bluuebunny/crossref_metadata_2025_split huggingface dataset:
MesenchymAl stromal cells for Traumatic bRain Injury (MATRIx): a study protocol for a multicenter, double-blind, randomised, placebo-controlled phase II trial
Authors: Zanier Elisa R. , Pischiutta Francesca , Rulli Eliana , Vargiolu Alessia , Elli Francesca , Gritti Paolo , Gaipa Giuseppe , Belotti Daniela , Basso Gianpaolo , Zoerle Tommaso , Stocchetti Nino , Citerio Giuseppe ,   on behalf of the MATRIx Study group
Published: August 2023

Abstract
Background
Traumatic brain injury (TBI) is a significant cause of death and disability, with no effective neuroprotective drugs currently available for its treatment. Mesenchymal stromal cell (MSC)-based therapy shows promise as MSCs release various soluble factors that can enhance the injury microenvironment through processes, such as immunomodulation, neuroprotection, and brain repair. Preclinical studies across different TBI models and severities have demonstrated that MSCs can improve functional and structural outcomes. Moreover, clinical evidence supports the safety of third-party donor bank-stored MSCs in adult subjects. Building on this preclinical and clinical data, we present the protocol for an academic, investigator-initiated, multicenter, double-blind, randomised, placebo-controlled, adaptive phase II dose-finding study aiming to evaluate the safety and efficacy of intravenous administration of allogeneic bone marrow-derived MSCs to severe TBI patients within 48 h of injury.

Methods/design
The study will be conducted in two steps. Step 1 will enrol 42 patients, randomised in a 1:1:1 ratio to receive 80 million MSCs, 160 million MSCs or a placebo to establish safety and identify the most promising dose. Step 2 will enrol an additional 36 patients, randomised in a 1:1 ratio to receive the selected dose of MSCs or placebo. The activity of MSCs will be assessed by quantifying the plasmatic levels of neurofilament light (NfL) at 14 days as a biomarker of neuronal damage. It could be a significant breakthrough if the study demonstrates the safety and efficacy of MSC-based therapy for severe TBI patients. The results of this trial could inform the design of a phase III clinical trial aimed at establishing the efficacy of the first neurorestorative therapy for TBI.

Discussion
Overall, the MATRIx trial is a critical step towards developing an effective treatment for TBI, which could significantly improve the lives of millions worldwide affected by this debilitating condition.
Trial Registration EudraCT: 2022-000680-49.
Foreland basin unconformity, Western Himalaya, Pakistan: timing gap, regional correlation and tectonic implications
Authors: Qasim Muhammad , Rehman Zia Ur , Ding Lin , Tanoli Javed Iqbal , Abbas Wahid , Jamil Muhammad , Bhatti Zahid Imran , Umar Muhammad 
Published: August 2023

AbstractThis study estimates the timing of unconformity between marine–continental transitional sequence of the Kuldana Formation and continental sequence of the Murree Formation for the first time across the Hazara-Kashmir syntaxis, western Himalaya, Pakistan. The ages of the studied units are constrained using detrital zircon U–Pb geochronology. The maximum depositional ages constrained by weighted mean and youngest detrital zircon age are 37 ± 1.7 Ma and 22.5 ± 0.6 Ma for top of Kuldana and base of Murree formations, respectively. Based on this age, the duration of hiatus is estimated to be ~ 14.5 Ma. The comparison of this unconformity and sedimentation pattern along strike suggests that the initial collision occurred in the central segment causing its early uplift and erosion with development of the unconformity. The sedimentation in the central segment culminated at ~ 37 Ma and resumed at ~ 22.5 Ma. The wider gap in central segment becomes narrower at western and eastern margin suggesting discontinuous deposition due to gradually closure of western and eastern margin. This supports the diachronous collision of the Indian and Asian plates with initial contact at the central segment.
Development and testing the feasibility of a sports-based mental health promotion intervention in Nepal: a protocol for a pilot cluster-randomised controlled trial
Authors: Rose-Clarke Kelly , Rimal Damodar , Morrison Joanna , Pradhan Indira , Hodsoll John , Jaoude Gerard Abou , Moore Brian , Banham Louise , Richards Justin , Jordans Mark , Prost Audrey , Lamichhane Nabin , Regmee Jaya , Gautam Kamal , Luitel Nagendra P. 
Published: August 2023

