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NCT06466200
Dentin hypersensitivity (DH) results in brief, sharp pain in response to a stimulus. It often seems to be underdiagnosed but also undertreated due to the lack of consensus on the topic. DH has been shown to affects patients' quality of life. The Dentine Hypersensitivity Experience Questionnaire (DHEQ)is developed and validated : which is questionnaire assessing specifically the impact of DH on patient's quality of life. The DHEQ aims to help diagnose DH and assess the impact and subjective experience of the patient in order to better meet their expectations in terms of treatment. A French version, the DHEQ-fr, has been proposed (translation-counter-translation process and pilot study); however, it has not yet been validated (psychometric tests, test-retest). The main objective of the present study is to validate DHEQ-fr through a multicenter clinical study (three centers in France) in adult patients. The secondary objective is to compare the results of DHEQ-fr with those of the general oral health assessment index and oral health impact profil for the same patients. Patients are split between three DH groups (Schiff scores 1, 2 and 3) and a control group (non-DH). The overall sample size (all centers considered) for the DH group is 162 subjects divided into 54 subjects for each Schiff score (1 to 3; after cold air stimulation), with a control group of 54 subjects. A re-test will be performed, at 15 days, on a random sample of 60 subjects from the study population (in total: 15 non-DH subjects; 15 with a Schiff score of 1; 15 with a score of 2; 15 with a score of 3). The study of psychometric properties such as acceptability, internal consistency, reproducibility and internal structure validity will allow the validation of this French version of the DHEQ.
NCT04307914
The FURTHER study aims to evaluate the effectiveness and cost-effectiveness of MR-HIFU (alone or in combination with EBRT) compared to EBRT alone, the standard-of-care, as a palliative treatment option to relieve CIBP. The FURTHER study consists of a multicenter, three-armed randomized controlled trial (FURTHER RCT) and a patient registry arm (FURTHER Registry), which will be performed in six hospitals in four European countries.
NCT07444697
The goal of this observational study is to assess changes in patients' erectile function after percutaneous coronary intervention (PCI) using a standard IIEF (International Index of Erectile Function) questionnaire at 1, 3, and 6 months post-PCI. By doing this, we try to compare patients' responses to PCI after having a heart attack and stable angina to see the real effect of myocardial infarction on erectile function status in the long term by comparing it with a very similar group.
NCT06003712
The purpose of this study is to determine if practicing mindfulness breathing exercises has an effect on the overall health of persons with SCI
NCT06497751
This study aims to provide preliminary evidence of the efficacy of couple-based intervention over usual care in HIV serodiscordant couples in China. The investigators hypothesize that couple-based intervention would be more effective than usual care concerning both partners' quality of life and relationship satisfaction. The investigators also pilot the feasibility, acceptability, and appropriateness of the intervention content and implementation. HIV serodiscordant couples in the intervention arm will receive three sessions of dyadic intervention. In contrast, couples in the control arm will receive usual care.
NCT06819592
This research is about whether treatment with a commonly used antibiotic can prevent infections in airway and lungs and improves the chance of surviving, if it is given soon after patients commence mechanical ventilation when they have been admitted to hospital with an acute severe brain injury. An acute severe brain injury can occur as a result of a stroke, a traumatic injury or due to lack of oxygen to the brain that happens as a result of a cardiac arrest. Patients who are unconscious after an acute severe brain injury often need assistance to breath adequately, and this assistance is given by a breathing tube, connected to a mechanical ventilator. This treatment is an emergency medical treatment. The breathing tube is inserted into the patients' airway by either their mouth or neck. For patients who need assistance with their breathing from a mechanical ventilator, infections in the airways and lungs, known as pneumonia, are a common complication. Everyone naturally has bacteria in their mouth, esophagus and stomach. Clinicians think that during the process of inserting the breathing tube, small amounts of these bacteria can be introduced into the airways and lung when people are unconscious following an acute severe brain injury, or during the process of placing the breathing tube into the airways. These bacteria are now in a place they aren't meant to be and can cause an infections in the airways and lungs known as pneumonia. The purpose of this research is to see if giving one dose of a common antibiotic can prevent patients developing pneumonia, which is associated with having a breathing tube inserted and being on a ventilator, improving the chance of recovery following the acute severe brain injury and ultimately improving the chance of surviving. When patients have a known infection, current guidelines are to treat them with antibiotics. Antibiotics work to kill the bacteria causing the infection. When a patient has an infection in their lungs, they often need to stay on the mechanical ventilator for longer. While current practice is to give patients with a proven infection in their airways and lungs (pneumonia) antibiotics, it is unknown if giving an antibiotic to patients to prevent these infections before they show signs of pneumonia may lead to better outcomes.
