ANZCTR search results

Study design: This is a pilot single-blinded randomised sham-controlled clinical trial with three-armed group design. Participants: Eligible participants must fulfil the inclusion criteria a) Being overweight (BMI greater or equal to 25) or obese with BMI between 30 and less 40; b) Adult with age over 18 years old; c) Be available during the period of this clinical trial; d) Agree to provide written consent for participating this clinical trial. The exclusion criteria: a) Serious chronic medical conditions, such as cardiovascular diseases, cancer, HIV; b) Pregnancy or lactation; c) Drug induced secondary obesity; d) Medical conditions which are known to link with obesity, such as polycystic ovary syndrome, hypothyroidism, Cushing syndrome, Hashimoto’s Disease; e) Mental conditions such as clinical depression and anxiety; f) Participants who are not willing to be treated by acupuncture or to practise meditation; g) Difficulties in understanding and reading English; h) Taking blood thinning medications; i) Auditory disorders who cannot listen to audio records; j) Participants who received treatment for overweight in the past 3 months, including medical treatment or participation in weight loss programs. Sample size was calculated based on the study by Gugel et al. (2012) comparing the acupuncture group with the sham acupuncture on BMI after treatment, the effect size estimate was 0.56. The sample size pilot trial will be 10 participants per group. The recruited participants will be randomised in to 3 groups: Electroacupuncture plus Mindfulness Meditation (EAM), Sham Electroacupuncture plus Mindfulness Meditation (SAM) and Electroacupuncture only (EAO). Treatment protocol: After two-week run-in period, all randomised participants will receive 1 session per week for 12 weeks and 8 weeks follow-up. During each session, the EAM group will receive 30-minute real EA using 8 weight-loss specific points and 10-minute MM practice with instructions for daily practice. SAM group will receive 30 minute SAM with 8 sham acupuncture points (1cm away from real acupuncture points and meridian) and10-minute MM practice. The EAO group will receive only real EA without MM. Data collections: The data will be collected at week 0, 3, 6, 9, 12, 14, 16, 20 weeks using validated and licensed instruments (obtained). Outcome measures include weight, BMI, waist and hips ratio, weight-related symptom measure (WRSM) and obesity and weight loss quality of life (OWL-QOL), Food intake and Power of food scale. The ethics application has been submitted to RMIT-HREC for approval. Statistical analysis: All collected data will be analysed comparing between groups and within group using SPSS. Intention-to-treat analysis will be applied to all clinical data collected.

The study is an open-label study of PRAX-944 to assess the safety, pharmacokinetics, and efficacy of escalating multiple oral doses in up to 12 adults with generalized epileptic syndromes with absence seizures. Each patient will complete 3 study periods: Screening, Treatment Period (up to 2 dose levels followed by a taper) and Safety Follow-up.

Aims 1. To determine whether a virtual reality (VR) application results in a significant reduction in pain in people with neuropathic pain following a spinal cord injury; and 2. To determine if the use of VR and changes in pain intensity or negative related perception of pain are associated with corresponding changes in electroencephalographic (EEG) patterns linked to the presence of neuropathic pain. Hypotheses 1. That using a VR application will reduce pain intensity or negative pain-related perceptions in people with neuropathic pain following spinal cord injury 2. That reductions in neuropathic pain using a VR application will be associated with a shift of EEG activity from a dysrhythmic brain wave pattern towards a normal brain wave alert state. Significance Evidence now shows that distraction type VR is useful for people with persistent pain who have difficulty diverting their attention away from ongoing pain by enhancing the level of immersion within a distracting environment. Given that meta-analysis shows no difference in effect between specifically developed computer software and commercially available packages, VR is becoming increasingly affordable and available for use in both clinical and experimental settings. Despite growing evidence of benefit and increased accessibility and affordability, there are no studies that have examined the effectiveness of distraction type VR in people with pain following spinal cord injury. The ability for patients to individually reduce the intensity of their neuropathic pain using affordable VR software would be a major advance for people who currently face major challenges in obtaining satisfactory relief of their pain. Methods Using a randomised crossover design, people with a spinal cord injury and a diagnosis of chronic neuropathic pain will undergo two 20-minute intervention sessions with a one-hour washout period between sessions. One session (active intervention) will comprise the use of immersive VR exploring a scene using an Oculus headset attached to a laptop. The alternate session (control intervention) will comprise viewing the same scene but directly watching the laptop screen. During each VR session, EEG recordings will be obtained from several cortical sites allowing analysis of cortical regions associated with neuropathic pain. In addition, the numerical rating of pain intensity, previously validated self-reporting measures determining psychological function known to influence pain severity such as depression, anxiety, stress, pain self-efficacy and pain catastrophising will be administered before and after each intervention. Benefit VR applications may be a feasible method for reducing long-term pain in people with SCI. Given encouraging experimental findings using not only specifically developed computer software but more importantly, affordable commercially available VR applications, we propose that people with SCI can use VR immersion to override pain and negative emotions and thoughts associated with SCI.