Abstract
Background
Mental wellbeing encompasses life satisfaction, social connectedness, agency and resilience. In adolescence, mental wellbeing reduces sexual health risk behaviours, substance use and violence; improves educational outcomes; and protects mental health in adulthood. Mental health promotion seeks to improve mental wellbeing and can include activities to engage participants in sport. However, few high-quality trials of mental health promotion interventions have been conducted with adolescents, especially in low- and middle-income countries. We sought to address this gap by testing SMART (Sports-based Mental heAlth pRomotion for adolescenTs) in a pilot cluster-randomised controlled trial (cRCT) in Bardiya, Nepal.

Methods
The objectives of the trial are to assess the acceptability and feasibility of SMART, test trial procedures, explore outcome distributions in intervention and control clusters and calculate the total annual cost of the intervention and unit cost per adolescent. The trial design is a parallel-group, two-arm superiority pilot cRCT with a 1:1 allocation ratio and two cross-sectional census surveys with adolescents aged 12–19, one pre-intervention (baseline) and one post-intervention (endline). The study area is four communities of approximately 1000 population (166 adolescents per community). Each community represents one cluster. SMART comprises twice weekly football, martial arts and dance coaching, open to all adolescents in the community, led by local sports coaches who have received psychosocial training. Sports melas (festivals) and theatre performances will raise community awareness about SMART, mental health and the benefits of sport. Adolescents in control clusters will participate in sport as usual. In baseline and endline surveys, we will measure mental wellbeing, self-esteem, self-efficacy, emotion regulation, social support, depression, anxiety and functional impairment. Using observation checklists, unstructured observation and attendance registers from coaching sessions, and minutes of meetings between coaches and supervisors, we will assess intervention fidelity, exposure and reach. In focus group discussions and interviews with coaches, teachers, caregivers and adolescents, we will explore intervention acceptability and mechanisms of change. Intervention costs will be captured from monthly project accounts, timesheets and discussions with staff members.

Discussion
Findings will identify elements of the intervention and trial procedures requiring revision prior to a full cRCT to evaluate the effectiveness of SMART.

Trial registration
ISRCTN, ISRCTN15973986, registered on 6 September 2022; ClinicalTrials.gov, NCT05394311, registered 27 May 2022.
Introducing electronic monitoring of disease activity in patients with chronic inflammatory demyelinating polyneuropathy (EMDA CIDP): trial protocol of a proof of concept study
Authors: Masanneck Lars , Voth Jan , Huntemann Niklas , Öztürk Menekse , Schroeter Christina B. , Ruck Tobias , Meuth Sven G. , Pawlitzki Marc 
Published: August 2023

Abstract
Introduction
Chronic inflammatory demyelinating polyneuropathy (CIDP) is one of the most common immune neuropathies leading to severe impairments in daily life. Current treatment options include intravenous immunoglobulins (IVIG), which are administered at intervals of 4–12 weeks. Determination of individual treatment intervals is challenging since existing clinical scores lack sensitivity to objectify small, partially fluctuating deficits in patients. End-of-dose phenomena described by patients, manifested by increased fatigue and worsening of (motor) symptoms, are currently difficult to detect. From a medical and socio-economic point of view, it is necessary to identify and validate new, more sensitive outcome measures for accurate mapping of disease progression and, thus, for interval finding. Digital health technologies such as wearables may be particularly useful for this purpose, as they record real-life data and consequently, in contrast to classic clinical 'snapshots’, can continuously depict the disease course.

Methods
In this prospective, observational, non-interventional, single-center, investigator-initiated study, CIDP patients treated with IVIG will be continuously monitored over a period of 6 months. Clinical scores and blood analyses will be assessed and collected during three visits (V1, V2, V3). Additionally, activity, sleep, and cardiac parameters will be recorded over the entire period using a wearable device. Further, patients' subjective disease development and quality of life will be recorded at various visits (read-outs). The usability of the smartwatch will be assessed at the end of the study.

