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NCT ID: NCT05096286 Completed - Clinical trials for Intracranial Metastatic Disease From Any Solid Malignancy

Simulation-Free Hippocampal-Avoidance Whole Brain Radiotherapy Using Diagnostic MRI-Based and Cone Beam Computed Tomography-Guided On-Table Adaptive Planning in a Novel Ring Gantry Radiotherapy Device

Start date: January 25, 2022
Phase: N/A
Study type: Interventional

Hippocampal-avoidance whole brain radiation therapy (HA-WBRT) limits radiation dose to the hippocampal-avoidance region while still delivering therapeutic doses of radiation to the whole brain. When used in addition to prophylactic memantine, this technique has been shown to better preserve cognitive function in patients with brain metastases outside of the hippocampal-avoidance region with no difference in intracranial progression-free and overall survival. However, HA-WBRT requires considerably longer planning time when compared to conventional WBRT (5-10 business days, compared to next-day), and studies have shown that brain metastases can grow in as rapidly as one week. A proposed solution for quicker initiation of HA-WBRT is the use of simulation-free radiation treatment planning, in which pre-existing diagnostic images are used to generate the radiation treatment plan (as opposed to acquiring planning-specific image sets). This will be paired with the use of artificial intelligence (AI)-assisted semi-automated planning using the FDA-approved treatment planning system called Ethos Therapy. The investigators have developed an institutional HA-WBRT auto-planning template, which has been retrospectively validated for the creation of plans that are compliant with the gold standard NRG Oncology CC001 clinical trial and are dosimetrically comparable to traditional HA-WBRT plans. Semi-automated plans will be constructed using diagnostic imaging, which will be refined as needed (adjustments for difference in gross head positioning between diagnostic imaging and radiation treatment positioning, etc.) while the patient is on the treatment table at fraction one using adaptive radiation planning. Adaptive radiotherapy is standard-of-care practice for other disease sites. The purpose of this study is to demonstrate the feasibility and safety of a simulation-free workflow for HA-WBRT that is AI-assisted and semi-automated.

NCT ID: NCT05096247 Completed - Wrinkle Clinical Trials

Post Market Study To Collect Efficacy Data For The Treatment Of Wrinkles With A Radiofrequency Device

Start date: September 3, 2021
Phase: N/A
Study type: Interventional

The intended use of the RF (radiofrequency) device used in this study is to assess the efficacy of the handpiece for the treatment of facial wrinkles. If the other device (Intense Pulsed Light) laser in this study is used, the intended use will be for the treatment of benign pigmented and/or vascular lesions.

NCT ID: NCT05096208 Completed - RSV Clinical Trials

Clinical Lot Consistency for RSVpreF in a Population of Healthy Adults 18 to ≤49 Years of Age

Start date: October 21, 2021
Phase: Phase 3
Study type: Interventional

This randomized, double-blinded, placebo-controlled Phase 3 study is designed to evaluate the safety, tolerability, and immunogenicity of 3 lots of RSVpreF in healthy adults.

NCT ID: NCT05096156 Completed - Contact Lens Clinical Trials

Evaluation of Wear Experience With Daily Contact Lenses

Start date: May 28, 2021
Phase: N/A
Study type: Interventional

To evaluate the wear experience of current monthly replacement contact lens wearers after they have been fit into a daily disposable contact lens.

NCT ID: NCT05096143 Completed - Heart Failure Clinical Trials

A Cohort Study to Compare the Hospitalization Between Naive Sacubitril/Valsartan and Naive ACEi/ARBs Heart Failure Patients With Reduced Ejection Fraction Using Secondary US Electronic Health Records Data

Start date: June 3, 2020
Phase:
Study type: Observational

A non-interventional retrospective cohort study conducted to compare the naive sacubitril/valsartan Heart Failure with reduced Ejection Fraction (HFrEF) patient population to a matched naive ACEi/ARB HFrEF patient population.

NCT ID: NCT05096117 Completed - Clinical trials for Alcohol Use Disorder

Human Laboratory Study of ASP8062 for Alcohol Use Disorder

Start date: December 13, 2021
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the effects of ASP8062, 25 mg once a day and matched placebo, on alcohol cue-elicited alcohol craving during a human laboratory paradigm after 2 weeks of daily dosing among subjects with moderate to severe alcohol use disorder (AUD) as confirmed by the Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5™). Secondary objectives include evaluation of ASP8062, 25 mg once a day, and matched placebo on reduction of alcohol consumption, alcohol craving, cigarette smoking (among smokers) and nicotine use (among nicotine users), mood, sleep, alcohol use negative consequences, study retention, and safety and tolerability throughout the last 4 weeks of the treatment phase of the study.

NCT ID: NCT05096039 Completed - Heart Failure Clinical Trials

Role of Sacubitril/Valsartan in Improving Provider Performance in Managing Heart Failure Under Medicare Alternative Payment Models

Start date: April 10, 2020
Phase:
Study type: Observational

This study evaluated the association between sacubitril/valsartan utilization and HF patients' Part A & B expenditures within the reimbursement framework of BPCI and MSSP, and identified BPCI/MSSP participants with the greatest potential for performance improvement (with respect to improving quality and efficiency of care for HF patients) through optimized utilization of sacubitril/valsartan.

NCT ID: NCT05096026 Completed - Vaccination Clinical Trials

Effect of Electronic and Mail Outreach From Primary Care Physicians for COVID-19 Vaccination Among Elderly Patients

Start date: March 29, 2021
Phase: N/A
Study type: Interventional

This randomized controlled trial tested the effect of culturally tailored and standard electronic secure messages and mailings from patients' primary care physicians to encourage COVID-19 vaccination among adults aged 65 and older.

NCT ID: NCT05095818 Completed - Clinical trials for Pre-Exposure Prophylaxis (PrEP)

Impact of Nursing Involvement on Implementation of HIV Prevention Services

PrEP-RN
Start date: April 1, 2021
Phase: N/A
Study type: Interventional

Women comprise 20% of new Human Immunodeficiency Virus (HIV) diagnoses in the United States (U.S.) with 86% attributed to heterosexual contact. HIV pre-exposure prophylaxis (PrEP) uptake among cisgender women (women who are assigned female at birth and identify as women) is low. A randomized controlled trial (RCT) will assess the feasibility and effectiveness of a registered nurse (RN)-led PrEP project in Obstetrics and Gynecology (OB/GYN) clinics. The PrEP-RN will counsel patients about their risks for HIV acquisition via telemedicine. Under protocol guidance, the PrEP-RN will order laboratory tests and initiate PrEP for at-risk women. A total of 440 at-risk cisgender women will be randomized 1:1 to the standard of care with electronic medical record (EMR) enhancements (e-SOC) or e-SOC with the PrEP-RN.

NCT ID: NCT05095792 Completed - Clinical trials for Treatment-resistant Depression

Effect of Ketamine on Neurological Activity as Measured by Electroencephalogram (EEG)

Start date: November 9, 2021
Phase:
Study type: Observational

This observational study will allow data to be collected to demonstrate changes in brain activity following administration of standard of care (SOC) Ketamine. By comparing genetic markers across participants, data on impact of genetic markers and response to Ketamine will also be analysed. This data will contribute to the design of future studies utilizing Ketamine for various psychiatric disorders. This study will focus on treatment-resistant Major Depressive Disorder (MDD).