ANZCTR search results

This study is testing the safety and tolerability of a single dose of SCS1 in healthy participants. Approximately 40 participants will be enrolled consecutively across multiple escalating dose cohorts to receive a single oral dose of SCS1 or placebo. Cohorts will proceed following satisfactory review of the prior cohort data (including the safety and tolerability data). Cohorts will be determined by escalations of not more than 5-fold. The study hypothesis is that the doses planned for administration will be safe and well tolerated.

Low-dose testosterone therapy is used by an increasing number of trans people, particularly those with a non-binary gender. However, very little is known about the impact of low-dose testosterone on gender dysphoria, gender euphoria, mental health and physiological outcomes. Currently, in our Austin Health gender clinic, following initial assessment of suitability and informed consent, due to large demand for appointments, there is a minimum 3-month waitlist prior to initiation of gender affirming hormone therapy. This is standard care. We will undertake a pragmatic intervention whereby after initial assessment and informed consent, we will randomise individuals to immediate low-dose testosterone therapy or delayed testosterone therapy (commencement of low-dose testosterone after the standard care 3-month waiting list). This will be followed by a 12-month extended follow-up following initiation of testosterone, At 6 months post-commencement of the intervention, a subgroup of participants from both groups will be invited to participate in semi-structured interviews with one of the study investigators. These interviews will explore the participants' motivations and goals for initiating low-dose testosterone, as well as the impact of testosterone on their gender dysphoria, gender euphoria, mental health and quality of life. This project is a trial of trans people newly commencing low-dose testosterone therapy. We aim to establish the influence of low-dose testosterone on gender dysphoria, gender euphoria, depression, suicidality and quality of life. We also aim to gain a greater understanding of the impact of low-dose testosterone on serum testosterone concentrations, and common biochemistry markers. In particular, we hypothesise that immediate access to low-dose testosterone, compared to no treatment, will reduce gender dysphoria, depression and suicidality, improve quality of life, and increase gender euphoria. We also hypothesise that low-dose testosterone will increase testosterone levels to an intermediate range between those expected for cisgender men and cisgender women.

The aim of this study is assessing the safety and tolerability of a single administration of an experimental radiotracer 99mTc-3BP-4961 (Investigational product or IP) and then perform a single photon emission computed tomography (SPECT) scan. Who is it for? You may be eligible for this study if you are male or female over 18 years of age, presenting with clinical suspicion of active cancer during investigation for a possible new cancer diagnosis profession in a patient with know solid tumour. Study details Participants will receive a single IP intravenous administration of 10-15MBq /Kg of 99mTc-3BP-4961 but not more than 1200 MBq total. Participants will then be scanned using SPECT and CT for cancer lesion. After completion of the intervention, participants will be assessed for safety and tolerability using laboratory parameters and observation of adverse events. It is hoped that findings from this study will help further investigation for histopathological confirmation or tumour presence or tumour recurrence. Note: this brief summary is intended for lay audience.

A Trans-Esophageal ElectroPhysiological Study (TE-EPS, TEEPS), uses an oesophageal probe to sense and pace the heart together with an electrocardiogram to perform a limited electrophysiology Study. For adults it is potentially a less invasive, more rapid and more cost-effective strategy for some heart rhythm disorders. TEEPS provides a diagnosis of SVT (supraventricular tachycardia) comparable to that an invasive electrophysiology study and can terminate the arrhythmia. Historical TEEPS systems require at least three interconnected systems, limiting applicability and ease-of-access. In this pilot study using a novel integrated system, fifteen patients scheduled to undergo EP Study will first undergo an additional 20-30 minute TEEPS study before proceeding to a routine invasive EP study. Fifteen further patients will be recruited from emergency department presentations with suspected SVT. TEEPS data will be evaluated for operator- and patient-related qualitative criteria to inform a future study of TEEPs to improve arrhythmia management in the emergency department.