Perspective
The study aims to evaluate different digital measurements obtained with the smartwatch and blood-based analyses for monitoring disease activity and progress in CIDP patients. In conjunction, both means of monitoring might offer detailed insights into behavioral and biological patterns associated with treatment-related fluctuations such as end-of-dose phenomena.

Trial registration

The study protocol was registered at ClinicalTrials.gov. Identifier: NCT05723848. Initially, the protocol was submitted prospectively on January 10, 2023. The trial was publicly released after formal improvements on February 13, 2023, after first patients were included according to the original protocol.
Suicidal behaviours among school-going adolescents in samoa: a secondary analysis of prevalence, protective, and risk factors
Authors: Sarfo Jacob Owusu , Gbordzoe Newton Isaac , Attigah Dean , Debrah Timothy Pritchard , Ofori Crescens Osei Bonsu , Obeng Paul 
Published: August 2023

Abstract
Background
Suicide has become a major threat to achieving Sustainable Development Goals three and four, especially for school-going adolescents worldwide. As part of efforts to prevent suicide, population-based studies regarding the prevalence and variables that predict suicidal behaviours are required to inform decisions. Despite this realisation, Samoa lacks empirical data on suicidal behaviours among adolescents. We conducted a secondary analysis of the 2017 Global School-based Student Health Survey to examine the prevalence of suicidal behaviours (idea, plan, and attempt) of school-going adolescents in Samoa.

Results
The prevalence of suicidal ideation, plan, and attempt was 24.1%, 23.8%, and 21.8%, respectively. Also, we found that having understanding parents was an important protective factor against all three suicidal behaviours among Samoan in-school adolescents. Suicidal ideation was predicted by cigarette smoking, having someone who smokes in adolescents’ presence, bullying, loneliness, and worrying about things they could not study. Also, cigarette smoking, bullying, having multiple sexual partners, and worrying increased the risk of having suicidal plans. Again, adolescents’ suicidal attempt was predicted by adolescent truancy, alcohol use, cigarette smoking, being bullied, having close friends, loneliness, and worry.

Conclusions
Rather than focusing on the school setting alone, suicide prevention interventions in Samoa should foster interdisciplinary collaborations to help reduce suicide.
How does the mediating role of the use of social media platforms foster the relationship between employer attractiveness and generation Z intentions to apply for a job?
Authors: El-Menawy Sara Mohamed Abdelaziz , Saleh Pancie Salah 
Published: August 2023

AbstractThe way Jobseekers apply for jobs has drastically changed due to the rise of digital technology. With the rise of social media Jobseekers nowadays typically utilize social networking sites or other online platforms to look for work and it has made it a vital part of the labor market, especially among the young generation. The aim of this research was to determine the mediating effect of Social Media Platforms on the relationship between Employer Attractiveness and Generation Z intentions to apply for a job. The researchers use a Judgmental sampling method among fresh graduates and final-year students of number of Private universities in Egypt. Structure Equation Modeling were then used to analyze the data. The finding of this research revealed that Social Media Platforms has a mediating effect on the relationship between Employer Attractiveness and Gen Z intentions to apply for a job. Moreover, when it comes to choosing an employer, the younger generations prioritize economic value, social value, Reputation and development-interest factors over the application-diversity, working environment aspects, and management and work life balance. Furthermore, this research revealed that, the significance of certain aspects of a job change depending on the participants' educational level and the study's program. The contribution of this research provides valuable insight into how employers are perceived by young job seekers. They can also be used to develop effective recruitment strategies and improve the communication between HR professionals and candidates.
Epidemiology of Anterior Cruciate Ligament Tears in National Collegiate Athletic Association Athletes: 2014/15 – 2018/19
Authors: Dewig Derek R. , Boltz Adrian J. , Moffit Reagan E. , Rao Neel , Collins Christy L. , Chandran Avinash 
Published: August 2023

ABSTRACT
Anterior cruciate ligament (ACL) tears are prevalent in National Collegiate Athletic Association (NCAA) sports, and updated epidemiological evidence is needed to adequately inform prevention efforts.

