bluuebunny/crossref_metadata_2025_split huggingface dataset:
Neurological and respiratory effects of lung protective ventilation in acute brain injury patients without lung injury: brain vent, a single centre randomized interventional study
Authors: Beqiri Erta , Smielewski Peter , Guérin Claude , Czosnyka Marek , Robba Chiara , Bjertnæs Lars , Frisvold Shirin K. 
Published: March 2023

Abstract
Introduction
Lung protective ventilation (LPV) comprising low tidal volume (VT) and high positive end-expiratory pressure (PEEP) may compromise cerebral perfusion in acute brain injury (ABI). In patients with ABI, we investigated whether LPV is associated with increased intracranial pressure (ICP) and/or deranged cerebral autoregulation (CA), brain compensatory reserve and oxygenation.

Methods
In a prospective, crossover study, 30 intubated ABI patients with normal ICP and no lung injury were randomly assigned to receive low VT [6 ml/kg/predicted (pbw)]/at either low (5 cmH2O) or high PEEP (12 cmH2O). Between each intervention, baseline ventilation (VT 9 ml/kg/pbw and PEEP 5 cmH2O) were resumed. The safety limit for interruption of the intervention was ICP above 22 mmHg for more than 5 min. Airway and transpulmonary pressures were continuously monitored to assess respiratory mechanics. We recorded ICP by using external ventricular drainage or a parenchymal probe. CA and brain compensatory reserve were derived from ICP waveform analysis.

Results
We included 27 patients (intracerebral haemorrhage, traumatic brain injury, subarachnoid haemorrhage), of whom 6 reached the safety limit, which required interruption of at least one intervention. For those without intervention interruption, the ICP change from baseline to “low VT/low PEEP” and “low VT/high PEEP” were 2.2 mmHg and 2.3 mmHg, respectively, and considered clinically non-relevant. None of the interventions affected CA or oxygenation significantly. Interrupted events were associated with high baseline ICP (p < 0.001), low brain compensatory reserve (p < 0.01) and mechanical power (p < 0.05).
The transpulmonary driving pressure was 5 ± 2 cmH2O in both interventions. Partial arterial pressure of carbon dioxide was kept in the range 34–36 mmHg by adjusting the respiratory rate, hence, changes in carbon dioxide were not associated with the increase in ICP.

Conclusions
The present study found that most patients did not experience any adverse effects of LPV, neither on ICP nor CA. However, in almost a quarter of patients, the ICP rose above the safety limit for interrupting the interventions. Baseline ICP, brain compensatory reserve, and mechanical power can predict a potentially deleterious effect of LPV and can be used to personalize ventilator settings.
Trial registrationNCT03278769. Registered September 12, 2017.

Graphical Abstract
Novel serum biomarkers for predicting neurological outcomes in postcardiac arrest patients treated with targeted temperature management
Authors: Song Hwan , Bang Hyo Jin , You Yeonho , Park Jung Soo , Kang Changshin , Kim Hyo Joon , Park Kyu Nam , Oh Sang Hoon , Youn Chun Song 
Published: March 2023

Abstract
Objective
To determine the clinical feasibility of novel serum biomarkers in out-of-hospital cardiac arrest (OHCA) patients treated with target temperature management (TTM).

Methods
This study was a prospective observational study conducted on OHCA patients who underwent TTM. We measured conventional biomarkers, neuron‑specific enolase and S100 calcium-binding protein (S-100B), as well as novel biomarkers, including tau protein, neurofilament light chain (NFL), glial fibrillary acidic protein (GFAP), and ubiquitin C-terminal hydrolase-L1 (UCH-L1), at 0, 24, 48, and 72 h after the return of spontaneous circulation identified by SIMOA immunoassay. The primary outcome was poor neurological outcome at 6 months after OHCA.

Results
A total of 100 patients were included in this study from August 2018 to May 2020. Among the included patients, 46 patients had good neurologic outcomes at 6 months after OHCA. All conventional and novel serum biomarkers had the ability to discriminate between the good and poor neurological outcome groups (p < 0.001). The area under the curves of the novel serum biomarkers were highest at 72 h after cardiac arrest (CA) (0.906 for Tau, 0.946 for NFL, 0.875 for GFAP, and 0.935 for UCH-L1). The NFL at 72 h after CA had the highest sensitivity (77.1%, 95% CI 59.9–89.6) in predicting poor neurological outcomes while maintaining 100% specificity.

