ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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31330 results sorted by trial registration date.
  • Assessing the acceptability and feasibility of a program to assist people diagnosed with cancer to talk about and plan for future medical care

    The primary purpose of this study is to assess the feasibility and accessibility of a series of interventions which aim to increase participation in advance care planning (ACP) for patients who have been diagnosed with cancer. ACP involves patients discussing and documenting their preferences for future medical care in case they are not able to communicate these later. Who is it for? You may be eligible to participate in this study if you are aged 18 or over, have been diagnosed with cancer of any kind and are receiving care from participating oncology outpatient clinics. Study details Participants in this study will be randomly allocated (by chance) to receive either the usual care regarding ACP, or to receive a number of prompts to encourage them to participate in ACP. These prompts include a letter from their oncologist and access to a website and DVD which all outline the purpose and benefits of ACP and provide information and worksheets to get started, as well as two text message prompts to encourage use of these tools. Participants will be asked to complete surveys regarding their use of the tools and how useful they were. It is hoped that the findings of this study will provide information as to whether these prompt strategies are feasible for increasing the uptake of ACP among cancer patients.

  • Effect of sodium bicarbonate and sodium phosphate supplementation on cycling performance

    Background: Sodium bicarbonate is a compound often used in food and baking, and has been associated with improvements in high intensity exercise of different modalities, including running, swimming and cycling (Burke and Pyne, 2007). Ingestion of sodium bicarbonate results in an increased blood alkalosis (measured via blood pH and blood bicarbonate concentration), which can aid in buffering hydrogen ions, and act to delay the onset of fatigue in high-intensity exercise (Carr et al., 2011). Sodium bicarbonate is most often ingested at a dose of 0.3 grams per kilogram of participants’ body mass, a dose that has been found to have the greatest effect on performance (McNaughton et al., 1992). Phosphate is an essential mineral that is obtained in the diet, and is a component of phosphocreatine and adenosine triphosphate, important components in oxygen transport within the red blood cell (Brewer et al., 2013). Phosphate can be ingested in the form of sodium phosphate, which has been associated with enhancements in endurance exercise performance (Cade et al., 1984) and peak aerobic capacity (Folland et al., 2008). The recommended dose of sodium phosphate is 50 mg per kg of participants’ fat free mass. Mechanisms associated with sodium phosphate supplementation include an increase in 2,3-diphosphoglycerate content in the blood, which can aid with the release of oxygen to the muscle, as well as an increased buffering capacity (Brewer et al., 2014). Participants: One hundred and twenty well-trained, male and female cyclists will be recruited to complete this study. Experimental Design: Experimental Testing Overview: Participants will visit the laboratory on three occasions. The first visit to the laboratory will require participants to complete a DEXA scan and simple anthropometric measures (height, mass and sum of 7 skin folds) to assess body composition, as well as a graded exercise test to determine maximal oxygen consumption (VO2max), and a familiarisation with the cycling performance test. The remaining two visits will require participants to complete cycling performance trials. For the second laboratory visit, participants will complete a baseline cycling performance test. The third laboratory visit will require participants to complete the same cycling performance test, under one of four supplementation conditions, assigned in a parallel groups design. The four experimental conditions are: 1) sodium phosphate and placebo, 2) sodium phosphate and sodium bicarbonate, 3) sodium bicarbonate and placebo, 4) placebo and placebo. Capillary and venous blood samples will also be taken during the second and third laboratory visits.

  • The effects of intermittent fasting and high intensity interval training on body composition, markers of metabolic and cardiovascular health and micro ribonucleic acid (miRNA) expression in overweight/obese individuals

