bluuebunny/crossref_metadata_2025_split huggingface dataset:
Evaluation of a multi-component, non-pharmacological intervention to prevent and reduce sleep disturbances in people with dementia living in nursing homes (MoNoPol-sleep): study protocol for a cluster-randomized exploratory trial
Authors: Dichter Martin N. , Berg Almuth , Hylla Jonas , Eggers Daniela , Wilfling Denise , Möhler Ralph , Haastert Burkhard , Meyer Gabriele , Halek Margareta , Köpke Sascha 
Published: January 2021

AbstractBackgroundSleep problems are highly prevalent in people with dementia. Nevertheless, there is no “gold standard” intervention to prevent or reduce sleep problems in people with dementia. Existing interventions are characterized by a pronounced heterogeneity as well as insufficient knowledge about the possibilities and challenges of implementation. The aim of this study is to pilot and evaluate the effectiveness of a newly developed complex intervention to prevent and reduce sleep problems in people with dementia living in nursing homes.MethodsThis study is a parallel group cluster-randomized controlled trial. The intervention consists of six components: (1) the assessment of established sleep-promoting interventions and an appropriate environment in the participating nursing homes, (2) the implementation of two “sleep nurses” as change agents per nursing home, (3) a basic education course for nursing staff: “Sleep problems in dementia”, (4) an advanced education course for nursing staff: “Tailored problem-solving” (two workshops), (5) workshops: “Development of an institutional sleep-promoting concept” (two workshops with nursing management and sleep nurses) and (6) written information and education material (e.g. brochure and “One Minute Wonder” poster). The intervention will be performed over a period of 16 weeks and compared with usual care in the control group.Overall, 24 nursing homes in North, East and West Germany will be included and randomized in a 1:1 ratio. The primary outcome is the prevalence of sleep problems in people with dementia living in nursing homes. Secondary outcomes are quality of life, quality of sleep, daytime sleepiness and agitated behavior of people with dementia, as well as safety parameters like psychotropic medication, falls and physical restraints. The outcomes will be assessed using a mix of instruments based on self- and proxy-rating. A cost analysis and a process evaluation will be performed in conjunction with the study.ConclusionsIt is expected that the intervention will reduce the prevalence of sleep problems in people with dementia, thus not only improving the quality of life for people with dementia, but also relieving the burden on nursing staff caused by sleep problems.Trial registrationCurrent controlled trials:ISRCTN36015309. Date of registration: 06/11/2020.
Enriched Music-supported Therapy for chronic stroke patients: a study protocol of a randomised controlled trial
Authors: Grau-Sánchez Jennifer , Segura Emma , Sanchez-Pinsach David , Raghavan Preeti , Münte Thomas F. , Palumbo Anna Marie , Turry Alan , Duarte Esther , Särkämö Teppo , Cerquides Jesus , Arcos Josep Lluis , Rodríguez-Fornells Antoni 
Published: January 2021

AbstractBackgroundResidual motor deficits of the upper limb in patients with chronic stroke are common and have a negative impact on autonomy, participation and quality of life. Music-Supported Therapy (MST) is an effective intervention to enhance motor and cognitive function, emotional well-being and quality of life in chronic stroke patients. We have adapted the original MST training protocol to a home-based intervention, which incorporates increased training intensity and variability, group sessions, and optimisation of learning to promote autonomy and motivation.MethodsA randomised controlled trial will be conducted to test the effectiveness of this enriched MST (eMST) protocol in improving motor functions, cognition, emotional well-being and quality of life of chronic stroke patients when compared to a program of home-based exercises utilizing the Graded Repetitive Arm Supplementary Program (GRASP). Sixty stroke patients will be recruited and randomly allocated to an eMST group (n = 30) or a control GRASP intervention group (n = 30). Patients will be evaluated before and after a 10-week intervention, as well as at 3-month follow-up. The primary outcome of the study is the functionality of the paretic upper limb measured with the Action Research Arm Test. Secondary outcomes include other motor and cognitive functions, emotional well-being and quality of life measures as well as self-regulation and self-efficacy outcomes.DiscussionWe hypothesize that patients treated with eMST will show larger improvements in their motor and cognitive functions, emotional well-being and quality of life than patients treated with a home-based GRASP intervention.Trial registrationThe trial has been registered atClinicalTrials.govand identified asNCT04507542on 8 August 2020.
Adjuvant albumin-bound paclitaxel combined with S-1 vs. oxaliplatin combined with capecitabine after D2 gastrectomy in patients with stage III gastric adenocarcinoma: a phase III multicenter, open-label, randomized controlled clinical trial protocol
Authors: Cheng Xiangdong , Wu Dan , Xu Nong , Chen Luchuan , Yan Zhilong , Chen Ping , Zhou Lei , Yu Jianfa , Cui Jiuwei , Li Wei , Wang Chang , Feng Wenming , Wei Yunhai , Yu Pengfei , Du Yian , Ying Jieer , Xu Zhiyuan , Yang Litao , Zhang Yunli 
Published: January 2021

