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Predicting Outcomes Using Infra-red SEnsors, a Feasibility Study.

General Anesthetic Drug Adverse Reaction

The aim of this study is to investigate if it is feasible to use a protocol in which avoiding oxygen desaturation in the brain during general anaesthesia can reduce the risk of negative postoperative behavior changes in children. We will recruit children from at least five centres around the world for this feasibility study. Brain oxygenation will be monitored with Near Red Infrascopy (NIRS) which is like a saturation monitor placed on the forehead of the child during anesthesia. The anesthesia is done as per routine, but we will ask the anesthesiologist to record what actions they took when there were signs of decreasing oxygen saturation in the brain. We will also ask the parents to fill in a questionnaire with 27 questions about changes in their child's behavior 7 days after the operation.

Начало: 31.03.2025 Край: 31.07.2026 Възраст: 6–59 г.

Australia, Belgium, Brazil +2 Uppsala University NCT06515080

Предстои набиране Фаза 4

Randomised Arthroplasty Infection Worldwide Multidomain Adaptive Platform (ROADMAP) Trial

Prosthetic Joint Infections of Hip Prosthetic Joint Infections of Knee Large Joint Prosthetic Joint Infections

Artificial joint infections are treated with different types of antibiotics and surgery. The ROADMAP study aims to find out which treatments currently used work best in regards to surgery, antibiotic choice as well as the time taking antibiotics. The study will compare different treatments against each other to see which treatment or treatment combination works to provide the best outcome and cure at 12 months. The study will focus on adults with infected artificial hips and knees. ROADMAP trial looks at normal good clinical care and does not ask any person taking part in the study to have any extra tests or treatments. If a person takes part in the study they will: * Sign a consent form * Give permission for infection and treatment information to be collected and entered into a central ROADMAP specific database and a separate registry of prosthetic joint infection patients. This medical information will include participants medical history, test results and treatment they received. The study will also collect information about medical care and how the participant is feeling at Day 100 and Day 365 (1 year) after starting the study. There are several different study parts. Each part focuses on research focus areas called domains. ROADMAP has 3 different domains; 1. Surgical, 2. Antibiotic choice and 3. Antibiotic Duration domains. Not every hospital is taking part in all 3 domains and if someone chooses to participate they do not have to participate in all domains. Specific domain details are: 1. Surgical Treatment Domain This domain will find out if it is better to do an operation to clean out the infection but keep the artificial joint in place (this is called a Debridement, Antibiotics and Implant Retention operation (DAIR)) or to clean out the infection and swap the artificial joint out for a new one (this is called a "revision" operation). DAIR usually involves a single operation but sometimes needs more. Revision surgery may be done in one operation (single stage revision) or two operations (two stage revision). Previous research has suggested that cure rates may be better with revision operations than with DAIR, but this is not clear. If the participant consents to the surgical domain they will be randomly allocated to either a DAIR, to clean the artificial joint but keep it in place, or to have surgery that cleans and replaces the artificial joint with a new one (revision). A revision operation, may involve one (single stage) or two different surgeries which can be days, weeks or months apart (two stage). The participants surgeon and treating team in consultation with the participant will decide what kind of treatment they are best to receive, DAIR, single stage or two stage revision. 2. Antibiotic Choice Domain Many different microorganisms (germs) can cause artificial joint infections and many different antibiotics are used to fight infections. ROADMAP will look at different antibiotics commonly used to treat artificial joint infection. This domain will focus on an antibiotic called rifampicin (also sometimes known as rifampin) as it is often added to other antibiotics to help treat artificial joint infections. Rifampicin is not a new antibiotic but it is not clear if treatment cure rates are better if it is added. All people taking part in this domain will be given antibiotics that will treat their artificial joint infection, called the "backbone antibiotics", but some will be given "backbone antibiotics" plus rifampicin. "Backbone antibiotics" can be either one antibiotic or a number of different antibiotics. These will be given into a vein (IV) at first, and will be changed to tablets or capsules later. All antibiotics in this domain are commonly used and the "backbone antibiotics" will be chosen by treating doctors after looking at the type of germ and what antibiotic may work for the germ, as well as medical history including past antibiotic reactions. Antibiotics are taken for approximately 12 weeks after DAIR surgery, however after revision surgery then the time taking antibiotics may be shorter or longer. 3. Antibiotic Duration Domain Antibiotic treatment times are the focus of this domain as it is not clear how long someone should take antibiotics when revision surgery is used to treat artificial joint infection. To show what antibiotic time period is best for treatment and cure people who have had revision surgery participating in this domain will receive either "standard" or "extended" duration of antibiotics. In this domain, after a one-stage revision, the participant will be randomised to have either 6 weeks or 12 weeks of antibiotics after the operation. If a two-stage revision operation has been done the participant will receive around 6 weeks of antibiotics between the two operation stages. After the two stage revision has been completed the participant will be randomised to either stop antibiotics or have a further 12 weeks of antibiotic treatment.

