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NCT ID: NCT06366672 Recruiting - Virus Diseases Clinical Trials

Evaluating the Human Immune Response to the JYNNEOS Vaccine

Start date: June 10, 2024
Phase: Early Phase 1
Study type: Interventional

This study is designed to evaluate the magnitude and duration of the human adaptive immune response to the JYNNEOS Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) vaccine in the blood, lung mucosa, skin and bone marrow.

NCT ID: NCT06366633 Not yet recruiting - Substance Use Clinical Trials

Web-based Mind-body Program for Comorbid Nontraumatic Upper-extremity Condition and Risky Substance Use

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

The investigator aims to conduct an open pilot study (N=12; 10 completers) to test the feasibility, acceptability, and credibility of an asynchronous web-based mind-body intervention (Toolkit for Resilient Life beyond Pain and Substance Use; Web-TIRELESS) for adult patients with a comorbidity of non-traumatic painful upper-extremity condition(s) (NPUC) and risky substance use. Deliverables: 1) Adapt and refine open pilot protocol, patient recruitment, and other study materials. 2) Assess the feasibility, acceptability, and credibility of Web- TIRELESS in preparation for a future feasibility RCT. Participants will complete 4 on-demand video sessions at their own pace (approximate pace of 1 session per week) and complete baseline and post-test assessments. participants may also partake in an exit interview to provide feedback on Web-TIRELESS to further refine the program and study protocol for future iterations.

NCT ID: NCT06366620 Recruiting - Peer Support Clinical Trials

Examining the Feasibility, Acceptability, and Fidelity of Utilizing Parent Training Graduates as Peer Supports

Start date: April 10, 2024
Phase: N/A
Study type: Interventional

Disruptive behavioral disorders are common in early childhood, affecting up to 15% of preschool-aged children. Behavioral parent training programs are a first-line evidence-based treatment for child disruptive behaviors. There is evidence showing that (a) these programs are effective in reducing disruptive behavior and improving long-term outcomes, and (b) there is an excellent return on investment for early intervention. Nevertheless, there is limited availability of behavioral parent training programs, particularly in rural settings, due to shortages of trained clinicians. Thus, there is a pressing need for expanding the mental healthcare workforce in rural/underserved areas. The study will involve an established parent-based behavioral intervention (First Approach Skills Training for Behavior; or FAST-B) with added pilot component incorporating parents who have previously been through parent behavioral management training programs as Peer Supports.

NCT ID: NCT06366503 Completed - Wrinkle Clinical Trials

Evaluating Procedure Pairing of a Post-Procedure Cream Versus a Comparator in Patients Treated With Fractional Ablative CO2 Laser for Facial Rejuvenation

Start date: October 3, 2023
Phase: N/A
Study type: Interventional

This randomized, single-center, double-blinded, split-face, controlled clinical trial was conducted to investigate the tolerability, safety, and efficacy of a post-procedure cream when used immediately after fractional ablative CO2 laser treatment and for 14 days post-procedure with three times daily application in healthy female subjects aged 35 to 65 with moderate to severe global facial overall photodamage (score of 4 to 9 out of the 10-point Modified Griffiths' scale). Furthermore, this clinical trial compared the active post-procedure cream to a comparator anhydrous formulation often paired with skin rejuvenation procedures. This is a cosmetic study with a FDA-regulated device. A total of 22 healthy female subjects completed the study.

NCT ID: NCT06366464 Recruiting - Clinical trials for Prader-Willi Syndrome

A Study of Pitolisant in Patients With Prader-Willi Syndrome

Start date: April 30, 2024
Phase: Phase 3
Study type: Interventional

This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, global clinical study to assess the efficacy and safety of pitolisant in patients living with Prader-Willi syndrome. The primary objective of this study is to evaluate the efficacy of pitolisant in treating excessive daytime sleepiness (EDS) in patients ≥6 years of age with Prader-Willi syndrome. Secondary objectives include assessing the impact of pitolisant on: - Irritable and disruptive behaviors - Hyperphagia - Other behavioral problems including social withdrawal, stereotypic behavior, hyperactivity/noncompliance, and inappropriate speech

