bluuebunny/crossref_metadata_2025_split huggingface dataset:
Tapering of prescribed opioids in patients with long-term non-malignant pain (TOPIO)—efficacy and effects on pain, pain cognitions, and quality of life: a study protocol for a randomized controlled clinical trial with a 12-month follow-up
Authors: Henrik Grelz , Patrik Midlöv , Anders Håkansson , Ulf Jakobsson , Marcelo Rivano Fischer , Åsa Ringqvist 
Published: July 2021

Abstract
Background
Opioids are still widely prescribed to long-term pain patients although they are no longer recommended for long-term treatments due to poor evidence for long-term efficacy, risks of serious side effects, and the possibility of inducing opioid hyperalgesia. In a Cochrane study from 2017, the authors identified an urgent need for more randomized controlled trials investigating the efficiency and effects of opioid tapering.
The study aimed to assess (1) the efficiency of a structured intervention in causing stable reductions of opioid consumption in a population with long-term non-malignant pain and (2) effects on pain, pain cognitions, physical and mental health, quality of life, and functioning in response to opioid tapering.

Methods
The study is a randomized controlled trial. The sample size was set to a total of 140 individuals after estimation of power and dropout. Participants will be recruited from a population with long-term non-malignant pain who will be randomly allocated to (1) the start of tapering immediately or (2) the control group who return to usual care and will commence tapering of opioids 4 months later. A 12-month follow-up is included.
When all follow-ups are closed, data from the Swedish drug register of the National Board of Health and Welfare will be collected and individual mean daily opioid dose in morphine equivalents will be calculated at three time points: baseline, 4 months, and 12 months after the start of the intervention. At the same time points, participants fill out the following questionnaires: Numeric Pain Rating Scale (NPRS), Tampa Scale of Kinesiophobia (TSK), Pain Catastrophizing Scale (PCS), Chronic Pain Acceptance Questionnaire (CPAQ-8), Hospital Anxiety and Depression Scale (HADS), and RAND-36. At baseline and follow-up, a clinical assessment of opioid use disorder is performed.

Discussion
A better understanding of the efficiency and effects of opioid tapering could possibly facilitate attempts to taper opioid treatments, which might prove beneficial for both the individual and society.

Trial registration
ClinicalTrials.gov NCT03485430. Retrospectively registered on 26 March 2018, first release date. “Tapering of Long-term Opioid Therapy in Chronic Pain Population. RCT with 12 Months Follow up (TOPIO).” First patient in trial 22 March 2018.
Detailed statistical analysis plan for the short-term versus long-term mentalisation-based therapy for outpatients with subthreshold or diagnosed borderline personality disorder randomised clinical trial (MBT-RCT)
Authors: Juul Sophie , Simonsen Sebastian , Poulsen Stig , Lunn Susanne , Sørensen Per , Bateman Anthony , Jakobsen Janus Christian 
Published: July 2021

Abstract
Background
Psychotherapy for borderline personality disorder is often extensive and resource-intensive. Mentalisation-based therapy is a psychodynamically oriented treatment option for borderline personality disorder, which includes a case formulation, psychoeducation, and group and individual therapy. The evidence on short-term compared with long-term mentalisation-based therapy is currently unknown.

Methods/design
The Short-Term MBT Project (MBT-RCT) is a single-centre, parallel-group, investigator-initiated, randomised clinical superiority trial in which short-term (20 weeks) will be compared with long-term (14 months) mentalisation-based therapy for outpatients with subthreshold or diagnosed borderline personality disorder. Outcome assessors, data managers, the data safety and monitoring committee, statisticians, and decision-makers will be blinded to treatment allocation. Participants will be assessed before randomisation and at 8, 16, and 24 months after randomisation. The primary outcome will be the severity of borderline symptomatology assessed with the Zanarini Rating Scale for Borderline Personality Disorder. Secondary outcomes will be functional impairment (Work and Social Adjustment Scale), quality of life (Short-Form Health Survey 36—mental component), global functioning (Global Assessment of Functioning), and proportion of participants with severe self-harm. In this paper, we present a detailed statistical analysis plan including a comprehensive explanation of the planned statistical analyses, methods to handle missing data, and assessments of the underlying statistical assumptions. Final statistical analyses will be conducted independently by two statisticians following the present plan.

