bluuebunny/crossref_metadata_2025_split huggingface dataset:
Double-blind placebo-controlled randomized clinical trial to assess the efficacy of montelukast in mild to moderate respiratory symptoms of patients with long COVID: E-SPERANZA COVID Project study protocol
Authors: Mera-Cordero Francisco , Bonet-Monne Sara , Almeda-Ortega Jesús , García-Sangenís Ana , Cunillera-Puèrtolas Oriol , Contreras-Martos Sara , Alvarez-Muñoz Gemma , Monfà Ramon , Balanzo-Joué Marina , Morros Rosa , Salvador-Gonzalez Betlem 
Published: January 2022

Abstract
Background
The coronavirus disease 2019 (COVID-19) pandemic continues to affect the globe. After 18 months of the SARS-CoV-2 emergence, clinicians have clearly defined a subgroup of patients with lasting, disabling symptoms. While big strides have been made in understanding the acute phase of SARS-CoV-2 infection, the pathophysiology of long COVID is still largely unknown, and evidence-based, effective treatments for this condition remain unavailable.

Objectives
To evaluate the efficacy of 10 mg oral montelukast every 24 h versus placebo in improving quality of life associated with mild to moderate respiratory symptoms in patients with long COVID as measured with the COPD Assessment Test (CAT) questionnaire. The secondary objectives will evaluate the effect of montelukast versus placebo on improving exercise capacity, COVID-19 symptoms (asthenia, headache, mental confusion or brain fog, ageusia, and anosmia), oxygen desaturation during exertion, functional status, and mortality.

Methods and analysis
Phase III, randomized, double-blind clinical trial. We will include 18- to 80-year-old patients with SARS-CoV-2 infection and mild to moderate respiratory symptoms lasting more than 4 weeks. Participants will be randomly allocated in a 1:1 ratio to the intervention (experimental treatment with 10 mg/day montelukast) or the control group (placebo group), during a 28-day treatment. Follow-up will finish 56 days after the start of treatment. The primary outcome will be health-related quality of life associated with respiratory symptoms according to the COPD Assessment Test 4 weeks after starting the treatment. The following are the secondary outcomes: (a) exercise capacity and oxygen saturation (1-min sit-to-stand test); (b) Post-COVID-19 Functional Status Scale; (c) other symptoms: asthenia, headache, mental confusion (brain fog), ageusia, and anosmia (Likert scale); (d) use of healthcare resources; (e) mortality; (f) sick leave duration in days; and (g) side effects of montelukast.

Ethics and dissemination
This study has been approved by the Clinical Research Ethics Committee of the IDIAPJGol (reference number 21/091-C). The trial results will be published in open access, peer-reviewed journals and explained in webinars to increase awareness and understanding about long COVID among primary health professionals.

Trial registration
ClinicalTrials.govNCT04695704. Registered on January 5, 2021. EudraCT number 2021-000605-24. Prospectively registered.
Effectiveness of lumbar stabilization exercise with real-time ultrasound imaging biofeedback on lumbar multifidus muscle cross-sectional area in individuals with non-specific chronic low back pain: a study protocol for a randomized controlled trial
Authors: Sarafadeen Raheem , Ganiyu Sokunbi O. , Ibrahim Aminu A. , Ismail Anas , Akindele Mukadas O. , Kaka Bashir , Awotidebe Adedapo W. 
Published: January 2022

Abstract
Background
Structural impairment of the lumbar multifidus muscle, such as reduced cross-sectional area, is evident among individuals with chronic low back pain. Real-time ultrasound imaging (RUSI) biofeedback has been reported to improve preferential activation of as well as retention in the ability to activate the lumbar multifidus muscle during lumbar stabilization exercises (LSE). However, evidence of the effectiveness of this treatment approach in individuals with non-specific chronic low back pain (NCLBP) is still limited. The purpose of this study is, therefore, to determine the effectiveness of LSE with RUSI biofeedback on lumbar multifidus muscle cross-sectional area in individuals with NCLBP.

Methods/Design
This study is a prospective, single-center, assessor-blind, three-arm, parallel randomized controlled trial to be conducted at National Orthopedic Hospital, Kano State, Nigeria. Ninety individuals with NCLBP will be randomized in a 1:1:1: ratio to receive LSE, LSE with RUSI biofeedback, or minimal intervention. All participants will receive treatment twice weekly for 8 weeks. The primary outcome will be the lumbar multifidus muscle cross-sectional area. The secondary outcomes will include pain (Numerical Pain Rating Scale), functional disability (Roland–Morris Disability Questionnaire), and quality of life (12-Item Short-Form Health Survey). All outcomes will be assessed at baseline, 8 weeks post-intervention, and 3 months follow-up.

