bluuebunny/crossref_metadata_2025_split huggingface dataset:
Use of ventilation/perfusion mismatch to guide individualised CPAP level selection in preterm infants: a feasibility trial
Authors: Bamat Nicolas A , Orians Carolyn M , Abbasi Soraya , Morley Colin J , Ross Russell Rob , Panitch Howard B , Handley Sara C , Foglia Elizabeth E , Posencheg Michael A , Kirpalani Haresh 
Published: September 2022

ObjectiveTo measure within-subject changes in ventilation/perfusion (V′/Q′) mismatch in response to a protocol of individualised nasal continuous positive airway pressure (CPAP) level selection.DesignSingle-arm, non-randomised, feasibility trial.SettingThree centres in the Children’s Hospital of Philadelphia neonatal care network.PatientsTwelve preterm infants of postmenstrual age 27–35 weeks, postnatal age >24 hours, and receiving a fraction of inspired oxygen (FiO2) >0.25 on CPAP of 4–7 cm H2O.InterventionsWe applied a protocol of stepwise CPAP level changes, with the overall direction and magnitude guided by individual responses in V′/Q′ mismatch, as determined by the degree of right shift (kilopascals, kPa) in a non-invasive gas exchange model. Best CPAP level was defined as the final pressure level at which V′/Q′ improved by more than 5%.Main outcome measuresWithin-subject change in V′/Q′ mismatch between baseline and best CPAP levels.ResultsThere was a median (IQR) within-subject reduction in V′/Q′ mismatch of 1.2 (0–3.2) kPa between baseline and best CPAP levels, p=0.02. Best CPAP was observed at a median (range) absolute level of 7 (5–8) cm H2O.ConclusionsNon-invasive measures of V′/Q′ mismatch may be a useful approach for identifying individualised CPAP levels in preterm infants. The results of our feasibility study should be interpreted cautiously and replication in larger studies evaluating the impact of this approach on clinical outcomes is needed.Trial registration numberNCT02983825.
Safety and efficacy of first-line nivolumab plus ipilimumab alternating with nivolumab monotherapy in patients with advanced renal cell carcinoma: the non-randomised, open-label, phase IIIb/IV CheckMate 920 trial
Authors: George Daniel J , Spigel David R , Gordan Lucio N , Kochuparambil Samith T , Molina Ana M , Yorio Jeff , Rezazadeh Kalebasty Arash , McKean Heidi , Tchekmedyian Nishan , Tykodi Scott S , Zhang Joshua , Askelson Margarita , Johansen Jennifer L , Hutson Thomas E 
Published: September 2022

ObjectivesThe non-randomised, open-label, phase IIIb/IV multicohort CheckMate 920 trial explored the safety and efficacy with a less frequent, but continual nivolumab plus ipilimumab (NIVO+IPI) dosing regimen (cohort 1) to determine whether this modification could potentially retain efficacy benefits while improving on the manageable safety profile previously observed with this combination in patients with advanced renal cell carcinoma (aRCC).SettingPatients were enrolled from 48 largely community-based sites in the USA.Participants106 patients with previously untreated, predominantly clear cell aRCC received treatment.InterventionsPatients received NIVO 6 mg/kg plus IPI 1 mg/kg on day 1 of the first week of each 8-week cycle; the combination alternated with NIVO 480 mg monotherapy on day 1 of the fifth week of each 8-week cycle. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent or study end. The maximum treatment duration was 2 years. The primary endpoint was the incidence of high-grade (grade 3/4 and grade 5) immune-mediated adverse events (IMAEs) within 100 days of the last dose. Select secondary endpoints included time to onset and resolution of high-grade IMAEs, progression-free survival (PFS) and objective response rate (ORR). The incidence of treatment-related adverse events and the overall survival (OS) were the exploratory endpoints.ResultsThe most common grade 3/4 IMAEs were diarrhoea/colitis (7.5%) and rash (6.6%) and no grade 5 IMAEs occurred, with a minimum follow-up of 28.5 months. The median PFS was 4.8 (95% CI 3.0 to 8.3) months, the ORR in evaluable patients (n=96) was 34.4% (95% CI 25.0 to 44.8), and the median OS was not reached (95% CI 24.8 months to not estimable).ConclusionsWhile no new safety signals were reported with less frequent, but continual NIVO+IPI dosing in CheckMate 920, the modified regimen was not associated with clinical benefits relative to the approved NIVO+IPI dose. These results support the continued use of the currently approved NIVO+IPI combination dosing schedule for patients with aRCC.Trial registration numberNCT02982954.
Longitudinal qualitative study of living with neurogenic claudication
Authors: Griffiths Frances , Srikesavan Cynthia , Ward Lesley , Boniface Graham , Williamson Esther , Lamb Sarah E 
Published: September 2022

