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NCT ID: NCT06403644 Recruiting - Clinical trials for Physiological Wellness

Evaluating the Technology and Assessing the Biological Effects of Commercially Available PhotoBioModulation Devices

Start date: March 11, 2024
Phase: N/A
Study type: Interventional

Photobiomodulation therapy (PBMT) involves applying non-ionizing forms of light from sources including lasers, LEDs, and broadband light, in the visible and near infrared spectrum, to the body to enhance performance, stimulate healing, modulate recovery, and improve health. The investigators will conduct a single-blinded randomized-control trial with sham control to investigate the effectiveness of providing PBMT in a military population, translating this cutting-edge research to application in the operational setting.

NCT ID: NCT06403605 Recruiting - Diabetic Foot Ulcer Clinical Trials

Bioresorbable Glass Fiber Matrix in the Treatment of Diabetic Foot Ulcers

BGWM
Start date: August 29, 2022
Phase: N/A
Study type: Interventional

This study is a prospective, multi-center, randomized controlled trial designed to collect patient outcome data on 2 commercially available SOC treatments for Diabetic Foot Wounds.

NCT ID: NCT06403345 Recruiting - Alzheimer Disease Clinical Trials

A Green Activity Prescription Program for Hispanic/Latino (Latinx) Persons Living With Dementia

GAP-H
Start date: July 15, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to test the Green Activity Program that was designed with Hispanic/Latino people living with memory challenges and their study partners to see if it can be done and if they enjoy the program. "Green activities" are nature activities that the person enjoys and can be done with other people or pets. For example, dog walking, hiking, outdoor yoga, and gardening are all green activities. The purpose of the program is to help people living with memory challenges participate in nature activities they enjoy. The goal of the program is to help people stay active and improve their health and well-being.

NCT ID: NCT06403098 Recruiting - Healthy Clinical Trials

The Effects of External Nasal Dilator Strips on Sleep and Cardiovascular Health

Start date: May 2, 2024
Phase: N/A
Study type: Interventional

The goal of this interventional study is to learn if wearing an external nasal dilator strip while sleeping changes objective and perceived sleep quality, immediate post-waking blood pressure, and immediate-post waking heart rate variability.

NCT ID: NCT06402773 Recruiting - Vasectomy Clinical Trials

A Safety Study in Human Subjects Evaluating the Use of the Signati System for Vasectomy

Start date: April 5, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the safety and effectiveness of the Signati SeparoTM System when used in general surgical procedures where ligation and division of vessels are desired, such as the vas deferens. This study will evaluate the Signati SeparoTM System as a vasectomy device.

NCT ID: NCT06402721 Recruiting - Clinical trials for Chronic Kidney Disease

A Study to Learn About How BAY 3283142 Moves Into, Through, and Out of the Body After a Single Dose in Participants With Reduced Liver Function Compared to Participants With Normal Liver Function

Start date: May 17, 2024
Phase: Phase 1
Study type: Interventional

Researchers are looking for a better way to treat people who have chronic kidney disease (CKD). CKD is a condition in which the kidneys' ability to work properly gradually decreases over time. The kidneys help the body get rid of waste through urine and filter the blood before sending it back to the heart. When kidney function decreases, waste builds up in the body, which can cause various complications. The study treatment, BAY 3283142, is under development to treat CKD. It works by activating a protein called soluble guanylate cyclase (sGC) that generates cGMP - a molecule that relaxes blood vessels and is thought to have beneficial effects in CKD. BAY3283142 is broken down in the liver by a specific enzyme before it is removed from the body. In this study, researchers want to understand how a mild or moderate reduction in liver function affects the blood levels of BAY3283142. The main purpose of this study is to learn how BAY3283142 moves into, through, and out of the body, after a single dose of BAY3283142 in participants with reduced liver function. For this, the researchers will analyze: - Area under the curve (AUC): a measure of the total amount of BAY3283142 in participants' blood over time - Maximum observed concentration (Cmax): the highest amount of BAY 3283142 in participants' blood The AUC and Cmax values for participants with reduced liver function will be compared with the values for participants with normal liver function. The study participants will be assigned to one of the four treatment groups based on their liver function: - Group 1: participants with mild reduction in liver function - Group 2: participants with moderate reduction in liver function - Groups 3 and 4: participants with normal liver function who will be matched for age, weight, and gender with participants with reduced liver function All participants will take a single dose of BAY3283142 as a tablet by mouth without food. Each participant will be in the study for around 5 to 6 weeks, which includes: - a visit within 28 days of starting treatment to confirm if the participant can take part in this study - a hospital stay for 7 days during which the participant will be given a single dose of BAY3283142 and the study doctor will monitor the participant's health - a visit after 7 to 10 days of taking BAY3283142 during which the study doctor will perform a health check-up on the participant During the study, the doctors and their study team will: - check participants' health by performing tests such as blood and urine tests, blood pressure measurements, and checking heart health using an electrocardiogram (ECG) - ask the participants questions about how they are feeling and what adverse events they are having An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective of whether they think it is related or not to the study treatment. Access to study treatment after the end of this study is not planned. Participants with liver problems can continue taking their other prescribed medicines as usual.

NCT ID: NCT06402565 Recruiting - Diabetic Foot Ulcer Clinical Trials

NOX1416 in Treatment of Chronic Non-Healing Diabetic Foot Ulcers

NTCDU
Start date: May 23, 2024
Phase: Phase 1
Study type: Interventional

The goal of this multi-center, randomized, placebo-controlled, evaluator-blinded study is to assess the safety and efficacy of NOX1416 in the treatment of chronic, non-healing, diabetic foot ulcers (DFUs). Subjects will be randomized to receive treatment with NOX1416 or placebo, as an adjunct to Standard of Care (SOC). The primary objective of the study is to demonstrate the safety and tolerability of NOX1416 as adjunct to SOC. The secondary objective is to evaluate the clinical benefit of daily NOX1416, as an adjunct to standard of care SOC. Each site will assign a physician (or designee) to serve as the blinded evaluator who is responsible for assessing the study endpoints. The blinded evaluator will not be involved in the clinical care of subjects.

