bluuebunny/crossref_metadata_2025_split huggingface dataset:
Cohort profile: evaluation of immune response and household transmission of SARS-CoV-2 in Costa Rica: the RESPIRA study
Authors: Loria Viviana , Aparicio Amada , Hildesheim Allan , Cortés Bernal , Barrientos Gloriana , Retana Daniela , Sun Kaiyuan , Ocampo Rebeca , Prevots D. Rebecca , Zúñiga Michael , Waterboer Tim , Wong-McClure Roy , Morera Melvin , Butt Julia , Binder Marco , Abdelnour Arturo , Calderón Alejandro , Gail Mitchell H , Pfeiffer Ruth M , Solís Cristina Barboza , Fantin Romain , Vanegas Juan Carlos , Mercado Rachel , Ávila Carlos , Porras Carolina , Herrero Rolando 
Published: December 2023

PurposeThe RESPIRA cohort aims to describe the nature, magnitude, time course and efficacy of the immune response to SARS-CoV-2 infection and vaccination, population prevalence, and household transmission of COVID-19.ParticipantsFrom November 2020, we selected age-stratified random samples of COVID-19 cases from Costa Rica confirmed by PCR. For each case, two population-based controls, matched on age, sex and census tract were recruited, supplemented with hospitalised cases and household contacts. Participants were interviewed and blood and saliva collected for antibodies and PCR tests. Participants will be followed for 2 years to assess antibody response and infection incidence.Findings to dateRecruitment included 3860 individuals: 1150 COVID-19 cases, 1999 population controls and 719 household contacts from 304 index cases. The age and regional distribution of cases was as planned, including four age strata, 30% rural and 70% urban. The control cohort had similar sex, age and regional distribution as the cases according to the study design. Among the 1999 controls recruited, 6.8% reported at enrolment having had COVID-19 and an additional 12.5% had antibodies against SARS-CoV-2. Compliance with visits and specimens has been close to 70% during the first 18 months of follow-up. During the study, national vaccination was implemented and nearly 90% of our cohort participants were vaccinated during follow-up.Future plansRESPIRA will enable multiple analyses, including population prevalence of infection, clinical, behavioural, immunological and genetic risk factors for SARS-CoV-2 acquisition and severity, and determinants of household transmission. We are conducting retrospective and prospective assessment of antibody levels, their determinants and their protective efficacy after infection and vaccination, the impact of long-COVID and a series of ancillary studies. Follow-up continues with bimonthly saliva collection for PCR testing and biannual blood collection for immune response analyses. Follow-up will be completed in early 2024.Trial registration numberNCT04537338.
Investigating trial design variability in trials of disease-modifying therapies in Parkinson’s disease: a scoping review protocol
Authors: Zeissler Marie-Louise , Boey Timothy , Chapman Danny , Rafaloff Gary , Dominey Thea , Raphael Karen G , Buff Susan , Pai Hari Venkatesh , King Emma , Sharpe Paul , O’Brien Fintan , Carroll Camille B 
Published: December 2023

IntroductionParkinson’s disease (PD) is a debilitating neurological disorder for which the identification of disease-modifying interventions represents a major unmet need. Diverse trial designs have attempted to mitigate challenges of population heterogeneity, efficacious symptomatic therapy and lack of outcome measures that are objective and sensitive to change in a disease modification setting. It is not clear whether consensus is emerging regarding trial design choices. Here, we report the protocol of a scoping review that will provide a contemporary update on trial design variability for disease-modifying interventions in PD.Methods and analysisThe Population, Intervention, Comparator, Outcome and Study design (PICOS) framework will be used to structure the review, inform study selection and analysis. The databases MEDLINE, Web of Science, Cochrane and the trial registry ClinicalTrials.gov will be systematically searched to identify published studies and registry entries in English. Two independent reviewers will screen study titles, abstracts and full text for eligibility, with disagreements being resolved through discussion or by a third reviewer where necessary. Data on general study information, eligibility criteria, outcome measures, trial design, retention and statistically significant findings will be extracted into a standardised form. Extracted data will be presented in a descriptive analysis. We will report our findings using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Scoping Review extension.Ethics and disseminationThis work will provide an overview of variation and emerging trends in trial design choices for disease-modifying trials of PD. Due to the nature of this study, there are no ethical or safety considerations. We plan to publish our findings in a peer-reviewed journal.
Effect of whole-body cryotherapy versus placebo cryotherapy on joint pain induced by aromatase inhibitors in women with early stage breast cancer: a randomised clinical trial
Authors: Duraes Martha , Garbay Marion , Ferrer Catherine , Duflos Claire , Rathat Gauthier 
Published: December 2023

