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Предстои набиране Фаза 2

Safety and Efficacy of HB-1 for Post-Traumatic Stress Disorder

PTSD Mental Illness

The purpose of this study is to determine the safety and efficacy of HB-1, versus placebo in male and female adult patients aged 18 to 65 years, inclusive, with Post-Traumatic Stress Disorder (PTSD).

Начало: 01.04.2026 Край: 01.10.2027 Възраст: 18–65 г. Лечение

Australia HB BioTech, LLC NCT07499440

Предстои набиране

Functional Outcomes and Control Using Synchron BCI - Australia

Neurologic Disorder Neurologic Diseases MND (Motor Neurone DIsease) Motor Neuron Disease +3

Functional Outcomes and Control Using Synchron BCI - Australia (FOCUS-AUS)

Начало: 01.04.2026 Край: 01.11.2027 Възраст: от 21 г. Друго

Australia Synchron, Inc. NCT07533903

Предстои набиране Фаза 1

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of IBIO-600 in Overweight or Obese Adults

Overweight , Obesity

The goal of this clinical trial is to learn which dose of study drug IBIO-600 has the right balance of safety, tolerability and impact on body composition in overweight and obese adult participants.

Начало: 01.04.2026 Край: 01.05.2027 Възраст: 18–65 г. Лечение

Australia iBio, Inc. NCT07487376

Предстои набиране Фаза 1

Study of ALA-101 in Patients With CD19 Positive Non-Hodgkin Lymphoma and Leukemia.

Non Hodgkin Lymphoma (NHL) Leukaemia

Phase 1 Open-Label Dose-Escalation and Expansion Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of ALA-101

Начало: 01.04.2026 Край: 30.08.2030 Възраст: от 18 г. Лечение

Australia Arovella Therapeutics Ltd NCT07518329

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deMISTify: The Impact of Ventilator Pressure Levels During Minimally Invasive Surfactant Therapy on Lung Aeration in Preterm Infants

Surfactant Deficiency Syndrome Neonatal

Infants born preterm (before 36 weeks' gestation age) have immature lungs and struggle to breathe on their own. They are supported via respiratory machines like ventilators, as well as pharmaceutical aids like surfactant replacement therapy. Surfactant replacement therapy is an established therapy for the treatment of respiratory distress syndrome, which is a common illness in infants born preterm. Surfactant replacement therapy can be delivered to an infant's lungs a few ways, including via a small tube that is briefly placed down an infant's throat. This is considered the least invasive method currently available, and is becoming more popular. It is referred to as minimally invasive surfactant therapy (MIST). A baby can receive surfactant via MIST if they are receiving non-invasive respiratory support, like from a continuous positive airway pressure (CPAP) machine. Doctors and researchers are looking for simple ways to make MIST more effective. This clinical trial will investigate if briefly increasing the air pressure delivered by a CPAP machine before giving MIST therapy will make MIST more effective. This strategy is called a lung recruitment manoeuvre (LRM), because it opens up more of the lungs - 'recruits' them - to help with oxygenation. The CPAP setting that is briefly changed is called positive end expiratory pressure (PEEP) - it increases the amount of air left in the lungs at the end of a breath. This stops parts of the lung collapsing when exhaling, which commonly occurs in the lungs of infants born preterm as they are immature. The goal of this clinical trial is to investigate if a LRM prior to MIST improves ventilation and lung aeration in preterm infants born 24-32 weeks' gestation. The main question it aims to answer is: How a LRM prior to MIST might impact patterns of ventilation and lung aeration in preterm infants, compared to no LRM prior to MIST. The current standard of care is no LRM before MIST. Researchers will compare this current standard against a LRM before MIST to see if it potentially improves patterns of ventilation. Participants will be randomly placed (by chance) to receive either no LRM before MIST (control) or a LRM before MIST (intervention). Participants will be randomised once their treating clinical team have decided to give MIST.

Начало: 01.04.2026 Край: 01.04.2028 Възраст: 24–32 г. Лечение

Australia Murdoch Childrens Research Institute NCT07522346

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COMPARATIVE EFFECTIVENESS OF EXERCISE, COGNITIVE BEHAVIOURAL THERAPY, AND THEIR COMBINATION FOR PEOPLE WITH CHRONIC MUSCULOSKELETAL PAIN AND POOR SLEEP: SLEEPFIT TRIAL

Osteo Arthritis Knee and Hip Low Back Pain Insomnia

This study aims to find out which lifestyle approach works best for people with chronic musculoskeletal pain (such as low back pain or hip/knee osteoarthritis) who also have poor sleep. Participants will be randomly assigned to one of three 12-month home-based programs: exercise, cognitive behavioral therapy for insomnia (CBT-I), or a combination of both. Each program includes up to 10 online sessions with a physiotherapist and guidance on managing pain, sleep, and physical activity. We will measure changes in pain, sleep quality, and overall health using questionnaires, wearable devices, sensory tests, and blood samples. The goal is to improve understanding of non-medication treatments for pain and sleep problems.