Abstract
Background
Surgery is the only treatment option for operable gastric cancer. The CLASSIC and ACTS-GC studies showed that the 5-year overall survival (OS) of patients with stage III gastric cancer undergoing D2 gastrectomy is still very low. Whether adjuvant nanoparticle albumin-bound paclitaxel (nab-paclitaxel) combined chemotherapy is more effective than the XELOX standard adjuvant chemotherapy in patients with stage III gastric cancer has not been confirmed.

Methods
This is a multicenter, open-label, phase III clinical study. In this trial, 616 patients with locally advanced stage III gastric cancer that underwent curative D2 radical surgery and achieved R0 are planned to be included. Patients will be randomized 1:1 to nab-paclitaxel combined with S-1 (AS) vs. oxaliplatin combined with capecitabine (XELOX). XELOX group: Patients assigned to the XELOX group received eight 3-week cycles of oral capecitabine (1000 mg/m2) twice daily on days 1–14 of each cycle plus intravenous oxaliplatin 130 mg/m2 on day 1 of each cycle. AS group: AS group received eight 3-week cycles of oral S-1 (80–120 mg) (< 1.25 m2, 40 mg; 1.25 to < 1.5 m2, 50 mg; and > 1.5 m2, 60 mg) twice daily on days 1–14 plus intravenous nab-paclitaxel 120 mg/m2 on days 1 and 8 of each cycle. The primary endpoint was the 3-year disease-free survival (3-year-DFS) defined as the time from randomisation to the time of recurrence of the original gastric cancer, development of a new gastric cancer, or death from any cause. The secondary endpoints were the overall survival, (defined as the time from the date of randomisation to date of death from any cause) and safety (any adverse event).

Discussion
Compared with previous studies, this study includes nab-paclitaxel based on S-1 adjuvant chemotherapy, which is expected to achieve better efficacy and lower toxicity than the standard treatment. This study is the first clinical study to evaluate the safety and efficacy of nab-paclitaxel combined with S-1 in patients with stage III gastric cancer after D2 radical resection.

Trial registration
This clinical trial has been registered with ClinicalTrials.gov, registration number: NCT04135781, on October 20th, 2019.
Linking political exposures to child and maternal health outcomes: a realist review
Authors: Barnish Maxwell S. , Tan Si Ying , Taeihagh Araz , Tørnes Michelle , Nelson-Horne Rebecca V. H. , Melendez-Torres G. J. 
Published: January 2021

AbstractBackgroundConceptual and theoretical links between politics and public health are longstanding. Internationally comparative systematic review evidence has shown links between four key political exposures – the welfare state, political tradition, democracy and globalisation – on population health outcomes. However, the pathways through which these influences may operate have not been systematically appraised. Therefore, focusing on child and maternal health outcomes, we present a realist re-analysis of the dataset from a recent systematic review.MethodsThe database from a recent systematic review on the political determinants of health was used as the data source for this realist review. Included studies from the systematic review were re-evaluated and those relating to child and/or maternal health outcomes were included in the realist synthesis. Initial programme theories were generated through realist engagement with the prior systematic review. These programme theories were adjudicated and refined through detailed engagement with the evidence base using a realist re-synthesis involving two independent reviewers. The revised theories that best corresponded to the evidence base formed the final programme theories.ResultsOut of the 176 included studies from the systematic review, a total of 67 included child and/or maternal health outcomes and were included in the realist re-analysis. Sixty-three of these studies were ecological and data were collected between 1950 and 2014. Six initial programme theories were generated. Following theory adjudication, three theories in revised form were supported and formed the final programme theories. These related to a more generous welfare state leading to better child and maternal health especially in developed countries through progressive social welfare policies, left-of-centre political tradition leading to lower child mortality and low birth weight especially in developed countries through greater focus on welfare measures, and increased globalisation leading to greater child and infant mortality and youth smoking rates in LMECs through greater influence of multinational corporations and neoliberal trade organisations.ConclusionWe present a realist re-analysis of a large systematically identified body of evidence on how four key political exposures – the welfare state, democracy, political tradition and globalisation – relate to child and maternal health outcomes. Three final programme theories were supported.
LncRNA HOTTIP leads to osteoarthritis progression via regulating miR-663a/ Fyn-related kinase axis
Authors: He Xianwei , Gao Kun , Lu Shuaihua , Wu Rongbo 
Published: January 2021

