bluuebunny/crossref_metadata_2025_split huggingface dataset:
Contextual sensory integration training vs. traditional vestibular rehabilitation: a pilot randomized controlled trial
Authors: Kelly Jennifer , Harel Daphna , Krishnamoorthy Santosh , Fu Gene , Morris Brittani , Medlin Andrew , Mischinati Sarah , Wang Zhu , Sutera John , Perlin Ken , Cosetti Maura , Lubetzky Anat V. 
Published: August 2023

Abstract
Background
We created a clinical virtual reality application for vestibular rehabilitation. Our app targets contextual sensory integration (C.S.I.) where patients are immersed in safe, increasingly challenging environments while practicing various tasks (e.g., turning, walking). The purpose of this pilot study was to establish the feasibility of a randomized controlled trial comparing C.S.I. training to traditional vestibular rehabilitation.

Methods
Thirty patients with vestibular dysfunction completed the Dizziness Handicap Inventory (DHI), Activities-Specific Balance Confidence Scale (ABC), Visual Vertigo Analog Scale (VVAS), Functional Gait Assessment (FGA), Timed-Up-and-Go (TUG), and Four-Square Step Test (FSST). Following initial assessment, the patients were randomized into 8 weeks (once per week in clinic + home exercise program) of traditional vestibular rehabilitation or C.S.I. training. Six patients had to stop participation due to the covid-19 pandemic, 6 dropped out for other reasons (3 from each group). Ten patients in the traditional group and 8 in the C.S.I group completed the study. We applied an intention to treat analysis.

Results
Following intervention, we observed a significant main effect of time with no main effect of group or group by time interaction for the DHI (mean difference − 18.703, 95% CI [-28.235, -9.172], p = 0.0002), ABC (8.556, [0.938, 16.174], p = 0.028), VVAS, (-13.603, [-25.634, -1.573], p = 0.027) and the FGA (6.405, [4.474, 8.335], p < 0.0001). No changes were observed for TUG and FSST.

Conclusion
Patients’ symptoms and function improved following either vestibular rehabilitation method. C.S.I training appeared comparable but not superior to traditional rehabilitation.

Trial registration
This study (NCT04268745) was registered on clincaltrials.gov and can be found at https://clinicaltrials.gov/ct2/show/NCT04268745.
Robotic arm training in neurorehabilitation enhanced by augmented reality – a usability and feasibility study
Authors: de Crignis Alexandra Charlotte , Ruhnau Salome-Thamar , Hösl Matthias , Lefint Jérémy , Amberger Tamara , Dressnandt Jürgen , Brunner Hans , Müller Friedemann 
Published: August 2023

Abstract
Background
Robotic therapy and serious gaming support motor learning in neurorehabilitation. Traditional monitor-based gaming outputs cannot adequately represent the third dimension, whereas virtual reality headsets lack the connection to the real world. The use of Augmented Reality (AR) techniques could potentially overcome these issues. The objective of this study was thus to evaluate the usability, feasibility and functionality of a novel arm rehabilitation device for neurorehabilitation (RobExReha system) based on a robotic arm (LBR iiwa, KUKA AG) and serious gaming using the AR headset HoloLens (Microsoft Inc.).

Methods
The RobExReha system was tested with eleven adult inpatients (mean age: 64.4 ± 11.2 years; diagnoses: 8 stroke, 2 spinal cord injury, 1 Guillain-Barré-Syndrome) who had paretic impairments in their upper limb. Five therapists administered and evaluated the system. Data was compared with a Reference Group (eleven inpatients; mean age: 64.3 ± 9.1 years; diagnoses: 10 stroke, 1 spinal cord injury) who trained with commercially available robotic therapy devices (ArmeoPower or ArmeoSpring, Hocoma AG). Patients used standardized questionnaires for evaluating usability and comfort (Quebec User Evaluation of Satisfaction with assistive technology [QUEST]), workload (Raw Task Load Index [RTLX]) and a questionnaire for rating visual perception of the gaming scenario. Therapists used the QUEST, the System Usability Scale and the short version of the User Experience Questionnaire.

