ANZCTR search results

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

You can narrow down the results using the filters

30856 results sorted by trial registration date.
  • Oral premedication absorption during bariatric surgery

    Prophylactic antiemetic and analgesic oral premedications are frequently prescribed preoperatively to enhance recovery after laparoscopic gastric sleeve resection. However, it is unknown whether these medications transit beyond the stomach or if they remain in the stomach or sleeve resection specimen, thereby negating their pharmacological effects. The purpose of this study is to identify whether age, sex, body mass index, and diabetes mellitus are associated with the presence or absence of oral premedication in the stomach or resected gastric specimen. Who is it for? The study will include adult patients undergoing bariatric surgery. This is a retrospective analysis of patients who underwent laparoscopic gastric sleeve resection who received premedications as part of usual anaesthesia and surgical care. Study details This study will evaluate the presence or absence of oral premedication in the stomach or sleeve resection specimens. The secondary aims will be to to evaluate whether age, sex, body mass index, or diabetes mellitus are associated with the presence or absence of oral premedication in the stomach or resected gastric specimen. Finally, the study will evaluated the association between premedication lead time and the presence or absence of premedication in the specimen. Premedication lead time is defined as the time in minutes from when the premedication tablets were administered orally to when the gastric sleeve was resected. It is hoped that this study will be hypothesis generating and provide valuable data for power calculations for future studies on evaluating the timing of premedication before bariatric surgery.

  • Does the Parkinson's Disease (PD) Warrior 10 week challenge exercise program for Parkinson's Disease improve quality of life and objective outcome measures?

    "PD Warrior" is a relatively new exercise program for people with Parkinson's Disease that is widely-used but little studied. Improvements in PD symptoms and beneficial effects on disease progression have been reported in patient surveys. Studies are yet to be undertaken confirming this. HPH-Ramsay Health Plus has a two year experience with PD Warrior and have noticed similar results. This study will assess a group of patients before and after a PD Warrior program using a number of patient outcome measures. The primary outcome will be PD-specific quality of life. Measures of motor outcome will be obtained using the Parkinson's Kinetigraph (PKG), an innovative mobile health technology device developed in Australia. This wrist-worn device is able to measure improvements in tremor, slowness of movement and mobility. We anticipate that the program will provide measurable benefits on quality of life and motor function in our patients. Study Intervention: The PD Warrior 10 week challenge exercise program. Involves attendance at a weekly one hour circuit class and a daily home exercise program. Study Outcomes: Baseline assessments prior to commencing the 10 week challenge exercise program and post completion of the program. These include quality of life (PDQ39 questionnaire), motor outcomes from the MDS- UPDRS scale Part 3 Motor examination, routinely used motor function measures - 10m walk test, 6 minute walk test, Timed Up and Go test, MiniBESTest balance test and timed hand function tests and wearing a Parkinsons Kinetigraph for 7 days pre and post the 10 week challenge exercise program.

  • Satoreotide Theranostic Pilot study in Extensive Stage in Small Cell Lung Cancer (ES-SCLC)

    This study aims to assess the safety and tolerability of two new drugs in patients with extensive stage small cell lung cancer (ES SCLC). The first drug (68Ga-SSO120/68Ga-Satoreotide Trizoxetan) is used as a tumour imaging agent for patients who have tumours with specific receptors, while the second drug (177Lu-SSO110) targets and damages cancer cells with these specific receptors. Who is it for? You may be eligible for this study if you are an adult aged 18 years or older, you have been diagnosed with extensive stage small cell lung cancer and if you are going to be receiving ICI maintenance therapy. All potential participants will be reviewed by the study investigators to ensure that they meet additional health criteria before enrolment. Study details All participants who choose to enrol in this study will undergo two screening scans using the new 68Ga-SSO120 imaging drug. The first scan will be to confirm eligibility to receive the 177Lu-SSO110 drug. If eligible, the first treatment dose with 177Lu-SSO110 will be scheduled at least 18 days after the 68Ga-SSO120 scan. The second scan with 68Ga-SSO120 will be taken at the end of treatment visit, which will be 6 weeks following the last dose of 177Lu-SSO110. For each scan, the 68Ga-SSO120 drug will be administered via an intravenous infusion 1 hour (40-90 minutes) before the PET/CT scan. The scans are anticipated to take 1-2 hours in total to complete. Participants who are confirmed to have somatostatin receptor 2 tumour cells based on the first screening scan will then be offered the opportunity to undergo treatment with the 177Lu-SSO110 drug. Participants who choose to enrol in the 177Lu-SSO110 arm of this study will have 177Lu-SSO110 administered via an intravenous infusion within 7 weeks after their last induction ICI therapy. Up to 3 additional 177Lu-SSO110 administration cycles will be given 6 to 9 weeks after the previous 177Lu-SSO110 administration. For participants with clinical benefit at the end of the 4 cycles the Investigator may request that the patient is provided with up to three additional treatments, which will be approved at the Sponsor’s discretion It is hoped this research will demonstrate that each of the study drugs, 68Ga-SSO120 and 177Lu-SSO110 are safe and well tolerated by patients with extensive stage small cell lung cancer. If the results of this initial study are positive, a larger trial involving a greater number of patients with extensive stage small cell lung cancer may be undertaken to further determine the potential benefits of the new drugs.

