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NCT07298694
This study aims to evaluate whether modifying the EPIC preference list to display combination blood pressure (BP) medications at the top and/or adding "(PREFERRED)" to the beginning of the medication listing increases prescribing of these medications. Combination BP medications are aligned with value-based care guidelines and may improve patient adherence and reduce pill burden. Currently, these medications may be under-prescribed in part due to their low visibility in the EPIC prescribing interface.
NCT07471529
This study evaluates a Just-In-Time Adaptive Intervention (JITAI) aiming to foster social support processes for adults with elevated depressive symptoms awaiting outpatient psychotherapy. Utilizing a daily-level micro-randomized trial (MRT) design conducted over 21 days, participants are assessed six times daily. Participants are randomized across four conditions: (1) vulnerability-triggered, (2) vulnerability and receptivity-triggered, (3) support-need-triggered, and (4) a no-intervention control. The primary objective of this study is to evaluate the effectiveness of the JITAI in reducing daily depressive symptoms and increasing received social support (primary outcomes), as well as reducing daily loneliness and enhancing perceived social support (secondary outcomes). Furthermore, the study aims to compare the relative efficacy of three distinct triggering strategies to identify the most effective timing for intervention delivery.
NCT07461038
Problem: While partner support benefits breastfeeding outcomes, its impact across perinatal stages on maternal co-parenting perception is unclear. Background: Spousal involvement plays a vital role in successful breastfeeding and maternal well-being. Aim: This study aimed to examine the effects of spousal participation in breastfeeding interventions at different perinatal stages on maternal co-parenting perceptions and infant feeding practices for full-term infants. Methods: Pregnant women who received antenatal care and delivered at our hospital, together with their partners, were recruited and categorized by the timing of partner involvement in breastfeeding activities: both antenatal and postnatal (Group A); antenatal only (Group B); postnatal only (Group C); and no antenatal education but routine postnatal guidance (Group D). Maternal breastfeeding self-efficacy and coparenting perception were assessed at 6, 12, and 24 weeks postpartum.
NCT07257705
This study is testing a new mobile application called the OASES App, developed by the University of Milano-Bicocca. The App is designed to help frontline clinicians (nurses, clinical officers, and nursing assistants) provide faster and more accurate emergency care for patients with life-threatening conditions such as severe diarrhea, breathing difficulties, and seizures. The OASES App guides clinicians step by step through internationally recognized emergency care guidelines, including triage, diagnosis, and treatment recommendations. It is intended to be used offline on a tablet, making it suitable for rural hospitals with limited resources. This is a pilot study to understand whether the App improves the way clinicians manage simulated emergency cases compared to standard practice. About 16 clinicians at Dr. Ambrosoli Memorial Hospital, Kalongo, Uganda will take part in structured simulation exercises using realistic patient scenarios. Each participant will manage cases with and without the App, so that the two approaches can be compared. The main goal is to evaluate whether the App helps clinicians follow evidence-based guidelines more consistently. Other goals include measuring accuracy of triage, diagnosis, and treatment decisions, as well as the time needed to complete cases and clinicians' perceptions of usability, trust, and feasibility. No real patients will be involved in this study. All scenarios are simulations conducted in a safe, controlled environment. The results will help refine the App and inform the design of a larger study in the future.
NCT05777187
Among patients with cognitive impairment (CI) that undergo surgery, the risk for developing postoperative delirium (POD) is high (50%) and associated with further morbidity and mortality. Yet, 30-40% of POD cases are preventable with perioperative management. This randomized pragmatic clinical trial aims to assess incidence of POD in adult surgical patients with CI, as well as provider adherence to a set of 12 perioperative best practice recommendations for perioperative management. Electronic health record (EHR) data will be used to identify patients as high risk for developing POD and clinical decision support (CDS) prompts within the EHR will display best practices. Cases will be randomized to either the control group, usual care or the intervention which includes the high-risk alert and best practice prompts.
