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NCT ID: NCT05848258 Recruiting - Clinical trials for Rheumatoid Arthritis

An Adaptive Phase 2a/2b Study of LY3871801 in Adult Participants With Rheumatoid Arthritis

Start date: May 23, 2023
Phase: Phase 2
Study type: Interventional

The main purpose of this study is to evaluate the efficacy and safety of LY3871801 in adult participants with active moderately-to-severe rheumatoid arthritis (RA).

NCT ID: NCT05848037 Not yet recruiting - Urinary Retention Clinical Trials

Assessment of CymActive™ Catheter Technology for UrinAry ReTention and AcceptancE (The ACCTUATE Study)

ACCTUATE
Start date: July 1, 2023
Phase: N/A
Study type: Interventional

The ACCTUATE: Assessment of CymActive™ Catheter Technology for UrinAry reTention and acceptancE study will begin the formal evaluation of a novel catheter design that addresses the specific needs of people living in the community with long term catheterisation. The primary endpoint of the study will be tolerability by measuring AEs, SAEs, AESIs through day 91. VAS scale assessments (1-10) across insertions and interventions by clinicians. The secondary endpoint will be a comparison in the number of re-presentations of patients requiring treatment in primary or secondary care for recurrent CAUTIs in both arms of the study along with comparing both arms to their medical history through routine standard of care.

NCT ID: NCT05848011 Recruiting - Immunotherapy Clinical Trials

A Study of Lorigerlimab With Docetaxel or Docetaxel Alone in Participants With Metastatic Castration-Resistant Prostate Cancer

Start date: September 28, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether the amount of time before disease progression can be prolonged in participants with metastatic castration-resistant prostate cancer (MCRPC) who receive lorigerlimab in addition to the standard of care (SOC) of docetaxel and prednisone. About 150 participants with mCRPC will be enrolled. Participants will be randomized in a 2:1 ratio to receive lorigerlimab with docetaxel and prednisone (experimental arm) or docetaxel and prednisone alone (standard-of-care arm). Lorigerlimab+docetaxel or docetaxel will be administered intravenously (IV) in clinic on Day 1 of each 3-week cycle. Prednisone will be administered orally twice daily. Lorigerlimab will be administered for up to 35 cycles. Docetaxel and prednisone will be administered up to 10 cycles until treatment discontinuation criteria are met. Participants will undergo regular testing for signs of disease progression using computed tomography (CT) scans, magnetic resonance imaging (MRI) and prostate-specific antigen (PSA) blood tests. Participants will be asked to complete questionnaires about their health and well-being. Routine examinations and blood tests will be performed and evaluated by the study doctor. Participants who have disease progression standard-of-care arm have the option of continuing on the study to receive lorigerlimab monotherapy.

NCT ID: NCT05847556 Recruiting - Hearing Loss Clinical Trials

Video Game Hearing Tests for Remote Monitoring of Ototoxicity

VAROT
Start date: March 16, 2022
Phase: N/A
Study type: Interventional

The reason for this clinical trial is to test different ways of carrying out hearing tests to be able to detect for hearing loss within the hospital and at home. Pathway 1: The goal of this clinical trial is to learn whether video game hearing tests work well to detect hearing loss caused by antibiotics at home in patients with long-term lung infections. Pathway 2: The goal of this clinical trial is to compare tablet-based (iPad) hearing tests with formal sound booth hearing tests in patients attending hospital outpatient clinics. Pathway 3: The goal of this clinical trial is to learn whether audio-training improves listening to speech in the presence of background noise. Researchers will compare participants receiving audio-training with those who did not receive audio-training. This will test if audio-training can improve participant's everyday listening experiences.

NCT ID: NCT05847452 Recruiting - Asthma Clinical Trials

Beyond the Eosinophil: Understanding the Impact of Eosinophil Depletion on T2 Inflammation. (BEUTI)

BEUTI
Start date: May 22, 2023
Phase:
Study type: Observational

Benralizumab is a relatively new treatment that is approved by NICE (National Institute for Health and Care Excellence, https://www.nice.org.uk/) for patients with severe asthma who have ongoing eosinophilic inflammation that remains poorly controlled despite high dose inhaled glucocorticosteroid medication. Eosinophils are a type of white blood cell that are linked to allergy and inflammation and are raised in people with severe asthma. Severe asthma is associated with a type-2 (T2) inflammation phenotype characterised by increased T2 cytokines (IL-13, IL-4, IL-5). Increased levels of eosinophils can cause inflammation in the lungs, increasing the risk of asthma attacks. The standard treatment for asthma involves taking inhaled glucocorticosteroid medication which primarily work by suppressing eosinophilic inflammation in the lungs. Benralizumab is a monoclonal antibody that targets a receptor on the surface of eosinophils called interleukin-5 receptor-α (IL-5Rα) leading to the rapid death of these cells and consequently a reduction in airways inflammation. In clinical trials, benralizumab has been shown to reduce both symptoms and the number of asthma attacks suffered by those with severe eosinophilic asthma. However, it remains unclear whether this clinical efficacy relates purely to the removal of the eosinophil, or additionally to the impact of this on other parts of the immune system. The BEUTI study will examine the structure and function of airway cells in patients with severe eosinophilic asthma. Particularly how the immune function of these cells changes with treatment and whether benralizumab leads to a reduction in T2 mediators and/or activation in airway cells. The aim is to take samples of cells from the airways during a bronchoscopy (a camera test looking into the lungs) before starting benralizumab and after 12 weeks of treatment. These investigations will allow us to better understand how benralizumab affects the cells within the airways and the pathways involved.