Начало: 01.04.2026 Край: 01.04.2029 Възраст: от 18 г. Лечение

Australia University of Sydney NCT07532070

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Study of Min-Max APAP Recommender Tool

Obstructive Sleep Apnea (OSA)

Pressure Match (The APAP Min-Max tool) is a software-based clinical decision-support tool, developed using a causal-inference modelling approach based on data from thousands of OSA patients. The model takes as inputs from patient variables (e.g., baseline AHI, gender, weight/BMI, mask interface type), and outputs recommended AutoSet minimum and maximum pressure settings (cmH₂O) tailored for that patient phenotype. The intended clinical role of the Pressure Match tool is to assist the clinician's choice of AutoSet pressure range when initiating CPAP therapy, with the goal of reducing clinician time/effort in manual titration and follow-up adjustments without compromising safety, efficacy or patient satisfaction. The purpose of this trial is to test Pressure Match in a clinical trial setting, to demonstrate non-inferiority against standard APAP settings.

Начало: 01.04.2026 Край: 01.03.2027 Възраст: от 18 г. Лечение

Australia ResMed NCT07400861

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The Effects of Open-label Placebos on Acute Stress

Acute Stress Stress

The goal of this study is to find out whether an open-label placebo nasal spray can reduce stress among individuals engaging in a high-stress canyon swing. The main questions the study aims to answer are: 1) Does an open-label placebo increase likelihood of participants completing another jump? 2) Does the placebo affect how long it takes participants to jump, reduce the reported stress levels before the jump 3) Does the placebo change how enjoyable participants find the jump? Researchers will compare participants who receive an open-label placebo nasal spray (a spray that contains no active medication and is clearly described as a placebo) with participants who receive no treatment (control). The aim is to see whether the placebo nasal spray can increase likelihood of participants completing another jump, reduce reported stress and improve participants overall enjoyment of the jump. Participants will: * Complete a short questionnaire before they jump * Either self administer a placebo nasal spray (one spray in each nostril) right before stepping through the gate to jump, or receive no treatment (control). * Complete a short questionnaire after completing the jump * Whether they complete another jump will be noted

Начало: 01.04.2026 Край: 01.11.2026 Възраст: от 18 г. Лечение

New Zealand University of Auckland, New Zealand NCT07522437

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Optimising Breathing Support at Extubation in Very Preterm Infants: A Clinical Study

Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome in Premature Infant

Many babies born very preterm (\

Начало: 31.03.2026 Край: 31.03.2028 Възраст: до 30 г. Поддържаща грижа

Australia Murdoch Childrens Research Institute NCT07251790

Предстои набиране Фаза 1

Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of SSS67 in Healthy Adult Participants Via Single Intravenous Infusion

Healthy

This is a randomized, double-blind, placebo-controlled, single ascending dose phase I clinical study to evaluate the safety, tolerability, PK, preliminary PD and immunogenicity of SSS67 in healthy adult participants after single intravenous infusion. The primary objective is to assess the safety and tolerability of SSS67 following single ascending doses. The secondary objectives are to characterize the PK, PD, and anti-drug antibody (ADA) profiles of SSS67 after single administration. The exploratory objective is to evaluate changes in body weight, waist circumference, and other related metabolic parameters following a single dose of SSS67.

Начало: 31.03.2026 Край: 02.04.2027 Възраст: 18–65 г. Лечение

Australia, China Shenyang Sunshine Pharmaceutical Co., LTD. NCT07487545

Предстои набиране Фаза 2

Safety and Efficacy of MiSaver (CB Cells) for Acute Myocardial Infarction, Phase II

Acute Myocardial Infarction (AMI)

This trial is a Phase II, multicenter clinical study. The purpose of this trial is to evaluate the safety and efficacy of MiSaver, a cellular therapy product, in patients who have experienced an acute myocardial infarction (AMI). Specifically, the study aims to assess the improvement in left ventricular function of the heart following the administration of MiSaver, as well as to determine the safety of using stem cell therapy in these patients. This trial will employ a single-blind design (subject-blinded), meaning that the participants will not be aware of whether they are receiving MiSaver or standard treatment, while the researchers will have this information. This design helps ensure transparency and adherence to ethical standards while also providing valuable clinical insights. By utilizing randomization, we can enhance the reliability and comparability of the study results. A portion of the participants will receive MiSaver, while the others will undergo standard treatment. This allows for a direct comparison of the two therapeutic approaches to determine their respective efficacy. The primary objective of this trial is to evaluate the safety and efficacy of MiSaver, in the treatment of patients with acute myocardial infarction (AMI). To achieve this, we will collect comprehensive participant data, including assessments of cardiac function, records of cardiac events, and quality-of-life surveys. By analyzing these data, we aim to gain a deeper understanding of the benefits and limitations of this treatment approach.

