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Showing 1-20 of 199 trials
NCT07037459
This trial will examine if maridebart cafraglutide as an adjunct to standard of care will lead to a reduction in heart failure (HF) events such as HF hospitalizations and urgent HF visits, cardiovascular (CV) deaths and improvement in HF symptoms in participants with HF with preserved ejection fraction (HFpEF) and HF with mildly reduced ejection fraction (HFmrEF) who are obese. This is a phase 3, global, multicenter, 2-part trial with a double-blind period and an open-label extension (OLE). The trial is event-driven, and Part 1 will conclude when approximately 850 primary endpoint events have occurred.
NCT03536975
Our main goal is to test a web platform accessible by computers, smartphones and tablets, addressed specifically to caregivers and people with mild cognitive deterioration or mild to moderate dementia providing added value services based on social networks, adapted interventions, clinic strategies and gamification to improve the quality of life of caregivers and people living with dementia (dyads) and permitting to leave in the community as long as possible. To evaluate the platform effectiveness and impact in dementia type disease affected people and caregivers a randomized, controlled, parallel, longitudinal is proposed. The objective will be to assess during 18 months aspects related to health of individuals (general aspect of health, neuropsychological, daily living functionalities, quality of life, treatment adherence, comorbidities ...), social aspects (improving dyad relationship…) and economics (cost-effectiveness of platform utilization), as well as satisfaction degree and usability of platform.
NCT02740634
This is a neuroimaging study designed to learn more about amyloid and tau burden in the brain of patients with typical and atypical Alzheimer's Disease and how burden may change over a one year period.
NCT03255174
The objective of this study is to evaluate the safety and hemostatic effectiveness of EVARREST as an adjunct to controlling mild to moderate soft hepatic parenchyma or soft tissue bleeding during open hepatic, abdominal, pelvic, retroperitoneal, and thoracic (non-cardiac) surgery in pediatric population.
NCT06182995
This pilot feasibility study will be a randomized control trial of usual care following Intensive Care Unit (ICU) discharge compared to the Anticipating Decline and Providing Therapy (ADAPT) screening and support intervention. The trial aims to enroll 120 older adults (age 60 or older).
NCT07497035
The aim of this study is to determine the impact of an equine therapy programme on the emotional state and autonomy of school-aged individuals with intellectual disabilities. Methodology: pre-post quasi-experimental study of a single group. Study subjects: individuals with intellectual disabilities enrolled at the Cambrils special education school. Variables related to stress (salivary cortisol), balance, autonomy, vital signs (blood pressure, heart rate, pulse oximetry) and clinical variables will be collected. Intervention: this will consist of 30 minutes of equine therapy and 30 minutes of activities related to horse care. All variables will be collected in an initial baseline measurement and some variables (stress, balance, autonomy and vital signs) will be monitored during and after the intervention.
NCT07476092
This randomized controlled trial aims to evaluate the effect of digital intelligence games on visual and cognitive performance in young individuals with intellectual disabilities. Participants aged 18-35 years receiving services from EÇADEM in Istanbul will be randomly assigned to either an intervention group receiving digital intelligence game training using the MentalUP application or a control group receiving routine services. Visual memory and cognitive performance will be assessed using the Benton Visual Retention Test and the Standardized Mini Mental Test at baseline, 3 months, 6 months, and 12 months. The study will investigate the short- and long-term effects of digital cognitive training on visual and cognitive functioning.
NCT07473479
The objective of this study was to evaluate whether the use of a virtual reality (VR) distractor reduces perceived pain during professional oral hygiene sessions in children with mild ID.
NCT07083154
The LIGHT-COG study is a 76-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial. A total of 420 type 2 diabetes patients with early dementia are randomized 1:1 to either the active treatment group (receiving subcutaneous injections of mazdutide weekly, with stepwise dose escalation to a maintenance dose per protocol) or the placebo group (receiving matched placebo injections). The primary objective is to evaluate the potential disease-modifying effects of mazdutide on cognitive dysfunction in type 2 diabetes.
NCT07449117
The purpose of this study is to investigate the immediate effects of non-invasive temporal interference stimulation (TIS) targeting the striatum on sentence processing and brain connectivity in patients with neurodegenerative diseases.
NCT07442448
The goal of this clinical trial is to evaluate the impact of Finerenone on myocardial remodeling in patients with diabetic kidney disease (DKD) and heart failure with a left ventricular ejection fraction (LVEF) ≥ 40%. The main questions it aims to answer are: 1. Does 6-month treatment with Finerenone significantly reduce myocardial fat infiltration (measured by MR Spectroscopy) and myocardial fibrosis (measured by extracellular volume fraction on CMR)? 2. Does Finerenone improve global left ventricular longitudinal systolic strain (GLS) and other structural remodeling indices in this patient population? Researchers will compare cardiac imaging parameters after 6 months of treatment to baseline values to see if Finerenone effectively reverses or slows down pathological cardiac changes. Participants will: 1. Take Finerenone (Kerendia) 10 mg or 20 mg orally once daily for a total of 6 months. 2. Undergo advanced cardiac imaging, including Cardiac Magnetic Resonance (CMR) and MR Spectroscopy (MRS), at the beginning of the study and after 6 months of treatment. 3. Receive regular clinical follow-up and blood tests to monitor safety (such as potassium levels and kidney function) and treatment efficacy.
