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A First-in-Human Study of the CIPHER System During Brain Surgery for Newly Diagnosed Glioma

Glioma Tumor Electrocorticography Brain

The goal of this clinical trial is to collect data on the use of the CIPHER System when used by a surgeon during brain tumor removal. The main questions it aims to answer are: * To evaluate the safety of the CIPHER System when used during brain tumor surgery (Primary) * To evaluate the function of the electrodes under recording and stimulating conditions during surgery (Secondary) Participants will undergo standard-of-care surgery to remove their tumor. Just before the tumor is removed, the CIPHER System will be tested on the main tumor and the surrounding margin areas. Participants will be monitored during standard hospital visits occurring during the recovery period after surgery as well as two- and six-weeks after surgery.

Начало: 01.03.2026 Край: 01.09.2026 Възраст: 18–75 г. Устройства

Australia Coherence Neuro Australia Pty Limited NCT07465796

Предстои набиране Фаза 2

Glucose Tolerance Study

Healthy Volunteers Glucose Tolerance

The goal of this clinical trial is to assess whether TRPTI (oleoylethanolamide) can improve glucose tolerance in healthy adults aged 18 years and above with BMI 18.5-29.9 kg/m². The main questions it aims to answer are: * Does TRPTI improve glucose tolerance as measured by glucose area under the curve (AUC) from 0-120 minutes following a glucose load? * Does TRPTI reduce peak glucose response and alter the time to peak glucose concentration? * Are there dose-dependent effects between 150 mg and 300 mg doses of TRPTI? Researchers will compare TRPTI 150 mg, TRPTI 300 mg, and placebo in a crossover design to see if TRPTI improves glucose metabolism and insulin sensitivity compared to placebo. Participants will complete 3 clinic visits (each lasting approximately 4 hours) with a minimum 6-day washout period between visits.

Начало: 01.03.2026 Край: 01.03.2027 Възраст: от 18 г. Лечение

Australia RDC Clinical Pty Ltd NCT07412730

Предстои набиране Фаза 1/2

A Study to Evaluate BBI-001 in Healthy Volunteers and in Patients With Hereditary Hemochromatosis

Hereditary Hemochromatosis

This study will be conducted in two parts run in parallel. Part 1 of the study (Phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose) will enroll healthy volunteers in 3 sequential dose escalating cohorts with BBI-101 or placebo administered 3 times per day (TID) for 14 days. Part 2 of the study (Phase 2a, randomized, multiple dose, two-period, two-sequence crossover) will evaluate the effect of BBI-001 on blood iron parameters in patients with hereditary hemochromatosis receiving 8 doses of BBI-001 or placebo treatment administered TID in Period 1 followed by administration of reverse treatment in Period 2. Dosing periods will be separated by 12 days.

Начало: 01.03.2026 Край: 01.02.2027 Възраст: 18–70 г. Лечение

Australia Bond Biosciences NCT07371793

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GDF-15 and Its Relationship With Treatment-related ADverse Events in Breast Cancer

Breast Cancer

GRADE is trying to find out if there is a link between a hormone called GDF-15 and the side effects that people can experience when taking T-DXd. GDF-15 can be measured in the blood. GDF-15 levels in the blood will go up when the body is stressed under certain conditions, including breast cancer. There is a link between high GDF-15 levels and the nausea and vomiting experienced with "morning sickness" in pregnancy. It has also been shown that GDF-15 levels will go up with the use of other types of chemotherapy that are known to cause nausea and vomiting. Side effects such as feeling sick (nausea), vomiting and weight loss are common with T-DXd. Sometimes, these can be so severe that treatment needs to be stopped early. The investigators can't predict who will get bad side effects and who will not. If the investigators can find out if there is a link between GDF-15 and the side effects of T-DXd, they can use this information in future clinical trials.

