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Found 1083 Actively Recruiting clinical trials
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The goal of this clinical trial is to learn, if the video-based exercise program "Bliib fit - mach mit!" can be used to improve physical fitness in older adults living in residential care facilities. The main questions it aims to answer are: Does the video-based exercise program improve participants' physical fitness? Does the video-based exercise program improve participants' quality of life, perceived fall risk, self-efficacy and daily physical activity levels? Researchers will compare this exercise program to an optimized standard care activation program (caregiver-led) to see if the video-based program can affect physical fitness in older adults living in residential care facilities. Participants will participate in the exercise or activation program for 12 weeks, four times a week, with each session lasting 20 minutes.
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Healthy Volunteer
Setting Location and Participants Selection of a target region within Bangladesh considered four factors that would facilitate successful screening: 1) Relatively high population density and adequate transportation network, 2) the presence of a Cyclone Preparedness Program (CPP) volunteer network, 3) An eye care hospital willing to serve referred clients, and 4) Support and assistance from local and regional government. Based on these criteria, the investigators selected and implemented the screening project in Char Fasson of coastal Bangladesh. Char Fasson is a sub-district (Upazila) of the Bhola District and has a population of 518,792. While the investigators initially considered another coastal sub-district of comparable size, Char Fasson was chosen because of data collection challenges in the original choice. Char Fasson showed greater levels of poverty and more limited healthcare access while governmental coordination was exemplary. Within Char Fasson, the investigators made special efforts to serve outlying, smaller islands within the sub-district. Partnership Team Successful delivery of the program relied on effective collaboration across a range of diverse partners, including major operational organizations, clinical affiliates, commercial suppliers, and technical advisors. The major partners responsible for day-to-day work included the organizer, Data Yakka (Palo Alto, California, USA) which is a healthcare technology company specializing in AI-assisted medical screening platforms and data management systems, the regional government (Char Fasson Upazila), the Bangladesh Disaster Preparedness Centre (BDPC, Dhaka), and the national government's Cyclone Preparedness Program (CPP, Dhaka). Among them, BDPC provided personnel for program execution and supervision while CPP mobilized its volunteers for paid work in clinical site staffing and program outreach to remote areas. The total number of CPP community volunteers in coastal Bangladesh is around 76,000, with 3,300 in Char Fasson. The main clinical partner was the Dr. K. Zaman Bangladesh National Society for the Blind Eye Hospital (BNSB, Mymensingh, Bangladesh), which provided on-site ophthalmology and optometry staffing as well as remote fundus image review and clinical consultation as needed. The Ad-din Medical College Hospital (Dhaka) provided additional resources. Clients requiring cataract surgery were referred to regional facilities vetted by BNSB or to services provided by the Ad-Din Hospital. Commercial supplier partners included VisionSpring (New York, New York, USA), a not-for-profit organization providing low-cost reading glasses that the program distributed free to those in need, Topcon Corporation (Tokyo, Japan) for its NW-500 robotic fundus imaging camera, and Aurolab (Madurai, India) for its HAWK I T2 slit lamp examination device. Thirona Retina (Nijmegen, Netherlands) supplied its RetCAD AI software algorithms for the detection of suspected DR, AMD, and glaucoma. The software evaluates image quality, generates heatmaps with deep learning, and provides disease likelihood scores. Previous research demonstrated that RetCAD showed high performance: 96% sensitivity and 94% specificity on the Messidor-2 dataset for DR, 95% sensitivity and 97% specificity on the private1 dataset for AMD, and 95% sensitivity and 86% specificity on the REFUGE dataset for glaucoma. Technical advisors, including Stanford University (Palo Alto, California, USA), Royal Victorian Eye and Ear Hospital (Melbourne, Australia), and Glaucoma Australia (Sydney, Australia), shared their expertise, guided technical program components, and provided external clinical oversight and case-by-case review for complex or unclear diagnosis. Data security The security and integrity of