NCT07415564
The protocol will include a 10-week Symptom Management and Survivorship Handbook (SMSH) intervention to address informational needs for the management of physical and psychological symptoms, bundled with telephone delivered health coaching to address their symptom interference with physical, psychological and social functioning. The SMSH intervention, which includes both symptom assessment and management, is simple to implement, scalable, and evidence-based will be delivered to all survivors and caregivers (dyads) in this study, and will serve as an active control. In addition to the SMSH, intervention arm dyads will receive health coaching to address symptom interference and reduce social isolation. Symptom burden is more pronounced in marginalized populations such as Latina/o, rural, older age survivors and their caregivers.18-20 Many health disparities in these populations are underwritten by social isolation due to lack of access, disconnection from linguistically competent health care, mobility, and geographic proximity,21-23 and health coaching can address these issues. The specific aims of the proposed feasibility study are to determine among survivors with metastatic or stage IV cancer and their caregivers (dyads): Aim 1: Demonstrate SMSH plus health coaching feasibility (recruitment, retention, satisfaction (acceptability and appropriateness) for cancer survivors and their caregivers. Benchmarks: Recruitment 70% approached, Retention 75%, and participant satisfaction through qualitative exit interviews in week 11. Aim 2: Collect preliminary data for the intervention impact on whether the SMSH + health coaching results in lowered burden of 24 symptoms (primary outcome) over weeks 1-10, and improved HRQoL (social, physical, psychological) (secondary outcome) at week 11, compared to SMSH alone. Aim 3. Examine the enactment of self-management strategies in SMSH+health coaching versus SMSH alone. The proposed pilot trial will provide proof of concept for the SMSH coupled with a live telephone delivered health coaching intervention to improve symptom management and HRQoL for metastatic breast, GI, and melanoma cancer survivors and caregivers. By addressing physical and psychological symptoms and survivorship using scalable, accessible interventions delivered via telephone, within reach of traditionally underserved populations, the findings have the potential to lay the foundation for the dissemination and implementation of a practical solution to meet survivor-caregiver needs both locally and nationally.
NCT07412379
Introduction: Human life expectancy has increased significantly, leading to a transformation in the global demographic structure. Cancer is considerably more common among older adults compared to younger populations, as age is one of the main risk factors for its development. In fact, most solid tumors are considered age-related diseases. For this reason, the incidence of cancer among older individuals is expected to continue rising. Oncological care for this population group is particularly complex and represents a significant challenge, as comorbidities and the social aspects of aging create clinical scenarios that differ greatly from those seen in younger patients. Objective: To identify the predictive factors of functional decline and quality of life at 12 months of follow-up, as well as oncological outcomes at 5 years of follow-up, in patients aged 65 years and older with gastrointestinal cancer who undergo curative-intent resective surgery at Hospital Universitario Mayor - Méderi, Bogotá, Colombia. Methodology: Longitudinal and analytical observational study of prospective prognostic cohort type. Expected Results: Predictive model of functional decline and quality of life, as well as oncological outcomes, in patients with gastrointestinal cancer undergoing curative-intent surgical procedures.