A first in human, single and multiple-ascending dose study to determine the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of SIR4156 in healthy adult and elderly participants. Results of this study will inform dose selection and design of studies to assess the efficacy and safety of SIR4156 in muscle degenerative diseases. The study hypotheses are that SIR4156 is safe and well tolerated in Adult and elderly healthy volunteer subjects; SIR4156 has a well acceptable PK profile with or without food effects and formulation difference; and SIR4156 could potentially increase the NAD+ level in adult and elderly healthy subjects

This study aims to assess the tolerability and efficacy of the ChezLeon DP-Tx product (neck wrap) for patients with head and neck lymphoedema (HNL) after radiotherapy. Who is it for? You may be eligible for this study if you are an adult patient who has completed adjuvant or definitive radiotherapy for a head and neck cancer, at least 3 months prior to enrolment into this study, and have visible and/or moderate grade external and internal lymphoedema. Study details Participants will be asked to wear the neck wrap as much as possible over a 6-week period and will be asked to provide feedback on tolerability of the neck wrap. HNL measurements will be taken at various timepoints to determine efficacy. It is hoped that findings from this study will help inform future clinical trials to develop this treatment device for head and neck lymphoedema after radiotherapy.

Without adequate ambient humidity, extremely preterm babies lose water through their skin, causing dehydration and hypernatraemia (high blood sodium concentration), which is associated with death, brain injury and disability. Skin water loss and hypernatraemia are reduced by increasing incubator humidity. However, there is worldwide variation in practice due to lack of high-quality clinical trials. Clinicians in Japan routinely use 95% incubator humidity compared to 80% in Australia. The HUM-TE study hypothesis is that in extremely preterm infants, initial incubator humidity of 95% compared with 80% reduces the risk of any hypernatraemia (serum sodium >=150 mmol/L) and/or mean sodium concentration in the first three days after randomisation and reduces the risk of skin injury, sepsis, IVH and brain damage. The concurrent process evaluation will explore context, uptake, acceptability and parent experience of starting incubator humidity at 95%. Skin integrity substudies will assess the effects of incubator humidity on skin barrier function.

Nutrition impact symptoms (NIS) are symptoms that affect food intake or choice and increase the risk of undernutrition. Contributing to the high prevalence, burden, and suboptimal management of NIS is the lack of a patient-reported tool that comprehensively assesses NIS. Therefore, in people undergoing cancer treatment, a cross-sectional survey will aim to assess nutrition impact symptom (NIS) incidence, frequency, and severity; frequency of NIS interference with eating and drinking; met and unmet NIS needs; and perceived importance of NIS. In a minimum of 100 participants, 27 patient-reported NIS will be assessed using a researcher-developed survey due to the lack of a comprehensive NIS tool existing. The comprehensiveness, relevance, and comprehensibility of the NIS survey will be assessed to aid in the further development and validation of the NIS tool.

This study aims to gather evidence on the mechanisms of action and optimal dose of ginger for chemotherapy-induced nausea and vomiting (CINV), one of the most distressing and common side-effects for people undergoing chemotherapy. Who is it for? You may be eligible for this study if you are an adult scheduled to undergo intravenous (IV) chemotherapy for any type of cancer, and have been deemed to be at moderate to high risk of nausea and vomiting. Study details Participants will be randomly allocated to receive either standard care, or low dose or high dose oral ginger supplements at the beginning of chemotherapy infusion. This will occur on a single test day, with outcome data collected using a novel technique called Body Surface Gastric Mapping (BSGM) in the baseline (fasting) states as well as during chemotherapy infusion. It is hoped that findings will guide the optimal ginger dose to improve the management of CINV and assist in the future application of BSGM as a non-invasive, low cost, and quick measure of CINV treatments.

Depression is a mental illness which is the leading cause of disease burden in middle and high-income countries. It is characterised by low mood (i.e., feeling sad), loss of interest in or pleasure from things that were previously enjoyable, changes in appetite or weight, fatigue and sleep disturbances. Up to 90% of people with depression experience sleep problems, which often precede the onset of mood symptoms. Problems with the circadian system, or 'body clock' can contribute to sleep problems and may play a role in the development of depression. It has been found that antidepressants increase the effect of light on the body clock, which may contribute to variability in treatment outcomes. For example, increased light sensitivity may be beneficial for patients who were previously insensitive to light, or for those who exhibit healthy light exposure patterns (as the positive effects would be enhanced). However, for patients with unhealthy light patterns, or who are already hypersensitive, increased sensitivity due to antidepressant treatment may lead to the exacerbation of symptoms. Better understanding the impacts of antidepressants, and light exposure, on treatment outcomes in depression may lead to simple ways for improving the efficacy of those very common medications. We aim to investigate the effect of citalopram use on the response of the circadian system to light and test the hypothesis that increased light sensitivity is predictive of better SSRI treatment efficacy for depression.