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Набира участници

Clinical Investigation of MAIA Microperimeter Device: Mesopic Normative Database Collection

Healthy Eyes

The purpose of this pre-market, multicentric cross-sectional study is to create a mesopic Normative Database for a new version of the MAIA device. Moreover, the study aims to evaluate MAIA safety and adverse events. These purposes will be achieved by collecting data of healthy subjects, who will undergo microperimetric examinations with the MAIA device during one single visit.

Начало: 23.04.2025 Край: 01.06.2026 Възраст: от 18 г. Друго

Australia, Switzerland, United States Centervue SpA NCT06991127

Набира участници Фаза 1/2

A Study of AP402 in HER2-Positive Patients With Locally or Advanced Solid Tumors

Advanced Solid Tumor

This is a Phase 1/2, multi-regional, multi-center, open-label, first-in-human (FIH), dose-escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary clinical activity of AP402 in HER2-positive patients with locally or advanced solid tumors.

Начало: 22.04.2025 Край: 01.12.2027 Възраст: от 18 г. Лечение

Australia AP Biosciences Inc. NCT06669975

Набира участници Фаза 4

Optimising TREATment for Severe Gram-Negative Bacterial Infections

Bloodstream Infection Ventilator Associated Bacterial Pneumonia Hospital Acquired Bacterial Pneumonia Carbapenem Resistant Bacterial Infection +1

TREAT-GNB is an innovative trial to expedite the evaluation of various antibiotic choices and treatment strategies for severe multidrug-resistant Gram-negative bacterial infections, specifically bloodstream and lower respiratory tract infections. This approach combines platform trial elements with adaptive clinical designs to streamline the evaluation of various treatment options and optimise resource utilisation. The overall aim of the TREAT-GNB platform trial is to identify interventions that improve survival in patients with severe infections due to Gram-negative bacteria. In the CR-GNB silo of TREAT-GNB, the primary objective is to quantify the effect on all-cause mortality at 28 days of a range of interventions in patients with bloodstream infections, ventilator-associated pneumonia, and hospital-acquired pneumonia caused by CR-GNB.

Начало: 21.04.2025 Край: 31.12.2028 Възраст: от 18 г. Лечение

Australia, China, Lebanon +9 National University of Singapore NCT07004049

Набира участници Фаза 1/2

A Study to Investigate the Safety, Tolerability, and Efficacy of AZD0120 in Adults With Refractory SLE

Lupus Erythematosus, Systemic

This is a Phase 1b/2, single-arm, open-label, multi-center, clinical study of AZD0120, a CD19/BCMA dual CAR T cell therapy, to evaluate the safety, tolerability, and efficacy in adult participants with refractory Systemic Lupus Erythematosus.

Начало: 21.04.2025 Край: 01.05.2029 Възраст: 18–70 г. Лечение

Australia, United States AstraZeneca NCT06897930

Набира участници Фаза 2

An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)

Progressive Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis (IPF)

This is an open-label extension study for participants who were previously enrolled in and completed an Avalyn Pharma Sponsored study with an inhaled antifibrotic, such as AP01. Eligible participants will have their final dose of drug at the end of study visit from the lead-in study and first AP-LTE-008 study visit on the same day.

Начало: 17.04.2025 Край: 31.12.2031 Възраст: от 18 г. Лечение

Australia, Canada, Czechia +8 Avalyn Pharma Inc. NCT06951217

Набира участници Фаза 2

A Study to Investigate Multiple Sclerosis Relapse Prevention With mRNA-1195 Compared With Placebo in Participants Aged 18 to ≤55 Years

Multiple Sclerosis

The primary objective of this trial is to evaluate the safety and reactogenicity of mRNA-1195 in participants with multiple sclerosis.

Начало: 16.04.2025 Край: 08.01.2029 Възраст: 18–55 г. Лечение

Australia, United Kingdom, United States ModernaTX, Inc. NCT06735248

Набира участници

Food Challenge at Home or in Medical Practice - the FoodCHOMP Study

Food Allergies

This is a pilot, multi-centre, randomised clinical trial evaluating the safety and feasibility of a home-based oral food challenge in adults with low-risk food allergy labels. Eligible participants are aged 18 years or older and have a self-reported food allergy with negative skin prick testing to the implicated food. Participants will be randomised to either a home-based or standard in-clinic food challenge. The primary aim is to determine the safety of home challenges, measured by the rate of immune-mediated adverse events. Secondary aims include feasibility of recruitment and delivery, protocol adherence, quality of life, and food reintroduction outcomes.

