ANZCTR search results

This will be a double-blind, randomised, placebo-controlled clinical trial. The primary aim of this trial is to assess whether an over-the-counter (OTC) nutritional supplement can improve sperm quality in 100 men and the pregnancy rates of their partners when compared to the placebo for 6 months. All participants will take 3 capsules per day for 6 months or 180 days, a total of 540 capsules/participant. Changes in quality will be based upon sperm concentration or motility. This OTC supplement, called “Conceive Well Men”, will be donated free-of-charge by Blackmores. The supplement is produced under the good manufacturing practice (GMP) and meets TGA standards as a ‘listed’ product, which indicates safety and quality. The importance of undertaking this project is to emphasise the role of sperm health as male infertility has become an increasing factor in managing infertility.

The effectiveness of external compensatory aids, such as smartphones and the use of apps, for improving performance in activities requiring memory has been widely supported. Despite this, smartphone adoption in memory rehabilitation has been low, likely due to the insufficient training that professionals receive for teaching compensatory strategies and the limited evidence regarding the most effective training methods. Two training approaches have traditionally been used to teach new skills in rehabilitation: Trial-and-error and techniques minimising errors (which have been grouped as "Systematic Instruction" approach). Both methods have produced mixed results in studies targeting the learning of electronic aids, thus indicating that further evidence is needed. Additionally, samples in existing studies have usually included mixed brain injured populations, thus limiting the applicability of results to stroke individuals. A relatively recently developed teaching technique, error-based learning, has emerged using self-regulatory skills training to teach individuals to frequently stop, check and modify their actions to correct errors while they are learning a new skill. This method has shown to be promising for learning everyday life skills in traumatic brain injury populations, but its efficacy has never been explored with stroke individuals or in teaching the use of a smartphone. The main objective of this study is to compare the efficacy of three training methods (Systematic Instruction-SI, Error-Based Learning-EBL, Trial and error-TEL) for training the use of an app in a smartphone, in people with acquired brain injury presenting with memory complaints. It is predicted that participants trained under SI and EBL will be more proficient than those trained with TEL at each time-point Other secondary aims of this study are to determine: 1. Whether learned skills are generalised to untrained apps: EBL will result in better generalisation of skills to untrained apps, and both SI and TEL will have limited generalisation and wont differ between them. 2. Whether the training increases the frequency of use of smartphone, in general and as a memory aid. 3. Whether the training in an app increases the memory self-efficacy of the user and the confidence to use a smartphone. There is no specific hypothesis for the last 2 aims, due to their exploratory nature

The primary purpose of this trial is to evaluate the clinical implementation of our NEST4E non-invasive method for aneuploidy screening of embryos that are unable to be biopsied and screened using the standard PGS technology. Our hypothesis is that this non-invasive technology will be capable of providing a genetic screening result for embryos that we would not be able to provide a result for using standard methods currently used. Seventy three patients will be recruited by informed consent to participate in this trial. The spent culture media will be collected from these embryos and the cell-free DNA analysed to determine the ploidy status of the embryo. Aim 1: For euploid embryos - determine the percentage concordance of media sample to 1st trimester screening. For aneuploid embryos- determine the percentage of embryos with concordance to confirmatory biopsy and standard PGS screening. Aim 2: Determine clinical pregnancy rates and live birth outcomes of transferred embryos

This study is evaluating the efficacy and safety of ZYN002, a clear gel that can be applied to the skin (called transdermal application) twice a day for treatment of symptoms of Fragile X Syndrome (FXS) Who is it for? Patients who have been diagnosed with Fragile X Syndrome and are aged between 3 and less than 18 years old. Study details All participants will undergo a screening process. Eligible participants will be randomized 1:1 to drug and placebo and will undergo up to a 14-week treatment period. Participants who are taking anti-epileptic drugs may undergo an additional 1-2 weeks of blinded treatment to taper off study drug treatment. During the treatment period, all participants may be either assigned to ZYN002 or placebo. All participants may receive placebo during the trial. The assignment will be done by a computer generated system and neither the study doctor or the participant or their caregivers will know which treatment is being given to them. The dose of the treatment will depend on the weight of the participants. If the participants weigh less than or equal to 35kg, they will receive 2 sachets of the gel through the day (1 sachet approximately every 12 hours) and if they weigh more than 35kg, they will receive 4 sachets of gel per day (2 sachets approximately every 12 hours). Parents/ caregivers will be instructed on proper application of the gel. The gel will be applied to clean, dry, intact skin of the upper arms/ shoulders. Blood samples will be collected for safety analysis of ZYN002. An independent analytical laboratory will also perform CGG repeat and methylation status analyses. Additionally, the parents/caregivers will be asked to complete some questionnaires. There will be other questionnaires and scales that will be completed at the site by the study doctor and/or with the participant and their parents/caregivers. Participation in this study may help the child’s/ adolescent’s FXS symptoms; however, we cannot guarantee that he/ she will get any benefits from this study. The results of this study may benefit future patients.