Purpose
To describe the epidemiology of ACL tears in NCAA men’s and women’s sports.

Methods
Injury and exposure data collected within the NCAA Injury Surveillance Program from 2014/15-2018/19 were analyzed. ACL tear frequencies, rates (IRs) and proportions were used to describe injury incidence by sport, event type, injury mechanism, and injury history. Injury rate ratios (IRRs) were utilized to examine differential injury rates, and injury proportion ratios (IPRs) were used to examine differential distributions.

Results
A total of 729 ACL tears were reported from 8,474,401 recorded athlete exposures (AEs) during the study period (IR = 0.86 per 10,000 AEs), and the competition-related ACL tear rate was higher than the practice-related rate (IRR = 5.52, 95% CI: [4.75, 6.39]). Among men’s sports, the highest overall ACL tear rate was observed in men’s football (IR = 1.44 per 10,000 AEs), while among women’s sports, the highest overall rate was observed in women’s soccer (IR = 2.60 per 10,000 AEs). Among sex-comparable sports, ACL tear rates were higher in women’s basketball, softball, and soccer, as compared with their men’s counterparts. ACL tears were more prevalently attributed to player-contact mechanisms in men’s sports than women’s sports (IPR = 1.73, 95% CI: [1.37, 2.19]), while more prevalently attributed to non-contact mechanisms in women’s sports than men’s sports (IPR = 1.17, 95% CI: [1.01, 1.35]).

Conclusions
ACL tear risk in women’s sports continues to warrant attention and prevention efforts. Given the differential rates by event type, future research efforts may also evaluate initiatives to reduce competition-related injury burden in NCAA sports.
Initial development and validation of item banks to measure problematic hypersexuality
Authors: van Tuijl Piet , Verboon Peter , van Lankveld Jacques 
Published: August 2023

Background: Problematic Hypersexuality (PH) is defined as a distress caused by hypersexuality, to the extent that seeking treatment is considered. PH was previously measured with instruments stemming from different perspectives on PH. These instruments might best be analyzed in unison to discover the most optimal set of characteristics to measure PH. Methods: A total of 58 items were investigated with Item Response Theory (IRT). We included 1211 participants (592 women, 618 men, 1 other) from a representative Dutch general population sample of 18 years or older. In addition, 371 participants (116 women, 253 men, 2 other) in a web-based survey who sought information on their current level of PH were included – of whom 50.4 % at least considered seeking help for hypersexuality. Results: After item selection based on item averages per group, 26 out of 58 items were retained and divided in two scales: Emotion Dysregulation-PH – 9 items representing the distressing emotional patterns coinciding with hypersexual preoccupation – and Negative Effects-PH – 17 items representing the negative consequences of patterns of hypersexual thoughts and behavior. Assumptions for IRT analyses were met (unidimensionality, local independence and monotonicity). After an IRT graded response model was fit, the scales showed sufficient reliability for the target population of hypersexual individuals. In the general population the scales showed large floor effects and were less reliable. Conclusions: With this study a first step is taken in validating two complementary item banks to measure PH. Further development of the item banks should include the investigation of responsiveness. New items should be constructed to assess less-explored areas of PH and improve differentiating power of the scales. This study showed that diagnostic accuracy for PH is currently difficult to attain with a survey, even when using an extended item set representing the most unique characteristics of PH.
A Numerically Exact Algorithm for the Bin-Packing Problem
Authors: Baldacci Roberto , Coniglio Stefano , Cordeau Jean-François , Furini Fabio 
Published: August 2023