Начало: 16.04.2025 Край: 01.12.2026 Възраст: от 18 г. Диагностика

Australia Austin Health NCT06916819

Набира участници

Benefits of Choir for Older Adults With Unaddressed Hearing Loss (WP2)

Hearing Loss, Age-Related Speech Intelligibility Psychosocial Functioning

Unaddressed age-related hearing loss is highly prevalent among older adults, typified by negative consequences for speech-in-noise perception and psychosocial wellbeing. There is promising evidence that group singing may enhance speech-in-noise perception and psychosocial wellbeing. However, there is a lack of robust evidence, primarily due to the literature being based on small sample sizes, single site studies, and a lack of randomized controlled trials. Hence, to address these concerns, this SingWell Project study utilizes an appropriate sample size, multisite, randomized controlled trial approach, with a robust preplanned statistical analysis. The objective of the study is to explore if group singing may improve speech-in-noise perception and psychosocial wellbeing for older adults with unaddressed hearing loss. The investigators designed an international, multisite, randomized controlled trial to explore the benefits of group singing for adults aged 60 years and older with unaddressed hearing loss. After undergoing an eligibility screening process and completing an information and consent form, the investigators intend to recruit 210 participants that will be randomly assigned to either group singing or an audiobook club (control group) intervention for a training period of 12-weeks. The study has multiple timepoints for testing, that are broadly categorized as macro (i.e., pre- and post-measures across the 12-weeks), or micro timepoints (i.e., pre- and post-measures across a weekly training session). Macro measures include behavioural measures of speech and music perception, and psychosocial questionnaires. Micro measures include psychosocial questionnaires and heart-rate variability. The investigators hypothesize that group singing may be effective at improving speech perception and psychosocial outcomes for older adults with unaddressed hearing loss-more so than participants in the control group.

Начало: 15.04.2025 Край: 01.09.2026 Възраст: от 60 г. Лечение

Australia, Canada, Germany +2 Toronto Metropolitan University NCT06580847

Набира участници Фаза 3

A Study Using Risk Factors to Determine Treatment for Children With Favorable Histology Wilms Tumors (FHWT)

Stage I Mixed Cell Type Kidney Wilms Tumor Stage II Mixed Cell Type Kidney Wilms Tumor Stage III Mixed Cell Type Kidney Wilms Tumor Stage IV Mixed Cell Type Kidney Wilms Tumor

This phase III trial studies using risk factors in determining treatment for children with favorable tissue (histology) Wilms tumors (FHWT). Wilms Tumor is the most common type of kidney cancer in children, and FHWT is the most common subtype. Previous large clinical trials have established treatment plans that are likely to cure most children with FHWT, however some children still have their cancer come back (called relapse) and not all survive. Previous research has identified features of FHWT that are associated with higher or lower risks of relapse. The term "risk" refers to the chance of the cancer coming back after treatment. Using results of tumor histology tests, biology tests, and response to therapy may be able to improve treatment for children with FHWT.

Начало: 15.04.2025 Край: 13.02.2031 Възраст: до 30 г. Лечение

Australia, Canada, United States Children's Oncology Group NCT06401330

Набира участници

Cognitive Bias Modification for Interpretation (CBM-I) in People With Type 2 Diabetes and Persistent Pain

Type 2 Diabetes Persistent Pain

The goal of this clinical trial is to examine the efficacy of cognitive bias modification for interpretation (CBM-I) in people with Type 2 Diabetes and persistent pain. The main question\[s\] it aims to answer is whether interpretation bias training away from pain improves pain outcomes. Participants in the CBM-I group will complete 4 online training sessions approximately half an hour each. Each session will present participants with ambiguous scenarios which may be pain-related, however the final word of the sentence will resolve the scenario as benign (thus training participants to make benign interpretations). A measure of interpretation bias will be administered following the fourth training session, and pain severity and interference will be measured at baseline, post-training, two week follow up, and three month follow up. The study hypothesises that participants in the CBM-I group will demonstrate a greater reduction in the co-primary outcomes of pain severity and pain interference over time compared to those in the placebo control.

Начало: 15.04.2025 Край: 15.10.2025 Възраст: от 18 г. Лечение

Australia University of Sydney NCT06908486

Набира участници Фаза 2

Pharmacogenomics for Better Treatment of Fungal Infections Clinical Trial

Fungal Infection Haematological Malignancy Blood Cancer Infectious Disease

This project aims to address invasive fungal infections in patients, by precision dosing of voriconazole based on CYP2C19 genotype testing with Bayesian dose-forecasting dosing software to develop patient-centric and maximally effective dosing regimens. This study investigates if voriconazole increases the proportion of patients achieving therapeutic exposure at day 8 of dosing compared with standard care; and will assess factors that influence the implementation of genotype testing and dosing software in the healthcare system, including fidelity, feasibility, acceptability and cost-effectiveness. It will recruit at least 104 kids and adults in a parallel-group randomised clinical trial. A hybrid feasibility sub-study will assess the scalability of genotype-directed dosing to ensure sustainable integration of the interventions into the clinical workflow. A health economic sub-study will evaluate the costs, health outcomes and cost-effectiveness of genotype-directed testing compared to standard care.

Начало: 14.04.2025 Край: 26.03.2027 Възраст: от 2 г. Лечение

Australia, United States The University of Queensland NCT06510699

Набира участници Фаза 1

Safety, Tolerability and Pharmacokinetics Study of L608 in Healthy Adults

Pulmonary Arterial Hypertension

This is the second single ascending dose study of L608 in healthy participants and is being conducted to evaluate the safety of L608 with dose level ranging from 15 μg to 30 μg.

