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Post Oesophagectomy Outcomes in a Single Regional Centre in Australia

Oesophageal Cancer

Literature review/rationale for project * Oesophageal cancer is associated with a grim prognosis despite many advances in treatment. Oesophagectomy is a key component of the care of patients who are candidates for curative treatment, however it is associated with substantial morbidity. * Several studies have suggested that oesophagectomies performed at higher volume tertiary centres are associated with lower morbidity and mortality than lower volume centres, and this has prompted changes to policy in countries such as Great Britain, Canada and the Netherlands with regards to the centralisation of these cases. A higher volume centre within Australia is likely to perform 6 or more procedures per year. * Currently within Australia, centralisation on a large scale has not occurred. This has been limited in part by resource provision and geographical barriers. Therefore, oesophagectomies in Australia are still routinely performed in regional centres. However, there is a paucity of recent outcomes data from these centres. Aims/objectives * Retrospective review of oesophagectomies undertaken in a single regional centre in Tasmania, Australia over 10 years (January 2014 to December 2023) * Assess outcomes (long and short-term complications and mortality) and compare to morbidity and mortality rates from larger international centres

Начало: 01.11.2024 Край: 30.11.2024

Australia Launceston General Hospital NCT06662513

Предстои набиране Фаза 1/2

REscuing Bone Marrow Function in Patients with AplaStic AnaEmia and Bone Marrow FaiLure Post AllogEneiC Transplantation 2

Poor Graft Function Aplastic Anemia Idiopathic

Allogeneic stem cell transplantation involves the transplanting of donor blood stem cells into a recipient, this is performed mainly for the treatment of blood cancers. The bone marrow is the organ that produces all blood cells and allogeneic stem cell transplantation results in the replacement of abnormal recipient bone marrow with donor blood cells as well as the production of donor immune cells from the donor bone marrow. The production of donor immune cells will hopefully lead to an immune response directed at any persisting cancerous cells leading to their eradication. As such, one of the key measures of success of a transplant is establishment of donor engraftment. Engraftment is considered successful when the patient has normal blood cell counts on routine laboratory testing as well as confirmation that the blood cells are being produced by donor bone marrow cells. Confirming donor blood cell production is done by a process called chimerism. Poor graft function (PGF) is a complication of allogeneic stem cell transplantation related to engraftment, manifested by low blood counts despite complete donor chimerism. This has significant consequences for the patient leaving them susceptible to infection because of low white blood cells and bleeding because of low platelets (the cell components that are important for blood clotting). There is currently no established treatment for this condition and patients with this condition who do not recover have a poor survival. Aplastic anaemia (AA) is a rare autoimmune condition that results in a patient's own immune system attacking important components of their bone marrow resulting in low blood counts. The current treatments for AA include suppressing the immune system or a bone marrow transplant, however long term survival for patients who do not respond to these treatments or relapse is poor and more effective treatments are required. There is emerging evidence that demonstrates that the components of the immune system are dysfunctional and result in excessive immune activation resulting in suppression of the bone marrow characteristic of PGF. Similar features of immune dysfunction has been demonstrated in AA. Ruxolitinib is a drug that may be able to reduce this excessive immune activation. Eltrombopag is a drug that has been shown to stimulate the production of blood cells. The aim of this study is to evaluate whether the combination of ruxolitinib and eltrombopag is safe and effective in the treatment of PGF and AA.

Начало: 30.10.2024 Край: 30.10.2026 Възраст: от 18 г. Лечение

Australia Melbourne Health NCT06607367

Предстои набиране Фаза 1

BF844 Safety and Pharmacokinetic Study in Healthy Volunteers

Usher Syndrome Type 3

First-in-Human Phase-1 Clinical Trial to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of Single and Multiple Ascending Doses of BF844 when Administered Orally to Healthy Adult Participants.

Начало: 09.09.2024 Край: 06.09.2025 Възраст: 18–45 г. Лечение

Australia EyeXCel Pty. Ltd. NCT06592131

Предстои набиране

Transperineal Ultrasound for Assessing and Predicting Response in Hospitalized Patients with a Flare of Ulcerative Colitis

Ulcerative Colitis

Our aim is to determine how useful transperineal ultrasound is to assess the severity of inflammation in patients with ulcerative colitis. At the moment, there is a small amount of evidence showing it may be just as good as flexible sigmoidoscopy for this purpose. It is a non-invasive test, which means if it is equivalent, it may reduce the need for invasive tests like flexible sigmoidoscopy in the future. Patients admitted to hospital with a flare of ulcerative colitis will be invited to participate. Participants will undergo standard of care treatment and investigation. In addition to this, they will undergo a specialized non-invasive ultrasound test through the perineum (TPUS) as well as the abdomen (TA-IUS). The results from this will be compared to the current standard, flexible sigmoidoscopy. Patients will undergo repeat ultrasound and flexible sigmoidoscopy ten weeks after hospital discharge. We aim to show that transperineal ultrasound is useful for assessing disease severity and predicting the treatment course of hospitalized patients, and may be able to replace flexible sigmoidoscopy in some circumstances.