Начало: 01.03.2026 Край: 01.09.2028 Възраст: от 18 г. Поддържаща грижа

Australia, Japan, United States Breast Cancer Trials, Australia and New Zealand NCT07465172

Предстои набиране Фаза 2

Gut Microbiome and Metabolic Health Study

Healthy Volunteers

The goal of this clinical trial is to assess whether TRPTI (oleoylethanolamide) can reduce plasma imidazole propionate levels and improve insulin sensitivity and metabolic health in healthy adults aged 18 years and above with BMI 18.5-29.9 kg/m². The main question it aims to answer is does TRPTI reduce plasma imidazole propionate (a gut microbiota-derived metabolite linked to insulin resistance)? Researchers will compare TRPTI 150 mg, TRPTI 300 mg, and placebo in a parallel design to see if TRPTI reduces imidazole propionate levels and improves metabolic health markers compared to placebo. Participants will: * Take 2 capsules of their assigned study product daily for 4 consecutive weeks * Attend 2 clinic visits (at baseline and week 4)

Начало: 01.03.2026 Край: 01.03.2027 Възраст: от 18 г. Лечение

Australia RDC Clinical Pty Ltd NCT07457723

Предстои набиране Фаза 1

A Phase 1, Open-Label Study to Evaluate Pharmacokinetics and Drug-drug Interactions of ENV-101 (Taladegib) in Healthy Participants

Idiopathic Pulmonary Fibrosis

The purposes of this study are to: 1. evaluate potential interactions between taladegib (ENV-101) and current standard-of-care (SOC) therapies for idiopathic pulmonary fibrosis (IPF), including nintedanib and pirfenidone, and 2. more fully characterize the pharmacokinetics (PK) of taladegib (i.e., how the body absorbs, distributes, metabolizes and excretes taladegib). This study will enroll 4 cohorts (groups) of participants. Each cohort will experience a different duration of treatment and sequestering (being housed) at the clinical site, followed by a 14-day follow-up period for safety evaluation. The longest duration of treatment for any cohort is 30 days.

Начало: 01.03.2026 Край: 01.10.2026 Възраст: 26–65 г. Лечение

Australia Endeavor Biomedicines, Inc. NCT07454291

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Multicomponent Breathlessness and Physical Activity Intervention in People With Asthma Using a Digital Platform

Asthma (Diagnosis) Breathlessness

Treating breathlessness could help people with asthma have fewer symptoms and be more physically active. People with asthma report that it is important to deal with breathlessness during physical activity programs, but past research hasn't focused on this need. The investigators have developed a multicomponent digitally supported intervention targeting breathlessness and physical inactivity. This study will test whether the multicomponent digital supported intervention will help people with asthma. The main question the study aims to answer is: Does the multicomponent digitally supported intervention improve quality of life? Participants will: * Be allocated to the intervention or usual care. Allocation to either group will be random (like tossing a coin). * Attend study visits to complete an assessment involving questionnaires and measurements * Receive telephone calls to ask questions about health * Be invited to take part in an interview to have a conversation about thoughts on participating in the study * Be asked to provide consent to collect information from Services Australia regarding use of health care services and medications

Начало: 01.03.2026 Край: 01.10.2028 Възраст: от 18 г. Друго

Australia University of Newcastle, Australia NCT07421115

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Nasal Airflow in Post-operative Patients

Invasive Ventilation

The goal of this investigation is to examine the effect of nasal airflow in invasively ventilated adult patients following planned surgery. The main questions it aims to answer are: * Does the investigational device produce an effect measured by EEG? * Are there differences in effect with modified airflow states?

Начало: 01.03.2026 Край: 01.02.2027 Възраст: от 18 г. Друго

New Zealand Fisher and Paykel Healthcare NCT07468266

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Chlorhexidine Caps for CLABSI Prevention in Hemodialysis: a Pilot Randomized Controlled Trial

Vascular Access Complication Device Related Infection Device Related Sepsis Catheter Infection +6

The goal of this clinical trial is to compare a chlorhexidine antimicrobial barrier cap in patients requiring hemodialysis treatment to the standard hemodialysis caps currently used within the Metro North Kidney Health Service. The main questions to answer are: * Study Feasibility * Occurrence of infectious complications related to renal central venous catheters Participants will be randomly allocated to receive either of the below hemodialysis caps to cover their hemodialysis catheter hub: * The standard hemodialysis cap used at the Royal Brisbane and Women's Hospital, or * The intervention hemodialysis cap containing chlorhexidine inside it Researchers will compare standard and chlorhexidine hemodialysis caps to see if the presence of chlorhexidine improves the occurrance of infectious complications related to the hemodialysis catheter.