    Intermittent fasting (IF) is any strategy where participants severely restrict caloric intake on one or more days of the week with 'normal' eating on non-fasting days, and has recently gained popularity for weight loss. Intermittent fasting compares well with other traditional nutritional interventions such as long term calorie restriction, with higher levels of dietary adherence reported over time. High intensity interval training (HIIT) has also been reported as an effective and time efficient exercise strategy for weight loss, as well as improvements to markers of cardiovascular and metabolic disease. Individually IF and HIIT are effective, however, their combined effects are unknown. This study intends to examine the short and long term impacts of IF, specifically a 2:5 ratio of fasting days to normal eating days, and HIIT on weight loss and cardio vascular and metabolic health. The influence of these interventions will be monitored separately, or in combination, on body composition, metabolic and cardiovascular health, fitness and quality of life. In addition, the study will identify changes in serum miRNA’s expression. To achieve these aims, overweight and obese individuals will undergo 1 of 3, 16 week interventions including: 1) 5:2 diet intermittent fasting diet, 2) supervised high intensity interval training (HIIT) performed 3 days a week, and 3) a combination of both interventions. Body composition, arterial stiffness, blood pressure, aerobic capacity (VO2 max) and quality of life will be measured at 0, 8 and 16 weeks. Additionally, blood samples will be taken and measured for lipid profiles, fasting plasma glucose, insulin resistance, markers of inflammation and expression levels of microRNA. Participants will also be asked to continue the interventions for a further period of 8 months self-directed, with follow up measurements performed at the 24, 36 and 52 weeks. Effective dietary and exercise interventions that promote long-term adherence and sustained beneficial effects on metabolic and disease markers are required to reduce the increasing rates of obesity.

  • Effects of mobilisation with movement in participants with distal radius fracture: A randomised controlled trial.

    The aim of this study is to see if adult patients who have suffered a fracture to the distal radius, which has been treated non-sugically, benefit from receiving Mulligan mobilisation with movement (MWM) plus self-MWMs. In this study the hypothesis to be tested is that adult patients who have suffered a fracture to the distal radius who receive four treatments of MWMs plus self-MWMS as well as simple ROM exercises, will demonstrate a significant difference in ROM, pain and function to patients who are treated with simple ROM exercises alone.

  • Prophylactic early parenteral nutrition in patients undergoing haematopoietic cell transplantation: A multi-centre randomised controlled trial..

    The purpose of this research project is to investigate whether treatment involving the earlier delivery of nutrition into the vein (intravenous nutrition) can improve the survival of patients who are scheduled to receive haematopoietic progenitor/stem cell transplantation (HPT), when compared with standard nutrition treatment. Standard nutrition treatment after HPT in Australia does involve providing patients with intravenous nutrition, but intravenous nutrition is usually only started after all other options fail. After HPT, patients are normally fed orally (by mouth) or by enteral (gut tube) feeding. If either of these two options fails to provide enough nutrition for two or three days in a row, intravenous nutrition is often provided directly into the vein. You may be eligible to join this research project if you are aged 18 years or above and have a haematological malignancy (blood cancer) for which you are about to commence conditioning chemoradiotherapy for allogeneic HPT. Participants in this research project will be randomly (by chance) allocated to one of two groups. Participants in one group will continue to receive standard nutrition treatment. Participants in the other group will commence early intravenous nutrition prior to chemoradiotherapy. If allocated to the intravenous nutrition arm of the research project, the amount of intravenous nutrition you will receive will be based on your medical condition and your body weight. The intravenous nutrition will also be adjusted based on the amount of food you are able to eat by mouth and/or are being fed by gut tube (enteral feeding). The research project will enrol participants over a 3-year period. All participants will be monitored for a minimum of 1 year, up to a maximum of 4 years, in order to evaluate disease response, survival time, quality of life and costs of treatment. It is hoped that the use of intravenous nutrition used early in allogeneic HPT will improve participant clinical outcomes, increase participant survival time and reduce costs to the acute care health system.

  • Chewing Gum for the Treatment of Post-Operative Nausea and Vomiting

    The aim of this pilot trial is to determine the efficacy and safety of chewing gum compared with ondansetron for the treatment of postoperative nausea or vomiting (PONV). PONV is a significant complication of general anaesthesia. In addition to patient dissatisfaction resulting from PONV, the cost burdens of anti-emetic therapy and delayed discharge from the PACU are considerable. Chewing gum in the postoperative period has been well established in the treatment of ileus resulting from gastrointestinal surgery, but its efficacy as a treatment for PONV has to date not been assessed. A prospective cohort study conducted by this research team on the use of chewing gum in the PACU confirmed its acceptability to patients and staff. We now propose to determine the non-inferiority of chewing gum to ondansetron for PONV. The results of this pilot study will guide a future large randomised controlled trial assessing the efficacy of this comparative simple therapy, of negligible cost. This study thus has the potential to significantly improve patient and health service outcomes. The aims of the pilot study 1. Refine and test the trial protocol for a large multicentre study 2. Assess acceptability of the trial protocol to our patients and anaesthetic/nursing staff, as a high recruitment and participation rate will be required for a viable definitive study. 3. Confirm the high rates of PONV despite prophylaxis seen in our prior trial, to inform sample size estimates for a definitive trial. 4. Assess the proportion of patients meeting criteria for chewing gum in the PACU, to guide the external validity of this trial. 5. Assess the event rates using the protocol developed Hypothesis to be tested Chewing gum in the immediate postoperative period is efficacious and safe compared to ondansetron in the treatment of PONV.

