ANZCTR search results

The purpose of this study is to determine whether topical sirolimus cream is able to reduce the occurrence of skin cancer in solid organ transplant recipients who are at high risk. Who is it for? You may be eligible for this study if you are aged 18 years or above. You will also have received an organ transplant 12 months ago or earlier, had previous skin cancer, and have 5 or more keratotic lesions on your face. Study details Participants will be randomly assigned to use either the sirolimus cream or a placebo cream. Participants will apply the cream to their face every night for six months. For monitoring, participants will be asked to visit the clinic at the start of the study, then 3 months and 6 months later and fill out questionnaires at these visits. At the 6-month visit, a blood test will also be done. Participants' health records will also be passively monitored for 24 months. It is hoped that this research will indicate if sirolimus cream is effective in preventing skin cancer, and thus reduce the occurrence of skin cancer in people who are at high risk.

The purpose of this study is to determine whether the BioEye application will provide eye marker information that may assist medical clinicians in administering pain management programs, to reduce opioid dependency for chronic pain sufferers. The hypothesis being tested is that opioid withdrawal can be detected by abnormalities in BioEye measurements, and these will correlate to subjective assessment of withdrawal. The study asks opioid dependent chronic pain patients to use the experimental eCovery app to monitor opioid use and have measurements of eye movement made using the BioEye eye tracking application at clinic visits over a three month period.

High risk MDS is a challenging condition with limited treatment options. Patients often depend on blood transfusions and unfortunately chemotherapy is rarely successful as a treatment option. The main type of therapy used in MDS are hypomethylating agents (HMAs) such as Azacitidine (AZA) and Decitabine (DEC). Traditionally, combination therapy has not proven to be effective in MDS given the increased toxicity of drugs used in combination with AZA, even where the overall responses may have been promising. Therefore, this trial aims to test a relatively non-cytotoxic drug called ES-3000, in combination with a HMA named ASTX727. Who is it for? You may be eligible to join this study if you are aged 16 years or above, and have a diagnosis of MDS or acute myeloid leukaemia (AML) with <30% blasts. Trial details: All participants will receive treatment in 28-day cycles. At first, each participant will receive a single cycle of ES-3000 alone, in order to take blood samples at various timepoints throughout the day to establish how the drug is metabolised by the body. ES-3000 is an oral tablet administered three times per day on days 1-14 of the cycle. Each subsequent participant recruited to the trial will receive a higher dose of ES-3000, until the dose is no longer tolerated. From the second cycle onwards, participants will receive the same dose of ES-3000 in combination with a previously established safe dose of ASTX727 once per day on days 1-5 of each cycle. This will continue until the participant experiences either unacceptable toxicity, or disease progression. Participants will be monitored for adverse effects for the duration of treatment, as well as every 3 months for assessment of their response to treatment through blood samples and bone marrow biopsies, and assessment of quality of life through completion of a questionnaire. It is hoped that this study may show that ES-3000 administered in combination with Inqovi is safe and effective for the treatment of MDS and AML. This study may help to inform the dosing of ES-3000 required for patients with these conditions in future.

Knee osteoarthritis causes persistent pain and difficulty in daily activities. Although exercise is the cornerstone of conservative treatment for knee osteoarthritis, its effects are, at best, moderate. We aim to conduct a ‘proof of concept’ study to explore the use of a novel intervention combining non-invasive brain stimulation and exercise therapy in people with knee osteoarthritis. We hypothesise that this intervention will have a greater effect on the biological mechanisms that contribute to persistent pain and disability in knee osteoarthritis, and therefore provide greater benefits than exercise therapy alone.

In some people, blood glucose levels become low (‘hypoglycaemic’) after a meal and cause symptoms such as shakiness, sweatiness and difficulty concentrating. These symptoms can be bothersome and may be severe. Current approaches to manage this condition, so-called ‘idiopathic reactive hypoglycaemia’, are limited as we do not know what is causing the blood glucose level to drop. When food passes through the intestine, various ‘hormones’ that influence blood glucose levels enter bloodstream. While this is a useful to prevent an abnormal elevation in blood glucose after a meal, we think individuals who have low blood glucose levels after eating may have abnormally fast movement of food through the stomach and intestine leading to increased release of these ‘hormones’. This study is designed to investigate this possibility and if shown to be the case, this would provide a basis for logical, and hopefully, more effective treatment for ‘idiopathic reactive hypoglycaemia’.