  • Effects of ketone supplementation on recovery from endurance exercise in recreationally active males

    Athletes across many disciplines engage in structured, periodized training plans to promote adaptation and ultimately optimise performance. However, recent research has made it clear that manipulating the provision of nutritional support throughout training and during the recovery periods can play an equally important a role in determining performance outcomes. Over the last 20+ years, exercise science research has primarily focused on the provision of carbohydrate and protein to facilitate glycogen replenishment and skeletal muscle repair, respectively. More recently, scientific studies have begun exploring whether supplementing with beverages containing ketone esters may provide an alternative fuel source to support exercise and subsequent recovery. To date, the evidence to support ketone use during exercise is mixed, but there have been promising findings suggesting that this fuel may promote muscle repair, and may reduce the likelihood of athletes developing symptoms of overtraining. While the finding that exogenous ketones may increase the activity of the machinery response for building new proteins is exciting; it remains to be determined whether supplementing with ketones can increase the rate of muscle protein synthesis (MPS) following exercise. Therefore, the primary aim of this study is to measure the effects of a ketone supplement or energy-matched placebo on MPS following an acute bout of endurance exercise in trained cyclists. In addition to a proposed enhancement of muscle repair and adaptation, the intake of ketone esters is claimed to act as an appetite suppressant to assist with the aggressive manipulation of physique prized by many road cyclists. Indeed, despite reports of an increased energy intake and reduction in markers of over-reaching in a ketone-supplemented group following intensified cycling training, there have been observations of suppression of hormones linked to hunger (e.g., ghrelin), self-reported hunger and desire to eat in the hours following the intake of ketone ester supplements in sedentary humans and supportive evidence in rodent models. Other effects associated with post-exercise ketosis achieved via adaptation to a ketogenic diet also merit investigation in relation to the post-exercise supplementation with ketone esters; these include alterations to iron and bone metabolism. Therefore, the secondary aim of this study is to examine the effect of ketone ester supplementation on other effects on post-exercise recover including impacts on hunger and appetite, as well as on markers linked to iron metabolism and bone health.

  • Strong for Oesophago-gastric Cancer Surgery - prehabilitation program for people with stomach cancer.

    The majority of patients undergoing oesophageal/stomach cancer surgery have reduced fitness. This means they are at greater risk for, and struggle to overcome post-surgical complications, which leads to further morbidity and mortality. This study aims to assess whether a prehabilitation exercise and nutrition program administered to participants prior to surgery has any impact on their physical, nutritional and psychological wellbeing after surgery. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with gastric, gastroesophageal junction or oesophageal cancer, you are scheduled to receive or are currently undergoing chemotherapy, radiotherapy or both and you are going to undergo elective surgery to treat your cancer after completing these therapies. Study details All participants who choose to enrol in this study will be given a personalised diet and exercise program to follow for 3 months prior to their elective surgery. During the initial visit, participants will undergo a series of physical assessments to determine their current fitness levels and will be asked to provide a diet history to assess their nutrition status. It is anticipated that this initial assessment will take 60 minutes. After the initial assessment, participants will be given a personalised exercise plan to follow, this will include 2x 45-60 minute one-on-one sessions with a physiotherapist each week for 3 months. Participants will also be asked to undertake additional moderate exercise, e.g. walking, for at least one hour per week for the 3 months. Participants will also be given nutritional advice including suggested meal plans to address target areas (e.g. reducing carbohydrates or increasing protein or vitamin intakes) to follow over the 3 months prior to their surgery. For the 5 days prior to and 5 days after their surgery, participants will also be provided with an immune-modulating supplement (drink) to consume. Participants who are assessed as at risk for anxiety and depression, and those participants who are struggling to comply with their exercise plan will also be offered one-on-one psychological counselling. Data collected from participants who are undergoing these interventions will be compared to historical patients who received standard of care prior to their surgery. It is hoped this research will demonstrate whether a targeted prehabilitation program has a positive effect on the physical, nutritional and mental wellbeing of patients who are undergoing treatment for gastric and oesophageal cancers. If this study does show a positive effect, the prehabilitation program may be expanded to a greater number of cancer patients.

  • Assessing the impact of walking with inflatable cuffs on fitness and function of older people

    Age-related declines in muscle mass and cardiovascular fitness have debilitating effects on tasks of daily living for older people. Exercise helps to maintain physical abilities, but many older individuals cannot tolerate the recommended high-intensities of training. This research will assess an innovative form of exercise to increase fitness for older people, combining low-intensity walking with wearing inflatable cuffs on the limbs to restrict blood flow, in a 24-week walking exercise intervention. The aims of this project are to determine the effects of BFR walking training on physical fitness, functional abilities, and cognitive function, in older people.