Начало: 01.09.2024 Край: 01.09.2025 Възраст: от 18 г.

Australia Sunshine Coast Hospital and Health Service NCT06496516

Предстои набиране Фаза 2/3

Skincubator, a Novel Incubator for Skin to Skin Contact Feasibility Study

Preterm Preterm Birth

The goal of this clinical trial is to test the feasibility of using the Skincubator, a wearable incubator for skin to skin contact of preterm babies and their parents. It will also learn about the safety of skincubator. The main questions it aims to answer are: * Can the Skincubator keep a stable temperature for the smallest babies and the first days after birth? * How many hours will the parents (and other family members) will succeed to perform skin to skin every day? Participants will: Be offered the opportunity to perform Skincubator care for as long as they want to each day during the week after enrolment.

Начало: 31.08.2024 Край: 01.09.2027 Възраст: до 14 г. Лечение

Australia Itamar Nitzan NCT06543433

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Feasibility Study to Support Cardiorenal Function in Acute Decompensated Heart Failure With Diuretic Resistance

Heart Failure Acute Decompensated Heart Failure Cardiorenal Syndrome Heart Failure, Congestive +3

Evaluation of the safety and efficacy of the ModulHeart System in patients hospitalized with acute decompensated heart failure (ADHF) and diuretic resistance

Начало: 01.08.2024 Край: 01.12.2024 Възраст: от 21 г. Лечение

Australia, Georgia Puzzle Medical Devices Inc. NCT06174623

Предстои набиране

Australasian Nanoparticle-mediated Magnetically Enhanced Diffusion for Ischemic Stroke

Ischemic Stroke Stroke

Rapidly restoring blood flow to the brain in patients with stroke caused by a blocked blood vessel in the brain is the key to reducing disability. Current treatments often leave small blocked arteries that cannot be safely opened with mechanical clot removal devices. Furthermore, stagnant flow limits access of clot-dissolving medication to the clot. This trial tests iron nanoparticles (similar to iron infused to replace low body stores but injected directly into the brain artery upstream of the blockage) combined with an external rotating magnet that draws the nanoparticles towards the clot, overcoming stagnant blood flow. The aim is to bring fresh blood which contains naturally-occurring clot-dissolving substances, and any clot-dissolving medication that may be circulating, to the surface of the clot with the aim of restoring blood flow to the brain. The trial will recruit up to 30 patients. All will receive injection of nanoparticles via an angiogram (small tube inserted into a leg or arm artery and fed up into the brain artery under Xray control). The procedure takes 30min and the degree of success in opening the artery at the end of procedure is the primary outcome, combined with an absence of symptomatic brain bleeding at 24h.

Начало: 01.08.2024 Край: 31.03.2027 Възраст: от 18 г. Лечение

Australia University of Melbourne NCT06495671

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Ventilation Using Radiographic Examination: Functional Lung Imaging Techniques for the Reduction of Toxicity in Functional Avoidance Radiation Therapy

Lung Neoplasm

The goal of this observational validation study is to determine the best implementation of fluoroscopic and CT ventilation imaging in patients having non-stereotactic ablative body radiotherapy (non-SABR) radiotherapy for stages II-IV lung cancer. The main questions it aims to answer are: * Assess the dosimetric variation in functional avoidance radiation therapy (RT) plans produced using these ventilation imaging techniques, * Establish a quality assurance procedure for functional lung avoidance radiation therapy, and * Evaluate the clinical acceptable thresholds for accuracy of the method. Participants will: Prior to radiation therapy treatment, patients will undergo: 1. A standard of care 4DCT scan for radiation therapy simulation, 2. Pulmonary Function Tests (PFT) 3. A 4D attenuation correction CT 4. Breath Hold Computed Tomography (BHCT) imaging where static end-inspiration and end-expiration BHCT scans will be acquired, 5. Nuclear medicine imaging where a Tc-99m MAA SPECT perfusion scan and a Galligas PET ventilation scan will be acquired, 6. Fluoroscopy where 1-breath cine-fluoroscope sequences will be acquired at five different angles across the chest, 7. A 4D Cone Beam Computed Tomography (4DCBCT) scan. 8. Scans in points 4 to 7 above will be repeated at the end of treatment. Individual participants provide their own internal control. Galligas PET ventilation images (control) are compared with ventilation images derived from additional scans (comparator) for each participant. Tc-99m MAA SPECT perfusion images (control) are compared with perfusion images derived from BHCT scans (comparator) for each patient. There will be no change to patient treatment and patients will be treated using a standard of care anatomical based treatment plan. The pre-treatment 4DCBCT scan is part of standard of care.