Conclusion
Novel serum biomarkers reliably predicted poor neurological outcomes for patients with OHCA treated with TTM when life-sustaining therapy was not withdrawn. Cutoffs from two large existing studies (TTM and COMACARE substudy) were externally validated in our study. The predictive power of the novel biomarkers was the highest at 72 h after CA.
BEAT CF pulmonary exacerbations core protocol for evaluating the management of pulmonary exacerbations in people with cystic fibrosis
Authors: Schultz Andre , McLeod Charlie , Berry Scott , Marsh Julie , McKenzie Anne , Messer Mitch , Wood Jamie , Saville Ben , Jaffe Adam , Ranganathan Sarath , Stick Steve , Wark Peter , Webb Steve , Snelling Tom 
Published: March 2023

Abstract
Background
Cystic fibrosis (CF) is a rare, inherited, life-limiting condition predominantly affecting the lungs, for which there is no cure. The disease is characterized by recurrent pulmonary exacerbations (PEx), which are thought to drive progressive lung damage. Management of these episodes is complex and generally involves multiple interventions targeting different aspects of disease. The emergence of innovative trials and use of Bayesian statistical methods has created renewed opportunities for studying heterogeneous populations in rare diseases. Here, we present the protocol for the BEAT CF PEx cohort, a prospective, multi-site, perpetual, platform enrolling adults and children with CF. The BEAT CF PEx cohort will be used to evaluate the comparative effectiveness of interventions for the treatment of PEx requiring intensive therapy (PERITs), with a primary focus on short-term improvements in lung function. This will be achieved through the conduct of cohort-nested studies, including adaptive clinical trials, within the BEAT CF PEx cohort. This protocol will outline key features of the BEAT CF PEx cohort, including the design, implementation, data collection and management, governance and analysis, and dissemination of results.

Methods
This platform will be conducted across multiple sites, commencing with CF treatment centers in Australia. People of all ages with a clinical diagnosis of CF will be eligible to participate, except those who have previously received a lung transplant. Data including demographic and clinical information, treatment details, and outcomes (including safety, microbiology, and patient-reported outcome measures including quality of life scores) will be systematically collected and securely stored via a digital centralized trial management system (CTMS). The primary endpoint is the absolute change in the percentage predicted forced expiratory volume in 1 s (ppFEV1) from the commencement of intensive therapy to 7 to 10 days afterwards.

Discussion
The BEAT CF PEx cohort will report clinical, treatment, and outcome data for PEx among people with CF and is intended to serve as a core (master) protocol for future nested, interventional trials evaluating treatment(s) for these episodes. The protocols for nested sub-studies are beyond the scope of this document and will be reported separately.

Trial registration
ANZCTR BEAT CF Platform – ACTRN12621000638831. Registration date: Sept. 26, 2022.
PROphylaxis for paTiEnts at risk of COVID-19 infecTion (PROTECT-V)
Authors: Humphrey Toby J. L. , Dosanjh Davinder , Hiemstra Thomas F. , Richter Alex , Chen-Xu Michael , Qian Wendi , Jha Vivekanand , Gatley Katrina , Adhikari Rakshya , Dowling Francis , Smith Rona M. 
Published: March 2023

Abstract
Background
Despite the introduction of vaccination, there remains a need for pre-exposure prophylactic agents against SARS-CoV-2. Several patient groups are more vulnerable to SARS-CoV-2 infection by virtue of underlying health conditions, treatments received or suboptimal responses to vaccination.

Methods
PROTECT-V is a platform trial testing pre-exposure prophylactic interventions against SARS-CoV-2 infection in vulnerable patient populations (organ transplant recipients; individuals with oncological/haematological diagnoses, immune deficiency or autoimmune diseases requiring immunosuppression or on dialysis). Multiple agents can be evaluated across multiple vulnerable populations sharing placebo groups, with the option of adding additional treatments at later time points as these become available. The primary endpoint is symptomatic SARS-CoV-2 infection, and each agent will be independently evaluated in real time when the required number of events occurs. Presently, three agents are approved in the platform: intranasal niclosamide, nasal and inhaled ciclesonide and intravenous sotrovimab.