Начало: 01.03.2026 Край: 01.02.2028 Възраст: от 18 г. Превенция

Australia The University of Queensland NCT07019610

Предстои набиране Фаза 1

A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AK0406 Injection in Healthy Adult Participants

Healthy Participants

This study is a phase I, single-center, randomized, double-blind, placebo-controlled study of AK0406 as a first-in-human (FIH) trial to evaluate the safety, tolerability and pharmacokinetics (PK) of AK0406 in healthy adult participants.

Начало: 01.02.2026 Край: 01.04.2027 Възраст: 18–65 г. Превенция

Australia Shanghai Ark Biopharmaceutical Co., Ltd. NCT07432698

Предстои набиране Фаза 2

Understanding the Role of the Locus Coeruleus in Insomnia

Insomnia

This research project aims to better understand the neurobiological mechanistic underpinnings of insomnia disorder. The main question is whether cortical hyperarousal in individuals with insomnia disorder, measured by electroencephalograhic (EEG) infraslow oscillation coupling of sigma power during non-rapid eye movement (NREM) sleep and theta power during rapid eye movement (REM) sleep, is related to locus coeruleus activity.

Начало: 01.02.2026 Край: 01.03.2027 Възраст: 30–65 г. Друго

Australia Woolcock Institute of Medical Research NCT07392177

Предстои набиране Фаза 2

Evaluating Safe Ketone Thresholds To Minimise Ketosis in People With Type 1 Diabetes Using Dapagliflozin

Type 1 Diabetes Mellitus

Sodium glucose cotransporter 2 (SGLT2) inhibitors are a type of medicine that help the kidneys get rid of extra sugar in the blood through urine. In people with type 2 diabetes (T2D), these medications help lower blood sugar levels, help people lose weight and improve heart and kidney health. SGLT2 inhibitors are mainly used in T2D, however some studies show they might also help people with type 1 diabetes (T1D). The same health benefits observed in people with T2D the investigators anticipate may help those with T1D. Currently, there is a safety concern that people with T1D using these medicines can raise the risk of diabetic ketoacidosis (DKA). DKA occurs when the body doesn't have enough insulin (a hormone made in the pancreas that helps your body use sugar (glucose) for energy), it starts to break down fats as a source of energy. This breakdown of fats produces ketones. Very high levels of ketones in the blood can make the blood acidic (toxic) and lead to DKA. If not treated in time, this can make the person living with T1D very ill and can be life-threatening. Because of this risk, health agencies like the FDA in the U.S., and the TGA in Australia have not approved use of SGLT2 inhibitors for people with T1D. Still, some experts believe SGLT2 inhibitors may safely be used alongside insulin in T1D if DKA risk is carefully managed. This might be possible with early detection and treatment of rising ketone levels. One approach is using continuous ketone monitors, which track ketone levels in real time and can alert users early. People would also need proper education on what to do if ketone levels start rising. To date, there's no official agreement on the exact ketone level that should trigger action. Some suggest action when ketone levels reach 1.0 or 1.5 mmol/L. A lower limit like 1.0 mmol/L may be safer, but it could also lead to too many alarms and extra stress, or unnecessary eating to bring ketones down. Therefore, the aim of this study is to assess if initiating responses to elevated ketone levels at a threshold of 1.0 mmol/L, compared to a threshold of 1.5 mmol/L, will reduce the risk of DKA in people with T1D using Dapagliflozin. The investigators will recruit 115 adults with T1D and provide Dapagliflozin (SGLT2 inhibitor) and continuous glucose and ketone monitoring (DGK) devices. Participants will be randomly assigned to two groups. Group 1 will wear a DGK with alarms set at ketone level of 1.0 mmol/L and receive education about taking action when ketone levels are ≥1.0 mmol/L. Group 2 will wear a DGK with alarms set at ketone level of 1.5 mmol/L and receive education about taking action when ketone levels are ≥1.5 mmol/L. Participants will be assessed for time spent with critically high ketone levels, incidence of DKA, glucose and person reported outcomes. Findings from this study will provide real life data and clinical evidence to help guide safe use of SGLT2 inhibitors in people with T1D by informing protocols for monitoring and managing associated DKA risks.