ObjectivesNeurogenic claudication (NC) causes pain and reduced mobility, particularly in older people, and can negatively affect mental and social well-being, so limiting successful ageing. This qualitative study explored how people with NC changed over 12 months.DesignA longitudinal qualitative study using semi-structured interviews.SettingParticipants were recruited from a UK clinical trial of a physiotherapy intervention for NC.ParticipantsInterviews were undertaken at baseline, 1 month after receiving any intervention and at 12 months. We analysed 30 sets of three interviews.ResultsInterview data were summarised for each time point into biopsychosocial domains: pain, mobility and activities of daily living, psychological impact, and social and recreational participation. Through comparative analysis we explored participant trajectories over time.Progressive improvement in at least one domain was experienced by 13 participants, but there was variability in trajectories with early improvements that remained the same, transient changes and no change also commonly observed.Eleven participants described co-present improvement trajectories in all domains. Three participants described co-present improvement in all domains except participation; one had never stopped their participation and two had unattainable expectations. Five participants described co-present improvement in one domain and deterioration in another and 14 participants described co-present no change in one domain and change in another.There was evidence of interaction between domains; for example, improved mobility led to improved participation and for some participants, specific factors influenced change. Of the 15 participants who experienced improved participation, 10 reported improvements in all other domains and five participants did not; for two, pain did not prevent participation, one used a walking aid and two had a positive psychological outlook.ConclusionThe daily lived experiences of older adults with NC are variable and include interaction between biopsychosocial domains. Therapist understanding of these trajectories and their interactions may help to provide personalised therapyTrial Registration NumberISRCTN12698674
Demographic and clinical characteristics of patients with delirium: analysis of a nationwide Japanese medical database
Authors: Ueda Naoya , Igarashi Masakazu , Okuyama Kotoba , Sano Hideki , Takahashi Kanae , P Qureshi Zaina , Tokita Shigeru , Ogawa Asao , Okumura Yasuyuki , Okuda Shoki 
Published: September 2022

ObjectivesDelirium commonly occurs during hospitalisation and is associated with increased mortality, especially in elderly patients. This study aimed to determine the demographic and clinical characteristics of patients with delirium in the Japanese real-world clinical setting using a nationwide database comprising claims and discharge abstract data.DesignThis was an observational, cross-sectional, retrospective study in hospitalised patients with an incident delirium identified by a diagnosis based on International Classification of Diseases, 10th Revision codes or initiating antipsychotics recommended for delirium treatment in Japan during their hospitalisation.SettingPatients from the Medical Data Vision database including more than 400 acute care hospitals in Japan were evaluated from admission to discharge.ParticipantsOf the 32 910 227 patients who were included in the database between April 2012 and September 2020, a total of 145 219 patients met the criteria for delirium.Primary and secondary outcome measuresDemographic and baseline characteristics, comorbidities, clinical profiles and pharmacological treatments were evaluated in patients with delirium.ResultsThe mean (SD) patient age was 76.5 (13.8) years. More than half of the patients (n=82 159; 56.6%) were male. The most frequent comorbidities were circulatory system diseases, observed in 81 954 (56.4%) patients. Potentially inappropriate medications (PIMs) with risk of delirium including benzodiazepines and opioids were prescribed to 76 798 (52.9%) patients. Approximately three-fourths of these patients (56 949; 74.2%) were prescribed ≥4 PIMs. The most prescribed treatment for delirium was injectable haloperidol (n=82 490; 56.8%). Mean (SD) length of hospitalisation was 16.0 (12.1) days.ConclusionsThe study results provide comprehensive details of the clinical characteristics of patients with delirium and treatment patterns with antipsychotics in the Japanese acute care setting. In this patient population, the prescription rate of injectable haloperidol and PIMs was high, suggesting the need for improved understanding among healthcare providers about the appropriate management of delirium, which may benefit patients.
Effect of melatonin on quality of life and symptoms in patients with cancer: a systematic review and meta-analysis of randomised controlled trials
Authors: Fan Rongrong , Bu Xiaofan , Yang Siyu , Tan Yan , Wang Tongyu , Chen Hongyun , LI Xuying 
Published: September 2022

