ANZCTR search results

The aim of this study is to compare the accuracy of novel, dynamic and static functional imaging, and also morphological imaging, with standard of care imaging for the detection of liver metastases in patients with neuroendocrine tumour (NET). Who is it for? You may be eligible to join this study if you aged 18 years or above and have been diagnosed with histologically proven WHO Grade I or Grade II NET with known liver metastases. Study details All participants in this study will receive three scans on a single day: an initial PET-MRI Scan, followed by a PET-CT Scan, and then a final PET-MRI Scan. For the initial PET-MRI scan a qualified Nuclear Medicine Technologist will ask you to lie on the scanner bed. They will insert a tube into your vein and inject a radioactive substance called Ga-68-DOTATATE as well as a special dye called contrast. The scan involves lying flat with knees supported and arms resting by your side. You will be scanned from the top of your head to the middle of your thighs. The scan time for the PET-MRI will be approximately 45 minutes. The PET-CT scan involves lying flat and takes approximately 30 minutes to scan you from the top of your head to the middle of your thighs. The final PET-MRI scan will not require any further injections. This scan will go from the top of your head to the middle of your thighs and should take approximately 30 minutes. This scan is performed to directly compare the PET-CT images to the PET-MRI images. The images generated will be independently reviewed by trained Nuclear Medicine physicians partaking in the study to count the number of liver metastases. It is hoped that additional dynamic PET may further increase the sensitivity of detecting liver metastases. This may potentially influence treatment options in individual patients, including possibly avoiding futile surgery in patients with more extensive disease burden than detected on current standard imaging

The Glasgow-Blatchford score (GBS) has been shown to be superior to other scoring systems, such as the Rockall score, in predicting clinical outcomes and the need for endotherapy in hospitalised patients with upper gastrointestinal (UGI) bleeding. Specifically, our prospective observational study in 708 patients has recently found that a score of three or less identifies patients who do not require endoscopic intervention, blood transfusion, or surgery, and thus, could potentially be discharged early with conservative management and outpatient endoscopy. Despite the clinical implication of these findings, the use of the GBS in the management of UGI bleeding has not been adopted in practice at the Royal Adelaide Hospital. In order to further evaluate the use of the GBS to triage patients, we would like to prospectively validate the cut-off GBS of three or less in the outcome and management of patients with UGI haemorrhage (UGIH). More specifically, we would like to examine whether the GBS cut-off of three can determine the need for urgent endoscopy (within 24 hours), endotherapy, blood transfusion or surgery in these patients.

The aim of the current study, is to investigate the efficacy of an 8 session Cognitive Behaviour Therapy intervention as an adjunct to a breathlessness clinic intervention on mastery of breathlessness and anxiety/depression scores compared to a waitlist control. Participants will have recently completed the breathlessness clinic at Westmead Hospital and still have high scores for depression and anxiety related to their disease symptoms. They will then be invited to participate in this study. They will be randomised to one of two groups, immediate enrolment in cognitive behaviour therapy or to an 10 week waitlist control group. This will allow comparison between the two groups. The cognitive behaviour therapy will be identical for each group. Questionnaires, lung function and activity tracker will be completed by all participants, at baseline and end of 10 week.

This study will investigate whether temporarily reducing dopamine transmission in the healthy brain affects an individual’s spatial selective attention, that is, the direction in space (left or right) in which an individual’s visual attention naturally falls. By combining this investigation with measures of electrical activity in the brain and genetic testing, we hope to gain a deeper understanding of the mechanisms involved in spatial attention and the influence on these mechanisms of genes implicated in the structure and function of the dopamine system in the brain. Uncovering the mechanisms of spatial attention may help us better understand and treat disorders involving spatial attention deficits, including Attention Deficit Hyperactivity Disorder, which involves an impaired awareness of, and ability to respond to, objects and information in a particular area of visual space.

