ANZCTR search results

The purpose of this study is to figure out the ideal dosing schedule for a new chemotherapy medication called ACT001. Who is it for? You may be eligible for this study if you are aged between 1 and 21 years and have brain cancer or another solid tumour. Study details Participants will take capsules of the study medication, either dissolved in apple juice or as tablets, twice per day for 28 days. The amount of medication taken will depend on the results of participants before you. All participants will provide blood samples and have CT and MRI scans. It is hoped this research will find better treatment option for children with advanced brain and solid tumours.

To determine the clinical pregnancy and live births arising from frozen embryos transferred (FET) which had been generated under the influence of IVF adjuvants given to women categorised as poor prognosis. Our hypothesis is that growth hormone, but not other adjuvants, administered in stimulation cycles may improve oocytes with resultant benefits to embryo quality which in turn may result in improved Clinical Pregnancy and Live Birth rates in subsequent FET cycles.

Pentoxifylline is a medication that decreases the viscosity of blood and helps red blood cells travel better through narrow blood vessels. Aneurysmal subarachnoid haemorrhage is a type of stroke that can be complicated by a second type of stroke called delayed cerebral ischaemia. This is a pilot, randomized controlled study to determine if pentoxifylline when used in aneurysmal subarachnoid haemorrhage decreases the rate of delayed cerebral ischaemia.

The purpose of this study is to evaluate the safety and performance of LipoCeramic simvastatin when administered as an oral capsule. Simvastatin is a commonly prescribed lipid-regulating drug which is used to treat hypercholesterolemia, where there is high levels of cholesterol present in the blood. LipoCeramic technology combines simvastatin with numerous approved ingredients to improve the absorption of the drug in the body. A total of twelve healthy male volunteers aged 18 or over, who meet all entry criteria will be accepted into the study. Participants will be randomly allocated to two groups which dictates which formulation they receive. The trial will be “double- blinded” which means neither the participants, nor the study staff, will know which formulations are being administered. Volunteers will undergo a screening process to determine their eligibility for the study. Successfully recruited volunteers will be required to attend the Clinical Trial Facility on three occasions for a full-day (8:00 am to 5:30 pm) visit, where they will receive one oral dose of a commercial simvastatin tablet and two doses of simvastatin in a LipoCeramic Formulation. There will be a 7-day wash-out period between doses, meaning volunteers will return to the Clinical Trial Facility 7 days and 14 days after administration of their first dose to receive subsequent treatments. Each dosing day will require blood sample collection prior to dosing and at 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6 and 8 hours post dose administration. Numerous safety assessments will also be performed throughout the day. The study will be held at the University of South Australia Clinical Trial Facility, located at the City East Campus, Bonython Jubilee Building, Frome Road. Volunteers will be financially reimbursed $600 for their time and inconvenience after completion of the study.

Innovative technologies for sensorimotor rehabilitation after acquired brain injury have dramatically increased over the past 20 years and their development, as well as the demand for access to these devices, is expected to continue to increase exponentially. Many of the developments have been technology-driven which may limit their application and acceptance in clinical settings. Emerging research shows promise, and collaborative research with engineers, therapists and end-users is critical for the successful translation of these devices into standard practice. Based on this premise, we aim to examine the potential benefits of using a novel device, which incorporates virtual reality, triggered-electrical stimulation and haptic feedback, as an adjunct therapy for the rehabilitation of people with stroke.

Children with Cerebral Palsy (CP) have decreased fitness compared to their typically developing peers. Land based exercise training in children with CP has demonstrated improvements in fitness, but there are barriers to ongoing exercise participation such as pain and movement difficulties. Exercising in water, using a novel high intensity interval training method (HIIT), may allow children with CP to exercise at high intensities, improving aerobic capacity, without pain. This pilot RCT will investigate the feasibility of water HIIT over ten weeks in 20 adolescents with CP who are ambulant. Measures will be collected around fitness, muscle mass, pain and health related quality of life.

Children of women depressed in pregnancy are likely to have an increased risk of behavioural problems such as anxiety, depression and attention deficit/hyperactivity, with effects on mental health lasting at least to adolescence. This study is a fully powered RCT (n=230 women and their infants) which will evaluate medium-term change in child outcomes following cognitive-behavioural therapy (CBT) for depression in pregnancy. We hypothesise that children in the intervention group will have fewer Internalising behavioural problems at the age of 24 months than children in the control group. Pregnant women (30 weeks or below) diagnosed with depression will be allocated to CBT intervention or to treatment as usual. During eight weekly CBT sessions, women will be provided with behavioural and cognitive strategies to help them recover from depression. Other child behavioural, motor and cognitive outcomes will also be assessed.

This is a randomised controlled trial of 40 consecutive patients undergoing elective total hip arthroplasty. The aim is evaluate the use of a tissue adhesive (Glubran 2, Matrix Surgical) for subcutaneous fat closure. Participants will be randomised to have their fat layer closed with either a tissue adhesive or dissolvable sutures. The participants will undergo an ultrasound at day 10 to 20 post-operatively to assess the degree of fluid accumulation in the fat layer. Outcomes will include the incidence and magnitude of superficial seroma, participant reported pain scores, blood loss and incidence of wound complications. We hypothesise that subcutaneous fat closed with the glue will have less fluid accumulation which may be a precursor to infection.

The purpose of this study is to evaluate the safety and feasibility of the Shockwave Medical Lithotplasty System for patients with severe calcified aortic stenosis, Who is it for? You may be eligible for this study if you are aged 18 or older and have severe calcified aortic stenosis. Study details All participants will receive TAVL treatment during a procedure under general anaesthesia in a cardiac catheterisation laboratory. All participants will be followed-up according to the protocol specific endpoints. Patients will undergo diagnostic tests such as CT scan, echocardiography (both transthoracic and oesophageal) , laboratory (blood tests) and undertake several questionnaires as a part of the clinical trial. It is hoped that this research will provide information into the non-surgical treatments of severe aortic stenosis thereby providing future non-surgery related options for the disease.

The primary aim of this pilot is to improve understanding of acceptability and benefits of an online and a face-to-face mindfulness-based cognitive therapy (MBCT) program for people with MS, and to generate preliminary data to inform the development of a larger multi-centre, randomised controlled trial (RCT) in order to promote wellness and quality of life of people with MS. This study aims to: 1) evaluate acceptability of an online and a face-to-face MBCT program against a yoga intervention, its overall effect on mental health and quality of life, and enablers and barriers to incorporating the mindfulness practice at home sustainably; 2) assess if there is improvement in mental health and quality of life in participants from baseline and immediately after the an online or a face-to-face MBCT program or against a yoga intervention and over a six-month follow-up after the program; and 3) evaluate economic data on the cost-effectiveness of the online and face-to-face MBCT program against the yoga intervention.