ObjectiveThis study systematically reviewed the effect of melatonin (MLT) on quality of life (QoL) and symptoms among patients with cancer.DesignSystematic review and meta-analysis.Data sourcesCochrane Library, PubMed, Embase, Web of Science, Medline, CINAHL, Scopus, ClinicalTrials.gov, China Biology Medicine (CBM), ProQuest and Open Grey were searched from inception to November 2021.Eligibility criteriaWe included randomised controlled trials (RCTs) assessing the effects of MLT on QoL, sleep quality, fatigue, depression, pain, stomatitis rate and stomatitis severity in adult patients with cancer, without language restrictions. Studies that reported the effects of MLT along with other interventions and had incomplete or absent outcome data were excluded.Data extraction and synthesisTwo independent reviewers extracted data, and another two reviewers assessed the risk of bias. The risk of bias for each eligible study was assessed using the Cochrane assessment tool. The mean difference or standard mean difference (SMD) with 95% CIs was used in the computation of continuous variables to synthesise data. The relative risk was used for dichotomous outcomes. Heterogeneity was assessed and quantified (I2 statistic).ResultsA total of 19 qualified studies that included 2101 patients with cancer (MLT: 1078, control: 1023) were included in the meta-analysis. The results indicated that MLT had no significant effect on QoL (SMD=−0.01, 95% CI (−0.14 to 0.11), p=0.83), sleep quality (SMD=−0.18, 95% CI (−0.62 to 0.26), p=0.42), fatigue (SMD=−0.34, 95% CI (−0.73 to 0.06), p=0.10), pain (SMD=−0.34, 95% CI (−0.7 to 0.02), p=0.06) or stomatitis severity (RR=0.78, 95% CI (0.47 to 1.30), p=0.35). MLT reduced stomatitis rate among patients with cancer (RR=0.47, 95% CI (0.26 to 0.88), p=0.02), except those with head and neck cancer (RR=1.09, 95% CI (0.92 to 1.29), p=0.35). MLT eased depression in patients who received administration for more than 14 days (SMD=−0.14, 95% CI (−0.27 to –0.01), p=0.03) and those who underwent surgery (SMD=−0.17, 95% CI (−0.32 to –0.03), p=0.02).ConclusionThe findings showed that MLT did not improve the QoL, sleep quality, fatigue, pain or stomatitis severity among patients with cancer. It had a limited effect on decreasing the stomatitis rate and easing depression. Different treatments, durations and cancer types were the main sources of heterogeneity. Further large-scale RCTs are urgently needed. In addition, the effects of different combinations of MLT dosage and duration, administration types and joint measures are worthy of further study.PROSPERO registration numberCRD42021292855.
Nursing support for symptoms in patients with cancer and caregiver burdens: a scoping review protocol
Authors: Kako Jun , Kobayashi Masamitsu , Kanno Yusuke , Kajiwara Kohei , Nakano Kimiko , Morikawa Miharu , Matsuda Yoshinobu , Shimizu Yoichi , Hori Megumi , Niino Mariko , Suzuki Miho , Shimazu Taichi 
Published: September 2022