Начало: 26.03.2025 Край: 31.12.2029 Възраст: от 18 г. Лечение

Australia University of Newcastle, Australia NCT06771050

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The Inflate Study; Defining the Soft Palate in the Upper Airway Flow Pathway

Focus of the Study is the Anatomy of the Soft Palate Non-invasive Ventilation

The goal of this clinical trial is to understand the impact of the size and shape of the soft palate on gas airflow in the upper airway in healthy volunteers. Utilizing Magnetic Resonance Imaging (MRI), this study aims to investigate: * How does soft palate anatomy change in different body positions? * What is the impact of positive pressure therapy, in the form of non-invasive ventilation (NIV) on soft palate anatomy? Researchers will compare MRI data without positive pressure to with positive pressure imaging to see if the addition of positive pressure impacts the size and shape of the soft palate. Researchers will also utilize measures of upper airway resistance to assess the impact of soft palate anatomy of airflow dynamics. Participants will be asked to: * Lie inside an MRI scanner for up to 90 minutes (including breaks), in different body positions * Undergo NIV therapy for 5-10 minutes while breathing normally inside an MRI scanner * Have their upper airway resistance measured, in different body positions

Начало: 25.03.2025 Край: 01.08.2027 Възраст: от 18 г. Фундаментална наука

New Zealand Fisher and Paykel Healthcare NCT06738589

Предстои набиране Фаза 1

A Clinical Trial to Evaluate the Relative Bioavailability of PRAX-628

Healthy

A phase I clinical trial to evaluate the relative bioavailability of PRAX-628 tablet formulation compared to capsule formulation

Начало: 24.03.2025 Край: 30.06.2025 Възраст: 18–55 г. Лечение

Australia Praxis Precision Medicines NCT06840925

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Neonatologist-Performed Lung Ultrasound (NPLUS) to Guide Respiratory Therapy

PreTerm Neonate Respiratory Distress Syndrome (RDS)

The goal of this cross-over clinical trial is to evaluate whether Neonatologist-Performed Lung Ultrasound (NPLUS) can be used in preterm babies on non-invasive breathing support to reduce the amount of oxygen they need. The main question it aims to answer is: When a baby's oxygen requirement goes up, does NPLUS help to target interventions and reduce oxygen requirements? Researchers will compare NPLUS to standard treatment. Participants will: Have a lung ultrasound performed whenever their oxygen requirement increases by more than 10%. The ultrasound findings will be used to target interventions that aim to improve air entry in the lungs. Each time this happens, the researchers will note what happens to the oxygen requirement afterwards. Each participant will participate for five days. For the first two days, they will be randomized to either the NPLUS arm or the usual care arm. There is then a 24 hour period of usual care. For the final two days, participants cross over to the other arm of the trial.

Начало: 01.03.2025 Край: 01.06.2026 Възраст: от 1 г. Лечение

Australia Royal Hospital For Women NCT06901206

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Implementation of the International Classification of Functioning, Disability and Health Model in Paediatric Cochlear Implant Recipients

Cochlear Impant Children

The aim of this study is to implement the International Classification of Functioning, disability and health (ICF) in paediatric Cochlear Implant (CI) recipients (\

Начало: 01.03.2025 Край: 01.03.2027

Australia, Belgium, Germany +3 University Hospital, Antwerp NCT06841900

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A Master Trial Assessing the Technical Feasibility of First-In-Human Real-Time Image Guided Radiation Therapy Methods

Cancer

The goal of this clinical trial is to determine whether Real-Time Image Guided Radiation Therapy is a feasible method for radiation therapy delivery for patients with cancer. The main questions it aims to answer are: * Can all fractions per patient which are intended to be delivered with the real-time IGRT method be completed as planned? * Can the beam accurately hit the tumour in ≥85% of fractions? * Are there any unexpected grade \>3 acute toxicities? Participants will not require any additional treatments or preparation procedures above those required for normal radiation therapy treatment, to participate in this study.

