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Quantification of retrograde ejaculation secondary to Silodosin and Alfuzosin in adult males: a randomized, blinded, placebo-controlled, crossover study
Expand descriptionMedications used for male lower urinary tract symptoms are known to cause retrograde ejaculation, however the extent of this is unknown. Quantification of ejaculatory dysfunction and impact on semen quality of medications used for male lower urinary tract symptoms (Silodosin and Alfuzosin) will provide urologists with more accurate and tangible statistics on their impact on ejaculation. Comparisons to placebo will further contextualise results to increase validity and utility of study findings. This will assist in counselling men starting Silodosin or Alfuzosin for lower urinary tract symptoms, to improve patient expectations and understanding, avoid unexpected side effects, and allow patients to make informed decisions in their choice to commence medical therapy for their symptoms. It is hypothesised that both Silodosin and Alfuzosin will result in retrograde ejaculation, demonstrated by a significant deterioration in semen analysis parameters and evidence of semen in urine on urine analysis, to the degree of subfertility, relative to placebo.
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Neuromodulatory interventions for reducing neuropathic pain after spinal cord injury
Expand descriptionThis study aims to evaluate the efficacy of two promising treatments for reducing neuropathic pain in individuals with spinal cord injury - electroencephalography neurofeedback (EEG-NF) and transcranial direct current stimulation (tDCS) - delivered individually and in combination in 20 sessions over 5 weeks. EEG-NF trains individuals to self-regulate brainwave activity, with the goal of regulating neural patterns associated with neuropathic pain. tDCS involves the application of an electrical current via two electrodes (anode and cathode) to modulate cortical excitability in a safe and non-invasive manner. The primary hypotheses for 6 weeks post-randomisation are: (1) Participants receiving EEG-NF will report significantly lower pain severity compared to those not receiving EEG-NF. (2) Participants receiving active tDCS will report significantly lower pain severity compared to those receiving sham tDCS. (3) Participants receiving the combination of EEG-NF and active tDCS will report significantly lower pain severity compared to those receiving either EEG-NF or active tDCS.
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A trial of non-invasive brain stimulation to treat patients with severe epilepsy
Expand descriptionThis study is a world-first pilot trial of a recently developed technique (transcranial magnetic stimulation) to treat patients with Lennox-Gastaut syndrome (LGS). Our recent brain imaging studies have shown that a key area of the brain (“prefrontal cortex”) may play an important role in driving seizures in LGS ans this has led us to hypothesise that changing the activity in this area may reduce a patient’s seizures and help with their learning. Transcranial magnetic stimulation (TMS) is a powerful and non-invasive way of altering brain activity, involving placing a coil over a small area of the patient’s scalp and delivering rapid magnetic bursts that can either increase or decrease activity in the brain area below the scalp. In this pilot study, we will deliver TMS to 10 patients with LGS, measuring safety, tolerability and whether it reduces seizures.
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EngAGE Community: A Student-led Telehealth Exercise Strategy Aiming to Improve Social, Psychological and Physical Wellbeing of Older Adults
Expand descriptionThe EngAGE program aims to provide senior Australians an avenue for fun, safe, and socially engaging exercise to combat the social, psychological and physical burdens of ageing. A secondary aim of EngAGE is to provide students of sports and exercise science and exercise physiology an opportunity for authentic work integrated learning opportunities. It is hypothesized that older adult participants will experience improvements in social, psychological and physical wellbeing and that students will see increases in their work readiness and confidence in their ability to work.
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A clinical study to compare the safety and tolerability of two formulations of a new Systemic Sclerosis drug in Healthy Participants - Part A
Expand descriptionThe purpose of this Part A study is to assess the pharmacokinetic and safety profile of asengeprast MEA salt. This study will allow Certa to determine the doses and the type of formulation to take into future clinical trials in patients with Systemic Sclerosis. You may be eligible for this study if you are a healthy male or female volunteer aged 18 to 65 years of age who has met all inclusion criteria and do not meet any exclusion criteria. Part A involves participants receiving a total of two single doses, one low and one high dose of the asengeprast new formulation over two treatment periods. Therefore, participants in Part A will receive a total of 2 single doses of the study drug. Participants will be screened and if eligible (i.e. they meet all of the inclusion criteria and none of the exclusion criteria) participants will be enrolled into the study. Being enrolled means being admitted into the study centre on two occasions for a 3-night inpatient stay. You will also be required to attend the study centre on two occasions, following your discharge. All participants will have their vital signs (heart rate, blood pressure, oxygen saturation, temperature and respiratory rate) and ECGs checked, and will provide blood and urine samples for testing to ensure asengeprast is safe and well tolerated.
