ANZCTR search results

This study is assessing the feasibility and safety of Stereotactic Ablative Body Radiosurgery (SABR) in patients with metastatic prostate cancer. Who is it for? You may be eligible for this study if you have Prostate Cancer that has spread to lymph nodes or the bones. Trial Details: The research project is testing a new treatment for prostate cancer that has spread beyond the prostate to the lymph nodes or bones. The new treatment is called Stereotactic Ablative Body Radiotherapy. Stereotactic ablative body radiotherapy (SABR) is a new form of cancer treatment involving high precision radiotherapy. Stereotactic Ablative Body Radiotherapy (SABR) appears to be effective in controlling cancer in other sites elsewhere in the body, including the lung, kidney and the liver. We aim to test the ability of this new technique to control cancers arising from the prostate, and that have spread to bone or lymph nodes. As part of this study you will be required to discuss your past medical history and progress of your prostate cancer with the doctor. A general physical examination with a focus on where the cancer has spread to is part of the study. You will have standard blood tests including your hormone levels and prostate specific antigen (PSA) level. Also as part of this study you will be required to have a special scan called an 18F-PET/CT (stands for fluoride-positron emission tomography/computer tomography) scan. This involves an injection of a radioactive chemical and then a scan to see where your prostate cancer has spread to. If the tests show that the research study is suitable for you, and you still wish to take part, you can join the study and begin the treatment. Prior to your stereotactic body radiotherapy you will be required to fill out quality of life and pain questionnaires. This may take up to 20 minutes of your time. You will have either a single session of stereotactic body radiotherapy (SABR) or in the rare situation where there is not enough time available you may be required to return for two sessions (if you have two lesions) and three sessions (if you have three lesions). In order to deliver this treatment, you will need to attend a ‘planning CT scan’ session, where you will receive a CT scan and your body measurements are taken in the position that you will be lying in for your radiotherapy. This visit takes approximately one hour. Once the radiotherapy treatment has been planned, a further ‘mock-up’ visit is required to ensure that the radiotherapy plan can be smoothly delivered when it comes to the time of treatment. This session will take between 45 minutes and 90 minutes. When the treatment starts, the total time required to deliver the treatment will be approximately one hour. All sessions are usually conducted on different days and we will contact you to give you the dates and times to attend for these sessions once they have been booked for you. Follow-up will involve a visit at approximately 1 month, and every 3 months until two years after the radiotherapy treatment. At each visit you will be reviewed by the doctor and have a prostate blood test (PSA). At each visit you will be expected to indicate on a questionnaire if you have any pain. At the 1, 3, 12 and 24 month visits you will be expected to fill out a quality of life questionnaire which will take about 20 minutes of your time. You will have a whole body bone scan at 12 or 24 months after your treatment. At 6 months after your radiotherapy treatment you will have another 18F-PET/CT scan, which will be very similar to the scan before your treatment. The purpose of this scan is to assess the effect of the treatment on your lesion(s).

In a recent series of studies performed by our group, we have shown that exposure to hyperbaric oxygen (HBO) leads to an increase in insulin sensitivity in male subjects and that this improvement can be measured in all men, not just those with diabetes. The aim of this study is to investigate the time course of this effect and explore the mechanisms involved when exposure to HBO induces an increase in peripheral insulin sensitivity. This study will also test whether the same thing happens in female subjects.

Atrial fibrillation (AF) is the most common heart arrhythmia affecting at least 240,000 Australians. Prevalence rises with age from approximately 1% of the whole population to 5% in those over 65 years. People with AF are up to seven times more likely to have a stroke than the general population, and AF related strokes are also likely to be more severe. In addition, one in every six strokes is AF related. Stroke is highly preventable in AF with the use of appropriate thromboprophylaxis. Therefore early identification and appropriate evidence based management of AF could lead to subsequent stroke prevention, significant reduction in the overall stroke burden and substantial savings to the health system. The study is designed to examine the feasibility of screening to identify undiagnosed AF in a primary care setting. Our hypothesis is that a simple primary care screening program may be effective in detecting those with undiagnosed AF. The specific aims are to: 1. Assess the feasibility and acceptability of screening for AF using a hand-held single-lead ECG device in people aged 65 years and over in the general practice setting. 2. Assess the satisfaction of GPs, reception staff and patients with the screening process in the general practice setting. 3. Examine process measures, such as the time taken to complete the intervention, competing demands for practice reception staff time, and the attitudes of patients and staff involved in the intervention. 4. Identify barriers (including technological barriers), enablers and other information relevant to the process of developing a larger-scale implementation study. We propose a cross-sectional study offered in up to 5 general practices in the Sydney metropolitan area. People aged 65 and over, attending general practices will be invited to volunteer for the screening. The screening will consist of an assessment with a handheld single-lead ECG device attached to an iPhone by the practice receptionist. This ECG will be transmitted to a secure website and reviewed by the patient's GP during their consultation. The primary outcome measure will be the acceptability of the screening process. A process evaluation will also be undertaken to better appreciate factors that might influence sustainability beyond the trial setting.