The purpose of this study is to determine the feasibility of an imaging technique in assessing the spread of cancer in women with cancer of the uterus. Who is it for? You may be eligible for this study if you are a female, over the age of 18, and have been diagnosed with Stage 1 or 2 cancer of the uterus. Study details All patients with early stage endometrial cancer at the Mater Adult Hospital in South Brisbane that are being treated with surgery will undergo sentinel lymph node mapping as part of their staging surgery. The sentinel lymph nodes will then be submitted to the pathologist for analysis. Patients will not need to undergo further tests or follow ups after this. There will be no special blood tests required for this study. All participants will have the routine bloods taken which are needed for surgery. It is hoped that this research will show that sentinel lymph node mapping can safely replace traditional full pelvic lymph node removal in selected women with endometrial cancer.

The administration of systemic antibiotic adjuncts following scaling and root planing to further expedite healing of the periodontal tissues is a topic of considerable interest, given the lack of evidence-based guidelines for their use in periodontal treatment. The aim of this study was to evaluate and compare the clinical and inflammatory cytokine effects between scaling and root planing alone, adjunctive azithromycin, or adjunctive amoxicillin plus metronidazole in the treatment of patients with generalised moderate-to-severe chronic periodontitis. It was initially hypothesized that patients receiving scaling and root planing + azithromycin would demonstrate greater reductions in clinical attachment level (greater than or equal to 1 mm) and inflammatory cytokine levels compared to the other treatment groups, after 2 months.

The purpose of this study is to investigate the safety and efficacy of stereotactic ablative body radiotherapy (SABR) plus Avelumab in patients with metastatic castration-resistant prostate cancer (mCRPC). Who is it for? You may be eligible for this study if you are an adult with metastatic castration-resistant prostate cancer (mCRPC) and have a predicted life expectancy of at least 6 months. Study details This project will investigate the combination of SABR and Avelumab for metastatic castration resistant prostate cancer (mCRPC). SABR is a noninvasive, high precision radiotherapy technique. The high precision of SABR allows a high dose of radiation to be delivered to the target areas with minimal toxicity to the surrounding areas. Avelumab is a monoclonal antibody that works against a protein called PD1 on the surface of the cancer cells. It is thought that cancer cells with increased levels of PD1 avoid detection by the body’s immune system. In this study, we hypothesise that combining Avelumab with standard therapy high dose precision radiotherapy (SABR) may enhance the antitumour efficacy of Avelumab in mCRPC. This study will evaluate the patient survival, tumour regrowth and side effects with this combined treatment in patients with mCRPC.

The laparoscopic sleeve gastrectomy (LSG) is currently the most commonly performed bariatric procedure in Australia. Long-term data is beginning to appear in the literature and indicates that up to half of patients who have undergone the surgery regain a significant amount of weight in the years following the surgery. These patients often progress to have further surgery to promote more weight loss. In some patients, the regain in weight is thought to be caused by the stomach stretching in size and the patient can then eat more again. Some surgeons have started placing a silastic ring around the stomach with the original surgery to prevent the stomach from stretching. Long-term data on the efficacy and safety of inserting a ring with a sleeve gastrectomy is scarce. It is also possible that a ring may have an effect on reflux and what foods a person can tolerate. This study will be a randomised prospective study with the purpose of evaluating the efficacy of a silastic ring in preventing sleeve dilatation (stomach stretching) and deduce any effect on complication rate; reflux; and food tolerance. The study will provide three-year data to assist in determining whether a banded LSG (using a ring) should become the preferred surgical option for the treatment of obesity. Approximately 95 patients who undergo a banded LSG and 95 patients who receive a standard LSG will be followed for a period of thirty-six months. Patients will be randomised into one of the two study groups. Anthropometric and metabolic data will be collected pre-operative, and at 6, 12, 24 and 36 months after surgery. Food tolerance and reflux evaluated . Stomach capacity will be measured by a Computerised Tomography (CT) Fizzogram at 36 months post-operative. Participants will be asked to have a nasopharyngeal 24 hr pH probe placed at 36 months’ post-operatively irrespective of symptoms as per current clinical practice. Patients presenting before 36 months with weight regain and /or symptomatic reflux will have a CT Fizzogram or oropharyngeal pH monitoring performed earlier, as per normal clinical practice.

