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NCT ID: NCT06138782 Recruiting - Anorexia Nervosa Clinical Trials

Identifying Networks Underlying Compulsivity in Anorexia Nervosa for Targeting With Neuromodulation

Start date: October 16, 2023
Phase: N/A
Study type: Interventional

Transcranial Magnetic Stimulation (TMS) is approved by the Food and Drug Administration (FDA) for the treatment of refractory Major Depressive Disorder (MDD) and obsessive-compulsive disorder (OCD). Anorexia nervosa (AN) is characterized by restrictive eating leading to low weight and associated complications. There is an emerging understanding that the symptoms of OCD and AN overlap as AN can be characterized by obsessive thought patterns around food and compulsive restricting and weight loss behaviors. Both conditions are characterized by a propensity toward cognitive inflexibility and the conditions may share neural substrates that maintain maladaptive habitual behaviors and cognitive rigidity. An evidence-based repetitive transcranial magnetic stimulation (rTMS) target for OCD is the orbitofrontal cortex (OFC). The investigators intend to determine if the OFC is also a potential rTMS target for AN and to determine if there is a characteristic pattern of functional network reorganization as characterized by functional magnetic resonance imaging (fMRI) in TMS responders.

NCT ID: NCT06138730 Recruiting - Depressive Symptoms Clinical Trials

Evaluating a Virtual Mentoring Program Plus Mental Health Videos for Teens

Start date: February 12, 2024
Phase: N/A
Study type: Interventional

This clinical trial evaluates Appa Health, a mental health smartphone and computer app for teenagers. Appa is built from two components. Component #1 shares short TikTok-style videos with teens to cover techniques from a science-backed mental health treatment, Cognitive Behavioral Therapy. These videos are designed by mental health experts and delivered by mental health influencers. Component #2 pairs teens with peer mentors with similar life experiences, who help guide teens through each week's video content. All peer mentors are trained and supervised by licensed mental health experts. The researchers believe Appa Health improves teens' mental health and well-being through teens' strengthened relationships and support from their mentor, as well as through the skills they gain through watching the videos. This study hopes to understand: (1) whether these Appa Health components improve teens' mental health and well-being, (2) how these components might improve teen outcomes, and (3) costs associated with each of these components. To answer these questions, the researchers will compare two versions of Appa support: Appa Complete and Appa Lite. Appa Complete involves pairing teens with mentors and sharing videos. Appa Lite involves only sharing videos with teens. First, the researchers will conduct a small version of this study to test procedures. Seventy-five teenagers (13-18 years old) with high depression or anxiety scores will be randomly given either: Appa Complete (mentoring + videos), Appa Lite (videos only), or a Waiting List Control. Based on the results of this smaller study, the researchers will change study procedures to improve teens' experiences and engagement in this research. After completing this smaller study, the researchers will run a larger version of the same study with 400 more teens. After teens are randomly given Appa Complete, Appa Lite, or a Waiting List Control, the researchers will test whether Appa's two treatment components improve teens' depression, anxiety, well-being, and other related outcomes. The researchers expect both Appa Complete and Appa Lite will improve teens' outcomes more than the Waiting List Control. The researchers also expect Appa Complete will improve teens' outcomes more than Appa Lite. The researchers will also measure costs associated with giving teens both treatment components and use this information to improve Appa's services for future teens.

NCT ID: NCT06138691 Recruiting - Clinical trials for Treatment Resistant Depression

KET-RO Plus RO DBT for Treatment Resistant Depression

KET-RO
Start date: October 4, 2023
Phase: Phase 1
Study type: Interventional

This pilot study will assess the safety and feasibility of intravenous (IV) ketamine combined with RO DBT in young adults with Treatment-Resistant Depression (TRD). In addition, this study will develop and utilize innovative methodological approaches to demonstrate the feasibility of precision medicine with this type of therapy.

