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Integrated Healthy Lifestyle and Pain Care for People With Musculoskeletal Conditions Living in Rural Areas.

Musculoskeletal Pain Osteoarthritis Low Back Pain

This study aims to compare the effects of an in-person physiotherapist-led lifestyle-focused pain care intervention with a virtual multidisciplinary lifestyle-focused pain care intervention on pain impact in people with musculoskeletal conditions and lifestyle risks. Adults residing in rural and regional locations in New South Wales (AUS) with musculoskeletal conditions (low back, knee or hip pain) recruited from hospital outpatient services (physiotherapy, emergency or orthopaedics) or in response to social media advertisements. Eligible consenting participants will be randomised in a 1:1 ratio to receive either in-person physiotherapy lifestyle intervention or the virtual enabled multidisciplinary intervention. Randomisation will be conducted using an electronic central randomisation service to ensure concealment of treatment allocation. Participants in both arms (in-person and virtual care) will have up to 10 consultations over six months and follow similar principles based on the previous Healthy Lifestyle for Pain (HeLP) intervention, but differ in their mode of delivery and access to multidisciplinary care. Participant data will be collected at baseline and weeks 12, 26, 39 and 52. The primary outcome will be Pain Impact measured using the Patient-Reported Outcomes Measurement Information System (PROMIS-29). The secondary outcomes will include participant's health behaviors and mediating outcomes, economic outcomes, process outcomes and adverse events.

Начало: 30.09.2025 Край: 29.02.2028 Възраст: от 18 г. Лечение

Australia University of Sydney NCT07173335

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LTFU for All Cell and Gene Therapy Studies

Hepatocellular Carcinoma Prostate Cancer

Master LTFU study will monitor the long-term safety and tolerability of cell or gene therapy study participants from AstraZeneca for up to 15 years post last cell or gene therapy treatment.

Начало: 17.09.2025 Край: 29.11.2041 Възраст: 18–130 г.

Australia, Japan, South Korea +1 AstraZeneca NCT06194461

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Home-Based Photo-Biomodulation for Management of Lymphoedema and Radiation Fibrosis in Patients After Head and Neck Cancer: A Single-Arm Feasibility Trial

Head and Neck Cancer

This feasibility trial will test the use of photo-biomodulation (PBM) therapy, predominantly self-delivered in the patient's home for 12-weeks, following completion of radiotherapy treatment for head and neck cancer. The primary objective is to establish feasibility of recruitment (uptake). Secondary objectives are to assess safety, additional elements of feasibility (adherence to the intervention, return of the device and attrition at the 3-month follow-up appointment) and acceptability of the trial to patients. Secondary measures will be performed to assess trends in effects of the intervention (pre-post intervention, within-group measures) for managing lymphoedema and radiation fibrosis.

Начало: 04.09.2025 Край: 31.10.2026 Поддържаща грижа

Australia Peter MacCallum Cancer Centre, Australia NCT07139782

Предстои набиране Фаза 1

A Research Study to Evaluate BLX-7006 in Healthy Adults

Normal Healthy Volunteer Safety After Oral Intake

This study will test an oral medicine called BLX-7006, which acts like the hormone Glucagon-like Peptide-1 (GLP-1) to help control blood sugar and body weight. Current GLP-1 medicines are given by injection. This study will see if BLX-7006 is safe, how the body processes it, and whether food changes how it is absorbed. The main goal is to see if BLX-7006 is safe and well tolerated. Secondary objectives of the study will measure how BLX-7006 moves through the body after an oral dose, including how quickly it is absorbed, how long it stays in the blood, and how the body removes it. It will also look at how the drug affects the body by looking at markers of glucose metabolism.

Начало: 01.09.2025 Край: 01.05.2026 Възраст: 18–65 г. Лечение

Australia Biolexis Therapeutics NCT07140055

Предстои набиране Фаза 1

A Research Study to Evaluate BLX-0871 in Healthy Adults

Normal Healthy Adults

This study will test an oral medicine called BLX-0871, which is being developed to improve metabolic health by activating AMP-activated protein kinase (AMPK), a key regulator of energy balance. The main goal is to see if BLX-0871 is safe and well tolerated when given to healthy adults. The study will also measure how the body processes BLX-0871, including how quickly it is absorbed, how long it stays in the blood, and how it is eliminated. Another objective is to see whether food affects the absorption of BLX-0871. It will also look at how the drug affects the body by looking at markers of AMPK activity.