Discussion
We have developed this statistical analysis plan before unblinding of the trial results in line with the Declaration of Helsinki and the International Conference on Harmonization of Good Clinical Practice Guidelines, which should increase the validity of the MBT-RCT trial by mitigation of analysis bias.

Trial registration
ClinicalTrials.gov NCT03677037. Registered on 19 September 2018
Randomised study within a trial (SWAT) to evaluate personalised versus standard text message prompts for increasing trial participant response to postal questionnaires (PROMPTS)
Authors: Cureton Lucy , Marian Ioana R. , Barber Vicki S. , Parker Adwoa , Torgerson David J. , Hopewell Sally 
Published: July 2021

Abstract
Background
Use of a person’s name in a text message has been shown to be effective in instigating behaviour change. We evaluated the effectiveness of a personalised text message (including the recipient’s name) versus a standardised text message for prompting a response from trial participants to complete and return postal follow-up questionnaires.

Methods
Using a randomised study within a trial (SWAT) embedded within the host GRASP (Getting it Right: Addressing Shoulder Pain) trial, participants who provided a mobile telephone number were randomised (1:1) by a central computer system to receive either (1) a personalised text message which included their name or (2) a standard text message. Text messages were sent by the trial office on the same day as the 6-month GRASP follow-up questionnaire. The primary outcome was questionnaire response rate, defined as the proportion of 6-month GRASP follow-up questionnaires returned by participants. Secondary outcomes included time to response, the proportion of participants sent a reminder follow-up questionnaire, and cost.

Results
Between March 2017 and May 2019 (recruitment period for GRASP trial), 618 participants were randomised to a personalised (n = 309) or standard (n = 309) text message and all were included in the analysis. The overall questionnaire response rate was 87% (n = 537/618); 90% (n = 277/309) of participants responded in the personalised text message group compared to 84% (n = 260/309) in the standard text message group (relative risk (RR) 1.07; 95% CI 1.00 to 1.13). Participants randomised to receive the personalised text message were more likely to return their initial postal questionnaire than those who received the standard text message (n = 185/309; 60% vs. n = 160/309; 52%) (RR 1.16; 95% CI 1.00 to 1.33); this represents an absolute percentage difference between intervention groups of 8%. Post hoc subgroup analysis showed that males under 65 years were the group most likely to return their initial questionnaire if they received a personalised text message.

Conclusion
Overall, participants who received a personalised text message were more likely to return their questionnaire than those who received the standard text message.

Trial registration
GRASP Trial ISRCTN16539266; SWAT Repository ID 35
Epigenetic rewriting at centromeric DNA repeats leads to increased chromatin accessibility and chromosomal instability
Authors: Decombe Sheldon , Loll François , Caccianini Laura , Affannoukoué Kévin , Izeddin Ignacio , Mozziconacci Julien , Escudé Christophe , Lopes Judith 
Published: July 2021

Abstract
Background
Centromeric regions of human chromosomes contain large numbers of tandemly repeated α-satellite sequences. These sequences are covered with constitutive heterochromatin which is enriched in trimethylation of histone H3 on lysine 9 (H3K9me3). Although well studied using artificial chromosomes and global perturbations, the contribution of this epigenetic mark to chromatin structure and genome stability remains poorly known in a more natural context.

Results
Using transcriptional activator-like effectors (TALEs) fused to a histone lysine demethylase (KDM4B), we were able to reduce the level of H3K9me3 on the α-satellites repeats of human chromosome 7. We show that the removal of H3K9me3 affects chromatin structure by increasing the accessibility of DNA repeats to the TALE protein. Tethering TALE-demethylase to centromeric repeats impairs the recruitment of HP1α and proteins of Chromosomal Passenger Complex (CPC) on this specific centromere without affecting CENP-A loading. Finally, the epigenetic re-writing by the TALE-KDM4B affects specifically the stability of chromosome 7 upon mitosis, highlighting the importance of H3K9me3 in centromere integrity and chromosome stability, mediated by the recruitment of HP1α and the CPC.

