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NCT ID: NCT06018337 Recruiting - Clinical trials for Metastatic Breast Cancer

A Study of DB-1303/BNT323 vs Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Metastatic Breast Cancer (DYNASTY-Breast02)

Start date: January 18, 2024
Phase: Phase 3
Study type: Interventional

The goal of this clinical trial is to assess the efficacy of DB-1303/BNT323 compared with investigator's choice chemotherapy in terms of progression-free survival (PFS) by blinded independent central review (BICR) in the HR+, HER2-low (immunohistochemistry [IHC]2+/in situ hybridization [ISH]- and IHC 1+) population.

NCT ID: NCT06018129 Recruiting - Clinical trials for Non-Hodgkin Lymphoma

A First-in-human Trial of GEN3017 in Hodgkin Lymphoma and Non-Hodgkin Lymphoma

Start date: September 21, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this trial is to evaluate the safety, tolerability, immunogenicity, pharmacokinetics (PK), pharmacodynamics (PD), and anti-tumor activity of GEN3017 as a monotherapy in participants with relapsed or refractory (R/R) CD30-expressing lymphomas. GEN3017 will be administered via subcutaneous injections. All participants will receive active drug; no one will be given placebo.

NCT ID: NCT06016946 Recruiting - Friedreich Ataxia Clinical Trials

Friedreich Ataxia Global Clinical Consortium UNIFIED Natural History Study

UNIFAI
Start date: June 28, 2023
Phase:
Study type: Observational [Patient Registry]

This project is a global, multicenter, prospective, longitudinal, observational natural history study that can be used to understand the disease progression and support the development of safe and effective drugs and biological products for Friedreich ataxia.

NCT ID: NCT06016738 Recruiting - Breast Cancer Clinical Trials

OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer

OPERA-01
Start date: November 16, 2023
Phase: Phase 3
Study type: Interventional

This phase 3 clinical trial compares the safety and efficacy of palazestrant (OP-1250) to the standard-of-care options of fulvestrant or an aromatase inhibitor in women and men with breast cancer whose disease has advanced on one endocrine therapy in combination with a CDK4/6 inhibitor.

NCT ID: NCT06016686 Recruiting - Epilepsy Clinical Trials

Microelectrode Recordings From the Vagus Nerve in Awake Humans

Start date: April 1, 2024
Phase: Phase 1
Study type: Interventional

This Anchillary project uses a refined technique of ultrasound-guided microneurography of the human cervical vagus nerve, an approach developed by Professor Vaughan Macefield and used safely to-date in 44 prior study participants. The overall goal of this project is to build upon prior data obtained using this approach by undertaking a detailed neurophysiological investigation of the human vagus nerve and to identify the nerve fibers activated during vagal nerve stimulation (VNS) in participants with implanted VNS devices in response to different stimulation parameters. In addition to providing data in unprecedented detail into the physiology of the human vagus nerve, this project will investigate different stimulus intensities, durations and frequencies that differentially excite myelinated and unmyelinated nerve fibers. These results will inform the CSP and guide future development of novel neural interfaces for VNS for various clinical applications.

NCT ID: NCT06016088 Recruiting - Clinical trials for Pseudomonas Aeruginosa

A Double-Blind, Active-Controlled, Multiple-Ascending Dose Study of Aerosolized RSP-1502 in Subjects With CF and Chronic PA Lung Infection

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

A double-blind, active-controlled, multiple-ascending dose, safety study of aerosolized RSP-1502 in subjects with cystic fibrosis Pseudomonas aeruginosa lung infection.

NCT ID: NCT06013969 Recruiting - Clinical trials for Generalized Pustular Psoriasis

A Study to Test Whether Spesolimab Helps People With Generalized Pustular Psoriasis (GPP) Who Need Treatment for Repeated Flares

Start date: October 11, 2023
Phase: Phase 4
Study type: Interventional

This study is open to adults with a serious skin disease called generalized pustular psoriasis (GPP) who have repeated flares of GPP. The purpose of this study is to find out whether a medicine called spesolimab helps people with repeated flares of GPP. Participants are given a single dose of spesolimab as an infusion into a vein on the first day of an outbreak of GPP. They may be given a second dose 1 week later if doctors think it is helpful. They are also treated for additional GPP flares. During the time of the study, doctors regularly examine participants' skin for signs of GPP to see how well the treatment works and take blood samples. The doctors also regularly check participants' health and take note of any unwanted effects.

NCT ID: NCT06013566 Recruiting - Clinical trials for Mild Traumatic Brain Injury

SSVEP Evaluation of Brain Function (PRO)

Start date: January 1, 2023
Phase:
Study type: Observational

The investigational device used in this clinical investigation, the Nurochek PRO System (NCPRO), is a portable electroencephalogram (EEG) headset which delivers a visual stimulus and measures a VEP. The visual stimulus is delivered to the subjects' eyes via light-emitting diodes, and the EEG measures the user's visual-evoked potential. This headset communicates with an application on a computer, which processes the signals and transmits them to a secure cloud server for analysis and storage of the data. Nurochek PRO is a development of the previously FDA cleared Nurochek System. The primary objective of this clinical investigation was to evaluate the performance of the investigational device (NCPRO) against clinical diagnosis of detection of mild traumatic brain injury (mTBI). The primary endpoint outlined for this study was set at the collection of 100 valid investigational device readings from individuals with concussion and 500 valid investigational device readings from healthy individuals who have had a plausible mechanism of sustaining a concussion, but do not have one. Additionally, readings from healthy individuals are also to be acquired. The aim of this study was to collect data from 100 readings from individuals with concussion. The initial assumption was that sites would provide players pre-season and make players available for testing post-concussion. In practice, some sites provided player data only post-concussion event (such as medical clinics). Participants were acquired from sporting clubs, medical clinicals and schools.

NCT ID: NCT06013241 Recruiting - Clinical trials for Chronic Rhinosinusitis Without Nasal Polyps

A Study of the Efficacy and Safety of Brensocatib in Participants With Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)

BiRCh
Start date: October 30, 2023
Phase: Phase 2
Study type: Interventional

The primary purpose of the study is to evaluate the efficacy of brensocatib at 10 and 40 milligrams (mg) once daily (QD) compared with placebo in improving clinical symptoms of CRSsNP.

NCT ID: NCT06012578 Recruiting - Healthy Subjects Clinical Trials

Study Evaluating ISM5411 Administered Orally to Healthy Volunteers

Start date: November 8, 2023
Phase: Phase 1
Study type: Interventional

The goal of this clinical trial is to learn about ISM5411 in healthy subjects. The primary objective is to evaluate the safety and tolerability of single and multiple oral doses of ISM5411 in healthy subjects.