bluuebunny/crossref_metadata_2025 huggingface dataset:
Clinical efficacy of Tailin formulation combined with continuous low-dose antimicrobial therapy for recurrent urinary tract infection: study protocol for a multicenter, double-blind, randomized, controlled clinical trial
Authors: Li Tonglu , Xu Yingru , Gong Xuezhong
Published: December 2021

Background

Given the increasing rates of antimicrobial resistance (AMR), recurrent urinary tract infection (rUTI) is becoming refractory more and more. Antibiotic prophylaxis including continuous low-dose antibiotic therapy (CLAT), is the common treatment for rUTI of the world. However, the presumably adverse reactions caused by CLAT alone should be paid more attention. Studies indicated that Chinese herbal medicine (CHM) might be an available treatment method for rUTI. Tailin formulation (TLF) is a herbal prescription developed for the treatment of rUTI in the 2000s in Shanghai Municipal Hospital of Traditional Chinese Medicine. Our previous studies have shown TLF could prevent urinary tract infection both in pyelonephritis (PN) rat model and in PN patients. Additionally, our published data demonstrated TLF is helpful to reduce the recurrence of rUTI and protect renal tubular function in clinic. In order to find a novel treating project for rUTI to increase the clinical curative effect, we thus try to combine TLF with CLAT to treat rUTI and design an optimized, pragmatically clinical trial to evaluate the efficacy and safety of this project.

Methods/design

This is a multicenter, double-blind, randomized, controlled clinical trial. We will enroll 200 eligible patients diagnosed with uncomplicated rUTI and then divide them randomly into two groups with a 1:1 ratio: TLF + CLAT group and placebo + CLAT group. This trial consists of two stages, a 12-week period of treatment and a 12-week period of post-treatment follow-up, respectively. The primary outcome will be the recurrence rate at the 12th week of the follow-up period; the second outcomes will be the post-treatment changes in renal and liver function; furthermore, traditional Chinese medicine (TCM) symptoms, non-infection-related physical signs, and subjective symptoms will be scored, and the number of episodes of each subject will be also recorded; meanwhile, vital signs indicators and serious adverse events (SAEs) will be monitored throughout the trial.

Discussion

This study will provide convictive research-derived data to evaluate clinical efficacy and safety of TLF combined with CLAT for rUTI, and provide an evidence-based recommendation for clinicians. Moreover, post-treatment changes in non-infection-related physical signs and subjective symptoms were included in the efficacy evaluation, which is important and more significant for assessing the clinical benefits for those rUTI patients.

Trial registration

Chinese Clinical Trial Registry ChiCTR2100041914. Registered on 10 January 2021. Protocol date and version: September 12, 2020; version 1.
The effectiveness of antibacterial therapeutic clothing based on silver or chitosan as compared with non-antibacterial therapeutic clothing in patients with moderate to severe atopic dermatitis (ABC trial): study protocol for a pragmatic randomized controlled trial
Authors: Ragamin Aviël , Fieten Karin B. , Tupker Ron A. , de Wit Jill , van Mierlo Minke M. F. , Jansen Marieke S. , Bronner Madelon B. , Schappin Renske , Schuren Frank H. J. , Romeijn Margreet L. E. , Arents Bernd W. M. , Polinder Suzanne , de Graaf Marlies , Rustemeyer Thomas , Schuttelaar Marie L. A. , Pasmans Suzanne G. M. A.
Published: December 2021

Background

Atopic dermatitis (AD) is a chronic inflammatory skin disease that affects 10 to 20% of children and between 2 and 15% of the adults in Western Europe. Since 2000, therapeutic clothing or functional textiles based on silver or chitosan as antibacterial agents were introduced for AD. These agents aim to reduce skin colonization with Staphylococcus (S.) aureus. Increased colonization with S. aureus is correlated with increased AD severity. The antimicrobial effects of silver and chitosan have been demonstrated before. At this point, there is insufficient evidence for the effectiveness of antibacterial therapeutic clothing in patients with AD.

Methods

This is a pragmatic randomized controlled double-blind multi-center trial comparing the effectiveness of antibacterial therapeutic clothing based on silver or chitosan as compared with non-antibacterial therapeutic clothing in patients with moderate to severe AD. A total of 165 participants, aged 0 to 80, diagnosed with moderate to severe AD are included. The study is performed in the Erasmus MC University Medical Center, University Medical Center Groningen, University Medical Center Utrecht, Amsterdam University Medical Centers, and St. Antonius Hospital Nieuwegein. Patients will be randomized 1:1:1 into one of the three intervention groups: group A will receive therapeutic clothing without antimicrobial agents, group B will receive microbial growth reducing therapeutic clothing based on chitosan, and group C will receive antimicrobial clothing based on silver. All therapeutic clothing is to be worn at night during the 12-month intervention period. Usual care is continued. The primary objective is to assess the effectiveness of antibacterial clothing (silver and chitosan group) as compared to non-antibacterial clothing assessed with the Eczema Area and Severity Index at 12 months compared to baseline. Secondary outcomes include between-group differences in physician- and patient-reported outcome measures, topical therapy use, S. aureus skin colonization, and safety. Data will be collected at baseline and after 1 month, 3 months, 6 months, and 12 months. A cost-effectiveness analysis will be performed.

