and patient global assessment) and health-related quality of life. Furthermore, we will explore the effect of the intervention on self-efficacy and outcome expectations (i.e., tertiary outcomes).

Discussion

By investigating the effectiveness of a pedometer-driven, face-to-face, and telephone-assisted counselling, behavior change intervention in complementary to usual rehabilitation, we hope to deliver applicable and generalizable knowledge to support physical activity after total hip arthroplasty and potentially enhance the outcome of the procedure.

Trial registration

www.clinicaltrials.govNCT04471532. Registered on July 15, 2020.
Evaluation of the recovery after heart surgery following preoperative supplementation with a combination of beta-hydroxy-beta-methylbutyrate, l-arginine, and l-glutamine: a double-blind randomized placebo-controlled clinical trial
Authors: Norouzi Mona , Nadjarzadeh Azadeh , Maleki Majid , Khayyatzadeh Sayyed Saeid , Hosseini Saeid , Yaseri Mehdi , Fattahi Hamed
Published: August 2022

Background

The preoperative period is a good time to improve nutrition status, compensate for nutrient deficiencies, and optimize immune function in patients’ underlying surgery. In some medical conditions, supplementation with a combination of l-glutamine (Gln), β-hydroxy-β-methylbutyrate (HMB), and l-arginine (Arg) had promising effects on improving recovery. The present study aimed to evaluate the effect of supplementation with Gln/Arg/HMB in patients undergoing heart surgery.

Methods

This randomized clinical trial was conducted on 70 patients undergoing cardiac surgery. Participants were requested to consume 2 sachets of a combination of 7 g l-arginine, 7 g l-glutamine, and 1.5 g daily HMB or placebo 30 days before operation. At the baseline and end of the study, left ventricular ejection fraction and the serum levels of troponin, creatine phosphokinase (CPK), CPK-MB, alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin were measured. Also, the Sequential Organ Failure Assessment (SOFA) score, time of stay in hospital and intensive care unit (ICU), and postoperative complications were recorded after surgery.

Results

In total, 60 preoperative patients (30 in each group) with a mean age of 53.13 ± 14.35 years completed the study (attrition rate = 85.7%). Subjects in the Gln/Arg/HMB group had lower serum levels of CPK-MB (median [IQR] = 49 [39.75] vs. 83 [64.55]; P = 0.011), troponin (median [IQR] = 2.13 [1.89] vs. 4.34 [1.99]; P < 0.001), bilirubin (median [IQR] = 0.50 [0.20] vs. 0.40 [0.22]; P < 0.001), and SOFA score (median [IQR] = 2 [2] vs. 5 [2]; P < 0.001) at end of the study compared to the placebo. Also, the time of stay in the hospital (median [IQR] = 5 [1] vs. 6 [3]; P < 0.001) and ICU (median [IQR] = 2.50 [1.00] vs. 3.50 [1.50]; P = 0.002) was lower in the Gln/Arg/HMB group.

Conclusion

The present study showed that perioperative supplementation with a combination of Gln, Arg, and HMB enhances the recovery, reduces myocardial injury, and decreases the time of hospital and ICU stay in cardiac surgery patients. These results need to be confirmed in a larger trial.

Trial registration

IRCT.ir IRCT20120913010826N31. Registered on 13 October 2020.
A vegan diet improves insulin resistance in individuals with obesity: a systematic review and meta-analysis
Authors: Chen Peng , Zhao Ying , Chen Yan
Published: August 2022

Background

A vegan diet has benefits on weight reduction and on the parameters of glucose and lipid metabolism. This meta-analysis aimed to investigate the efficacy of plant-based diets on insulin resistance and blood lipids in patients with obesity.

Methods

PubMed, Embase, and the Cochrane Library were searched for available papers published up to March 2021. The primary outcome was insulin resistance which was assessed by Homeostasis Model Assessment Insulin Resistance (HOMA-IR), other metabolic parameters measures including the pre/post-diet changes in triglycerides, HDL-cholesterol, total cholesterol, LDL-cholesterol. All analyses were performed using the random-effects model.

Results

Six studies (seven datasets) were included. Compared with baseline, the plant-based diet improved the HOMA-IR (SMD = 1.64, 95%CI 0.95, 2.33; I2 = 91.8%, Pheterogeneity < 0.001), total cholesterol (SMD = 2.51, 95% CI 0.88, 4.13; I2 = 98.0%, Pheterogeneity < 0.001), HDL-cholesterol (SMD = 1.55, 95% CI 0.66, 2.44; I2 = 92.0%, Pheterogeneity < 0.001), and LDL-cholesterol (SMD = 2.50, 95% CI 1.30, 3.70; I2 = 94.4%, Pheterogeneity < 0.001), but not the triglycerides (SMD = − 0.62, 95% CI − 1.92, 0.68; I2 = 97.8%, Pheterogeneity < 0.001). The sensitivity analyses showed that the results were robust.