This study aims to find out if treatment with a combination of Ipilimumab and Nivolumab, with weekly paclitaxel before surgery, and treatment with Nivolumab after surgery, is safe and effective in women and men diagnosed with triple negative breast cancer. Who is it for? You may be eligible for this study if you are 18 years or older, have been diagnosed with triple negative breast cancer, will be having neoadjuvant treatment (treatment with anthracycline-based chemotherapy before surgery) and your tumour is >= 15mm in size after anthracycline-based chemotherapy. Trial Details. Participants may have commenced anthracycline based chemotherapy prior to signing consent to this study. Tumour block/sections from the initial diagnostic core biopsy must be available. Up to 3 weeks before starting study treatment, all participants will have a breast and axillary ultrasound, and provide research core biopsies and research blood tests. The tumour must be biopsied prior to the start of neoadjuvant study therapy and a primary tumour size of >= 15 mm on imaging (mammogram or ultrasound) is required for eligibility. Participants will have clinic visits every 2 weeks during pre-surgery treatment (nivolumab, ipilimumab and paclitaxel) for 12 weeks. They will receive nivolumab every 2 weeks (6 doses), ipilimumab every 6 weeks (2 doses) and paclitaxel every week (12 doses). Participants will have a breast and axilla ultrasound repeated before surgery. If tumour is available at surgery, research biopsies will be collected. Nivolumab will re-start when safe to do so 3-6 weeks post-surgery. All participants will have clinic visits with the first dose of nivolumab after surgery, and then every 4 weeks for 9 visits (36 weeks). Nivolumab is dosed every 4 weeks post-surgery for up to 9 doses. The total duration of study treatment is 1 year. Participants will be followed as per local investigator standard of care (SOC) at 6 months, 12 months, 24 months and 36 months following start of study treatment by phone or SOC visits.

Functional outcomes of peripheral nerve injury using standard microsurgical repair alone are extremely poor despite the tremendous advances in surgery and medicine. These poor outcomes are due to the slow nerve regeneration process through the injury site and further growth to the target sites (muscle motor units, sensory and propioreceptors). In simple language, the muscle is an electric motor that needs continual supply of electricity to keep it running in good condition. The nerve is the electric wire and the nerve impulse is the electricity. When there is an injury to the nerve the electric wire is divided and the motor cannot work. The motor will deteriorate and weaken irreversibly if the re-establishment of electricity supply is too slow. When the electricity supply is re-established within a time interval short enough to prevent irreversible damage of the motor, the reconditioned and weaken motor will run again. We hypothesise that the process of regeneration can be enhanced and sped up by electrical stimulation of the repaired nerve intraoperatively. We plan to test this hypothesis in patients suffering from ulnar and median nerve injury. They will undergo microsurgical repair of the nerve under general aesthetic as routine practice and then receive intra-operative low frequency electric stimulation of the repaired nerve for 1 hour. Functional outcomes of patients randomised to receive the experimental treatment will be compared with controls (patients who receive nerve repair alone) over the course of a 24 month follow up period allowing us to determine if the added therapy translates into clinically beneficial outcomes.

Myocardial infarction (‘Heart attack’) remains a significant cause of morbidity and mortality. Despite re-opening blocked heart arteries, there is still a group of patients that have a worse outcome due to disease of smaller arteries, not visible with conventional diagnostic x-ray imaging. A tool that directly measures involvement of the smaller arteries at the time of the initial heart attack would therefore be desirable. The index of microvascular resistance is such a technique that uses a special pressure wire to look at changes in flow in heart arteries in order to calculate resistance within the smaller vessels. We plan to use this tool in patients with heart attacks to assess the small vessel (microcirculatory) involvement. We will also take a small amount of blood to look at specific blood tests that show degrees of inflammation and the function of blood cells. The blood sample will be stored in -80C freezer for various inflammatory markers tests at a later stage. We will also assess the effect of medications given for heart attacks on the small blood vessel function. The goal of this study is to investigate factors that influence the function of the small blood vessels. We will utilise this technique in order to improve treatment for all patients who have a heart attack and improve our understanding of the disease process and ultimately provide new treament options that may benefit the Australian community.