This trial will assess patients with Dupuytren’s Disease in two settings: those who have early stages of the disease, and those who have progressive flexion contractures. It is the first trial of its kind and aims to assess safety and efficacy in the use of radiotherapy in both settings. We hypothesise that radiotherapy reduces the incidence of disease progression in people with Dupuytren’s Disease managed in the early stages with a policy of observation, or in the later stages following local treatment in the form of NA.

The purpose of this study is to explore the clinical impart of providing telehealth for community based palliative care for patients in rural Victoria. You may be eligible for this study if you are an adult with a diagnosis of a life-limiting illness. If you participate in this research you will be randomly allocated either to the telehealth consultation group or the "usual" care group in which we will simply ask you to complete questionnaires which will greatly assist us to assess and compare telehealth to usual care. The random choice is done using a dedicated computer program to ensure it is completely random. If you are in the telehealth group then your GP/palliative care community nurse will make an appointment with the specialist palliative care doctor based at the Monash Medical Centre in Clayton for a video conference. Your palliative care nurse with assistance from our team will provide all the equipment needed for this to take place in your home as part of one of their usual nursing visits. Before you begin, the specialists will already have your information, from your GP and nurse. It is hoped that this research will provide the basis for more extensive research. The system used for the video conference is a special dedicated system is completely confidential and nothing from the consultation is stored.

Infants and children with airway abnormality often require surgery of their upper airway to improve their breathing; a procedure called microlaryngoscopy. During this procedure the child is anaesthetised and the anaesthetist controls the child’s breathing. In these situations, known as ‘shared airway’ cases, both the surgeon and anaesthetist require simultaneous access to the child’s airway. The anaesthetist needs to maximise oxygen delivery and provide adequate depth of anaesthesia while the surgeon requires direct access to the airway and an unobstructed view to perform the procedure. In these circumstances it is often impractical for the anaesthetist to place an artificial breathing (endotracheal) tube to deliver oxygen and inhaled anaesthetic gases, therefore oxygen delivery must be achieved by other means. During this kind of surgery it is not uncommon for blood oxygen levels to fall (hypoxia). Surgery may need to be interrupted by the anaesthetist to correct this, potentially compromising patient safety, prolonging the procedure, increasing exposure to anaesthesia and reducing surgical efficiency. At Lady Cilento Children’s Hospital (LCCH), we recently conducted a clinical audit of the anaesthetic care of children undergoing airway surgery and found that 32% of children experienced one or more hypoxemic events (low oxygen levels). A further 23% of surgeries required interruption to apply rescue oxygenation. The method the anaesthetist chooses to oxygenate the child may help prevent this type of serious complication. Traditionally, anaesthesia technique has involved the delivery of low flow oxygen via a ‘Nasopharyngeal Low Flow Oxygen’ (NLFO) system, in which oxygen is delivered at flow rates of 2-6L/min, typically via an oxygen catheter tube placed in the nose. Our research team at LCCH has been investigating the use of a new mode of oxygenation for children undergoing anaesthesia called ‘High-Flow Nasal Oxygen Insufflation’ (HFNOI). In HFNOI, warm and humidified oxygen is delivered to the airway via nasal cannulae at weight-specific flow rates. For example, HFNOI can be delivered at rates of 2L/kg therefore a 10 kg infant the child would receive 20L/min. Matching flow to the patient’s breathing demand this allows the anaesthetist to deliver oxygen to the child at the required concentration. Recent studies conducted in anaesthetised children at LCCH, have demonstrated HFNOI is an effective alternative oxygen delivery technique that can be safely used in infants and children with abnormal airways. The choice of oxygenation method may have significant ramifications for the child, and for surgical efficiency. However, to date there have been no high-quality studies evaluating HFNOI in comparison to other oxygenation techniques during paediatric airway surgery. Therefore, we would like to test the two techniques to determine whether HFNOI is superior to traditional anaesthesia oxygenation methods during paediatric airway surgery. We will achieve this aim using a randomised controlled trial to compare HFNOI with NLFO as the mode of oxygen delivery, during microlaryngoscopy in infants and children. The investigators hypothesise that HFNOI will confer advantages over the alternative techniques when used as an airway management and oxygenation technique during anaesthesia of spontaneously breathing infants or children undergoing microlaryngoscopy surgery. It is important to determine which mode or modes of oxygenation confer the lowest incidence of hypoxia and rescue oxygenation during these surgeries. If we can demonstrate that HFNOI reduces the risk of hypoxia and surgical interruption, this has the potential to both improve both the safety and the operating efficiency of these surgeries for children.