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NCT ID: NCT06112314 Recruiting - Advanced Melanoma Clinical Trials

IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301)

PRISM-MEL-301
Start date: December 18, 2023
Phase: Phase 3
Study type: Interventional

This is a phase 3, randomized, controlled study of IMC-F106C plus nivolumab compared to standard nivolumab regimens in HLA-A*02:01-positive participants with previously untreated advanced melanoma.

NCT ID: NCT06112301 Recruiting - Clinical trials for B-Cell Lymphoproliferative Disorder

Pivotal, Clinical Study for the Accuracy Evaluation of the IdentiClone Dx IGH Assay

Start date: January 2, 2024
Phase:
Study type: Observational

This protocol describes the pivotal accuracy study for the IdentiClone Dx IGH (IC IGH Dx) Assay. The intent of the accuracy study is to demonstrate agreement between the results of the IC IGH Dx Assay and a predicate devise or assay on retrospective and residual de-identified DNA extracted from peripheral blood (PB) samples from individuals with suspected B-Cell Lymphoproliferations. The predicate device will be the LymphoTrack Dx IGH (FR1/FR2/FR3) Assays - MiSeq (LT Dx IGH-CE-IVD), which is a CE-IVD assay with a similar intended use as the IC IGH Assay on the same sample type.

NCT ID: NCT06112249 Recruiting - Prevention Clinical Trials

SAFE Workplace Intervention for People With IDD

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

The purpose of this study is to examine the feasibility and efficacy of a systematic training approach targeting behaviors to increase safety and prevention of airborne diseases such as COVID-19 in the workplace for individuals with Intellectual and Developmental Disabilities (IDD). This project is designed to determine proof of concept and proof of product for a peer support intervention, the SAFE program, to increase knowledge and safe workplace practices. There is an identified immediate need for individuals with IDD to receive training in an accessible format. The SAFE program has been developed in an accessible format for those with IDD. It focuses on education regarding actionable behaviors that reduce the risk of acquiring and transmitting COVID-19 and other airborne diseases. The study will implement a peer-mediated and occupational therapy lead program, SAFE, to identify and address potential implementation issues and further refine the program curriculum. Additionally, the efficacy of the program on perceived safety and well-being, observable preventative behaviors and self-advocacy will be examined.

NCT ID: NCT06112093 Recruiting - Headache Clinical Trials

Repetitive Transcranial Magnetic Stimulation for Post-concussion Headaches

Start date: October 23, 2023
Phase: N/A
Study type: Interventional

This study aims to examine the long-term effect of repetitive transcranial magnetic stimulation (rTMS), a non-invasive brain stimulation technique, on chronic headaches following mild traumatic brain injury (mTBI). rTMS has been shown to be effective in reducing chronic headaches without side effects commonly seen in medications, such as sleepiness and addiction. This study uses rTMS to manage chronic headaches to improve post-concussion symptoms and reduce the economic burden due to delayed recovery. This project aims to better identify biomarkers for diagnosis and prognosis and maximize recovery from mTBI.

NCT ID: NCT06112080 Recruiting - Asthma Clinical Trials

Wearable Auscultation Device Validation in Children

Start date: August 7, 2023
Phase:
Study type: Observational

This observational clinical study is an evaluation of a diagnostic tool through comparison. Similar to a validation study, the output of the RESP device will be compared to physician auscultation, surrogated by having an attending pulmonologist listen to blinded recordings.

NCT ID: NCT06112002 Recruiting - Clinical trials for Malignant Solid Neoplasm

Evaluation of an Education Program to Increase Knowledge and Participation in Clinical Trials Among Racial/Ethnic and Rural Populations

Start date: August 15, 2022
Phase: N/A
Study type: Interventional

This clinical trial evaluates a culturally tailored educational outreach intervention for increasing clinical trial knowledge, referral, and participation among racial/ethnic minority and rural populations. Clinical trials are research studies that involve people. Through clinical trials, researchers are able to determine whether new treatments are safe and effective and work better than current treatments. Clinical trials can also help find new ways to prevent and detect cancer and improve the quality of life for people during and after treatment. Recruitment and retention of underrepresented groups in clinical trials remains a challenge. Racial and ethnic minority groups bear a disproportionate burden of cancer compared with other groups yet these populations continue to be underrepresented in clinical trials. This clinical trial uses community health educators (CHEs) to facilitate individual and group education sessions to improve knowledge of what constitutes a clinical trial, the value of participating in clinical trials, and why it is important for racial/ethnic minorities to participate in clinical trials.

NCT ID: NCT06111794 Not yet recruiting - Clinical trials for Traumatic Brain Injury

The REACH Intervention for Caregivers of Veterans and Service Members With TBI

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

This randomized waitlist control trial will evaluate the effects of a psychoeducational intervention called Resources for Enhancing All Caregivers' Health - Traumatic Brain Injury (REACH TBI) to decrease caregiver strain (primary outcome) and improve caregiver self-efficacy, anxiety, depression, and health care frustrations (secondary outcomes). This study will modify and adapt an award-winning caregiver intervention, Resources for Enhancing All Caregivers Health in the Department of Veterans Affairs (REACH VA), to support the needs of Caregivers of Veterans and Service Members with TBI.

NCT ID: NCT06111781 Recruiting - Prostate Cancer Clinical Trials

The SUGAR Study: (SBRT and Ultrashort GnRH Antagonist-Relugolix) for Clinicogenomic Unfavorable Intermediate Risk Prostate Cancer

Start date: April 15, 2024
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to measure the toxicity and effectiveness of the following treatments for cFIR/cgUIR prostate cancer patients. Stereotactic body radiotherapy (SBRT) alone or Stereotactic body radiotherapy (SBRT) combined with Ultrashort GNRH Antagonist called Relugolix (an oral drug). Treatments will be randomly assigned to study patients. The main questions it aims to answer are the following: 1. Whether the proportion of men who undergo SUGAR have a superior rate of attaining PSA nadir of <= 0.2 compared to SBRT alone, and 2. Whether SUGAR is superior to historical rates of minimal clinically important decline (MCID) in sexual and hormonal function at 6 months for patients undergoing 6 months of androgen deprivation therapy (ADT) Men aged 18+ with cFIR/cgUIR will be enrolled. Specifically, patients must meet one of the following 2 criteria: 1) Gleason score must be Gleason 3+4 with a PSA < 20 ng/mL, or 2) Gleason 6 (3+3) and PSA > 10 ng/mL and < 20 ng mL.

NCT ID: NCT06111768 Recruiting - Clinical trials for Cardiorenal Syndrome

Sodium-Glucose Cotransporter-2 Inhibitor for Acute Cardiorenal Syndrome: A Feasibility Study

SGLT2i in CRS
Start date: May 30, 2024
Phase: Phase 2
Study type: Interventional

The long-term objective of this study is to test whether the addition of SGLT2 inhibitors to usual care during acute heart failure management in patients who develop kidney injury shortens the time to achieving symptomatic improvement and kidney function recovery. The study aims to assess feasibility and acceptability of such a randomized clinical trial.

NCT ID: NCT06111755 Recruiting - Smoking Cessation Clinical Trials

Quit Smoking Text Message Study

Start date: March 26, 2024
Phase: N/A
Study type: Interventional

This project will address research gaps and advance the science of smoking cessation by conducting a randomized controlled trial of an evidence-based, population-level quit smoking text messaging program with or without a smartband.