ANZCTR search results

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

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31604 results sorted by trial registration date.
  • Magnetic and Indocyanine Green (ICG) Sentinel Lymph Node Mapping in Colorectal Cancer: A Feasibility and Validity Clinical Trial

    The purpose of this study is to evaluate the safety of a new magnetic tracer (FerroTrace) and an infrared dye (Indocyanine Green - ICG) to be used together in colorectal cancer surgery to find the lymph nodes the cancer is most likely to have spread to (the sentinel lymph nodes). This study will also evaluate the feasibility and accuracy of the new magnetic tracer (FerroTrace) and infrared dye (ICG) for finding the sentinel lymph nodes. If the sentinel nodes are clear of cancer, there is a very high probability the cancer has not spread. Finally, the study will also investigate whether the new tracer enables better detection of cancer cells in lymph nodes on Magnetic Resonance Imaging (MRI) before surgery. Who is it for? You may be eligible to join this study if you are aged between 18 and 75 years, have a confirmed diagnosis of primary colorectal cancer and are scheduled for surgery to remove the primary tumour. Study details All participants will undergo their surgery to remove the primary tumour as originally scheduled, with the addition of receiving the new magnetic tracer (Ferrotrace) and the infrared dye (ICG) during the surgery. Participants will then be monitored for 14 days after the surgery for complications. It is hoped that this research project will demonstrate the new method is safe and feasible, and can enable larger follow on trials to determine if the new method improves staging accuracy and can improve patient outcomes.

  • TaxAdapt: A clinical trial testing the feasibility, acceptability, and safety of docetaxel in men with prostate cancer that has spread

    The purpose of this study is to test the idea of a new way of using an old drug in men with prostate cancer that has spread. Who is it for? You may be eligible for this study if you have prostate cancer that has spread and you are offered to take a chemotherapy infusion called docetaxel by your oncologist. Study details If a man about to take docetaxel chooses to take part in the study, their oncologist will advise them to pause taking their medication if their PSA blood test falls by over half. If their PSA blood test returns to pre-treatment levels, participants will then be advised to recommence taking the tablets again until again, the PSA blood test has decreased by more than 50%. The idea is to take breaks from the chemotherapy, using it for long enough to control the cancer, but then stopping and saving it up until later to treat the cancer again. The blood tests, scans, and doctors appointments in the trial are almost identical to normal treatments; men on the trial will be asked to complete short questionnaires, and have an extra blood test every three months. It is hoped this study will demonstrate this strategy of treatment will reduce side-effects, and may improve the lives and survival of men with prostate cancer.

  • Does targeted dietary advice via telecommunications (video, phone and text) reduce blood phosphate levels in patients with kidney failure on dialysis?

    Compared to participants who are randomised to the normal care group participants randomised to the intensive telenutrition phosphate control strategy will have lower serum phosphate and reduced intake of high phosphate dietary sources.

  • A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Preliminary Efficacy of SIR1-365 in Patients with Chronic Prostatitis/Chronic Pelvic Pain Syndrome

    SIR1-365 is a potent and selective allosteric kinase inhibitor of RIP1 with favorable drug-like properties in vitro and in vivo. RIP1 inhibitors may be beneficial for the treatments of degenerative diseases including neurodegenerative and systemic inflammatory diseases. The primary objective is to assess the overall safety and tolerability of SIR1-365 administered orally at 200 mg, two times per day (BID) for 28 days relative to the placebo group. The secondary objectives are to assess the effects of SIR1-365 on clinical efficacy endpoints, and the biomarkers indicative of inflammation, and target engagement as well as the plasma SIR1-365 levels.

  • Lower limb rehabilitation for patients with peripheral artery disease.

    Peripheral artery disease (PAD) is a disease that leads to a reduction in blood flow to the legs. This study looks at the feasibility of using heart rehabilitation, which is well established in Australia, to help patients with PAD. We will conduct an 8-week supervised exercise program for patients with PAD and provide a medical risk assessment, education and counselling, and address lifestyle factors (diet, exercise, medication use), and how you’re feeling. After 8 weeks of supervised exercise, you will be prescribed a home exercise program. After 6 months, we will re-assess your ability to walk, as well as your symptoms, strength, and overall state of health and well-being. The exercise program will be tailored to your ability. We believe using the heart model for exercise, education and counselling will help to improve physical activity, symptoms, and quality of life in patients with PAD, similar to those with heart problems.

