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NCT07658079
Nutrition is the intake of essential nutrients in sufficient quantities and at the appropriate times to maintain and improve health and enhance quality of life. Enteral nutrition is superior to parenteral nutrition and should be preferred. To protect the gastrointestinal mucosa and maintain normal flora, patients should begin enteral nutrition as soon as possible. In patients who cannot take food orally, enteral nutrition is provided via a nasogastric/nasojejunal tube or gastrostomy tube. Gastrostomy is the first choice for patients with a functional gastrointestinal system, poor oral intake, and requiring long-term nutritional support. Feeding tubes can be placed percutaneously or surgically. Percutaneous endoscopic gastrostomy (PEG) is a minimally invasive procedure that does not increase morbidity or mortality, is cheaper, and saves time compared to surgical gastrostomy. It was first applied in 1980 as an alternative to surgical gastrostomy. During the procedure, a line was defined between the navel and the middle of the left lower costal margin. A feeding tube was then inserted at the junction of the middle 2/3 and the outer 1/3 under local anesthesia, and feeding was started the following day. Vudayagiri et al. reported that the placement site is generally 2 cm medial to the costal margin and 2 cm below the xiphoid process. Different methods for placing a PEG tube into the stomach (pull technique, push technique, and Russell method) have been described in the literature, with the most common being the "pull" technique. The 2005 ESPEN guidelines noted that in the "pull" technique, gastroscopic visualization of the anterior gastric wall is performed, followed by determination of the puncture site at the distal corpus level. The exact location of the PEG feeding tube, both on the skin and within the gastric lumen, is not fully understood. Its localization on the abdominal skin will be optimally achieved through endoscopic transillumination. However, its level within the gastric lumen is predictable. In our study, we aimed to investigate how measuring the distance of the feeding tube from the pylorus in patients undergoing PEG placement affects post-procedure outcomes and to determine the optimal level within the gastric lumen. Additionally, the placement of the catheter on the skin will be recorded in each patient. Traditionally, tube feeding has been delayed until up to 24 hours after percutaneous endoscopic gastrostomy (PEG) procedure. However, results from various randomized controlled trials suggest that early feeding may be an option. A meta-analysis indicated that early feeding (\< or = 4 hours) after PEG placement may be a safe alternative to delayed or next-day feeding. However, although there was no difference in overall complications in this meta-analysis, there was a significant increase in gastric residual volume on day 1 in patients who started early feeding. In another meta-analysis conducted by Szary et al., early tube feeding ≤3 hours after PEG placement; Complications, death within ≤72 hours, or significant gastric residual volume on day 1 were found to be significantly different from delayed or next-day feeding. Our study will be the first of its kind in this field. Therefore, to minimize all factors that could negatively affect the results, we will initiate enteral feeding 24 hours after the traditionally used procedure.
NCT04585269
The purpose of this project is to evaluate efficacy of Bright IDEAS, an evidence-based problem-solving skills training (PSST) program, as a supportive care intervention for young adult (YA) cancer patients compared with enhanced usual psychosocial care with 344 young adult patients newly diagnosed with cancer.
NCT07218861
Individuals with minoritized sexual and gender identities (i.e., LGBTQ+ individuals) are at a greater risk for self-injurious thoughts and behaviors than their cisgender, straight peers (Haas et al., 2010; Liu et al., 2017; Gorse, 2022). There is a dearth of empirically supported interventions for self-injurious thoughts and behaviors (Linehan, 2008; Riblet et al., 2017), and those that exist are not tailored to people in the LGBTQ+ community (Gorse, 2022; Haas et al., 2010). Therefore, the aim of this study is to test the effectiveness of a brief LGBTQ+ affirming text message intervention in reducing self-injurious thoughts and behaviors among LGBTQ+ individuals.
NCT07549126
This study is stage 2, round 1 of a larger study which refines and optimizes the EMBED clinical decision support (CDS); see NCT03658642 to increase number of ED physicians following standard of care for the administration of buprenorphine to appropriate patients with opioid use disorder.