NCT07415174
Postoperative neck pain is common after thyroidectomy and may impair early recovery. This prospective randomized controlled study aimed to evaluate the effects of postoperative neck range-of-motion (ROM) and isometric strengthening exercises on neck pain and early-stage quality of life in patients undergoing thyroidectomy. Between November 2024 and April 2025, 93 patients who underwent thyroidectomy were enrolled. Surgical indications included multinodular goiter, Graves' disease, and fine-needle aspiration biopsy results classified as Bethesda categories III-VI. Patients were randomized into an intervention group (n = 48) and a control group (n = 45). Patients in the intervention group performed cervical ROM and isometric strengthening exercises from postoperative day 1 to day 10, while the control group received standard postoperative care without a structured exercise program. Both groups were evaluated on postoperative days 1 and 10. Pain severity was assessed using the Visual Analog Scale (VAS), and quality of life was assessed using the Neck Pain, Discomfort, and Early-Stage Quality of Life Questionnaire (NPDEPQ).
NCT06276023
Building on limitations of prior research, the investigators developed the Mindful and Self-Compassionate Care Program (MASC) to help caregivers of persons with Alzheimer Disease and Related Dementias (ADRD) manage stress associated with the general caregiver experience including stress stemming from managing challenging patient behaviors. MASC teaches: (1) mindfulness skills; (2) compassion and self-compassion skills; and (3) behavioral management skills. MASC also provides psychoeducation and group-based training and skill practice to facilitate skill uptake and integration within the caregiver experience and tasks. The main aim is to: Demonstrate feasibility, acceptability, credibility, fidelity, preliminary efficacy and evidence for proposed mechanism of MASC through a pilot randomized controlled trial. Relevant stakeholders (caregivers of persons with ADRD) will participate in the intervention.
NCT07221422
This is a mixed-methods study designed to develop and evaluate an innovative coaching program for physician trainee mothers. Approximately 48 participants will be recruited from informational flyers posted in resident work areas and distributed by program directors and GME. Interested participants will email study staff. Participants will be randomized to the control or intervention arm. Intervention participants will meet monthly with a novice physician coach of their choice (one-on-one) and a certified physician coach (with an assigned group of 6 peers through video-conferencing). Participants in both arms of the study will respond to surveys at three points: enrollment (baseline), 4 months, and 7 months. At each point, they will spend approximately 10 minutes filling the survey. The survey will query demographics, burnout, professional fulfillment, imposter phenomenon, self-valuation, self-efficacy, resilience, quality of life, and impact of work on professional relationships. The coaching intervention will last 4 months, and the 7 month survey will be used only to assess long-term effects of the intervention. At the conclusion of the study (7 months after enrollment), participants will be interviewed over video communication (secure Partners or Harvard Zoom) for approximately 30 minutes.
NCT05825469
The goal of this research study is to develop a nutrition algorithm to optimize nutritional status and improve quality of life during for participants who are completing or have completed cancer treatment. The name of the intervention used in this research study is: Nutrition Algorithm for Cancer Health Outcomes (NACHO) (a technology-based platform that houses the algorithms for the person-centered nutrition program)
NCT07074314
Premenstrual Syndrome (PMS) describes somatic, cognitive, emotional, and behavioral symptoms that occur in women during the luteal phase of the menstrual cycle and resolve with the onset of menstruation. These symptoms are common during the reproductive years. The emotional symptoms of PMS include depression, outbursts of anger, irritability, crying spells, anxiety, confusion, social withdrawal, poor concentration, insomnia, increased short sleep, and changes in sexual desire. Premenstrual symptoms negatively impact women's relationships with family, work, and friends, as well as their social activities. Furthermore, premenstrual symptoms negatively impact a woman's quality of life, making them an important issue to address early in a woman's life. Numerous treatment methods are used to reduce or eliminate PMS symptoms. Laughter yoga is one of the alternative medicine methods that has recently emerged and is used to maintain and improve health. No studies have examined the effectiveness of laughter yoga in reducing premenstrual syndrome. This study aims to determine the effects of laughter yoga on quality of life and premenstrual symptoms in young people experiencing premenstrual syndrome.
