ANZCTR search results

Primary dysmenorrhea (PD) is a common menstrual complaint with a high prevalence and significantly impacts physical and mental health. Low-level laser acupuncture (LLLA) has been used in a few health conditions with positive outcomes. However, the evidence in the use of LLLA for PD is still limited and inconclusive. LLLA is a non-invasive, painless, and safe modality that could be an option for PD management. This study aims to investigate the feasibility and therapeutic effect of LLLA for manage PD.

Australia is currently in the midst of a syphilis epidemic which began a decade ago. Benzathine penicillin G (BPG) is the treatment of choice for non-CNS syphilis infections. Primary, secondary or early latent syphilis is treated with 2.4 million units (MU) of BPG, while late latent syphilis requires 2.4 MU weekly for 3 weeks in total. BPG is typically administered by IM injection which is associated with significant pain and distress in the recipient. This has been shown to negatively impact adherence, especially where multiple doses are indicated. Subcutaneous (SC) administration of BPG is a potentially more efficacious alternative to IM injection. Prior work done by our group in healthy adult volunteers have demonstrated acceptable tolerability and a superior pharmacokinetic profile. Our study aims to demonstrate the safety and tolerability of a single 7.2MU dose of BPG given as a subcutaneous infusion for treatment of syphilis. Secondary objectives are to demonstrate efficacy of SC BPG and estimate duration that plasma penicillin concentrations remain above the target of 18mg/mL. Primary outcome is the assessment of safety and tolerability including serious adverse events or reactions. Secondary outcomes are the change in nontreponemal specific serology titre at 6 months, plasma penicillin concentrations at 3 weeks and proportion of patients with treatment failure requiring re-treatment at 6 months. We will recruit 40 adult patients with confirmed syphilis infection from those referred to the sexual health service at Fremantle Hospital. The study will also incorporate a qualitative component exploring patient's experience and perception of receiving subcutaneous infusion. Participants will be followed up for 6 months from day of treatment. If we are successful in demonstrating safety, tolerability and efficacy of SC high dose penicillin in non-CNS syphilis infections, this has the potential to radically transform the treatment paradigm.

The purpose of this study is to assess whether virtual reality (VR) is a feasible technique for improving patient understanding for the purposes of consent for surgery in individuals with colorectal cancer. Who is it for? You may be eligible for this study if you are aged 18 years or older and are planned for elective surgical resection of colorectal cancer. Study details After their standard consultation with the colorectal surgeon, participants will be randomised (i.e. allocated by chance) to undergo either standard consent process or VR consent. All participants will be shown their 2D CT images with the researcher as a part of standard consent, which will take approximately 20 minutes. These images are in greyscale and permit viewing of only one ‘slice’ of the body at one time. Following this, participants in the VR consent group will additionally be shown immersive VR three dimensional models of the anatomy and pathology relevant to the proposed surgery, which will take an additional 20 minutes. Immediately after completion, participants will answer a questionnaire to determine their understanding of the proposed operation and satisfaction with the consent process. Data will also be collected to determine the feasibility and cost of delivering VR consent to patients. It is hoped that this study may show that VR is feasible, effective, and acceptable to patients for obtaining consent prior to surgery for colorectal cancer.

The primary objective of this study is to determine whether including health information on social networking sites improves how postpartum women feel about their bodies. Secondary objectives include determining whether including health information ‘more frequently’ versus ‘less frequently’ also impacts how women feel and whether social networking sites are an acceptable platform for conveying health information to women in the postpartum period. We hypothesise that the inclusion of health information will serve to interrupt the flow of harmful ‘idealistic’ imagery typical of social networking sites and have a positive impact on how postpartum women feel about their bodies. We also hypothesise that social networking sites will be viewed as an acceptable platform for receiving health information.

Study Aims This study aims to assess feasibility, therapeutic utility and cost effectiveness of multidisciplinary therapy coaching compared to lifestyle guidance for individuals with premanifest and manifest Huntington's disease. Who is it for? You may be eligible to participate in this study if you are aged 18 years or older and been diagnosed with premanifest or early stage manifest Huntington's disease. Study details Participants will be randomly assigned (by chance) to receive either multidisciplinary therapy coaching or lifestyle guidance. Those in the multidisciplinary therapy coaching will receive personalized exercise, cognitive and sleep hygiene coaching for twelve months. Those in the lifestyle guidance group will receive a booklet containing information on gold standard recommendations on exercise, cognitive and sleep hygiene. All participants will undergo a series of diagnostic and clinical tests, including cognitive, mood, sleep, activities of daily living tests and questionnaires. Potential study outcomes It is hoped this research will inform the treatment of individuals with premanifest and manifest HD.

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.