patient data was ensured through multiple layers of protection. The secure, encrypted patient data portal was developed by Data Yakka using Java (Oracle, Austin, Texas, USA) with Angular for data entry and Spring Boot for backend micro services management, including a program dashboard for real-time monitoring. Patient information was securely stored in PostgreSQL RDS (Amazon Web Services, Seattle, Washington, USA), while fundus images were stored in Amazon S3 with server-side encryption using managed keys. This protected all sensitive data from unauthorized access. Personal identifiers were segregated from clinical details to enhance patient privacy. Keycloak was implemented for secure authentication and authorization. A comprehensive audit trail was maintained, logging all user interactions (access, edits, and deletions) to ensure compliance with the European Union's General Data Protection Regulation (GDPR) and the U.S.'s Health Insurance Portability and Accountability Act of 1996 (HIPAA). This also provided immediate detection of potential data security threats. Finally, to enhance system reliability, the investigators deployed Multi-AZ, which enabled automatic failover, high availability in case of hardware disruptions, and disaster recovery. Ethical Considerations Ethical approval was obtained from the Institutional Ethical Committee of BNSB (reference date/number 118/2025). To comply with Bangladesh's data regulatory policies, consent was waived for most components of the screening process and was obtained for the fundus images (retina and optic disc) because they constitute personal health information, are stored electronically, and their use in the future is anticipated. Before taking fundus images, screening staff described the reason, purpose, acquisition, use, confidential storage, deletion, and withdrawal mechanism for the fundus images and the required personal information. Informed consent was then obtained from the participants, including their signatures to verify their voluntary participation. The study was conducted in strict compliance with Declaration of Helsinki and ethical international and country-specific requirements. 2.2 Screening \& Care Process Timeline The program duration was planned for 10 months. This paper covers the program's initial stage and is current as of early April 2025. From October to December 2024, the investigators carried out a three-month-long creation and refinement of the screening model and electronic platform. Next, in December 2024, the model was tested and further enhanced during a pre-opening testing period for troubleshooting and initial data collection. Between January 2025 and July 2025, full-time data collection is planned with participant recruitment and screening then follow-up. Process The implementation of participant recruitment, data collection, screening, and follow-up was separated into twelve steps. This standardized framework ensured the integration of screening with data collection and follow-up eye care services. Fundus imaging was offered selectively to higher-risk patients with specific criteria including: random blood glucose \>7.9 millimoles per liter (mmol/L), blood pressure ≥140/90 millimeters of Mercury (mmHg), age ≥50 years, or clinical suspicion of retinal pathology based on patient report or slit lamp examination. Data Analysis Statistical analyses will be performed using Microsoft Excel. After data collection and cleaning, the investigators calculated descriptive statistics, including percentages, means, and standard deviations (SD), to analyze proportions, central tendency, and dispersion of demographic and diagnostic data. For statistical comparisons, the calculations for statistical significance will use 2-tailed t-tests with a threshold of p\<0.05 considered statistically significant. Eye condition diagnosis was based on the presence of a condition in either one or both eyes. Estimates of cost will initially calculate costs associated with the first 8000 screened individuals. The investigators also projected trends in both screening numbers and costs through a hypothetical 6-month time point by extrapolating screening numbers and variable costs of the program to 6 months. Fixed costs are non-recurring, volume-independent expenses, including program computers, blood pressure and blood glucose measurement devices, and fundus imaging and slit lamp equipment. Variable costs include consumables and operation fees based on unit usage, calculated by multiplying unit costs by the total screening, such as consumable testing costs, eyeglasses distribution, and office supplies. Per-person cost breakdown followed a dual-tier approach: fixed costs were evenly allocated among all screened individuals, while marginal cost reflected the average variable expenditure per screening.