Abstract
Background
Long non-coding RNA (lncRNA) has been implicated in the progression of osteoarthritis (OA). This study was aimed to explore the role and molecular mechanism of lncRNA HOXA terminal transcriptional RNA (HOTTIP) in the development of OA.

Methods
The expression of HOTTIP, miR-663a and Fyn-related kinase (FRK) in the OA articular cartilage and OA chondrocyte model induced by IL-1β was determined by qRT-PCR. CCK-8, colony formation and flow cytometry were used to determine the cell proliferation and apoptosis of OA chondrocytes. The specific molecular mechanism of HOTTIP in OA chondrocytes was determined by dual luciferase reporter assay, qRT-PCR, western blotting and RNA pull-down.

Results
The expression of HOTTIP and FRK were up-regulated, while miR-663a was down-regulated in OA cartilage tissues. Knockdown of HOTTIP decreased the proliferation and induced the apoptosis of OA cartilage model cells, while overexpression of HOTTIP increased the proliferation and reduced the apoptosis of OA cartilage model cells. Moreover, HOTTIP could bind to miR-663a as competitive endogenous RNA. Inhibition of miR-663a expression could alleviate the effect of HOTTIP knockdown on the proliferation and apoptosis of OA cartilage model cells. Furthermore, FRK was found to be a direct target of miR-663a, which could markedly down-regulate the expression of FRK in OA chondrocytes, while HOTTIP could remarkably up-regulate the expression of FRK. In addition, miR-663a inhibition increased the proliferation and reduced the apoptosis of OA cells, while FRK knockdown reversed the effect of miR-663a inhibition on the proliferation and apoptosis of OA cells. Meanwhile, overexpression of miR-663a decreased the proliferation and induced the apoptosis of OA cells, while overexpression of FRK reversed the effect of miR-663a overexpression on the proliferation and apoptosis of OA cells.

Conclusion
HOTTIP was involved in the proliferation and apoptosis of OA chondrocytes via miR-663a/ FRK axis, and HOTTIP/miR-663a/FRK might be a potential target for the treatment of OA.
Evaluation of efficacy and safety of percutaneous transforaminal endoscopic surgery (PTES) for surgical treatment of calcified lumbar disc herniation: a retrospective cohort study of 101 patients
Authors: Wang Hao , Zhou Tianyao , Gu Yutong , Yan Zuoqin 
Published: January 2021

AbstractBackgroundPercutaneous transforaminal endoscopy has been widely used to treat lumbar disc herniation (LDH), but the steep learning curve and difficulties in removing the calcified disc hinders the application of conventional endoscopy in treating calcified lumbar disc herniation (CLDH). In 2017, we first reported Percutaneous Transforaminal Endoscopic Surgery (PTES) as an easy-to-learn posterolateral transforaminal endoscopic technique to decompress the nerve root for LDH. We used our PTES technique to remove the calcified LDH and the purpose of this study is to evaluate the safety and efficacy of this technique.MethodsForty-six patients with CLDH and fifty-five patients with uncalcified lumbar disc herniation (ULDH) underwent PTES to decompress the nerve root. Visual analogue scale was collected before the surgery, immediately, one week, one month, two months, three months, six months, 12 months and 24 months after surgery. The outcomes of MacNab classification were collected 24 months after surgery. Intra- and Post-operative complications were also recorded.ResultsFor CLDH patients, the VAS score was 9 (5–10) before operation, and then dropped to 2 (1–4) after surgery. VAS score continually decreased to 0 (0–3) at 24 months after surgery. 95.65% of CLDH patients showed excellent or good outcomes. ULDH group showed similar MacNab classification (94.55%) and VAS changing curve. The therapeutic effect of PTES in treating CLDH was as good as that in treating uncalcified patients.ConclusionsPTES is an effective and safe method to treat calcified lumbar disc herniation.
Successful pregnancy after operation in an infertile woman caused by luteinizing hormone-secreting pituitary adenoma: case report and literature review
Authors: Zhang Yi , Chen Cheng , Lin Min , Deng Kan , Zhu Huijuan , Ma Wenbin , Pan Hui , Wang Renzhi , Yao Yong 
Published: January 2021

