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NCT ID: NCT06374550 Not yet recruiting - Clinical trials for Mental Health Wellness 1

Jump Start on the Go: Improving Resiliency and the Social-Emotional Development of At-Risk Preschool Children

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

The purpose of this study is to test the Jump Start on the Go (JS Go), an app-based program and see how helpful it is at improving resiliency and behavior support within childcare settings.

NCT ID: NCT06374537 Recruiting - Frailty Clinical Trials

Evaluate the Impact of Targeted Physical Activity on Clinically Debilitated Dialysis Patients.

Start date: May 22, 2019
Phase: N/A
Study type: Interventional

This research is being done to better understand the impact of the use of a specific physical activity training program (GH Method) in dialysis/kidney disease patients.

NCT ID: NCT06374498 Not yet recruiting - Clinical trials for Coronary Artery Disease

Study to Determine the Clinical Significance of Intravascular OCT-NIRAF

Start date: April 30, 2024
Phase: N/A
Study type: Interventional

Patients undergoing coronary angiography for stable or acute coronary disease presentations and eligible for percutaneous coronary intervention (PCI) will be imaged with OCT-NIRAF at baseline and with CCTA 12 months apart to demonstrate that: 1. NIRAF coronary artery signal level (patient, artery, lesion basis) is correlated with the severity of coronary artery disease. 2. NIRAF coronary artery signal level is a predictor of plaque progression on a per patient, per artery, or per lesion basis.

NCT ID: NCT06374459 Not yet recruiting - Clinical trials for Hormone Receptor Positive HER-2 Negative Metastatic Breast Cancer

Zunsemetinib in Combination With Capecitabine in Patients With Hormone Receptor-Positive and HER2-Negative Metastatic Breast Cancer With Bone Metastasis

Start date: July 31, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This is a phase Ib/II study evaluating the safety and efficacy of zunsemetinib (ATI-450) with capecitabine in patients with hormone receptor-positive and HER2-negative (HR+/HER2-) metastatic breast cancer (MBC).

NCT ID: NCT06374394 Recruiting - Clinical trials for Respiratory Syncytial Virus Infections

A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a COVID-19 mRNA Vaccine in Adults Aged 50 Years and Above

Start date: April 29, 2024
Phase: Phase 3
Study type: Interventional

This study will assess the immunogenicity, safety and reactogenicity of the RSVPreF3 OA investigational vaccine when it is co-administered with a COVID-19 messenger ribonucleic acid (mRNA) vaccine (Omicron XBB.1.5), compared to administration of the vaccines separately in adults aged 50 years and above.

NCT ID: NCT06374381 Enrolling by invitation - Clinical trials for Autism Spectrum Disorder

PEACE for ImPACT Study

Start date: December 1, 2023
Phase: N/A
Study type: Interventional

Investigators will test the impact of the PEACE implementation toolkit and determine the level of implementation support needed to improve early intervention providers use of caregiver coaching with families of young children with autism who receive early intervention services. The study will also assess caregiver and child outcomes for families receiving caregiver coaching and the cost effectiveness of the PEACE implementation toolkit. The investigators will enroll 200 early intervention providers, and 400 parent-child dyads.

NCT ID: NCT06374303 Completed - Food Security Clinical Trials

Novel Intervention to Improve Food Insecurity Among Individuals With Opioid Use Disorder: A Randomized Clinical Trial