Начало: 30.03.2026 Край: 31.12.2027 Възраст: от 45 г. Лечение

Australia, Taiwan HONYA Medical Co Ltd NCT07134712

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Oral Probiotics for Halitosis in Healthy Adults

Halitosis

The aim of this study is to evaluate efficacy of a probiotic lozenge containing BLIS M18, BLIS K12 and a prebiotic in healthy adults.

Начало: 15.03.2026 Край: 15.07.2026 Възраст: 18–70 г. Фундаментална наука

New Zealand John Hale NCT07384130

Предстои набиране Фаза 1

JSKN016HC in Patients With Advanced or Metastatic Solid Malignant Tumors

Advanced Solid Tumor Malignancies

This is a Phase I, open-label, multicenter, first-in-human study to evaluate the safety, tolerability, PK/pharmacodynamic (PD) characteristics, and anti-tumor activity of JSKN016HC in subjects with advanced malignant solid tumors.

Начало: 01.03.2026 Край: 01.07.2028 Възраст: от 18 г. Лечение

Australia Jiangsu Alphamab Biopharmaceuticals Co., Ltd NCT07475559

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Speech-Evoked Auditory Potentials: Multisite Pediatric Evaluation

Hearing Impairment

The goal of this study is to evaluate the sensitivity of a newly-developed prototype device in its ability to measure brain responses to speech sounds in an infant population. The main research questions are: 1) Is the prototype sensitive to brain response differences from infants with hearing loss with and without hearing aids? and 2) How do the measured brain responses from infants with hearing loss compare to infants with normal hearing who are the same age? Participants will have their brain responses measured using the prototype in response to average-level non-sense speech sounds across 1 to 2 sessions in a "no-hearing aids" condition. Participants with hearing loss who are already fit with hearing aids will additionally undergo a "with hearing aids" recording condition.

Начало: 01.03.2026 Край: 01.12.2026 Възраст: 3–24 г. Здравни услуги

Australia, Canada Susan Scollie NCT07392164

Предстои набиране

Catheter Ablation Versus Anti-arrhythmic Drugs for Premature Ventricular Complexes

Premature Ventricular Complexes Premature Ventricular Contraction (PVC) Premature Ventricular Beats

Premature ventricular complexes (PVCs) are extra, abnormal heart beats arising from the ventricles of the heart and are the most common ventricular arrhythmia. PVCs can be treated with medication or with a procedure called catheter ablation. It is not known which provides a better cure or provides better quality of life. The purpose of this research project is to study the best way to treat PVCs by comparing the use of medication to catheter ablation to assess which approach is better at reducing symptoms and improving quality of life.

Начало: 01.03.2026 Край: 01.03.2028 Възраст: от 18 г. Лечение

Australia Western Sydney Local Health District NCT07445334

Предстои набиране Фаза 1/2

Safety, Tolerability, and Pharmacokinetics of SVG103 (Paxalisib) in Focal Cortical Dysplasia Type II (FCD-II), Tuberous Sclerosis Complex (TSC) or Hemimegalencephaly (HME)

Focal Cortical Dysplasia Tuberous Sclerosis Complex (TSC) Hemimegalencephaly

This is a multinational, open-label, single-arm trial of adjunctive SVG103 (paxalisib) treatment in adults with FCD-II, TSC, and HME.

