Automated Medication Platform With Video Observation and Facial Recognition to Improve Adherence to Antiretroviral Therapy in Patients With HIV/AIDS
This is a 90-day medication adherence study testing the HiDO is an automated AI-driven direct observation medication adherence platform, which is a 510K-exempt, Class I medical device with 24 people with HIV/AIDS, ages 18 to 55, who are currently taking ART and reporting less than 100% adherence. The aims of the study are to see whether the device can achieve >95% ART adherence among all participants averaged over 90 days and to perform usability testing using the System Usability Scale and Net Promoter scores.
NCT05454514 — HIV Infections
Status: Completed
http://inclinicaltrials.com/hiv-infections/NCT05454514/
Pragmatic Implementation of the Improving Canadians' Walking Aids Skills, Learning, and Knowledge (ICanWALK) App-based Walking Skills Training Program
Walking aids (WA), such as crutches, canes, and walkers allow individuals to move independently after lower body impairment. Improper WA use may lead to upper body discomfort, pain, or injury. Improper WA use has been associated with increased risk of falls, which may result in traumatic brain injury or even death. WA-related accidents and injuries may not only affect an individual patient's quality of life; they may also increase healthcare system resource use and caregiver burden. WA-related injuries may be preventable if WA are properly fit and sufficient training is provided to the WA user. Smartphone applications (apps) are widely used technologies that have been used to improve health outcomes in populations of healthy and chronically ill individuals. We have developed an app that can be used to teach WA users how to properly fit and use their devices. This app is called Improving Canadians' Walking Aid skills, Learning, and Knowledge (ICanWALK©). The development of the Walking Aids Skills Measurement Test (WASMT ©) allows for the objective measurement of how well an individual uses their walking aid. It is important to develop such a measurement in order to see whether interventions such as mobile applications change a walking aid user's ability to walk with their device. This 12-item objective evaluation measures the ability of an individual to use their walking aid in different settings, while picking up an object off the ground, navigating stairs, or encountering terrains such as gravel or grass. Three hypotheses will be explored through this clinical trial. Hypothesis 1: Patients who use the ICanWALK© app while using crutches will have improved balance confidence compared to the control group. Hypothesis 2: Patients who use the ICanWALK© app while using crutches will have improved balance, improved mobility, less pain, and fewer falls compared to the control group. Hypothesis 3: The WASMT © will have an inter-rater reliability of 70% (k=0.85).
NCT05347875 — Lower Limb Fracture
Status: Not yet recruiting
http://inclinicaltrials.com/lower-limb-fracture/NCT05347875/
Validating Clinical Decision Aids for the Assessment and Management of Febrile Infants Presenting to Emergency Care in the UK and Ireland.
Febrile infants under 3 months of age represent a high risk group for invasive bacterial infection (IBI) and UTI with approximately 10-20% having bacteremia, meningitis or urinary tract infection. The assessment of febrile infants is challenging, and current National Institute for Health and Care Excellence (NICE) guidance advocates a cautious approach with the majority of infants requiring a septic screen, parenteral broad-spectrum antibiotics, and admission to hospital. Internationally there is significant variation in the approach to febrile infants with European and USA guidance advocating a tailored approach based on clinical features and biomarker testing. None of the available clinical decision aids (CDA) have been validated in a UK and Irish cohort. The main objectives of the FIDO study are to report performance accuracy of CDA in a UK (United Kingdom) and Irish population, and describe the aetiology of SBI in young infants. The FIDO study is a prospective observational cohort study of infants under 90 days of age with a measured fever greater than 38 Centrigrade within 24 hours of presentation. The study will run for approximately 12 months and recruit a minimum of 1000 participants.Symptoms, clinical features and laboratory results will be recorded on an electronic case report form (CRF) by the attending clinician.
NCT05259683 — Sepsis
Status: Completed
http://inclinicaltrials.com/sepsis/NCT05259683/
Comparison of Hearing Aid Fitting Outcomes Between Self-fit and Professional Fit for MDHearing Smart Hearing Aids
Hearing aids are commonly used to help people with hearing loss hear better in daily listening environments. MDHearing Smart hearing aids are designed to use the MDHearing app to adjust hearing aids to each individual's hearing loss. This study intends to show whether the MDHearing Smart hearing aids can be fitted by each user reliably and if each user can use the MDHearing app on their smartphone or tablet to make adjustments to achieve good aided benefit, which will be compared to those fitted by audiology professionals. This study includes three components: human factor study, self-fit study, and professional-fit study. The information obtained will be useful for both audiology professionals and people with impaired hearing.