NCT ID: NCT06138652 Completed - Anxiety Clinical Trials

Reducing Anxiety Levels Through the Dharma Life App-Based and Mentor-Based Program Targeting Personality Characteristics: A Randomized Control Trial

Start date: September 1, 2021
Phase: N/A
Study type: Interventional

The purpose of this study was to examine whether an app- and mentor-based program reduced anxiety among individuals reporting difficulties with anxiety. For the intervention group, this study involved completing an 8-week program focused on helping participants reach their personality goals. The program involved app-based games, journaling, and completing behavioral challenges. Participants engaged with the study app for approximately 15 minutes per day and spoke with a study mentor weekly for 1 hour. Participants were asked to complete surveys prior to and after the program. The pre-program survey lasted approximately 1 hour, and the post-program survey lasted approximately 30 minutes. For the control group, this study involved completing surveys. Participants were asked to complete surveys 8 weeks apart. The first batch of surveys lasted approximately 1 hour, and the follow-up surveys lasted approximately 30 minutes.

NCT ID: NCT06138639 Recruiting - Clinical trials for Duchenne Muscular Dystrophy

A Study of SGT-003 Gene Therapy in Duchenne Muscular Dystrophy (INSPIRE DUCHENNE)

Start date: April 5, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This is a multicenter, open-label, non-randomized study to investigate the safety, tolerability, and efficacy of a single IV infusion of SGT-003 in participants with Duchenne muscular dystrophy. There will be 2 cohorts in this study, dosed sequentially. Cohort 1 will include participants 4 to <6 years of age, inclusive. Cohort 2 will only be opened after dosing and monitoring a subset of participants in Cohort 1. Cohort 2 will include participants 6 to <8 years of age, inclusive. All participants will receive SGT-003 and will be enrolled in the study for 5 total years for long-term follow up.

NCT ID: NCT06138626 Enrolling by invitation - Anesthesia Clinical Trials

Test of Excessive Anesthetic Fresh Gas Flow Alerting in the Electronic Medical Record to Reduce Excessive Fresh Gas Flow

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

The primary objective of this quality improvement intervention is to test the efficacy of excessive fresh gas flow alerting in the electronic medical record for anesthesia providers.

NCT ID: NCT06138613 Recruiting - Motion Sickness Clinical Trials

Motion Delos: An Open Label Safety and Efficacy of Tradipitant in Participants Affected by Motion Sickness

Start date: February 27, 2023
Phase: Phase 3
Study type: Interventional

An open label study to investigate the safety and efficacy of tradipitant in participants affected by motion sickness during travel

NCT ID: NCT06138587 Recruiting - Leukemia Clinical Trials

Preemptive CIML NK Cell Therapy After Hematopoietic Stem Cell Transplantation

Start date: January 24, 2024
Phase: Phase 1
Study type: Interventional

The purpose of this research study is to test the safety and efficacy of cytokine induced memory-like (CIML) natural killer (NK) cells expanded with Interleukin-2 (IL-2) at preventing relapse in acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or MDS and myeloproliferative neoplasm (MPN) overlap syndrome after a standard-of-care stem cell transplant. Names of the study therapies involved in this study are: - CIML NK cells intravenous infusion (cellular therapy) - Subcutaneous Interleukin-2 (recombinant, human glycoprotein)

NCT ID: NCT06138561 Recruiting - Bladder Cancer Clinical Trials

Management of Cisplatin-Ineligible Patients With Metastatic Bladder Cancer and The Role of Geriatric Assessments

Start date: March 5, 2024
Phase:
Study type: Observational

The goal of this study is to better understand how to best treat participants with advanced bladder cancer who may not be able to tolerate all of the chemotherapy drugs that have been shown to be effective. In this study, investigators are assessing the role of the survey, the Geriatric-8, and its ability to predict outcomes in older participants undergoing cancer treatments. Additionally, investigators are evaluating the differential impact of treatments on quality of life in an older and at risk population.

NCT ID: NCT06138548 Not yet recruiting - Clinical trials for Subchondral Insufficiency Fracture

Bio-Integrative, Fiber-Reinforced Kneebar for Treating Subchondral Insufficiency of the Knee

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

The OSSIOfiber® Trimmable Fixation Nails are indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis and bone grafts in the presence of appropriate additional immobilization (e.g., rigid fixation implants, cast, brace). Our hypothesis is that the use of OSSIOfiber® Trimmable Fixation Nails for treating subchondral insufficiency of the knee will result in improvement of patient-reported outcomes and imaging findings. The primary objective of this study is to evaluate the effectiveness of implanting bio-integrative OSSIOfiber® Trimmable Fixation Nails, organized in a bi-cortical rafter formation within the tibia or femur for the management of subchondral insufficiency. This use is not considered off-label because we are using the TFNs in the way they are intended to be used via FDA approval.