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NCT ID: NCT06385080 Recruiting - Clinical trials for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Recurrent/Metastatic Head and Neck Cancer

OrigAMI-4
Start date: April 22, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine safety and preliminary efficacy of amivantamab monotherapy, amivantamab in addition to pembrolizumab, and amivantamab in addition to paclitaxel in participants with recurrent/metastatic head and neck cancer. The study will also confirm the recommended Phase 2 combination dose (RP2CD) for amivantamab in addition to paclitaxel.

NCT ID: NCT06384885 Recruiting - Clinical trials for Swimming Induced Pulmonary Edema

Ultrasound Investigation Into Swimming Induced Pulmonary Edema in Open Water Swimming Athletes

SIPE
Start date: April 15, 2024
Phase:
Study type: Observational [Patient Registry]

Swimming-induced pulmonary edema (SIPE) is a potentially life-threatening condition that can affect swimmers of all abilities. The pathophysiology is not well understood and early identification strategies are not established. Handheld ultrasound is a validated tool for the identification of pulmonary edema and is not well-studied in this population. Understanding the incidence of signs of pulmonary edema and its usefulness as a sign of early pulmonary edema would be beneficial This study evaluates triathletes and open water swimmers at endurance events. A validated protocol for lung ultrasound is used to identify the signs of pulmonary edema. The findings will be analyzed for differences in experience level, type of athlete, gender, age, and environmental factors. The findings may then be used in the future to aid in the early identification and treatment of athletes and military personnel in similar situations to decrease morbidity and mortality.

NCT ID: NCT06384781 Recruiting - Opioid Use Disorder Clinical Trials

Development, Refinement, and Validation of a Peer Support Specialist Checklist for Individuals With Opioid Use Disorder / STAMPS: South Carolina Buprenorphine Treatment Initiation, Adherence, and Retention Utilizing Mobile Health Units and Peer Support Specialists

Start date: April 2024
Phase:
Study type: Observational

This study seeks to develop a tool to better guide and operationalize peer recovery coaching service delivery specifically for patients with opioid use disorder. This study will entail the initial development, acceptability, and validity of this tool in a sample of both peer support specialists (PSSs) and patients with opioid use disorder (OUD). This checklist will be adapted from ACE model PSS interventions for SUD broadly. Open-ended qualitative research questions regarding PSSs roles and responsibilities, patients' needs for recovery support, and perceptions of the checklist will be administered. Participants (PSSs and individuals with OUD) will also answer survey questions in which they indicate their satisfaction and likely to use the tool with the proposed services offered in the checklist. Outcome measures include satisfaction, perceived use of use, and perceived helpfulness of the checklist. We hypothesize that using both PSS and patient input will result in a validated intervention protocol with demonstrated acceptability using it with patients with OUD.

NCT ID: NCT06384651 Recruiting - Infections Clinical Trials

Intraosseous vs. Intravenous Vancomycin Administration in Total Ankle Arthroplasty

IOTAA
Start date: December 13, 2023
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare two different antibiotic regimens and techniques during total ankle arthroplasty (TAA). Primary Objective: Comparable levels of vancomycin will be found in bone, soft tissue, and systemic samples between patient groups. Secondary Objective: Compare 30 day and 90 day post-operative complication rates (infection) between the control (standard IV administration of vancomycin) vs the interventional group (intraosseous administration of vancomycin). The investigators hypothesize that there will be no difference in complication (infection) rates between groups.

NCT ID: NCT06384404 Recruiting - Osteosarcoma Clinical Trials

Upfront Surgical Resection for Osteosarcoma

UFSR for OS
Start date: March 25, 2024
Phase:
Study type: Observational

The goal of this pilot study is to learn about patients with newly diagnosed osteosarcoma of an extremity, and whether surgically removing the tumor prior to the administration of any chemotherapy will improve functional outcomes. In order to learn about the patient's experience, the study team will administer questionnaires to the patient and surgeon at various timepoints to assess recovery and the function of the extremity.

NCT ID: NCT06384378 Recruiting - Alzheimer Disease Clinical Trials

Systemic and Central Inflammation in AD

Start date: March 17, 2023
Phase: Phase 2
Study type: Interventional

Inflammation could provide a new focus for therapeutic intervention. In this study, we will measure blood and cerebrospinal fluid (CSF) inflammation biomarkers and compare them to measurements of brain glial activation obtained by positron emission tomography (PET). In addition, we will determine the effect of low-dose interleukin-2 (IL-2) immunotherapy, given over 22 weeks, on these inflammation biomarkers.

NCT ID: NCT06384079 Recruiting - Ureteral Stricture Clinical Trials

Duration of Ureteral Rest Prior to Ureteral Reconstruction Surgery

Start date: May 2024
Phase:
Study type: Observational

Our objective is to assess the effect of duration of ureteral rest, defined as time from conversion of ureteral stent to percutaneous nephrostomy, on stricture length prior to ureteral reconstruction surgery.

NCT ID: NCT06383026 Recruiting - Breast Cancer Clinical Trials

Transgender and Gender-Diverse Breast Cancer Screening Pilot

Start date: April 17, 2024
Phase:
Study type: Observational

This investigation is a prospective breast cancer screening study open to all transgender and gender-diverse persons (regardless of sex assigned at birth). Using a mixed methods approach, the study will 1) gather prospective quantitative breast imaging data in conjunction with gender-affirming therapy and family cancer history and 2) investigate TGD persons perceptions and experiences in the breast cancer screening program, and 3) identify individual and systems-level barriers to breast cancer screening.

NCT ID: NCT06382662 Recruiting - Clinical trials for Cognitive Impairment

Effect of Metaxalone 640 mg (M640) on Truck Driving Ability and Cognition Compared to Other Skeletal Muscle Relaxants

Start date: April 15, 2024
Phase: Phase 4
Study type: Interventional

Every participant will receive active study drug and (tone) 1 comparator, in two (2) stages, one after the other. Each drug will be taken one (1) time after a high fat meal. Vital signs and discussion of medications, illness or injury are considered safety assessments and will be discussed at every visit. There will be (four) 4 visits.

NCT ID: NCT06382311 Recruiting - Influenza, Human Clinical Trials

A Study to Find and Confirm the Dose and Assess Safety, Reactogenicity and Immune Response of a Vaccine Against Pandemic H5N1 Influenza Virus in Healthy Younger and Older Adults

Start date: April 18, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

The aim of this study is to evaluate the safety, reactogenicity and immunogenicity of the Flu Pandemic messenger RNA (mRNA) vaccine (including dose-finding and dose-confirmation) administered healthy adults 18 to 85 years of age.