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NCT ID: NCT06023589 Recruiting - Asthma Clinical Trials

A Study to Investigate the Efficacy and Safety of Tezepelumab Compared With Placebo in Children 5 to < 12 Years Old With Severe Asthma

HORIZON
Start date: August 24, 2023
Phase: Phase 3
Study type: Interventional

To assess the efficacy and safety of tezepelumab in pediatric participants with severe uncontrolled asthma on medium to high-dose inhaled corticosteroids (ICS) and at least one additional asthma controller medication with or without oral corticosteroids.

NCT ID: NCT06023576 Recruiting - Breast Cancer Clinical Trials

A Study of Blood Pressure Control During Cancer Treatment

Start date: August 18, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study to find out whether an intensive approach to treating high blood pressure during breast cancer treatment is safe and more effective than standard blood pressure treatment at lowering blood pressure levels and the risk of cardiotoxicity in patients with cancer. Other studies have shown lowering blood pressure improves the health of patients. However, these studies have not included people with cancer. The PROTECT trial is testing a treatment strategy regarding intensive versus standard SBP goals, and is not testing specific medications.

NCT ID: NCT06023563 Completed - Clinical trials for Autism Spectrum Disorder

Effect of Virtual Reality-based Training on Balance and Walking in Youth With Autism Spectrum Disorder

Start date: May 15, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to assess the effect of short-term (3 days/week for 2 weeks) Virtual Reality (VR) active video gaming intervention on static and dynamic balance, versus traditional balance training exercises, in youth with ASD. The participants in the intervention group will engage in VR active video gaming using the Nintendo Switch Sports under supervision via Zoom for 6 sessions occurring over 2 weeks, from their home. While, the participants in the control group will engage in standard physical therapy exercises for balance and walking under supervision via Zoom, for 6 sessions occurring over 2 weeks, from their home. Their balance and walking will be assessed 3 times, 3-5 days before the intervention, 3-5 days after the intervention and 4-weeks after the intervention. - Participants static balance will be assessed by standing on pressure mat, under 2 conditions, eyes open and eyes closed for 30 seconds each. - The Pediatric Berg's balance Scale (PBS), a 14-point scale containing everyday activities, will be used as a clinical measure for assessing the static and dynamic balance. - 13-infra-red camera motion capture system, Qualisys, will be used for assessing the walking. The difference in the balance and walking parameters will be assessed and compared.

NCT ID: NCT06023537 Recruiting - Obesity Clinical Trials

Using Technology to Investigate Lapses in a Weight Loss Program Among Individuals With Overweight and Obesity

Start date: July 11, 2023
Phase: N/A
Study type: Interventional

Approximately 70% of American adults have overweight/obesity, which increases risk of major medical issues and preventable death (Abdelaal et. al, 2017). Many individuals with overweight/obesity attempt to lose weight through behavioral strategies, e.g., adopting a reduced-calorie diet and/or increased physical activity. However, it is exceedingly difficult to consistently adhere to a reduced-calorie diet and high levels of physical activity; as such, most individuals attempting to lose weight via these methods experience repeated instances of non-adherence, i.e., dietary and physical activity lapses. These lapses are a core driver of weight loss failure, undermining individuals' ability to achieve weight control (Forman et al, 2017). As such, it is important to understand what predicts these lapses, which in turn allows for better lapse prevention. The current study proposes to measure these risk factors in an ecologically valid manner, i.e., in the moment they occur and in the context of individuals' everyday lives, using advanced technology. Specifically, the current study will use ecological momentary assessments (EMA; brief, repeated surveys delivered in one's natural environment, typically via a smartphone) and sensor technology (e.g., Fitbit and sensors on smartphone devices) to measure momentary risk factors of dietary and physical activity lapse, as well as the lapses themselves. Findings from this research project will lay the groundwork for a sophisticated just-in-time adaptive intervention (JITAI), a tailored, personalized intervention that targets momentary risk factors (e.g., cravings) via in-the-moment support, thereby reducing lapse occurrence and improving adherence to behavioral weight control prescriptions.

NCT ID: NCT06023511 Completed - Clinical trials for ICU Acquired Weakness

Safety and Efficacy of the MyokinE100 (CL-EMS Alpha) Device in Inducing Visible Muscle Contraction in Healthy Volunteers

Start date: August 22, 2023
Phase: N/A
Study type: Interventional

Every patient admitted to the Intensive Care Unit (ICU) is at risk of developing "Intensive Care Unit Acquired Weakness" (ICUAW). ICUAW is associated with increased rate of mortality, prolonged duration of mechanical ventilation, ICU and hospital stay, rehabilitation time, and reduced quality of life. Currently, there is no effective treatment for ICUAW. Health Discovery Labs is conducting a research study to evaluate the safety of using an innovative experimental medical device in ICU settings that could mitigate ICUAW. This study is meant to demonstrate whether this new device interferes with standard ICU monitors.