Discussion

This trial will provide data on the effectiveness, cost-effectiveness, and safety of antibacterial therapeutic clothing for patients with AD.

Trial registration

ClinicalTrials.gov NCT04297215. Registered on 5 March 2020
Incremental Velocity Error as a New Treatment in Vestibular Rehabilitation (INVENT VPT) Trial: study protocol for a randomized controlled crossover trial
Authors: Ervin Ann-Margret , Schubert Michael C. , Migliaccio Americo A. , Perin Jamie , Coulibaly Hamadou , Millar Jennifer L. , Roberts Dale , Shelhamer Mark , Gold Daniel , Beauregard Stephanie , Pinto Robin , Brungart Douglas , Ward Bryan K. ,   for the INVENT VPT Research Group
Published: December 2021

Background

A clinical pattern of damage to the auditory, visual, and vestibular sensorimotor systems, known as multi-sensory impairment, affects roughly 2% of the US population each year. Within the population of US military service members exposed to mild traumatic brain injury (mTBI), 15–44% will develop multi-sensory impairment following a mild traumatic brain injury. In the US civilian population, multi-sensory impairment-related symptoms are also a common sequela of damage to the vestibular system and affect ~ 300–500/100,000 population. Vestibular rehabilitation is recognized as a critical component of the management of multi-sensory impairment. Unfortunately, the current clinical practice guidelines for the delivery of vestibular rehabilitation are not evidence-based and primarily rely on expert opinion. The focus of this trial is gaze stability training, which represents the unique component of vestibular rehabilitation. The aim of the Incremental Velocity Error as a New Treatment in Vestibular Rehabilitation (INVENT VPT) trial is to assess the efficacy of a non-invasive, incremental vestibular adaptation training device for normalizing the response of the vestibulo-ocular reflex.

Methods

The INVENT VPT Trial is a multi-center randomized controlled crossover trial in which military service members with mTBI and civilian patients with vestibular hypofunction are randomized to begin traditional vestibular rehabilitation or incremental vestibular adaptation and then cross over to the alternate intervention after a prescribed washout period. Vestibulo-ocular reflex function and other functional outcomes are measured to identify the best means to improve the delivery of vestibular rehabilitation. We incorporate ecologically valid outcome measures that address the common symptoms experienced in those with vestibular pathology and multi-sensory impairment.

Discussion

The INVENT VPT Trial will directly impact the health care delivery of vestibular rehabilitation in patients suffering from multi-sensory impairment in three critical ways: (1) compare optimized traditional methods of vestibular rehabilitation to a novel device that is hypothesized to improve vestibulo-ocular reflex performance, (2) isolate the ideal dosing of vestibular rehabilitation considering patient burden and compliance rates, and (3) examine whether recovery of the vestibulo-ocular reflex can be predicted in participants with vestibular symptoms.

Trial registration

ClinicalTrials.gov NCT03846830. Registered on 20 February 2019.
A report from the NIHR UK working group on remote trial delivery for the COVID-19 pandemic and beyond
Authors: Masoli Jane A. H. , Down Kim , Nestor Gary , Hudson Sharon , O’Brien John T. , Williamson James D. , Young Carolyn A. , Carroll Camille ,   on behalf of the NIHR Remote Trial Delivery Working Group
Published: December 2021

Background

Prior to the COVID-19 pandemic, the majority of clinical trial activity took place face to face within clinical or research units. The COVID-19 pandemic resulted in a significant shift towards trial delivery without in-person face-to-face contact or “Remote Trial Delivery”. The National Institute of Health Research (NIHR) assembled a Remote Trial Delivery Working Group to consider challenges and enablers to this major change in clinical trial delivery and to provide a toolkit for researchers to support the transition to remote delivery.

Methods

The NIHR Remote Trial Delivery Working Group evaluated five key domains of the trial delivery pathway: participant factors, recruitment, intervention delivery, outcome measurement and quality assurance. Independent surveys were disseminated to research professionals, and patients and carers, to ascertain benefits, challenges, pitfalls, enablers and examples of good practice in Remote Trial Delivery. A toolkit was constructed to support researchers, funders and governance structures in moving towards Remote Trial Delivery. The toolkit comprises a website encompassing the key principles of Remote Trial Delivery, and a repository of best practice examples and questions to guide research teams.

Results

The patient and carer survey received 47 respondents, 34 of whom were patients and 13 of whom were carers. The professional survey had 115 examples of remote trial delivery practice entered from across England. Key potential benefits included broader reach and inclusivity, the ability for standardisation and centralisation, and increased efficiency and patient/carer convenience. Challenges included the potential exclusion of participants lacking connectivity or digital skills, the lack of digitally skilled workforce and appropriate infrastructure, and validation requirements. Five key principles of Remote Trial Delivery were proposed: national research standards, inclusivity, validity, cost-effectiveness and evaluation of new methodologies.