Start date: April 19, 2022
Phase: N/A
Study type: Interventional

The adverse consequences of illicit opioid use (e.g., overdose, premature death) are the focus of intensive research efforts. However, other serious health problems among individuals with opioid use disorder (OUD) have received far less attention. Food insecurity (FI) is 4-7 times greater among individuals with OUD than the general population. In addition to the increased healthcare utilization and costs, poor health outcomes, and adverse social consequences associated with FI in the general population, patients with co-occurring FI and OUD are at increased risk for licit and illicit drug use, sexual and drug risk behaviors, infectious disease, and a two-fold greater odds of premature death. In this randomized pilot study, we evaluated a novel, mail-based meal delivery intervention for improving household FI and other outcomes among individuals receiving methadone or buprenorphine maintenance for OUD. Fifty adults with FI and OUD were randomized to one of two 12-week experimental conditions: Nutritional Education (NE) participants received brief education, a list of FI-related resources in their community, and assistance with contacting those resources. NE + Meal Delivery (NE+MD) participants received the same educational platform plus weekly meal deliveries using a commercial service that delivers premade, refrigerated meals directly to the participant's home. The primary outcome of household FI was measured at monthly assessments using the USDA Household Food Security Survey. Secondary measures included depression symptoms (Beck Depression Inventory), quality of life (RAND-36 Quality of Life Survey), and drug use as measured by biochemical urinalysis. The NE+MD intervention was associated with significant improvements in household FI, with fewer NE+MD participants meeting criteria for FI vs. NE participants at all three assessment timepoints (p's<.05). Retention rates were similar between the two groups (88% and 84% for NE+MD and NE conditions, respectively; p=.68). Intervention acceptability was also high, with NE+MD participants rating the enjoyment and convenience of the meals at 81 and 93, respectively (range: 0-100). Changes in FI status were also associated with improvements in other areas of functioning. NE+MD participants experienced reductions in depression symptomatology, with Beck Depression Inventory scores lower than intake at Weeks 4 and 8 (p's<.05) and no changes among NE participants. NE+MD participants also experienced improvements on four of the eight subscales of the RAND-36 Quality of Life Health Survey (i.e., General Health, Bodily Pain, Mental Health, Role Emotional; p's<.05), with no changes among NE participants. This study represents the first effort to develop and evaluate a novel intervention to reduce FI and related problems among individuals with OUD. These pilot data support the feasibility, acceptability and initial efficacy of the NE+MD intervention for improving household FI, as well as provide exciting new preliminary evidence suggesting that FI may be linked to participants' mental and physical health.

NCT ID: NCT06374290 Recruiting - Smoking Cessation Clinical Trials

Study of Injectable Naltrexone and Oral Bupropion Among Cigarette Smokers With Schizophrenia

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

The purpose of this study is to assess the feasibility and safety of injectable naltrexone (NTX;380 mg) in conjunction with oral bupropion (BUP; 450 mg daily)NTX-BUP administration among individuals with schizophrenia spectrum disorders that smoke cigarettes and to evaluate change on smoking-related measures and symptoms of schizophrenia.

NCT ID: NCT06374277 Recruiting - Stroke Clinical Trials

Pharmacy-led Transitions of Care Intervention to Improve Medication Adherence

MedAAAction
Start date: April 6, 2024
Phase: N/A
Study type: Interventional

Socioeconomically disadvantaged populations with multiple chronic conditions have high rates of nonadherence to essential chronic disease medications after hospital discharge. Medication nonadherence after hospital discharge is significantly associated with increased mortality and higher rates of readmissions and costs among these patients. Major patient-reported barriers to essential medication use after hospital discharge among low-income individuals are related to social determinants of health (SDOH) and include: 1) financial barriers , 2) transportation barriers, and 3) system-level barriers. Although, medication therapy management services are important during care transitions, these services have not proven effective in improving medication adherence after hospital discharge, highlighting a critical need for innovative interventions. The Medication Affordability, Accessibility, and Availability in Care Transitions (Med AAAction) Study will test the effectiveness of a pharmacy-led care transitions intervention versus usual care through a pragmatic randomized controlled trial of 388 Medicaid and uninsured hospital in-patients with MCC from three large healthcare systems in Tennessee. The intervention will involve: 1) medications with zero copay, 2) bedside delivery then home delivery of medications, and 3) care coordination provided by certified pharmacy technicians/health coaches to assist with medication access, medication reconciliation, and rapid and ongoing primary care follow-up. We will examine the impact of the intervention during 12 months on 1) medication adherence (primary outcome) and 2) rapid primary care follow-up, 30-day readmissions, hospitalizations and emergency department visits, and costs. We will conduct key informant interviews to understand patient experience with the acre received during and after care transitions. By examining effectiveness of the intervention on outcomes including medication adherence, health care utilization, costs, and patient experience, this study will provide valuable results to health systems, payers, and policymakers to assist in future implementation and sustainability of the intervention for socioeconomically disadvantaged populations.

NCT ID: NCT06374264 Not yet recruiting - Clinical trials for Neuromyelitis Optica Spectrum Disorder

Acceptability and Safety of MR-C-014 in Persons With Neuromyelitis Optica Spectrum Disorder

aNiMatO
Start date: June 15, 2024
Phase: N/A
Study type: Interventional

The purpose of this proof of concept study is to assess the acceptability and safety of MR-C-014 in persons with Neuromyelitis optica spectrum disorder (NMOSD) who have a gait deficit.