This is a research investigation into physiotherapy treatment after Total Knee Replacement surgery. This trial is specifically designed to compare two different types of physiotherapy exercise groups, to evaluate whether they provide equal benefit to patients in regards to both physical measures and patient reported satisfaction. The treatment group will be given a modified physiotherapy protocol with the main exercise being stationary pedalling, it will also include gait retraining and walking as well as a knee extension (straightening) stretch. The control group will be given a standard multi­exercise physiotherapy program which includes seated knee bends, Inner range knee strengthening exercise and functional strength exercises such as mini squats and calf raises. The control group will also be given the knee extension stretch and gait ­retraining, however, they will not be given any stationary pedalling exercises. A selection of outcome measures will be recorded at 2 days, 12 days and 4 months post-operatively in conjunction with the participant's Orthopaedic surgeon review. Outcome measures will include: Time of which the patient is deemed safe for discharge from hospital by the treating physiotherapist Timed Up & Go test functional measure test 10 Meter timed walk test 6-minute walk test Knee Range of Motion Measurement Subjective measurement tools including the EQ5D survey (incorporating a VAS pain scale), and the Oxford Knee Score. The significance of the results of this study would be to provide evidence for substituting a standard physiotherapy protocol, which includes a variety of treatment modalities and exercises, with a simplified one which can be mostly patient driven. If the results of the simplified bike pedal group are better than or no different than the standard multi­exercise physiotherapy group then there would be implications for greater time efficiency for treating physiotherapists and an overall cost benefit associated with this.

The primary aim of the current study is to compare two psychological treatment methods for gambling disorders in the Australian context. One treatment is a cognitive behavioural treatment (CBT; Petry, 2005), that centres on the reinforcement of non-gambling behaviour, and on helping the client identifying “triggers” to their gambling and better managing these. The second treatment is Cognitive Deconstructional Therapy (CDT; Anjoul, unpublished) that centres on identifying client misconceptions about their preferred form of gambling and providing corrective information. Both treatments have displayed benefit in the treatment of problem gambling, and determining which is more effective will be useful knowledge in improving treatment delivery to problem gamblers. The study will be conducted at the University of Sydney’s Gambling Treatment and Research Clinic. The clients of the clinic will be invited to participate in the study, with an aim to recruit approximately 200 participants. The study will be conducted as a randomised controlled trial, with eligible participants randomly allocated to one of the two treatment conditions. Treatments will be administered by registered and intern psychologists who have had extensive training in both therapies. Participants will be administered a battery of questionnaire assessments at the commencement of therapy, and completion of therapy, and at 6, 12 and 24 months post-treatment. Including recruitment, treatment and follow-up phases of the research, it is expected that the trial will take approximately 4 years to complete.

Obstructive sleep apnoea (OSA) is common and an important contributor to cardiovascular disease, stroke, and depression. The first line treatment for OSA is continuous positive airway pressure (CPAP) which is highly effective in treating OSA. However, up to 50% of patients are unable or unwilling to tolerate CPAP. Nasal masks are most frequently used, however oronasal masks covering the nose and mouth, may be chosen due to patient preference, nasal obstruction or air leak through the mouth. There is growing evidence suggesting that oronasal masks are less effective in controlling OSA. Patients using oronasal masks are a clinically difficult group of patients to treat, often requiring higher CPAP pressures, with significant mask leaks, a higher residual AHI and lower adherence to treatment. Mandibular Advancement Devices (MAD) are emerging as an alternative treatment particularly in patients with mild to moderate OSA, CPAP intolerant OSA and primary snorers. The O2Vent T is a custom-made MAD with an enclosed airway that allows airflow through the device. Like all MADs, the lower jaw is brought forward to stabilize the upper airway, however unlike other devices, patients can also breathe through the device while the jaw position stabilized. This may be of benefit to those with nasal obstruction and a tendency to mouth breathe i.e. patients using oronasal masks. Our aim is to assess whether treatment effectiveness can be improved with combination CPAP and MAD, in a group of patients with OSA who are sub-optimally treated with CPAP using an oronasal mask. Treatment effectiveness is a clinical decision based on factors including compliance, residual Apnoea-Hypopnea Index (AHI), pressure requirements and leak. We hypothesize that compared to CPAP with oronasal mask, combination therapy will result in: a) Lower pressure requirements b) Lower AHI c) Lower leak d) Better compliance Participants will be monitored for CPAP efficacy and compliance using their oronasal mask for 4 weeks using an auto-titrating CPAP (APAP). They will be fitted with a customized MAD (O2Vent T) and then use this in combination with their APAP (combination therapy) for a further 4 week period. Further advancement of the MAD may need to occur if clinically indicated (ie for a period of 4 to 12 weeks maximum). Treatment effectiveness between the groups will be compared using downloaded data from the participants APAP machines. This will include AHI, pressure requirements, usage and leak, which will all be downloaded from the participants APAP machines at the end of the relevant treatment periods.