IntroductionHormone therapy (HT) is a major adjuvant treatment for breast cancer. Despite their effectiveness, aromatase inhibitors can cause several side effects, including arthralgia in 35%–50% of patients. These side effects frequently lead to the premature discontinuation of HT. Whole-body cryotherapy (WBC) can be used for managing arthritic pain. The primary objective of this study will be to evaluate the effect of WBC on aromatase-induced joint pain, compared with placebo cryotherapy, in patients with hormone-dependent breast cancer receiving adjuvant aromatase inhibitors. The secondary objectives will be to evaluate WBC safety and its effect on analgesic consumption, HT adherence and quality of life.Methods and analysisIn this randomised, placebo-controlled, double-blinded clinical trial, 56 patients with aromatase inhibitor-induced joint pain and a Brief Pain Inventory-Short Form (BPI-SF) score ≥3 for the worst pain experienced in the previous week will be randomised into the WBC or placebo cryotherapy arm (10 sessions in each group). The primary outcome will be the BPI-SF score at week 6 post-treatment. The secondary outcomes will include the BPI-SF scores at months 3 and 6 post-treatment, the BPI-SF pain severity index and pain interference index, the Health Assessment Questionnaire score, the number of days of aromatase inhibitor treatment and analgesic consumption in the 15 days before the visits at week 6 and months 3 and 6 after cryotherapy. The incidence of adverse events will also be investigated.Ethics and disseminationEthics approval was obtained from the Ethics Committee Est IV of Hospital Civil, Strasbourg, France. Protocol V.5 was approved in December 2022. The results will be disseminated in a peer-reviewed journal and presented at international congresses.Trial registration numberNCT05315011.
Differentiating Alzheimer’s disease from mild cognitive impairment: a quick screening tool based on machine learning
Authors: Lü Wenqi , Zhang Meiwei , Yu Weihua , Kuang Weihong , Chen Lihua , Zhang Wenbo , Yu Juan , Lü Yang 
Published: December 2023

BackgroundAlzheimer’s disease (AD) is a neurodegenerative disorder characterised by cognitive decline, behavioural and psychological symptoms of dementia (BPSD) and impairment of activities of daily living (ADL). Early differentiation of AD from mild cognitive impairment (MCI) is necessary.MethodsA total of 458 patients newly diagnosed with AD and MCI were included. Eleven batteries were used to evaluate ADL, BPSD and cognitive function (ABC). Machine learning approaches including XGboost, classification and regression tree, Bayes, support vector machines and logical regression were used to build and verify the new tool.ResultsThe Alzheimer’s Disease Assessment Scale (ADAS-cog) word recognition task showed the best importance in judging AD and MCI, followed by correct numbers of auditory verbal learning test delay recall and ADAS-cog orientation. We also provided a selected ABC-Scale that covered ADL, BPSD and cognitive function with an estimated completion time of 18 min. The sensitivity was improved in the four models.ConclusionThe quick screen ABC-Scale covers three dimensions of ADL, BPSD and cognitive function with good efficiency in differentiating AD from MCI.
INvestigational Study Into Transplantation of the Uterus (INSITU): a cross-sectional survey among women with uterine factor infertility in the UK assessing background, motivations and suitability
Authors: Jones Benjamin P , Vali Saaliha , Kasaven Lorraine S , Mantrali Ifigenia , Saso Srdjan , Bracewell-Milnes Timothy , Nicopoullos James , Thum Meen-Yau , Diaz-Garcia Cesar , Quiroga Isabel , Yazbek Joseph , Smith James Richard 
Published: December 2023