Начало: 01.09.2025 Край: 01.05.2026 Възраст: 18–65 г. Лечение

Australia Biolexis Therapeutics NCT07140081

Предстои набиране Фаза 3

RECOMMEND Platform Trial

Extracorporeal Membrane Oxygenation Complication ARDS (Acute Respiratory Distress Syndrome) Intensive Care Medicine Cardiac Arrest (CA) +1

The goal of this platform trial is to determine the efficacy, safety and cost-effectiveness of various interventions in patients with acute cardiorespiratory failure requiring extracorporeal membrane oxygenation (ECMO) The main question the platform trial aims to address is to determine the effect of a range of interventions on survival, organ support and resource utilisation to day 28 for hospitalised patients receiving ECMO. Researchers will compare various interventions within multiple platform trial domains to see if the interventions have effects on survival, organ support and resource utilisation for the patient cohort. Participants will be enrolled in accordance with the platform trial's domain structure to answer the research questions.

Начало: 01.09.2025 Край: 01.06.2029 Поддържаща грижа

Australia Australian and New Zealand Intensive Care Research Cent NCT06526533

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Improving a Bile Duct Drainage Procedure in Patients With Inoperable Cancer Blocking the Bile Ducts: Comparing Two Types of Endoscopically Placed Internal Stents to Prevent Blockage of a Lumen Apposing Metal Stent

Malignant Biliary Obstruction Advanced Pancreatic Cancer and Cholangiocarcinoma Inoperable Malignant Biliary Obstruction Lumen Apposing Metal Stents

This study looks at the best way to treat bile duct blockage in people with advanced cancer that cannot be removed by surgery. A blocked bile duct can cause serious symptoms like yellowing of the skin (jaundice), infection, and pain. A common procedure called ERCP sometimes doesn't work in these patients. A newer method called EUS-guided choledochoduodenostomy (EUS-CDS) uses internal ultrasound to place a special metal tube (called a LAMS) to allow bile to drain. However, over time this stent can still become blocked. To reduce this risk, doctors can place a second stent inside the first. This study is comparing two types of these second stents: * A plastic stent (double pigtail stent or DPS) * A metal stent (fully covered self-expanding metal stent or FCSEMS) The study will include patients at Waikato Hospital. After the first stent is placed, they will be randomly assigned to receive either a DPS or FCSEMS. Patients will be followed for 6 months to see how well the stents work. The aim is to find out which approach keeps the bile duct open longer and reduces the need for further procedures or hospitalisation, helping improve care and comfort for people with advanced cancer

Начало: 01.09.2025 Край: 01.03.2028 Възраст: от 18 г. Превенция

New Zealand Waikato Hospital NCT07115420

Предстои набиране Фаза 1

A Phase 1 Study to Assess the Safety and Effects of Single and Multiple Doses of KS101 in Healthy Volunteers

Healthy Participants Alzheimer Disease Chronic Kidney Disease

This study is the first clinical trial involving study drug KS101. The goal of this clinical trial is to investigate whether KS101 is safe, whether it causes side effects, and how KS101 is broken down in the body, in healthy participants. This information will be used to learn more about KS101 and to determine the most effective dose for age related diseases such as chronic kidney disease and Alzheimer's Disease, with the fewest unwanted side effects. There are 3 parts to this study. In Part 1, participants will take KS101 or a placebo once and will stay in the study centre for a 4-night inpatient stay. Participants will return for outpatient visits on Days 8 and 29. In Part 2, participants will take KS101 twice, once after a meal and once without a meal and will stay in the study centre for a 7-night inpatient stay. Participants will return for outpatient visits on Days 11 and 32. In Part 3, participants will take KS101 or a placebo once daily for 5 days and will stay in the study centre for an 8-night inpatient stay. Participants will return for outpatient visits on Days 12 and 33.

Начало: 30.08.2025 Край: 06.08.2026 Възраст: 18–55 г. Лечение

Australia Klotho Sciences Australia Pty Ltd. NCT07143331

Предстои набиране Фаза 1

A Study Testing the Safety and Effects of Single Doses of S1-221 in Healthy Volunteers

Healthy Participants

The purpose of this Phase 1 study is to evaluate the safety, tolerability, and pharmacokinetics (PK) profile of single ascending doses of S1-221 administered orally to healthy adult participants. S1-221 is a liquid containing cannabidiol (CBD) and Δ9-tetrahydrocannabinol (THC). Acute subjective effects will be evaluated as a pharmacodynamic (PD) assessment and changes in plasma endocannabinoid levels will be assessed as an exploratory objective. Data from this study will be used to select doses to be evaluated in subsequent studies to investigate the efficacy and safety of S1-221 in migraine patients.