Начало: 01.02.2026 Край: 01.02.2028 Възраст: 24–85 г. Лечение

Australia St Vincent's Hospital Melbourne NCT07225465

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LTFU of PCL Breast Scaffolds Used in 2021-BRV-004

Breast Implant Revision

The objective of this study is to assess the long-term safety and performance of the PCL Breast Scaffold in women who previously underwent breast silicone implant revision and received the PCL Breast Scaffold combined with autologous fat grafting (AFG) in the 2021-BRV-004 clinical trial (ClinicalTrials.gov ID: NCT05437757). In addition, this study will investigate the suitability of mammography in the subset of patients that fall into the national breast screening age category - individuals aged 40 years and older. The main questions this study aims to answer are: * "Is the PCL Breast Scaffold combined with autologous fat grafting a safe and effective method of soft-tissue reconstruction following breast implant revision?" * "Is mammography a suitable follow-up screening and diagnostic tool for patients implanted with the PCL Breast Scaffold?" Participants will attend annual follow-up visits from 3 to 5 years after PCL Breast Scaffold implantation for clinical assessments and patient-reported outcome questionnaires.

Начало: 01.02.2026 Край: 01.02.2029

Australia BellaSeno Pty Ltd NCT07383012

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Speed of Lung Inflation During Ventilation of Extremely Preterm Infants

Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome in Premature Infant

Babies born extremely preterm (\

Начало: 01.02.2026 Край: 01.08.2027 Възраст: 6–7 г. Лечение

Australia Murdoch Childrens Research Institute NCT07101419

Предстои набиране Фаза 2

The AminoECMO Pilot Trial

Acute Kidney Injury

Acute kidney injury (AKI) is a serious problem for patients in intensive care, especially those on life-support machines like ECMO (which helps the heart and lungs). More than half of these patients develop severe kidney problems that often require dialysis, and this greatly increases the risk of poor outcomes. Doctors try to prevent AKI by treating the underlying illness, avoiding kidney-harming drugs, and carefully managing fluids. But these methods are mostly supportive - they don't actively improve kidney function. Studies in surgical patients (especially heart and urology operations) show that giving amino acids before surgery can reduce the chance of developing AKI. A major clinical trial even found that this approach significantly lowered AKI rates in heart surgery patients. Amino acids (the building blocks of protein) seem to boost kidney performance. When given through a drip or feeding tube, they increase blood flow to the kidneys and may "wake up" unused kidney capacity - a concept called "functional renal reserve." It's not yet clear whether amino acids help critically ill patients on ECMO. More research is needed to see if this promising strategy can improve kidney function and outcomes in the sickest patients.

Начало: 01.02.2026 Край: 30.11.2027 Възраст: 18–65 г. Превенция

Australia Australian and New Zealand Intensive Care Research Cent NCT07438262

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INTERACT4 Expansion - Validation Study

Intracerebral Hemorrhage

As an investigator-initiated and conducted, multi-centre, open-label, single-arm prospective observational trial, INTERACT4 Expansion aims to evaluate the diagnostic accuracy of GFAP measured using a point-of-care device, for identifying ICH in participants presenting with acute stroke-like symptoms in the pre-hospital setting compared with imaging-confirmed ICH.

Начало: 01.02.2026 Край: 01.06.2027 Възраст: от 18 г.

Australia The George Institute NCT07231315

Предстои набиране Фаза 1

A Phase 1 Open-label Study to Evaluate Safety in Healthy Participants and Participants With Idiopathic Inflammatory Myopathy (IIM)

Healthy Idiopathic Inflammatory Myopathies

The purpose of this study is to determine the safety and tolerability of XmAb657 in healthy participants and participants with IIM. Participants will be given XmAb657 subcutaneously (SC) by injection under the skin.

