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NCT ID: NCT06305624 Not yet recruiting - Clinical trials for Alcohol Use Disorder

Implementation of Mobile-based Programs for Alcohol Cessation in Treatment of Alcohol-associated Liver Disease

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

This protocol describes a randomized controlled trial testing the effectiveness and implementability of the CHESS Health Connections smartphone application among patients with alcohol-associated liver disease (ALD) at two medical centers in Michigan and Wisconsin, in two types of clinics: general hepatology and multidisciplinary that offers care for advanced ALD alongside co-located, integrated mental health and substance abuse treatment. The long-term goal of this and future work is to prevent disease progression and promote healthy behaviors by improving the rate of abstinence among patients with ALD earlier in the course of their disease. 298 participants will be enrolled and can expect to be on study for up to 6 months.

NCT ID: NCT06305585 Not yet recruiting - Clinical trials for Psychological Stress

Can a Novel Manual Therapy Technique Help Relieve Stress? Assessing Effects of Primal Reflex Release on the Body's Stress Response

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

Stress, when left unmanaged, can have detrimental effects on both physical and mental health, contributing to conditions such as high blood pressure, anxiety, and even cardiovascular disease. Effective stress management therapies may help maintain overall well-being and reduce the risk of long-term health complications. The Primal Reflex Release Technique (PRRT) is a novel manual therapy that may reduce markers related to stress such as heart rate variability (HRV) and patient-reported outcomes (PROs). Therefore, the purpose of this study is to elucidate the potential for PRRT to improve HRV and PROs.

NCT ID: NCT06305299 Not yet recruiting - Ovarian Cancer Clinical Trials

Autologous CAR-T Cells Targeting B7H3 in Ovarian Cancer iC9-CAR.B7-H3 T Cells

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

The purpose of this study is to test the safety and tolerability of using a new treatment called autologous T lymphocyte chimeric antigen receptor cells against the B7-H3 antigen (iC9-CAR.B7-H3 T cells) in patients with ovarian cancer that came back after receiving standard therapy for this cancer. The iC9.CAR.B7-H3 treatment is experimental and has not been approved by the Food and Drug Administration. The study team wants to know how much (dose) of the iC9-CAR.B7-H3 T cells are safe to use in patients without causing too many side effects and what is the maximum dose could be tolerated. There are two parts to this study. In part 1, approximately blood will be collected from subjects to prepare the iC9.CAR.B7-H3 T cells. The study team will collect disease-fighting T cells from the blood and modify them to prepare the iC9.CAR.B7-H3 T cells. In part 2, the iC9.CAR.B7-H3 T cells will be given to eligible subjects by infusion three days after completion of lymphodepletion chemotherapy.

NCT ID: NCT06304493 Not yet recruiting - Clinical trials for Respiratory Insufficiency

REMINDers for Incentive Spirometry in PACU (REMIND-IS in PACU)

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

The purpose of this study is to determine if the frequency of use of incentive spirometry during the stay in the Post-Anesthesia Care Unit (PACU) increases with visual and auditory electronic reminders, as compared to not having those reminders.

NCT ID: NCT06303869 Not yet recruiting - Stroke Clinical Trials

Deep Brain Stimulation Motor Ventral Thalamus (VOP/VIM) for Restoration of Speech and Upper-limb Function in People With Subcortical Stroke

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

The goal of this study is to verify whether the use of deep brain stimulation can improve motor function of the hand and arm and speech abilities for people following a stroke. Participants will undergo a surgical procedure to implant deep brain stimulation electrode leads. The electrodes will be connected to external stimulators and a series of experiments will be performed to identify the types of movements that the hand and arm can make and how speech abilities are affected by the stimulation. The implant will be removed after less than 30 days. Results of this study will provide the foundation for future studies evaluating the efficacy of a minimally-invasive neuro-technology that can be used in clinical neuro-rehabilitation programs to restore speech and upper limb motor functions in people with subcortical strokes, thereby increasing independence and quality of life.

