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BACKGROUND/OBJECTIVES: This protocol describes a study to investigate the feasibility and preliminary efficacy of a novel Teaching Kitchen Multisite Trial (TK-MT) for adults with cardiometabolic abnormalities. The TK-MT protocol describes a hybrid lifestyle intervention combining in-person and virtual instruction in culinary skills, nutrition education, movement, and mindfulness with community support and behavior change strategies. This 18-month-long randomized controlled trial aims to evaluate the feasibility of implementing a 12-month, 24 class program, assess preliminary study efficacy, and identify barriers and facilitators to implementation. METHODS: The intervention program includes 16 weeks of intensive hands-on culinary and lifestyle education classes followed by eight monthly virtual classes. Psychometric assessments and biometric data will be collected at baseline, 4, 12, and 18 months. Semi-structured interviews and open-ended surveys will be conducted during the 12-month follow-up assessment. RESULTS: Feasibility will be assessed through recruitment, attendance, and fidelity data. Secondary outcomes will analyze changes in health behaviors, biometric data, and anthropometric measures using mixed-effects regression models. Qualitative data will undergo thematic analysis. CONCLUSIONS: As envisioned and described in detail in this manuscript, this study will inform the development and implementation of reproducible, scalable teaching kitchen interventions. The protocol described here is intended to set the stage for future investigations to evaluate evidence for the impact of teaching kitchen interventions on dietary habits, physical activity, and overall health and well-being.

The HEALthy Brain and Child Development (HBCD) Study, a multi-site prospective longitudinal cohort study, will examine human brain, cognitive, behavioral, social, and emotional development beginning prenatally and planned through early childhood. The acquisition of multimodal magnetic resonance-based brain development data is central to the studys core protocol. However, application of Magnetic Resonance Imaging (MRI) methods in this population is complicated by technical challenges and difficulties of imaging in early life. Overcoming these challenges requires an innovative and harmonized approach, combining age-appropriate acquisition protocols together with specialized pediatric neuroimaging strategies. The HBCD MRI Working Group aimed to establish a core acquisition protocol for all 27 HBCD Study recruitment sites to measure brain structure, function, microstructure, and metabolites. Acquisition parameters of individual modalities have been matched across MRI scanner platforms for harmonized acquisitions and state-of-the-art technologies are employed to enable faster and motion-robust imaging. Here, we provide an overview of the HBCD MRI protocol, including decisions of individual modalities and preliminary data. The result will be an unparalleled resource for examining early neurodevelopment which enables the larger scientific community to assess normative trajectories from birth through childhood and to examine the genetic, biological, and environmental factors that help shape the developing brain.

Patients diagnosed with metastatic basal cell carcinoma (BCC) have a poor prognosis. The current standard of care for adults with locally advanced or metastatic BCC who are not candidates for surgery or radiation therapy is treatment with hedgehog pathway inhibitors (HHIs). For patients who progress while on this therapy, further treatment options are limited. There is also a need for real-world clinical practice data on the clinical characteristics, management, disease progression, and survivorship of these patients. The ongoing CemiplimAb-rwlc Survivorship and Epidemiology (CASE) study is a phase IV, multicenter, prospective, noninterventional survivorship and epidemiology cohort study evaluating the effectiveness and safety of cemiplimab, a fully human immunoglobulin G4 monoclonal antibody that blocks the interaction between the programmed cell death-1 (PD-1) receptor and its ligands. This paper describes one cohort of the CASE study of patients with locally advanced or metastatic BCC who have failed or are intolerant of HHIs or for whom HHI therapy is not appropriate. Outcome measures of the study include response to treatment, quality of life, safety, treatment patterns, patient experience, and survival. This study could provide a more complete characterization of this patient population and fill knowledge gaps related to real-world treatment utilization and patient outcomes. Clinical Trial registration: NCT03836105 [ABSTRACT FROM AUTHOR]

