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This study aims to evaluate the Safety, Tolerability of VG161 in the treatment of people with advanced malignant tumours that have not responded to conventional therapies. Who is it for? You may be eligible to join this study if you are aged 18 years or older and have late stage carcinoma which is refractory/relapsed and/or intolerant of standard therapies or for which no standard therapy exists. Eligible participants must have at least 1 injectable cutaneous or subcutaneous lesion greater than or equal to 20 mm in longest diameter. Study details: Part A of this study involves up to 3 increasing dose levels of VG161. The treatment will be given as a single dose, and the dose level will not be increased until the lower dose has been determined to be safe. Part B will test up to 3 increasing dose levels of VG161 given as multiple doses. Treatment will be given in cycles of 28 days, with VG161 given once daily on days 1-5, followed by a 23- day observation period each cycle. Participants from Part A will be able to take part in Part B only if eligibility criteria are still met. The study will also involve taking a variety of biological samples including, blood, urine, and tissue. The samples will be used to assess your eligibility to participate in the study, your safety profile during study participation, and to evaluate how the study drug is metabolised in the body. It is hoped that this study can provide greater insight to novel treatments that may stimulate anticancer immunity and help fight cancer. Furthermore it is hoped this treatment can improve control of disease.

Many patients with type 2 diabetes exhibit exercise intolerance (decreased capacity to exercise) and this is often associated with poorer insulin and glucose (glycaemic) control, accelerated disease progression, reduced quality of life, and decreased longevity and survival. However, the primary causes behind exercise intolerance and poor glycaemic control in these patients are not well understood. Using modern biochemical and ultrasound imaging techniques this project aims to determine whether skeletal muscle microvascular dysfunction (impaired blood flow through small blood vessels), is the main underlying cause behind exercise intolerance and poor glycaemic control. Furthermore, this study will investigate whether a 3-month home-based exercise program can improve muscle microvascular function, glycaemic control and exercise tolerance in patients with T2D.

Minimally invasive gynaecology (MIG) requires a high level of pain medication both during the operation and after the operation. This is from the pain elicited during surgical skin incision, gas used in MIG and cutting of tissue and organs. Pain relief after surgery still has a high reliance on opioid medication. In opioid-naïve patients even small doses can lead to poor side effects including nausea and vomiting, slowing of gut transit and difficulty with breathing. A nerve block to the superior hypogastric nerves has been studied previously through observational trials. First in patients with pelvic cancers and more recently for patients after surgery. It is not a difficult nerve block to teach to laparoscopic surgeons. Ropivacaine which is used for the nerve block is a well-studied medication and approved for use by the TGA in Australia. It is also cheap. We plan to study the effect this nerve block as it could be useful adjunct to post-operative pain relief in the future. This is a single-centre, patient-blinded randomised controlled trial. Patients undergoing minimally invasive gynaecological surgery will be randomised to receive a superior hypogastric nerve block with Ropivacaine at the end of their surgery versus no nerve block. The primary outcome to be studied will be total opioid use in the first 24 hours after surgery. Our secondary outcome is pain scores at regular intervals in the first 24 hours. This will be performed using a visual analogue scale from 1 to 10. Our hypothesis is that patients receiving a nerve block will use 30% less opioid over the first 24 hours compared to patients not receiving one. We also predict patients receiving the nerve block will have lower pain scores.

Type 1 diabetes (T1D) results from the killing of insulin-producing pancreatic beta cells by cells of the immune system. We aim to slow the progressive, immune-mediated loss of insulin-producing beta cells that occurs after clinical presentation. We have identified a pathway that is important for immune cells to kill beta cells, and a drug that will block this pathway and prevent beta cell death. This drug, baricitinib, is already in clinical use for rheumatoid arthritis, and is currently in clinical trials for other diseases, including childhood autoimmune diseases. We hypothesize that baricitinib treatment for 48 weeks will preserve beta cell function in children and young adults with recently-diagnosed T1D. The trial aims to recruit 83 participants aged 12-30 years who have been recently diagnosed with T1D. Two thirds of the participants will be randomly assigned to receive baricitinib, one third will receive placebo. Our trial will test if baricitinib can slow the progressive loss of insulin-producing beta cells in these patients. The primary objective is to determine if baricitinib can reduce the loss of meal-stimulated plasma C-peptide, a measure of beta-cell function. Maintaining endogenous insulin in recent-onset T1D improves glucose control and may lead to long-term improvements in glucose and lower rates of serious diabetes complications and death.