We propose a numerically exact algorithm for solving the Bin-Packing Problem (BPP) based on a branch-price-and-cut framework combined with a pattern-enumeration method. Key to the algorithm is a novel technique for the computation of numerically safe dual bounds for the widely adopted set covering reformulation of the BPP (tightened with additional valid inequalities) with a precision that is higher than the one of general-purpose floating-point solvers. Our branch-price-and-cut algorithm also relies on an exact integer (fixed-point) label setting algorithm for solving the pricing problem associated with the tightened set-covering formulation. To the best of our knowledge, ours is the first algorithm for the BPP that is numerically exact and practical for solving large-scale instances. Extensive computational results on instances affected by notorious numerical difficulties (those of the Augmented Non-IRUP class) show that our exact algorithm outperforms all of the not numerically exact state-of-the-art algorithms based on branch-and-cut-and-price techniques that rely on a set-covering formulation of the BPP. History: Accepted by Andrea Lodi, Area Editor for Design & Analysis of Algorithms − Discrete.
Whispering-gallery optical microprobe for photoacoustic imaging
Authors: Sun Jialve , Tang Shui-Jing , Meng Jia-Wei , Li Changhui 
Published: August 2023

Optical ultrasonic probes, exemplified by Fabry–Perot cavities on optical fibers, have small sizes, high sensitivity, and pure optical characteristics, making them highly attractive in high-resolution ultrasonic/photoacoustic imaging, especially in near-field or endoscopic scenarios. Taking a different approach, we demonstrate an ultrasensitive and broadband ultrasound microprobe formed by an optical whispering-gallery-mode polymer microcavity coupled to a U-shaped microfiber. With the high-quality (Q) factors (>106), the noise equivalent pressure of the ultrasound microprobe reaches 1.07  mPa/√Hz with a record broadband response of 150 MHz and a large detection angle of 180°. Our results show that this optical microprobe can overcome the strong decay resulting from ultrasound diverging and medium absorption through short working distances. We further demonstrate high-quality in vivo whole-body photoacoustic imaging of a zebrafish larva. Our implementation provides a new strategy for developing miniature ultrasound detectors and holds great potential for broad applications.
Immunogenicity and safety of Quadrivalent Influenza HA vaccine compared with Trivalent Influenza HA vaccine and evaluation of Quadrivalent Influenza HA vaccine batch-to-batch consistency in Indonesian children and adults
Authors: Fadlyana Eddy , Dhamayanti Meita , Tarigan Rodman , Prodjosoewojo Susantina , Rahmadi Andri Reza , Sari Rini Mulia , Rusmil Kusnandi , Kartasasmita Cissy B. 
Published: August 2023

One of the newest strategies developed by the Global Influenza Strategy has been to broaden the composition of the current influenza vaccine formulations from trivalent products to quadrivalent products. This study aimed to assess the immunogenicity and safety of Quadrivalent Influenza HA vaccine (QIV) compared with Trivalent Influenza HA vaccine (TIV) and to evaluate three consecutive batches of QIV equivalence in Indonesian children and adults. This was an experimental, randomized, double blind, four arm parallel group bridging study involving unprimed healthy children and adults aged 9–40 years. A total of 540 subjects were enrolled in this study and randomized into four arm groups. Each subject received one dose of TIV or QIV with three different batch codes. Serology tests were performed at baseline and 28 days after vaccination. Hemagglutination inhibition (HI) antibody titers were analyzed for Geometric Mean Titer (GMT), seroprotection, and seroconversion rates. Solicited, unsolicited, and serious adverse events were observed up to 28 days after vaccination. A total of 537 subjects completed the study per protocol and were analyzed for immunogenicity criteria. All randomized subjects were analyzed for safety criteria. The percentage of the subjects with anti-HI titer ≥1:40 28 days after QIV vaccination was 99.5% for A/H1N1; 99.5% for A/H3N2; 93.1% for B/Texas, and 99.0% for B/Phuket. The seroprotection, GMT, and seroconversion rates of QIV were not significantly different from those of TIV for the common vaccine strains (p > 0.01) and were significantly different from those of TIV for the added B/Phuket strains (p < 0.01). Most solicited injection-site and systemic reactions with either vaccine were mild to moderate and resolved within a few days. Antibody response to QIV were equivalence among vaccine batches and comparable between age groups for each of the 4 strains. QIV was immunogenic and well-tolerated and had immunogenicity and safety profiles compared with TIV for all common strains. The immunogenicity of the three batches of QIV was equivalent for the four strains.
Trial registration. Clinical Trial registration: NCT03336593.