Background: Stroke is a leading cause of mortality and disability globally, with an increasing burden in low- and middle-income countries, including those in Africa. While stroke affects both men and women, emerging evidence suggests that women may face unique risk factors and challenges that contribute to their susceptibility to stroke. However, there is a lack of comprehensive understanding regarding the specific risk factors for stroke among women in Africa. Purpose: This scoping review protocol aims to systematically explore and map the existing literature on stroke risk factors among women in Africa. Method: The review will follow the methodological framework outlined by Arksey and O'Malley, enhanced by the Joanna Briggs Institute guidelines for scoping reviews. A systematic search will be conducted across multiple electronic databases, including Cochrane Library, Web of Science, EBSCO, Medline and Google Scholar, using a predefined search strategy. The search strategy will include a combination of keywords and Medical Subject Headings (MeSH) terms related to stroke, risk factors, women, and Africa. Result: Data extraction will involve the systematic recording of relevant information from included studies, including study characteristics, participant demographics, stroke risk factors examined, and key findings. Thematic analysis will be conducted to identify common themes and patterns across the literature, with a particular focus on risk factors specific to women in Africa. Conclusion: This scoping review will provide a comprehensive overview of the current state of knowledge regarding stroke risk factors among women in Africa. Findings from this review will inform future research directions, clinical practice, and public health interventions aimed at reducing the burden of stroke among women in the African context. [ABSTRACT FROM AUTHOR]

Background: Volume overload is a major mortality risk in hemodialysis (HD) patients. Drug therapy and conventional dialysis limitations underscore the importance of managing volume load through effective lifestyle interventions. In this regard, WeChat, along with its built-in self-monitoring function, has demonstrated considerable potential for application. WeChat, a versatile social media platform in China, integrating Facebook, WhatsApp, Twitter, and PayPal functionalities, shows potential in managing volume load, especially when paired with home monitoring. This method may also reduce adverse events and improve patient outcomes. Method: The study will be conducted at the Hemodialysis Center of the Hospital of Chengdu University of Traditional Chinese Medicine, recruiting 135 participants. All patients will be cluster randomly assigned to three group according to their HD schedules. The control group will receive standard care. The WeChat group will receive volume load management via WeChat message in addition to standard care. The home monitoring-feedback group will be required to monitor their blood pressure and weight at home, and upload the number to WeChat subscription account "Health Dialysis" in addition to standard care and volume load management via WeChat message. Data will be collected during the baseline period, one, two, and three months after the intervention starts, and three months after the intervention ends to evaluate the effectiveness of this intervention measure. Discussion: This study aims to effectively manage the volume load of HD patients and enhance their quality of life through a combination of intervention methods utilizing the WeChat platform and home monitoring. If this intervention measure proves effective, it will not only provide empirical evidence for managing HD patients through the WeChat platform but also serve as a reference model for other HD centers in addressing patient volume load issues. What's more, if significant differences are observed between the results of the WeChat groups and the home monitoring-feedback group, this will further substantiate the importance and impact of home monitoring in volume load management. Trial registration: ClinicalTrials.gov (NCT06333574). Registered 13 March 2024. [ABSTRACT FROM AUTHOR]

Simple Summary: The validation of predictive models is essential for informing clinical decisions, particularly in new individual populations or as diagnostic methods advance. This study evaluates the performance of the Barcelona-MRI predictive model (BCN-MRI PM) for identifying significant prostate cancer (sPCa) within the context of an advanced prostate biopsy protocol. In a cohort of 457 men suspected of having PCa, the model demonstrated high accuracy and clinical applicability, reducing unnece-ssary biopsies by 24.9% while maintaining a 95% detection rate for sPCa. These results validate the efficacy of the BCN-MRI PM and support its readiness for clinical implementation in this diagnostic framework. Background/Objectives: Validation of predictive models (PMs) is crucial to be implemented in new populations or when advances in diagnostic approaches occurred. The aim of this study is to validate the BCN-MRI PM for sPCa when a highly effective prostate biopsy protocol is used. Methods: A prospective cohort of 457 men suspected of having PCa, for whom MRI results were reported with the Prostate Imaging-Reporting and Data System (PI-RADS) v 2.1, underwent a per 0.5 mm-core mapping targeted biopsy of suspicious lesions and perilesional areas, followed by a 12-core-systematic biopsy. These procedures took place between 1 February 2022, and 29 February 2024, at a reference center for prostate biopsy. The individual likelihood of sPCa was assessed through the BCN-MRI risk calculator. Results: The overall sPCa detection rate was 58.3%. The calibration curve of the BCN-MRI PM showed an appropriate accuracy between expected and observed probabilities with a discrimination ability for sPCa yielding an area under the curve (AUC) of 0.862 (95% CI 0.828–0.896) comparable to the AUC of 0.858 (95% CI 0.833–0.883) observed in the development cohort. The application of the BCN-MRI PM provided a net benefit over performing biopsies on all men, avoiding 24.9% of prostate biopsies at 95% sensitivity for sPCa, compared to the 23.7% reduction observed in the development cohort. Conclusions: We conclude that the BCN-MRI PM is ready to be implemented when this biopsy protocol is employed. [ABSTRACT FROM AUTHOR]