Discussion
To our knowledge, this study will be the first powered randomized controlled trial to compare the effectiveness of LSE training with and without RUSI biofeedback in individuals with NCLBP. The outcome of the study may provide evidence for the effectiveness of LSE with RUSI biofeedback on enhancing the recovery of the lumbar multifidus muscle in individuals with NCLBP.

Trial registration
Pan African Clinical Trials Registry (PACTR201801002980602). Registered on January 16, 2018.
DUbbing Language-therapy CINEma-based in Aphasia post-Stroke (DULCINEA): study protocol for a randomized crossover pilot trial
Authors: Fuentes Blanca , de la Fuente-Gómez Lydia , Sempere-Iborra Cristian , Delgado-Fernández Celia , Tarifa-Rodríguez Aida , Alonso de Leciñana María , de Celis-Ruiz Elena , Gutiérrez-Zúñiga Raquel , López-Tàppero José , Martín Alonso Marta , Pastor-Yborra Sylvia , Rigual Ricardo , Ruiz-Ares Gerardo , Rodríguez-Pardo Jorge , Virués-Ortega Javier , Borobia Alberto M. , Blanco Paloma , Bueno-Guerra Nereida 
Published: January 2022

Abstract
Background
Communication is one of the most important predictors of social reintegration after stroke. Approximately 15–42% of stroke survivors experience post-stroke aphasia. Helping people recover from aphasia is one of the research priorities after a stroke. Our aim is to develop and validate a new therapy integrating dubbing techniques to improve functional communication.

Methods
The research project is structured as three work packages (WP). WP1: development of the dubbed language cinema-based therapy: Two research assistants (a speech therapist and a dubbing actor) will select the clips, mute specific words/sentences in progressive speech difficulty, and guide patients to dub them across sessions. Words to be dubbed will be those considered to be functionally meaningful by a representative sample of aphasic patients and relatives through an online survey. WP2: a randomized, crossover, interventional pilot study with the inclusion of 54 patients with post-stroke non-fluent aphasia. Patients will be treated individually in 40-min sessions twice per week for 8 weeks. Primary outcomes will be significant pre/post differences in scores in the Communicative Activity Log (CAL) questionnaire and Boston Diagnostic Aphasia Examination (BDAE) administered by a psychologist blinded to the patients’ clinical characteristics. Secondary outcomes: General Health Questionnaire (GHQ)-12, Stroke Aphasia Quality of Life Scale (SAQOL-39), Western Aphasia Battery Revised (WAB-R), and the Stroke Aphasic Depression Questionnaire (SADQ10). WP3: educational activities and dissemination of results. WP3 includes educational activities to improve public knowledge of aphasia and dissemination of the results, with the participation of the Spanish patients’ association Afasia Activa.

Discussion
This pilot clinical trial will explore the efficacy of a new therapeutic tool based on dubbing techniques and computer technology to improve functional communication of patients suffering from post-stroke aphasia with the use of standardized test assessment.

Trial registration
ClinicalTrials.govNCT04289493. Registered on 28 February 2020.
Occurrence and subtyping of Blastocystis in coypus (Myocastor coypus) in China
Authors: Liu Xuehan , Ni Fuzhen , Wang Rongjun , Li Junqiang , Ge Yaming , Yang Xuefeng , Qi Meng , Zhang Longxian 
Published: January 2022

Abstract
Background
Blastocystis is an anaerobic unicellular protist frequently detected in the gastrointestinal tracts of humans and animals worldwide. However, the prevalence and subtype distribution of Blastocystis in the coypu (Myocastor coypus) population have not been reported so far. The aim of this study was to determine the prevalence, genetic characteristics, and zoonotic potential of Blastocystis isolates detected in coypus in China.