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.
NCT06650254
The World Health Organization and the United Nations Children\&amp;#39;s Fund report that exclusive breastfeeding for six months and continuing breastfeeding for two years or longer with appropriate complementary foods is one of the most powerful practices to increase the survival and well-being of the child. Some difficulties experienced during the breastfeeding process negatively affect the continuation of breastfeeding and prevent the baby from receiving breast milk. It has been determined in the studies in the literature that various interventions have been made and recommendations have been made to increase breastfeeding rates. However, it has been seen that there is a need for studies that address the needs of mothers regarding breastfeeding problems in a holistic manner and provide support in line with their needs. In order to increase breastfeeding success and ensure the continuity of effective breastfeeding, it is obvious that a holistic assessment of mothers; breastfeeding problems is needed, physical, psychospiritual, sociocultural and environmental factors that may cause deterioration in comfort are determined and comfort-focused nursing support is provided. In this context, the aim of the study is to determine the effect of the breastfeeding support structured according to Kolcaba\&amp;#39;s comfort theory given to mothers in the postpartum period on the breastfeeding comfort of mothers, and the second aim is to develop the \&amp;#34;Postpartum Breastfeeding Comfort Scale\&amp;#34; and test its validity and reliability. Hypotheses of the study: H0: The breastfeeding support structured according to Kolcaba\&amp;#39;s comfort theory given to mothers in the postpartum period is not an effective method in increasing the breastfeeding comfort of mothers. H1: The breastfeeding support structured according to Kolcaba\&amp;#39;s comfort theory given to mothers in the postpartum period increases the breastfeeding comfort of mothers. H2: "Postpartum Breastfeeding Comfort Scale" is a valid and reliable tool for measuring mothers\&amp;#39; breastfeeding comfort.
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.
NCT06790641
Mental health conditions occurring during pregnancy and up to one year postpartum (the perinatal period) occur in 1 in 5 perinatal individuals. To improve mental health care during the perinatal period, this study will implement and compare a health care model of improving mood and anxiety disorder care in practices with a health care-community partnership model. The study will include 32 perinatal care settings across the United States. Half of them will have the health care model, the other half will have the health care-community partnership model. The study is designed to answer the question, "Should states and healthcare systems put resources into a healthcare system approach or a healthcare-community partnership approach to mental health care?" The results of this study will help states and healthcare systems decide how to develop pathways for increasing access to mental health care for pregnant and postpartum individuals.
NCT06601946
Various studies have shown that rapid and correctly performed cardiopulmonary resuscitation (CPR) significantly increases the survival rate after cardiac arrest. Such a situation can affect anyone, anywhere and at any time, making it all the more important to master the basic skills and abilities of Basic Life Support (BLS). Thanks to constant technical progress, there are now numerous digital tools in the field of lay resuscitation. There are also feedback devices for CPR for laypersons, the use of which is currently the subject of scientific debate. In order to evaluate the influence of various tools on the quality of lay resuscitation, we are planning a prospective, randomized study in a parallel group design. This study is aimed at medical laypersons between the ages of 18 and 70 who have completed a BLS course (e.g. first aid course for driver\'s license) within the last 10 years. All participants are asked to take part in a mannequin-based simulation scenario in a public place. As part of this simulation scenario, the BLS algorithm is to be performed (recognizing respiratory-circulatory arrest, calling for help, performing chest compressions, organizing a defibrillator). After performing the 1-minute cardiac massage, the scenario is ended. We plan to randomize into 3 groups. Group 1 will receive paper-based information material on how to perform BLS correctly. Group 2 will receive a first aid app. Group 3 will receive a small medical device (CorPatch®), which gives direct feedback on the quality of chest compressions (e.g. frequency, depth), including an accompanying app for support. The time to blood flow (defined as the succession of 5 sufficient chest compressions in this study) will be evaluated as the primary outcome. Secondarily, resuscitation management will be evaluated using a validated BLS checklist, the time to critical actions (such as time to alert the emergency services), the quality of CPR, the cognitive load of the participants and the user-friendliness of the assigned aid.