NCT06581484
The theory-informed digital health intervention, called as "Empower My Congenital Health (EmpowerMyCH)" aims to activate and engage ACHD patients in building confidence toward navigating the adult healthcare system. This tool is built after incorporating the theories of behavior change, gathering inputs from target patients in all stages of its design and implementation. The key features of the tool include a digital medical passport, updated congenital information, community support, and patient stories and advice. The investigators aim to test the acceptability, feasibility, efficacy, and effectiveness of the intervention.
NCT07348926
This study aims to examine the psychological status and quality of life of families with children who have rare genetic disorders. The focus of the study is to understand how the child's level of functional independence relates to the well-being of the family. Functional independence will be assessed using standardized tools, and parental psychological status and quality of life will be evaluated with validated questionnaires. The information gathered from this study may help improve the understanding of how rare genetic disorders affect family dynamics and daily functioning. The results may guide health care professionals in planning family-centered physiotherapy, psychological support, and care programs.
NCT07343284
This study is titled "Effect of a Nursing Intervention Based on Health Education on Functionality, Depression Symptoms, and Quality of Life in Patients with Ischemic Stroke." It is a quasi-experimental, longitudinal, prospective clinical trial that will beconducted with patients who have suffered an ischemic stroke and were treated in the neurology unit of the Lucus Augusti University Hospital, the same center where this study will take place. The primary objective of the study is to determine the effect of a nursing intervention based on health education on quality of life and depression symptoms in individuals who have experienced an ischemic stroke. To achieve this objective, variables such as cognitive status, depression symptoms, autonomy and ability to perform basic activities of daily living, neurological deficits, and quality of life will be assessed. Regarding the total number of subjects to be studied, according to the Stroke Atlas in Galicia published by the Spanish Society of Neurology in 2018, the autonomous community of Galicia had a population of 2,701,819 inhabitants. Applying an incidence rate of 187.4 cases per 100,000 inhabitants according to the IBERICTUS study, an estimated 5,064 new stroke cases occur each year in Galicia. The province of Lugo had 324,842 inhabitants as of January 1, 2024, according to the INE; therefore, applying the same incidence rate, an estimated 609 new stroke cases occur per year. Considering the proportion of ischemic strokes compared to other types of strokes (80:20), the estimated number of ischemic stroke cases in Lugo would be 487. The representative sample size of stroke patients in the province of Lugo would be 70 patients, with 35 patients receiving the intervention and 35 serving as controls. Independent Variables: Sociodemographic: sex, age, event date. Clinical: stroke type, treatment modality (rt-PA or thrombectomy), falls, pain, pressure ulcers, aspiration, pneumonia, dysphagia, vital signs. Health education: received vs. not received. Dependent Variables: Cognitive status (MMSE). Depression symptoms (BDI). Autonomy and ADL performance (Barthel Index). Neurological deficits (NIHSS). Quality of life (European Quality of Life Scale). Instruments Mini-Mental State Examination (MMSE) Beck Depression Inventory (BDI) Barthel Index NIH Stroke Scale (NIHSS) Visual Analogue Scale (VAS) European Quality of Life Scale (EQLS)
NCT07337681
Children and adolescents receiving cancer treatment often experience fatigue, reduced physical activity, and decreased quality of life. Although exercise has been shown to reduce these problems, maintaining regular and safe physical activity during cancer treatment can be difficult due to treatment side effects, safety concerns, and limited access to supervised programs. This study aims to evaluate the feasibility, safety, and effectiveness of a wearable technology-supported exercise program on fatigue and health-related quality of life in pediatric cancer patients aged 13 to 18 years. Participants will be randomly assigned to either an intervention group or a control group. The intervention group will participate in an 8-week structured exercise program delivered through a mobile application, including video-guided exercise sessions performed three times per week and monitored continuously using a wearable activity tracker. The control group will receive standard care and will wear the activity tracker for passive monitoring only. Fatigue and quality of life will be assessed at baseline, mid-intervention, and after completion of the program. Physical activity, heart rate, sleep patterns, and adherence to the exercise program will be objectively monitored using wearable devices. The findings from this study are expected to provide evidence on whether a digitally delivered, wearable-supported exercise program is a feasible and beneficial approach to improving well-being in children and adolescents undergoing cancer treatment.