Abstract
Background
Functional gonadotroph adenomas (FGAs) are rare adenomas that most commonly secrete FSH. However, solitary LH-secreting pituitary adenomas are unusual.

Case presentation
A 30-year-old woman with elevated LH and normal FSH presented with inability to conceive. An MRI revealed an enlarged sella turcica and an intrasellar mass. Treatment with transsphenoidal resection led to normalization of LH and estradiol, as well as successful pregnancy. And we reviewed 6 cases of LH-secreting pituitary adenomas from 1981 to 2020.

Conclusions
Our case is unique because of the LH-secreting pituitary adenoma without FSH hypersecretion. This case indicates that pituitary adenoma should be considered when other diseases causing infertility have been excluded.
Challenges for palliative care day services: a focus group study
Authors: Hasson Felicity , Jordan Joanne , McKibben Laurie , Graham-Wisener Lisa , Finucane Anne , Armour Kathy , Zafar Shazia , Hewison Alistair , Brazil Kevin , Kernohan W. George 
Published: January 2021

Abstract
Background
Palliative care day services provide a safe environment for people with palliative care needs, enabling them to access a range of services while acting as a respite services for family caregivers. Viewed as marginal services, they are often under resourced and under researched. The aim of this study was to understand how palliative day care services contribute to client care from the perspective of management and hospice multidisciplinary teams.

Methods
A descriptive qualitative study, using six focus groups conducted with staff at three United Kingdom hospices in England, Scotland and Northern Ireland. Thirty-five participants were recruited, including management and staff. Discussions were transcribed and analysed thematically.

Results
Four key themes emerged: (1) variations of care, beyond heterogeneity of patients; (2) unclear referrals and inconsistent patient population; (3) recognising strengths and challenges and (4) an uncertain future. A major focus of group discussions was the model of care and the benefits of the service, however the importance of demonstrating services’ effectiveness and value for money was highlighted.

Conclusions
Management and hospice staff believed day-services to be a helpful introduction to palliative care, providing both social and medical support. Economic pressures and patient demand were influencing them to move from a social model to a hybrid model. Further research is needed to understand the effectiveness of the service.
Empathy in nurse-patient interaction: a conversation analysis
Authors: Wu Yijin 
Published: January 2021

AbstractBackgroundConsiderable attention has been drawn to empathy in nursing and the concept of empathy has firmly been embedded in nursing discourse. However, little has been known about the details of how nurses express empathy to their patients. In this study, we aim to conduct a qualitative study of actual nurse-patient conversations through which empathy was achieved.MethodsThe data in this study was based on audio-recording of sessions of conversations between participating nurses and patients in two Chinese hospitals. The participants in this study involved 6 female nurses and 14 patients. Based on Bachelor’s (1988) categorization of empathy, this study described and analyzed the actual empathic sequences in nursing conversations in an attempt to demonstrate how nursing empathy was interactionally achieved using the method of conversation analysis. Conversation analysis (CA), focusing on the study of talk in interaction, is a useful method for the qualitative analysis of empathic talk in nursing.ResultsBy drawing on prior theoretical work as well as on empathic sequence in nursing, this study described and analyzed some of the conversational resources nurses and patients used in achieving empathy. It has been shown that empathy can be interactionally and sequentially achieved in actual sequences of talk. Specifically, nursing empathy is a collaboratively constructed action instead of the nurse’s own committed action, which is produced in specific interactional contexts.ConclusionConversation analysis is a very useful method for describing and analyzing the nurse-patient interaction, especially for studying empathy in nursing care. The sequences in this study present example of exemplary empathic interaction between nurses and patients, which might shed some light on how nurses express empathy to their patients. Also, this study could help to increase the understanding of the mirco-process of empathy in nursing and contribute to improving nursing communicative skills.
Reduction in cardiovascular mortality following severe hypoglycemia in individuals with type 2 diabetes: the role of a pragmatic and structured intervention
Authors: Pearson Sam M. , Whittam Beverley , Kulavarasalingam Kavita , Mitchell-Gears Amelia , James Cathyrn , Ajjan Ramzi A. 
Published: January 2021

