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NCT ID: NCT05763719 Active, not recruiting - Mental Health Issue Clinical Trials

Pathways to Improved Adolescent Mental Health in Conflict Affected Families

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

The study combined a youth-friendly economic empowerment program (Rabbits for Resilience (RFR) with a gender equality couple curriculum program (HIKA) to advance knowledge on the combined and synergistic impact of structural interventions and pathways with families for improved adolescent mental health in resource-poor communities. The investigators' multidisciplinary team will conduct a randomized controlled trial with three arms (RFR only, HIKA only, RFR + HIKA) with young adolescents ages 10-14 years and the adolescents' mothers and fathers living in 1080 rural households in 30 villages in two rural conflict-affected territories of South Kivu province of Eastern Democratic Republic of Congo (DRC)

NCT ID: NCT05763407 Active, not recruiting - Heart Failure Clinical Trials

Early Feasibility Study of the FIRE1™ System in Heart Failure Patients (FUTURE-HF2)

Start date: June 19, 2023
Phase: N/A
Study type: Interventional

Early Feasibility Study of the FIRE1™ System in Heart Failure Patients to evaluate the feasibility and safety of implanting the FIRE1 system in stable HF patients

NCT ID: NCT05763381 Active, not recruiting - Plantar Fascitis Clinical Trials

Low-Level Laser Therapy for Plantar Fasciitis

Start date: August 11, 2022
Phase: N/A
Study type: Interventional

Plantar fasciitis (PF), a degenerative injury of the connective tissue in the foot, results in pain-related disability in Service Members and contributes to decreased physical activity and excessive healthcare costs. Even if effective, current treatment protocols may require 6-12 months of therapy to return individuals to pain-free activity. Photobiomodulation therapy (PBMT) uses non-ionizing light to elicit biological changes in tissues resulting in beneficial therapeutic outcomes. Evidence supports use of PBM for other degenerative connective tissue conditions, such as achilles tendinopathy and epicondylitis. A previous pilot study was completed in an active-duty military and civilian population, which demonstrated a positive effect of two PBM dose parameters on function and pain levels in participants with chronic PF when combined with stretching and ice. These positive findings from the aforementioned study are promising in the treatment of this common and debilitating issue, but require the addition of a sham comparison to rigorously eliminate any potential placebo effect of the treatment protocol, and further refine the treatment protocol in order to make evidence-based clinical recommendations. As such, proposing a follow-up study and the addition of an objective outcome measure will strengthen the impact of the study. SPECIFIC AIM 1: To assess the clinical effectiveness of photobiomodulation compared to sham photobiomodulation to improve function and decrease pain. SPECIFIC AIM 2: To evaluate the effectiveness of photobiomodulation compared to sham photobiomodulation to resolve plantar fascial thickening. DESIGN: A prospective randomized sham-controlled trial to meet the aims of the study. METHOD: A sample of up to 100 active-duty military members will be randomly assigned to the Sham-PBMT or PBMT group. At baseline, during the treatment protocol, and at long-term (3 and 6 months) follow-up, measures of foot function, pain, and plantar fascial thickness will be collected for analysis. The proposed methods will allow the study team to establish if PBMT is clinically effective to accelerate recovery compared to Sham-PBMT and result in resolution of fascial thickening, decrease in pain, and improved function. LONG-TERM GOAL: The long-term goals of the research include developing PBMT protocols for broad application to other painful and duty-limiting conditions.

NCT ID: NCT05762835 Active, not recruiting - Pediatric Disorder Clinical Trials

Neonatal Intensive Care Unit Virtual Family-Centered Rounds

Start date: March 13, 2023
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate the impact of virtual family-centered rounds in the neonatal intensive care unit on parental and neonatal outcomes.

NCT ID: NCT05762445 Active, not recruiting - Clinical trials for Chronic Pancreatitis

PAtient-CenTric Chronic Pancreatitis Registry (PACT-CP)

PACT-CP
Start date: June 2, 2021
Phase:
Study type: Observational [Patient Registry]

The main objective of this study is to generate real-world evidence reflecting the experience of individuals with exocrine pancreatic insufficiency (EPI) due to chronic pancreatitis (CP). Efforts will be directed toward understanding the unmet need and therapeutic burden to identify the most critical factors that influence treatment choices/prescribing patterns, quality of life, and healthcare utilization outcomes in standard of care for individuals with EPI due to CP.

