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Showing 1-20 of 271 trials
NCT05713071
In the proposed study, we will be evaluating the effects of pylorus sparing antral myotomy alone, without concomitant endoscopic sleeve gastroplasty (ESG), on weight loss for subjects undergoing the procedure with a history of obesity. This is referred to as Bariatric Endoscopic Antral Myotomy (BEAM). To better understand treatment effects, we will track weight loss, gastric emptying with gastric emptying breath tests (GEBT), and gut hormones (i.e. ghrelin). This pilot, single-center, randomized, controlled, clinical study aims to assess the safety, tolerability, and short-term efficacy of BEAM, in addition to exploring its impact on gastric physiology. This will also provide data that may be used in designing a larger clinical trial that could be submitted for NIH grant funding.
NCT07082218
Following adolescent concussion, poor sleep health is common and relates to the development of persisting post-concussion symptoms, and uninjured adolescents (independent of concussion) also commonly experience sleep insufficiency. Given the sparse guidance that exists for clinicians to provide evidence-based sleep health recommendations for adolescents with a concussion, the primary objectives of this prospective randomized clinical trial of adolescents with a recent concussion are to discover if a multidimensional and prescriptive sleep health intervention leads to: 1) faster symptom resolution time, better sleep quality, or longer sleep duration; and 2) improved sleep habits, mental health, or academic engagement, relative to standard-of-care post-concussion sleep health guidance. Findings from this research will provide the basis for more precise sleep health recommendations for adolescents who experience a concussion.
NCT07059858
Many neurodevelopmental, psychiatric, and medical disorders are commonly associated with intellectual disability. The presence of neurodevelopmental and psychiatric (NDP) comorbidities has been reported to negatively impact the clinical outcomes of bowel or bladder dysfunction. Pediatric bladder and bowel dysfunction (BBD) is a common but underdiagnosed condition characterized by a spectrum of lower urinary tract symptoms and is often associated with constipation. Lower urinary tract symptoms include dysuria, urinary urgency, daytime incontinence, and enuresis, while bowel symptoms include constipation and encopresis. Most BBD cases are functional and not neurogenic in origin. In children with special needs, all types of urinary incontinence are reported to occur more frequently compared to children without developmental or behavioral disabilities. Intellectual disability (IQ \<70) is also identified as a significant risk factor for urinary incontinence, with prevalence increasing as IQ decreases. In these children, lower urinary tract symptoms such as overactive bladder, dysfunctional voiding, and low fluid intake are also observed. Furthermore, according to support plans and medical records, 94% of individuals with intellectual and multiple disabilities experience constipation. Interestingly, lower levels of intellectual disability (profound and severe ID) have been associated with a lower prevalence of constipation. Although there are studies in the literature examining bladder and bowel functions separately in specific diagnostic groups with intellectual disability, the number of studies that assess bladder and bowel functions together in children with any form of intellectual disability is limited. Moreover, to our knowledge, there is no study in the literature that evaluates bladder and bowel functions along with child participation and parental quality of life in children with intellectual disability. Based on this gap in the literature, the aim of our study is to examine bladder and bowel functions, participation, and quality of life in children with intellectual disability
NCT06342440
This study aims to develop a highly sensitive, specific, and cost-effective blood assay for early detection of colorectal adenomas and cancer, using advanced machine learning and state-of-the-art biological analyses.
NCT07624448
The goal of this study is to help children with autism and a co-occurring intellectual disability and their families learn practical strategies for managing issues like irritability, aggression, and other challenging behaviors. The main objective of this study is: To adapt current Regulating Together materials to create an outpatient group program for emotion dysregulation in autism and co-occurring intellectual disability (ASD + ID) that will improve psychosocial outcomes for youth with ASD + ID.