Abstract
Background
Mortality in individuals with diabetes with severe hypoglycemia requiring ambulance services intervention is high and it is unclear whether this is modifiable. Our aim was to characterise this high-risk group and assess the impact of nurse-led intervention on mortality.

Methods
In this single centre study, patients with diabetes and hypoglycemia requiring ambulance call out were randomized to nurse led support (intensive arm) or managed using existing pathways (standard arm). A third group agreed to have their data collected longitudinally (observational arm). The primary outcome was all-cause mortality comparing intensive with combined standard and observational arms as well as standard arm alone.

Results
Of 828 individuals identified, 323 agreed to participate with 132 assigned to intensive, 130 to standard and 61 to observational arms. Mean follow up period was 42.6 ± 15.6 months. Mortality in type 1 diabetes (n = 158) was similar across study arms but in type 2 diabetes (n = 160) this was reduced to 33% in the intensive arm compared with 51% in the combined arm (p = 0.025) and 50% in the standard arm (p = 0.06). Cardiovascular deaths, the leading cause of mortality, was lower in the intensive arm compared with combined and standard study arms (p < 0.01).

Conclusions
Medium-term mortality following severe hypoglycemia requiring the assistance of emergency services is high in those with type 2 diabetes. In individuals with type 2 diabetes, nurse-led individualized intervention reduces cardiovascular mortality compared with standard care. Large-scale multicentre studies are warranted to further investigate this approach.
Trial registration The trial was retrospectively registered on http://www.clinicaltrials.gov with reference NCT04422145
Triglyceride–glucose index is associated with the risk of myocardial infarction: an 11-year prospective study in the Kailuan cohort
Authors: Tian Xue , Zuo Yingting , Chen Shuohua , Liu Qian , Tao Boni , Wu Shouling , Wang Anxin 
Published: January 2021

AbstractBackgroundThe triglyceride–glucose (TyG) index, which is a simple surrogate marker of insulin resistance, has been suggested as a contributor of cardiovascular disease. However, evidence on the effect of long-term elevation of the TyG index exposure on myocardial infarction (MI) is limited. The current study aimed to evaluate the association of baseline and long-term elevation of the TyG index exposure with the risk of MI.MethodsA total of 98,849 participants without MI at baseline (2006) were enrolled from the Kailuan study. The baseline TyG index was calculated as ln [fasting triglyceride (mg/dL) × fasting glucose (mg/dL)/2]. The long-term TyG index was characterized in two ways as follows. The updated mean TyG index was calculated as the mean of TyG index at all previous visits before MI occurred or the end of follow-up; alternatively, the TyG index was calculated as the number of visits with a high TyG index in 2006, 2008, and 2010, ranging from 0 (no exposure) to 3 (had high TyG index at all three study visits). Hazard ratio (HR) and 95% confidence interval (CI) was estimated using multivariable Cox proportion hazard models.ResultsDuring a median follow-up of 11.03 years, 1555 incident MI occurred. In the multivariable-adjusted model, the risk of MI increased with quartiles of the baseline and updated mean TyG index, the HR in quartile 4 versus quartile 1 was 2.08 (95% CI,1.77–2.45) and 1.58 (1.18–2.12), respectively. Individuals with a high TyG index at all three visits had a 2.04-fold higher risk (95% CI, 1.63–2.56) of MI compared with no exposure. Subgroup analyses showed that the associations were more pronounced in women than in men (Pinteraction = 0.0411).ConclusionsElevated levels of the baseline and long-term TyG index are associated with an increased risk of MI. This finding indicates that the TyG index might be useful in identifying people at high risk of developing MI.