Начало: 01.07.2024 Край: 01.09.2026 Възраст: от 18 г.

Australia University of Sydney NCT06159660

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Electronic Capturing of Activities During REhabilitation for Upper Limb After Stroke

Stroke

This is a prospective cohort study to determine the feasibility of accurate, complete, and timely real-time electronic capturing of upper limb motor intervention sessions during usual care. In clinical trials accurate reporting of usual care for people with stroke is scarce, thus understanding the control group compared to the experimental group is poor. The unit of measure in this study is therapy sessions, where a clinician is providing usual care to a patient. The observed sessions will occur in two Austin Health settings: Acute at Austin Hospital; subacute, across Royal Talbot Rehabilitation Centre or the Heidelberg Repatriation Hospital. For each session, patient characteristics, dose and content of upper limb interventions will be electronically captured in REDCap. Additionally, the sessions will be video recorded to allow a second rater to assess feasibility. The secondary aim is to determine if there is an association between the dose and content of upper limb intervention sessions and the contextual factors of stroke patients. Two participant groups will be recruited: Stroke patients and Clinicians (Occupational Therapists and Allied Health Assistants).

Начало: 01.07.2024 Край: 01.12.2026 Възраст: от 18 г.

Australia University of Melbourne NCT06527261

Предстои набиране

MRI Hypoxia Study for Glioblastoma Multiforme (GBM) Radiation Therapy

Glioblastoma Multiforme

This study is designed to evaluate the role of Oxygen Enhanced (OE) Magnetic resonance imaging (MRI) and Blood Oxygenation Level Dependent (BOLD) MRI in detecting regions of hypoxic tumour and to evaluate their use as imaging methods to selectively deliver targeted radiotherapy to regions of aggressive disease.

Начало: 01.06.2024 Край: 01.12.2025 Възраст: от 18 г.

Australia University of Sydney NCT05500612

Предстои набиране

LIAISON NES Influenza (FLU) A/B, Respiratory Syncytial Virus (RSV), & Coronavirus Disease 2019 (COVID-19) in Symptomatic Patients in Australia

Influenza A Influenza Type B Coronavirus Disease 2019 Respiratory Syncytial Virus (RSV) +7

To establish the relative accuracy of the LIAISON® NES Flu A/B, RSV \& COVID-19 assay for viral nucleic acid targets from professionally collected or patient self-collected dry nasal (NS) swabs and to establish the relative accuracy of the LIAISON PLEX® RSP Flex assay from NS and nasopharyngeal swabs (NPS) in applicable transport media from human patients exhibiting clinical signs and symptoms of a respiratory tract infection.

Начало: 06.05.2024 Край: 31.10.2024 Диагностика

Australia DiaSorin Molecular LLC NCT06392451

Предстои набиране Фаза 1/2

Study of MHB088C in Participants With Advanced or Metastatic Solid Tumors

Advanced or Metastatic Solid Tumors

This study will evaluate the safety/tolerability, pharmacokinetics and efficacy of MHB088C in participants with advanced or metastatic solid tumors.

Начало: 23.01.2023 Край: 31.07.2026 Възраст: от 18 г. Лечение

Australia Minghui Pharmaceutical Pty Ltd NCT05652855

Предстои набиране Фаза 1/2

Study of MHB036C in Participants With Advanced or Metastatic Solid Tumors

Advanced Solid Tumor

This study will evaluate the safety, pharmacokinetics, and anti-tumor efficacy of MHB036C in participants with advanced or metastatic solid tumors.

Начало: 23.01.2023 Край: 30.06.2026 Възраст: от 18 г. Лечение

Australia Minghui Pharmaceutical Pty Ltd NCT05642949

Активно (без набиране) Фаза 2

This is an Early-stage Clinical Trial to Determine a Safe and Effective Dose for Tivoxavir Marboxil in Patients With Mild to Moderate Influenza

Influenza

This is an early-stage clinical trial to determine a safe and effective dose for Tivoxavir Marboxil (TRX-100) in patients with mild to moderate Influenza. Participants will take a study drug as well as a standard therapy. A descriptive statistics will be used to present the study results.