Discussion
Despite the introduction of vaccination, there remains a need for pre-exposure prophylactic agents against SARS-CoV-2. Several patient groups are more vulnerable to COVID-19 disease by virtue of underlying health conditions, treatments received or suboptimal responses to vaccination.

Trial registration
ClinicalTrials.gov NCT04870333. EudraCT 2020-004144-28
Overall morbidity after total minimally invasive keyhole oesophagectomy versus hybrid oesophagectomy (the MICkey trial): study protocol for a multicentre randomized controlled trial
Authors: Klotz Rosa , Diener Markus K. , Schmidt Thomas , Hackert Thilo , Graf Sandra , Fuchs Hans F. , Grimminger Peter , Egberts Jan-Hendrick , Gockel Ines , van der Sluis Pieter C. , Doerr-Harim Colette , Klose Christina , Feißt Manuel , Mihaljevic Andre L. 
Published: March 2023

Abstract
Background
Oesophageal cancer (EC) is the sixth leading cause of cancer death worldwide. Oesophageal resection is the only curative treatment option for EC which is frequently performed via an abdominal and right thoracic approach (Ivor-Lewis operation). This 2-cavity operation is associated with a high risk of major complications. To reduce postoperative morbidity, several minimally invasive techniques have been developed that can be broadly classified into either hybrid oesophagectomy (HYBRID-E) via laparoscopic/robotic abdominal and open thoracic surgery or total minimally invasive oesophagectomy (MIN-E). Both, HYBIRD-E and MIN-E, compare favourable to open oesophagectomy. However, there is still an evidence gap comparing HYBRID-E with MIN-E with regard to postoperative morbidity.

Methods
The MICkey trial is a multicentre randomized controlled superiority trial with two parallel study groups. A total of 152 patients with oesophageal cancer scheduled for elective oesophagectomy will be randomly assigned 1:1 to the control group (HYBRID-E) or to the intervention group (MIN-E). The primary endpoint will be overall postoperative morbidity assessed via the comprehensive complication index (CCI) within 30 days after surgery. Specific perioperative parameters, as well as patient-reported and oncological outcomes, will be analysed as secondary outcomes.

Discussion
The MICkey trial will address the yet unanswered question whether the total minimally invasive oesophagectomy (MIN-E) is superior to the HYBRID-E procedure regarding overall postoperative morbidity.

Trial registration
DRKS00027927 U1111-1277-0214. Registered on 4th July 2022
The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) for serious mental illness in community mental health part 1: study protocol for a hybrid type 2 effectiveness-implementation cluster-randomized trial
Authors: Sarfan Laurel D. , Agnew Emma R. , Diaz Marlen , Dong Lu , Fisher Krista , Spencer Julia M. , Howlett Shayna A. , Hache Rafael Esteva , Callaway Catherine A. , Kilbourne Amy M. , Buysse Daniel J. , Harvey Allison G. 
Published: March 2023

Abstract
Background
Serious mental illness (SMI) can have devastating consequences. Unfortunately, many patients with SMI do not receive evidence-based psychological treatment (EBPTs) in routine practice settings. One barrier is poor “fit” between EBPTs and contexts in which they are implemented. The present study will evaluate implementation and effectiveness outcomes of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) implemented in community mental health centers (CMHCs). TranS-C was designed to target a range of SMI diagnoses by addressing a probable mechanism and predictor of SMI: sleep and circadian problems. We will investigate whether adapting TranS-C to fit CMHC contexts improves providers’ perceptions of fit and patient outcomes.