NCT01524276
The purpose of the Registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products. The Registry data is intended to benefit and support interests of patients, hospitals, clinicians, regulatory bodies, payers, and industry by streamlining the clinical surveillance process and facilitating leading edge performance assessment via the least burdensome approach.
NCT07390019
In this planned project, we aim to evaluate the FamCASP model and the digital screening tool SCa-N as an intervention within routine cancer care. An expected outcome of FamCASP is an increase in family health as expressed in lower levels of psychological distress, improved coping strategies and family climate and a decrease in unmet needs as measured by family members' self-reports as well as their descriptions during interviews. Hence, the specific aims are to: I. Describe differences in psychological distress, coping strategies, family climate and unmet needs between baseline and follow-up in family members receiving support according to the FamCASP model in outpatient cancer clinics and to explore whether or not there are differences between family members receiving support and those who do not receive support. II. Describe family members' experiences of receiving support according to the FamCASP model. III. Describe family members' experiences of interacting with the digital tool.
NCT07376369
The transition to motherhood, particularly for first-time (primiparous) women, is a critical life period requiring substantial psychological and social adjustment. Hormonal changes, increased caregiving responsibilities, sleep disturbances, and potential social isolation during pregnancy and the postpartum period may increase vulnerability to stress, anxiety, and depressive symptoms. Postpartum depression (PPD) is a common mental health concern that adversely affects maternal well-being, mother-infant interaction, and infant development, with insufficient social support identified as one of its most significant risk factors. Maternal self-efficacy, defined as a mother's perceived competence in caring for and responding to her infant's needs, is a key indicator of successful adaptation to the parenting role. Evidence suggests that maternal self-efficacy develops primarily within the first months after childbirth and tends to be lower in primiparous women. Low parenting self-efficacy has been associated with increased depressive symptoms, higher parenting stress, impaired mother-infant bonding, and negative developmental outcomes for the infant. Among social support sources, partner support plays a particularly protective role during the transition to parenthood. Emotional, informational, and practical support provided by the partner has been shown to enhance maternal self-efficacy, reduce psychological distress, improve marital adjustment, and lower the risk of postpartum depression. Conversely, low perceived partner support and relationship difficulties are associated with an increased risk of PPD in primiparous mothers. The aim of this study is to examine the relationship between perceived partner support and postpartum parenting self-efficacy and depressive symptoms in primiparous women. Additionally, the study seeks to evaluate the explanatory and protective role of partner support on maternal self-efficacy and postpartum depression during the early postpartum period.
NCT07363772
\<Study Design\> This study is a cluster-randomized, stratified, non-inferiority trial designed to evaluate the feasibility, efficacy, and educational effectiveness of HEROS 4.0, a mixed-reality (MR)-based cardiopulmonary resuscitation (CPR) training system, compared with conventional instructor-led CPR training. \<Objective \& Hypothesis\> The primary objective is to determine whether MR-based HEROS 4.0 CPR training is non-inferior to standard video- and instructor-based CPR training in improving CPR performance quality. The central hypothesis is that participants trained using HEROS 4.0 will achieve comparable CPR quality to those trained using traditional methods, while benefiting from enhanced immersion, scalability, and accessibility. \<Participants\> A total of 120 adults aged 18-50 years who have not received CPR training within the previous 12 months will be recruited. Participants will be assigned to one of two clusters and randomized in a 1:1 ratio to either the HEROS 4.0 MR training group or the conventional CPR training group. \<Intervention \& Control\> Participants will undergo CPR training according to their assigned group: Intervention group (HEROS 4.0): Participants will receive a two-stage CPR training program consisting of pre-training and on-site MR-based training. As pre-training, participants will be instructed to watch a 40-minute instructional video (conventional CPR training group video) at home prior to their visit. After completing the pre-training, participants will undergo 20 minutes of MR-based CPR training using the HEROS 4.0 system in a dedicated CPR training booth. Control group (Conventional CPR training): Participants will receive 60 minutes of standard CPR education delivered through instructional videos and in-person instructor guidance, reflecting current community CPR training practice. \<Outcomes\> Immediately after training, all participants will undergo a standardized cardiac arrest simulation using a CPR quality-measurement manikin. This simulation will assess objective CPR performance metrics as well as subjective outcomes through questionnaires. To evaluate knowledge retention and skill durability, all assessments will be repeated 6 months after training using the same simulation scenario and outcome measures. The primary outcome is chest compression fraction measured during the standardized simulated cardiac arrest scenario. Secondary outcomes include quantitative measures of CPR quality and participant-reported outcomes based on survey.