Introduction: The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Guidelines Committee develops evidence-based surgical guidelines. Involvement of patient partners is important to ensure patient concerns and values are adequately addressed and incorporated. This standard operating procedure (SOP) for the process of patient partner involvement within the guidelines is described here. Methods: This document outlines the SAGES Patient Partners SOP to involve patient partners in a consistent and reproducible manner. Results: SAGES has now developed a SOP to include patient partners so that patient views are represented in current guidelines. Conclusion: Guidelines must be patient centric and in order to do so must include patient partners. The SAGES Guidelines Patient Engagement Update to Standard operating Procedure aims to provide an outline for systematically doing so. [ABSTRACT FROM AUTHOR]

Introduction: The SAGES Guidelines Committee creates evidence-based clinical practice guidelines (CPGs). Updates which incorporate new evidence into the guidelines are necessary to maintain relevance for clinical use. A description of our standard operating procedure for this process is described here, which contributes to SAGES' commitment to producing high-quality clinical recommendations. Methods: This paper outlines the SAGES Clinical Practice Guideline Update Standard Operating Procedure in order to incorporate regular updates to our guideline development process. Results: SAGES has developed an evidence-based, standardized approach in updating current clinical practice guidelines to ensure that physicians and patients have access to the most appropriate recommendations. Conclusion: Societies that promote guidelines within their organization must make an intentional effort to regularly evaluate the relevance of their recommendations. The SAGES Guidelines Update Standard Operating Procedure aims to provide a framework to reliably and systematically review existing guidelines and update them as needed. [ABSTRACT FROM AUTHOR]

Background: Accidental hypothermia is associated with high morbidity and mortality. Research on treatment strategies for accidental hypothermia is complicated by the low incidence and heterogeneous patient population. We have developed a new method for clinical trials of experimental hypothermia, to enable further studies of active rewarming. If cold ambient air is effective as a cooling method, this would mimic the most frequent clinical setting of hypothermic patients and provide a feasible cooling method for field studies. We aimed to induce mild hypothermia in healthy volunteers by exposure to cold ambient air, and tested the hypothesis that drug-induced suppression of endogenous thermoregulation would be required. Methods: In a randomized, double-blind, crossover design, 15 healthy volunteers wearing wet clothes were put in a windy climate chamber set to 5 °C. Each participant completed the experimental procedure twice, once receiving active drugs (meperidine and buspirone) and once receiving placebo. The experiments were separated by a one-week wash-out period. Primary outcome was core temperature at termination, defined as 3 h of exposure or 35 °C. The between-groups difference was assessed using analysis of covariance (ANCOVA) with left censoring (Tobit model) and individual random intercept. Secondary outcomes were trajectory of core temperature and reduction of shivering. Results: At termination, the active drug vs placebo group differed in temperature by 1.4 °C. With adjustment for the removal of participants reaching 35 °C, the estimated mean difference was 1.7 °C (1.4–2.0, p < 0.001). Shivering was effectively reduced, but not completely inhibited by the drug regimen, and core temperature declined at a rate of − 0.82 °C per hour. Conclusion: The novel protocol utilizing cold air as a cooling method and drug-induced suppression of endogenous thermoregulation, is effective and enables future research projects. We have provided suggestions for minor alterations. Trial registration: EudraCT ID 2023–506020-81–00. [ABSTRACT FROM AUTHOR]