ImportanceThe study summarises the selection prescreen criteria currently used in the UK for a uterus transplant and highlights the number of women who are suitable to proceed.ObjectivesTo assess the demographics, motivations, reasons and suitability among women with absolute uterine factor infertility (AUFI) to undergo uterine transplantation (UTx).DesignA cross-sectional survey.SettingAn electronic questionnaire was sent via email to women with AUFI who had previously been referred to the UTx research team or approached the Womb Transplant UK Charity. The questions assessed suitability to undergo UTx based on demographic information, perceptions to adoption and surrogacy and reasons why UTx was preferable. Responses were assessed against the study selection criteria.ParticipantsWomen with AUFI.Results210 women completed the questionnaire. The most common aetiology of AUFI in our cohort was Mayer-Rokitansky-Küster-Hauser (68%; n=143) whereas 29% (n=62) had previously undergone hysterectomy. 63% (n=132) of the cohort had previously considered adoption, 5% (n=11) had attempted it and 2 (1%) had successfully adopted. The most common reason cited to undergo UTx over adoption was to experience gestation (n=63; 53%), while 37% (n=44) wanted a biologically related child. 76% (n=160) of participants had previously considered surrogacy, 22 (10%) had attempted it and 2 (1%) had successfully become mothers using a surrogate. The most common reason to undergo UTx over surrogacy was to experience gestation (n=77; 54%). 15% (n=21) were concerned about the legal implications, 14% (n=20) identified the financial cost as a barrier and 8% (n=12) could not consider it due to religious reasons. On adhering to the selection criteria, 65 (31%) women were suitable to proceed with the trial.ConclusionThe study demonstrates that implementing commonly used selection criteria for a UTx led to an attrition rate of more than two-thirds of women who requested to initially undergo the process. As more studies present outcomes following UTx, critical assessment of the selection criteria currently used is warranted to ensure potential recipients are not being unnecessarily excluded.Trial registration numberNCT02388802.
Psychosocial interventions promoting personal recovery in people with schizophrenia: a scoping review protocol
Authors: Quistgaard Maria , Myklebust Oda Leonarda Pollestad , Aure Thomas , Austin Stephen Fitzgerald , Berring Lene Lauge , Vernal Ditte Lammers , Storebø Ole Jakob 
Published: December 2023

IntroductionPersonal recovery is an important aspect for many individuals diagnosed with schizophrenia, as people can live rich, fulfilling lives despite ongoing symptoms. Prior reviews have found several factors to be associated with personal recovery, but a comprehensive overview of the psychosocial interventions aimed at improving personal recovery in schizophrenia is needed.Methods and analysisKey terms relating to personal recovery and psychosocial interventions to promote personal recovery will be searched for in the following databases: PubMed, EMBASE, PsycINFO, CINAHL, MEDLINE, Google Scholar, Web of Science Core Collection and Cochrane. Additionally, a simple search for grey literature will be conducted in The Networked Digital Library of Theses and Dissertations. Two reviewers will individually screen and extract the data, and the selection of sources will be documented in a Preferred Reporting Items for Systematic reviews and Meta-Analyses flow chart. A content analysis will be conducted on the data, and the findings will be presented in tables, and narratively synthesised. Lastly, research gaps will be identified, and recommendations for future research will be proposed.Ethics and disseminationEthics approval was not required for the development or publishing of this protocol. Findings will be disseminated through conferences, meeting with patient organisations and consumers, and published in a peer-reviewed scientific journal.
Non-pharmacological interventions in primary care to improve the quality of life of older patients with palliative care needs: a systematic review of randomised controlled trials
Authors: Seiça Cardoso Carlos , Rita Matos Joana , Prazeres Filipe , Gomes Barbara 
Published: December 2023