NCT07236424
Clinical Trial This clinical trial aims to determine the impact of physiotherapy interventions on mental health, quality of life, and spinal mobility in older adults. The physiotherapy intervention will consist of group exercise therapy (3 times a week, 40 minutes, 4 weeks in total), walking activities (3 times a week, 30 minutes, 4 weeks in total), and education on optimal positions and movements in daily activities (one session lasting 60 minutes) The main questions it aims to answer are: 1. Are group exercise therapy and walking optimal for reducing symptoms of depression and anxiety and improving quality of life in older adults placed in nursing homes in a short period of time 2. Do physiotherapy interventions improve spinal mobility (anteflexion and extension)?
NCT04068311
This project will implement a 2 step protocol for multidisciplinary geriatric assessment in the Emergency Department (ED). Candidate: Dr. Lauren Southerland is a Geriatric- and Emergency Medicine-trained physician at The Ohio State University Wexner Medical Center. Training: The career development plan will build upon Dr. Southerland's unique fellowship training in Geriatrics with courses in Implementation and Dissemination Science, a Black Belt in Lean Six Sigma, and Master's in Public Health courses. This combination will position her as an expert in Implementation research, with the career goal of translating validated, effective elements of geriatric care into the daily practice of Emergency Medicine. Mentors: Dr. Southerland has an experienced mentorship team who will provide guidance in the intricacies of emergency research (Dr. Jeffrey Caterino, MD, MPH), implementation strategies and studies of hospital staff and nurses (Dr. Lorraine Mion, PhD), implementation frameworks and reporting (Dr. Christopher Carpenter, an emergency medicine physician at Washington University at St. Louis), and identifying environmental and human factor barriers to quality care. Project: Multidisciplinary assessment by geriatricians, physical therapists, case managers, and pharmacists identifies and addresses underlying geriatric issues in older ED patients. However, only a few EDs across the country have been able to incorporate multidisciplinary care for their older patients, due to barriers such as personnel costs, work flow culture, and the 24 hour ED care model. We developed a two-step protocol to address these barriers: Step 1 is quick, sensitive screens for fall risk (4 Stage Balance Test), delirium (Brief Delirium Triage Screen), and frailty (Identifying Seniors at Risk Score). Patients with concerning results will be placed in an ED Observation Unit for (step 2) multidisciplinary geriatric assessment. In Aim 1 we will use the Consolidated Framework for Implementation Research and Lean Six Sigma methods to identify and address residual barriers to full implementation. Aim 2 will evaluate the effectiveness of this protocol in regards to patient-oriented outcomes (functional status and health-related quality of life at 90 days). By using implementation frameworks and processes, we will develop a protocol that is effective, sustainable, and ready for dissemination to EDs across the US.
NCT07321964
Atrial fibrillation (AF) is the most common cardiac arrythmia, associated with increased risk of stroke, heart failure, reduced quality of life (QoL), and psychological distress. This randomized controlled trial investigates the effect of MediYoga - a program incorporating deep breathing, low-intensity yoga, and meditation- on disease-specific QoL, blood pressure, and heart rate in 456 patients with paroxysmal AF. With a strong focus on sustainability, the study is fully digital: participants are recruited online, and the 12-week intervention is delivered through an application to smartphone. Additionally, the participants receive online support via Teams. Data will be collected at baseline, 3, 6, and 12 months. The primary outcome is disease specific QoL; secondary outcomes include blood pressure, heart rate, generic QoL, and psychological wellbeing. Qualitative interviews will explore patients' experiences with the intervention.