NCT ID: NCT06023459 Not yet recruiting - Clinical trials for Substance-Related Disorders

Extended-release Buprenorphine Compared to Sublingual Buprenorphine in Rural Settings (RXR)

RXR
Start date: July 1, 2024
Phase: Phase 3
Study type: Interventional

This pilot trial will explore the feasibility, acceptability, and effectiveness of the most recently approved formulation of injectable extended-release buprenorphine (XR-BUP) for treatment of opioid use disorder (OUD) in rural settings. We will randomize 144 eligible individuals with moderate to severe OUD in a 2:1 ratio to one of two medication conditions: (1) XR-BUP (128mg target), administered every 4 weeks or (2) SL-BUP (16mg-24 mg/day target).Participants will receive study medication treatment for the 14 week-intervention period, including an initial ~2-week period of induction/stabilization. The study will use a mixed-methods approach (participant assessments, study medication records, qualitative interviews) for assessing feasibility and acceptability, and results will include patient outcome data on the comparative effectiveness of XR-BUP versus SL-BUP for patients with OUD in rural settings.

NCT ID: NCT06023446 Enrolling by invitation - Alzheimer Disease Clinical Trials

Can (Optical Coherence Tomography) Pictures of the Retina Detect Alzheimer's Disease at Its Earliest Stages?

Start date: September 29, 2023
Phase:
Study type: Observational

Years before someone experiences the symptoms of Alzheimer's disease, a compound called amyloid beta (Aβ) builds up in the brain. Excess Aβ - directly or indirectly - causes many of the symptoms of Alzheimer's dementia. However, recent studies of the FDA-approved drugs lecanemab (Leqembi®) and aducanumab (Aduhelm®) indicate that removing Aβ from the brain doesn't stop Alzheimer's. Clearly, there are other problems that need to be fixed. The investigators are interested in the cause of Aβ buildup. Non-neuronal support cells, called glia, keep neurons healthy by regulating water and nutrient levels for the neurons. They also help clear Aβ away from neurons. Maybe Aβ builds up when glia are unhealthy. Glia are very hard to study in the brain. Luckily, the light-sensing part of the eye - the retina - is an extension of the brain. The investigators study glia in the retina to learn about glia in the brain. To study retinal glia, the investigators take pictures of the retina with optical coherence tomography (OCT). OCT is safe, painless, and is used in many eye clinics to look at the structure of the retina. When the investigators take OCT pictures under a bright light, and compare those to OCT pictures collected in darkness, it gives the investigators information about glial function. In a study published in 2020 ("Optical coherence tomography reveals light-dependent retinal responses in Alzheimer's disease") the investigators showed that this functional OCT measurement was different in people with Alzheimer's dementia, compared to age-matched healthy adults. The goal of this observational study is to compare people at a pre-dementia stage of Alzheimer's disease to people who do not have any signs at all of Alzheimer's disease. By "pre-dementia stage", the investigators mean people who are either cognitively normal, or have mild cognitive impairment, but have had a medical test that shows the chemical beginnings of Alzheimer's disease. Members of the comparison group will also be cognitively normal, or have mild cognitive impairment, but had a medical test that shows utterly no signs of Alzheimer's disease. The main question this study, is whether functional OCT can tell these two groups apart. If so, that would: - Help build the case for glial health being important in the earliest stages of Alzheimer's, which in turn could lead to new treatment strategies, and - Suggest that functional OCT might be used as an early (pre-dementia) screening test for Alzheimer's disease Participants will: - undergo a brief eye exam (the investigators will not dilate pupils for this study) - undergo a paper-and-pencil cognitive test (to help verify "normal" or "mild cognitive impairment" status) - take brief one-page survey to collect demographic information (like age) - permit limited access to pre-existing medical or research records (to verify the presence/absence of the chemical beginnings of Alzheimer's disease) - take several OCT pictures of both eyes, in light and after 2 minutes of darkness (several rounds of images are taken) The expectation is that all study procedures will fit within 2 hours of one day.

NCT ID: NCT06023407 Enrolling by invitation - Alzheimer Disease Clinical Trials

Feasibility of Improving Glycemia With Heat Therapy to Prevent AD

FIGHT-AD
Start date: February 27, 2024
Phase: N/A
Study type: Interventional

The investigators will determine if heat therapy can improve blood (Aim 1) and brain (Aim 2) glucose metabolism in cognitively healthy older adults (65+) who are at risk for AD. The investigators will also examine the degree to which changes in blood and brain glucose metabolism track together and explore several additional potential mechanisms that are critical to understanding the brain benefits of heat therapy (Aim 3). These aims will provide a comprehensive understanding of the impact of heat therapy on whole body metabolic function and brain health.

NCT ID: NCT06023394 Recruiting - Inguinal Hernia Clinical Trials

Laryngeal Mask Airway in Laparoscopic Hernia Repair

Start date: March 27, 2023
Phase: N/A
Study type: Interventional

This prospective randomized study will evaluate the effectiveness of laryngeal mask airway (LMA) versus endotracheal intubation (ETT) for patients undergoing laparoscopic inguinal hernia at CMH.

NCT ID: NCT06023368 Enrolling by invitation - Pediatric Cancer Clinical Trials

Reducing Port Access Pain and Clinic Wait Time: An Evaluation of EMLA Cream Versus nüm™ Vapocoolant Spray

Start date: December 23, 2023
Phase: Phase 4
Study type: Interventional

The goal of this clinical trial is to compare a sterile vapocoolant spray to EMLA cream in children with access ports. Participants will receive either the spray or cream prior to port access and rate pain on a scale. Researchers will compare spray vs cream to see if the spray is as effective as the cream in reducing pain associated with port puncture.