Conclusions

The rapid changes towards Remote Trial Delivery catalysed by the COVID-19 pandemic could lead to sustained change in clinical trial delivery. The NIHR Remote Trial Delivery Working Group provide a toolkit for researchers recommending five key principles of Remote Trial Delivery and providing examples of enablers.
Effect of preoperative CT angiography examination on the clinical outcome of patients with BMI ≥ 25.0 kg/m2 undergoing laparoscopic gastrectomy: study protocol for a multicentre randomized controlled trial
Authors: Meng Cheng , Cao Shougen , Liu Xiaodong , Li Leping , He Qingsi , Xia Lijian , Jiang Lixin , Chu Xianqun , Wang Xinjian , Wang Hao , Hui Xizeng , Sun Zuocheng , Huang Shusheng , Duan Quanhong , Yang Daogui , Zhang Huanhu , Tian Yulong , Li Zequn , Zhou Yanbing
Published: December 2021

Background

Gastric cancer, which is the fifth most common malignancy and the third most common cause of cancer-related death, is particularly predominant in East Asian countries, such as China, Japan and Korea. It is a serious global health issue that causes a heavy financial burden for the government and family. To our knowledge, there are few reports of multicentre randomized controlled trials on the utilization of CT angiography (CTA) for patients who are histologically diagnosed with gastric cancer before surgery. Therefore, we planned this RCT to verify whether the utilization of CTA can change the short- and long-term clinical outcomes.

Method

The GISSG 20–01 study is a multicentre, prospective, open-label clinical study that emphasises the application of CTA for patients who will undergo laparoscopic gastrectomy to prove its clinical findings. A total of 382 patients who meet the inclusion criteria will be recruited for the study and randomly divided into two groups in a 1:1 ratio: the CTA group (n = 191) and the non-CTA group (n = 191). Both groups will undergo upper abdomen enhanced CT, and the CTA group will also receive CT angiography. The primary endpoint of this trial is the volume of blood loss. The second primary endpoints are the number of retrieved lymph nodes, postoperative recovery course, hospitalization costs, length of hospitalization days, postoperative complications, 3-year OS and 3-year DFS.

Discussion

It is anticipated that the results of this trial will provide high-level evidence and have clinical value for the application of CTA in laparoscopic gastrectomy.

Trial registration

ClinicalTrials.gov, NCT04636099. Registered November 19, 2020
A uracil auxotroph Toxoplasma gondii exerting immunomodulation to inhibit breast cancer growth and metastasis
Authors: Xu Li-Qing , Yao Li-Jie , Jiang Dan , Zhou Li-Juan , Chen Min , Liao Wen-Zhong , Zou Wei-Hao , Peng Hong-Juan
Published: December 2021

Background

Breast cancer is the most common cause of cancer-related death among women, and prognosis is especially poor for patients with triple-negative breast cancer (TNBC); therefore, there is an urgent need for new effective therapies. Recent studies have demonstrated that the uracil auxotrophToxoplasma gondiivaccine displays anti-tumor effects. Here, we examined the immunotherapy effects of an attenuated uracil auxotroph strain ofT. gondiiagainst 4T1 murine breast cancer.

Methods

We constructed a uracil auxotrophT. gondiiRH strain via orotidine 5′-monophosphate decarboxylase gene deletion (RH-Δompdc) with CRISPR/Cas9 technology. The strain’s virulence in theT. gondii-infected mice was determined in vitro and in vivo by parasite replication assay, plaque assay, parasite burden detection in mice peritoneal fluids and survival analysis. The immunomodulation ability of the strain was evaluated by cytokine detection. Its anti-tumor effect was evaluated after its in situ inoculation into 4T1 tumors in a mouse model; the tumor volume was measured, and the 4T1 lung metastasis was detected by hematoxylin and eosin and Ki67 antibody staining, and the cytokine levels were measured by an enzyme-linked immunosorbent assay.

Results

The RH-Δompdcstrain proliferated normally when supplemented with uracil, but it was unable to propagate without the addition of uracil and in vivo, which suggested that it was avirulent to the hosts. This mutant showed vaccine characteristics that could induce intense immune responses both in vitro and in vivo by significantly boosting the expression of inflammatory cytokines. Inoculation of RH-Δompdcin situ into the 4T1 tumor inhibited tumor growth, reduced lung metastasis, promoted the survival of the tumor-bearing mice and increased the secretion of Th1 cytokines, including interleukin-12 (IL-12) and interferon-γ (INF-δ), in both the serum and tumor microenvironment (TME).

Conclusion

Inoculation of the uracil auxotroph RH-Δompdcdirectly into the 4T1 tumor stimulated anti-infection and anti-tumor immunity in mice, and resulted in inhibition of tumor growth and metastasis, promotion of the survival of the tumor-bearing mice and increased secretion of IL-12 and IFN-γ in both the serum and TME. Our findings suggest that the immunomodulation caused by RH-Δompdccould be a potential anti-tumor strategy.

