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NCT ID: NCT05351047 Completed - Healthy Volunteers Clinical Trials

A Study to Assess Safety, Tolerability, PK and PD of AZD2373 in Healthy Male Participants of Sub-Saharan West African Ancestry

Start date: April 4, 2022
Phase: Phase 1
Study type: Interventional

This is a Phase 1 study to assess the the safety, tolerability and pharmacokinetics (PK) of AZD2373, following subcutaneous (SC) administration of multiple ascending doses (MAD) of AZD2373 in healthy male participants of sub-Saharan West African ancestry.

NCT ID: NCT05350800 Completed - Healthy Volunteer Clinical Trials

A Study to Evaluate the Drug Exposure of Single Ascending Doses of BMS-986369 and the Effect of Food on the BMS-986369 in Healthy Participants

Start date: September 12, 2022
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, drug levels of BMS-986369 following administration of single ascending oral doses (SAD) in healthy adult participants. The study will also explore the effect of high-fat meal on the single-dose drug level of BMS-986369 in healthy adult participants.

NCT ID: NCT05350514 Completed - Clinical trials for Diabetes Mellitus, Type 2

Preclinical Imaging Biomarkers of Alzheimer's Disease Neuropathology in Young Adults With Youth-onset Diabetes: a Proof-of-concept Study

Start date: July 19, 2022
Phase:
Study type: Observational [Patient Registry]

The goal of the study is to characterize preclinical Alzheimer's Disease and related dementias (AD/ADRD) neuropathology in a selected group of young adults with youth-onset diabetes, and an age-similar group of young adults without diabetes.

NCT ID: NCT05350501 Completed - Colorectal Cancer Clinical Trials

EO2040 in Combination With Nivolumab, for Treatment of Patients With Minimal Residual Disease of Colorectal Cancer

CLAUDE
Start date: March 1, 2023
Phase: Phase 2
Study type: Interventional

The current study will evaluate the microbiome-derived therapeutic vaccine EO2040 in combination with nivolumab in patients with circulating tumor DNA-defined Minimal Residual Disease (MRD) of colorectal cancer stage II, III, or IV after completion of standard curative therapy.

NCT ID: NCT05350449 Completed - Loneliness Clinical Trials

Loving Kindness Meditation Among Adults 50 Years and Older

Start date: May 2, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test the feasibility and acceptability of loving-kindness meditation among adults 50 years and older. It will also examine the benefits of this intervention and compare the outcomes between two groups (intervention and wait-list control).

NCT ID: NCT05350423 Completed - Nephrolithiasis Clinical Trials

Trial Assessing Renal Damage During Ureteroscopy

Start date: October 22, 2021
Phase: N/A
Study type: Interventional

This is an ongoing randomized controlled trial of patients undergoing URSLL with unilateral non-obstructing renal stones. Patients are randomized to undergo URSLL with either the TFL or Ho:YAG laser. Each patient's urine is collected immediately pre-op (V1), 1 hour post-op (V2), and 10 days post-op (POD#10, V3). Samples are analyzed by enzyme-linked immunosorbent assay (ELISA) for the following biomarkers: Kidney injury molecule-1 (KIM-1), Neutrophil gelatinase-associated lipocalin (NGAL), and β2-microglobulin (β2M), then normalized to urine creatinine.

NCT ID: NCT05350410 Completed - Dementia Clinical Trials

"Healthy Actions and Lifestyles to Avoid Dementia or Hispanos y el ALTo a la Demencia Program"

HALT-AD
Start date: April 5, 2022
Phase: N/A
Study type: Interventional

This initial four-months pilot study will focus on at least three educational courses (introduction to dementia and lifestyle risk factors, sleep and diet). It may also include a fourth educational course on social connectivity and loneliness. Completion of this initial pilot study will allow for a round of improvements informed by data from the program, on usability, as well as feedback from participants and citizen advisors. This will allow for an iterative process to build the program to its full content, with feedback to optimize the user experience and ensure the accessibility of the content. The information generated from this study will help inform the development of the second program's prototype, expected to benefit from the initial pilot to become more user-friendly, effective and accessible to the target audience. This pilot study will be a longitudinal study of an inception cohort exposed to the HALT-AD online educational program for a four-month study. It will utilize pre- and post- intervention collection of quantitative and qualitative data to evaluate the program's first prototype.

NCT ID: NCT05350319 Completed - Clinical trials for Shoulder Arthroplasty

Prospective Low Dose CT for Total Shoulder Arthroplasty/Reverse Shoulder Arthroplasty

Start date: November 21, 2022
Phase:
Study type: Observational

This study is a prospective, departmental funded study examining the outcomes of simulated Low Dose CT scans compared to Conventional Dose CT scans in patients who present to Duke University for total shoulder arthroplasty or reverse shoulder arthroplasty.

NCT ID: NCT05350189 Completed - Clinical trials for Contrast Enhancement in Magnetic Resonance Imaging

A Study Called GUS to Understand How Much of the Contrast Agent Gadavist is Used and How Much is Wasted in Two Different Containers (Single-dose Vials and Imaging Bulk Packages ) in a Real-world Setting

Start date: November 3, 2022
Phase:
Study type: Observational

This is an observational study, in which data associated with the wastage with the use of Gadavist single-dose vials, as compared to the wastage associated with the use of the Gadavist imaging bulk packages (IBP) used for contrast-enhanced magnetic resonance imaging (MRI) using Gadavist will be compared. MRI is a medical technique, which creates detailed images of the organs, soft tissues and structures inside the body. Combination of MRI with a "dye" that is injected into the vein (called contrast media, like Gadavist) creates what is called a contrast-enhanced MRI that enables clearer pictures of the body and helps doctors to see problems better than an MRI without contrast media. The drug Gadavist (also called gadobutrol) is a gadolinium-based contrast media for diagnostic use in MRI, which is given as an injection into the vein to improve the quality of the MRI pictures. Gadavist is already approved for several indications including imaging of brain and spinal cord, breast imaging, imaging of blood vessels, and diagnoses of heart disease. It helps doctors for example to detect: - areas with disrupted blood brain barrier (BBB), which is crucial to protect the brain from toxic components and pathogens (germs, viruses, disease-causing agents) - abnormal blood vessels in certain blood vessels - presence and size of breast cancer - heart disease The dosing of Gadavist is weight-based and currently available in single-use vials, which are associated with wastage. To reduce wastage and wastage associated costs, multi-dose vials, also called imaging bulk packages (IBP) were developed, which are already approved in the USA since January 2021. The aim of this study is to understand how much of the contrast agent Gadavist is used and how much is wasted in two different containers (single-dose vials and Imaging Bulk Packages (IBP)) in a real-world setting. To do this, researchers will review information collected regarding the amount of Gadavist used for patients undergoing contrast-enhanced MRI for any indication regarding: - vial type (single-dose or IBP) - size of single-dose or IBP - volume of administered dose (mL) - date of administration - time of administration - injection modality (manual vs power) - type of power injector, if applicable There will be no study-mandated visits or treatments. The decision to undergo a contrast-enhanced MRI with Gadavist will be made by the study participants with their doctors before data collection, and independently of this study. Data will be collected over a period of approximately 6-weeks, until the data collection of 1200 participants for each comparison group (vial type) is completed. No patient information beyond Gadavist dose will be collected in this study.

NCT ID: NCT05350046 Completed - Hearing Loss Clinical Trials

Development of Physical Activity Features for Ear-worn Devices

Start date: July 11, 2022
Phase: N/A
Study type: Interventional

This study incorporates data collection to aid in development of software features related to physical activity for users of ear-worn devices.