Начало: 30.08.2025 Край: 28.02.2026 Възраст: 18–65 г. Лечение

Australia Delphian Therapeutics Australia Pty, Ltd NCT07146945

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Stimulating Percutaneous Array for Urinary Reflex Control (SPARC)

Over Active Bladder

The Confidanz Smart Patch System consists of a Smart Patch containing one transcutaneous gel electrode and one percutaneous microneedle array electrode that sits directly superficial to the posterior tibial nerve. An applicator is used by the patient to deploy the microneedles into the skin. A Capital Stimulation Unit (CSU) is magnetically aligned with the Smart Patch and generates biphasic current wave form to the posterior tibial nerve through the patch. The CSU is connected to a mobile application via Bluetooth, allowing control over the stimulation intensity parameters. Primary Objective: To investigate the safety of the Confidanz Smart Patch System for adults diagnosed with idiopathic overactive bladder. Secondary Objective: To measure the reduction from baseline in average incontinence events (IE) per day at 6- and 12-weeks. Primary Hypothesis: The use of the Confidanz Smart Patch System is safe for use in adults with idiopathic overactive bladder.

Начало: 29.08.2025 Край: 30.01.2026 Възраст: от 18 г. Лечение

Australia Australis Scientific PTY LTD NCT07149103

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Optimised Treatment for Hypertension Trial

Hypertension

This randomized trial compares two prescribing strategies to treat high blood pressure. One approach involves remote treatment informed by randomized trial evidence without regular monitoring of blood pressure ("fire and forget"), whilst the other involves usual care treatment with access to frequent blood pressure monitoring. The study will enrol participants with uncontrolled high blood pressure and randomize participants 1:1 to a "fire and forget" treatment group or a "more blood pressure monitoring" group for a total of 12 weeks. "Fire and forget" involves choosing the most appropriate treatment based on the highest quality evidence (randomized trial data), after which participants will stop measuring blood pressures until the end of study. The "more blood pressure monitoring" group will involve treatment as usual but with the access to frequent and high quality blood pressure monitoring. The goal of this research is to: 1. determine which prescribing approach is more effective at lowering blood pressure after 12 weeks (end of study) 2. assess the safety, feasibility and acceptability of the two treatment approaches.

Начало: 28.08.2025 Край: 30.12.2026 Възраст: от 18 г. Лечение

Australia The George Institute NCT06935760

Предстои набиране Фаза 1

Safety of Intrathecal Riluzole in Patients With Amyotrophic Lateral Sclerosis

Amyotrophic Lateral Sclerosis Motor Neuron Disease

The purpose of this study is to investigate the safety and tolerability of intrathecal riluzole in adults with amyotrophic lateral sclerosis.

Начало: 15.08.2025 Край: 15.01.2027 Възраст: от 18 г. Лечение

Australia Brain Trust Bio NCT07093268

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Clinical Performance Study of Microbio InfectID-BSI for Detection of Bacteria and Yeast With Patient Blood Samples

Bloodstream Infection Sepsis Septic Shock

The objective of the study is to determine the efficacy of the Microbio InfectID-BSI qPCR kit in a clinical laboratory environment using patient whole blood for pathogen detection and identification versus standard of care methods from blood culture. The objective of this study is to determine the sensitivity and specificity of the Microbio InfectID-BSI qPCR kit by the evaluation of clinical blood samples versus standard of care methods from blood culture.

Начало: 01.08.2025 Край: 01.11.2026

Australia, United Kingdom, United States Microbio Co Ltd NCT06531031

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Virtual Reality for Vocational Recovery

Mental Health Disorder

Unemployment is higher among young people who experience mental ill-health compared to the general population. This can have a lasting impact on young people, many of whom are highly motivated to gain employment and education. There are many challenges to seeking, gaining, and maintaining employment for young people. To address these challenges and help young people meet their employment and education goals, investigators have developed a VR intervention to support vocational skill building. The aim of the current study is to evaluate the feasibility, acceptability, and safety, of the Virtual Reality for Vocational Recovery (VR4VR) intervention. A small group of vocational specialists will support up to 20 young people with their vocational outcomes using VR4VR over a 3-6week period. Both young people and specialists will complete questionnaires related to acceptability of the intervention, including qualitative interviews. Data on feasibility and safety will also be collected. Results will inform whether VR is feasible, acceptable, and safe to support vocational outcomes within vocational services that support young people with mental health difficulties, potentially supporting further intervention development and larger trials.