NCT07368452
This randomized educational trial compared a structured video-based Basic Life Support (BLS) training program with simulation-based BLS training among fourth-year medical students. Participants were allocated to one of the two training formats and completed a BLS knowledge test before and immediately after training. Performance was assessed using an Objective Structured Clinical Examination (OSCE) conducted 3 weeks after training. The primary outcome was OSCE performance at 3 weeks, and secondary outcomes included knowledge test scores and knowledge gain.
NCT07368010
The ARREVE-3 trial will evaluate whether a structured palliative care protocol can improve end-of-life management for mechanically ventilated ICU patients in whom a decision to withdraw life-sustaining therapies has been made. This cluster-randomized controlled trial compares protocol-based care with usual practice across participating centers. The intervention includes comprehensive guidance on symptom management, sedation, nursing care, withdrawal procedures, and family support, supported by standardized staff training. The primary endpoint is adherence to recommended end-of-life practices, while secondary outcomes assess patient comfort, communication with relatives, and the impact on families and healthcare professionals
NCT06154044
The goal of CELL-VAD Pilot trial is to investigate a personalized stem cell therapy approach for patients with advanced non-ischemic chronic heart failure (NICM) who are supported by LVAD. In the clinical trial, the investigators aim to enroll 10 patients with NICM, scheduled for LVAD implantation. After successful LVAD implantation, patients will be enrolled and followed for 2 months to allow for postoperative rehabilitation and heart failure medical therapy and LVAD support optimization. All patients will then undergo autologous CD34+ cell therapy which will be intracoronaryly delivered to the target myocardium using NOGA electromechanical mapping system. All patients will be followed for 6 months after cell therapy. At baseline, and at 1, 3, and 6 months after cell therapy, the investigators will perform comprehensive clinical evaluation.
NCT07322081
This study is designed to investigate the effects of a Mindfulness-Based Stress Reduction (MBSR) program on cognitive control and flexibility, psychological well-being, and self-compassion among primary caregivers of individuals with chronic mental illnesses. Caregivers of individuals with chronic mental health conditions are exposed to prolonged psychological, emotional, and cognitive demands, which may negatively affect their mental well-being and coping capacities. The study adopts a mixed-methods approach using an exploratory sequential design in order to obtain a comprehensive understanding of caregivers' needs and experiences and to evaluate the potential impact of the intervention. Qualitative findings are intended to inform the development and structuring of the MBSR program, while the quantitative phase is designed to examine changes in key psychological outcomes following the intervention. The study aims to contribute to the growing body of evidence supporting mindfulness-based interventions for caregiver populations and to inform future mental health service practices.
