ANZCTR search results

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

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31386 results sorted by trial registration date.
  • 68Ga-NTA-476 Imaging in Men with Prostate Cancer

    This study is investigating a new agent to be used in PET imaging for prostate cancer, called 68Ga-NTA-476. It aims to find out where 68Ga-NTA-476 goes in the body once it is injected into a person and whether there are any side effects or issues with tolerating the compound. This will be compared to an existing imaging compound which is currently used in Australia called 18F-DCFPyl. 68Ga-NTA-476 has been developed and tested in the laboratory; however, this is the first time that it will be tested in humans. It is hoped that this compound will provide more accurate PET imaging with less non-specific activity to enhance diagnostic and therapeutic outcomes. Who is it for? You may be eligible for this study if you are an adult older than 18 years of age, you have been diagnosed with prostate cancer and do not have any significant other health issues. Study details All participants who choose to participate will complete a Screening Visit to make sure that they meet the eligibility requirements for the study. Procedures completed during this visit will include demographic details, medical history, physical examination, vital signs, ECG, blood samples to check overall health status and a 18F-DCFPyl PET scan. Following confirmation of eligibility, participants will complete an Imaging Day Visit. During this visit, single dose of 68Ga-NTA-476 will be injected via a vein into the body. Following this, PET scans will be completed at about 0-30 minutes, 1 hour, and 4-6 hours. Participants will be observed in the clinical for a total of 6 hours to check vital signs and record any side effects. Between 7-9 days after this, a final study visit will be completed. Blood samples will be collected to check overall health status and the research team will check to see if any side effects were experienced. A total of 10 participants will be enrolled in this study at Melbourne Theranostic Innovation Centre in Australia

  • Facts and Fiction in the Internet Age: A trial on online myths and education about important social issues.

    The internet and social media have been powerful tools to educate the public about social issues. However, some information is incorrect, and it can be difficult to know which information to trust. Online education offers an effective and efficient way of learning about important social issues like climate change and vaccines. This research project’s goal is to test the effectiveness of an online tool that educates people about important social issues. We will test whether one online tool is more effective than another at educating people about important social issues.

  • Pre-operative video about bowel function and supportive care in colorectal cancer: feasibility study

    The purpose of the study is to determine the feasibility of pre-operative educational videos on bowel cancer related functional recovery. Who is it for? You may be eligible for this study if you are an adult who has had pre-operative clinical staging confirming stage I-III or limited stage IV colorectal cancer. In addition, you should have elective surgery for cancer resection +/- temporary stoma scheduled >7 days after the time of referral to the study. Study details At least 5 days before your scheduled surgical procedure, participants will be asked to view a series of 4 videos with estimated duration 6-10 minutes each, covering the topics of bowel and general health, bowel, bladder and sexual function, and pelvic floor muscle exercise. Following this, participants will be asked to complete satisfaction and knowledge measures. It is hoped that findings from this study will help investigators develop tools to aid patient understanding of bowel issues associated with surgery and provide coping strategies for the potential side effects from surgery and treatment.

  • Evaluation of Faecal microbiota following PRobiotics in Infants of Mothers with Diabetes (PRIMD) trial: a double-blind placebo-controlled pilot randomized trial

    Infants born to mothers with gestational diabetes have abnormal gut bacteria, which may predispose them to adverse health outcomes such as inflammatory disorders, allergies, diabetes, obesity, neuro-developmental and neuro-behavioural impairment, cardiovascular and immune-mediated diseases. We aim to supplement these infants with probiotics to alter the bad bacteria with the hope to improve their health outcomes. Currently there are no trials in this area.

  • Gastric Residual Volume Assessment by Stomach Ultrasound Compared to Aspiration in the Intensive Care Unit

    In critically ill patients, especially those requiring mechanical ventilation, enteral nutrition is a fundamental aspect of metabolic support. When oral feeding is insufficient to meet nutritional needs, enteral feeding becomes the preferred method of nutritional support. However, more than 50% of ICU patients experience gastric dysmotility, which leads to reduced rates of gastric emptying. This can result in several complications, such as regurgitation and aspiration, increasing the risk of developing pneumonia. Therefore, monitoring gastric emptying is an essential part of ICU management, aimed at reducing these risks and making informed decisions regarding nutritional support. We hypothesize that there will be a close relationship between ultrasound of the stomach and aspiration for the assessment of gastric residual volume in patients admitted to the intensive care unit. In a convenience sample of 30 adult patients admitted to the intensive care unit, we will Sequential assessment of gastric residual volume performed first by ultrasound of the stomach followed by aspiration of the stomach contents with the volume of the aspirated fluid measured. Two ultrasound procedures will be performed by two independent intensive care doctors. Aspiration of the stomach contents will be performed by the patient’s bedside critical care nurse immediately following completion of the 2nd ultrasound.