NCT ID: NCT06402331 Recruiting - Clinical trials for Metastatic Castration-resistant Prostate Cancer

FPI-2265 (225Ac-PSMA-I&T) for Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC)

AlphaBreak
Start date: March 5, 2024
Phase: Phase 2/Phase 3
Study type: Interventional

This is an open-label, randomized, multicenter study of FPI-2265 (225Ac-PSMA-I&T). The dose optimization Phase 2 part will be investigating the safety, tolerability, and anti-tumor activity of novel dosing regimens of FPI-2265 in participants with PSMA-positive mCRPC who have been previously treated with 177Lu-PSMA-617 or another 177Lu-PSMA radioligand therapy (RLT).

NCT ID: NCT06402318 Recruiting - COVID-19 Clinical Trials

Passive Detection- SARS-CoV-2 (COVID-19) A&M Breathalyzer (PROTECT Kiosk) for Operational Medicine

COVID-19
Start date: December 27, 2023
Phase:
Study type: Observational

The primary objective of this effort will be to optimize and operationalize innovative passive surveillance systems and in parallel, the effort will identify, evaluate, and transition groundbreaking new technologies in diagnostics for operationalization. To meet the objective and execute the deliverables for this program of effort, the A&M Breathalyzer PROTECT Kiosk will be tested, modified and validated at Brooke Army Medical Center (BAMC). The collaborative efforts between the PI, Dr. Michael Morris at BAMC and Co-Investigator Dr. Tony Yuan at USU- Center for Biotechnology (4D Bio3) will assess the passive detection technology and provide a capability survey of use-case scenarios for different operational settings. Goals: 1. Optimization and operationalize the A&M Breathalyzer PROTECT Kiosk, portable mass spectrometer (MS) Detector for Deployment in Military Operational Medicine Environments. The Breathalyzer will be deployed to BAMC to test its detection capabilities of COVID-19 among symptomatic and asymptomatic COVID-19 carrier vs. those not infected compared to gold standard RT-PCR. 2. Evaluate the passive sensing, breath capture system, built within the A&M Breathalyzer PROTECT Kiosk. The conversion of the active breath capture system, currently requires a straw that the subject breaths into, where then a series of sensors built in the Breathalyzer would automatically sample the exhaled breath within proximity for recent COVID-19 exposure. This task would conclude with a set of sensors and sensor inputs that would be analyzed by the Atomic AI platform built in the device. Field testing at BAMC is planned to determine the level of detection and discrimination for sensor combinations to SARS-CoV2 components and biomarkers detected. This testing would update the Atomic AI algorithm, within the device, to understand the accuracy of positive detection and the resulting sensitivities.

NCT ID: NCT06402253 Recruiting - Healthy Subjects Clinical Trials

A Music and Visual Arts Digital Intervention in Teenagers to Promote Healthy Engagement With Social Media.

SMART
Start date: March 1, 2024
Phase: N/A
Study type: Interventional

The primary goal of this interventional study is to explore whether 3 months of arts-based digital interventions can change the way in which teenagers (13-16 years of age) use social media and are affected by them. The main questions it aims to answer are: - Can we give teenagers new, stimulating, and more goal-oriented ways of using social media through arts-based digital trainings and active discussions around social media? - Can these arts-based digital interventions also help teenagers to overcome the negative consequences of social media overuse (such as depression, anxiety, and reduced attention and cognitive performance)? Secondarily, this study also aims to explore the brain and behavioral traits associated with these arts-based interventions to better understand how they work. Researchers will compare a music composition intervention with two other interventions: an active control intervention based on visual-arts instead of music (i.e., photography), and a passive approach to control for the mere pass of time. Participants will: - Complete a baseline and a post-intervention evaluation where researchers will obtain measures of cognitive performance (attention and executive functions, mainly), mood, mental health, brain structure and function, and social media usage and attitudes towards these platforms. - Complete weekly measures regarding their use of social media platforms and their mood. - Complete 3-month arts-based composition / edition intervention (based on music or visual-arts/photography), or the equivalent time with no intervention (passive control group). The motivation of this study was driven by the observation that, in recent years, there has been an increasing use of social media and digital devices in teenagers, while the scientific community still does not fully understand the effects of the overuse of these digital means and platforms. Moreover, some of the negative effects described to be associated with the passive overuse of social media tap on the same brain structures that are benefited by musical and artistic trainings. Hence, we thought it could be worth trying to use arts-based training to help teenagers compensate for or overcome the negative effects of social media at the neural, cognitive, mood and mental health levels. This study introduces novelty through three main aspects. Firstly, it employs a digital art creation approach that requires no classical art training, making it more accessible and less intimidating. Secondly, it incorporates commonly used digital devices (e.g., phones/tablets) and motivating environments into the learning process, integrating the development of new digital skills and the practice of critical thinking around the use of SM into normal classroom activities. Finally, the study employs a multi-methodological approach to explore the brain mechanisms underlying mental-health and cognitive changes resulting from arts-based interventions. Finally, we believe that conclusions from SMART will: - set the basis for developing preventive and therapeutic interventions for depression and anxiety in teenagers, - promote educational programs that provide optimal tools for adolescents to navigate social media in a healthy manner, and - inspire educational policy.