Graphical abstract
Trichomonas vaginalis induces apoptosis via ROS and ER stress response through ER–mitochondria crosstalk in SiHa cells
Authors: Gao Fei Fei , Quan Juan-Hua , Lee Min A. , Ye Wei , Yuk Jae-Min , Cha Guang-Ho , Choi In-Wook , Lee Young-Ha
Published: December 2021

Background

Trichomonas vaginalis causes lesions on the cervicovaginal mucosa in women; however, its pathogenesis remains unclear. We have investigated the involvement of the endoplasmic reticulum (ER) in the induction of apoptosis by T. vaginalis and its molecular mechanisms in human cervical cancer SiHa cells.

Methods

Apoptosis, reactive oxygen species (ROS) production, mitochondrial membrane potential (MMP), ER stress response and Bcl-2 family protein expression were evaluated using immunocytochemistry, flow cytometry, 5,5′,6,6′-tetrachloro-1,1′,3,3′-tetraethyl-imidacarbocyanine iodide dye staining and western blotting.

Results

Trichomonas vaginalis induced mitochondrial ROS production, apoptosis, the ER stress response and mitochondrial dysfunction, such as MMP depolarization and an imbalance in Bcl-2 family proteins, in SiHa cells in a parasite burden- and infection time-dependent manner. Pretreatment with N-acetyl cysteine (ROS scavenger) or 4-phenylbutyric acid (4-PBA; ER stress inhibitor) significantly alleviated apoptosis, mitochondrial ROS production, mitochondrial dysfunction and ER stress response in a dose-dependent manner. In addition, T. vaginalis induced the phosphorylation of apoptosis signal regulating kinase 1 (ASK1) and c-Jun N-terminal kinases (JNK) in SiHa cells, whereas 4-PBA or SP600125 (JNK inhibitor) pretreatment significantly attenuated ASK1/JNK phosphorylation, mitochondrial dysfunction, apoptosis and ER stress response in SiHa cells, in a dose-dependent manner. Furthermore, T. vaginalis excretory/secretory products also induced mitochondrial ROS production, apoptosis and the ER stress response in SiHa cells, in a time-dependent manner.

Conclusions

Trichomonas vaginalis induces apoptosis through mitochondrial ROS and ER stress responses, and also promotes ER stress-mediated mitochondrial apoptosis via the IRE1/ASK1/JNK/Bcl-2 family protein pathways in SiHa cells. These data suggest that T. vaginalis-induced apoptosis is affected by ROS and ER stress response via ER–mitochondria crosstalk.

Graphical Abstract
Seasonal epidemiology of gastrointestinal nematodes of cattle in the northern continental climate zone of western Canada as revealed by internal transcribed spacer-2 ribosomal DNA nemabiome barcoding
Authors: Wang Tong , Redman Elizabeth M. , Morosetti Arianna , Chen Rebecca , Kulle Sarah , Morden Natasha , McFarland Christopher , Vineer Hannah Rose , Colwell Douglas D. , Morgan Eric R. , Gilleard John S.
Published: December 2021

Background

Gastrointestinal nematode (GIN) epidemiology is changing in many regions of the world due to factors such as global warming and emerging anthelmintic resistance. However, the dynamics of these changes in northern continental climate zones are poorly understood due to a lack of empirical data.

Methods

We studied the accumulation on pasture of free-living infective third-stage larvae (L3) of different GIN species from fecal pats deposited by naturally infected grazing cattle. The field study was conducted on three organic farms in Alberta, western Canada. Grass samples adjacent to 24 fecal pats were collected from each of three different pastures on each farm. Internal transcribed spacer-2 nemabiome metabarcoding was used to determine the GIN species composition of the harvested larvae. The rotational grazing patterns of the cattle ensured that each pasture was contaminated only once by fecal pat deposition. This design allowed us to monitor the accumulation of L3 of specific GIN species on pastures under natural climatic conditions without the confounding effects of pasture recontamination or anthelmintic treatments.

Results

In seven out of the nine pastures, grass L3 counts peaked approximately 9 weeks after fecal deposition and then gradually declined. However, a relatively large number of L3 remained in the fecal pats at the end of the grazing season. Nemabiome metabarcoding revealed thatCooperia oncophoraandOstertagia ostertagiwere the two most abundant species on all of the pastures and that the dynamics of larval accumulation on grass were similar for both species. Daily precipitation and temperature across the whole sampling period were similar for most of the pastures, and multiple linear regression showed that accumulated rainfall 1 week prior to sample collection had a significant impact on the pasture L3 population, but accumulated rainfall 3 weeks prior to sample collection did not.

Conclusions

The results suggest that the pasture L3 population was altered by short-term microclimatic conditions conducive for horizontal migration onto grass. Overall, the results show the importance of the fecal pat as a refuge and reservoir for L3 of cattle GIN on western Canadian pastures, and provide an evidence base for the risk assessment of rotational grazing management in the region.

Graphical Abstract
Involvement of lncRNA IL21-AS1 in interleukin-2 and T follicular regulatory cell activation in systemic lupus erythematosus
Authors: Hao He , Nakayamada Shingo , Ohkubo Naoaki , Yamagata Kaoru , Zhang Mingzeng , Shan Yu , Iwata Shigeru , Zhang Tong , Tanaka Yoshiya
Published: December 2021

Background

The single nucleotide polymorphism (SNP) rs62324212, located in IL21 antisense RNA 1 (IL21-AS1), has been identified as a genetic risk variant associated with systemic lupus erythematosus (SLE). We aimed to probe the characteristics of IL21-AS1 and explore its clinical relevance focusing on T helper subsets and disease activity in patients with SLE.

