ANZCTR search results

The main aim of this study is to investigate liver tumour motion management using audiovisual (AV) biofeedback, and test the hypothesis that the more regular respiration as produced by AV biofeedback will result in more reproducible liver tumour motion which will have numerous clinical advantages. We will conduct a 30 liver cancer patient clinical CBCT imaging and correlative outcomes study. Who is it for? This study is open to liver cancer patients aged 18 and over with either primary hepatocellular carcinoma or liver metastases who are eligible for stereotactic radiotherapy. Patients will also need to have radio-opaque markers (fiducials and/or surgical clips) previously implanted in the liver. Trial Details In this study, participants will receive two additional cone-beam CT (CBCT) scans to investigate the impact of audiovisual (AV) biofeedback on liver tumour motion. AV biofeedback is a non-invasive, interactive respiratory guide designed to significantly reduce respiratory irregularities in order to maximise the accuracy of treatment planning as well as the efficiency of treatment delivery. The AV biofeedback system consists of a pair of audio-visual goggles that provide the participant with the audio and visual guidance-prompts. Each study session will take 1 hour to set up and pack up the equipment in addition to the two CBCT scans. There will be one study session for each of the 30 patients, the frequency of the study sessions will be dependent on the recruitment rate of liver cancer patients at RPA hospital. Hypothesis We hypothesize that the more regular respiration as produced by AV biofeedback will result in more reproducible liver tumour motion which will have numerous clinical advantages such as improved image quality, dose distributions and treatment margins.

A stroke occurs when the blood flow to the brain is suddenly stopped which causes brain cells in the area to die (infarct) because they are no longer receiving the oxygen and nutrients that they need to function. A stroke can have a devastating effect on the person because the brain controls the way we move, think, speak, and perform different tasks. It is very important to treat people after a stroke as soon as possible so that they are able to recover movement in the affected body parts and look after themselves without having to be dependent on others. Normally movement of the arm and leg is controlled by the opposite side of the brain. After stroke, the unaffected side of the brain may exert a dampening effect on the stroke affected side, preventing it from being active and controlling the opposite side of the body. This study aims to (1) Look at how easy it will be, over a 9 month period, to recruit 40 people presenting to SCGH who have had a particular type of stroke and as a result are unable to use their hand/arm; (2) record techniques used by physiotherapists and occupational therapists to help these people to use their affected arm after stroke; (3) study the effects of a safe low current electrical stimulation (transcranial direct current stimulation - tDCS) to the healthy side of the brain to reduce its dampening down effect on activity in the stroke affected brain. Stimulation, via electrodes placed on the scalp, will be applied at the same time as the affected arm is being treated. This study will recruit patients within 1 week after their stroke. They will be randomly split into two groups: group 1 will receive treatment to their arm plus tDCS to the healthy side of the brain and group 2 will receive treatment to their arm plus ‘pretend electrical stimulation’ (sham tDCS) to the brain.

Nationally, 10,000 young Australians present to emergency departments with alcohol-related injuries and illnesses each month. Much of this adversity could be prevented if more young people had access to effective brief interventions (BIs) for alcohol use. Telephone-delivered BIs provide an innovative, youth friendly and accessible way of delivering treatment. This is the first randomized controlled trial (RCT) to compare the efficacy and cost-effectiveness of telephone-delivered BIs for reducing alcohol use and related harm in young people. 390 young people who present to an emergency department with an alcohol-related injury/illness will be randomized to receive: (i) 1 session of assessment feedback and information (AF); (ii) 2 sessions of AF plus motivational interviewing intervention (MI), or (iii) 2 sessions of a new personality-targeted intervention (PI) incorporating AF and MI. Hypotheses Efficacy will be greatest for PI, followed by MI, and then AF at 1, 3, 6 and 12 months in terms of the: (i) the primary outcome variables of alcohol use and related problems, and (ii) secondary outcome variables of psychological distress, functioning, severity of alcohol dependence, alcohol injuries, coping self-efficacy to resist using alcohol, and cost effectiveness

The prognosis for patients with FL has significantly improved during the last decade with the incorporation of Rituximab into therapy. Rituximab maintenance has become a standard of care after initial rituximab-chemotherapy for remission induction. Lenalidomide is an immune system modulating drug that has anti-lymphoma properties demonstrated in smaller studies of patients with relapsed/refractory Diffuse large B-cell lymphoma. Lenalidomide consolidation added to Rituximab maintenance therapy may convert PET+ patients to PET-, without causing unmanageable side effects. Positron emission tomography (PET) is a medical imaging tool that can detect cancer in its early stages, help to monitor cancer treatment and check if the cancer is coming back. Lay Summary: Follicular lymphoma is the most common type of slow growing non Hodgkin lymphoma. Treatments and outcomes have improved considerably in the last 10 years with the introduction of the drug, rituximab to standard chemotherapy treatments. However, the disease returns repeatedly in many patients. PET scanning is a type of test used by doctors to outline where the lymphoma is in the body. PET scans will ‘light up’ the areas of active follicular lymphoma. Such positive PET scans after the end of treatment indicate that it is likely the lymphoma will return soon. This study is for patients with returned disease who have already received treatment again and so are at even higher risk of disease returning yet again. Patients will receive rituximab and up to 24 months of another drug, lenalidomide, which is designed to help the body’s own immune system to keep the lymphoma away. The study will decide if the extra treatment with lenalidomide can change the scan result to negative and improve patient outcomes.

