ANZCTR search results

A new residential in-reach program has been introduced in the Grampians region. The purpose of this project is to examine the effects of this new program in the region. The program will provide medical care to people who live in residential aged care homes when they experience a rapid deterioration in their health without the need to go to hospital if it is not necessary, and receive any care in their place of residence. This project will monitor hospital presentation for 14 months as the program is rolled-out in the region to evaluate its effects. It is hypothesised that this program will reduce emergency department and urgent care centre presentations from residential aged care facilities.

People with epilepsy suffer not only from the effects of their chronic and disabling condition but also the uncertainty surrounding when and how it will affect them. New Australian technology that is currently under investigation - the Epiminder system - is designed to allow for continuous recording of brainwave activity (electroencephalography, or EEG) for months to years, using an implant under the scalp. This technology has the potential to offer unprecedented insights and certainty for patients and the clinicians who care for them. This project will evaluate this new 'subscalp' monitoring technology, to see how it can improve the lives of people with epilepsy. Specifically, we hypothesise (believe) that this new long-term subscalp brainwave monitoring will be more accurate than traditional methods of (people recording seizures in diaries), and that this increased accuracy will lead to better outcomes for people with epilepsy. NB: The Epiminder system is for investigational use only and it’s not approved in any geography.

This is a double-blind, placebo-controlled study to assess the safety of GB-7624 and how this drug acts in the body in healthy volunteers. GB-7624 may be indicated for use in patients with atopic dermatitis, but a trial of the drug in healthy volunteers is needed before trials in atopic dermatitis patients can proceed. Who is it for? You may be eligible for this study if you are aged 18 to 65 years and are in good general health without a clinically significant medical history. Study details All healthy volunteer participants who choose to enrol in this study will be assigned by chance to receive single or multiple doses of GB-7624 or placebo. All participants will have their vital signs checked (heart rate, blood pressure, temperature, etc). and will provide blood and urine samples for testing. It is hoped this research will determine the maximum dose of GB-7624 that can be administered safely without causing severe reactions. Once the dose of GB-7624 has been determined in healthy volunteers, a trial investigating the efficacy of GB-7624 as a treatment for patients with atopic dermatitis may proceed.

Background and Rationale: Clinical trials are pivotal in advancing stroke care, yet participation remains low, exacerbating disparities, especially across age and gender demographics. This study aims to investigate the barriers to and facilitators of participation in clinical trials to enhance person-centred approaches in stroke research. Objectives: 1.To analyse the trends in age, gender, and rationales for non-participation in clinical trials among adult patients with stroke over the past 6 years at a tertiary Hospital in a large metropolitan area of Australia. 2.To develop and refine frameworks for patient recruitment that reduce barriers and enhance facilitation in stroke clinical trials. Study Design: A retrospective observational study complemented by a qualitative analysis of existing data from stroke patients who were eligible for clinical trial participation from January 2019 to January 2025.

This is an open-label, phase II study for treatment of high-risk myelodysplastic syndromes (MDS) or Acute Myeloid Leukaemia (AML). The purpose of this study is to evaluate the safety, response and survival of Imetelstat treatment in patients that do not respond to Hypo-Methylating Agent (HMA)-based therapy. This multi-centre study will recruit participants across Australia, Germany and France. A total of up to 46 subjects will be recruited for this study. You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with MDS or AML. People with high-risk myelodysplasia (MDS) currently have limited treatment options. This group of patients often rely on blood transfusions and unfortunately, some standard of care therapies are not often successful as a treatment option. Participants who meet the eligibility criteria for this study will receive 2-hour intravenous (IV) infusion with Imetelstat twice in a 28-day cycle (once every 14 days) for at least 4 cycles. After 4 treatment cycles (8 administrations of Imetelstat) response assessment will be performed on all patients. Non-responding patients will discontinue Imetelstat treatment, undergo End of Treatment and enter the follow-up phase of the trial. Patients who are categorized as responders according to the primary endpoint definition and have Bone Marrow blasts =>5% at the response assessment (Visit 9) will continue Imetelstat treatment every 14 days until loss of response/disease progression. Patients who are categorized as responders according to the primary endpoint definition and have Bone Marrow blasts <5% will continue Imetelstat treatment every 28 days until loss of response/disease progression. During and after completion of the treatment participants will be assessed for overall response using response assessment, safety and toxicity using adverse events, overall survival and progression free survival from medical records, and quality of life questionnaires. It is hoped that this research project will contribute to the field of Myelodysplastic Syndromes and that it may be used to improve health outcomes.

Given the potential therapeutic effects of nocturnal hypoxaemia, this randomised controlled feasibility trial aims to examine the impacts of nocturnal oxygen versus medical air via stationary oxygen concentrator on health outcomes in people with fibrotic intersitial lung disease. This trial will be the first sham-controlled trial to examine effects of nocturnal oxygen therapy in fibrotic ntersitial lung disease.

The study aims to assess if salvage reirradiation with stereotactic ablative body radiation therapy (SABR) is a safe and feasible management option for locally recurrent prostate cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have locally recurrent prostate cancer following prior radiotherapy to the prostate. Study details: All participants will receive prostate SABR reirradiation (over 5 fractions) and 6 months of ADT. At baseline, participants will require imaging, blood tests, and questionnaire completion. Further blood tests will be required every 6 months up to 5 years post treatment, and at 2 years, some participants will require a further biopsy while all participants will require MRI. The findings will help guide clinicians on whether prostate SABR re-irradiation is a safe and effective option for this group of patients who currently have limited evidence-based local salvage treatment options.

Imagery Rehearsal Therapy (IRT) is a psychological treatment which is thought to reduce the frequency and intensity of trauma-related nightmares. Experiencing nightmares is common after being exposed to stressful life event and these typically subside over time. However, some people who have been exposed to a traumatic event will experience ongoing and frequent nightmares. The aim of this study is to determine whether IRT is an effective intervention in reducing the frequency and intensity of post-traumatic nightmares as well as overall Posttraumatic Stress Disorder (PTSD) symptoms.

Endometriosis is a common condition that affects around 1 in 10 Australian women. The condition is highly burdensome for sufferers, causing debilitating chronic pain; symptom recurrence; compromised fertility; impaired sexual function, and a substantial reduction in quality of life (QOL). Gastrointestinal (GI) symptoms similar to those seen in irritable bowel syndrome (IBS) are particularly common among women with endometriosis, affecting up to 90% of patients. Despite this, we have poor understanding regarding the physiological mechanisms driving these GI symptoms. Candidate mechanisms include changes in gut microbiota, co-morbid psychological disorders, chronic inflammation and/or visceral hypersensitivity. This study will examine whether GI symptoms in patients with endometriosis are associated with the presence of visceral hypersensitivity and/or chronic subclinical inflammation. Understanding the physiological mechanisms driving GI symptoms in endometriosis is essential to the development of treatments targeting these pathways.

Corneal ectasia such as keratoconus, post-LASIK ectasia and pellucid marginal degeneration induce irregular astigmatism which degrades visual quality. Often people with these conditions cannot achieve normal or functional vision in spectacles or soft contact lenses because of their irregular nature. The rigid anterior surface of a scleral contact lens provides an optical interface that regularises vision. However, even with a scleral contact lens some irregular astigmatism remains uncorrected and contributes to degradation of visual quality. By mapping the irregular astigmatism left over with a conventional scleral contact lens on the eye we can reduce irregular astigmatism even further with ‘aberration control’. The purpose of this study is to investigate the effect of aberration control on the front surface of scleral lenses on visual performance and on the reduction of irregular astigmatism in corneal ectasia.