Results
A total of 308 fecal samples were collected from coypus in seven regions across China and subsequently examined. Blastocystis was detected in 44 (14.3%) specimens by nested PCR amplification of the small subunit ribosomal rRNA (SSU rRNA) gene. Further DNA sequencing and phylogenetic analyses resulted in the identification of two zoonotic known subtypes, ST4 and ST5, and an unknown subtype. ST4 was the most predominant subtype observed in the samples. ST5 infections were only observed in three coypus. Factors that were associated with prevalence of Blastocystis included age, geographical region and subtype. Interestingly, this is the first report about a potentially novel subtype infecting coypus.

Conclusions
This is the first comprehensive report of Blastocystis in M. coypus across a wide geographic range of China. A moderate degree of genetic divergence was observed. The presence of zoonotic subtypes in farmed M. coypus suggests that these animals have the potential to transmit blastocystosis to both humans and domestic animals. These findings provide a better understanding of the genetic diversity of Blastocystis in rodents and contribute towards the establishment of efficient blastocystosis control strategies in the investigated areas.

Graphical abstract
Replication and transcription machinery for ranaviruses: components, correlation, and functional architecture
Authors: Ke Fei , Yu Xue-Dong , Wang Zi-Hao , Gui Jian-Fang , Zhang Qi-Ya 
Published: January 2022

Abstract
Background
Ranaviruses (family Iridoviridae) are promiscuous pathogens that can infect across species barriers in poikilotherms and can replicate in amphibian and fish cells and even in cultured mammalian cells. However, as nucleocytoplasmic large DNA viruses (NCLDVs), their replication and transcription mechanisms remain largely unknown. Here, we screened and uncovered the replication and transcription machinery of two ranaviruses, Andrias davidianus ranavirus (ADRV) and Rana grylio virus (RGV), by a combination of methods, including the isolation of proteins on nascent DNA, recombinant virus-based affinity, and NanoLuc complementation assay.

Results
The ranavirus replication and transcription machinery was deeply dissected and identified as a complicated apparatus containing at least 30 viral and 6 host proteins. The viral proteins ADRV-47L/RGV-63R (DNA polymerase, vDPOL), ADRV-23L/RGV-91R (proliferating cell nuclear antigen, vPCNA), ADRV-85L/RGV-27R (single-stranded DNA binding protein, vSSB), ADRV-88L/RGV-24R (vhelicase/primase), etc., constitute the core replisome. Specifically, the core of the transcription complex, the viral RNA polymerase, contain the host RNAPII subunits Rpb3, Rpb6, and Rpb11, which was a first report in NCLDVs. Furthermore, correlations and interactions among these factors in the machinery were described. Significantly, the replisome core protein vDPOL (ADRV-47L) can interact with numerous viral and host proteins and could act as a linker and regulation center in viral DNA replication and transcription. Thus, these results depicted an architecture for ranavirus replication and transcription.

Conclusions
Up to 36 components from ranavirus and their host were found to form viral replisomes and transcription complexes using a series of precise methods, which further constructed an architecture for ranavirus replication and transcription in which vDPOL was a key central factor and various components correlated and cooperated. Therefore, it provides a cornerstone for further understanding the mechanisms of the replication and transcription of ranaviruses which can ensure the efficient production of progeny virus and adaptation to cross-species infection.
Computerized cognitive training in people with depression: a protocol for a systematic review and meta-analysis
Authors: Lampit Amit , Launder Nathalie H. , Minkov Ruth , Rollini Alice , Davey Christopher G. , Finke Carsten , Lautenschlager Nicola T. , Gavelin Hanna Malmberg 
Published: January 2022

Abstract
Background
People with depression often present with concurrent cognitive impairment. Computerized cognitive training (CCT) is a safe and efficacious strategy to maintain or enhance cognitive performance in a range of clinical populations. However, its efficacy in people with depression and how it varies across populations and design factors are currently unclear.

Methods
We searched MEDLINE, EMBASE, and PsycINFO from inception to 13 July 2021 for randomised controlled trials examining the efficacy of CCT vs any control condition on cognitive, mood, psychiatric symptoms, psychosocial, and daily functioning in adults with depression. Eligible samples include studies specifically targeting people with major depressive disorder as well as those with other diagnoses where at least 50% of the sample meets the clinical criteria for depression, with the exception of major psychiatric disorders or dementia. The primary outcome is change in the overall cognitive performance. Multivariate analyses will be used to examine the effect sizes on each outcome category as well as possible effect modifiers and correlations between categories. The risk of bias will be assessed using the Cochrane risk of bias tool version 2.