IntroductionTerminally ill patients with cancer experience a variety of symptoms, and their families experience certain caregiver burdens. Most studies on this topic have focused on the symptoms experienced by patients with cancer. There is little established evidence to show how nursing support affects these symptoms and burdens. Nurses provide support by extrapolating their clinical experience, practical knowledge and insights gained from the treatment phase of patients with cancer, regardless of the existence or degree of evidence. This study presents a scoping review protocol with the aim of categorising the feasibility of nursing support from the initial to the terminal phases in the trajectory of cancer care.Method and analysisThis review will be guided by Arksey and O’Malley’s five-stage scoping review framework and Levac’s extension. Our research project team will focus on the pain, dyspnoea, nausea and vomiting, constipation, delirium, fatigue and skin disorders experienced by patients with cancer as well as the burdens experienced by caregivers of such patients. All available published articles from database inception to 31 January 2022 will be systematically searched using the following electrical databases: PubMed, CINAHL, CENTRAL in the Cochrane Library and Ichushi-Web of the Japan Medical Abstract Society databases. In addition, we will assess relevant studies from the reference list and manually search each key journal. The formula creation phase of the literature search involves working with a librarian to identify relevant keywords. At least two reviewers will independently screen and review articles and extract data using a data chart form. Results will be mapped according to study design and analysed for adaptation in the field of terminal cancer.Ethics and disseminationThis review does not require ethical approval as it is a secondary analysis of pre-existing, published data. The findings will be disseminated through peer-reviewed publications and conference presentations.
Intracapsular tonsillectomy in the treatment of recurrent and chronic tonsillitis in adults: a protocol of a prospective, single-blinded, randomised study with a 5-year follow-up (the FINITE trial)
Authors: Piitulainen Jaakko Matias , Uusitalo Tapani , Sjöblom Henrik M , Ivaska Lotta E , Jegoroff Henri , Kauko Tommi , Kokki Hannu , Kytö Eero , Mansikka Iisa , Ylikoski Jenni , Jero Jussi 
Published: September 2022

IntroductionThe standard surgical treatment for recurrent or chronic tonsillitis is extracapsular tonsillectomy. Recent studies show that intracapsular tonsillectomy has the potential to reduce the postoperative morbidity of patients undergoing tonsil surgery. The Finnish Intracapsular Tonsillectomy (FINITE) trial aims to provide level I evidence to support the hypothesis that the recovery time from tonsil surgery can be reduced with intracapsular tonsillectomy. Additionally, from this trial, major benefits in quality of life, reduction of postoperative complications, treatment costs and throat symptoms might be gained.Methods and analysisThe FINITE trial is a prospective, randomised, controlled, patient-blinded, three-arm clinical trial. It is designed to compare three different surgical methods being extracapsular monopolar tonsillectomy versus intracapsular microdebrider tonsillectomy versus intracapsular coblation tonsillectomy in the treatment of adult patients (16–65 years) suffering from recurrent or chronic tonsillitis. The study started in September 2019, and patients will be enrolled until a maximum of 200 patients are randomised. Currently, we are in the middle of the study with 125 patients enrolled as of 28 February 2022 and data collection is scheduled to be completed totally by December 2027. The primary endpoint of the study will be the recovery time from surgery. Secondary endpoints will be the postoperative pain scores and the use of analgesics during the first 3 weeks of recovery, postoperative haemorrhage, quality of life, tonsillar remnants, need for revision surgery, throat symptoms, treatment costs and sick leave. A follow-up by a questionnaire at 1–21 days and at 1, 6, 24 and 60 months will be conducted with a follow-up visit at the 6-month time point.Ethics and disseminationEthical approval was obtained from the Medical Ethics Committee of the Hospital District of Southwest Finland (reference number 29/1801/2019). Results will be made publicly available in peer-reviewed scientific journals.Trial registration numberNCT03654742.
Protocol for a Global Burns Research Priority Setting Partnership to agree the most important unanswered questions in international burns care
Authors: Richards Hollie , Staruch Robert , King Anni , Pugh Catrin , Kinsella Suzannah , Savović Jelena , Young Amber 
Published: September 2022

IntroductionBurns affect 11 million people globally and can result in long-term disability with substantial associated healthcare costs. There is limited research funding to support trials to provide evidence for clinical decision-making. Research prioritisation ensures that research focuses on the topics most important to stakeholders, addressing issues of research waste and evidence gaps. The aim of this project is to agree the global top 10 research priorities important to international patients, carers and clinicians from all income status countries.Methods and analysisThe Global Burns Research Priority Setting Partnership will use James Lind Alliance methods to establish the top 10 research priorities in global burns care. An initial international online multilingual survey will collect candidate research priorities from stakeholders. To increase equity in participation, the survey will also be available via the social media app WhatsApp. Additionally, interviews will be conducted. Data will be analysed to identify and collate research questions and to verify that the priorities are true clinical uncertainties. This list will then be ranked by stakeholders in order of importance via a second online survey. Finally, a consensus meeting will identify the top 10 research priorities.Ethics and disseminationThe University of Bristol Medical School Faculty Ethical Committee has approved this project. Research into burn care should be prioritised to ensure that funding is focused where most needed. This should be undertaken internationally, to ensure inclusion of the views of professionals and patients from lower income countries, where the incidence of thermal burns is highest. The involvement of the James Lind Alliance will ensure that the methodology is robust and that the patient voice is heard. The final top 10 priorities will be disseminated to funders, governments and researchers internationally to inform future global burns research.
Impact of cerebral hypoperfusion–reperfusion on optic nerve integrity and visual function in the DBA/2J mouse model of glaucoma
Authors: Fraenkl Stephan Alexander , Simon Quentin , Yucel Yeni , Gupta Neeru , Wittwer Valéry V , Frueh Beatrice E , Tschanz Stefan A 
Published: September 2022