ObjectivesOur systematic review aimed to summarise non-pharmacological interventions applicable in primary care that improve the quality of life of older patients with palliative care needs.DesignSystematic review.Primary and secondary outcome measuresThe primary outcome was patients’ quality of life. Secondary outcomes were symptoms relief and patients’ well-being measures.Methods and analysisWe searched MEDLINE, EMBASE, PsycINFO, Cochrane and CINAHL up to October 2022 for randomised controlled trials (RCTs). We also handsearched abstract books of relevant congresses and scientific meetings in the last 5 years. Screening, data extraction and quality evaluation (Cochrane risk-of-bias (RoB) V.2.0 tool and Grading of Recommendations, Assessment, Development and Evaluations (GRADE)) were done independently by two reviewers, with disagreements solved by a third reviewer. Findings were narratively synthesised.ResultsWe identified 4 RCTs, including 268 patients. One study used a broad criteria of palliative care needs (‘progressive, life-threatening disease’), two studies focused on advanced cancer and one study on heart failure. The non-pharmacological interventions evaluated were advance care planning conducted by general practitioners (GPs); social worker-aided palliative care; online primary palliative care training for GPs and spiritual history taking by nurses and GPs. No intervention showed a statistically significant impact on quality of life and the evidence was low according to GRADE.ConclusionThe results highlight a dearth of evidence on what non-pharmacological interventions can be effectively done in primary care to improve the quality of life of older persons with palliative care needs. The results should be interpreted with caution, as the search more comprehensively covers interventions delivered by GPs.PROSPERO registration numberCRD42020154216.
Effects of repetitive transcranial magnetic stimulation over the contralesional dorsal premotor cortex on upper limb function in severe ischaemic stroke: study protocol for a randomised controlled trial
Authors: Dai Wenjun , Yang Xi , Liu Canhuan , Ding Hongyuan , Guo Chuan , Zhu Yi , Dong Manyu , Qian Yilun , Fang Lu , Wang Tong , Shen Ying 
Published: December 2023

IntroductionRepetitive transcranial magnetic stimulation (rTMS) is an evidence-based treatment widely recommended to promote hand motor recovery after ischaemic stroke. However, the therapeutic efficacy of rTMS over the motor cortex in stroke patients is currently restricted and heterogeneous. This study aimed to determine whether excitatory rTMS over the contralesional dorsal premotor cortex (cPMd) facilitates the functional recovery of the upper limbs during the postacute stage of severe ischaemic stroke.Methods and analysisThis study will be conducted as a single-blind, controlled, randomised study, in which 44 patients with poststroke hemiplegia with a course of disease ranging from 1 week to 3 months and Fugl-Meyer upper limb score ≤22 will be enrolled. The study participants will be randomly assigned to groups A (n=22) and B (n=22). The two groups are based on routine rehabilitation training and drug treatment; group A will be treated with low-frequency (1 Hz) rTMS over the contralesional primary motor cortex (cM1), and group B will be treated with high-frequency (10 Hz) rTMS over cPMd. For 2 weeks, rTMS will be administered once a day, 5 days a week. The primary outcome is the Fugl-Meyer assessment of the upper limb. The secondary outcomes include the Arm Subscore of the Motricity Index, Hong Kong edition of Functional Test for the Hemiplegic Upper Extremity, Modified Barthel Index and Modified Ashworth Scale score of the paralysed pectoralis major and biceps brachii. Furthermore, data of diffusion tensor imaging and functional MRI will be collected. These outcomes will be assessed before and after the completion of the intervention.Ethics and disseminationThis study has been approved by the Ethics Committee of the First Affiliated Hospital of Nanjing Medical University (2020 SR-266). The findings of this study will be spread through networks of scientists, professionals and the general public as well as peer-reviewed scientific papers and presentations at pertinent conferences.Trial registration numberChiCTR2000038049
Effects of the different intensities of task-oriented training on the upper extremity motor function and self-care ability of stroke survivors: study protocol for a multiarm parallel-group randomised controlled trial in a tertiary hospital in China
Authors: Liu Shengfeng , Zhang Kai , Li Xuecha , Li Chunxiang , Peng Mengsi 
Published: December 2023

IntroductionAlthough task-oriented training (TOT) may provide added therapeutic value to stroke survivors, current TOT guidance offers insufficient advice on standardisation, particularly choices of intensity, for clinical practice. Therefore, this study aims to explore the effects of different intensities of TOT on motor function and self-care ability of stroke survivors.Methods and analysisThis randomised controlled clinical trial will recruit 72 participants from a tertiary hospital, diagnosed with decreased self-care ability and upper limb motor dysfunction post-stroke. All participants will be randomly assigned to one of three experimental groups or the control group to undergo intervention for 8 weeks. The participants in the control group (n=18) will receive traditional occupational therapy, while those in the experimental groups will receive different intensities of TOT (50%, 75% and 100% intensity for groups A, B and C, respectively). This protocol designed a more innovative and optimised TOT programme to explore the optimal intensity of TOT on stroke survivors. The primary outcome is Canadian Occupational Performance Measure, and the secondary outcomes include Modified Barthel Index, Wolf Motor Function Test and Motor Activity Log.Ethics and disseminationThe Second Affiliated Hospital of Hainan Medical University Ethics Committee approved the medical and ethical protocol for this study (LW2022015). All participants will sign an informed consent form. The results will be presented in scientific conferences and published in peer-reviewed journals.Trial registration numberChiCTR2200056390.
Self-reported prevalence of asthma and its associated factors among adult rural population in Bangladesh: a cross-sectional study using WHO PEN protocol
Authors: Rakhshanda Shagoofa , Abedin Minhazul , Wahab Abrar , Barua Lingkan , Faruque Mithila , Banik Palash Chandra , Shawon Riffat Ara , Rahman AKM Fazlur , Mashreky Saidur Rahman 
Published: December 2023