Results
Therapy with the RobExReha system was safe and feasible for patients and therapists, with no serious adverse events being reported. Patients and therapists were generally satisfied with usability. The patients’ usability ratings were significantly higher in the Reference Group for two items of the QUEST: reliability and ease of use. Workload (RTLX) ratings did not differ significantly between the groups. Nearly all patients using the RobExReha system perceived the gaming scenario in AR as functioning adequately despite eight patients having impairments in stereoscopic vision. The therapists valued the system’s approach as interesting and inventive.

Conclusions
We demonstrated the clinical feasibility of combining a novel robotic upper limb robot with an AR-serious game in a neurorehabilitation setting. To ensure high usability in future applications, a reliable and easy-to-use system that can be used for task-oriented training should be implemented.

Trial registration
Ethical approval was obtained and the trial was registered at the German Clinical Trials Register (DRKS00022136).
Characteristics and economic burden of patients with somatoform disorders in Chinese general hospitals: a multicenter cross-sectional study
Authors: Yang Xiangyun , Luo Jia , Wang Pengchong , He Yue , Wang Cong , Yang Lijuan , Sun Jing , Li Zhanjiang 
Published: August 2023

Abstract
Background
In China, patients with somatoform disorders (SFD) often seek medical treatment repeatedly in outpatient clinics of general hospitals, which increases unreasonable medical expenses. It is imperative to provide early screening to these patients and specialized treatment to reduce the unnecessary cost. This study aimed to screen patients with SFD in general hospitals using a new Chinese questionnaire and explore the characteristics and economic burden of these patients.

Methods
Patients (n = 1497) from the outpatient department of neurology, cardiology and gastroenterology of three large general hospitals were included. Participants were screened using a newly developed questionnaire, the Self-screening Questionnaire for Somatic Symptoms (SQSS), to identify the patients with SFD (total SQSS score ≥ 29 points). We compared the demographics and clinical information of patients with and without SFD. Logistic regression was used to explore potential factors related to medical expenses, visits to doctors and sick leave days taken.

Results
The frequency of detection of patients with SFD was 17.03%. There were significant differences in employment, doctor visits, symptom duration, medical expenses, sick leave days, PHQ-15 scores, and PHQ-9 scores between patients with SFD and without SFD. General nonspecific somatic symptoms were frequently present in patients with SFD. Several potential factors were associated with higher medical expenses, repeated doctor visits, and sick leave days taken in the regression analysis.

Conclusion
The findings indicate that patients with SFD are common in general hospitals, and their direct and indirect economic burden is higher than that of non-SFD patients, which indicates that more screening effort should be made to this group to early identify their problems. Certain characteristics were identified among patients with SFD and several factors were associated with negative consequences of SFD, all of which might be prevented by developing a preventive intervention program to reduce the economic burden of the patients.
Integrating knowledge and action: learnings from an implementation program for food security and food sovereignty with First Nations communities within Canada
Authors: Domingo Ashleigh , Yessis Jennifer , Charles Kerry-Ann , Skinner Kelly , Hanning Rhona M. 
Published: August 2023

Abstract
Background
Collaborative approaches to knowledge translation (KT) are important for advancing community-engaged research. However, there is a need for examples of participatory approaches that have effectively supported public health research, program development, and implementation with First Nations communities. To strengthen KT with communities, we proposed a set of guiding principles for participatory planning and action for local food system change. Principles emerged from a cross-community analysis of Learning Circles: Local Healthy Food to School (LC:LHF2S) a participatory program (2015–2019) for Indigenous food system action. The objective was to identify guiding principles for participatory planning and action from key learnings and successes on scaling-up of the Learning Circles (LC) model vertically in Haida Nation, British Columbia (BC), and horizontally in three distinct community contexts: Gitxsan Nation, Hazelton /Upper Skeena, BC; Ministikwan Lake. The application of these principles is discussed in the context of our ongoing partnership with Williams Treaties First Nations to support community planning to enhance food security and sovereignty.

Methods
A cross-community thematic analysis was conducted and guided by an implementation science framework, Foster-Fishman and Watson’s (2012) ABLe Change Framework, to identify key learnings and successes from adapting the LC approach. Information gathered from interviews (n = 55) and meeting reports (n = 37) was thematically analyzed to inform the development of guiding principles. Community sense-making of findings informed applicability in a new community context embarking on food systems work.

Results
Emergent guiding principles for participatory food system planning and action are described within four main areas: (1) create safe and ethical spaces for dialog by establishing trust and commitment from the ground up, (2) understand the context for change through community engagement, (3) foster relationships to strengthen and sustain impact, and (4) reflect and embrace program flexibility to integrate learnings.

