ANZCTR search results

This research is designed to determine the clinical utility of a human amnion membrane (biological) product and assess whether it is safe and effective in a group of patients that have a failed full thickness skin graft (FTSG) on their nasal tip or nasal ala in the previous 3 months. It is hypothesized that participants who receive an amnion membrane allograft will have superior epithelization and revascularization resulting in improved healing and a reduction in scar contracture compared with patients receiving standard of care management. Who is it for? You may be eligible to participate in this study if you are male or female aged 18 years or older, fluent in written and spoken English, is a Southeast Queensland (SEQ)-based resident, and within 3 months of a failed full-thickness skin graft (FTSG) characterised by ongoing pain, numbness, erythema, oedema where this clear tissue breakdown and a presence of necrotic eschar. Study details At the time of screening, study participants will be randomized to receive active treatment with an amnion membrane allograft or standard of care. For participants in the amnion membrane allograft group, the nasal wound bed will be cleaned and previous failed graft removed. Then amniotic membrane will be transplanted in to the wound bed and secured with Hypafix tape. A secondary dressing that enables moistened wound healing will be applied above the amnion membrane allograft. After the procedure is complete, patients will be discharged following a review of their vital signs. Study participants will return to clinic at Day 6 (+/- 2) and Day 11 (+/- 2) after intervention, to have their outer dressing changed and the amnion bandage reviewed. At one month and 3 months post-operatively, the study participants will return for further assessments of the wound bed. Imaging investigations of the graft site will be conducted at each follow up visit using a 3D surface scanning device, along with a symptom-directed physical exam and collection of vital sign measures, concomitant medications, and adverse events. A final follow up visit will be conducted at three months after amnion membrane allograft transplant. At the End of Study visit, the wound bed will be assessed for epithelial repair and graft function. It is hoped the finding from this study will show human amnion membrane (biological) is a superior epithelization and revascularization in treating FTSG, improve healing and a reduction in scar contracture compared with standard care management.

This study aims to learn about the safety and tolerability of the study drug, paxalisib when taken by female participants with advanced breast cancer. Who is it for? You may be eligible for this study if you are a female at least 18 years of age, with a life expectancy greater than 12 months, at least one confirmed lesion, and satisfy haematologic, renal and hepatic function tests. For Arm 1 cohort, you will need to have a HER2-negative stage IV breast cancer diagnosis, confirmed gBRCAm (BRCA1, BRCA2 or both) and prior treatment with chemotherapy in the metastatic setting. For Arm 2 cohort, you will need to have a recurrent, unresectable or metastatic triple-negative breast cancer diagnosis, confirmed PD-L1 positive, treatment in combination with chemotherapy, and no prior PD-1/PD-L1 therapy. Study details Participants in Arm A will be randomly allocated to cohort A1 or cohort A2, and administer Paxalisib (15mg or 30 mg orally once daily) plus Olaparib (300mg orally twice daily) in 28 day cycles. Participants in Arm B will be randomly allocated to cohort B1 and cohort B2, and administer Paxalisib (15 mg or 30 mg orally once daily) and Pembrolizumab (200mg intravenous infusion once daily) over 21 days together with chemotherapy (intravenous nanoparticle albumin-bound paclitaxel, or gemcitabine–carboplatin) administered per standard of care protocol. During the study period, participants will be assessed for adverse events, circulating tumour cells count, immune cell signature, and clinical activity of Paxalisib. It is hoped this research will determine whether paxalisib, when given in combination with either olaparib or pembrolizumab/chemotherapy, is safe and well tolerated, has any side effects and if there is any clinical activity that may improve outcomes for participants with advanced breast cancer.

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.