NCT ID: NCT06303804 Not yet recruiting - Opioid Misuse Clinical Trials

Prevention of Opioid Misuse and Overdose Deaths Among Hispanic/Latinx Adolescents: A Family-based Perspective

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

The purpose of this study is to develop culturally-competent family-focused educational modules targeting opioid knowledge and attitudes (including targeting safe storage and prevention of accidental opioid overdose in adolescent populations) and examine changes acceptability, knowledge, and attitudes scores

NCT ID: NCT06303778 Not yet recruiting - Clinical trials for Alcohol Use Disorder (AUD)

Combining a Smartphone App With Medications to Manage Heavy Drinking

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

One in 10 Veterans have an alcohol use disorder. However, few Veterans receive evidenced-based psychosocial interventions or medications to treat alcohol use disorder. Barriers to receiving these treatments include long wait times, stigma, and long distances from treatment facilities. Even fewer Veterans receive psychosocial and medication interventions together, despite clinical practice guidelines recommending both and evidence of better outcomes. Expanding access to these treatments in primary care is a VA priority but delivering psychosocial interventions is difficult in this setting, and medication is often the only option. Smartphone apps that deliver alcohol interventions may improve drinking outcomes and ensure Veterans can receive both treatments in primary care. This study will determine whether medications and an app for alcohol use problems offered to Veterans in primary care results in improved drinking outcomes, compared to Veterans receiving medications only. Study data will inform how to spread the app across the VA nationally.

NCT ID: NCT06303544 Not yet recruiting - Child Obesity Clinical Trials

More Outside Your Door: A Diet/Physical Activity Intervention to Decrease Risk of Obesity in Alaska Native Preschoolers

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

The preschool age is a crucial period of growth and an optimal time to begin to establish healthy eating and physical activity habits leading to better food and activity choices into adulthood, thereby minimizing risk for obesity-related diseases and decreasing the cardiometabolic disparities in this Indigenous population. More Outside Your Door is a multi-level, randomized, stepped-wedge intervention trial designed to reduce the disparity of childhood obesity in Yup'ik Alaska Native children by increasing the proportion of nutrient-dense traditional and traditional-like foods offered and increasing physical activity, particularly outdoor activities related to traditional Yup'ik subsistence and lifestyle practices. This 5-year intervention trial targeting 3-5 year olds is conducted in partnership with Rural Action Community Action Program Head Start programs in 12 rural Alaskan communities, where each site is assigned annually to a wedge group to receive either a community-altered culturally-tailored 8-month traditional foods and activities curriculum intervention or the standard regional Head Start program intervention.

NCT ID: NCT06303193 Not yet recruiting - Clinical trials for Myelodysplastic Syndromes

Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms

Start date: June 26, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

Background: Myelodysplastic syndrome (MDS) and myelodysplastic/myeloproliferative neoplasm (MDS/MPN) are blood disorders that can cause serious complications in children and adults. MDS and MDS/MPN can also progress to acute myeloid leukemia. Treatments for these disorders are risky and not always effective. Better treatments are needed. Objective: To test a study drug (pacritinib) in adults and children with MDS or MDS/MPN. Eligibility: Children (aged 12 to 17 years) and adults (aged 18 years and older) with MDS or MDS/MPN. Design: Participants will be screened. They will have a physical exam with blood tests. They will have tests of their heart function. They may have a bone marrow biopsy: An area over the hip will be numbed; a needle will be inserted to remove a sample of soft tissue from inside the hipbone. Pacritinib is a capsule taken by mouth. All participants will take the study drug 2 times a day, every day, in 28-day cycles. They will write down the date and time they take each capsule. Doctors will assign varying dosages of the drug to different participants. Participants will have clinic visits each week during cycle 1; every 2 weeks during cycle 2; and gradually increasing to every 3 months after cycle 13. Treatment will continue for up to 8 years. Bone marrow biopsies, heart tests, and other tests will be repeated at intervals throughout the study. Participants will also fill out questionnaires about their quality of life, the symptoms of their disease, and other topics.

NCT ID: NCT06303115 Not yet recruiting - Smoking Clinical Trials

CSD231005 Nicotine Pouch Biomarkers of Exposure

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

This will be a multi center open label, randomized, controlled, switching parallel-group study designed to assess changes in select biomarkers of exposure (BoE) in generally healthy smokers following a 5 day in-clinic switch to use of nicotine Pouch investigational products (IPs) compared to continued usual brand (UB) cigarette smoking or smoking abstinence.