Non-alcoholic steatohepatitis (NASH) is an advanced form of non-alcoholic fatty liver disease (NAFLD). NAFLD is caused by a build-up of fat in the liver. This build-up causes inflammation and damage, known as NASH, leading to scarring of the liver and developing the life-threatening condition of cirrhosis. There are no medicines currently approved for the treatment of NASH. Current treatments include dietary changes, weight loss, increased exercise and treatment of associated dyslipidaemia and metabolic syndrome. Recent studies suggest that lifestyle changes (nutritional counselling and exercise) with or without 100mg per day of a mixed tocotrienol product for 3 months showed a decrease in liver stiffness. 79% of those who improved were from the tocotrienol group and 21% from the lifestyle only group. This study will compare treatment with the tocotrienol, TransT3-60, a sublingual powder, to matching placebo, to compare the effects on liver structure measured by ultrasound and magnetic resonance imaging. Safety assessments will be conducted at baseline and 4 weekly intervals. A total of 80 participants will be randomly allocated (1:1) to either the tocotrienol treatment (TransT3-60) or to the placebo group for 24 weeks.

Sleep is important for the optimal health and performance of an athlete. Data suggests that as sleep debt accumulates, sports-related performance is further reduced. Athletes with sleep difficulties are prone to accumulating sleep debt and are therefore of greater risk of impaired performance. This athlete cohort need sleep intervention, with recent research indicating diet influences an athlete’s sleep. Protein supplements high in the amino acid tryptophan may promote sleep through increases in melatonin, with individuals experiencing sleep difficulties believed to be more receptive to the sleep-promoting benefits of tryptophan. Therefore, this study aims to investigate the effect of a potentially sleep-promoting protein supplement (alpha-lactalbumin) on the sleep and performance of athletes with sleep difficulties.

We will evaluate, in a proof-of-concept trial, whether exclusion of FEW-containing foods which are commonly reported as triggers in CD is efficacious in maintaining remission in patients. The study design will be a randomised controlled trial of the FEW foods exclusion diet compared to standard IBD dietary management. The primary outcome for this study is the composite intestinal ultrasound and faecal calprotectin. We predict that the diet low in fats, emulsifiers and wheat will maintain IBD remission for longer than the enhanced standard care diet

We hypothesize that concussion will alter the amplitude and frequency characteristics of measured head movements induced by cerebral blood flow during a cardiac cycle, and that it will be feasible to measure these changes using a non invasive, external device at various timepoints after concussion. We will evaluate the feasibility of using a novel, external cranial accelerometry device for individuals with concussion. Specifically we will determine the practicality of obtaining head pulse recordings at various time points after injury and during recovery from concussion.

Low muscle mass (sarcopenia) is emerging as a significant risk factor for non-alcoholic fatty liver disease (NAFLD) and there is evidence to suggest this risk may be even higher in those with obesity. While weight loss, through hypocaloric diets and aerobic exercise is currently the mainstay of NAFLD prevention and management a concurrent loss of muscle (lean) mass often occurs with this approach. Studies conducted in non-NAFLD participants have indicated weight loss in conjunction with a higher protein intake and/or progressive resistance training (PRT) may improve or attenuate the associated loss of muscle (lean) mass during weight loss interventions. Yet, no study to date has assessed the feasibility of a higher protein intake from predominately plant-based sources in conjunction with exercise incorporating AT plus PRT in a NAFLD cohort. Uptake and adherence to community and clinic-based exercise programs is typically poor. Telehealth has emerged as an encouraging intervention delivery method to expand participant reach and accessibility by shifting treatment from clinics and hospitals to patients’ homes for people with chronic disease such as NAFLD and T2D. For example, telehealth facilitates contact to and overcomes several barriers to traditional exercise and nutrition interventions, including access to evidence-based programs anytime and anywhere, cost, transport and issues related to geographical location. Furthermore, telehealth allows regular follow-ups with healthcare professionals and can be individualised according to each patient’s needs. However, few lifestyle focused telehealth programs have been conducted in NAFLD cohorts, and before they can be widely implemented further research is required required to assess the feasibility, adherence, and effectiveness of telehealth as a model of healthcare delivery for people with NAFLD . Therefore the aim of this 12-week randomsied controlled trial is to evaluate whether a telehealth intervention focused on increasing daily protein intake (predominately from plant-based sources) combined with a smart device exercise app to promote regular muscle strengthening exercise is safe and feasible for middle aged and older adults with NAFLD. Secondly, whether the above mentioned telehealth lifestyle intervention can improve lifestyle behaviours related to overall physical activity and diet quality and functional muscle strength.