NCT07071935
Amyotrophic lateral sclerosis (ALS) is a disease that causes weakness of the muscles of the body. The disease can eventually lead to severe breathing problems, which is the most common cause of death from ALS. The treatment for breathing is non-invasive ventilation (NIV). It is a machine that helps a person breathe by pushing air in and out of their lungs through a mask worn over the face. Research has shown that NIV can improve the quality of life and survival of someone with ALS. Unfortunately, NIV is not equally beneficial for everyone. The investigators do not yet know the best time or method for starting NIV in ALS. Europe and Canada allow starting NIV much earlier in ALS than the United States. Current recommendations for starting NIV are based on the opinion of experts rather than large research studies. Medical insurance companies will not cover NIV until significant breathing weakness occurs. After NIV is started, there is no evidence-based guidance on the best way to adjust NIV to benefit patients as much as possible. Some patients have difficulty tolerating NIV, but it is not clear how to identify these individuals ahead of time. The investigators have created a new prediction tool that can identify patients at high risk of breathing problems within the next 6 months. This may help the study team identify who is more likely to benefit from starting NIV early. The investigators have published a paper that shows that NIV helps people with ALS live longer. This paper also showed that patients get more benefit with use NIV for at least 4 hours per day. The investigators published another paper that measured a gas called carbon dioxide (CO2), which goes high if someone's breathing is weakened. This paper showed that patients with ALS may live longer when CO2 levels are lowered using NIV. The investigators also have data suggesting that certain characteristics may predict who is less likely to use NIV at least 4 hours per day. In this study, the investigators will collect pilot data on starting early NIV in individuals with ALS who do not yet meet insurance criteria for covering NIV. The research team will first use their previously published prediction tool to identify patient risk. Then, subjects would be randomized to start early NIV or to usual care. The usual care group would eventually start NIV as would occur if the participants were not in the study. The purpose of this study is to collect data to help the investigators plan a larger randomized clinical trial. This study has 4 objectives. First, the project aims to identify individuals who would benefit from earlier NIV. The research team will use the original prediction tool to identify risk of severe breathing problems within the next 6 months. Second, the project aims to show that it is feasible to start NIV early. Third, the project aims to gather data on the effect of randomization on symptoms, CO2 levels, and outcomes. Fourth, the project aims to identify traits that may make someone less likely to use NIV.
NCT06737302
Cerebral palsy (CP) refers to a non-progressive movement disorder, which occurs due to damage to the developing brain around the time of birth. Symptoms of sleep disordered breathing (SDB) include noisy breathing during sleep,increased day-time sleepiness and reduced energy levels. In the long term, SDB might have an effect on the brain and learning, as well as putting strain on the heart. Children with CP have a higher risk of sleep breathing problems compared to typically-developing children, and the negative impact of sleep disturbance in children with CP on their family members/carers' sleep and mental health cannot be understated. Early recognition and management of SDB is important for children with CP to give these children the best possible sleep quality, and to maximise learning potential. SDB in children with CP is often under-recognised and under-treated. Treatment of SDB in children with CP might involve wearing a mask that delivers pressurised air to hold open a child's airway and make breathing easier when they are asleep. This is called 'respiratory support' which can be continuous pressure (CPAP) or non-invasive ventilation (NIV) which is pressure support with a back-up breathing rate. There is limited knowledge on the appropriate indications or timing to use them. Though respiratory support in children with CP is proven to help with breathing during sleep, its impact on quality of life, number of hospital admissions or frequency of chest infections is unknown. This study will look at the number of children with CP on respiratory support across the UK, as well as the number of children newly diagnosed with SDB and/or established on respiratory support over a 1-year period. This study will also explore socioeconomic factors that might influence access of sleep services and the perceived facilitators and barriers to successfully initiating respiratory support in children with CP.