ObjectiveOne of the most important risk factors for developing a glaucomatous optic neuropathy is elevated intraocular pressure. Moreover, mechanisms such as altered perfusion have been postulated to injure the optical path. In a mouse model, we compare first negative effects of cerebral perfusion/reperfusion on the optic nerve structure versus alterations by elevated intraocular pressure. Second, we compare the alterations by isolated hypoperfusion-reperfusion and isolated intraocular pressure to the combination of both.Methods and analysisMice were divided in four groups: (1) controls; (2) perfusion altered mice that underwent transient bi-common carotid artery occlusion (BCCAO) for 40 min; (3) glaucoma group (DBA/2J mice); (4) combined glaucoma and altered perfusion (DBA/2J mice with transient BCCAO). Optic nerve sections were stereologically examined 10–12 weeks after intervention.ResultsAll experimental groups showed a decreased total axon number per optic nerve compared with controls. In DBA/2J and combined DBA/2J & BCCAO mice the significant decrease was roughly 50%, while BCCAO leaded to a 23% reduction of axon number, however reaching significance only in the direct t-test. The difference in axon number between BCCAO and both DBA/2J mice was almost 30%, lacking statistical significance due to a remarkably high variation in both DBA/2J groups.ConclusionElevated intraocular pressure in the DBA/2J mouse model of glaucoma leads to a much more pronounced optic nerve atrophy compared with transient forebrain hypoperfusion and reperfusion by BCCAO. A supposed worsening effect of an altered perfusion added to the pressure-related damage could not be detected.
Bedside lung ultrasonography: comparison with chest radiography (BLUR), a diagnostic study in a developing country
Authors: Arthur Manisha , Pichamuthu Kishore , Turaka Vijay Prakash , Putta Tharani , Jeeyavudeen Mohammad Sadiq , Zachariah Anand , Sathyendra Sowmya , Hansdak Samuel George , Iyadurai Ramya , Karuppusami Reka , Sudarsanam Thambu David 
Published: September 2022

Abstract

Background
This study determines the diagnostic utility of lung ultrasonography (LUS) in a medical ward in a developing country. In a low resource country like India, we hope that use of lung ultrasound in primary and secondary hospitals will assist in earlier and better bedside diagnosis.

Methods
This prospective diagnostic study was done to test the diagnostic accuracy of LUS against a composite reference standard, which included clinical history and examination, basic laboratory investigations, imaging and the diagnosis at discharge. We evaluated 321 consecutive patients, admitted in our medical wards with an LUS within 24 hours of the chest radiograph being done.

Findings
Between August 2016 and August 2017, we enrolled 321 patients. The sensitivity and specificity of the LUS for all pathologies were found to be 82.5% (76.50 to 87.20) and 78.2% (69.09 to 85.26) respectively. A subgroup analysis including the patients in whom CT was part of the composite reference standard showed sensitivity and specificity of 87.9% and 92.9% for all lung pathologies. It was found that there was superior sensitivity and specificity of LUS compared with chest radiograph in a subgroup analysis of pulmonary oedema and acute respiratory distress syndrome (ARDS).

Interpretation
We found that the LUS was better than chest radiograph and as good as CT in most pathologies, especially pulmonary oedema and ARDS. We believe that training in the basics of bedside LUS must be part of the medical curriculum and a low-cost ultrasound machine must be made available in medical wards, so that clinical diagnosis can be supplemented with this tool. In a low resource setting like India, where access to chest radiograph and CT may be difficult particularly in a rural setup, expertise in LUS would be helpful in easy bedside diagnosis and saving cost on a CT scan.