Начало: 01.03.2026 Край: 01.06.2027 Възраст: 18–65 г. Лечение

Australia Sovargen NCT07287202

Предстои набиране

Self-management Interventions to Reduce Cardiovascular Risks in Breast Cancer Survivors

Breast Cancer

The goal of this proposed single-group pre-post pilot study is to assess the feasibility and acceptability of the codesigned Nurse-led and GP-supported self-management interventions (NGPS) to reduce cardiovascular risks in breast cancer survivors with cardiovascular diseases. The study will also assess the preliminary effects of the NGPS intervention on various outcomes, such as behavioural, physiological, psychological, and healthcare usage. These outcomes will be measured at three time points, which include the baseline measurement at recruitment (T1-week 1), right after the four weeks' intervention (T2-week 4), and eight weeks after completing the intervention (T3-week 12). The study will be conducted in the primary care centres, and the self-management interventions are behavioural change interventions such as physical activity, diet modifications, tobacco cessation, weight management, eliminating or reducing alcohol consumption, and mind-body exercises such as yoga. The main questions it aims to answer are: 1. What are the recruitment, retention, attrition, and completion rates of participants and potential adverse effects related to the NGPS interventions for the participants throughout the pilot study? 2. What are the adherence rates of the NGPS protocol, participants' response and completion rates of the study instruments during the data collection period of the pilot study? 3. Do this pilot study results indicate any significant differences in cardiovascular health outcomes (e.g., BMI and blood pressure), physical activity, dietary intake, QoL, self-efficacy, anxiety and depression between and across different time points (Baseline (T1), post-intervention (T2), follow-up (T3))?

Начало: 01.03.2026 Край: 01.02.2027 Възраст: от 18 г. Поддържаща грижа

Australia University of Southern Queensland NCT07313397

Предстои набиране Фаза 1/2

Intratumoral N17350 in Advanced Solid Tumors

Neoplasms, Solid Tumor Breast Neoplasms, Triple-Negative Squamous Cell Carcinoma of Skin Melanoma +3

The goal of this clinical trial is to learn if N17350 works to treat advanced solid tumors in adults. It will also learn about the safety of N17350 and help determine the best dose to use in future studies. The main questions it aims to answer are: 1. Does N17350 cause tumors to shrink or stop growing in some participants with advanced solid tumors? 2. Are there any side effects for participants when taking N17350? 3. What is the safest dose of N17350 and the dose that should be used for further study? 4. Researchers will give N17350 directly into tumor lesions using a needle (intratumoral injection). This is an open-label study, meaning all participants will receive N17350 and there is no placebo. Participants will: 1. Receive injections of N17350 into tumor lesions every second week for 8 or 12 weeks 2. Visit the clinic regularly for checkups, blood tests, and monitoring for side effects 3. Have imaging scans (such as CT or MRI) to measure tumors and assess response 4. Provide blood samples and, when required, tumor samples to help researchers understand how N17350 affects the tumor and the immune system

Начало: 01.03.2026 Край: 01.11.2029 Възраст: от 18 г. Лечение

Australia Onchilles Pharma Inc NCT07339176

Предстои набиране Фаза 3

Phase 3 Trial of VMX-C001 vs Usual Pharmacological Care in Patients Taking a FXa Direct Oral Anticoagulant Who Require Urgent Surgery With or Without Heparin.

Blood Loss, Surgical Coagulation Disorder

The goal of this clinical trial is to learn if VMX-C001 works to to allow blood clotting control in participants who take FXa Direct Oral Anticoagulants (DOACs) during surgery or other invasive procedures that carry a high risk of bleeding. The main question it aims to answer is: ● What is the proportion of participants in whom the stopping of bleeding was classed as good or excellent during the procedure, as judged by a group of experts who did not know which treatment was given? Researchers will compare a fixed dose of VMX-C001 to the usual treatment that would be given for the required procedure. Participants will: * Be given either a fixed dose of VMX-C001 or usual treatment before they undergo the required procedure in theatre * Have regular clinical assessments, including laboratory tests, during their hospital stay following the procedure * Return to the clinic for a check-up and tests approximately 28 days after the procedure was conducted.

Начало: 01.03.2026 Край: 01.01.2031 Възраст: от 18 г. Лечение

Australia, New Zealand, United States VarmX B.V. NCT07288489

Предстои набиране Фаза 1/2

A Randomised Controlled Phase 1 Study of Vaccine Therapy for Control or Cure of Chronic Hepatitis B Virus Infection

Chronic Hepatitis b

This is a pilot study to determine the safety and efficacy of a novel adjuvanted hepatitis B virus (HBV) vaccine formulated as a potential therapeutic vaccine against chronic HBV infection. An ongoing human clinical trial of this HBV vaccine in a prophylactic setting has confirmed this vaccine to be more effective at inducing seroconversion as measured by development of Hepatitis B surface antibody (HBsAb) in poor responder subjects than the standard alum-adjuvanted HBV vaccine, providing promise that this new vaccine may also be able to induce HBV viral control and/or seroconversion in chronically infected subjects

Начало: 01.03.2026 Край: 30.06.2027 Възраст: от 18 г. Лечение

Australia Vaxine Pty Ltd NCT03038802

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