Начало: 01.03.2025 Край: 01.12.2030 Възраст: от 18 г. Лечение

Australia University of Sydney NCT06708221

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Prokinetics and Body Surface Gastric Mapping in Dyspeptic Patients: Baseline and Treatment Effects

Gastroparesis Functional Dyspepsia

Functional dyspepsia and gastroparesis are common stomach disorders with symptoms like early satiety, nausea, and abdominal pain, and are often evaluated with gastric emptying tests, although the correlation with symptoms is weak. Prokinetic agents (e.g., metoclopramide, erythromycin) and symptom modulators (e.g., nortriptyline, mirtazapine) are commonly used, but selecting the right medication can be difficult, as it's often based on symptoms rather than the underlying gastric issues. Body Surface Gastric Mapping (BSGM) using the Gastric Alimetry device is a novel, non-invasive tool to assess gastric myoelectrical activity and symptoms. This study aims to perform two BSGM recordings-one before and one after medical therapy-to understand how medications affect gastric function and identify baseline BSGM factors that could predict responses to treatment, potentially guiding tailored therapies based on individual gastric dysfunction.

Начало: 26.02.2025 Край: 26.08.2028 Възраст: от 18 г.

Australia, New Zealand, United States University of Auckland, New Zealand NCT06854120

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Neurological Impact of Weight Reduction and Fitness Interventions

Obesity and Overweight

This study will test how significant weight loss through bariatric surgery, combined with a personalised exercise program, affects brain inflammation. Th investigators want to understand the connection between obesity-related body inflammation, metabolic issues, and brain inflammation and function.

Начало: 01.02.2025 Край: 01.12.2027 Възраст: 18–80 г. Фундаментална наука

Australia University of Sydney NCT06830252

Предстои набиране Фаза 1

A Single Ascending Dose Study of DT-216P2 in Normal Healthy Participants

Friedreich Ataxia

This purpose of the study is to evaluate the safety, tolerability and pharmacokinetics of single ascending doses of DT-216P2 administered either subcutaneously (SC) and intravenously (IV) in normal healthy participants. Approximately 36 participants will be enrolled into this study.

Начало: 01.02.2025 Край: 01.12.2025 Възраст: 18–45 г. Лечение

Australia Design Therapeutics, Inc. NCT06772870

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Efficacy of Mobile-delivered Sleep Restriction Therapy for Treatment of Insomnia Disorder: Randomised Controlled Trial

Insomnia

The "SleepFix Study" is a clinical trial designed to evaluate the efficacy of mobile-delivered sleep restriction therapy (dBTi) in comparison to digital sleep health education (control) for treating insomnia disorder in adults aged 18 and above. The study is conducted entirely online, with 558 participants (279 in each group) and aims to determine the impact of the interventions on insomnia symptom severity, sleep metrics, subjective sleep quality, fatigue, anxiety, depressive symptoms, quality of life, medication usage, and workforce productivity.

Начало: 01.02.2025 Край: 26.10.2028 Възраст: от 18 г. Лечение

Australia Woolcock Institute of Medical Research NCT06114901

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Echo Acquisition Despite Geographic Separation by Replication of Human Movements (EAGER)

Echocardiography

Echocardiography is a cornerstone of modern cardiology management, but access in rural and remote areas is limited. We have developed a robot ("Edler" named after the originator of echocardiography) which enables a sonographer to complete an examination at a distance. This study seeks to compare the images obtained by both methods, the completeness of the exam over a feasible time, and to identify particular components of the exam that are difficult to obtain using the robot.

Начало: 15.01.2025 Край: 31.12.2025 Диагностика

Australia Baker Heart and Diabetes Institute NCT06742905

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Study on the Medical Education Capability of the EyeTeacher Artificial Intelligence Platform

Medical Education

With the rise of generative artificial intelligence and large language models, medical education is undergoing a significant transformation. Numerous studies have highlighted the limitations of traditional educational knowledge acquisition and the potential impact of artificial intelligence on medical education, resident training, and continuing education for clinical practitioners. However, there is a lack of real-world experiments on the effectiveness of AI-integrated education. Artificial intelligence can provide extensive educational resources and tools that are not limited by geographical location or language, thereby lowering the barrier to accessing high-quality medical education and promoting educational equity. Nevertheless, the performance of AI models trained by different medical institutions or healthcare systems may vary. To offer a more universal, accessible, high-quality, and interconnected educational journey. We have developed a virtual ophthalmology teacher, which developed based on foundational model and large language models. This model, named EyeTeacher provide comprehensive theoretical knowledge and clinical skills enhancement for untrained medical students. To verify the effectiveness of our EyeTeacher across different national ophthalmology education systems and languages, we plan to implement a randomized controlled trial. This trial will assess the clinical capabilities of all participants and explore the advantages and disadvantages of the system compared to traditional teaching methods.