Background: A new paradigm of hybrid working exists, with most office workers sharing their work between the office and home office environment. Working from home increases time spent or prolonged sitting, which is associated with an increased risk of chronic disease. Interventions to reduce sitting time, specifically designed for both the office and home-office environments, are required to address this growing public health issue. This study presents a protocol to evaluate the effectiveness of a digital intervention (Click2Move) to reduce sitting time and improve employees' health and occupational wellbeing among hybrid office workers. Methods: A two-arm cluster randomised controlled trial will be undertaken among hybrid office employees. In total, 200 employees will be recruited across four companies across Europe (The Netherlands, Spain, Ireland, and Slovenia). Participants within each company will be randomly allocated to the intervention or control group at the unit/cluster level. The intervention group will receive the novel multicomponent Click2Move intervention (including environmental, organisational, and individual strategies) for 12 months, and the control groups will maintain their usual work practices. The primary outcome will be occupational sedentary time measured via activPAL3TM at baseline and at 3, 6 and 12 months follow-up. Secondary outcomes will include device-based (activPAL3TM) and self-reported (Global Physical Activity Questionnaire and Workforce Sitting Questionnaire) physical activity and sedentary behaviour; self-reported musculoskeletal disorders (Standardised Nordic Questionnaire) and pain (Numeric Rating Scale); self-reported presenteeism and absenteeism (Health and Work Performance Questionnaire), job satisfaction (Need for Recovery scale) and fatigue (single-item 5-point Likert scale). Focus groups will be conducted with employees post-intervention. Linear mixed models, accounting for covariates, will be employed to determine the effects of the intervention. Additionally, we will perform a full process evaluation analysis. Discussion: The proposed study will offer a comprehensive evaluation of a digital intervention aimed at reducing sedentary behaviour among hybrid office workers, offering practical solutions to enhance the health, wellbeing and productivity of a growing segment of the workplace. Trial registration: ClinicalTrials.gov NCT06247228. Registered 30 January 2024. [ABSTRACT FROM AUTHOR]

Background: According to WHO, "noncommunicable diseases (NCDs) kill 41 million people" annually, as the primary cause of death globally. WHO's Global Action Plan for the prevention and control of NCDs 2013–2020 (extended) tackles this issue and its implications regarding inequalities between countries and populations. Based on combined behavioural, environmental and policy approaches, health promotion aims to reduce health inequities and address health determinants through 3 strategies: education, prevention and protection. It is a well-known fact that long-term efficiency in health promotion, that is to say the promotion of health and well-being, involves interventions and programmes which target / involve children [1]. As a focal point in communities and a key environment for children, school is an important setting to implement health promotion programmes, especially integrated approaches and interventions targeting Life Skills (LS). Indeed, LS contribute to health and well-being, particularly for pupils. This article presents the research protocol of a French integrated school-based health promotion interventional research programme which intends to support the health promoting schools (HPS) approach in France: Explo'Santé. It results from a partnership between the University of Lyon and the French League against Cancer. Methods: Explo'Santé is an observational study based on a mixed methods research design, which aims to evaluate the effects of a health promotion programme, to elicit its implementation process and identify contextual factors. This 3-year, complex programme targets primary school pupils aged 8 to 10. It incorporates health education sessions, to develop pupils' LS and health literacy (HL), and to promote healthy environments. Teachers and French League prevention officers are trained to support skill development and programme sustainability. Data collection includes quantitative data via questionnaires, to assess programme impact on approximately 700 pupils, as well as 36 teachers, and 6 prevention officers, as well as qualitative data collected via focus groups with pupils, and interviews with teachers, parents, prevention officers, and school heads, to understand the barriers and promoting factors to the implementation of the programme, the differences in process and effects in different contexts, and its potential for sustainability. Discussion: Explo'Santé was designed to contribute to school-based health promotion strategies, by including key players, promoting partnerships, targeting multiple levels of impact and effect, and to ensure every step is research-based and informed. Finally, this study aims to identify the elements which would enable Explo'Santé to become a model in France and internationally. [ABSTRACT FROM AUTHOR]

