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NCT ID: NCT06292923 Recruiting - Clinical trials for Secondary Progressive Multiple Sclerosis

A Study of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis Patients

Start date: November 15, 2023
Phase: Phase 2
Study type: Interventional

Foralumab is a human anti-CD3 monoclonal antibody being developed for the treatment of autoimmune and inflammatory diseases. The goal of this Phase 2a, randomized, double-blind placebo-controlled, multicenter dose-ranging study is to evaluate the use of nasal foralumab in patients with non-active secondary progressive multiple sclerosis (SPMS). The primary objectives that this study aims to answer are: 1. To determine the safety and tolerability of 50 μg/dose and 100 μg/dose of foralumab nasal compared to placebo 2. To investigate the effect of foralumab relative to placebo on the change from baseline [18F]PBR06-positron emission tomography (PET) scans for microglial activation, after 12 weeks (3) months of study treatment.

NCT ID: NCT06292637 Recruiting - Depression Clinical Trials

Cognitive Behavioral and Faith Fellowship to Improve Thy Health

CB-FAITH
Start date: June 2024
Phase: N/A
Study type: Interventional

Investigators will examine the efficacy of a faith-based depression intervention, in reducing symptoms of depression among African American adults in Wisconsin. Twelve church groups, each with 10 people (N=120) will be invited to participate. This intervention will be the first evidence-based, faith-based intervention designed for African Americans if validated.

NCT ID: NCT06292221 Recruiting - Depression Clinical Trials

Personalized Depression Treatment Supported by Mobile Sensor Analytics

DepWatch
Start date: April 4, 2024
Phase: N/A
Study type: Interventional

The current best practice guidelines for treating depression call for close monitoring of patients, and periodically adjusting treatment as needed. This present study seeks to develop and investigate an innovative digital system, DepWatch, that leverages mobile health technologies and machine learning tools to provide clinicians objective, accurate, and timely assessment of depression symptoms to assist with their clinical decision making process. Specifically, DepWatch collects sensory data passively from smartphones and wristbands, without any user interaction, and uses simple user-friendly interfaces to collect ecological momentary assessments (EMA), medication adherence and safety related data from patients. The collected data will be fed to machine learning models to be developed in the project to provide weekly assessment of patient symptom levels and predict the trajectory of treatment response over time. The assessment and prediction results are then presented using a graphic interface to clinicians to help them make critical treatment decisions. The main question the present clinical trial aims to answer are as follows: 1. Feasibility of the digital tool, DepWatch, to assist clinicians in depression treatment and inform their clinical decision process 2. Effectiveness of the digital tool, DepWatch, to improve depression treatment outcomes All study participants will carry the DepWatch app on their smartphones and wear a Fitbit provided by the study team during the study period. They will also complete brief questionnaires via the app at specific time intervals throughout the study period.

NCT ID: NCT06292117 Recruiting - Ischemic Stroke Clinical Trials

Implementation of Onsite Rapid CYP2C19 Assay for Genotype Guided Dual Antiplatelet Therapy After Acute Ischemic Stroke

ORCA-AIS
Start date: April 16, 2024
Phase:
Study type: Observational

The goal of this observational study is to use a genetic test to help doctors prescribe the most effective medications after a patient has a stroke. One type of stroke is caused by a blood clot in brain vessels. After a patient has this kind of stroke, they are often given a combination of two blood thinners to prevent it from happening again. One of these blood thinners, called clopidogrel, is less effective in some people due to differences in their DNA. Clopidogrel needs to be activated by a specific enzyme in the body known as CYP2C19. This enzyme does not work as well if there are variations in the section of DNA that tells the body how to make CYP2C19. It can be predicted who has less CYP2C19 enzyme activity with a genetic test. If these patients are given a different blood thinner, it can reduce their risk of another stroke compared to if they are given clopidogrel. The main questions this study aims to answer are: - What are the best strategies to implement this genetic test in the hospital? - Does implementation of this genetic test change providers' decisions on which medication to prescribe after a participant has a stroke? Participants in this study will have a genetic test done onsite looking for variations in the section of DNA that tells the body how to make CYP2C19. This genetic test will only look for 11 known variations; the genome will not be sequenced. The investigators will alert the doctor of the patient's test results so they can prescribe the appropriate blood thinner. Through this, the investigators will learn the best practices for successful implementation of this genetic test.

NCT ID: NCT06292104 Recruiting - Clinical trials for Postural Orthostatic Tachycardia Syndrome

Phenotyping of Postural Orthostatic Tachycardia Syndrome (POTS)

Start date: March 5, 2024
Phase:
Study type: Observational [Patient Registry]

This is an observational study to deeply phenotype the disorder of POTS using multiple testing modalities.