NCT ID: NCT05847387 Recruiting - Clinical trials for Corneal Endothelial Cell Loss

The Viability Control of Human Endothelial Cells Before Keratoplasty (V-CHECK) Study

V-CHECK
Start date: December 1, 2023
Phase:
Study type: Observational

The purpose of this international cohort study is to validate a new method for preoperative assessment of endothelial viability in donor corneal tissues for transplantation, and to correlate endothelial health as assessed by the surgical team to functional and structural long-term outcomes in the cohort of patients receiving them.

NCT ID: NCT05847322 Recruiting - Clinical trials for Pertussis/Whooping Cough

Periscope Phase C Bordetella Pertussis Human Challenge Study With Delayed Antibiotic Therapy for 6 Weeks

Start date: December 6, 2022
Phase: N/A
Study type: Interventional

Primary objective- To assess the safety of nasal inoculation of healthy volunteers with B. pertussis with antibiotic therapy given to eradicate colonisation at 6 weeks after inoculation or at symptom onset, whichever occurs first Secondary objectives - To measure the rate of natural clearance of carriage of B. pertussis following nasal inoculation - To assess the kinetics of B. pertussis colonisation density following nasal inoculation - To describe the microevolution of B. pertussis and adaptation of the resident microbiome during B. pertussis carriage - To measure B. pertussis-specific antibody and cellular immunological responses in healthy volunteers during colonisation with B. pertussis - To identify biomarkers that correlate with natural clearance of B. pertussis carriage after induced B. pertussis colonisation - To detect transmission of B. pertussis to bedroom contacts of inoculated volunteers during prolonged asymptomatic colonisation

NCT ID: NCT05847023 Completed - Stroke Clinical Trials

Proof-of-concept Study of LUNA Intervention in Aphasia

LUNA
Start date: June 14, 2020
Phase: Phase 1
Study type: Interventional

Existing evidence-based treatments for word-level and sentence-level impairments following aphasia typically do not generalise to gains in everyday communication for people with aphasia (after stroke). Novel treatments need to be developed to address this. LUNA is a novel multi-level discourse treatment for people with mild to moderate aphasia that addresses personal narratives in a personalised and meta-linguistic and metacognitive manner. This is a feasibility randomised waitlist controlled trial of LUNA, in 28 people with post-stroke chronic aphasia. It will test feasibility, acceptability, preliminary efficacy, and treatment fidelity. Findings will enable the investigators to judge whether there is merit in proceeding to a larger definitive trial.

NCT ID: NCT05846581 Recruiting - Clinical trials for Chronic Kidney Diseases

Registry of GORE® ACUSEAL Vascular Graft in Dialysis Access

AVG22-09
Start date: January 12, 2024
Phase:
Study type: Observational [Patient Registry]

The goal of this observational study is to evaluate safety and performance of GORE® ACUSEAL Vascular Graft for the treatment of CKD in patients with ESRD in hemodialysis. The main questions it aims to answer are: - Safety: Freedom from device-related infection adverse events at 24 months from device implant - Performance: Secondary patency at 24 months from device implant. Participants, after informed consent is obtained, will be implanted with GORE® ACUSEAL Vascular Graft and followed for 24 months in standard of care, to evaluate safety and performance of the device.

NCT ID: NCT05845814 Active, not recruiting - Clinical trials for Metastatic Urothelial Carcinoma

A Study of Efficacy and Safety of Pembrolizumab Plus Enfortumab Vedotin (EV) +/- Investigational Agents in First-Line Metastatic Urothelial Carcinoma (mUC) (MK-3475-04B/KEYMAKER-U04)

Start date: June 23, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This study is a substudy being conducted under one pembrolizumab umbrella master study KEYMAKER-U04. The substudy will consist of 2 parts. Part 1 will evaluate the efficacy and safety of coformulated favezelimab/pembrolizumab plus EV and coformulated vibostolimab/pembrolizumab plus EV relative to pembrolizumab plus EV. There will be no comparison of coformulated favezelimab/pembrolizumab plus EV versus coformulated vibostolimab/pembrolizumab plus EV. If ORR and/or DRR are substantially better on coformulated favezelimab/pembrolizumab plus EV and/or coformulated vibostolimab/pembrolizumab plus EV compared with pembrolizumab plus EV, after evaluation of the totality of data, the sponsor might consider Part 2 (expansion) to further characterize the efficacy and safety of the treatment arms under study.