Mobility and falls are common in people with cognitive impairment/complaints. We aim to test whether a balance and cognitive training program delivered at home via a computer application and tablet will improve risk factors for falls such as mobility, balance and brain function. Hypotheses Compared to a health education program, a 6-month home-based exercise training program delivered via a tablet computer (Standing Tall-COG) will improve the following in people with cognitive impairment (this term includes both objective and subjective cognitive complaints). Primary Outcome 1. Gait speed Secondary Outcome 2. Gait and cognitive dual-task cost 3. Balance under single and dual-task 4. Muscle strength, reaction time 5. Cognitive function 6. Activities of daily living 7. Balance confidence 8. LifeSpace Exploratory outcome - falls over 6 months

This is an open label phase II trial of a combination of therapies targeting prostate cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have confirmed prostate cancer which is suitable for radical prostatectomy with curative intent. Study details All participants in this trial will be treated with two medications called Degarelix and Erdafitinib for a period of 3 months, followed by Degarelix alone for a further 1-month prior to radical prostatectomy. Participants will be assessed at regular intervals in order to determine the safety, tolerability and response rate to treatment when compared with historically treated patients. Assessments include blood tests, eye examinations, heart examinations and vital signs. We cannot guarantee or promise that participants will receive any benefits from this research; however, possible benefits may include further knowledge for treatment options for patients in the future with high risk prostate cancer.

Fibre is a component of all plant materials and in Australia is consumed in the diet largely through bread and cereals (40%) and also to a smaller extent fruits and vegetables (10 and 30% respectively). There is increasing interest in fibre, in particular, resistant starch for maintenance of large bowel health and prevention of chronic diseases such as cardiovascular disease, type 2 diabetes and certain cancers. Resistant starch, as its name suggests, resists digestion in the small intestine and travels to the large bowel where fermentation and short chain fatty acid production occur. This promotes healthy colonic function and hinders the growth of pathogenic bacteria. Unfortunately most commonly consumed starchy foods contain only very small amounts of this kind of dietary fibre. CSIRO has developed a new wheat variety containing very high levels of amylose, a form of starch that is more resistant to digestion. High amylose wheat has the potential to greatly improve resistant starch intakes in the Australian community. The purpose of this study is to investigate the influence of high amylose wheat foods on markers of digestive health and bowel function in men and women. This clinical trial is a vital step on the path to developing staple food products that will deliver health and economic advantages for Australians. The aim of this trial is to assess digestive health outcomes of high amylose wheat food products following daily consumption for 4 weeks, in healthy Australian men and women.

Relationship quality between community-dwelling people with dementia (PwD) and their family caregivers (FCG) is recognised as a major factor that influences health and wellbeing of both, and consequently impacts their ability to live together in the family home. The family home with familiar people and surroundings is recognised as the optimal care environment for PwD. Supporting PwD to remain in the family home also reduces care costs to individuals and society, and is recognised as a strategic priority by the Australian Government. The aim of this study was to determine the feasibility of delivering and measuring the effects of a therapeutic group singing and home-based music program on the primary outcome of relationship quality and secondary wellbeing outcomes for PwD and their FCGs. We wanted to test the feasibility of the study protocol, establish the appropriateness of the measures for answering the research questions, and collect pilot data to determine sample size for a randomised controlled trial. We also wanted to collect qualitative data through interviewing participants to gather information about their experience of the choir, home music program, and quantitative research measures. The Quantitative outcome measures to be trialled in this feasibility study include:: • Quality Carer Patient Relationship (QCPR) • Rating Anxiety in Dementia Scale (RAID) • Quality of Life – Alzheimer’s Disease (QoL-AD) • Rating Anxiety in Dementia Scale (RAID) • Quality of Life – Alzheimer’s Disease3 (QoL-AD) • Cohen-Mansfield Agitation Inventory – Short Form (CMAI-SF) • Apathy Evaluation Scale (AES) • Satisfaction with Life Scale (SWLS) • Positive Aspects of Caregiving Questionnaire (PACQ) • Patient Health Questionnaire–9 (PHQ-9) • Flourishing Scale (FS) 15 PwD + FCG dyads will attend 20 weekly choir sessions facilitated by registered music therapists.. Eligible participants will be community-dwelling people with a diagnosis of dementia and family caregivers who provide the majority of care in the home. Outcome measure questionnaires will be completed prior to the intervention (baseline), midpoint (week 11), and following completion of 20 choir sessions (week 21). Interviews will be conducted with participants after their final assessment.