NCT05165121 — Hearing Loss
Status: Completed
http://inclinicaltrials.com/hearing-loss/NCT05165121/
A Virtual Reality Platform Simulating Visual Impairment for Testing of Electronic Travel Aids and Performing Orientation and Mobility Training
In this study, the study team utilize virtual reality (VR) to simulate visual impairments of different types and severity in healthy subjects. The platform implements three of the most widespread forms of visual impairment in the United States (US): age-related macular degeneration (AMD), diabetic retinopathy (DR), and glaucoma, each with three levels of severity, (mild, moderate, and severe). At present, glaucoma is further developed toward a multidimensional visual impairment simulation. The platform is utilized: i) to provide a safe, controllable, and repeatable set of environments for development and preliminary testing of electronic travel aids (ETAs) in a variety of conditions (i.e., using the ETA to navigate in the immersed environment); and ii) to equip blind and low vision (BVI) professionals, inclusive of orientation and mobility (O&M) instructors, with a controlled, tunable training platform for skill/capacity building, assessment, and refinement of O&M techniques, as well as visually impaired trainees with a safe and immersive environment to improve their O&M skills and learn novel techniques. Two sets of hypothesis-driven experiments are proposed to assess the feasibility of the platform with respect to these two objectives.
NCT05135195 — Glaucoma
Status: Completed
http://inclinicaltrials.com/glaucoma/NCT05135195/
The Dreamer Girls Project: Adaptation of SISTA/SIHLE for HIV/AIDS and Substance Abuse Prevention Among Black Adolescent Girls
The study will use focus group methodology in the formative evaluation phase. Focus group methodology provides a rich source of data and understanding of phenomena by allowing the researcher to examine the interaction among participants
NCT05014074 — HIV/AIDS
Status: Not yet recruiting
http://inclinicaltrials.com/hiv-aids/NCT05014074/
Investigation of the Impact of Inducible, Replication-competent Latent HIV-1 as an Impediment to HIV/AIDS Cure in the Context of Sustained Viral Suppression
In 2014, the Joint United Nations Program on HIV/AIDS (UNAIDS) issued treatment goals for Human Immunodeficiency Virus (HIV), the 90-90-90 target. It is important to track success results at each stage of the HIV continuum of care to evaluate progress towards the 90-90-90 target. Although ART can suppress HIV-1 infection to undetectable levels of plasma viremia, HIV DNA integrate and persist in resting CD4+ T cells. Most of the HIV DNA in these cells is defective and cannot cause infection. However, latent HIV-1 genomes that encode replication-competent virus can resurface once ART is discontinued. This latent reservoir is believed to be the largest impediment to a cure by ART alone. There is need for expansion of research examining HIV latency in the context of sustained viral suppression with an eye towards developing a possible cure regimen that could be used on a large scale. To date, there have been no systematic studies to quantify the latent reservoir in virally suppressed HIV-infected patients in Africa. Detecting how much of the inducible virus is left in the human body after ART poses the greatest challenge to fully curing HIV. This study is designed to enroll 222 virally suppressed HIV infected men and women, who will be prospectively followed to document antiviral cocktail, viral suppression and incidences of rebound, measure the size of the latent HIV reservoir and examine the immunological correlates of the latent reservoir. Data generated through this study will provide a clear framework for high-burden countries to reduce gaps at each stage of the HIV continuum of care, maximize linkage, retention and health outcomes.
NCT04938518 — HIV-1-infection
Status: Recruiting
http://inclinicaltrials.com/hiv-1-infection/NCT04938518/
The Efficacy of an Artificial Intelligence Platform to Adapt Visual Aids for Patients With Low Vision: a Randomised Controlled Trial
According to the WHO's definition of visual impairment, as of 2018, there were approximately 1.3 billion people with visual impairment in the world, and only 10% of countries can provide assisting services for the rehabilitation of visual impairment. Although China is one of the countries that can provide rehabilitation services for patients with visual impairment, due to restrictions on the number of professionals in various regions, uneven diagnosis and treatment, and regional differences in economic conditions, not all visually impaired patients can get the rehabilitation of assisting device fitting. Traditional statistical methods were not enough to solve the problem of intelligent fitting of assisting devices. At present, there are almost no intelligent fitting models of assisting devices in the world. Therefore, in order to allow more low-vision patients to receive accurate and rapid rehabilitation services, we conducted a cross-sectional study on the assisting devices fitting for low-vision patients in Fujian Province, China in the past five years, and at the same time constructed a machine learning model to intelligently predict the adaptation result of the basic assisting devices for low vision patients.
NCT04919837 — Artificial Intelligence
Status: Recruiting
http://inclinicaltrials.com/artificial-intelligence/NCT04919837/
Using Headphone Presentation to Investigate Compression Strategy Modifications in Hearing Aids for Moderate-to-severe Hearing Loss
The stimuli consist of speech in quiet, speech in noise, reverberant speech, and music recorded with different hearing aid settings, post-processed for headphone presentation and incorporated in an online sound survey. Participants will receive tablets and headphones to conduct a sound quality rating at home. The survey will involve a training session and within-subject repeated measures. Stimuli will be randomized.
NCT04882709 — Hearing Loss
Status: Terminated
http://inclinicaltrials.com/hearing-loss/NCT04882709/
The Effect of Personal Protective Aids on Hypertension and Diabetes in People Exposed to High Levels of Air Pollution
This is a randomized controlled trial to evaluate personal protective aids (air purifier and N95) as a therapeutic measure in people with hypertension and diabetes exposed to high levels of PM2.5 in India.
NCT04854187 — Diabetes Mellitus
Status: Recruiting
http://inclinicaltrials.com/diabetes-mellitus/NCT04854187/