Methods

rs62324212 genotyping was determined using allelic discrimination by quantitative PCR. Gene expression in peripheral blood mononuclear cells and cell surface markers in CD4+ T cells were analyzed using PCR and flow cytometry. The association among IL21-AS1, CD4+ T cell subsets, and SLE disease activity was accessed.

Results

Ensembl Genome Browser analysis revealed that rs62324212 (C>A) was located in the predicting enhancer region of IL21-AS1. IL21-AS1 was expressed in the nucleus of CD4+ T and B cells, but its expression was decreased in patients with SLE. IL21-AS1 expression was positively correlated with mRNA levels of IL-2 but not IL-21, and it was associated with the proportion of activated T follicular regulatory (Tfr) cells. Furthermore, we observed a significant negative correlation between IL21-AS1 expression and disease activity in patients with SLE (n = 53, p < 0.05).

Conclusion

IL21-AS1 has an effect on disease activity through an involvement of IL-2-mediated activation of Tfr cells in SLE. Thus, targeting the IL21-AS1 may provide therapeutic approaches for SLE.
Feature partitioning for robust tree ensembles and their certification in adversarial scenarios
Authors: Calzavara Stefano , Lucchese Claudio , Marcuzzi Federico , Orlando Salvatore
Published: December 2021

Machine learning algorithms, however effective, are known to be vulnerable in adversarial scenarios where a malicious user may inject manipulated instances. In this work, we focus on evasion attacks, where a model is trained in a safe environment and exposed to attacks at inference time. The attacker aims at finding a perturbation of an instance that changes the model outcome.We propose a model-agnostic strategy that builds a robust ensemble by training its basic models on feature-based partitions of the given dataset. Our algorithm guarantees that the majority of the models in the ensemble cannot be affected by the attacker. We apply the proposed strategy to decision tree ensembles, and we also propose an approximate certification method for tree ensembles that efficiently provides a lower bound of the accuracy of a forest in the presence of attacks on a given dataset avoiding the costly computation of evasion attacks.Experimental evaluation on publicly available datasets shows that the proposed feature partitioning strategy provides a significant accuracy improvement with respect to competitor algorithms and that the proposed certification method allows ones to accurately estimate the effectiveness of a classifier where the brute-force approach would be unfeasible.
Unsupervised domain adaptation for lip reading based on cross-modal knowledge distillation
Authors: Takashima Yuki , Takashima Ryoichi , Tsunoda Ryota , Aihara Ryo , Takiguchi Tetsuya , Ariki Yasuo , Motoyama Nobuaki
Published: December 2021

We present an unsupervised domain adaptation (UDA) method for a lip-reading model that is an image-based speech recognition model. Most of conventional UDA methods cannot be applied when the adaptation data consists of an unknown class, such as out-of-vocabulary words. In this paper, we propose a cross-modal knowledge distillation (KD)-based domain adaptation method, where we use the intermediate layer output in the audio-based speech recognition model as a teacher for the unlabeled adaptation data. Because the audio signal contains more information for recognizing speech than lip images, the knowledge of the audio-based model can be used as a powerful teacher in cases where the unlabeled adaptation data consists of audio-visual parallel data. In addition, because the proposed intermediate-layer-based KD can express the teacher as the sub-class (sub-word)-level representation, this method allows us to use the data of unknown classes for the adaptation. Through experiments on an image-based word recognition task, we demonstrate that the proposed approach can not only improve the UDA performance but can also use the unknown-class adaptation data.
Optimum energy harvesting model for bidirectional cognitive radio networks
Authors: Hasan Mohammad Kamrul , Chowdhury Md. Monwar J. , Ahmed Shakil , Sabuj Saifur R. , Nibhen Jamel , Bakar Khairul A. A.
Published: December 2021

Wireless devices’ energy efficiency and spectrum shortage problem has become a key concern worldwide as the number of wireless devices increases at an unparalleled speed. Wireless energy harvesting technique from traditional radio frequency signals is suitable for extending mobile devices’ battery life. This paper investigates a cognitive radio network model where primary users have their specific licensed band, and secondary users equipped with necessary hardware required for energy harvesting can use the licensed band of the primary user by smart sensing capability. Analytical expressions for considered network metrics, namely data rate, outage probability, and energy efficiency, are derived for uplink and downlink scenarios. In addition, optimal transmission power and energy harvesting power are derived for maximum energy efficiency in downlink and uplink scenarios. Numerical results show that outage probability improves high transmission power in the downlink scenario and high harvested power in the uplink scenario. Finally, the result shows that energy efficiency improves using optimum transmission power and energy harvesting power for downlink and uplink scenarios.
Protocol for a meta-narrative review on research paradigms addressing the urban built environment and human health
Authors: Kim Jinhee , Harris-Roxas Ben , de Leeuw Evelyne , Lilley David , Crimeen Alana , Sainsbury Peter
Published: December 2021

Background

Urban health is a field of research and practice that has attracted the interest of various disciplines. While it is encouraged for diverse disciplines to contribute to a multidisciplinary field of study such as urban health, this often results in tensions, conflicts or competition between the different traditions that stem from different epistemological backgrounds.