Conclusion
Our cellular model allows to demonstrate the direct role of pericentromeric H3K9me3 epigenetic mark on centromere integrity and function in a natural context and opens interesting possibilities for further studies regarding the role of the H3K9me3 mark.
An implementation science approach to evaluating pathogen whole genome sequencing in public health
Authors: Ferdinand Angeline S. , Kelaher Margaret , Lane Courtney R. , da Silva Anders Gonçalves , Sherry Norelle L. , Ballard Susan A. , Andersson Patiyan , Hoang Tuyet , Denholm Justin T. , Easton Marion , Howden Benjamin P. , Williamson Deborah A. 
Published: July 2021

Abstract
Background
Pathogen whole genome sequencing (WGS) is being incorporated into public health surveillance and disease control systems worldwide and has the potential to make significant contributions to infectious disease surveillance, outbreak investigation and infection prevention and control. However, to date, there are limited data regarding (i) the optimal models for integration of genomic data into epidemiological investigations and (ii) how to quantify and evaluate public health impacts resulting from genomic epidemiological investigations.

Methods
We developed the Pathogen Genomics in Public HeAlth Surveillance Evaluation (PG-PHASE) Framework to guide examination of the use of WGS in public health surveillance and disease control. We illustrate the use of this framework with three pathogens as case studies: Listeria monocytogenes, Mycobacterium tuberculosis and SARS-CoV-2.

Results
The framework utilises an adaptable whole-of-system approach towards understanding how interconnected elements in the public health application of pathogen genomics contribute to public health processes and outcomes. The three phases of the PG-PHASE Framework are designed to support understanding of WGS laboratory processes, analysis, reporting and data sharing, and how genomic data are utilised in public health practice across all stages, from the decision to send an isolate or sample for sequencing to the use of sequence data in public health surveillance, investigation and decision-making. Importantly, the phases can be used separately or in conjunction, depending on the need of the evaluator. Subsequent to conducting evaluation underpinned by the framework, avenues may be developed for strategic investment or interventions to improve utilisation of whole genome sequencing.

Conclusions
Comprehensive evaluation is critical to support health departments, public health laboratories and other stakeholders to successfully incorporate microbial genomics into public health practice. The PG-PHASE Framework aims to assist public health laboratories, health departments and authorities who are either considering transitioning to whole genome sequencing or intending to assess the integration of WGS in public health practice, including the capacity to detect and respond to outbreaks and associated costs, challenges and facilitators in the utilisation of microbial genomics and public health impacts.
Differential expression of micro RNA-29 family in non-diabetic adults of diabetic and non-diabetic parents
Authors: Abbas Uzair , Imdad Bushra , Mughal Sikander Adil , Baloch Israr Ahmed , Khan Afshan Mehboob , Kamran Durr-e-Sameen 
Published: July 2021

Abstract
Objective
MicroRNAs are known to regulate 60% of genes at post translational level. MicroRNAs including Micro RNA-29 family play a vital role in cellular activities and have validate role in numerous metabolic disorders inclusive of diabetes mellitus and its complications. While micro RNA profile changes years before the occurrence of disease. This cross-sectional study was conducted in non-diabetic adults of diabetic and non-diabetic parents to explore the early changes in expression of micro RNA-29 family as it can be served as early biomarker of type 2 diabetes in non-diabetic adults. This study was conducted from January 2019 to January 2021. Micro RNA was extracted from plasma of 50 participants and expression was compared through qPCR. While data was analyzed through SPSS version 21.0.

