ANZCTR search results

This is a first-in-human, randomised, double-blinded, placebo-controlled, study to evaluate the safety, tolerability, PK and PD of SZN-1326 conducted in multiple parts. Parts 1 and 2 will be conducted in Australia and include a single ascending dose part (SAD) and a multiple ascending doses part (MAD) enrolling healthy volunteers (HVs). The primary purpose of the study is to characterise the safety and tolerability of single ascending doses of SZN-1326 in healthy volunteers (HVs).

Testicular torsion, or twisting of the testicle, is a very important diagnosis to make correctly and quickly in order to prevent potential loss of a testicle. In other countries ultrasound is used frequently to make or rule out this diagnosis but in Australia it is not used very often. Doctors instead rely on their history taking and examination skills to make the diagnosis. Several clinical calculators have been developed recently to help assist doctors to make these diagnoses. One calculator that has been shown to be helpful in other countries is the TWIST score (Testicular Workup for Ischemia and Suspected Torsion) but no one has investigated if it is also helpful in Australia. The purpose of this study is to determine if the TWIST score is beneficial in the diagnosis of testicular torsion. It is hypothesised the TWIST score will be more accurate than doctors alone in making the diagnosis.

The purpose of this study is to assess the level of compliance in wearing glasses for the purpose of measuring eyelid movements in relation to seizures in an outpatient setting. This will be achieved by objective measurement of time worn, in relation to temporal proximity of seizure events as well as using a questionnaire to assess the level of acceptance by participants in using the glasses. In addition it will be asses whether changes in eyelid movements occur immediately before, during and/or following NES, using the glasses and whether eyelid movements in NES patients exhibit different characteristics than in previously collected eyelid movement data from people without NES, including people with epilepsy.

We recently discovered deficiency of a molecule called oxidized nicotinamide adenine dinucleotide in hearts from patients with stiff heart failure. In a mouse model of stiff heart failure, we then demonstrated that replenishing this molecule using the stable precursor nicotinamide riboside could completely rescue this disease. Now, we would like to test in this study if oral administration of nicotinamide riboside can sufficiently replenish this molecule in patients hearts using samples of their heart tissue taken at the time of cardiothoracic surgery.

Post-Traumatic Stress Disorder (PTSD) is a common and disabling condition. It has significant costs in terms of lost productivity, treatment costs, morbidity and excess mortality (including suicide and premature death from co-morbid medical conditions). Current treatments are only effective in one third of patients. There is a pressing need for new treatments. Transcranial Direct Current Stimulation is a novel, non-invasive method of stimulating the brain in order to produce clinical effects. It has been used widely to treat symptoms of depression. Only one small study has examined its effect on symptoms of PTSD, the results were promising. tDCS is an easily administered treatment with low cost and few side-effects. It can be provided using small portable devices and can be administered remotely. This can address one of the key obstacles to current neurostimulation treatments, that of access. The proposed study aims to investigate the impact of tDCS compared to sham tDCS in participants with severe PTSD. Participants will be recruited from the Psychological Trauma Recovery Service inpatient unit. After giving informed consent, participants will be randomised to receive either active or sham tDCS for 20 minutes/day for 10 days over 2 weeks. Measured outcomes will include symptoms of PTSD, depression, side-effects of tDCS and results of electroencephalogram (EEG) studies. Should this study replicate the successful findings of a similar recently published trial then this treatment could be a very significant addition to the currently available treatments for PTSD.

Aging is characterised by changes to bone, muscle and fat tissues, and these changes are associated with falls, fractures and chronic disease including heart disease and diabetes. The aim of this project is to explore in middle aged and older adults, how bone, muscle and fat communicates, and how exercise may modify these tissues. We will assess this following a single session of high intensity cycling exercise, and following 4 weeks of high intensity cycling training. The study includes blood and urine sampling before and after exercise in the acute exercise session, and following the 4 weeks of training to assess if certain markers of bone, muscle and fat health that circulate in the blood and urine are modified by exercise. Muscle (thigh muscle) and fat (abdomen) biopsies are optional in this study, and are taken before and after exercise. This project will bring new insights into how exercise can modify the way in which bone-muscle-fat communicates leading to potentially new pharmacological/non-pharmacological interventions important for healthy ageing.

The purpose of this study is to compare the effect of eyelid wipes with and without Manuka honey in order to ascertain whether the Manuka honey (in the form of eyelid wipes) provides any potential benefits to patients with dry eye. Participants will be randomly assigned to use either the test eyelid wipes with Manuka honey or the control standard eyelid wipes without Manuka honey once daily for one month. Measurements of ocular signs and symptoms will be collected before and after one month of treatment, and the results between treatment groups will be compared. The hypothesis is that the eyelid wipes with Manuka honey will reduce the amount of bacteria on the eyelid more than the standard eyelid wipes, and consequently improve other signs and symptoms of dry eye.

eCliPSE is an online clinical portal that facilitates access to evidence-based eHealth treatments for people with comorbid mental health and alcohol/other drug use problems. The present study aims to evaluate the uptake of eCliPSE. We will compare a direct-to-consumer marketing strategy (DtC) and an Integrated Translation and Engagement Model (ITEM) of implementation designed to engage 'users' (i.e. consumers and health services). The study will be a 3-level cluster randomised controlled trial that will compare the uptake of and outcomes of eCliPSE across consumers, services, and LHDs received the DtC intervention alone versus ITEM + DtC together.

A cohort study of patients undergoing a medical intervention for weight loss at a bariatric surgery clinic (laparoscopic sleeve gastrectomy, endoscopic sleeve gastroplasty, intragastric balloon or medication) between March 2019 and March 2020. A food and eating behavioural checklist developed by health professionals at the clinic was used to identify and record problems in the medical checklist. Patient demographic data, outcomes, number of follow-up appointments attended, psychology notes will be accessed via medical records. Data will be analysed to determine whether there is an association between food and eating behavioural problems, adherence to follow-up appointments and adverse events. Results may be used to patient outcomes by improving the multidisciplinary intervention model provided at bariatric surgery clinics.

This study aims to assess the current use of robotic surgery for patients with locally advanced and recurrent pelvic cancer. Who is it for? You may be eligible for this study if you are an adult aged 18 or older, you have been diagnosed with locally advanced or recurrent pelvic cancer that requires extended resection (surgery to remove the lesions) and you are being treated at a centre where a robotic approach for surgery may be offered. Patients will be eligible regardless of whether they do or do not undergo surgery with a robotic approach. Study details This is an observational study, the decision to enrol in this study will not impact upon whether participants are, or are not offered surgery using a robotic approach. Participants who choose to enrol in this study will be asked to consent to their medical data being collected from their records, and will also be asked to complete a series of questionnaires about their quality of life and recovery post-surgery. It is anticipated that these questionnaires will be completed online usually and will take up to 30 minutes. Participants will be asked to complete these questionnaires at 4 timepoints, up to 1 year after their surgery. It is hoped this research will enable researchers to learn about the current use or robotic-assisted surgery, share their findings on techniques and help find out important information to plan and run a future trial to test the benefit of a robotic approach.