NCT05367102
The overarching objective for the Supporting Health Relationships (SHR) program is to create and sustain families in the Bronx by improving relationship skills, improving parenting skills, and improving parental financial support for children. The investigator's local evaluation addresses a research question about the effectiveness of delivering the SHR curriculum virtually: To what extent do couples show improvements in engagement, skills learning, and relationship quality outcomes when receiving the curriculum over Zoom?
NCT07499375
Diabetes imposes a growing global burden due to rising care costs and reduced quality of life from its complications. Managing the disease remains challenging for many patients, highlighting the need for effective, scalable support strategies. Peer support has shown promise in improving diabetes self-management, yet evidence from randomized trials in Ethiopia, particularly on both clinical and economic outcomes, is limited. Thus, this study aimed to evaluated the effect of a peer support intervention on glycemic control and economic burden among patients with diabetes.
NCT07192393
PREM-IMPACT is a UK-based observational study exploring how caring for a very premature baby-particularly one affected by necrotising enterocolitis (NEC)-impacts families over the first year after hospital discharge. NEC is a serious bowel disease that can occur in premature babies, often requiring surgery and prolonged hospitalisation. This study runs alongside the WHEAT International Trial, which investigates whether pausing or continuing milk feeds during blood transfusions affects the risk of NEC in very preterm babies. PREM-IMPACT acts as a nested economic evaluation of the WHEAT Trial, helping to understand whether different feeding practices around transfusion offer good value for money from both the NHS and family perspective. PREM-IMPACT will collect detailed data on babies' health-related quality of life, as well as the financial, emotional, and social impact on parents and siblings. Families are recruited from neonatal units when their baby is ready to go home and complete questionnaires at three timepoints: 1) just before discharge, 2) six months later, and 3) twelve months later. Questionnaires cover health, wellbeing, healthcare use, and costs to the family (such as travel, time off work, or extra care needs). A dedicated research nurse based at the lead NHS site helps coordinate follow-up centrally. By studying families of babies with and without NEC, this project aims to clarify the burden of prematurity and NEC on infant outcomes and family wellbeing. The results will inform future policy decisions, including whether pausing or continuing milk feeds during transfusion should be adopted in routine neonatal care.
NCT07501897
This study aims to evaluate a new wound treatment called cold atmospheric plasma (CAP) for patients receiving extracorporeal life support (ECLS). Patients on extracorporeal life support (ECLS) often develop wounds at the sites where tubes are inserted, and these wounds can be difficult to heal and prone to infection. cold atmospheric plasma (CAP) is a gentle, non-heat treatment that can kill bacteria, reduce inflammation, and promote wound healing. In this study, patients will be randomly assigned to receive either standard wound care alone or standard care plus cold atmospheric plasma (CAP) treatment. Researchers will compare both groups to see whether cold atmospheric plasma (CAP) can reduce infection, improve healing speed, and decrease the need for additional procedures. The study will also monitor safety to ensure the treatment is well tolerated. The goal is to find a more effective and safe way to improve wound healing in critically ill patients.