Начало: 11.04.2025 Край: 30.06.2026 Възраст: 18–65 г. Лечение

New Zealand Pharmosa Biopharm Inc. NCT06429930

Набира участници

Evaluation of a Novel Auto-Adjusting Positive Airway Pressure Algorithm for the Treatment of Obstructive Sleep Apnea Clinical Study

Obstructive Sleep Apnea

This study aims to assess the effectiveness of an investigational algorithm in the treatment of obstructive sleep apnea.

Начало: 10.04.2025 Край: 01.12.2025 Възраст: от 18 г. Лечение

Australia ResMed NCT06769607

Набира участници Фаза 1

A Study of Intravenous CPTX2309 in Healthy Participants and Participants With Moderate to Severe Rheumatoid Arthritis (RA) or Systemic Lupus Erythematosus (SLE)

Healthy Volunteers Rheumatoid Arthritis Systemic Lupus Erythematosus

The purpose of this study is to assess the safety and tolerability of CPTX2309 in healthy adult participants and adult participants with moderate to severe rheumatoid arthritis or systemic lupus erythematosus.

Начало: 09.04.2025 Край: 01.11.2027 Възраст: 18–65 г. Лечение

Australia Capstan Therapeutics NCT06917742

Набира участници Фаза 3

A Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Maintenance Treatment Versus Standard of Care in Participants With Platinum-sensitive Recurrent Ovarian Cancer (MK-2870-022/TroFuse-022/ENGOT-ov84/GOG-3103)

Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cancer

The main goals of this study are to learn about the safety of sacituzumab tirumotecan with bevacizumab and if people tolerate it; and if people who take sacituzumab tirumotecan with or without bevacizumab live longer without the cancer getting worse than those who receive standard of care treatment.

Начало: 09.04.2025 Край: 09.11.2032 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +23 Merck Sharp & Dohme LLC NCT06824467

Набира участници Фаза 3

A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer

Breast Cancer

This study will evaluate the efficacy and safety of the combination of inavolisib plus a cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) and letrozole versus placebo plus a CDK4/6i and letrozole in the first-line setting in participants with endocrine-sensitive PIK3CA-mutated hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), advanced breast cancer (ABC).

Начало: 09.04.2025 Край: 30.05.2032 Възраст: от 18 г. Лечение

Argentina, Australia, Brazil +17 Hoffmann-La Roche NCT06790693

Набира участници Фаза 3

Long-Term Safety and Efficacy of Plozasiran in Adults With Hypertriglyceridemia

Hypertriglyceridemia

This is an open-label study to be conducted in adults with hypertriglyceridemia (HTG) and severe hypertriglyceridemia (SHTG). Each participant must have completed all required visits per protocol in the parent study AROAPOC3-2003 (USA and Canada participants only; NCT# 05413135), AROAPOC3-3001(Canada and Japan participants only; NCT05089084), AROAPOC3-3003 (NCT06347003), AROAPOC3-3004 (NCT06347016) or AROAPOC3-3009 (Argentina, Italy, South Africa, and Spain; NCT06347133). Subjects who previously met all eligibility requirements for AROAPOC3-3003 or AROAPOC3-3004 and were not permitted to proceed to randomization per the Sponsor's direction in order to prevent excessive over-enrollment may also be enrolled in this trial. The subjects must meet all other applicable eligibility criteria prior to enrollment and have an HbA1c results of \

Начало: 09.04.2025 Край: 01.07.2028 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +20 Arrowhead Pharmaceuticals NCT06822790

Набира участници Фаза 3

Study to Evaluate the Effectiveness and Safety of Ozanimod Compared to Fingolimod in Children and Adolescents With Relapsing Remitting Multiple Sclerosis

Multiple Sclerosis, Relapsing-Remitting

The purpose of this study is to evaluate the effectiveness, safety, tolerability, drug levels and drug effects of ozanimod compared to fingolimod in children and adolescents with relapsing remitting multiple sclerosis (RRMS).

Начало: 08.04.2025 Край: 13.07.2036 Възраст: 10–17 г. Лечение

Australia, Italy, Mexico +7 Celgene NCT06408259

Набира участници

Clinical Feasibility and Evaluation Study of POINT-GUARD Embolic Protection Device During TAVR (GUARDIAN)

Transcatheter Aortic Valve Implantation (TAVI) Aortic Valve Stenosis Transcatheter Aortic Valve Replacement

The purpose of this study is to assess the feasibility and safety of the Transverse Medical, Inc. Point-Guard device. This feasibility study is a limited clinical investigation of the Point-Guard device. The study will be conducted to evaluate the device design concept with respect to clinical safety and device functionality.

Начало: 07.04.2025 Край: 01.03.2026 Възраст: от 18 г. Устройства

Australia Transverse Medical, Inc. NCT06962371

Набира участници Фаза 1

A Phase I Study to Evaluate LIFE-001

Healthy Volunteers

The goal of this clinical trial is to learn if LIFE-001 is safe and tolerable for healthy adult volunteers.

Начало: 07.04.2025 Край: 13.11.2026 Възраст: 18–65 г. Лечение

Australia LifeMine Therapeutics NCT06904807

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