Discussion
To the best of our knowledge, this will be the first systematic review and meta-analysis of narrowly defined CCT across clinical populations with depression. We aim to investigate not only whether CCT is efficacious for cognition, but also how such effects vary across design factors, what other clinically relevant outcomes might respond to CCT, and the extent to which they differ across populations.

Systematic review registration
PROSPERO CRD42020204209
Best approximation of $(\mathcal{G}_{1},\mathcal{G}_{2})$-random operator inequality in matrix Menger Banach algebras with application of stochastic Mittag-Leffler and $\mathbb{H}$-Fox control functions
Authors: Rezaei Aderyani Safoura , Saadati Reza , Rassias Themistocles M. , Park Choonkil 
Published: January 2022

AbstractWe stabilize pseudostochastic $(\mathcal{G}_{1},\mathcal{G}_{2})$
(

G
1

,

G
2

)
-random operator inequality using a class of stochastic matrix control functions in matrix Menger Banach algebras. We get an approximation for stochastic $(\mathcal{G}_{1},\mathcal{G}_{2})$
(

G
1

,

G
2

)
-random operator inequality by means of both direct and fixed point methods. As an application, we apply both stochastic Mittag-Leffler and $\mathbb{H}$
H
-fox control functions to get a better approximation in a random operator inequality.
A personalized biomedical risk assessment infographic for people who smoke with COPD: a qualitative study
Authors: Gupta Samir , Panchal Puru , Sadatsafavi Mohsen , Ghanouni Parisa , Sin Don , Pakhale Smita , To Teresa , Zafari Zafar , Nimmon Laura ,   for the Canadian Respiratory Research Network
Published: January 2022

Abstract
Background
Chronic obstructive pulmonary disease (COPD) causes 3 million deaths each year, yet 38% of COPD patients continue to smoke. Despite proof of effectiveness and universal guideline recommendations, smoking cessation interventions are underused in practice. We sought to develop an infographic featuring personalized biomedical risk assessment through future lung function decline prediction (with vs without ongoing smoking) to both prompt and enhance clinician delivery of smoking cessation advice and pharmacotherapy, and augment patient motivation to quit.

Methods
We recruited patients with COPD and pulmonologists from a quaternary care center in Toronto, Canada. Infographic prototype content and design was based on best evidence. After face validation, the prototype was optimized through rapid-cycle design. Each cycle consisted of: (1) infographic testing in a moderated focus group and a clinician interview (recorded/transcribed) (with questionnaire completion); (2) review of transcripts for emergent/critical findings; and (3) infographic modifications to address findings (until no new critical findings emerged). We performed iterative transcript analysis after each cycle and a summative qualitative transcript analysis with quantitative (descriptive) questionnaire analysis.

Results
Stopping criteria were met after 4 cycles, involving 20 patients (58% male) and 4 pulmonologists (50% male). The following qualitative themes emerged: Tool content (infographic content preferences); Tool Design (infographic design preferences); Advantages of Infographic Messaging (benefits of an infographic over other approaches); Impact of Tool on Determinants of Smoking Cessation Advice Delivery (impact on barriers and enablers to delivery of smoking cessation advice in practice); and Barriers and Enablers to Quitting (impact on barriers and enablers to quitting). Patient Likert scale ratings of infographic content and format/usability were highly positive, with improvements in scores for 20/21 questions through the design process. Providers scored the infographic at 77.8% (“superior”) on the Suitability Assessment of Materials questionnaire.

Conclusions
We developed a user preference-based personalized biomedical risk assessment infographic to drive smoking cessation in patients with COPD. Our findings suggest that this tool could impact behavioural determinants of provider smoking-cessation advice delivery, while increasing patient quit motivation. Impacts of the tool on provider care, patient motivation to quit, and smoking cessation success should now be evaluated in real-world settings.
Update of the keratin gene family: evolution, tissue-specific expression patterns, and relevance to clinical disorders
Authors: Ho Minh , Thompson Brian , Fisk Jeffrey Nicholas , Nebert Daniel W. , Bruford Elspeth A. , Vasiliou Vasilis , Bunick Christopher G. 
Published: January 2022