Conclusions
Emergent principles offer guidance to supporting Indigenous community-led research and mobilization of knowledge into action. Principles are intended to support researchers and health system administrators with taking a collaborative approach that fosters relationships and integration of community leadership, knowledge, and action for food system change. Application of principles with implementation frameworks can strengthen KT in Indigenous contexts by incorporating community protocols and perspectives in support of Indigenous self-determined priorities.
The prevalence of bronchiectasis in patients with alpha-1 antitrypsin deficiency: initial report of EARCO
Authors: Stockley Robert A. , Pye Anita , De Soyza Joshua , Turner Alice M. , Miravitlles Marc ,   the EARCO study investigators, Torres-Duran María , Tanash Hanan , Rodríguez-García Carlota , López-Campos José Luis , Chlumsky Jan , Guimaraes Catarina , Rodríguez-Hermosa Juan Luis , Corsico Angelo , Martinez-González Cristina , Hernández-Pérez José María , Bustamante Ana , Parr David G. , Casas-Maldonado Francisco , Hecimovic Ana , Janssens Wim , Lara Beatriz , Barrecheguren Miriam , González Cruz , Stolk Jan , Clarenbach Christian F. 
Published: August 2023

Abstract
Background
Although bronchiectasis has been recognised as a feature of some patients with Alpha1-Antitrypsin deficiency the prevalence and characteristics are not widely known. We wished to determine the prevalence of bronchiectasis and patient characteristics. The first cohort of patients recruited to the EARCO (European Alpha1 Research Collaboration) International Registry data base by the end of 2021 was analysed for radiological evidence of both emphysema and bronchiectasis as well as baseline demographic features.

Results
Of the first 505 patients with the PiZZ genotype entered into the data base 418 (82.8%) had a reported CT scan. There were 77 (18.4%) with a normal scan and 38 (9.1%) with bronchiectasis alone. These 2 groups were predominantly female never smokers and had lung function in the normal range. The remaining 303 (72.5%) ZZ patients all had emphysema on the scan and 113 (27%) had additional evidence of bronchiectasis.

Conclusions
The data indicates the bronchiectasis alone is a feature of 9.1% of patients with the PiZZ genotype of Alpha1-antitrypsin deficiency but although emphysema is the dominant lung pathology bronchiectasis is also present in 27% of emphysema cases and may require a different treatment strategy.
Synergistic efficacy of simultaneous anti-TGF-β/VEGF bispecific antibody and PD-1 blockade in cancer therapy
Authors: Niu Mengke , Yi Ming , Wu Yuze , Lyu Lijuan , He Qing , Yang Rui , Zeng Liang , Shi Jian , Zhang Jing , Zhou Pengfei , Zhang Tingting , Mei Qi , Chu Qian , Wu Kongming 
Published: August 2023

Abstract
Background
Recently, therapeutic antibodies against programmed cell death 1 (PD-1) and its ligand (PD-L1) have exerted potent anticancer effect in a variety of tumors. However, blocking the PD-1/PD-L1 axis alone is not sufficient to restore normal immune response. Other negative regulators of antitumor immunity, like TGF-β and VEGFA, are also involved in immune escape of tumor cells and induce immunotherapy resistance.

Methods
We developed a novel anti-TGF-β/VEGF bispecific antibody Y332D based on the Nano-YBODY™ technology platform. The CCK-8, flow cytometry, SBE4 luciferase reporter assay, western blotting and transwell assays were used to measure the biological activities of the anti-TGF-β moiety. The NFAT luciferase reporter assay, luminescent cell viability assay and tube formation assay were used to measure the biological activities of the anti-VEGF moiety. The in vivo anticancer efficacy of Y332D alone or in combination with PD-1 blockade was evaluated in H22, EMT-6, 4T1, and AKT/Ras-driven murine hepatocellular carcinoma tumor models. Immunofluorescent staining, flow cytometry, RNA-seq and quantitative RT-PCR were adopted to analyze the alterations in the tumor microenvironment.