Insomnia is a common and distressing sleep disorder. Untreated insomnia is responsible for increasing health care utilisation through negatively impacting on mood (depression & anxiety), family and workplace behaviour which in turn increases a socioeconomic burden on the community (Ohayon 2002; Siebern & Manber 2010; Hilman et al., 2008). Cognitive Behavioural Therapy (CBT-i) is the most efficacious treatment for insomnia by enabling the individual to change current ineffective behaviours and challenge faulty beliefs about sleep (Morin et al., 2006). Effective behavioural sleep interventions include sleep restriction therapy (Edinger & Means, 2005) stimulus control therapy (Bootzin, 1972) paradoxical intention (Morin 1993) and sleep hygiene (Hauri, 1991). These behavioural sleep interventions have successful treatment outcomes when run by the equivalent of Practice Nurses in Scotland and do not require trained psychologists (Espie et al., 2001; Espie et al., 2007). Although CBTi has proven effectiveness, access to both sleep centres and professionals who are able to provide such services is limited in most major cities and is often absent in rural communities in Australia. More recently a “stepped care” model to treat insomnia has been proposed (Espie 2009). This model proposes a generic pyramid where the majority of patient care is undertaken at baseline with an evidence-based but less intense treatment intervention whilst “greater expertise” in both assessment and treatment is used towards the top step of the pyramid. This model has considerably validity in the treatment of insomnia patients using group CBTi which has an efficacious record in a number of different age groups and settings. For many rural families the cost of going to capital cities for an ongoing treatment intervention is not feasible. There are also the ongoing issues of social isolation and increased depression rates particularly in young men in rural communities. Treating insomnia symptoms is an effective first step to address these issues. Training Practice Nurses to undertake a predominantly Behavioural Therapy (BT) intervention will enable the provision of a treatment which is both easily accessible and has been shown to improve sleep and mood in most individuals. The primary aim of this project is to assess the outcomes of a BT intervention for insomnia when delivered by Nurse practitioners in a medical setting in rural NSW.

The present study examines whether transcranial direct current stimulation (tDCS) over the left dorsal lateral prefrontal cortex (DLPFC) impacts upon executive functioning in healthy older adults. Based on previous research, the following particular hypotheses may be proposed: (i) older adults will perform poorly on tests of executive function compared to younger adults (ii) anodal (excitatory) tDCS of left DLPFC will enhance performance on measures of executive functioning in older adults (iii) cathodal (inhibitory) tDCS of left DLPFC will lead to decreased performance on measures of executive functioning in older adults (iv) sham tDCS of left DLPFC will not impact upon performance on measures of executive function

Stretching exercises are commonly prescribed by healthcare professionals in treating musculoskeletal conditions of the foot. This comparison study aims to find out how dry needling can affect the effectiveness of stretching exercises in treating heel pain. The treatment of dry needling plus a stretching exercise program will be compared against a stretching exercise program only in this study. Participant satisfaction and the degree of calf muscle relaxation will be compared between the two treatment groups.

This study aims to assess whether the use of a 'retroflexion' technique improves adenoma (tumour) detection in the right colon. Who is it for? You may be eligible to join this study if you are aged 18 years or above and are scheduled to undergo a complete colonoscopy. Trial details All participants in this trial will undergo a single colonoscopy which includes a technique known as 'retroflexion' in the right colon. This is standard practice for many endoscopists. The procedure duration is approximately 20 minutes with retroflexion only adding an extra 1-2mins to the total procedure time. Adenoma detection rate from the standard forward view assessment will be compared to that from retroflexion. It is thought that retroflexion may improve the detection of polyps behind folds that may not be seen on standard forward view.

This study will evaluate the safety and tolerability of combining the 3 drugs, vinorelbine, cyclophosphamide, and Rapamycin, in children with recurrent/refractory malignant disease. Who is it for? You (or your child) may be eligible to join this study if you/they are aged less than 22 years of age and have been diagnosed with any of the following solid tumours/malignancies: all brain tumours, Rhabdomyosarcoma, Soft tissue sarcomas, Osteogenic sarcoma, Ewing sarcoma, Neuroblastoma, Wilms’ tumour. The disease must have either relapsed or not responded to initial therapy. Trial details All participants in this trial will undergo treatment with a combination of the three drugs vinorelbine, cyclophosphamide, and rapamycin. Cyclophosphamide is administered one per day orally, rapamycin is administered twice per day orally, and vinorelbine will be administered on days 1, 8 and 15 of each 28 day cycle intravenously (i.e. into the vein). This cycle will be repeated every 28 days. If the initial dose level is tolerated by patients, then it will be increased for the next patient group in order to determine the optimum dose combination for both heavily pre-treated and less heavily pre-treated participants. In addition to evaluating the toxicity of this drug regimen and determining a dosage range, the potential efficacy of the regimen will be assessed. All participants will be regularly monitored and assessed for a period of up to 5 years in order to evaluate the safety and tolerability of this treatment.

The aim of this study is to investigate the different impact of slow versus fast injection of the anti-VEGF agent, ranibizumab, which is the treatment participants are receiving for the treatment of age-related macular degeneration (AMD). The study will run for 4 months and involve 2 study visits. Participants will receive the intravitreal injection that they are already receiving for AMD. The IOP will be measured before the injection, 2 minutes after the injection and 15 minutes after the injection. Study participants will be randomly assigned to two groups (group A and group B). Participants assigned to group A will receive their intravitreal injection as a quick push in the first visit and slowly (over 3-4 seconds) in the second visit. Participants assigned to group B will receive the opposite allocation. The two injections will be given 4-12 weeks apart according to the scheduled treatment for the participants AMD.

This study is a single-center, prospective, open-label, safety/efficacy study enrolling up to 10 patients. Safety and efficacy are the primary objectives based on analysis of reported and observed adverse events and the WOMAC validated OA questionnaire (pain component). A series of validated subject-completed questionnaires, a visual analogue scale for pain and formal orthopaedic examination, will be performed over the course of the 60 months at the following intervals: baseline, 6 weeks, 3 months, 6, 12, 18, 24, 36, 48 and 60 months. X-ray data will be collected pre-operatively and the following post operative intervals 3, 6, 12, and 24 months.