AbstractIntermediate filament (IntFil) genes arose during early metazoan evolution, to provide mechanical support for plasma membranes contacting/interacting with other cells and the extracellular matrix. Keratin genes comprise the largest subset of IntFil genes. Whereas the first keratin gene appeared in sponge, and three genes in arthropods, more rapid increases in keratin genes occurred in lungfish and amphibian genomes, concomitant with land animal-sea animal divergence (~ 440 to 410 million years ago). Human, mouse and zebrafish genomes contain 18, 17 and 24 non-keratin IntFil genes, respectively. Human has 27 of 28 type I “acidic” keratin genes clustered at chromosome (Chr) 17q21.2, and all 26 type II “basic” keratin genes clustered at Chr 12q13.13. Mouse has 27 of 28 type I keratin genes clustered on Chr 11, and all 26 type II clustered on Chr 15. Zebrafish has 18 type I keratin genes scattered on five chromosomes, and 3 type II keratin genes on two chromosomes. Types I and II keratin clusters—reflecting evolutionary blooms of keratin genes along one chromosomal segment—are found in all land animal genomes examined, but not fishes; such rapid gene expansions likely reflect sudden requirements for many novel paralogous proteins having divergent functions to enhance species survival following sea-to-land transition. Using data from the Genotype-Tissue Expression (GTEx) project, tissue-specific keratin expression throughout the human body was reconstructed. Clustering of gene expression patterns revealed similarities in tissue-specific expression patterns for previously described “keratin pairs” (i.e., KRT1/KRT10, KRT8/KRT18, KRT5/KRT14, KRT6/KRT16 and KRT6/KRT17 proteins). The ClinVar database currently lists 26 human disease-causing variants within the various domains of keratin proteins.
Design for poverty alleviation and craft revitalization in rural China from an actor-network perspective: the case of bamboo-weaving in Shengzhou
Authors: Li Wenjia , Li Ziwei , Kou Huaiyun 
Published: January 2022

Abstract
Design for poverty alleviation (DPA) is becoming an active promoter and effective practice form of rural social innovation. This study aims to explore the sustainable, collaborative design path of rural poverty alleviation. Based on actor network theory, this study analyzes the poverty alleviation process of rural actor network construction and participatory translation through the perspective of design integration. The case study chooses the traditional Chinese handicraft, Shengzhou bamboo weaving, to discuss the key links and elements of sustainability such as the role, benefits, and interaction of multiple actors. The staged effectiveness and social impact of the design integration are evaluated by questionnaire surveys, in-depth interviews, qualitative and quantitative data collections, a logistic regression model was used to test for significant effects while adjusting for multiple factors simultaneously. The analysis shows that although DPA is difficult to realize the fundamental adjustment of the rights and interests of rural craftsmen, it plays a key role in guiding the development of industrial goals, expected economic and social benefits, brings huge driving force and implementation effect to rural social innovation. The actor network theory solves the problem of separation between the individual and network attributes of DPA among stakeholders, and provides an innovative basis for rural social innovation to choose effective design intervention and mechanisms to balance the rights and interests of various stakeholders.
Burial-induced deterioration in leather: a FTIR-ATR, DSC, TG/DTG, MHT and SEM study
Authors: Vyskočilová Gabriela , Carşote Cristina , Ševčík Richard , Badea Elena 
Published: January 2022

Abstract
In this study we used an analytical approach based on complementary techniques that targets all structural levels of collagen in leather to investigate how vegetable-tanned leather deteriorates during soil burial tests. For the first time, a group of deterioration markers specific to molecular, fibrillar and fibrous structure of collagen in leather was associated with the deterioration of buried leather. The application of the second order derivative of FTIR-ATR spectra analysis allowed us to detect loosening of collagen–tannin matrix, de-tanning and gelatin formation based on the behaviour of collagen and tannin spectral components (intensity variation and shifts). Collagen denaturation observed by DSC analysis and its thermo-oxidative behaviour measured by TG/DTG analysis, as well as the altered morphology of collagen (namely melt-like fibres and distorted fibrillar ultrastructure) imaged by SEM confirmed the FTIR-ATR analyis results. These analytical outcomes enabled us to understand the effect of leather hardening/cementing through soil mineral penetration into its fibrous structure and thus correctly interprete the higher-than-expected shrinkage temperatures and intervals determinatd by MHT method. Thus, MHT method proved to be suitable for a quick evaluation method that can direcly support the first conservation decision after excavation. The combination of FTIR-ATR, DSC, TG/DTG and SEM can be particularly useful to provide insights on the deterioration mechanism of archaeological leather and support best decision on its long-term preservation.