At the Royal Children's Hospital in Brisbane the standard of care in burns dressings for small to medium partial thickness burns has changed over the years. Currently, silver containing dressings are used to prevent infection and promote healing. However despite the large number of burns dressings available on the market, very few high level trials have been conducted in children or adults. This study aims to determine the effect of various silver and silicone containing burns dressings for the treatment of partial thickness burns in children. The study hypothesises that: 1. Rate of healing, need for grafting and subsequent scarring from a burn wound is partly determined by the choice of dressing used. 2. The choice of dressings used can partly assist with pain and anxiety strategies during dressing change procedures; and impacts on a child's comfort and engagement in activities. 3. The dressing which best fulfils the above qualities will also be the most cost effective.

This project aims to investigate whether a self-help interactive program delivered via tablet devices can help Indigenous youth to reduce their suicidal ideation. Participants will be randomly assigned to either the intervention group, which includes therapeutic activities grounded in acceptance and commitment therapy or a wait list control group. We predict those using the intervention program will report reduced suicidal ideation and mental distress after using the program for 6 weeks.

This study is to evaluate the feasibility, effectiveness, and acceptability of an internet-delivered treatment program for depression and anxiety amongst dialysis patients using an open trial design (pilot study). The study also aims at modifying the content and materials to enhance the treatment acceptability and effectiveness by obtaining participants’ feedback and incorporating the evidence-based components specific to dialysis patients

Otitis media (OME/AOM) is a major problem amongst Indigenous children living in remote Australian communities. Medical treatment often fails and ENT surgeons are called upon to provide surgical care. This multi-centre randomised trial compares the outcomes of two current treatments (Myringotomy/ adenoidectomy V grommet tubes/ adenoidectomy). There are 11 sites proposed across WA, NT & N Qld. 280 Indigenous children aged 3-10 years will be randomized into 2 groups; (1) adenoidectomy with ventilation tubes (VTA) (2) adenoidectomy with myringotomy only (MA) The children will be followed up with monthly phone calls for 12 months following surgery by which time the OM will likely have recurred if were to do so. At the end of 12 months study staff will visit the children in their community for hearing assessments and nasal swabs. The outcome measures will be a reduction in the prevalence of OME/AOM, hearing impairment, aural discharge / perforation, and the also effect of treatment on nasal colonisation with pathogenic bacteria.

Although intramuscular (IM) injections of androgen's are known to be effective, they result in varying degrees of pain at the injection site that may last for a day or two. These injections need to be given into a precise location of the buttocks and require staff with expert training. Unlike many other injections these cannot be self-injected due to the difficulty of safely injecting into the buttocks. A SC injection, if effective, may be given by yourself in your own home, which would be more convenient to avoid extra medical visits as well as saving GP and hospital resources. Many men who require androgen replacement therapy may have bleeding disorders or are on medications that may intentionally slow the ability of their blood to clot. These men have a theoretical risk of bleeding and a very large bruise deep in an important muscle may later become infected and cause significant disability. As a result men using these anti-clotting drugs are usually prescribed other forms of androgen replacement therapy that are not always optimal. A subcutaneous (SC) injection, if effective, may be used in these men. This is a randomised crossover study of testosterone Undecanoate given subcutaneously and intramuscularly in patients receiving testosterone replacement therapy. Each participant will receive a single IM injection and a single (SC) injection of TU. An IM injection is standard of care and duration of action is approximately 12 weeks. It is expected a SC injection will have a duration of action of 12 weeks. Thus the study will take 24 weeks for each participant to complete both arms. This is the second stage of a 2 stage research study. This is stage 2 of study ACTRN12613000068763

This study will evaluate whether combination dietary supplementation of selenium and green tea can reduce the risk of developing bowel cancer in healthy humans. Who is it for? You may be eligible to join this study if you are a healthy man or woman aged between 50-75 years, with no active bowel disease. You should have no previous colorectal cancer and no allergy or intolerance to nuts or green tea products. Trial details Participants will be randomly (by chance) divided into three groups. Participants in one group will eat 6 brazil nuts per day (providing 48mcg selenium/day). Participants in the second group will take 4 green tea extract capsules daily. A third group will take both of these in combination. All dietary interventions are continued for 6 weeks. Participants will be required to give blood samples and rectal biopsies before and after treatment (at 6 weeks) in order to assess response to the different dietary interventions. This study will provide valuable information on how a combinational dietary approach may reduce the risk of developing colorectal (bowel) cancer in humans.