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NCT ID: NCT05609032 Active, not recruiting - HIV Infections Clinical Trials

Development and Pilot Testing of the Sense2Quit App

Start date: March 6, 2023
Phase: N/A
Study type: Interventional

This is a pilot randomized controlled trial to examine the feasibility, acceptability and preliminary efficacy of the Sense2Quit App in a sample of 60 PLWH who smoke.

NCT ID: NCT05608044 Active, not recruiting - Clinical trials for Metastatic Colorectal Cancer

A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer

Start date: November 30, 2022
Phase: Phase 2
Study type: Interventional

This is an open-label, Phase 2, multicenter study to evaluate the efficacy, safety, tolerability, and pharmacokinetic profiles of botensilimab as monotherapy and in combination with balstilimab or standard-of-care treatments in participants with refractory metastatic colorectal cancer.

NCT ID: NCT05607576 Active, not recruiting - Diabetes Clinical Trials

Dexcom G6 for Total Pancreatectomy With Islet Autotransplantation (TPIAT) Patients

Start date: March 1, 2022
Phase: N/A
Study type: Interventional

A single-center prospective trial on the effects of standard of care radiation exposure on the Dexcom G6 continuous glucose monitoring (CGM) device.

NCT ID: NCT05607030 Active, not recruiting - Clinical trials for Prosthetic-joint Infection

A Second Trial of the Abbreviated Protocol Two-Stage Exchange

Apex-2
Start date: January 23, 2023
Phase: Phase 2
Study type: Interventional

Apex-2 is a multi-site, parallel group, randomized trial. Patients will be randomly assigned in a 1:1 ratio to the Experimental Arm or the Control Arm. The objective of the study is to evaluate safety and determine efficacy of the VT-X7 system. Efficacy is evaluated as superiority of the Experimental Arm in a composite endpoint of Overall Success at 180 days, consisting of a revision prosthesis implanted at Stage 2, absence of periprosthetic joint infection (PJI), absence of continued antibiotic therapy for treatment or prophylaxis of PJI, absence of revision surgery and absence of mortality. Secondary objectives are to evaluate overall success at 365 days, overall safety of the VT-X7 procedure, quality of life (QoL), and patient survival. The exploratory objective is to compare Experimental and Control Arms in exploratory endpoints. Follow-up: Patients will be evaluated at 90-, 180-, and 365-day follow-up visits.

NCT ID: NCT05606965 Active, not recruiting - Influenza Clinical Trials

A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Adults

Start date: November 2, 2022
Phase: Phase 2
Study type: Interventional

The main purpose of the study is to evaluate the safety, reactogenicity, and the humoral immunogenicity of mRNA-1010 and comparator influenza vaccines against homologous influenza A and B strains at Day 29.

NCT ID: NCT05606887 Active, not recruiting - Clinical trials for Burnout, Professional

Identifying Mental Health Distress in EM Physicians

Start date: October 3, 2023
Phase: N/A
Study type: Interventional

This project seeks to develop and test provider-centered strategies that improve the detection and facilitate the treatment of physiologic and mental health symptoms in emergency medicine physicians. This will be done by investigating the feasibility and acceptability of wearable device and EMA feedback with personalized linkage to an evidence-based mental health platform at the University of Pennsylvania Health System.

NCT ID: NCT05606328 Active, not recruiting - Delirium Clinical Trials

Implementation Outcome Assessments of the Emergency Department Delirium Screening and Detection Program

ED-DDP
Start date: February 28, 2023
Phase: N/A
Study type: Interventional

Delirium occurs in up to 20% of older adults presenting to the Emergency Department (ED) and is associated with poor outcomes. Failure to identify patients with ED delirium not only prevents initiation of mitigation strategies, but is also a barrier to advancing the field in terms of evaluating management and clinical outcomes. This project studies the potential of an ED Delirium Detection Program (ED-DDP), developed to address the need for consistent and accurate ED delirium detection. This research will have two objectives: - Aim 1 will conduct a pilot stepped wedge cluster randomized trial (SW-CRT) of the ED-DDP across 3 diverse EDs to determine preliminary efficacy of the detection training program, and - Aim 2 will use a mixed methods approach to assess RE-AIM implementation outcomes (Reach, Efficacy, Adoption, Implementation, and Maintenance) of the training program. Aim 1 will consist of a multicomponent 1-day delirium champion workshop where the training is delivered, real-time direct observation/training of champions via telehealth, practical training of nurses throughout each ED by champions, and patient chart review. In Aim 2, the investigators will assess implementation outcomes using training logs, tele-observation, interviews with champions and nurses, and electronic medical record screening. The overarching aim of this proposal is to determine the preliminary efficacy of the training program for improving ED delirium screening, detection, and management in older adults, while also evaluating implementation outcomes of the program for champions/nurses. The investigators will use findings from this study to inform a full-scale SW-CRT to evaluate the impact of the program on patient outcomes at Northwell Health. The long-term goal of this study is to implement and disseminate a comprehensive ED-DDP that will improve screening, detection, and management of ED delirium in older adults.

NCT ID: NCT05606003 Active, not recruiting - COVID-19 Clinical Trials

Using a Community-level Just-in-Time Adaptive Intervention to Address COVID-19 Testing Disparities

Start date: June 7, 2021
Phase: N/A
Study type: Interventional

In collaboration with community partners, this study will identify disparities and dynamics of COVID-19 testing and infections in three Texas regions; and implement a multilevel intervention that increases access to testing and referrals to follow-up care among vulnerable populations. Using a three-arm group-randomized controlled trial, this study will assess the impact of multi-level interventions influencing motivation and access to testing. The outcomes of this study are measured at the population level and no individual data will be gathered. Analyses of de-identified PHI data from local and regional health departments on COVID testing and infection rates will be used to assess intervention outcomes.

NCT ID: NCT05605964 Active, not recruiting - Prostate Cancer Clinical Trials

Randomized Study to Evaluate MACE in Patients With Prostate Cancer Treated With Relugolix or Leuprolide Acetate

Start date: January 25, 2023
Phase: Phase 3
Study type: Interventional

This was a randomized study to evaluate the risk of major adverse cardiovascular events (MACE) for relugolix compared with leuprolide acetate. Enrollment in this study was discontinued by the Sponsor on 01 Dec 2023. In an effort to mitigate any treatment interruptions, actively enrolled patients will be allowed to remain on study drug up to a period of 12 months ending Dec 2024 if they choose to remain in the discontinuation phase of the study.

NCT ID: NCT05605782 Active, not recruiting - Clinical trials for Multiple Sclerosis, Relapsing-Remitting

A Post-Authorization, Long-term Study of Ozanimod Real-world Safety

ORION
Start date: June 30, 2022
Phase:
Study type: Observational

The purpose of this study is to determine the rates of adverse events of interest (AEIs) in a real-world population of participants with relapsing remitting multiple sclerosis (RRMS) receiving Ozanimod, sphingosine-1 phosphate (S1P) receptor modulator, compared to the rates of these events in two population of participants: - Participants not exposed to ozanimod with RRMS who have received treatment with other S1P-receptor modulators disease modifying treatments (DMTs) - Participants not exposed to ozanimod with RRMS who have received treatment with other non-S1P-receptor modulators disease modifying treatments (DMTs)