Начало: 05.01.2025 Край: 30.12.2025 Възраст: 21–40 г. Друго

Australia, China, Ghana +4 Tsinghua University NCT06759012

Предстои набиране Фаза 1/2

A Study to Evaluate the Safety, Tolerability and Efficacy in Patients With Burn(s)

Burns Burn Degree Second

For Phase 1, researchers will explore the safety, and tolerability of PMS-101 and determine the recommended Phase 2 dose (RP2D) using the donor site. For Phase 2a, researchers will compare PMS-101 to a standard-of-care to see if PMS-101 works to treat mid-dermal burns.

Начало: 01.01.2025 Край: 28.02.2025 Възраст: 18–70 г. Лечение

Australia Primoris Therapeutics NCT06440239

Предстои набиране Фаза 2

Surgery and Reducing Ionizing Radiation of the Unknown Primary

Head and Neck Squamous Cell Carcinoma HPV Positive Oropharyngeal Squamous Cell Carcinoma

About 3% of people with head and neck cancer have cancer in their lymph nodes, but doctors are unable to find the primary tumour. This situation has become more common due to human papillomavirus (HPV), a virus linked to certain cancers. Generally, patients with HPV-related cancers have a good outlook, with around 90% surviving for at least five years. Recent advancements in medical technology, such as advanced imaging and specialized surgeries, have significantly improved doctors' ability to find these hidden tumours. These techniques can locate the primary tumour in 70-80% of cases. If the tumour remains undetected, it could be very small or potentially eliminated by the body's immune system. The best way to treat this type of cancer is still debated. Current treatment options include surgery to remove lymph nodes or radiation therapy. There is no clear agreement on which areas should receive radiation. Often, surgery is performed on one side of the throat to try and locate the tumour's origin. Researchers are exploring ways to minimize the harmful side effects of treatment. Some studies suggest that surgery alone might be sufficient for patients with small tumours in their neck, but more research is needed. Another important question is whether radiation needs to cover the entire throat area. Recent findings suggest that omitting radiation from some areas might reduce side effects such as difficulty swallowing and dry mouth. The SUPERIOR trial aims to investigate whether reducing the amount of radiation can still be effective and improve patients' quality of life. The study also examines whether surgery alone is adequate for certain patients with HPV-related cancers.

Начало: 01.01.2025 Край: 30.05.2027 Възраст: от 18 г. Лечение

Australia, Canada London Health Sciences Centre Research Institute OR Law NCT06578871

Предстои набиране Фаза 2

Effector and Memory Immune Responses to HPV Vaccination in Vietnamese Women Post Virus Exposure

HPV Infection Cervical Cancer Anogenital Cancer Anogenital Warts

A Study to evaluate if the 3 dose extended schedule (0-6-18 months) for the HPV vaccine Gardasil-9 provide similar immune responses and short term protection against HPV infection compared to the regular 3 dose schedule (0-2-6 months) in high risk women in Vietnam

Начало: 14.12.2024 Край: 31.12.2027 Възраст: 18–26 г. Превенция

Australia, Vietnam National Institute of Hygiene and Epidemiology, Vietnam NCT06681636

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An Observational Study Using The LumAssure Device In Participants Undergoing Assessment Of Skin Conditions.

Skin Cancers - Basal Cell Carcinoma Skin Cancers - Squamous Cell Carcinoma Melanoma of Skin Inflammatory Dermatoses +3

This is an observational study in adult males and females utilising skin condition measurements using the LumAssure Raman device. Data will be used to determine accuracy under the ROC curve (AUCROC) of the LumAssure device for differentiating between benign and cancerous skin conditions. The measurements will provide data which will be used to establish spectral parameters for different skin conditions. Measurements will be benchmarked against diagnoses from medical specialists, and when available confirmed with histological data. The main question it aims to answer is : What is the accuracy, in terms of the area under the ROC curve (AUCROC) of the LumAssure device for differentiating between benign skin conditions and skin cancers in adult males and females? Participants include males and females aged ≥18 years who are undergoing assessment of a skin condition (a lesion or rash) by a dermatologist, general practitioner, or plastic surgeon. Participants' attending the clinics will have their skin conditions examined by a clinician. The LumAssure device will then be used to measure Raman spectra of skin conditions and marked by the clinician. The Raman measurements will be benchmarked against skin condition assessment and, where available, diagnosis by a dermatologist, general practitioner, or a plastic surgeon, and for those lesions undergoing biopsy, confirmed with histology data.