Начало: 01.08.2025 Край: 01.12.2025 Възраст: 18–25 г. Друго

Australia Orygen NCT07114887

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Clinical and Radiographic Outcomes of the JointMedica Polymotion Resurfacing (PHR) Device

Healthy Real World Data Safety and Effectiveness Patient Reported Outcome (PRO)

The goal of this observational study is to generate Real World Evidence (RWE) on the device performance of the Polymotion Hip Resurfacing (PHR) system and its use in patients who have been implanted with the device for the treatment of hip osteoarthritis. This study will assess the following endpoints: * The survivorship of the Acetabular Cup (Kaplan-Meier estimate) through 2 years of follow-up. * Radiographic success of the implanted cups, through quantitative motion analysis to assess migration of the acetabular cups. * Absence of subsequent surgical intervention at the acetabulum of there operated hip. * Absence of serious, device-related adverse events. * Patient reported outcomes through Harris Hip Score and SUSHI - UCLA Hip Score questionnaires.

Начало: 25.07.2025 Край: 31.12.2026 Възраст: от 21 г.

Australia, Canada, New Zealand JointMedica Inc. NCT07080671

Предстои набиране Фаза 1

Experimental Malaria Infection of Healthy Malaria-Naive Adults by Mosquito Bite With the Genetically Modified Plasmodium Falciparum NF54/iGP3 GAP

Malaria Falciparum Malaria Infection Malaria Transmission

The goal of this clinical trial is to learn if the genetically-modified malaria parasite NF54/iGP3 will safely infect humans with malaria. The investigators will also determine how the parasite grows in humans, and the effect of anti-malarial drugs. Researchers will use a controlled human malaria infection (CHMI) model to infect participants with malaria to observe the development of the disease, collect malaria-infected blood, and then treat the participants to cure the malaria infection. The collected malaria-infected blood will be used to create a frozen stock of malaria parasites for use in future research.

Начало: 01.07.2025 Край: 01.07.2026 Възраст: 18–55 г. Друго

Australia University of Melbourne NCT06881732

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The Effect of Glioblastoma PSMA Expression Following Tumour VEGF Blockade From Bevacizumab

Glioblastoma Glioblastoma Multiforme (GBM)

This trial is a single arm study for patients receiving bevacizumab for IDH-wildtype glioblastoma. Patients receiving bevacizumab (an anti-VEGF therapy) will receive PSMA scans to investigate the role of PSMA expression in glioblastoma and its relationship to VEGF expression.

Начало: 01.07.2025 Край: 01.07.2027 Възраст: от 18 г.

Australia Royal North Shore Hospital NCT07052877

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A Clinical Trial Assessing the Safety and Effectiveness of Orthokeratology Lenses in Patients With Myopia and Myopic Astigmatism

Myopia Myopic Astigmatism

This is a prospective, multi-centre, single-arm clinical trial to evaluate the effectiveness and safety of MCOK-01 lenses in patients with myopia and myopic astigmatism who need dioptric correction. A maximum number of 220 participants are planned to be enrolled , with a minimum of 150 planned to complete the trial (30% dropout). All participants will be enrolled in Australia. Enrolled participants will wear the lenses every night for up to 12 months, removing them upon waking. 8 follow up visits will be completed during treatment, after: 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months and 12 months of wearing the lenses.

Начало: 01.07.2025 Край: 01.12.2026 Възраст: 6–40 г. Лечение

Australia Menicon Co., Ltd. NCT07047924

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The PREBEAT Trial: Digital PREhaBilitation in thE Cardiac Surgical populATion

Cardiovascular Diseases

The goal of this randomised controlled trial is to learn if a digital prehabilitation program is feasible in patients awaiting cardiac surgery. The main questions it aims to answer are: 1. Is the digital health program usable? 2. Is the digital health program acceptable? 3. Do patients adhere to the digital health program? Researchers will compare a group using the digital prehabilitation program with standard care to see if the program is feasible and explore any differences in health outcomes. Participants will * Use a digital health mobile phone application to guide you through exercise, nutrition and preparation for surgery. * Engage in telehealth consultations. * Complete questionnaires * Complete exercise testing

Начало: 01.07.2025 Край: 01.12.2026 Възраст: 18–100 г. Поддържаща грижа

Australia Claire Hines NCT06983808

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CPAP and Glucose Metabolism in Non-Diabetic OSA Subjects

Obstructive Sleep Apnea Pre-diabetes

The purpose of the current study is to investigate whether alleviation of OSA by CPAP positively impacts glucose metabolism in non-diabetic patients.

Начало: 01.07.2025 Край: 28.02.2027 Възраст: 18–65 г. Лечение

Australia Woolcock Institute of Medical Research NCT05335083

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