Results
Y332D could maintain specific binding affinities for TGF-β and VEGFA. Y332D almost entirely counteracted the in vitro biological functions of TGF-β and VEGFA, including immunosuppression, activated TGF-β signaling, epithelial-mesenchymal transition (EMT), activated VEGF/VEGFR signaling, HUVEC proliferation and tube formation. The in vivo experiment data demonstrated that Y332D was more effective in inhibiting tumor growth and metastasis than anti-TGF-β and anti-VEGF monotherapies. In combination therapies, Y332D plus PD-1 blockade exhibited the most potent and durable anticancer effect. Mechanistically, Y332D plus PD-1 blockade upregulated the density and function of tumor-infiltrating lymphocytes and exerted reinvigorated antitumor immunity.

Conclusion
Y332D could simultaneously block TGF-β and VEGF signalings. In comparison with the monotherapies, Y332D combined with PD-1 blockade exerts superior antitumor effect through improving immune microenvironment.
What motivates and demotivates emergency response volunteers? A survey-based factor analysis study
Authors: Prytz Erik , Norrblom Petter , Pilemalm Sofie , Andersson Granberg Tobias , Jonson Carl-Oscar 
Published: August 2023

Abstract
Background
Organized volunteer initiatives can reduce response times and improve outcomes in emergencies such as cardiac arrests or fires. Retention of volunteers is important to maintain good coverage and capabilities. The current study explores factors underlying volunteers’ motivation to continue as volunteers.

Methods
Data from 5347 active volunteers were collected through an online survey. An exploratory factor analysis was used to identify underlying factors that were then used in a regression analysis to predict intention to continue as a volunteer. Group differences based on, among others, number of alarms and prior professional experience in emergency response were explored.

Results
The results showed that the factors community, self-image, and competence were the strongest positive predictors for the motivation to continue, whereas alarm fatigue and negative experience were the strongest negative predictors. Volunteers with professional background had higher competence and lower Alarm fatigue. Volunteers from rural areas and small cities had higher community than those in large cities.

Conclusions
Alarm fatigue can make it hard to retain volunteers, which could be addressed using improved dispatch algorithms. Support after dispatch is important to prevent negative experiences. Finally, increased competence, e.g. through education and training, can improve volunteer’s motivation to continue.
Statistical analysis plan and protocol updates for Gestational diabetes in Uganda and India: Design and Evaluation of Educational Films for Improving Screening and Self-management (GUIDES) trial
Authors: Birk Nick , Oakley Laura L. , Mallinson Poppy A. C. , R Deepa , Babu Giridhara R. , Nyirenda Moffat , Kinra Sanjay 
Published: August 2023

Abstract
Background
Timely detection and management of gestational diabetes mellitus (GDM) have been identified as a high priority for policymakers in low- and middle-income countries (LMICs). The GUIDES trial will evaluate a package of three interconnected film-based interventions aimed at improving the timely detection and management of GDM. The protocol for this trial has previously been published; this publication outlines the statistical analysis plan for the trial.

Methods and design
The GUIDES study is a multi-country cluster-randomised controlled trial consisting of one trial conducted in Uganda and one in India (30 clusters in each country). Mixed effects models will be used to compare the primary study outcomes of the proportion of women who are tested for GDM between 24 and 32 weeks of pregnancy and the mean fasting blood sugar of women with GDM at 34-week follow-up while accounting for clustering. Secondary analyses will compare the proportion of women with self-reported GDM diagnosis at 32 weeks of pregnancy and the proportion of women with adverse perinatal outcomes related to GDM up to 4 weeks after birth in each trial arm.

Trial status and discussion
Follow-up is expected to end in March 2023 in Uganda and in May 2023 in India. Analyses will be carried out following this statistical analysis plan in the month following trial completion.

Trial registration
ClinicalTrials.gov NCT03937050. Registered on 3 May 2019. Clinical Trials Registry India CTRI/2020/02/023605. Registered on 26 February 2020.
Efficacy of an Internet-based intervention with self-applied exposure therapy in virtual reality for people with panic disorder: study protocol for a randomized controlled trial
Authors: Schultz Josephine , Baumeister Anna , Schmotz Stella , Moritz Steffen , Jelinek Lena 
Published: August 2023

Abstract
Background
Due to several treatment barriers, many individuals with panic disorder do not receive evidence-based treatment. One promising option to narrow this treatment gap is Internet-based psychotherapy, which has been shown particularly effective in guided formats. Still, there remains room for improvement to make these digital therapies more accessible, cost-efficient, and aligned with best practices for in-person interventions (e.g., exposure). The smartphone app “Invirto – Treatment for Anxiety” offers digitally guided, evidence-based treatment of panic disorders including virtual reality (VR) for exposure therapy. The aim present study is to investigate the efficacy, safety, and acceptance of Invirto in comparison to a care-as-usual (CAU) control group.