NCT02414438
The study uses a randomized controlled study design of pediatric neurologists and developmental pediatricians and front-line (primary care) pediatricians to determine if use of FirstStepDx PLUS and Next StepDx PLUS are associated with higher clinical quality, less variability in clinical practice, and lower costs from decreased resource utilization. The Clinical Performance and Value Vignettes (CPV) used in this study simulate a clinical encounter for individuals with an atypical phenotype and clinical presentation indicative of a possible genetic disorder. We will measure the difference in combined diagnostic and treatment CPV® domain score post-intervention versus baseline comparing intervention and control groups
NCT06041152
The goal of this pilot, exploratory, clinical trial is to investigate the effects of psilocybin on synaptic vesicular density (SVD) as measured by the positron emission tomography (PET) radiotracer, 18F-SynVesT-1, in participants with amnestic Mild Cognitive Impairment (aMCI) and healthy participants. The investigators hypothesize that SVD levels in the brain will be higher following the ingestion of psilocybin in comparison to placebo, and that increases in SVD will be associated with improvements in cognition. 10 participants (6 with aMCI, and 4 sex and age matched healthy volunteers) will: * Be randomized to receive either: 1. Two 25 mg macrodoses of psilocybin separated by 1 week. 2. Two placebo doses separated by 1 week. * Receive a baseline 18F-SynVesT-1 PET scan, clinical, and neuropsychological assessments. * Receive a 18F-SynVesT-1 PET scan one week after the last dose of treatment. * Depending on available funds, receive a third PET scan at any time within 4 weeks of the screening visit to quantify tauopathy with the \[18F\]T807 radiotracer. * Receive clinical and neuropsychological testing 1, 4, and 12 weeks after the last treatment. Researchers will compare placebo vs. experimental groups to see if psilocybin will increase SVD, and if increases in SVD are associated with cognitive improvements.
NCT07429968
DSPPea34 (Shared Care Program for Children and Adolescents) is an experimental health program designed to provide rapid, guided care orientation for youth aged 6-18 when a first-line psychological follow-up is considered by a general practitioner or pediatrician. The program links hospital-based services and community providers by offering prompt contact and assessment by a registered nurse and/or psychiatrist, with structured feedback to the referring physician. Primary objective: To identify facilitators that support the engagement of all professionals involved in the care pathway of children and adolescents with psychological difficulties. Facilitators will be mapped across five stages of the pathway: (1) intake, (2) assessment, (3) orientation/referral, (4) inter-partner collaboration, and (5) discharge from the program. Results will be used to refine DSPPea34 specifications to inform broader implementation. Methods and study population (primary objective): A Delphi survey will be conducted with stakeholders directly interacting with families and youth within DSPPea34 (e.g., general practitioners (GP), pediatricians, program clinicians) as well as with program users. Secondary objectives and data sources: To describe (i) the sociodemographic and clinical characteristics of youth using DSPPea34 services and (ii) their care trajectories using quantitative methods. Data will be extracted from DSPPea34 records via the SPICO coordination file (the tool used to facilitate exchanges between the GP/pediatrician, DSPPea34, and the psychologist in charge of follow-up) and complemented by soliciting longitudinal outcome information from the referring physician based on DSPPea34 follow-up. Findings from this mixed-methods evaluation are expected to guide the optimization and potential scale-up of the DSPPea34 model.
NCT04565509
The primary goal of this project is to identify the best messaging and implementation strategies to maximize SARS-CoV-2 testing for children with intellectual and developmental disabilities (IDD) and their teachers to help ensure a safe school environment. Additionally, we will understand nationally the perceptions of COVID-19 and identify facilitators and barriers to help with the adoption of testing in other parts of the US and the necessary strategies to address other mitigation strategies including vaccination.
NCT06019182
This observational natural history study will follow individuals with MEHMO (Mental disability, Epileptic seizure, Hypopituitarism/Hypogenitalism, Microcephaly, Obesity) syndrome or an eIF2-pathway related disorder, who have symptoms such as intellectual delay, seizures, abnormal hormone and blood sugar levels, and decreased motor skills. No current treatment for these conditions is available. A major impediment to the testing of potential therapeutic interventions is the lack of well-defined outcome measures. This protocol seeks to identify biochemical and clinical markers to monitor disease progression, and better understand the natural history of these conditions. Any person diagnosed with MEHMO syndrome or related conditions, who can travel to the NIH Clinical Center can participate in this study. The study involves: * General health assessment and evaluation * Imaging studies * Laboratory tests * Collection of blood, urine, spinal fluid, skin biopsy.
NCT07422857
This study is to evaluate the efficacy and safety of \[18F\]-APN-1607 Injection in PET imaging for detecting AD-related cognitive impairment.
NCT07272902
This study is testing two different ways of treating atrial fibrillation (AF) in people who also have heart failure with mildly reduced or preserved heart function. Patients will randomly be assigned to either rhythm control using catheter ablation or rate control using medicines. The pilot phase will determine if a larger study can be successfully carried out to see which approach better improves survival, reduces hospitalizations, and enhances quality of life.
NCT07414303
The goal of this prospective, observational study is to (1) collaborate with our stakeholders to identify essential mTBI-information from existing evidence-based materials to develop a Post-mTBI Educational Resource for children with mTBI and their parents and (2) implement our Post-mTBI Educational Resource into clinical practice to determine feasibility, acceptability, and appropriateness at Baylor Scott and White (BSW) clinical sites that treat children with mTBI.
NCT06259201
The goal of this flexible single-subject design vagus nerve stimulation (VNS) study is to examine the behavioral, cognitive, and biorhythmic effects of VNS in children and adults with autism and developmental disabilities. The main aims are: * Pilot the creation of a profile for those who will respond to VNS with the long-term goal of designing clinical trials. * Examine the effects of VNS on a broad range of symptoms. Participants will select between 1, 2, or 3 months of daily VNS treatment and complete study visits each month.