This meta-narrative review aims to identify and describe the multiple paradigms and articulate the underlying epistemological, ontological, methodological, and aetiological differences in their approaches. Articulating the paradigms not only contributes to the advancement of research, but also provides a framework for understanding the different policy beliefs and ideas policy actors hold and apply in the policy process.

Methods

We apply the meta-narrative method to systematic literature review which includes the following six iterative phases. The planning phase includes the finalisation of the review protocol and assembly of review team. The search phase includes a comprehensive literature search in key databases and a double-sided systematic snowballing method. We will search multidisciplinary databases including Web of Science, Scopus and ProQuest, and topic-specific databases including Urban Studies Abstracts (EBSCO), MEDLINE, and EMBASE from their inception onwards. Bibliometric analyses of this literature will be used to triangulate the mapping of the paradigms. The mapping phase includes identifying the dominant paradigms and landmark publications through agreement with the review team. In the appraisal phase, the literature will be assessed by their respective quality standards, followed by data extraction to identify the individual narratives in the conceptual, theoretical, methodological, and instrumental dimensions of each paradigm. The synthesis phase will review the data to compare and contrast and identify the overarching meta-narratives. The recommendation phase will include dissemination of the findings from the review.

Discussion

The meta-narrative review will reveal the how the different paradigms conceptualise, frame and prioritise urban health issues, their preferred methodologies to study the phenomenon, and the nature of the solutions to improve human health. This review will assist researchers and practitioners in understanding and interpreting evidence produced by other traditions that study urban health. Through this, urban health researchers and practitioners will be able to seek coherence in understanding, explaining, and exploring the urban health phenomenon.

Systematic review registration

Open Science Framework (https://osf/io/tn8vk)
Correlates of interpersonal emotion regulation problems in Loss of Control eating (LOC) in youth: study protocol of the combined online and App based questionnaire, laboratory and randomized controlled online intervention i-BEAT trial
Authors: Munsch Simone , Forrer Felicitas , Naas Adrian , Mueller Verena , Rubo Marius , Hannoun Fouad , Mugellini Elena
Published: December 2021

Background

Binge Eating Disorder (BED) represents a common eating disorder associated with marked health impairments. A subclinical variant, loss of control eating (LOC) is prevalent in youth. LOC is associated with similar mental distress as full-blown BED, increases the risk to develop a BED and promotes continuous weight gain. The etiology of LOC is not yet fully understood and specialized treatment for youth is scarce.

Methods

The i-BEAT study includes a cross-sectional and longitudinal online questionnaire study (N = 600), an App based daily-life approach and a laboratory virtual reality study in N = 60 youths (14–24 years) with and without LOC as well as a controlled randomized online treatment trial to investigate the feasibility, acceptance and efficacy of a CBT and an interpersonal emotion regulation module for youth (N = 120). The primary outcomes include self-reported as well as measured (heart rate variability, gaze behavior, reaction times in stop signal task) associations between emotion regulation problems (such as dealing with RS), psychological impairment and binge eating in a healthy control group and youth with LOC. Secondary outcomes encompass general eating disorder pathology, social anxiety, body mass index, hyperscanning behavior and therapists’ rating of patients’ condition pre and post treatment. Epigenetic correlates of RS are assessed in healthy controls and youth with LOC and explored before and after treatment.

Discussion

The expected findings will specify the role of interpersonal emotion regulation problems such as coping with the experience of social exclusion and rejection sensitivity (RS) in LOC and clarify, whether including a training to cope with RS adds to the efficacy of a cognitive behavioral treatment (CBT).

Trial registration: German Clinical Trial Register: DRKS00023706. Registered 27 November 2020, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00023706
Comparison of different machine learning approaches for tropospheric profiling based on COSMIC-2 data
Authors: Lasota Elżbieta
Published: December 2021

Precise and reliable information on the tropospheric temperature and water vapor profiles play a key role in weather and climate studies. Among the sensors supporting the observations of the troposphere, one can distinguish the Global Navigation Satellite System Radio Occultation (RO) technique, which provides accurate and high-quality meteorological profiles. However, external knowledge about temperature is essential to estimate other physical atmospheric parameters. To overcome this constraint, I trained and evaluated four different machine learning models comprising Artificial Neural Network (ANN) and Random Forest regression algorithms, where no auxiliary meteorological data is needed. To develop the models, I employed 150,000 globally distributed (45°S–45°N) RO profiles between October 2019 and December 2020. Input vectors consisted of bending angle or refractivity profiles from the Formosa Satellite-7/Constellation Observing System for Meteorology, Ionosphere, and Climate-2 mission together with the month, hour, and latitude of the RO event. While temperature, pressure, and water vapor profiles derived from the modern ERA5 reanalysis and interpolated to the RO location served as the models’ targets. Evaluation on the testing data set revealed a good agreement between all model outputs and ERA5 targets, where slightly better statistics were noted for ANN and refractivity inputs. Vertically averaged root mean square error (RMSE) did not exceed 1.7 K for the temperature and reached around 1.4 hPa and 0.45 hPa for the total and water vapor pressures. Additional validation with 477 co-located radiosonde observations and the operational one-dimensional variational product showed slightly larger discrepancies with the mean RMSE of around 1.9 K, 1.9 hPa, and 0.5 hPa for the temperature, pressure, and water vapor, respectively.