Atherosclerosis is the build-up of cholesterol deposits (plaque) within the walls of the coronary arteries which are the blood vessels supplying heart muscle. If the plaque ruptures, it can cause a reaction and block off the vessel causing a heart attack. Vessel inflammation is a major contributor to both plaque formation and rupture. The fat (adipose tissue) surrounding the coronary arteries is a rich source of inflammatory chemical messengers, many of which are the same as those found in plaques, and in particular plaques considered to be vulnerable to rupture, called high risk plaques (HRP). Computed tomography coronary angiography (CTCA) is a widely used investigation for the assessment of plaque as well as HRP. Inflammation of the coronary arteries, however, is not as easily assessed. Specialised imaging methods are limited by cost, availability and image resolution. Circulating blood markers of inflammation do not reflect what happens at the level of the vessel. Therefore, the ability to measure a regional marker of inflammation is highly desirable and may improve risk prediction beyond the current measures that CTCA provides. Pericoronary adipose tissue (PCAT) is the layer of fat immediately adjacent to the coronary artery wall. It has been demonstrated that inflammatory chemical messengers cross between the vessel and adjacent fat in both directions. Therefore, PCAT may act as a sensor of vessel inflammation, as well as a driver of plaque formation. A recent seminal scientific study showed that exposure to inflammatory chemical messengers stops fat cells from maturing. The density (attenuation) of PCAT can be accurately assessed on CTCA, and has been validated as a marker of inflammation. A more negative fat attenuation represents less inflammation (fat-rich tissue) whereas higher values suggest greater inflammation (less fat maturation). With increasing evidence of the benefits of anti-inflammatory medications to reduce cardiovascular events, the use of CTCA to detect vascular inflammation as well as its established role in plaque analysis represent an ideal tool for a single, non-invasive imaging test to guide future research into coronary plaque formation and vulnerability. Our hypotheses are: 1. Patients with heart attacks will demonstrate lower PCAT attenuation than stable and asymptomatic patients. 2. Persisting high PCAT attenuation predicts plaque progression and vulnerability. 3. The baseline PCAT attenuation at sites of HRP predicts future heart attacks. This study aims to demonstrate that PCAT attenuation will exhibit a gradient of increasing inflammation from normal vessel to HRP. We will aim to define a threshold at which PCAT attenuation predicts HRP presence and progression, to then guide future studies using anti-inflammatory medications. The long-term goal is the ability to detect inflammation in normal vessels free of plaque and therefore are at risk of accelerated plaque progression.

The Transplantation Standardised Outcomes of Nephrology initative has identified infection as a core outcome. Infections are a common complication following kidney transplantation, occurring in more than 65% KTR in Australia, and 40-50% of transplant recipients worldwide. It is expected that the burden of infectious complications will continue to rise based on the growing prevalence of diabetes mellitus and increasing potency of immunosuppressive regimens. Infectious complications following kidney transplantation are associated with significant mortality. Infection-related mortality occurs in approximately 15-20% of KTR worldwide. In Australia, infection accounts for approximately 22% of deaths in the KTR population, with 75% of these deaths occurring in individuals with a functioning graft. Infectious complications are associated with prolonged length of hospital stay, admission to intensive care unit and post-acute care, and early hospital readmission. Treating infectious complications following kidney transplantation has been estimated to cost the Australian Government approximately $8 billion between 2009 and 2020, and places additional strain on healthcare providers. The development of strategies to mitigate infectious complications following kidney transplantation is therefore of great importance. It has been hypothesised that an individual’s gastrointestinal microbiota may modify the risk of infectious complications in KTR. A study of ileal microbiota from nineteen small bowel transplant recipients has highlighted that the relative compositions of multiple bacterial taxa were diagnostic of infectious illness and acute rejection. Additionally, marked disruption of intestinal flora in human recipients of allogenic stem cell grafts was informative of the risk for bacteraemia. There has been minimal work done on the microbiota of KTR and the underlying pathogenesis, clinical consequences and potential for therapeutic manipulation are poorly understood. As the gastrointestinal microbiota is intimately influenced by diet, the discovery of this relationship between the kidney and gastrointestinal microbiota, known as the kidney-gastrointestinal axis, may be a therapeutic opportunity for nutritional intervention. Thus, this study will explore the benefit of manipulation of the gastrointestinal microbiota, via prebiotic supplementation, examining the feasibility of performing a randomised controlled trial of prebiotic supplementation in reducing infections and gastrointestinal upset in kidney transplant recipients.