  • Examining the impact of sleep restriction on reward learning

    A disruption in reward processing is suggested to underpin a number of mental health disorders. Current evidence indicates alterations in brain regions during the anticipation and receipt of reward characterise individuals with eating-related disorders (e.g., obesity, binge-eating), non-substance addictions and substance use disorders. These alterations may facilitate compulsive behaviours and potentiate craving. Current evidence suggests reward processing is also impaired in conditions of sleep disruption, with a number of studies indicating impaired ability to discriminate between reward and punishment and increased reward-driven approach behaviour following sleep deprivation. Given an increasing number of individuals in today’s society function without adequate sleep this may indicate a role for sleep disruption in the development and maintenance of disorders characterised by disrupted reward-processing. This study aims to assess the mechanisms through which reward learning and appetitive behaviour could be impacting on clinical populations via sleep. We hypothesise adults who undergo sleep restriction (prescribed a 5 hour sleep opportunity), relative to well rested adults (prescribed an 9 hour sleep opportunity), will have disrupted reward learning. Furthermore, we hypothesise key sleep stages, particularly REM sleep parameters (e.g., percentage, duration, onset latency, etc.), will mediate the relationship between sleep restriction and poor reward learning.

  • Impact and usability of a digital health intervention designed in the workplace

    BodyGuide’s education and exercise programs are delivered via smart algorithms, based on the user's responses to a series of questions relating to their discomfort. The algorithms also detect risk and encourage users to engage with traditional care where appropriate. BodyGuide programs are 100% self-service, allowing users to access curated, trusted information promoting self-care health literacy. As an evidence-based foundation, we will conduct a research study that will: • Develop an effective framework for evaluating patient outcomes in combination with assessing the usability of BodyGuide as a digital health solution • Systematically validate BodyGuide for efficacy (patient outcomes) and usability • Validate asynchronous support coupled with group learning (through webinars, telehealth and coaching) • Identify user defined barriers/facilitators to the digital health BodyGuide program Aims Objective 1: Create an appropriate framework to measure the efficacy and usability of BodyGuide Objective 2: Systematically validate the BodyGuide App for efficacy (based on patient outcomes) and usability – this is the basic BodyGuide model with no telehealth or coaching Objective 3: Assess the impact of adding asynchronous support coupled with group learning (through webinars, telehealth and coaching) on patient outcomes Objective 4: Identify user defined barriers/facilitators to the digital health BodyGuide program

  • The Veg4Me feasibility study: investigating the effect of digitally-delivered personalised support on vegetable intake in young adults living in rural Australia

    Australians living in rural and regional communities are more likely to die early and experience higher rates of preventable disease than those living in the cities, resulting in higher rates of risk factors for chronic diseases, such as high blood pressure and obesity, and higher burden on health care systems. Rural communities also have reduced access to nutrition professionals than metropolitan communities, mostly due to health care workforce challenges and geographical barriers. Diets low in vegetables are a main contributor to the health burden experienced by rural Australians, which is further compounded by unhealthful rural food environments, and socioeconomic inequities. Yet, only 8% of Australians meet recommended intakes, and this is as few as 3% in young adults living in rural areas. Digital health solutions, such as mobile and web-applications, offer an accessible, scalable and inexpensive delivery model for rapid translation of interventions into rural communities that can be personalised to meet the needs of the user. As most adults own a digital device, such as a smartphone, digital health interventions provide an suitable solution for interventions to increase vegetable consumption, However, digital health solutions will have limited success without addressing the needs of rural communities. An increasing body of literature is engaging with the community for the design of digital interventions, rather than for the community, to ensure it meets the need of the target population and there is evidence that co-designed interventions can result in improved engagement and experience of the user, as well as improved dietary intake. This feasibility randomised controlled trial will investigate the feasibility and acceptability of a co-designed and personalised web application (Veg4Me) compared with a non-personalised web application, to address unique barriers to vegetable intake experienced by young adults living in rural areas of Victoria. If feasible, this intervention will be examined for effectiveness for increasing vegetable intake and to understand context for implementation in rural communities.

  • The effect of ingesting carbohydrate drink on stomach size and cardiac flow in healthy volunteers

    ERAS (enhanced recovery after surgery) protocols have been demonstrated to improve certain surgical outcomes. St Vincent’s Hospital Melbourne employs an ERAS protocol for colorectal surgical candidates. Among many measures, is the provision for ingestion of 400ml of carbohydrate fluid 2 hours before surgery. This intervention aims to reduce patient length of stay at no increased risk of aspiration events. Contemporary literature includes several studies that aim to investigate the transit of preoperative carbohydrate ingestion via non-invasive gastric ultrasound, specifically utilising gastric antrum cross sectional area (CSA). These studies find that the transit of carbohydrate oral drinks, ingested at least 2 hours before surgery, do not remain in the stomach upon intubation: the pre-operative ingestion does not appear to increase the risk of pulmonary aspiration caused by an ‘at risk’ stomach. Any potential changes to a patient's haemodynamic state caused by ingestion of this fluid however, have not been investigated to date. Understanding the haemodynamic effect of this intervention would aid the clinician (i.e., the anaesthetist) in their attempt to provide patient-centred, safe, peri-operative fluid management. This is important, as failure to safely manage a patient's fluid status could precipitate deleterious states such as fluid overload (too much fluid) or hypovolemia (too little fluid).

Tags:
  • Finding clinical trials