  • ENDOmetriosis appearance with hormonal COntraceptives at LaparOscopy: a pRospective cohort study (ENDO-COLOR Trial)

    Endometriosis is a common condition where deposits of endometrium are found outside of the uterus, typically in other pelvic organs. Endometriosis has a significant impact on quality of life, pain, sexual function and fertility for women who suffer from it. Laparoscopy (keyhole surgery) plays a crucial role in allowing diagnosis of endometriosis and therapeutic benefit in excision of disease. While black pigmented “powder-burn” endometriosis lesions are classically described, other non-pigmented red or white lesions are common. Causes of variation in lesion appearance have not been well explored and are not well understood. Past studies have found high concentrations of iron deposition in endometriotic lesions compared to normal peritoneum. This iron deposition is due to cyclical bleeding into ectopic endometrial implants, due to falling progesterone levels at the end of the menstrual cycle. Macrophages (a type of white blood cell) initially phagocytose (ingest) haemoglobin, which is broken down into iron and then converted to hemosiderin, which is typically black or pigmented. These hemosiderin-laden macrophages are one of the diagnostic features of endometriosis on histopathology. Hormonal contraceptive medications are commonly used to treat endometriosis. They prevent pain through a range of mechanisms but crucially by suppressing a woman's production of sex hormones, thereby preventing cyclical bleeding from endometriosis deposits and an associated inflammatory response. We hypothesize that the use of hormonal contraceptives would inhibit proliferation of endometrial tissue and subsequent bleeding from endometriotic deposits. This effect of hormonal contraceptives would also reduce the number of haemosiderin-laden macrophages in endometriosis lesions, thereby reducing their black appearance. No previous studies have investigated the factors that influence lesion appearance at laparoscopy. As such reasons for variation in lesions and the effect of hormonal contraceptives on lesion appearance is unknown. Fewer black lesions may lead to more missed lesions at laparoscopy, with more lesions appearing red or white. It may also lead to atrophy of endometrial glandular tissue leading to difficulty in diagnosing endometriosis on histopathology. If this effect exists, awareness of it by surgeons would be useful and may facilitate complete excision of endometriosis at initial laparoscopy. This has been shown to improve pain and quality of life compared to incomplete excision. Our primary objective is to assess whether the use of hormonal contraceptives effects the colour of endometriosis lesions at laparoscopy. Our secondary objective is to assess if hormonal contraceptives effect the histological appearance of endometriosis lesions and if this this is related to their colour.

  • Dietary Intake, Nutrition Beliefs and Attitudes of Pregnant Women with Inflammatory Bowel Disease

    This study aims to assess the dietary intake of pregnant women with inflammatory bowel disease (IBD), investigate the impact of IBD on dietary intake, and explore beliefs and attitudes towards nutrition during pregnancy. It is hypothesised that pregnant women with IBD, especially those with active IBD, are more likely to have dietary intakes that fall below the national dietary guideline targets compared to healthy pregnant cohorts. The findings could guide educational initiatives and interventions focused on improving the nutritional adequacy of dietary intakes and support provided to women with IBD during pregnancy. Enhancing maternal nutrition through tailored interventions could improve the health and well-being of both the mother and foetus, leading to better pregnancy outcomes.

  • The evaluation of a novel biosensor to continuously monitor human fetal scalp lactate intrapartum

    An interventional study to evaluate the feasibility and reliability of a novel sensor (DelivAssure) to continuously measure indicators of fetal well-being during labour and delivery, and the acceptability of the device to pregnant women and their caregivers.

  • Evaluation of i-RECOveR-TH: An interdisciplinary intervention for delayed recovery after concussion using telehealth

    Concussion/mild traumatic brain injury represents a public health concern given its prevalence and potential long-term consequences, with up to 30% of people with concussion experiencing delayed recovery/persisting post-concussion symptoms (PPCSs). PPCSs can interfere with successful return to activities (e.g., school, work, sports) causing significant stress for months to years after injury. PPCSs are multifactorial and interdisciplinary treatments are recommended. Limited options for evidence-based interdisciplinary treatments exist, particularly in rural areas where concussion rates are higher. Our team of international leaders in concussion research, developed and piloted an Interdisciplinary Rehabilitation program for Concussion Recovery (i-RECOveR; ACTRN12620001111965) with positive results. Specialised interdisciplinary treatments such as i-RECOveR, however, are usually limited to urban cities and inaccessible in rural areas. Telehealth can increase access to treatments such as i-RECOveR, although the evidence for telehealth concussion interventions is unestablished. As well as increasing access to treatments such as i-RECOveR, a telehealth model may assist with accessibility issues relating to the injury itself. Our previous research identified the potential benefit of telehealth which included eliminating the need to travel to appointments, which for some individuals with debilitating PPCSs, often exacerbated their symptoms compounding anxiety and fatigue. In an Australian and possibly world first, this study will pilot an 8-week interdisciplinary intervention comprised of coordinated neuropsychology, physiotherapy and medical treatments via telehealth in 12 adults with PPCSs. Concussion symptoms will be assessed as well as treatment goal attainment. There is no comparator group. This research has the potential to establish a feasible, effective, and accessible intervention, increasing the reach of specialised concussion services to those living in rural and remote areas.

  • Testing the Guiding Lifelong Oral Health Wellness Program for mental health consumers.

    Mental health significantly impacts holistic well-being, affecting a large portion of the global population, with 42.9% of Australians aged 16-85 having encountered a mental disorder. Individuals with mental disorders often struggle with daily routines, including personal care like oral hygiene, leading to higher rates of dental issues such as decay, gum disease, and tooth loss. Factors such as psychiatric medication side effects, high sugar consumption, cognitive difficulties, lack of motivation, and limited access to oral care contribute to this vulnerability. This project aims to address these challenges by providing education, in-mouth toothbrushing demonstrations, and support for effective oral hygiene practices. By doing so, it seeks to empower individuals with mental health conditions and promote an integrated approach to oral and mental well-being.

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