Начало: 13.12.2024 Край: 28.02.2026 Възраст: от 18 г.

New Zealand University of Auckland, New Zealand NCT06661577

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Study Investigating the Role of Routine Screening and Molecular Characterisation of Brain Metastasis in the Management of High-risk Metastatic Breast Cancer

Breast Cancer Metastatic Brain Metastasases

The purpose of this study is to improve outcome of breast cancer patients who develop brain metastases. This will investigate the benefits of early detection of brain metastases using brain imaging. In patients diagnosed and currently being treated for advanced or metastatic breast cancer, current guidelines do not recommend routine brain imaging. However, there is emerging evidence suggesting that patients diagnosed without symptoms of brain metastases may have a better outcome than those with symptoms such as headache, vomiting and weakness. In current practice, if signs and symptoms suggestive of brain metastases are to develop, then the doctor will arrange imaging of the brain, which may be a computerised tomography (CT scan) and/or a magnetic resonance imaging (MRI) scan. Should brain metastasis be detected, local radiotherapy, chemotherapy or targeted treatments will be offered. When initially diagnosed with metastatic or advanced breast cancer, participant will or would have undergone a brain scan by either MRI or CT during normal standard full-body CT scan (chest, abdomen and pelvis) imaging. In this study, each time participants have a regular full-body CT scans to assess treatment progress, they will also have an additional CT scan of the brain. Participants will have a total of 12 extra brain scans, with scans taking place every three months for the first 2 years, and every 6 months for the following years. These scans will occur at the same location as your current treatment. There will be no extra costs involved in the study and participants will be in the study for 4 years and following their follow-up details will be collected from medical records. Some participants who develop brain metastases during the followup will have neurosurgery to remove these metastases. The investigators will collect either fresh or archived tissues and a cerebrospinal fluid (CSF) sample at the time of surgery from those patients. If the treating investigators do not think neurosurgery is an option, they will ask participants to have a lumbar puncture for the collection of CSF. The purpose of this optional CSF collection is to take a liquid biopsy to check for markers (or biomarkers) potentially expressed by the breast cancer tumour cells in the brain. Participants will also be asked to provide a blood sample as well as old tumour from breast surgery (other metastatic tumour tissue). The information obtained from this component of the study will not impact a parcipants current management, but it will help researchers to develop better treatments for breast cancer brain metastases in the future.

Начало: 01.12.2024 Край: 31.12.2029 Възраст: от 18 г.

Australia Monash University NCT06728150

Предстои набиране Фаза 1

Study of EPI-003 in Select Nucleos(t)Ide Analogue-Treated, Chronic Hepatitis B Patients

Chronic Hepatitis B HBV (Hepatitis B Virus)

This study is an open-label, 2-Part (Single Ascending Dose \[Part 1\] And Dose Expansion) study that will evaluate the safety of EPI-003 administered to patients with chronic infection with HBV (CHB). EPI-003 is a liver-targeted antiviral therapeutic for intravenous (IV) injection that is capable of precise epigenetic modifications of the HBV genome without causing mutations in the gene sequence itself. This study is designed to determine the safety and pharmacokinetic (PK) and pharmacodynamic (PD) profile of EPI-003 in this patient population.

Начало: 01.12.2024 Край: 30.06.2027 Възраст: 18–65 г. Лечение

Australia, China, New Zealand Epigenic Therapeutics, Inc NCT06661148

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Textbook Outcomes After Oesophagectomy in Regional Australia

Oesophageal Cancer Nos

The goal of this observational cohort study is to assess textbook outcomes after oesophagectomy in a regional Australian hospital. This is a composite quality measure that include 9 parameters related to cancer care. Researchers will compares the textbook outcome rate in this regional hospital and compare it to textbook outcomes rates from other Australian hospitals, as well as hospitals overseas. Participants will not be actively involved in this study, as all data will be collected from medical records only.

Начало: 01.12.2024 Край: 01.12.2024

Australia Launceston General Hospital NCT06721715

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