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Population aging requires the implementation of sustained integrated strategies and programs to improve intrinsic capacity and delay disability in older adults. The +AGIL Barcelona program exemplifies a pragmatic, multicomponent intervention that effectively improves physical function by integrating health and community resources. This study aims to co-design, adapt, and scale up +AGIL to diverse socioeconomic areas in Barcelona, assessing its effectiveness and evaluating the process of progressive implementation. Methods: Multicenter, pragmatic, Stepped-Wedge Cluster Randomized Trial, performed in three Primary Care Centers in Barcelona (PCCs), involving older adults screened as frail by the Gérontopôle Frailty Screening Tool (total sample size=396, 198 per arm). After a co-design phase to adapt the protocol to each local context, the intervention will be introduced sequentially at each site, according to a randomly determined schedule, until all PCCs are exposed. The intervention, previously piloted in a different PCC, is based on a Comprehensive Geriatric Assessment followed by a 10-week tailored boost multicomponent intervention aligned with the Integrated Care for Older People (ICOPE) framework of the World Health Organization - WHO - (physical exercise being the core element). After three months, continuity of activation is pursued through the integration of community resources (public or private gyms, civic centers etc). The primary outcome will be. The investigators designed a mixed-methods evaluation, measuring physical performance improvement using the Short Physical Performance Battery (SPPB) as the primary quantitative outcome, plus a qualitative assessment of participants' experience and program implementation. Discussion: This study will provide relevant information on the implementation and impact of pragmatic, real-life interventions to improve intrinsic capacity and prevent disability in older adults.
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Healthy Volunteer
All currently existing longevity measures are surrogate endpoints that have not been prospectively validated against actual mortality and aging outcomes. The 100-Year Human Aging Study is a prospective, pragmatic, observational trial that addresses this gap by enrolling participants in comprehensive clinical screening and following them longitudinally until death to determine which measurements - alone and in combination - are predictive of mortality, serious disease, and functional disability. The study prioritizes dynamic measurements: the physiological, cognitive, social, and environmental capacities that change with aging and are most likely to carry predictive signal for mortality and functional outcomes. These include cardiorespiratory fitness (cardiopulmonary exercise testing with ventilatory threshold analysis), strength (grip, explosive power, functional movement), mobility and balance, neurocognitive performance, sensory function (vision, hearing, smell, light touch), and metabolic function (oral glucose tolerance, continuous glucose monitoring), in addition to other testing. Structural and imaging assessments include body composition and bone mineral density by DEXA, echocardiography, resting and stress electrocardiography, spirometry, retinal fundus photography, and vascular ultrasound. Laboratory measures are drawn on-site and processed through a CLIA-certified reference laboratory. Complete medical, surgical, family, social, occupational, and environmental histories are obtained at each visit. Participation ranges from single-service visits - including standalone DEXA, cardiopulmonary exercise testing, and physician consultation - to the full two-visit comprehensive screening battery. All participation pathways contribute clinical data to the longitudinal mortality and aging outcomes linkage framework regardless of service level. Participants are encouraged to return for repeat testing to build longitudinal health trajectories across the lifespan. At enrollment and across longitudinal follow-up, the study platform generates individualized investigational constructs including biological age estimate, predicted death age, and predicted cause of death profile. These are explicitly investigational hypotheses, not validated clinical standards. Their predictive validity relative to actual mortality, aging outcomes, and functional disability is a central scientific question this study is designed to answer - both for individual measures and for composite multi-system models. All data are archived in their highest-dimensional raw form to preserve the ability to apply future analytical methods retroactively. Participants are followed with periodic contact and offered repeat screening throughout the lifespan. Longitudinal outcomes ascertainment includes all-cause mortality, cause-specific mortality, incident serious health events, chronic disease diagnosis, functional independence, disability status, and health behavior change.
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The primary objective is to assess the efficacy, safety and satisfaction associated with the resurfacing treatment of perioral lines and wrinkles with the 2,910 nm mid-infrared Fiber Laser (UltraClear, Acclaro Medical) using both superficial epidermis ablation capabilities and the deep ablative and coagulative capabilities into the dermis for rejuvenation. Participants will receive up to two treatments spaced 6-8 weeks apart, followed by a 1-month and 3-month follow-up visit during which the device will be evaluated for its effectiveness defined as improvement addressing perioral lines and wrinkles utilizing multiple scales completed by the investigator and blinded Independent Photographic Reviewers (IPRs). Additionally, safety, subjective overall aesthetic improvement and satisfaction will be monitored and tracked.