Начало: 01.02.2026 Край: 01.02.2027 Възраст: 18–75 г. Лечение

Australia Xencor, Inc. NCT07284797

Предстои набиране Фаза 1/2

SL-28 for Advanced Solid Tumours

Head & Neck Cancer Pancreas Carcinoma Pancreas Cancer, Metastatic Lung Adenocarcinoma +14

Second Life Therapeutics is developing SL-28, an allogeneic, non-genetically modified cell-based therapy for the treatment of advanced solid tumours. The company has recently demonstrated a novel, non-genetic approach to modulate immune cell activity through targeted manipulation of the Universal Receptive System. The purpose of this open label, multi-center clinical trial is to evaluate the anti-tumor activity, safety, and pharmacokinetics, single-agent SL-28 in patients with a diverse array of solid tumors. The study includes an initial Phase 1 dose escalation to determine recommended dose(s) for expansion of SL-28 as a monotherapy and Phase 2 expansion cohorts. The study will enroll patients with advanced solid tumours, including those who failed previous lines of chemo- and immunotherapies.

Начало: 01.02.2026 Край: 01.03.2027 Възраст: от 18 г. Лечение

Australia Second Life Therapeutics NCT07341737

Предстои набиране Фаза 1/2

A Study of VV-14305 for the Treatment of Thyroid Eye Disease

Thyroid Eye Disease (TED)

The goal of this study is to evaluate the safety, tolerability, and efficacy of KRIYA-586 (VV-14305) in treating thyroid eye disease (TED).

Начало: 01.02.2026 Край: 01.02.2029 Възраст: 18–80 г. Лечение

New Zealand Kriya Therapeutics, Inc. NCT07404111

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Novel Technologies to Improve Echocardiographic Estimates of Left Ventricular Filling Pressure in Heart Failure Combined With Atrial Fibrillation

Heart Failure (HF) Atrial Fibrillation (AF)

Heart failure and atrial fibrillation are two of the most common heart diseases globally. Nearly half of all patients with heart failure also have atrial fibrillation. When heart failure and atrial fibrillation occur together, the risk of hospitalization and premature death increases significantly. However, there is a lack of reliable tools to assess how severely the heart is affected in these patients. This makes it difficult both to establish the correct diagnosis, tailor treatment, and predict who is at greatest risk of hospital admission or death from the disease. One of the most important targets in heart failure is the filling pressure in the left ventricle. When this pressure is high, it means that the heart has difficulty receiving blood, leading to shortness of breath and fluid retention in the body. Today, filling pressure is usually estimated using ultrasound (echocardiography), but the available methods are primarily developed for patients without atrial fibrillation. In patients with both heart failure and atrial fibrillation, the measurements are so uncertain that they cannot be used as a reliable basis for clinical decision-making. In this study, entitled Heart Failure combined with Atrial Fibrillation (HFcAF), the investigators will test new ultrasound methods that combine novel measures of cardiac chamber function with established techniques. Artificial intelligence will be used to identify the most useful combinations of parameters, select cardiac cycles that are best suited for analysis in atrial fibrillation, and automate and optimize the measurements. This approach may provide both more accurate and faster assessments, while also making the methods easier to implement in clinical practice. The aim is to improve the estimation of filling pressure so that it becomes more precise also in patients with atrial fibrillation. The investigators will then examine whether these improved methods can be used to predict which patients are at highest risk of hospitalization or death due to heart failure. The study is designed as a prospective multicenter study, in which patients are recruited from several hospitals in different countries. This will make the results robust and generalizable to a wide range of patient populations. The investigators anticipate that the project will pave the way for better diagnostics and risk stratification in heart failure combined with atrial fibrillation and, in the longer term, contribute to improved guidelines and treatment for a large number of patients. If successful, the project will provide a new tool that can contribute to earlier and more targeted treatment, thereby improving quality of life and prognosis for a large group of patients.

Начало: 01.02.2026 Край: 01.12.2029 Възраст: от 18 г.

Belgium, France, Japan +7 Oslo University Hospital NCT07436299

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