The BED Study is a pilot randomised controlled trial to investigate whether physical changes to the Birth Unit room, increase mobility and upright positioning labour. Previous studies suggest that increased mobility decreases the use of pharmacological analgesia, decreases the length of labour, decreases the caesarean section rate, improves maternal satisfaction and therefore reduces length of hospital stay In Auburn Hospital Birth Unit, standard room set up encourages women to immediately place themselves on the bed and stay there throughout their labour. This study will examine if a simple change to the physical set up of the room (moving the bed to the side of room) and placing alternative birth equipment (e.g. yoga balls and birth mats) will encourage women to mobilise during labour. We will randomise 80 women to each arm of the study: standard birth room set up or alternate room set up without bed in central position. Data will be collected from a form that the primary midwife completes, the eMaternity database on length of labour, mobility during labour, pharmacological pain relief, caesarean section, length of hospital admissions and both the women and midwife caring for her in labour will also complete a short survey prior to discharge on the birth experience and satisfaction with the Birth Unit room.

The primary aim of the study will be to longitudinally analyse the effect a 6-week pulse of exercise has on the level of inflammatory biomarkers including TNF alpha and a multiplex of other cytokines at different times frames (>1year) after burn. A cross-over trial will be conducted with participants randomised to either an exercise or control condition in the first phase. In the second phase participants will cross over into the alternate condition e.g phase 1 exercise condition participants will change over to the control condition in phase 2. Outcome measurement and blood sampling time points will be pre-intervention, at 3 weeks after commencement of intervention/control and then at 6 weeks (completion of study period 1). These will then be repeated in study period 2 at the same time points. Evidence suggests that exercise directly influences inflammation and immune function therefore we hypothesize the chronic inflammatory load after burn injury will decrease after 6 weeks of exercise.

This study will investigate a new drug, sodium selenate, for the treatment of behavioural variant frontotemporal dementia (bvFTD). Up to 120 patients with bvFTD will be recruited in to the study. Half of the patients will receive 52 weeks of treatment with sodium selenate (15 mg three times a day), and the other half a placebo (a sugar pill). The main outcome of the study will be the change in brain volume over 52 weeks, comparing the treatment group to the placebo group. Additional outcomes will look at the overall safety and tolerability of the treatment, the levels of tau (a protein involved in the development of bvFTD) in the cerebrospinal fluid, the rate of cognitive decline and changes in behavioural symptoms observed in patients over the 52 weeks of treatment.

The purpose of this study is to see if the medication ixekizumab might be used to treat underlying inflammation associated with chronic venous ulcers. The study is for anyone with a chronic venous ulcer that has failed to respond to standard therapy (compression bandaging for four consecutive weeks). 28 patients are required for this trial. 14 patients will receive the treatment medication and 14 will receive the placebo medication. Neither the patients nor the staff will know who is receiving which medication. You will receive injections fortnightly for 12 weeks including continuing with the dressings and compression bandaging that you were being treated with prior to the trial. After the 12 weeks it is hoped that this medication Ixekizumab will have added in a significant reduction in the wound size.

The study is investigating the safety, tolerability and pharmacokinetics of multiple ascending doses of the already approved drug Zolmitriptan in 48 adult healthy volunteer subjects, for the potential treatment of people with Austism spectrum disorders.

Atrial fibrillation (AF) is a heart-beat irregularity that is often asymptomatic to patients and increases the risk of stroke. This project will develop and test an automated ECG self-screening station that will be put in GP waiting rooms to detect AF among patients 65 years of age and older. Patient self-screening will be integrated within the workflow and software of GP practices. We propose that this intervention could become the mechanism for widespread implementation of the new Australian and international AF screening and management guidelines, and thereby contribute to the greater prevention of avoidable strokes in Australia.