  • Investigating the Effect of Plant Based Diets on Cardiovascular Disease Risk

    The switch to plant-based diets (PBD) is not only an emerging societal trend but a global movement. Diets with an emphasis on higher intakes of plant foods and lower intakes of animal foods (i.e. plant-based) have been associated with a lower risk of cardiovascular morbidity and mortality as well reduced risk of major risk factors such as obesity, type 2 diabetes mellitus and hypertension. This cross-sectional cohort study aims to investigate the dietary profile and nutritional adequacy of current plant-based dietary patterns followed by middle-aged Australians and compare the risk of cardiovascular disease across plant-based dietary patterns and omnivorous diet (regular meat eaters). It is hypothesised that individuals following a PBD will have significantly different food group and nutrient intakes to individuals who regularly eat animal flesh. Moreover, the cardio-metabolic risk profile will differ between individuals following a PBD and individuals who are regular meat eaters. It is also hypothesised that the dietary profile and indicators of cardio-metabolic disease will differ across various types of PBDs and some PBDs may even be nutritionally inadequate when compared against the Australian Dietary Guidelines and/or Nutrient Reference Values. Unlike other studies where PBD are often categorised under the same category (e.g vegetarian) findings from this study will provide more specific information across the difference PBD categories and therefore more comprehensive evidence to potentially support future dietary guidelines around PBD.

  • A randomised control trial investigating the effect of temazepam on sleep in critically ill patients

    The DREAM study aims to compare a single dose of temazepam to a placebo, to investigate whether this will improve sleep in patients in the intensive care unit (ICU) of a tertiary hospital. Currently, there is no evidence on whether temazepam, a commonly prescribed sleep aid in the ICU, is effective in promoting sleep for critically ill patients. Patients will be given a weight adjusted dose of temazepam, or a blinded placebo, on a single night during their stay in the ICU. Both subjective measures of sleep (bedside nurse assessment), and objective measures (polysomnography) where available will be collected.

  • Single-Arm, Multicenter, Study to Evaluate Safety and Efficacy of an Ultra-Low Frequency Spinal Cord Stimulator in Subjects with Painful Diabetic Neuropathy

    This study seeks to evaluate the safety and effectiveness of an experimental type of spinal cord stimulator. The device is not yet approved for use in Australia for the treatment of Painful Diabetic Neuropathy. The experimental device is used for 15 days and is then removed. The experimental stimulator delivers a different wavelength that other traditional spinal cord stimulators and it may help to alleviate pain.

  • The Effect of Reflective Groups for Junior Doctors on the Incidence of Burnout

    Reflective groups for doctors to reduce burnout. The hypothesis is that sharing difficult work-related experiences in a safe and supportive group environment will develop psychological preparedness for similar experiences in the future, via imaginal exposure and and enhance the ability to regulate associated stress by and normalise appropriate communicate about stressful experiences, which will encourage ongoing use of reflection and communication after the intervention ends. The primary aim to is reduce burnout and secondary aim is for participants to experience the treatment as helpful and supportive.

  • Towards implementation of pharmacogenomics-guided therapy in patients with mental illness - Stage Preliminary (P) and Stage 1 (ENACT)

    Background: Genetic factors play an important role in contributing to the variability in response to pharmacological agents. For example, genetic variants can affect the activity of enzymes involved in drug metabolism, either reducing or enhancing drug exposure and thus altering drug response and toxicity profiles. Despite the evidence, Australia has been slow in adopting PG testing to guide therapy. A recent Australian Parliamentary Inquiry into the Management of Healthcare Delivery in NSW, in its published report 8/56 in September 2018, expressed concerns that PG testing is not being adequately utilised in the public mental health system. It further identified PG testing as one of the key mental health priorities and made recommendations that NSW Health actively pursues and funds the increased use of PG testing as a means of improving treatment for patients with mental illness. Primary purpose: To develop a model of care which will be informed by the attitudes and acceptability of PG, as well as the support and resource requirements, amongst potential ends users which includes clinicians and patients. Study objectives: The primary objective of this project is to assess patient and clinician experiences, opinions and reported outcomes when utilising PG testing results, as well as barriers encountered in using PG. The secondary objective is to investigate potential impact of PG, by retrospectively auditing PG testing results, and determining the average number of major versus moderate DGI per patient, the incidence of actionable DGI (defined as one that would trigger a change in prescription), as well as the proportion of patients having at least one actionable DGI for a medication they were taking at the time of PG testing or have taken in the past. The proportion of patients whose experience of medication side effects and/or ADR may be explained by their PG results will also be determined.

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