NCT06710483
This randomized clinical trial is an innovative pilot project to determine the acceptance and impact of telehealth visits on youth with intellectual and developmental disabilities (IDD), their caregivers, and dentists. The impact of the telehealth visit will be assessed by: 1) determining if the intervention group was more likely to achieve the set goals and 2) Likert scaled surveys of satisfaction of caregivers and dentists. Qualitative data will be collected to inform improvement on clinical interviews by the dentist.
NCT07586722
This study aims to investigate the effects of a 12-week pickleball training program on cognitive and motor outcomes in adolescents with mild intellectual disability. Pickleball is a low-impact racket sport that combines elements of tennis, badminton, and table tennis, and is considered suitable for promoting both physical and cognitive engagement. A total of 32 students aged 14-18 years with mild intellectual disability, enrolled in a special education vocational school, will participate in the study. Participants will be assigned to either an intervention group (n = 16) or a control group (n = 16). The intervention group will receive structured pickleball training three times per week for 12 weeks, while the control group will continue their regular educational activities without additional intervention. Cognitive outcomes will be assessed using standardized computerized tests, including sustained attention (Mackworth Clock Test), visual-spatial memory (Corsi Block Test), selective attention and reaction (Change Detection Test), and working memory (Digit Span Test). Motor outcomes will be evaluated using grip strength, balance assessments, and the Bruininks-Oseretsky Test of Motor Proficiency (BOT-2). Assessments will be conducted at four time points: baseline (pre-test), mid-intervention (6th or 7th week), post-intervention (week 12), and follow-up (4-6 weeks after completion). The primary aim is to determine whether structured pickleball training improves cognitive performance and motor skills in adolescents with mild intellectual disability. Findings from this study are expected to contribute to evidence-based physical activity interventions for individuals with intellectual disabilities and to expand the literature on the role of racket sports in cognitive and motor development.
NCT06628999
Physical activity for healthy ageing is an important feature and the possibility to detect practical solutions to solve the need for feasible health promotion interventions to reduce health disparities and wellbeing in individuals with intellectual disability (ID) is an open question. In this perspective, vision has a remarkable role in spatial cognition and organization, especially in individuals with ID. Therefore, the aim is to investigate the effectiveness of a perceptual-vision training program on cognitive performance (inhibitory control) and physical fitness (balance, agility and muscular strength) in adults with ID throughout 16 weeks. Participants with mild ID will be randomly divided into a perceptual-vision training group, a perceptual-vision training-detraining group and a control group. Cognitive performance and physical fitness will be assessed at baseline, mid and at the end of 16 weeks. In conclusion, a visual training program may present the potentiality to impact various health domains, from cognition to physical performance in individuals with intellectual disabilities, promoting their healthy aging.
NCT04240561
This current translational project, funded by NIH, aims to better understand the impact of various signal modification strategies for older adults with Alzheimer's dementia and its potential precursor, known as amnestic mild cognitive impairment. The investigators hypothesize that adults with Alzheimer's dementia represent an extreme case of restricted cognitive ability, such that very low working memory capacity and overall reduced cognitive capacity will limit benefit from advanced signal processing. Thus, the investigators hypothesize that adults with Alzheimer's dementia will receive greater benefit from acoustically simple, high-fidelity hearing aid processing that minimally alters the acoustic signal.
NCT07105800
This pilot study investigates the effects of a music-based dance intervention on executive function and physical performance in middle-aged and older adults with cognitive impairment. Dance, as a form of dual-task training, integrates music, rhythmic movement, and cognitive-motor coordination. When combined with group interaction and partner-guided physical cues, it has the potential to enhance both cognitive and motor functions simultaneously. The intervention features a simple, structured dance sequence designed to stimulate rhythm, attention, and coordination through music-based movement. This study aims to evaluate the feasibility and preliminary efficacy of this approach in improving executive function and lower limb physical performance among individuals with cognitive impairment.
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.