Methods
TranS-C will be implemented in at least ten counties in California, USA (N = 96 providers; N = 576 clients), via facilitation. CMHC sites are cluster-randomized by county to Adapted TranS-C or Standard TranS-C. Within each county, patients are randomized to immediate TranS-C or usual care followed by delayed treatment with TranS-C (UC-DT). Aim 1 will compare TranS-C (combined Adapted and Standard) with UC-DT on improvements in sleep and circadian problems, functional impairment, and psychiatric symptoms. Sleep and circadian problems will also be tested as a mediator between treatment condition (combined TranS-C versus UC-DT) and functional impairment/psychiatric symptoms. Aim 2 will evaluate whether Adapted TranS-C is superior to Standard TranS-C with respect to provider perceptions of fit. Aim 3 will evaluate whether the relation between TranS-C treatment condition (Adapted versus Standard) and patient outcomes is mediated by better provider perceptions of fit in the Adapted condition. Exploratory analyses will (1) compare Adapted versus Standard TranS-C on patient perceptions of credibility/improvement and select PhenX Toolkit outcomes and (2) evaluate possible moderators.

Discussion
This trial has the potential to (a) expand support for TranS-C, a promising transdiagnostic treatment delivered to patients with SMI in CMHCs; (b) take steps toward addressing challenges faced by providers in delivering EBPTs (i.e., high caseloads, complex patients, poor fit); and (c) advance evidence on causal strategies (i.e., adapting treatments to fit context) in implementation science.

Trial registration
Clinicaltrials.gov NCT04154631. Registered on 6 November 2019. https://clinicaltrials.gov/ct2/show/NCT04154631
Comparing the clinical and cost-effectiveness of remote (telehealth and online) cognitive behavioral therapy-based treatments for high-impact chronic pain relative to usual care: study protocol for the RESOLVE multisite randomized control trial
Authors: Mayhew Meghan , Balderson Benjamin H. , Cook Andrea J. , Dickerson John F. , Elder Charles R. , Firemark Alison J. , Haller Irina V. , Justice Morgan , Keefe Francis J. , McMullen Carmit K. , O’Keeffe-Rosetti Maureen C. , Owen-Smith Ashli A. , Rini Christine , Schneider Jennifer L. , Von Korff Michael , Wandner Laura D. , DeBar Lynn L. 
Published: March 2023

Abstract
Background
Cognitive behavioral therapy for chronic pain (CBT-CP) is an effective but underused treatment for high-impact chronic pain. Increased access to CBT-CP services for pain is of critical public health importance, particularly for rural and medically underserved populations who have limited access due to these services being concentrated in urban and high income areas. Making CBT-CP widely available and more affordable could reduce barriers to CBT-CP use.

Methods
As part of the National Institutes of Health Helping to End Addiction Long-term® (NIH HEAL) initiative, we designed and implemented a comparative effectiveness, 3-arm randomized control trial comparing remotely delivered telephonic/video and online CBT-CP-based services to usual care for patients with high-impact chronic pain. The RESOLVE trial is being conducted in 4 large integrated healthcare systems located in Minnesota, Georgia, Oregon, and Washington state and includes demographically diverse populations residing in urban and rural areas. The trial compares (1) an 8-session, one-on-one, professionally delivered telephonic/video CBT-CP program; and (2) a previously developed and tested 8-session online CBT-CP-based program (painTRAINER) to (3) usual care augmented by a written guide for chronic pain management. Participants are followed for 1 year post-allocation and are assessed at baseline, and 3, 6, and 12 months post-allocation. The primary outcome is minimal clinically important difference (MCID; ≥ 30% reduction) in pain severity (composite of pain intensity and pain-related interference) assessed by a modified 11-item version of the Brief Pain Inventory-Short Form at 3 months. Secondary outcomes include pain severity, pain intensity, and pain-related interference scores, quality of life measures, and patient global impression of change at 3, 6, and 12 months. Cost-effectiveness is assessed by incremental cost per additional patient with MCID in primary outcome and by cost per quality-adjusted life year achieved. Outcome assessment is blinded to group assignment.

Discussion
This large-scale trial provides a unique opportunity to rigorously evaluate and compare the clinical and cost-effectiveness of 2 relatively low-cost and scalable modalities for providing CBT-CP-based treatments to persons with high-impact chronic pain, including those residing in rural and other medically underserved areas with limited access to these services.