Conclusions

In obese individuals with insulin resistance, a vegan diet improves insulin resistance and dyslipidemia, except for triglycerides.
JIB-04, a histone demethylase Jumonji C domain inhibitor, regulates phenotypic switching of vascular smooth muscle cells
Authors: He Yi , Yi Xin , Zhang Zihao , Luo Hanshen , Li Rui , Feng Xin , Fang Ze-Min , Zhu Xue-Hai , Cheng Wenlin , Jiang Ding-Sheng , Zhao Fang , Wei Xiang
Published: August 2022

Background

Vascular smooth muscle cell (VSMC) phenotype switching is critical for neointima formation, which is the major cause of restenosis after stenting or coronary artery bypass grafting. However, the epigenetic mechanisms regulating phenotype switching of VSMCs, especially histone methylation, are not well understood. As a main component of histone lysine demethylases, Jumonji demethylases might be involved in VSMC phenotype switching and neointima formation.

Methods and results

A mouse carotid injury model and VSMC proliferation model were constructed to investigate the relationship between histone methylation of H3K36 (downstream target molecule of Jumonji demethylase) and neointima formation. We found that the methylation levels of H3K36 negatively correlated with VSMC proliferation and neointima formation. Next, we revealed that JIB-04 (a pan-inhibitor of the Jumonji demethylase superfamily) could increase the methylation levels of H3K36. Furthermore, we found that JIB-04 obviously inhibited HASMC proliferation, and a cell cycle assay showed that JIB-04 caused G2/M phase arrest in HASMCs by inhibiting the phosphorylation of RB and CDC2 and promoting the phosphorylation of CHK1. Moreover, JIB-04 inhibited the expression of MMP2 to suppress the migration of HASMCs and repressed the expression of contraction-related genes. RNA sequencing analysis showed that the biological processes associated with the cell cycle and autophagy were enriched by using Gene Ontology analysis after HASMCs were treated with JIB-04. Furthermore, we demonstrated that JIB-04 impairs autophagic flux by downregulating STX17 and RAB7 expression to inhibit the fusion of autophagosomes and lysosomes.

Conclusion

JIB-04 suppresses the proliferation, migration, and contractile phenotype of HASMCs by inhibiting autophagic flux, which indicates that JIB-04 is a promising reagent for the treatment of neointima formation.
Positive predictive value of ultrasound in correctly identifying an inguinal hernia: a single-centered retrospective pilot study
Authors: Ridha Heroo , de Vries Roelof P. H. , Nijholt Ingrid M. , Abbes Saskia , Boomsma Martijn F. , Nijveldt Robert J.
Published: August 2022

Objectives

To determine the clinical utility of preoperative ultrasound imaging for predicting an inguinal hernia in need of surgery. In addition, we aimed to identify factors associated with false positive (FP) ultrasound examinations.

Methods

In this retrospective pilot study, we included all 175 patients who underwent inguinal hernia surgery in our hospital in 2019 and of whom a positive preoperative ultrasound examination of the groin area was available. The positive predictive value (PPV) of the ultrasound examination was determined using inguinal hernia detected during surgery (yes/no) as golden standard. To identify possible predictive factors, we compared the characteristics of patients with a FP ultrasound with patients with a true positive (TP) ultrasound.

Results

PPV of ultrasound examinations to identify an inguinal hernia in need of surgery correctly was 90.9% (159/175). The patients with a FP ultrasound examination had a significantly higher body mass index (BMI) than the patients with a TP ultrasound examination (27.6 ± 4.2 vs 25.8 ± 2.3, p = 0.043).

Conclusions

With a false positive percentage of 9.1%, there is still room for improvement of preoperative diagnostic imaging. Studies with larger cohorts are necessary to establish prediction models that have the potential to reduce FP ultrasound results.
Insufficient S-adenosylhomocysteine hydrolase compromises the beneficial effect of diabetic BMSCs on diabetic cardiomyopathy
Authors: Wang Ying , Zhang Yuying , Chen Kegong , Liu Jie , Wu Donghong , Cheng Yao , Wang Hongjie , Li Yanbo
Published: August 2022

Background

Autologous stem cell therapy is a promising strategy for cardiovascular diseases including diabetic cardiomyopathy (DCM), but conclusions from clinical trials were compromised. We assumed that diabetes might induce the dysfunction of stem cells and thus limit its therapeutic effect. This study aimed to compare the effect of diabetes and nondiabetes-derived bone marrow mesenchymal stem cells (BMSCs) transplantation on DCM and explored the potential mechanism.

