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NCT ID: NCT06458790 Not yet recruiting - Obesity, Childhood Clinical Trials

Black Resilient Caregivers

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

To determine the feasibility of an intervention to promote the physical and socioemotional health of African American (AA) families.

NCT ID: NCT06458530 Not yet recruiting - PreDiabetes Clinical Trials

Examining the Effects of Vivo on Physical Function and Glycemic Level in Sedentary Older With Prediabetes.

Start date: July 31, 2024
Phase: N/A
Study type: Interventional

This is a 12-week randomized, controlled trial that seeks to examine the effect of Vivo on 1) change in lower extremity strength defined as number of chair stands done in 30 seconds and 2) change in average glycemic level (HbA1c) compared to a wait list control.

NCT ID: NCT06458439 Not yet recruiting - Clinical trials for Lymphoma, Non-Hodgkin

Epcoritamab-CAR T Cells for Large B-cell Lymphomas

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

This study investigates the feasibility and efficacy of epcoritamab treatment before CAR T cells. This study also investigates if, when patients have residual lymphoma after CAR T cells, epcoritamab can help to effectively treat that lymphoma.

NCT ID: NCT06458192 Not yet recruiting - Depression Clinical Trials

Adaptive Messaging to Support Depression Self-Management

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

This is a pilot randomized controlled trial of an adaptive 8-week text messaging intervention for depression self-management. Among 100 individuals with elevated depression symptoms, we will compare the effects of 8 weeks of the adaptive text messaging intervention (n=40) to 8 weeks of a non-adaptive text messaging intervention (n=40), and 8 weeks of a psychoeducation-only intervention (n=20). We will include a 6-month post-treatment follow-up to verify that treatment gains are maintained. Both messaging arms will receive 8 weeks of daily text messaging. Messages will prompt learning and applying cognitive and behavioral self-management strategies. Whereas the non-adaptive messaging system will randomly select daily messaging styles (representing a variety of self-management strategies and message tones), the adaptive messaging system will apply reinforcement learning to select daily messaging styles to maximize user engagement. Text messages will also be used to solicit feedback such as message ratings to inform the reinforcement learning algorithm (if applicable). The psychoeducation control group will receive a few brief text messages per week providing weblinks to access psychoeducation information. We will recruit participants through digital methods (e.g., advertising on social media platforms like Facebook and Instagram). Administration of study measures will occur at baseline, weeks 4 and 8, and 3-month and 6-month follow-up. The primary outcomes is depression symptom severity (PHQ-9). Secondary outcomes are: anxiety severity (GAD-7) and suicidality (DSI-SS). Using an Intention to Treat paradigm, we will test our hypothesis that: H1: Relative to the psychoeducation-only control, messaging interventions will reduce depression (H1a) and anxiety and suicidal ideation (H1b). H2: Relative to non-adaptive messaging, adaptive messaging will reduce depression (H1a) and anxiety and suicidality (H2b). H3: Adaptive messaging will reduce depression relative to non-adaptive messaging by producing greater objective and subjective engagement.

NCT ID: NCT06458153 Not yet recruiting - Stroke Clinical Trials

Imaging Speech in Neurotypical Adults and Individuals With Cerebellar Stroke

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

The goal of this research study is to learn how the brain areas that plan and control movement interact with the areas responsible for hearing and perceiving speech in healthy adults and people who have had cerebellar strokes. The main questions it aims to answer are: 1. What regions of the brain's sensory systems show changes in their activity related to speech? 2. To what extent do these regions help listeners detect and correct speech errors? 3. What is the role of the cerebellum (a part of the brain in the back of the head) in these activities? Participants will be asked to complete several experimental sessions involving behavioral speech and related tests and non-invasive brain imaging using electroencephalography (EEG) and functional magnetic resonance imaging (fMRI).

NCT ID: NCT06458127 Not yet recruiting - Clinical trials for Chronic Graft-versus-host Disease

Tele-Palliative Care Intervention for Patients With Chronic Graft-Versus-Host Disease

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

This research study is evaluating the feasibility and acceptability of implementing a telehealth palliative care intervention in patients with moderate to severe chronic graft-versus-host disease.