ObjectiveFor over a decade, the prevalence of asthma remained unchanged at around 7% in Bangladesh. Although asthma causes significant morbidity among both children and adults, updates on epidemiological data are limited on the prevalence in Bangladesh. This study attempted to determine the prevalence of asthma, and its modifiable and non-modifiable lifestyle predictors in a rural population of Bangladesh.MethodThis study was part of a cross-sectional study that applied the WHO Package of Essential Noncommunicable Disease Interventions via census in a rural area of Bangladesh, where self-reported data on asthma were recorded. Data on anthropometric measurement, sociodemographic characteristics and behavioural risk factors were collected following the standard protocol described in the WHO STEP-wise approach to surveillance (STEPS) questionnaire. Analysis included descriptive statistics to assess the prevalence of asthma and its risk factors, and binary logistic regression to determine contributing factors.ResultThe overall prevalence of asthma was 4.2%. Asthma was predominant among people above 60 years (8.4%). Higher asthma was noted among males (4.6%), self-employed (5.1%), with a family history of asthma (9.1%), with comorbidities besides asthma (7.8%) and underweight (6.0%) compared with their counterparts. The OR of having asthma was 1.89, 1.93, 1.32, 1.50, 2.60, 0.67, 0.67 and 0.78 if a respondent was 45 years old or more, married, underweight, ever smoker, with a family history of asthma, housewife, employed and consumed red meat, respectively, while considering all other variables constant, compared with their counterparts.ConclusionThe study emphasised asthma to be a public health concern in Bangladesh, although it seems to have decreased over the last decade. Among others, red meat intake and nutritional status were strongly associated with asthma, and the linkage among these is still a grey area that needs further exploration.
Virtual reality as an adjunct to pulmonary rehabilitation of patients with chronic obstructive pulmonary disease: a protocol for systematic review and meta-analysis
Authors: Li Yi , Jiang Hongzhan , Lyu Zhi 
Published: December 2023

IntroductionChronic obstructive pulmonary disease (COPD) is a prevalent chronic lung disease characterised by persistent and progressive airflow obstruction resulting from tracheal and/or alveolar lesions. Patients afflicted with COPD endure a poor quality of life primarily due to the symptoms of the disease. Pulmonary rehabilitation (PR) constitutes a core component of the comprehensive management of individuals dealing with COPD. Nevertheless, suboptimal adherence and completion rates are the chief impediments associated with PR. Virtual reality (VR) is emerging as a promising approach to support patients with COPD in their PR journey. Currently, no comprehensive systematic review has evaluated the impact of VR as a PR adjunct in patients with COPD. We aimed to investigate and summarise the evidence from recent studies related to the effect of VR as an adjunct to PR in COPD cases.Methods and analysisWe will conduct a comprehensive search of databases, including Web of Science, CINAHL, PubMed, Embase, Cochrane Central Register of Controlled Trials and ClinicalTrials.gov, from their inception up to May 2023 to identify randomised controlled trials examining VR as an adjunct to PR in patients with COPD, with no restrictions on publication status or language. Our primary outcome measure will be the 6-min walk test. Two independent researchers will screen the literature for suitable articles for inclusion in this meta-analysis. Data collection and assessment of bias risk will be performed. This meta-analysis is intended to furnish data on each outcome as sufficient data become available. Heterogeneity will be assessed using the χ2test and I2statistics. The current review will adhere to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.Ethics and disseminationEthical approval is waived due to the retrospective nature of this study. Furthermore, the findings will be disseminated through peer-reviewed journals.PROSPERO registration numberCRD42022374736.