Methods

Rats with diabetes were induced using high-fat diets and streptozotocin (STZ) injection. BMSCs harvested from diabetic and nondiabetic rats were infused into DCM rats, and the effects on the heart were identified by echocardiography and histopathology. The inhibition or overexpression of SAHH in nondiabetic and diabetic BMSCs was used to confirm its key role in stem cell activity and cardiac therapy.

Results

Compared with normal BMSCs, the therapeutic effects of diabetic rat-derived stem cells on improving cardiac function and adverse remodeling were significantly attenuated. In vitro, diabetic BMSCs had lower cell viability and paracrine function than nondiabetic BMSCs. It was further found that diabetic BMSCs had obvious mitochondrial oxidative stress damage and S-adenosylhomocysteine (SAH) accumulation due to S-adenosylhomocysteine hydrolase (SAHH) deficiency. SAHH inhibition by adenosine dialdehyde (ADA) or shSAHH plasmid in normal BMSCs significantly reduced the favorable effects on endothelial cell proliferation and tube-forming capacity. In contrast, SAHH overexpression in diabetic BMSCs significantly improved cellular activity and paracrine function. Transplantation of BMSCs with SAHH overexpression improved cardiac adverse remodeling and angiogenesis. Activation of the Nrf2 signaling pathway may be one of the key mechanisms of SAHH-mediated improvement of stem cell viability and cardiac repair.

Conclusions

Diabetes leads to compromised bioactivity and repair capacity of BMSCs. Our study suggests that SAHH activation may improve the cardioprotective effect of autologous transplantation of diabetes-derived BMSCs on patients with DCM.

Graphical abstract

Diabetes induced the inhibition of S-adenosylhomocysteine (SAH) expression and aging phenotype in BMSCs and thus decreased the cell viability and paracrine function. Compared with normal BMSCs, the therapeutic effects of diabetic rat-derived BMSCs on improving cardiac function and adverse remodeling were significantly attenuated. SAHH overexpression in diabetic BMSCs significantly rescued cellular function partly via activating Nrf2/HO-1 signal. Transplantation of diabetic BMSCs with SAHH overexpression improved angiogenesis and cardiac adverse remodeling in rats.
Effectiveness and safety of stem cell therapy for diabetic foot: a meta-analysis update
Authors: Sun Yuming , Zhao Jinhong , Zhang Lifang , Li Zhexuan , Lei Shaorong
Published: August 2022

Background

Diabetic foot (DF) is one of the most common and serious complications of diabetes mellitus (DM), which brings great psychological and economic pressure to patients. This study aimed to evaluate the efficacy of stem cells in the treatment of diabetic foot.

Methods

All relevant studies in Cochrane, Embase, PubMed, Web of Science, China National Knowledge Infrastructure, and WanFang databases were systematically searched for meta-analysis. The outcomes consisted of ulcer or wound healing rate, amputation rate, new vessels, ankle–brachial index (ABI), transcutaneous oxygen pressure (TcPO2), pain-free walking distance, and rest pain score. Dichotomous outcomes were described as risk ratios (RR) with 95% confidence intervals (CIs), while continuous data were presented as standardized mean differences (SMDs) with 95% CIs. Statistical analysis was performed with RevMan 5.3 software.

Results

A total of 14 studies with 683 participants were included in the meta-analysis. Meta-analysis showed that stem cell therapy was more effective than conventional therapy in terms of ulcer or wound healing rate [OR = 8.20 (5.33, 12.62)], improvement in lower extremity ischemia(new vessels) [OR = 16.48 (2.88, 94.18)], ABI [MD = 0.13 (0.04, 0.08)], TcO2[MD = 4.23 (1.82, 6.65)], pain-free walking distance [MD = 220.79 (82.10, 359.48)], and rest pain score [MD = − 1.94 (− 2.50, − 1.39)], while the amputation rate was significantly decreased [OR = 0.19 (0.10, 0.36)].

Conclusions

The meta-analysis of the current studies has shown that stem cells are significantly more effective than traditional methods in the treatment of diabetic foot and can improve the quality of life of patients after treatment. Future studies should conduct large-scale, randomized, double-blind, placebo-controlled, multicenter trials with high-quality long-term follow-up to demonstrate the most effective cell types and therapeutic parameters for the treatment of diabetic foot.