NCT ID: NCT06366451 Recruiting - Clinical trials for Head and Neck Squamous Cell Carcinoma

PBI-MST-01 (NCT04541108) Substudy AZN-05: Intratumoral Microdosing of Rilvegostomig, Volrustomig, and Sabestomig in HNSCC

Start date: May 22, 2024
Phase: Early Phase 1
Study type: Interventional

This is a multi-center, open-label, Phase 0 substudy designed to evaluate the localized pharmacodynamics (PD) of rilvegostomig, volrustomig, and sabestomig within the tumor microenvironment (TME) when administered intratumorally in microdose quantities via the CIVO device in patients presenting with Head and Neck Squamous Cell Carcinoma (HNSCC) with a surface accessible lesion, who are scheduled for tumor and/or regional node dissection as part of their standard treatment. PD effects due to injected investigational agents will be compared to those elicited by pembrolizumab alone, which will also be injected in microdose quantities via the CIVO device.

NCT ID: NCT06366399 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

The Acute T-Rex (Timing of Resistance Exercise) Study

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

The primary aim of this study is to evaluate if a single bout of AM vs PM resistance exercise has different effects on insulin sensitivity and sleep. A randomized cross-over trial be used to compare resistance exercise at two different times of the day. Each condition will take place in a laboratory setting. Each condition will consist of exercise, overnight sleep, and oral glucose tolerance tests the following day. The AM exercise will occur ~1.5 hours after habitual wake, and PM exercise will occur ~11 hours after habitual wake. After a 2-6 week washout, participants will complete the other condition. The hypothesis is that PM exercise will be more beneficial than AM exercise in improving insulin sensitivity. This study could identify if there is a better time of day to perform resistance exercise to decrease risk of developing Type 2 Diabetes Mellitus.

NCT ID: NCT06366347 Not yet recruiting - Endometrial Cancer Clinical Trials

ALPINE: Maintenance Letrozole/Abemaciclib vs Pembrolizumab

Start date: September 2024
Phase: Phase 2
Study type: Interventional

A standard treatment for endometrial cancer is chemotherapy and pembrolizumab together followed by pembrolizumab maintenance for two years. This treatment regimen has shown benefit in terms of delaying cancer progression in prior clinical trials, but the benefit of the pembrolizumab maintenance treatment and whether all participants need it is unclear. This research is being done on the maintenance portion of treatment to compare the efficacy between the combination of letrozole + abemaciclib and pembrolizumab alone following chemotherapy and pembrolizumab. The names of the study drugs involved in this study are: - Abemaciclib (a type of cyclin-dependent kinase (CDK) inhibitor) - Letrozole (a type of aromatase inhibitor) - Pembrolizumab (a type of monoclonal antibody)

NCT ID: NCT06366282 Not yet recruiting - Traumatic Injury Clinical Trials

Pediatric and Caregiver Traumatic Stress Intervention (PACTS)

PACTS
Start date: June 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to learn more about how to help the caregiver and child survivor of a traumatic injury handle post-traumatic stress disorder and/or depression.

NCT ID: NCT06366256 Recruiting - Clinical trials for Speech Sound Disorder

Simplified Ultrasound Feedback for Speech Remediation

SUFSR
Start date: October 24, 2023
Phase: N/A
Study type: Interventional

Recent research in motor control shows that people learn new movements best when they receive feedback external to the body. Traditional ultrasound speech therapy works well for many children, but involves teaching children to focus on their internal tongue movements. The goal of the study is to test whether ultrasound biofeedback delivered without showing children a display of their tongue movements will be effective as a treatment for residual speech sound disorders in children. We focus on children who have trouble producing the sound "r" as in "rabbit". The first aim is to develop a fast reliable system to track movements of different parts of the tongue using ultrasound and to identify which combinations of movements will produce a good "r" and which do not. The second aim is to develop a motivational game in which children receive feedback on the success of their tongue movements by what happens to an animated character on a screen. This developed version of ultrasound feedback therapy will be compared to the traditional version of ultrasound feedback therapy to determine how the two approaches can best be utilized in the clinic.