Results
29a and 29b had lower expression in participants with family history of DM compared to those having no family history of DM (P < 0.0001). While micro RNA 29c was found to be significantly higher in participants with positive family history of type 2 diabetes as compared to those without family history of diabetes (P = 0.001).
Pleth variability index and fluid management practices: a multicenter service evaluation
Authors: Forget Patrice , Lacroix Simon , Deflandre Eric P. , Pirson Anne , Hustinx Nicolas , Simonet Olivier , Wandji Fabrice , von Montigny Serge , Amraoui Jibba 
Published: July 2021

AbstractObjectivesThe introduction of a new technology has the potential to modify clinical practices, especially if easy to use, reliable and non-invasive. This observational before/after multicenter service evaluation compares fluid management practices during surgery (with fluids volumes as primary outcome), and clinical outcomes (secondary outcomes) before and after the introduction of the Pleth Variability Index (PVI), a non-invasive fluid responsiveness monitoring.ResultsIn five centers, 23 anesthesiologists participated during a 2-years period. Eighty-eight procedures were included. Median fluid volumes infused during surgery were similar before and after PVI introduction (respectively, 1000 ml [interquartile range 25–75 [750–1700] and 1000 ml [750–2000]). The follow-up was complete for 60 from these and outcomes were similar. No detectable change in the fluid management was observed after the introduction of a new technology in low to moderate risk surgery. These results suggest that the introduction of a new technology should be associated with an implementation strategy if it is intended to be associated with changes in clinical practice.
A deep insight into CRISPR/Cas9 application in CAR-T cell-based tumor immunotherapies
Authors: Razeghian Ehsan , Nasution Mahyuddin K. M. , Rahman Heshu Sulaiman , Gardanova Zhanna R. , Abdelbasset Walid Kamal , Aravindhan Surendar , Bokov Dmitry O. , Suksatan Wanich , Nakhaei Pooria , Shariatzadeh Siavash , Marofi Faroogh , Yazdanifar Mahboubeh , Shamlou Somayeh , Motavalli Roza , Khiavi Farhad Motavalli 
Published: July 2021

AbstractTo date, two chimeric antigen receptors (CAR)-T cell products from autologous T cells have been approved by The United States Food and Drug Administration (FDA). The case-by-case autologous T cell generation setting is largely considered as a pivotal restraining cause for its large-scale clinical use because of the costly and prolonged manufacturing procedure. Further, activated CAR-T cells mainly express immune checkpoint molecules, including CTLA4, PD1, LAG3, abrogating CAR-T anti-tumor activity. In addition, CAR-T cell therapy potently results in some toxicity, such as cytokine releases syndrome (CRS). Therefore, the development of the universal allogeneic T cells with higher anti-tumor effects is of paramount importance. Thus, genome-editing technologies, in particular, clustered regularly interspaced short palindromic repeat (CRISPR)-Cas9 are currently being used to establish “off-the-shelf” CAR-T cells with robust resistance to immune cell-suppressive molecules. In fact, that simultaneous ablation of PD-1, T cell receptor alpha constant (TRAC or TCR), and also β-2 microglobulin (B2M) by CRISPR-Cas9 technique can support the manufacture of universal CAR-T cells with robust resistance to PD-L1. . Indeed, the ablation of β2M or TARC can severely hinder swift elimination of allogeneic T cells those express foreign HLA-I molecules, and thereby enables the generation of CAR-T cells from allogeneic healthy donors T cells with higher persistence in vivo. Herein, we will deliver a brief overview of the CAR-T cell application in the context of tumor immunotherapy. More importantly, we will discuss recent finding concerning the application of genome editing technologies for preparing universal CAR-T cells or cells that can effectively counter tumor escape, with a special focus on CRISPR-Cas9 technology.
RETRACTED ARTICLE: Design and Implementation of Track and Field Training Information Collection and Feedback System Based on Multi-sensor Information Fusion
Authors: Li Ling , Li Chengliang 
Published: July 2021