NCT ID: NCT05762419 Active, not recruiting - Clinical trials for Diffuse Intrinsic Pontine Glioma

FUS Etoposide for DMG

Start date: June 5, 2023
Phase: Phase 1
Study type: Interventional

The blood brain barrier (BBB) prevents some drugs from successfully reaching the target tumor. Focused Ultrasound (FUS) using microbubbles and neuro-navigator controlled sonication is a non-invasive method of temporarily opening up the blood brain barrier to allow a greater concentration of the drug to reach into the brain tumor. This may improve response and may also reduce system side effects in the patient. The primary purpose of this study is to evaluate the feasibility of safely opening the blood brain barrier in children with progressive diffuse midline gliomas (DMG) treated with oral etoposide using focused ultrasound with microbubbles and neuro-navigator-controlled sonication. For the purpose of the study, the investigators will be opening up the blood brain barrier temporarily in one or two locations around the tumor using the non-invasive focused ultrasound technology, and administrating oral etoposide in children with progressive diffuse midline glioma.

NCT ID: NCT05762133 Active, not recruiting - Clinical trials for Maternal Perinatal Depression

African-American Social Support Effectiveness Treatment

ASSET-PPD
Start date: August 27, 2020
Phase: N/A
Study type: Interventional

The objective of this treatment study is to develop and test an augmentation therapy in conjunction with maternal psychiatric treatment that targets the fathers' support of the mothers' mental health and contributions to the family environment to reduce maternal stress. The African-American Social Support Effectiveness Treatment-Partners alleviating Perinatal Depression (ASSET-PPD) intervention will be delivered to fathers in an individual setting to target the context in which a mother lives to expand her support beyond the direct reach of her treatment professional. This study provides skills and training to fathers who have a partner with prenatal depression. The aim is to reduce maternal depression during the perinatal period and improve the family environment for the infant.

NCT ID: NCT05760248 Active, not recruiting - Clinical trials for Subcutaneous Fat Disorder

Safety and Efficacy Study of 10XB-101 in Adults With Bilateral Flank Adiposity

Start date: May 4, 2023
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to test the safety and effectiveness of an injection study drug in decreasing bilateral flank adiposity. The main question it aims to answer is: •How safe and effective is the injection study drug in removing bilateral flank adiposity compared to a placebo? Participants will be: - Be given injections every month for 5 months over the right and left flanks. - Be asked to be seen in the clinic for 13 visits and 3 phone call visits during a duration of 1 year.

NCT ID: NCT05759949 Active, not recruiting - Breast Cancer Clinical Trials

First-in-Human Study of RLY-5836 in Advanced Breast Cancer and Other Solid Tumors

Start date: March 29, 2023
Phase: Phase 1
Study type: Interventional

This is a Phase 1, first-in-human, open-label study designed to evaluate the maximum tolerated dose (MTD), recommended phase 2 dose (RP2D), safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of RLY-5836 in advanced solid tumors in participants harboring a PIK3CA mutation in blood and/or tumor per local assessment. The study consists of 2 parts, a dose escalation (Part 1) and a dose expansion (Part 2).

NCT ID: NCT05758415 Active, not recruiting - Clinical trials for Rotator Cuff Tendinopathy

Study of Efficacy and Safety of Secukinumab in Participants With Moderate-severe Rotator Cuff Tendinopathy

Start date: August 2, 2023
Phase: Phase 3
Study type: Interventional

The purpose of the present study is to assess the efficacy of secukinumab 300 mg s.c. (subcutaneous) compared to placebo, each in combination with standard of care, in improving signs, symptoms and physical function in participants with moderate to severe rotator cuff tendinopathy (RCT), using a randomized, double-blind, placebo controlled, parallel group design to minimize bias.