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CLL12 - An ALLG phase II trial of venetoclax treatment with epcoritamab in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma
Expand descriptionThe primary purpose of this study is to evaluate the efficacy and safety of combining a T-cell engager epcoritamab with venetoclax in patients with relapsed/refractory chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). This combination therapy aims to address the unmet clinical need for novel treatment strategies in these patients. Who is it for? This study is for patients with documented relapsed or refractory CLL or SLL patients that have received at least one initial treatment that works throughout the entire body. Study details Venetoclax is taken by mouth once a day. After gradually increasing the venetoclax dose up to 35 days, all patients will receive 26 cycles of venetoclax. Each cycle has a duration of 28 days. All patients will then begin treatment with epcoritamab. Epcoritamab is given as an injection under the skin. All patients will receive weekly injections for the first 3 cycles. For patients receiving 6 cycles, it will be given every two weeks during cycles 4-6. For patients receiving 12 cycles, it will be given every two weeks during cycles 4-9 and every four weeks during cycles 10-12. It is hoped this research will identify the most effective and safest dosage for patients, improving overall survival and molecular response rates, while reducing treatment-related complications and deaths for those with CLL and SLL.
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Gaining a Holistic Understanding of Eating Disorders: Phenotyping and Genotyping Illness
Expand descriptionThis study aims to better understand eating disorders by examining the biological, psychological, social, and neurological factors that contribute to their development, maintenance, and recovery. People aged 14 and over with a current or past eating disorder will be invited to take part in a series of assessments, including surveys, interviews, cognitive tasks, brain imaging, and biological sample collection. By collecting this information, the study hopes to identify patterns and individual differences that could help improve early identification and develop more personalised and effective treatments in the future. We hypothesise that eating disorders are influenced by a combination of genetic, brain-based, behavioural, and environmental factors, and that understanding these in greater detail will lead to better outcomes for individuals affected by these conditions.
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Coagulation assessment of sublingual oestrogen (CASE) trial comparison of clotting profile and risk in transgender females on oral vs sublingual estrogen for gender affirming hormonal therapy
Expand descriptionWe aim to study the levels of hormones and the clotting tendency of blood whilst a patient is on oral oestrogen and compare it to when they are on sublingual oestrogen. This will help us gain a better understanding of the comparative risk of a VTE whilst on sublingual oestrogen and the efficacy of sublingual oestrogen for transgender women. At this stage, we are hoping to include about 30 trans women on feminising gender affirming hormone therapy.
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Assessment of Impact on Management by Zircaix PET/CT (AIMZ PET/CT)
Expand descriptionThis study is designed to investigate how a specialised PET/CT scan using 89Zr-girentuximab can assist in detecting and evaluating tumours that express a protein known as CA-IX. The goal is to determine how this scan compares with standard diagnostic approaches and whether it improves treatment planning for certain cancers. Who is it for? This research is suitable for adults aged 18 years and older with a suspected or confirmed diagnosis of clear cell renal cell carcinoma (ccRCC), mesothelioma, or another cancer type expected to express CA-IX. Participants must be medically stable, able to provide informed consent, and have an expected survival of more than three months. Study details Participants referred by their treating doctor will undergo a PET/CT scan using the imaging agent 89Zr-girentuximab at the Melbourne Theranostic Innovation Centre. All eligible participants will receive the scan as part of the study. Clinical teams will compare results from this scan with other routine imaging tests, biopsy results, and clinical outcomes over a 12-month period to assess its accuracy and usefulness. Additional follow-up will involve reviewing medical records and may include phone interviews to evaluate treatment decisions. It is hoped that the result from this study will demonstrate the clinical impact of girentuximab, highlighting its value in the management of patients with CAIX expressing tumours.
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The effect of a food as medicine intervention to support mental health and wellbeing in autistic adults – A Pilot Randomised Controlled Trial
Expand descriptionThis project aims to examine the feasibility, efficacy, safety and acceptability of a Mediterranean diet intervention for improving mental wellbeing and quality of life in Autistic Adults living in Australia. It utilises a 6-week pilot randomised control trial design with a wait-list control group. While previous trials have shown a positive effect of dietary interventions for improving mental wellbeing in the general public, it is not known if these findings will translate to autistic adults. It is expected that a personalised approach to implementing a Mediterranean diet - which accommodates sensory/personal needs and preferences of autistic adults, will result in high feasibility and acceptability among participants.