NCT07347509
his study aims to investigate the acute effects of a single pre-exercise dose of branched-chain amino acids (BCAA) and L-arginine supplementation on anaerobic performance, sprint speed, agility, lactate response, and post-exercise heart rate recovery in male football players competing in a youth development league. Twenty-one football players participating in the T.F.F. U-19 Development League will be randomly assigned to one of three groups: BCAA (n = 7), L-arginine (n = 7), or placebo (n = 7). Participants will receive either 12 g of BCAA (4:1:1), 5 g of L-arginine, or an equivalent amount of maltodextrin, administered 1.5 hours before training. Performance assessments will include 10 m and 20 m sprint tests, an agility test, the Wingate anaerobic power test, blood lactate measurements, and post-exercise heart rate recovery measurements taken at the 1st, 3rd, and 5th minutes of recovery. Data will be analyzed using repeated measures analysis of variance to examine within- and between-group differences.Data obtained from the study were analyzed using the JASP 0.95.4 software. Pre-test and post-test values of the experimental and control groups were evaluated using Repeated Measures ANOVA. Effect size was determined using Eta Squared (η²), and differences between groups were identified using Tukey post hoc analysis. A 95% confidence interval was applied, and statistical significance was accepted at p \< 0.05. In the BCAA group, 20 m sprint performance (p \< 0.05) and agility test results (p \< 0.05) improved significantly compared to the control group. Additionally, heart rate recovery at the 3rd and 5th minutes was significantly faster in the BCAA group compared to both the L-arginine and placebo groups (p \< 0.05). In the L-arginine group, no significant improvements were observed in sprint performance, agility, lactate response, or Wingate parameters compared to placebo. No significant differences were found between groups in lactate response or anaerobic power variables (peak, mean, and minimum power, and fatigue index) (p \> 0.05). A single dose of BCAA supplementation improves short-distance sprint performance, agility, and heart rate recovery in football players; however, it does not have a significant effect on anaerobic power or lactate response. Acute L-arginine supplementation did not produce a significant ergogenic effect on these parameters. The findings suggest that amino acid supplementation may produce more pronounced effects with chronic rather than acute application
NCT05731661
While the sequelae and toxicities after ovarian and endometrial cancer treatments are well described in the literature, the actual needs of patients for supportive oncology care remain poorly documented. Moreover, there is no data available to estimate the complexity of the oncological support care actions to be implemented. It is expected that an evaluation of the needs for supportive oncology care and its organization in day hospitalization for supportive oncology care will lead to an improvement in personalized post-cancer follow-up for these patients and to an improvement in their long-term quality of life.
NCT07312019
Drug-related iatrogenesis is a major public health issue, accounting for a significant proportion of adverse events and hospitalizations in emergency departments. Optimizing prescription management in this context is critical to improve both patient safety and physician efficiency This study aims to evaluate the impact of the POSOS AI-driven device on the medical time required for prescription management in polymedicated patients admitted to emergency departments. The main objective is to establish whether the use of POSOS can reduce transcription time compared to standard electronic management.
NCT07310979
This prospective clinical study aims to evaluate the clinical and radiographic outcomes of a novel triple-abutment system with hyperbolic paraboloid geometry installed on Morse taper dental implants. The system is designed to support three adjacent crowns on a single implant, aiming to optimize load distribution and preserve peri-implant tissue stability. Thirty systemically healthy adults missing three adjacent teeth will undergo implant placement, followed by a healing period of approximately three months for osseointegration prior to prosthetic loading. Metal-ceramic restorations will then be cemented over triple abutments. Clinical and radiographic evaluations will be performed at T1 (3-4 months after prosthetic loading) and T2 (12-18 months after prosthetic loading). The primary outcome will be marginal bone level change assessed by standardized periapical radiographs. Secondary outcomes include probing depth, bleeding on probing, plaque index, keratinized mucosa height, and patient-reported satisfaction. The study aims to investigate whether this innovative abutment design provides stable peri-implant conditions and favorable clinical performance when applied to Morse taper implants.
NCT06758180
Adult Basic Life Support (BLS) is a critical skill in emergency situations. Teaching this skill effectively to students in first aid and emergency aid programs is essential for imparting both theoretical knowledge and practical competencies. Educational methods have a direct impact on students' knowledge levels and skill acquisition. In addition to traditional teaching methods, advancements in educational technology have introduced innovative approaches such as interactive video games into this field. This study compares the effects of two different instructional methods-video-assisted education and interactive video game-supported education-on students' learning outcomes and practical performance in adult BLS training.