Graphical Abstract
Reverse pseudohyperkalemia in a newly diagnosed pediatric patient with acute T-cell leukemia and hyperleukocytosis: a case report and literature review
Authors: Alabdulqader Muneera , Al Alawyat Hanaa , Kasem Mohammed F. , Ibrahim Abdelfattah , Omara Abdelwahab
Published: December 2021

Background

Hyperkalemia is a serious medical condition that requires immediate intervention. However, pseudohyperkalemia and reverse pseudohyperkalemia are misleading clinical manifestations that can result in incorrect diagnosis and consequent harmful intervention.

Case presentation

An 11-year-old girl manifested an incidental finding of hyperleukocytosis (WBC > 400 × 109/L), with 90% blast cells during routine pre-operative investigations for adenotonsillectomy. Initial investigations demonstrated elevated serum potassium levels (7.5 mmol/L), despite concomitantly normal levels in venous blood gas samples (3.9–4.4 mmol/L) and being clinically stable with normal 12-lead ECG. Surprisingly, plasma potassium level was exacerbated, in comparison to the serum level by > 1 mmol/L. This finding is consistent with reverse pseudohyperkalemia that is associated with hyperleukocytosis in acute leukemia that does not require any active intervention.

Conclusion

This case report emphasizes the significance of interpreting potassium levels accurately, preferably utilizing whole-blood potassium level over serum and plasma level in newly diagnosed leukemia cases with hyperleukocytosis. Additionally, having a high index for the possibility of reverse pseudohyperkalemia, secondary to leakage from fragile leukocytes, avoids unnecessary treatment that might cause harm to the patient.
Sharks, rays and chimaeras of the Seine and Unicorn seamounts (NE Atlantic Ocean)
Authors: FREITAS Mafalda , SOUSA Ricardo , IDEIA Pedro , GASPAR Madalena , DELGADO João , COSTA Ana Luísa , dos SANTOS Antonina , BISCOITO Manuel
Published: December 2021

Background

Seamounts are underwater mountains which typically rise rather steeply at least several hundred meters above the deep-sea floor. These geological features interrupt water flow and hence may induce changes in the circulation of different water masses, in turn causing different physical and biological effects. For this reason, seamounts are biodiversity hotspots, housing a wide number of species, as is with the case of the Seine and Unicorn seamounts, which are a part of the Madeira-Tore seamount chain located between Portugal mainland, southwestern Europe and Madeira archipelago (NE Atlantic).

Methods

Fisheries independent surveys allowed the collection of Chondrichthyes specimens from the Seine and Unicorn seamounts. Individuals were caught over the course of two research cruises, first in 2004 and later in 2017, with species distribution ranging from the summit down to 2500 m of depth.

Results

Fifteen species belonging to 7 different taxonomical families were collected in the two surveyed areas. Two species were recorded for the first time and added to the checklist of the Seine seamount (Centrophorus granulosus and Somniosus rostratus), and three species for the Unicorn seamount (C. granulosus, Centroscymnus coelolepis and Centroselachus crepidater). Distribution and frequency of occurrence for the collected species were evaluated in relation to depth.

Conclusions

This work is a valuable contribution to the knowledge of seamount-associated fish fauna. Moreover, the checklist of sharks, rays and chimaeras was updated for the Seine and Unicorn seamounts, summing up 20 species.
Incidental exposure to hedonic and healthy food features affects food preferences one day later
Authors: Dutriaux Léo , Papies Esther K. , Fallon Jennifer , Garcia-Marques Leonel , Barsalou Lawrence W.
Published: December 2021

Memories acquired incidentally from exposure to food information in the environment may often become active to later affect food preferences. Because conscious use of these memories is not requested or required, these incidental learning effects constitute a form of indirect memory. In an experiment using a novel food preference paradigm (n = 617), we found that brief incidental exposure to hedonic versus healthy food features indirectly affected food preferences a day later, explaining approximately 10% of the variance in preferences for tasty versus healthy foods. It follows that brief incidental exposure to food information can affect food preferences indirectly for at least a day. When hedonic and health exposure were each compared to a no-exposure baseline, a general effect of hedonic exposure emerged across individuals, whereas health exposure only affected food preferences for high-BMI individuals. This pattern suggests that focusing attention on hedonic food features engages common affective processes across the general population, whereas focusing attention on healthy food features engages eating restraint goals associated with high BMI. Additionally, incidental exposure to food features primarily changed preferences for infrequently consumed foods, having less impact on habitually consumed foods. These findings offer insight into how hedonic information in the obesogenic food environment contributes to unhealthy eating behavior that leads to overweight and obesity. These findings further motivate the development of interventions that counteract the effects of exposure to hedonic food information and that broaden the effects of exposure to healthy food information.
Optimizing song retention through the spacing effect
Authors: Katz Joel J. , Ando Momo , Wiseheart Melody
Published: December 2021

