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NCT ID: NCT06067555 Recruiting - Vaccine Reaction Clinical Trials

Intradermal Influenza Vaccination

Start date: January 24, 2024
Phase: Early Phase 1
Study type: Interventional

The goal of this study is to characterize the immune response, both innate and adaptive, as well as locally and systemic, to intradermal (ID) vaccination in healthy individuals. The intervention involves intradermal administration of an FDA-approved intramuscular seasonal influenza vaccine, using an FDA-approved device MicronJet. Investigators will measure antibody titers, cell subtypes, and multi-omic profiles, by collecting skin and peripheral blood at baseline and at several time points after vaccination. The primary objective is to identify baseline correlates of immune response in the skin and peripheral blood to the seasonal influenza vaccine. The investigators secondary goals are to describe the inflammatory response in the skin over time.

NCT ID: NCT06067503 Recruiting - Breast Cancer Clinical Trials

Biomarkers to Detect Endocrine Therapy Resistance

Start date: April 30, 2024
Phase: Phase 2
Study type: Interventional

This pilot observational study is being done to identify possible biomarkers of response to endocrine therapy in patients with ER/PR+ metastatic lobular breast cancer (LBC) starting new endocrine therapy. 18F-fluorofuranylnorprogesterone Positron Emission Tomography/Computed Tomography (FFNP-PET/CT) and liquid biopsies will be performed at baseline and after 4 weeks of treatment. Baseline levels and dynamic on-treatment changes in estrogen signaling as measured by FFNP-PET/CT and circulating tumor cell (CTC) liquid biopsy will be correlated with clinical response to endocrine therapy and progression-free survival in the above cohort of patients.

NCT ID: NCT06067451 Recruiting - PreDiabetes Clinical Trials

SMART GOALS for Youth With Prediabetes

Start date: December 10, 2023
Phase: N/A
Study type: Interventional

The goal of this study is to compare the impact of a SMART ((specific, measurable, attainable, realistic, or timely) Goal setting protocol on body weight, metabolic parameters (Hemoglobin A1c, lipids), diet quality and physical activity frequency in obese children with prediabetes in the outpatient setting. The main question is if participants using the SMART Goal Setting Protocol (SGSP) will have a significant reduction. The participants randomized to the study group will receive the SGSP, consisting of the SMART Goal Selection Guide (SGSG) and Weekly Goal Monitoring Tool (WGMT), in BMI Z-score, A1c, and dyslipidemia in 6 months compared to controls.

NCT ID: NCT06067438 Recruiting - Atrial Fibrillation Clinical Trials

Amiodarone for the Prevention of Atrial Fibrillation After Minimally Invasive Esophagectomy in Patients With Esophageal Cancer

Start date: July 25, 2024
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well amiodarone works in the prevention of atrial fibrillation (AF) after a minimally invasive esophagectomy (MIE) in patients with esophageal cancer. Atrial fibrillation (AF) is an irregular heart rhythm, usually associated with a rapid rate, that is caused by abnormal electrical activity within the atria. AF is the most common complication after MIE for esophageal cancer. There has never been a study of AF after MIE that has used unbiased assignment of patients to receive preventative amiodarone or not. Further, there is no standard recommendation or guideline for preventative medications, such as amiodarone, to decrease the risk of AF in patients having MIE performed for cancer. In fact, most medical centers in the United States and around the world do not give preventative amiodarone after esophagectomy. Giving amiodarone after MIE surgery may be able to reduce the risk of AF for patients with esophageal cancer.

NCT ID: NCT06067347 Recruiting - Clinical trials for T-Cell and NK-Cell Neoplasm

A Global Study of the PETAL Consortium

PETAL
Start date: January 2024
Phase:
Study type: Observational [Patient Registry]

The goal of this observational study is to correlate molecular alterations with outcomes including overall survival (OS), progression-free survival (PFS) for patients with a new diagnosis, primary refractory or relapse, of mature T-cell and NK-cell neoplasms (TNKL). We hypothesize that machine learning will uncover distinct genetic vulnerabilties that underlie treatment response and resistance for patient with TNKL.

NCT ID: NCT06067295 Recruiting - Prostate Carcinoma Clinical Trials

Longitudinal Advanced Prostate Cancer Cohort (LAPCC)

Start date: February 21, 2023
Phase:
Study type: Observational

This study examines information from patients with prostate cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). By collecting biological samples (like blood, urine, and tissue), and health information (such as treatment, diet, and quality of life) researchers hope to learn more about prostate cancer and ways to improve outcomes in the future.

NCT ID: NCT06067269 Recruiting - Clinical trials for Prostate Adenocarcinoma

Hormone Therapy (Apalutamide) and Image-guided Stereotactic Body Radiation Therapy for the Treatment of Patients With Prostate Cancer, HEATWAVE Trial

HEATWAVE
Start date: March 28, 2024
Phase: Phase 2
Study type: Interventional

This phase II trial evaluates apalutamide in combination with image-guided stereotactic body radiation therapy (SBRT) for the treatment of patients with prostate cancer. Prostate cancer usually needs the hormone testosterone to grow. Apalutamide is a hormone therapy that blocks the effect of testosterone on prostate tumor cells. This may help stop the growth of tumor cells that need testosterone to grow. Image-guided SBRT is a standard treatment for some types of prostate cancer. This treatment combines imaging of cancer within the body, with the delivery of therapeutic radiation doses produced on a linear accelerator machine. SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Combining apalutamide with image-guided SBRT may increase a prostate cancer patient's chances of achieving an extremely low prostate specific antigen response, which is an early predictor of disease cure.

NCT ID: NCT06067230 Recruiting - Clinical trials for Respiratory Syncytial Virus

A Study to Investigate the Immunogenicity and Safety of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in High-risk Adults

Start date: October 6, 2023
Phase: Phase 3
Study type: Interventional

The study is divided into 2 parts (Part A and Part B). Part A of the study will evaluate the safety and immune response to mRNA-1345 in high-risk adults aged ≥18 to <60 years. Part B of the study will evaluate the safety and immune response to mRNA-1345 in adults who received solid organ transplant (SOT).

NCT ID: NCT06067139 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Sleep for Health Study on the Effects of Cognitive Behavioral Therapy for Insomnia on Diabetes Risk

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

This study tests whether providing cognitive behavioral therapy for insomnia (CBT-I) to people with prediabetes results in a reduction in glucose levels compared to a patient education control program.

NCT ID: NCT06067126 Completed - Overweight Clinical Trials

Post-delivery Maternal-offspring Obesity and Metabolic Risk After a Prepregnancy Weight-loss Intervention

PrepareD
Start date: April 3, 2019
Phase:
Study type: Observational

The goal of PrepareD is to examine whether the prepregnancy weight-loss intervention administered during the Prepare trial [NCT02346162] has an influence in the postnatal period. PrepareD is a cohort study (no intervention) that will address new specific aims through one in-person visit with mothers and children, dietary recalls, actigraphy, and the use of medical record weights. The goal is to collect data when the child is 3 years old. However, due to the COVID-19 pandemic, the investigators expanded the data collection window in order to collect data up to when the child is 5 years old. The investigators hypothesize that intervening on women before pregnancy is the key to breaking the multigenerational cycle of obesity.