Purpose: Postherpetic neuralgia (PHN) is a type of refractory neuropathic pain that causes significant suffering, disability, economic loss, and medical burden. In this study, we aim to evaluate the efficacy and safety of interferon (IFN)-α1b injection into the intervertebral foramen of patients with PHN. Patients and methods: This is a study protocol for a randomized, double-blind placebo-controlled multicenter clinical trial. A total of 200 participants with PHN from 11 hospitals will be recruited and randomly assigned to the treatment group administered with IFN-α1b and control group treated with placebo in a 1:1 ratio. Both groups will also receive oral pregabalin 150 mg twice daily and lidocaine injection into the intervertebral foramen as conventional therapy. This trial will involve a screening period, a 2-week intervention, and a 3-month follow-up. The primary outcomes will include the visual analog scale score and duration of pain relief. The secondary outcomes will include the 36-item short-form, dosage and duration of painkillers taken, viral load of varicella-zoster virus DNA, humoral cytokine level, and dosage and frequency of rescue medication. All adverse events and severe adverse events will be assessed during the study. Conclusion: This study is expected to provide evidence for the efficacy and safety of IFN-α1b injection into the intervertebral foramen in patients with PHN. Clinical trial registration: https://www.chictr.org.cn/indexEN.html, identifier ChiCTR240008996. [ABSTRACT FROM AUTHOR]

Background: Psychotherapy for Prolonged Grief Disorder (PGD), a condition characterized by an intense and persistent grief response, has received increased attention over the past decades. Evidence-based approaches to prevent PGD are currently scarce, and not always effective. This paper introduces a protocol for a clinical trial exploring the effectiveness of a Meaning Reconstruction psychotherapy approach (MR) assisted with ayahuasca, a traditional indigenous medicine. Method: The outlined protocol is a three-arm, non-randomized controlled trial focused on reducing normal and pathological grief symptoms, comparing the effectiveness of Ayahuasca-assisted MR therapy (A-MR), MR therapy alone (MR) and No Treatment (NT). At least 69 people who lost a first-degree relative during the prior year, and with a Texas Revised Inventory of Grief score up 39 (TRIG ≥ 40), will participate in the trial. Participants will be allocated to an A-MR (n ≥ 23), MR (n ≥ 23) or NT (n ≥ 23) group. Those from the A-MR and MR therapy groups will undergo a therapeutic process involving 9 sessions of online psychotherapy. In addition, the A-MR condition involves 2 group sessions of ayahuasca. The primary outcomes will be normal and pathological grief severity as measured by the TRIG and Traumatic Grief Inventory Self-Report (TGI-SR), administered at baseline, post-treatment, and 3-month follow up. Measures of quality of life, post-traumatic growth, meaning-made, psychological flexibility, and self-belief consistency will be also included. In addition, subjective effects of ayahuasca and acceptance-avoidance promoting effects will be assessed following ayahuasca administration. Finally, we will analyze the potential mediating effect of meaning-made, psychological flexibility and self-belief consistency in grief symptoms (as measured by the TRIG and TGI). Discussion: This trial is the first to empirically examinate the potential of psychedelic-assisted psychotherapy for grief, as well as the potential processes of change that may account for it. Clinical trial registration: https://clinicaltrials.gov , identifier NCT06150859. [ABSTRACT FROM AUTHOR]

Concerning numbers of childhood behavior problems have been reported worldwide. Parenting interventions are considered one of the most effective early strategies to intervene with externalizing conduct. This protocol outlines a feasibility RCT that aims to implement a parenting intervention in Portugal and (a) test key feasibility parameters, (b) assess the fidelity and acceptability of the program, and (c) explore its effectiveness in childhood behavior problems, parenting skills, parental concern, and parental sense of competence. A double-blinded, two-arm feasibility RCT is described. The participants are the primary caregivers of children between the ages of two and eleven years old that identify difficulties in managing their child's behavior. Families will be randomly assigned to an intervention arm and a waitlist control arm. Parents in the intervention arm will participate in the Being a Parent program (Portuguese version: Ser Pai & Ser Mãe), an eight-week group intervention. Outcomes will be assessed using quantitative and qualitative measures throughout three assessment periods (pre- and post-intervention, and follow-up). This study marks the first feasibility RCT of the Being a Parent program outside the UK. The findings will provide information on the global strength of this program. Challenges and clinical implications are also discussed. [ABSTRACT FROM AUTHOR]