NCT06105892
This study will test a portable virtual reality (VR) system with integrated eye tracking called Virtual Eye Rotation Vision Exercises (VERVE). The proposed VERVE platform will deliver vergence therapy in an automated manner. This research will involve 30 non-traumatic brain injury (TBI) binocularly normal (BNC) Veterans and 50 post-traumatic convergence insufficiency (PTCI) Veterans who will undergo Active and Sham therapy (equally divided groups) to determine the effectiveness of VERVE vergence therapy.
NCT07279714
This pilot study will evaluate the safety and tolerability of the natural health product, fisetin, in older adults with mild cognitive impairment or mild Alzheimer's disease dementia.
NCT06997198
The primary goal of this study is to investigate the efficacy of deutetrabenazine treatment of TD in this previously untreated patient population. Compare movement disorder deutetrabenazine treatment response in persons with IDD to response seen in patients without IDD treated with deutetrabenazine in other treatment settings (per literature review). Compare global deutetrabenazine treatment response with validated instruments. In addition, we plan to: * Assess the safety of deutetrabenazine in the treatment of TD in persons with IDD. * Assess change in Activities of Daily Living (ADLs) in persons with IDD and TD treated with deutetrabenazine, utilizing a validated ADL instrument. * Assess change in Quality of Life (QOL) in persons with IDD and TD treated with deutetrabenazine, utilizing a validated QOL instrument. * Assess caregiver burden with a validated caregiver burden instrument. In this study, 25 participants with IDD and TD will undergo Deutetrabenazine treatment for 24 weeks. The participants will be seen for a total of 5 visits: at baseline, and at follow up visits at 3 weeks, 6 weeks, 12 weeks, and 24 weeks. This study does not include a comparison group. Therefore, researchers will compare the response of the study participants to deutetrabenazine treatment with those from a previous reported work that resulted in the FDA approval of this medication. This will be an open-label, Phase 4 study.
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.
NCT06669546
This study aims to explore a non-invasive way to improve memory and slow cognitive decline in older adults by enhancing sleep quality. Dementia, a leading cause of death worldwide, is often associated with disturbed sleep, particularly the loss of deep, slow-wave sleep (SWS). SWS is important for memory and clearing waste from the brain. Poor SWS can worsen memory loss and allow harmful waste to build up, which may increase the risk of dementia. The investigators are testing whether phase-locked auditory stimulation (PLAS) can improve SWS in people at a mild stage of cognitive impairment. PLAS uses short sounds played at specific moments to strengthen slow-wave brain activity during sleep. The investigators previous laboratory based research has shown that this can improve memory and help with clearing waste from the brain. Now, the investigators want to test this in a real-world setting, over a longer period, which is unfeasible in a laboratory setting. In this study, 60 older adults will use home-use devices that deliver either real or sham (soundless) PLAS across two different 4-week periods. Memory will be tested using engaging "serious games." Before and after each experimental period, blood samples will be taken to measure dementia-related markers, and cognitive batteries will be performed. The investigators expect that PLAS will improve sleep, and that this will have a downstream effect on memory and brain clearance, potentially slowing the process of cognitive decline. If successful, this could lead to the development of an affordable treatment that helps people maintain brain health and prevent dementia.
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).
NCT05651919
Type 2 diabetes (T2D), especially when associated with metabolic syndrome (MS) is at high risk to develop heart failure with preserved ejection fraction (HFpEF) or heart failure with mildly reduced ejection fraction (HFmrEF), and the specific impact of T2D+MS in cardiac function impairment is usually known as "diabetic cardiomyopathy" (DC). Cardiac remodelling (ie hypertrophy) and subtle myocardial dysfunction are highly prevalent in T2D+MS but not specific enough to predict further HFpEF or HFmrEF. Also, current biomarkers can identify but do not predict HFpEF or HFmrEF in T2D patients; Furthermore, specific biomarkers are needed. Peripheral blood mononuclear cells (PBMC) obtained from a peripheral blood sample can provide insights from calcic and inflammatory pathways, and may identify more specific molecular signatures shared between T2D+MS and HFpEF.