  • Preventing falls in older people after discharge from hospital as a result of a fall

    Older people returning home after a hospitalisation episode for a fall face a period of substantially increased risk of falls. Importantly, having had one fall is a risk factor for future falls and developing a fear of falling. This project aims to improve quality of life, reduce rate of falls and risk of falling by targeting a high 'at risk' group that have previously been little studied: older people after hospitalisation for a fall. This project will pilot and evaluate the effectiveness of a home-based intervention that comprises an individualised balance exercise program, a medication review and client education for older people living in the community, following an episode of acute care in hospital. The intervention specifically aims to : improve health-related quality of life, balance and mobility; increase knowledge and confidence in preventing a fall; reduce fear of falling; reduce exposure to falls-risk increasing medicines; and develop hospital discharge strategies

  • Music During Pleural Procedures

    Pleural procedures are performed both for diagnostic and therapeutic purposes. Similar to other endoscopy procedures, it is known that patients undergoing pleural procedures can experience considerable pain and anxiety. The use of sedative and analgesic medications can somewhat alleviate these symptoms. However these medications can be expensive and can result in side effects such as respiratory depression. On the contrary, music is an inexpensive and non-pharmacological intervention that has been shown to reduce pain and anxiety in patients undergoing endoscopy and surgical procedures. However, to date, there have not been any studies that have evaluated the effects of music therapy in patients undergoing pleural procedures. Our study aims to fill an important gap in knowledge. If our proposed study demonstrates that music indeed reduces anxiety and pain levels in patients undergoing pleural procedures, it will reduce the patient morbidity and lead to a more comfortable hospital experience. This may also result in reduce need for sedative and analgesic medications for our patients, resulting in cost savings and risk reduction for our health service.

  • Phase 0 Trial of Gallium-68 tris-hydroxypyridinone prostate specific membrane antigen (Ga-68 THP-PSMA) positron emission tomography (PET) scanning for prostate cancer

    The primary aim of this study is to test the safety as well as define the normal and abnormal scan appearances following injection of a radioactive substance called Gallium-68 tris-hydroxypyridinone – prostate specific membrane antigen (Ga-68 THP-PSMA) and imaging with positron emission tomography (PET). Who is it for? You may be eligible to join this study if you have prostate adenocarcinoma and are scheduled to undergo a prostatectomy. Study details: In this study, we will use a radioactive molecule (called Gallium-68) that, after injection into a vein, specifically attaches to prostate cancer cells by binding to a receptor called PSMA. You will need to visit the hospital for an additional occasion for approximately 4 hours. An intravenous line will be inserted into a vein in each arm, one to give the investigational product, and another for sampling your blood during the scan. Ga-68 THP-PSMA will be injected and several scans performed over a 3 hour period. You will be closely observed throughout this period with regular recording of your vital signs. The radioactive molecule used in this study is not approved by the Therapeutic Goods Administration (TGA). This study will help inform the utility of this agent for imaging prostate cancer, and design of future larger studies assessing accuracy.

  • Schema Therapy for Eating Disorders

    Researchers at Western Sydney University are conducting a trial on group Schema Therapy for Eating Disorders. Participating in the study would involve attending a group therapy program conducted by two Clinical Psychologists, which will be held at the University of Western Sydney, Bankstown Campus. The program consists of one 90-minute group session per week, for 25 weeks. Participants must be 18 years or older and must have some form of disordered eating (e.g. anorexia nervosa, bulimia nervosa, binge-eating disorder, eating disorder not otherwise specified). Participants must not have current suicidal thinking. Participants will be asked to attend a screening session to assess their suitability for the group. If suitable, they will be invited to attend a second appointment to be interviewed and to complete some questionnaires. They will be asked to take part in another interview and questionnaire session at the end of treatment, and again 6 and 12 months later. It is expected that those participating in the treatment group will lead to a significant reduction in eating disorder symptoms, reductions in general psychological symptoms and improvement of quality of life. This study is to identify whether or not schema therapy is effective in reducing symptoms. The study will explore patient perspectives about what was helpful and not helpful about group schema therapy.

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