NCT ID: NCT06292013 Recruiting - Clinical trials for Atherosclerotic Cardiovascular Disease (ASCVD)

A Study to Investigate the Effect of Lepodisiran on the Reduction of Major Adverse Cardiovascular Events in Adults With Elevated Lipoprotein(a) - ACCLAIM-Lp(a)

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

The purpose of this study is to evaluate the efficacy of lepodisiran in reducing cardiovascular risk in participants with high lipoprotein(a) who have cardiovascular disease or are at risk of a heart attack or stroke. The study drug will be administered subcutaneously (SC) (under the skin).

NCT ID: NCT06292000 Recruiting - Obesity Clinical Trials

Examining the Effects of Morning and Evening Exercise on Glucose Regulation in Adults With Prediabetes

TExIS
Start date: February 1, 2024
Phase: N/A
Study type: Interventional

Purpose of the Study: This study is to learn more about how exercising at different times of the day (morning versus evening) affects metabolism of glucose in the body, sleep, activity outside of exercise, and other factors. Procedures: - 2 screening visits to make sure you are eligible to be in the study. This will include a fasting blood draw and heart tracing (EKG). - If you are eligible, you will complete both exercise conditions in a random order. All participants in the study will complete the following separated by 3-4 weeks: - Baseline condition of NO exercise - Morning exercise for 3 days in a row - Evening exercise for 3 days in a row - You will be provided with an example diet to follow for the days you are completing the baseline and exercise conditions (three days total for each condition). This diet will be a "traditional" diet with a controlled amount of carbohydrates, protein, and fat per day. The investigators will provide you with examples of meals to eat during this time. - You will be asked questions and complete questionnaires about your health history, sleeping and awakening habits, and sleepiness levels. - You will undergo one x-ray scan to measure your level of body fat. - You will be asked to wear an activity monitor and sleep monitor for 6 days in a row three times during this study. - You will be asked to wear a continuous glucose monitor (CGM) for 6 days in a row three times during this study. - You will be asked to measure your saliva melatonin levels three times in the study. This will be done once per hour for 5 hours (a total of 6 saliva samples). - You will be asked to complete a procedure called a "hyperinsulinemic-euglycemic clamp" where you will have an IV placed and insulin and glucose infused with frequent lab and finger stick blood sugars monitored closely. This will be done 3 times during the study.

NCT ID: NCT06291870 Recruiting - Clinical trials for Obstructive Sleep Apnea

Predictors of Post-COVID Clinical and Cognitive Consequences

SCLC
Start date: January 19, 2023
Phase:
Study type: Observational [Patient Registry]

The CDC describes Post-acute sequelae of SARS-COV-2 infection (PASC) for the wide range of physical and mental health consequences experienced by some patients. These sequelae may be present four or more weeks after SARS-COV-2 infection, including patients who had initial mild or asymptomatic acute infection. However, there is complete absence of data whether chronic sleep changes due to COVID-19 infection may influence these physical and mental health consequences. While fatigue is one of the common post-COVID conditions, there are no systematic examinations of sleep disturbances in COVID-19 survivors. This will be a pilot observational retrospective and prospective cohort study, to systematically assess if sleep disturbances and severity of sleep apnea comprise a modifiable facet of PASC as well as the short-term and longer-term effects of COVID-19 infection itself on sleep, cognitive function, exercise capacity and lung function.

NCT ID: NCT06291818 Recruiting - Clinical trials for Paralytic Lagophthalmos

Self-Adhering Magnetic Device to Treat Corneal Exposure

Start date: April 17, 2024
Phase: N/A
Study type: Interventional

Paralytic lagophthalmos can be difficult to treat and manage. It has a host of causes and effects, one of which (for the latter) is exposure keratopathy. Untreated, this can lead to corneal ulceration, inflammation, and potentially blindness. Despite a variety of attempts at treating this complex condition, none have satisfactorily reduced complications ranging from ease of use to aesthetics. With improvement in magnetic technology, however, that may change. Barmettler et al (2014) have demonstrated preliminary success of externally affixed magnets in closing both model and patient eyelids. As such, we hypothesize that magnetic devices can be used to treat corneal exposure by controlling eyelid position.

NCT ID: NCT06291727 Recruiting - Clinical trials for Arthroplasty, Replacement, Knee

Mepivacaine vs Bupivacaine Spinal Anesthesia for TKA

Start date: February 16, 2024
Phase: Phase 4
Study type: Interventional

This study is a prospective, double-blind prospective randomized controlled trial comparing mepivacaine and bupivacaine spinal anesthesia for same-day discharge readiness following a unilateral primary elective TKA procedure. Study data will be collected during the patient's hospital stay for their TKA procedure, and the primary outcome of same-day discharge readiness will be assessed the day of surgery. Patients will also be contacted at Day 3 post-op to assess for any complications, current level of pain, and pain medication utilization.