Trial registration
ClinicalTrials.gov NCT04523714. This trial was registered on 24 August 2020.
The effects of qigong intervention based on the Internet on quality of life and physical fitness in Chinese postoperative breast cancer patients: a protocol of randomized controlled trial
Authors: Li Chengxiang , Dong Xiaosheng , Yu Lina , Yuan Kai , Yi Xiangren , Shen Yuanlong , Niu Hu 
Published: March 2023

Abstract

Background

The purpose of this study is to verify the improvement of remote qigong intervention on the quality of life and physical fitness of breast cancer patients after surgery by means of a randomized controlled trial and to compare it with the conventional exercise combination of aerobic exercise and resistance training.

Methods/design
The research approach applied in this study is a randomized controlled trial. After completing the baseline questionnaire and physical fitness test, participants were randomly assigned to either the qigong group or the combined exercise rehabilitation group. Patients in the qigong group performed Qigong-Baduanjin twice a week for 30 min each time under remote guidance and practiced Baduanjin by themselves at other times. Patients in the combined exercise rehabilitation group were given resistance training twice a week for 30 min under remote guidance, and walking the rest of the time. At the end of the 12-week intervention, outcomes testing and data collection were carried out. The primary outcomes are quality of life, measured using the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36), and the Functional Assessment of Cancer Therapy-Breast (FATC-B). The secondary outcomes include cardiopulmonary endurance, upper limb strength, lower limb strength, and skinfold thickness.

Discussion
The importance of postoperative exercise rehabilitation for breast cancer has been gradually accepted by more and more doctors and patients, but further research and development of simple and practical means of exercise rehabilitation are necessary. Remote qigong intervention for breast cancer patients via the Internet will be a great alternative.

Trial registration
Chinese Clinical Trial Registry ChiCTR1900027989. Registered on December 7, 2019.
Effectiveness of structured self-evaluation of video recorded performance on peripheral intravenous catheter insertion: a randomised control trial study protocol
Authors: Hernon Orlaith , McSharry Edel , Simpkin Andrew , MacLaren Iain , Carr Peter J. 
Published: March 2023

AbstractBackgroundClinical psychomotor skills training is a core component of undergraduate nursing education. Performing technical skills competently involves the use of cognitive and motor function. The training of these technical skills is typically carried out in clinical simulation laboratories. Peripheral intravenous catheter/cannula insertion is an example of a technical skill. It is the most common invasive procedure performed in the healthcare environment. Owing to unacceptable clinical risk and complications to patients, it is imperative that practitioners performing these skills are trained effectively to provide patients with best practice and high-quality care. Technologies identified as innovative teaching methods to help train students in this skill and in the skill of venepuncture include virtual reality, hypermedia and simulators. However, little high-quality evidence exists to confirm such educational approaches are effective.Methods/designThis study is a single-centre, non-blinded, two-group, pre-test and post-test randomised control trial. The randomised control trial will investigate whether a formal structured self-evaluation of videoed performance (experimental group) has an impact on nursing students’ peripheral intravenous cannulation knowledge, performance and confidence. The control group will also be videoed performing the skill but they will not view or self-evaluate their videoed performance. The peripheral intravenous cannulation procedures will be carried out in a clinical simulation laboratory using a task trainer. The data collection tools will be completed online using survey forms. Students will be randomised into the experimental group or into the control group using simple random sampling. The primary outcome measures the nursing students’ knowledge level of the skill of peripheral intravenous cannulation insertion. Secondary outcomes evaluate procedural competence and self-reported confidence and practices in the clinical environment.DiscussionThis randomised control trial will investigate whether this pedagogical approach, using video modelling and self-evaluation, will positively influence students’ knowledge, confidence and performance in the skill of peripheral intravenous cannulation. Evaluating such teaching strategies using stringent methodologies may be impactful in influencing the training provided to healthcare practitioners.Trial registrationThe randomised control trial detailed in this article is an educational research study and so does not fall under the ICMJE definition of a clinical trial as “any research project that prospectively assigns people or a group of people to an intervention, with or without concurrent comparison or control groups, to study the relationship between a health-related intervention and a health outcome”.