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The objective of this study is to compare the surgical outcomes and parameters between cataract surgeries performed using the NGENUITY® 3D Visualization System (Alcon, TX, USA), a 3D imaging system, and the current standard binocular microscope in highly myopic patients. The focus is on evaluating the differences in depth of field and their impact on intraoperative parameters and outcomes. This prospective randomized controlled trial aims to enroll patients with both high myopia and cataracts requiring surgical intervention. Participants will be randomly assigned to undergo cataract surgery using the current standard binocular microscope (control group) or the NGENUITY® 3D Visualization System (Alcon, TX, USA) (study group). The study will compare intraoperative parameters, surgical outcomes, and the incidence of potential complications, including the frequency of microscope adjustments during surgery, total distance of adjustments during surgery, distance needed to achieve clear focus from the corneal surface to the posterior capsule, surgical duration, cumulative ultrasound energy during surgery, and occurrence of surgical complications.
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Healthy Volunteer
The proportion of older adults is on the rise in Canada, with the fastest growth recorded among those seventy years of age or older. The prevalence of cardiovascular risk factors (CVRF) such as diabetes, hypertension, and high cholesterol increases drastically with age. Individuals with CVRF often show impaired cognition, such as attention and memory deficits. In healthy older adults, exercise training and cognitive stimulation can help enhance cognitive performances. More precisely, combined intervention, including physical and cognitive training, has shown beneficial effects on cognition in older adults without cognitive impairment and with mild cognitive impairment. However, the effect of such programs on cognition in individuals with CVRF is not well documented. This project compares the effect of a physical exercise program, including aerobic and resistance training, alone or combined with cognitive training on cognitive performances and brain imaging outcomes in individuals with CVRF and healthy controls.
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Healthy Volunteer
This is a randomized controlled trial employing a type II hybrid implementation-effectiveness design. This will enable the investigators to evaluate both clinical outcomes and important processes that impact the implementation of the co-designed intervention. The intervention will consist of i) weekly interactive group-based health education sessions focused on: increasing knowledge, skills, and behaviours related to physical activity, healthy eating, and available community supports for older adults; this will include facilitated physical activity delivered by a certified exercise physiologist or certified personal trainer with experience and expertise working with older adults and interactive nutrition sessions; socialization to foster peer and community connections, co-learning, and decrease social isolation; and skill-building to support independence and quality of life; and ii) tailored system navigation support to increase access to and use of health and social services systems and address barriers or unmet needs This trial has a pragmatic design in the following ways: i) recruiting a population with broad inclusion criteria, reflective of the general population of older adults; ii) conducting the study in existing community settings (when in-person delivery is feasible) and virtually, in partnership with organizations already delivering virtual supports due to the pandemic; iii) leveraging existing resources, staff, and service delivery organizations in the intervention arm that are available in usual care; iv) supporting flexibility delivery of the intervention (e.g., tailoring to participant group needs), as would be done through other community programs in usual care; v) flexibility in adherence to the intervention, in ways that are consistent with usual care; vi) selecting primary and secondary outcomes that are participant-relevant; and vii) using intention to treat analyses based on all available data. The study will be delivered in community settings in urban neighbourhoods identified as areas of health inequities in the cities of Hamilton and Toronto, Ontario.
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Healthy Volunteer
The objectives of the study are to investigate the feasibility and pilot-test the benefits of the computer-based E-MinD Life (Semantic) program to promote everyday performance in healthy older adults, older adults with memory complaints, mild cognitive impairment (MCI) and mild dementia in Hong Kong using a randomised control trial. Three groups of participants will be recruited: (1) 15 healthy older adults, (2) 15 older adults aged over 65 years with memory complaints, or older adults aged over 65 years, meeting the diagnostic criteria for MCI with a Clinical Dementia Rating score of 0 or having mild dementia with a Clinical Dementia Rating score of 1. All participants will have no depression and other clinical conditions that may affect their cognition. Their scores on the Montreal Cognitive Assessment will be recorded. Their carers or family members are invited to participate.
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The goal of this clinical trial is to compare protein supplements in patients with kidney failure on dialysis. The main questions it aims to answer are: * To determine whether the supplementation of egg white protein pudding in a population of individuals with kidney failure on dialysis is feasible. * To determine whether egg white protein pudding supplementation improves serum albumin similar to other standard nutritional supplements. * To determine the effects of the egg white protein pudding on frailty measures, dietary intakes and analytes in the blood. Participants will receive either the egg white pudding (experimental) or control (Ensure plus) at the end of their dialysis treatments 3-days per week for 12 weeks.
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