Background: Amyotrophic lateral sclerosis (ALS) is a chronic, progressive disease that affects both upper and lower motor neurons. Some physicians have used traditional Chinese therapies (TCT) to treat ALS. However, there has been no systematic review or meta-analysis to evaluate the effectiveness and safety of TCT interventions. This review aims to analyze the effects of TCT interventions for patients with amyotrophic lateral sclerosis. Methods and analysis: This study will include randomized, non-randomized, and quasi-experimental clinical trials, with participants being any age Amyotrophic Lateral Sclerosis (ALS) patients who have undergone TCT treatment. Two researchers will independently search databases including CENTRAL, PubMed, PEDro, EMBASE, CNKI, CBM, and SPORTDiscus, without restrictions on language or publication date. These researchers will independently screen titles and abstracts and extract data from the included studies. If deemed suitable for meta-analysis, data synthesis will be conducted using Review Manager V.5.3 software; any discrepancies will be resolved by a third researcher. The meta-analysis will compare the effects of TCT with placebo or other interventions. The main endpoint evaluated was the decrease in the overall score of the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R; scoring from 0 to 48, where higher scores denote greater functionality) over a period of 24 weeks. Additional endpoints included the reduction rates in isometric muscle power, levels of phosphorylated axonal neurofilament H subunits in plasma, and slow vital capacity measurements. Furthermore, the study monitored the duration until occurrence of death, tracheostomy, or the need for long-term ventilation, as well as the time until death, tracheostomy, long-term ventilation, or hospital admission. Ethics and dissemination: Throughout the entire process of this systematic review, no personal information was used, hence ethical review is not required. The results of this meta-analysis will be disseminated through publication in peer-reviewed journals and/or conference presentations. [ABSTRACT FROM AUTHOR]

Retroperitoneal robotic-assisted laparoscopic pyeloplasty (R-RALP) is the commonest urologic procedure performed in children, entailing retroperitoneal CO2 insufflation and lateral decubitus, whose effects on cardiopulmonary variables are poorly known. We, therefore, studied hemodynamic and respiratory changes due to CO2 insufflation and lateral decubitus in children undergoing R-RALP and their effects on regional tissue oxygenation. Between 1/2021 and 7/2024, children affected by ureteropelvic joint obstruction (UPJO) underwent a pyeloplasty by R-RALP at Necker Enfants Malades Hospital (Paris, France), using a standardized surgical technique and a lung-protecting anesthetic protocol aimed to prevent hypercarbia. Cerebral and renal Near InfraRed Spectroscopy (NIRS) were added to standard monitoring. Mean monitoring parameters and NIRS values were derived from the prospectively kept continuous reading at eight preset points and analyzed. 37 patients were prospectively included (21 males), with a mean age of 6.0 ± 3.9 years, and mean body weight of 22.5 ± 11.3 kg; 15 patients were operated on in Left Lateral Decubitus (LLD) and 22 in Right Lateral Decubitus (RLD). No different LLD/RLD time trends were observed for standard monitoring parameters and NIRS measurements. Conversely, EtCO2 was higher in the RLD group at trocars insertion (T4, + 3.3 mmHg), beginning of CO2 insufflation (T5, + 2.9), and 45 min after the start of the procedure (T6, + 3.1). At the same time points, Pplat was higher in the LLD group at T4 (+ 3.0 cmH2O); T5, (+ 3.4) and T6 (+ 4.7). During R-RALP, the combination of RLD and CO2 insufflation promotes hypercarbia, while LLD requires increasing Pplat pressures, potentially favoring lung injury and hemodynamic instability during prolonged procedures. [ABSTRACT FROM AUTHOR]