NCT06436638
In patients with high levels of fear and anxiety, it is recommended to perform dental procedures under sedation or general anesthesia depending on the nature of the procedure. In dental treatment under anesthesia, it is important that the procedure is comfortable and well tolerated by the patient. In addition, patient comfort is important in all dental procedures to prevent the development of avoidance behavior. During dental procedures performed under anesthesia, the oral cavity is completely within the scope of the surgical or procedure field. In this respect, sedation and general anesthesia in dental procedures and operations have specific risks and challenges.Since there is a risk of respiratory depression, hypoxia and hypercarbia during deep sedation, non-invasive ventilation support provided to patients with airway devices would be beneficial. In the research clinics where the study will be conducted, deep sedation with non-invasive mechanical ventilation support using a nasal CPAP (Continuous Positive Airway Pressure) mask or nasal airway is applied during the extraction of impacted molars. Thus, many dental procedures are routinely performed under deep sedation without the need for general anesthesia. There are very limited data in the literature on the use of a nasal CPAP mask during sedation for different procedures in patients with obstructive sleep apnea or obesity. However, no study comparing ventilation support during deep sedation with nasal CPAP mask and nasal airway has been found in the literature. The aim of this study is to compare the non-invasive ventilation support provided with 2 different airway devices during the procedure in terms of intraoperative and postoperative related complications, ventilation parameters, patient and surgeon satisfaction. The hypothesis of the study is that two different ventilation support methods during deep sedation may be superior to each other in terms of anesthesia quality, postoperative complications related to airway devices, patient and surgeon satisfaction. In the study, a total of 60 patients (Group airway, n;30, Group Mask, n;30) from 2 centers are planned to be included in the study by performing power analysis with a statistical power of the trial \>0.8. The permutation method will be applied within the scope of the restricted randomization method to determine the group of patients to be included.
NCT07476833
This observational study investigates the wellbeing of parents in German-speaking Switzerland in everyday contexts using smartphone-based Ecological Momentary Assessment (EMA). Family caregiving can be both rewarding and burdensome, yet little is known about how parental wellbeing fluctuates in daily life and across caregiving situations. The study aims to examine momentary subjective wellbeing, caregiving activities, and contextual factors in natural settings. Participants complete repeated real-time assessments via a digital diary application five times a day over a 14-day study period. The study seeks to characterize within-person variability in parental wellbeing and identify contextual factors associated with positive and negative daily experiences.
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.
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.
NCT03994796
This phase II trial studies how well genetic testing works in guiding treatment for patients with solid tumors that have spread to the brain. Several genes have been found to be altered or mutated in brain metastases such as NTRK, ROS1, CDK, PI3K, or KRAS G12C. Medications that target these genes such as abemaciclib, paxalisib, entrectinib and adagrasib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Genetic testing may help doctors tailor treatment for each mutation.
NCT06237179
To test the preliminary effectiveness of a home-based exercise training (ET) intervention to improve exercise capacity (VO2 peak \& 6-minute walk distance \[6MWD\]) among prostate cancer (PC) patients compared to controls receiving healthy living education (HLE) at 12 weeks.
NCT05490004
Veterans and their families are more likely to experience forms of family violence like intimate-partner violence and child maltreatment. Evidence suggests that healthcare and social service providers (HSSPs) need more training to effectively and confidently recognize and respond to these situations. The Violence, Evidence, Guidance, Action (VEGA) Educational Intervention is a novel education intervention aimed at improving provider's preparation for these clinical encounters. The goal of this project is to determine the acceptability and feasibility of a future randomized-controlled trial comparing two approaches (facilitator-led VEGA or self-directed VEGA) to administering the VEGA training to understand whether/how these approaches can support HSSPs continued care of veterans and their families. The investigators aim to generate initial estimates of the effectiveness of both approaches in improving HSSPs knowledge and skills to effectively recognize and respond to intimate-partner violence and related forms of family violence, including child maltreatment. As well, the investigators aim to contribute to the knowledge base regarding optimal educational approaches for HSSP education in family violence. The investigators hypothesize that there will be significant increases in preparedness, knowledge and skills, and self-efficacy to recognize and respond to both CM and IPV in both the experimental and AC arms from Time 1 (baseline) to Time 2 (immediately after the intervention) and Time 1 (baseline) to Time 3 (3 month follow-up). These improvements will be slightly attenuated in the experimental arm. Qualitative data pertaining to perceived value and impact will corroborate the quantitative findings.