The spacing effect refers to the improvement in memory retention for materials learned in a series of sessions, as opposed to massing learning in a single session. It has been extensively studied in the domain of verbal learning using word lists. Less evidence is available for connected discourse or tasks requiring the complex coordination of verbal and other domains. In particular, the effect of spacing on the retention of words and music in song has yet to be determined. In this study, university students were taught an unaccompanied two-verse song based on traditional materials to a criterion of 95% correct memory for sung words. Subsequent training sessions were either massed or spaced by two days or one week and tested at a retention interval of three weeks. Performances were evaluated for number of correct and incorrect syllables, number of correctly and incorrectly pitched notes, degree notes were off-pitch, and number of hesitations while singing. The data revealed strong evidence for a spacing effect for song between the massed and spaced conditions at a retention interval of three weeks, and evidence of no difference between the two spaced conditions. These findings suggest that the ongoing cues offered by surface features in the song are strong enough to enable verbatim recall across spaced conditions, as long as the spacing interval reaches a critical threshold.
Eliciting health state utilities for Aromatic L-amino Acid Decarboxylase (AADC) deficiency: a UK vignette study
Authors: Smith Adam B. , Hanbury Andria , Buesch Katharina
Published: December 2021

Purpose

The aim of this study was to generate health state utilities for aromatic L-amino acid decarboxylase (AADC) deficiency, a rare genetic, lifelong neurogenerative condition predominantly manifesting in young infants.

Methods

Participants were presented with health state vignettes. These had been previously developed based on published literature, clinician input, interviews with parents of AADC deficiency patients and expert opinion. A total of 5 health state vignettes were presented: bedridden, head control, sitting unsupported, standing with assistance and walking with assistance. Health state utilities (HSU) were elicited using time-trade off (TTO; 10-year time horizon) and the standard gamble (SG). The vignettes were completed online by panel participants drawn from a representative sample of the United Kingdom residential population.

Results

A total of 1598 participants completed the vignettes. Around 21% had incongruent responses (higher utilities for the bedridden compared to walking health states). Incongruent responses were associated with shorter task completion times, gender and parental status. These responses were removed from the analysis. Health state utilities (HSU) increased correspondingly as health states improved for both the TTO and SG. The mean HSU (standard deviation) for the TTO task were: bedridden state 0.49 (0.34); head control 0.54 (0.33), sitting unsupported 0.63 (0.31); standing with assistance 0.68 (0.31); and walking with assistance 0.73 (0.31). For the SG, mean health state utilities were: 0.56 (0.28), 0.57 (0.27), 0.67 (0.24), 0.70 (0.24), and 0.75 (0.25), respectively.

Conclusion

Health state utilities were derived for AADC deficiency through a vignette study. These will be used for a cost-effectiveness model of an AADC deficiency treatment.
Multidisciplinary management of juvenile nasopharyngeal angiofibroma
Authors: Abouzeid Walid , Sultan Ahmed , Shadad Mohamed
Published: December 2021

Background

Juvenile nasopharyngeal angiofibroma (JNA) is a rare benign, but the locally aggressive, vascular tumor that occurs almost exclusively in young men. Although this tumor accounts for only about 0.5% of head and neck tumors, it is by far the most common benign nasopharyngeal neoplasm. It is presented typically with epistaxis, obstructive symptoms, and chronic otomastoiditis. The examination of this tumor reveals pale reddish-blue mass. The tumor is seen on imaging as vividly augmenting soft-tissue mass centered on the sphenopalatine foramen. The treatment of choice is usually surgical resection; either open or endoscopic. Pre-operative embolization is usually done to help with hemostasis. We aim to address the efficiency and the safety of endovascular modality in JNA.

Methods

In the period between January 2012 to December 2017, 20 male patients with age ranging from 6 to 20 years were referred to the Endovascular Unit, at Departments of Neurosurgery in Sohag, Alexandria, and Tanta University Hospitals with JNF. Preoperative trans-arterial embolization was done, followed by endoscopic surgical resection by our ENT surgeons. All patients were subjected to clinical and radiological Imaging evaluation pre embolization, post embolization, and post endoscopic resection. All patients had clinical and radiological follow-ups for at least 1 year.

Results

20 male patients with JNA underwent preoperative super-selective trans-arterial embolization. The average age at presentation was 13 years. All patients underwent successful embolization with total obliteration of vascular blush of the tumor in 15 patients, and near-total obliteration of blush in 5 patients. The dramatic effect of preoperative embolization was observed on limiting intraoperative blood loss (average 200 ml) and decreasing the time of surgery (average 2.5 h). There was no permanent morbidity or mortality related to either embolization or endoscopic resection in all patients.

Conclusions

Trans-arterial embolization is strongly recommended in patients with JNA, it offers a good assist to the surgeon, reduces blood loss, decreases the amount of transfusion, improves the degree of resection, reduces operative time, and decreases the incidence of recurrence.