Начало: 15.12.2025 Край: 01.01.2027 Възраст: 18–64 г. Лечение

Australia Traws Pharma, Inc. NCT07371650

Активно (без набиране)

EQUIP - Evaluation of Quality of Imaging on a Next-generation Total Body Pet Scan in Comparison to Conventional PET

Cancer

The GE Healthcare Omni Total Body (TB) 128cms (Omni TB) is a long-axial field-of-view (LAFOV) PET/CT scanner and will be installed in a pre-market phase at the Peter MacCallum Cancer Centre. The main features and functionality of this new scanner include high sensitivity, high resolution digital detectors based on silicon photomultipliers. The ultra-high sensitivity and extended field of view are designed to support the ability to reduce administrated dose and/or shorten acquisition time without compromising the image quality of the PET imaging. To verify the appearance of images acquired on the Omni TB with images acquired on our conventional PET/CT equipment, a study imaging a cohort of patients on both devices is proposed. The study involves no additional radiopharmaceutical administration. Additionally, in keeping with ALARA (as low as reasonably achievable) radiation dose practices, it will be possible to model acquisition settings (duration, administered activity and reconstruction parameters) using the system raw data and a suite of research tools to optimise acquisition parameters.

Начало: 24.11.2025 Край: 24.12.2026 Възраст: от 18 г. Диагностика

Australia Peter MacCallum Cancer Centre, Australia NCT07263815

Активно (без набиране) Фаза 3

A Study on a New Tetravalent Dengue Vaccine (TDV) Formulation in Healthy Adults

Dengue Fever

Dengue fever is caused by an infection with the dengue virus. Vaccination with Dengue Tetravalent Vaccine (TDV) can help prevent dengue fever. The TDV in current formulation has been approved by health authorities in many countries around the world. The main aim of the study is to confirm that the TDV new formulation induces the similar immune response as approved TDV. Healthy adults who live in an area in which dengue fever does not occur will receive 2 TDV vaccinations 3-months apart with either the new or the current TDV. Blood samples will be taken before and after the vaccinations. These are necessary to check how well the vaccine works to activate the immune system. During the study, participants will visit their study clinic 5 times.

Начало: 07.11.2025 Край: 30.07.2027 Възраст: 18–60 г. Лечение

Australia Takeda NCT07047521

Активно (без набиране) Фаза 3

Weight Loss in People Living With Overweight or Obesity Following Treatment With Cagrilintide

Obesity Overweight

This study will look at how much cagrilintide helps people with overweight or obesity lower their body weight. Cagrilintide is a new investigational medicine. Doctors may not yet prescribe cagrilintide. Participants will either get cagrilintide or placebo. Which treatment participants get is decided by chance. Participants are two times more likely to get cagrilintide than placebo. Like all medicines, the study medicine may have side effects. Possible side effects will be followed carefully during the study. For each participant, the study will last for about 1 year and 6 months.

Начало: 05.11.2025 Край: 29.06.2027 Възраст: от 18 г. Лечение

Argentina, Australia, Canada +7 Novo Nordisk A/S NCT07220642

Активно (без набиране) Фаза 1

A Study of Avoralstat In Participants With Diabetic Macular Edema

Diabetic Macular Edema (DME)

The goal of this study is to assess the safety and therapeutic potential of a single dose of avoralstat in adult participants with DME.

Начало: 02.10.2025 Край: 01.09.2026 Възраст: от 18 г. Лечение

Australia, United States BioCryst Pharmaceuticals NCT07228559

Активно (без набиране)

Clinical Investigation of a Femtosecond Laser for Corneal Flap Creation

Refractive Errors

The purpose of this study is to see how safe the WaveLight Ultraviolet Femtosecond Laser, Model 1026 (UV fs-Laser), is for creating corneal flaps during laser-assisted in situ keratomileusis (LASIK) surgery. This study will be conducted in Australia.

Начало: 27.08.2025 Край: 01.07.2026 Възраст: от 18 г. Лечение

Australia Alcon Research NCT07036835

Активно (без набиране)

A Clinical Study to Determine What Effect the EyeCool Treatment Has on the Eye's Surface Anatomy and Inflammation Response After Being Treated for Having Chronic Ocular Surface Pain (COSP)

Eye Pain

The goal of this clinical trial is to understand what effect a cold treatment with an investigational device, ETX-4143, has on the anatomical structures and the inflammatory response of the surface of the eye in those people who suffer from chronic ocular surface pain (COSP). The trial will also tell us more about the safety of this investigational device. The main questions this study aims to answer are: * What anatomical changes happen to corneal surface nerves after treatment with ETX-4143 * What changes in inflammatory mediators and cell response take place after treatment with ETX-4143 Researchers will obtain images of the corneal surface nerves for analysis using a confocal microscope and collect tear bio samples for analysis. Participants will: * Be screened for having chronic ocular surface pain * Will be treated with ETX-4143 cold treatment for 4 minutes * Fill out a weekly questionnaire on eye pain for 12 weeks * Be seen in the clinic 2 weeks, 6 weeks, and 12 weeks after treatment to have images of the corneal surface taken, and to collect a tear bio sample

Начало: 25.08.2025 Край: 15.03.2026 Възраст: 22–90 г. Лечение

Australia EyeCool Therapeutics, Inc. NCT07059754

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