NCT ID: NCT06458049 Not yet recruiting - Clinical trials for Sexual Function Disturbances

Sexual Health and Rehabilitation Online (SHAREonline)

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

SHAREonline is a study for young female cancer survivors that are experiencing changes in sexual health and function. The purpose of this research is to compare two brief interventions delivered by videoconference to learn if they help women effectively manage these changes and restore sexual health and functioning.

NCT ID: NCT06457997 Not yet recruiting - Lung Cancer Clinical Trials

A Study of PHN-010 in Patients With Advanced Solid Tumors

Start date: July 2024
Phase: Phase 1
Study type: Interventional

This first-in-human study will evaluate safety, tolerability, anti-tumor activity, immunogenicity, pharmacokinetics and pharmacodynamics of PHN-010, a novel antibody-drug conjugate (ADC), in patients with advanced solid tumors.

NCT ID: NCT06457256 Not yet recruiting - ADHD Clinical Trials

Hybrid Effectiveness-Implementation Trial of a School Clinician Training and Psychosocial ADHD/ODD Intervention Program Adapted for Schools Across Mexico

(CLS-A-FUERTE)
Start date: July 1, 2024
Phase: N/A
Study type: Interventional

Neurodevelopmental disorders of Attention-Deficit/ Hyperactivity Disorder (ADHD) and Oppositional Defiant Disorder (ODD) are extremely common but underserved with Evidence- Based Treatments (EBT) worldwide. Thus, our team developed, implemented and evaluated a school clinician training and ADHD/ODD intervention (i.e., the Collaborative Life Skills [CLS] program) for Mexico: a setting with high unmet need. We integrated technology into our in-person program (CLS-FUERTE) to create a digitally enhanced version (CLS-R-FUERTE). Given findings demonstrating feasibility, acceptability, and efficacy of both program versions, we propose a Type 2 Hybrid Effectiveness-Implementation Design to evaluate the program effectiveness, mechanisms of intervention change, and maintenance barriers/facilitators in a scaled-up cluster randomized controlled trial across two Mexican states -while simultaneously exploring an implementation strategy in which we adapt the program to enhance maintenance given each school's needs/resources (i.e., CLS-A-FUERTE). Our implementation process is guided by the Exploration, Preparation, Implementation, and Sustainment (EPIS) model with evaluation following the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) Framework. Aim 1) Test the effectiveness and implementation of the CLS-A-FUERTE school clinician training and ADHD/ODD intervention program adapted for schools across Mexico. We expect: H1) School clinicians will engage in training and implement chosen intervention components with fidelity H2) Teachers and/or families will engage in chosen intervention components and adhere to the strategies H3) Students receiving the CLS-A-FUERTE intervention will show greater improvements in ADHD/ODD symptoms and associated impairment compared to students receiving school services as usual Aim 2) Evaluate mechanisms of sustained intervention change. We expect: H4) Improvements in parenting behaviors will mediate sustained intervention effects H5) Improvements in teacher and/or school clinician competency will mediate intervention effects Aim 3) Identify CLS-A-FUERTE maintenance barriers and facilitators. We expect across adaptations that sustained intervention effects and continuation of program activities at follow-up will relate to: H6) Program feasibility (i.e., cost estimates) and acceptability (i.e., participant satisfaction) H7) Characteristics of participating schools and school context factors Aim 4) Expand research capacity to a novel university setting. We expect emerging investigators will: H8) Complete clinical research coursework and produce deliverables (i.e., presentations, papers, grants) H9) Show improved EBT skills, research capacity and culture ratings, and competency as program trainers

NCT ID: NCT06457152 Not yet recruiting - Heart Failure Clinical Trials

Multi-Center Project: Building Electronic Tools To Enhance and Reinforce CArdiovascular REcommendations - Heart Failure

BETTER CARE-HF
Start date: September 1, 2024
Phase: N/A
Study type: Interventional

This study will test an automated, electronic health record (EHR-)embedded alert to improve prescribing of guideline-directed medical therapy for patients with heart failure and reduced ejection fraction (HFrEF). The investigators have previously tested and implemented this alert at NYU Langone Health (NYULH), and will now test and implement this alert across three other health systems.