Methods
We plan to conduct a randomized controlled trial with two conditions (intervention vs. CAU), three assessment times via online surveys (t0: baseline; t1: 3 months after baseline; t2: follow-up assessment 6 months after baseline), and a total of 128 participants with a clinical diagnosis of panic disorder (symptoms must be experienced ≥ 1 year). Recruitment will take place via email, phone, and the study website. The primary outcome will be the change in anxiety symptoms as measured by Beck’s Anxiety Inventory from t0 to t1. Secondary outcomes will be the change in anxiety symptoms (measured by the Panic and Agoraphobia Scale, PAS; Questionnaire on panic-related Anxieties, Cognitions and Avoidance, ACA), depressive symptoms (measured by the Beck-Depression-Inventory, BDI-II), treatment satisfaction (measured by the Client Satisfaction Questionnaire, CSQ-8; Treatment Adherence Perception Questionnaire, TAPQ-adapt; Positive and Negative Effects of Psychotherapy Scale, PANEPS-I), psychological flexibility (measured by the Acceptance and Action Questionnaire-II, AAQ-II), and dissociation during VR exposure (measured by an adapted version of the Peritraumatic Dissociative Experiences Questionnaire, PDEQ-adapt). Participants in the intervention group will receive access to the intervention (Invirto) right after t0, while the CAU group will receive access to Invirto after t1. We expect a larger change in both the primary and secondary outcomes from t0 to t1 in the intervention group in comparison to the CAU group.

Discussion
This study is one of the first to evaluate an Internet-based intervention for people with panic disorder that includes self-application of VR exposure therapy. The findings are expected to extend the body of knowledge about effective Internet-based treatment options for people with panic disorder. The empirical and clinical implications and the limitations of the study are discussed.

Trial registration
DRKS00027585 (www.drks.de/drks_web/), date of registration: 13 January 2022.
Effect of concurrent resistance-aerobic training on inflammatory factors and growth hormones in children with type 1 diabetes: a randomized controlled clinical trial
Authors: Nazari Marzieh , Shabani Ramin , Hassanzadeh-Rad Afagh , Esfandiari Mohammad Ali , Dalili Setila 
Published: August 2023

Abstract
Background
Exercise training is a major factor in controlling type 1 diabetes mellitus (T1DM) in children. The present study aimed to assess the effect of concurrent resistance-aerobic training on selected inflammatory factors and hormones related to blood glucose homeostasis in children with T1DM.

Methods
In this randomized controlled clinical trial, 40 children (with the mean age of 11.11 ± 2.29 years) were randomly assigned to an experimental (N = 20) or control group (N = 20). They underwent a 16-week training program, composed of concurrent resistance-aerobic training performed intermittently for 60 min three times a week. Before and after training, blood samples were analyzed for glucose homeostasis, selected inflammatory factors, and growth factors. Data were analyzed by paired t-test and analysis of covariance (ANCOVA) in IBM SPSS version 22.

Results
The exercise training intervention reduced fasting blood sugar index (P = 0.002) and glycosylated hemoglobin significantly (P = 0.003). The growth hormone levels were increased significantly only in the experimental group (P = 0.037), whereas no significant difference was noted in the insulin-like growth factor-1 (P = 0.712). It was also found that interleukin-1β and high-sensitivity C-reactive protein did not change in the experimental or control group as compared to the pretest (P > 0.05).

Conclusion
As it was shown, it seems that concurrent resistance-aerobic training may improve blood glucose homeostasis and growth hormone. Therefore, these findings may suggest the benefit from exercise training of moderate intensity in children with T1DM. Besides, we recommend undertaking further clinical trials to determine if the exercise training was effective.

Trial registration
This study was registered in the Iranian Registry of Clinical Trials under the code IRCT20150531022498N30: https://en.irct.ir/trial/41031. Registered on July 26, 2019. All experiments on the participants were following the Declaration of Helsinki.