AbstractTrack and field sports are known as the "mother of sports". Whether in the field of athletics, fitness, or education, modern track and field sports have developed rapidly. The field of athletics has reached the point where it challenges the limits of humans. The development of China is inseparable from the support of science and technology, and it is inseparable from human scientific research on track and field sports. In order to improve the scientific level of track and field training methods and develop our country's sports industry, this paper designs a track and field training information collection and feedback system based on multi-sensor information fusion. In the method part, this article briefly introduces the content of track and field sports, the mode of multi-sensor information fusion and the existing sports information collection system, using weight coefficient fusion method, D-S evidence theory algorithm and Kalman filter algorithm. This paper designs an information collection and feedback system based on multi-sensor information fusion, and conducts demand analysis, comparative analysis, and data record analysis on this system. By designing the experimental group and the control group, it can be seen that the average performance of the two groups of athletes in the 50-meter run in 8 weeks has improved, and the data of the experimental group and the control group show significant differences. After the experiment, the average performance of the male athletes in the control group increased from around 8.32 to around 8.12, an increase of 4.7%. The performance of male athletes in the experimental group increased from 8.37 to 7.92, an increase of 5.6%. It can also be known that before the experiment, the average performance of the athletes in the selected control group was due to the experimental group, but after 8 weeks of experiment, the increase in the experimental group was higher than that of the control group. This shows that the data collection and feedback system using multi-sensor information fusion can be more accurately and differentiatedly applied to track and field training, and can find problems in athletes, so as to prescribe the right medicine.
Regularly ideal invariant convergence of double sequences
Authors: Pancaroǧlu Akın Nimet 
Published: July 2021

AbstractIn this paper, we introduce the notions of regularly invariant convergence, regularly strongly invariant convergence, regularlyp-strongly invariant convergence, regularly$(\mathcal{I}_{\sigma },\mathcal{I}^{\sigma }_{2})$(Iσ,I2σ)-convergence, regularly$(\mathcal{I}_{\sigma }^{*},\mathcal{I}^{\sigma *}_{2})$(Iσ∗,I2σ∗)-convergence, regularly$(\mathcal{I}_{\sigma },\mathcal{I}^{\sigma }_{2} )$(Iσ,I2σ)-Cauchy double sequence, regularly$(\mathcal{I}_{\sigma }^{*},\mathcal{I}^{\sigma *}_{2})$(Iσ∗,I2σ∗)-Cauchy double sequence and investigate the relationship among them.
Effects of morbidity on smoking cessation: a national smoking cessation program
Authors: Seo Young-Gyun , Jo Min-Woo , Paek Yu-Jin , Choi Jaekyung 
Published: July 2021

Abstract
Background
In smokers with chronic diseases, we examined the abstinence rates over 6 months and its affecting factors in the context of the Korea National Health Insurance Service (NHIS) smoking cessation program.

Methods
To identify 6-month abstinence, we extracted a sample of 15,017 participants using the multi-stage stratified cluster sampling method from the 359,047 individuals enrolled in the 2016 NHIS smoking cessation program and 1500 smokers responded to the telephone survey. From this group, 1245 individuals (48.50 ± 12.55 years; men 89.8%) were enrolled, as they had no missing information for confounding variables. We compared chronic disease distribution between participants and current smokers in the 2016 Korea National Health and Nutrition Examination Survey. We evaluated the factors affecting continuous abstinence rate (CAR) across patients with different chronic diseases: hypertension, diabetes mellitus (DM), dyslipidemia (DL), chronic obstructive pulmonary disease, and major depressive disorder (MDD).

Results
While participation of DM patients was high, the participation of DL patients was relatively low. The CAR over 6 months was 44.74%. The adjusted odds ratio (OR) for continuous abstinence over 6 months was significantly lower in the MDD group than in the no-MDD group (OR 0.43, 95% confidence interval [CI] 0.21 to 0.85). The factors of program completion (complete versus incomplete: OR 3.11, 95% CI 2.43 to 3.98), region (non-metropolitan areas versus Seoul metropolitan area: OR 1.28, 95% CI 1.01 to 1.61), and nicotine dependence (severe versus light or moderate: OR 0.64, 95% CI 0.50 to 0.83) were significantly associated with CAR.

Conclusions
The smoking cessation program was not actively recruiting smokers with chronic diseases. The CARs in each disease group were not different from those in the non-disease groups, except that the MDD group had a lower CAR over 6 months than the no-MDD group. Recruiting smokers with chronic diseases and improving their CARs depends on the careful identification of their characteristics.