ANZCTR search results

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

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32712 results sorted by trial registration date.
  • A pilot study to assess the feasibility of an integrated survivorship intervention to improve patient and service level outcomes for men with prostate cancer. ‘The True NTH Pilot Study’

    This study aims to implement and evaluate the feasibility of an integrated care model for prostate cancer patients that incorporates both local and centralised services. You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with localised prostate cancer within the previous 3 months, OR diagnosed with advanced prostate cancer for at least 12 months. All patients in this study will be provided with local and centralised prostate cancer support services. These include Care Coordination, Information Provision and Decision Support, Practical Support, Peer Support, Lifestyle Plan, Speialised Support Services, and Advanced Prostate Cancer Comorbidities Management. While each component of the intervention is available for all participants, the intervention and each of its components are tailored to the patient’s stage of disease and their health related needs. Delivery of specialised support services will depend on resource availabililty, access, treating specialist /team preference and preference of the patient. Patients in this study will be asked to complete 3 surveys over a 6 month period (at the commencement of participation, followed by 3 and 6 months after the commencement of participation) in order to assess their quality of life, prostate cancer symptoms and mental health. In addition, service and carer-related outcomes will be measured. At 6 months after the commencement of participation, patients, carers and key personnel involved in delivering the intervention will be invited to complete an online survey and participate in individual interviews. This is a pilot study focused on determining feasiblity of a larger randomised study. If the intervention is effective, men with prostate cancer will have access to evidence based supportive care interventions that will contributed to improved health outcomes and quality of life.

  • Six year follow up of children at high hereditary risk of allergy born to mothers participating in the DOMInO Trial.

    The aim of the 6 year allergy follow up is to see if taking fish oil supplements during pregnancy can reduce the development of allergies in children and how long these effects may last. At 1 year of age, we found that there were fewer children with atopic eczema and fewer children with a positive skin prick test to egg in the group whose mothers took fish oil supplements during pregnancy than those in the control group that took vegetable oil capsules. As children reach school age we expect asthma and hayfever to become more common and by examining all children at 6 years of age, we will be able see whether the effects of fish oil supplementation during pregnancy are long standing or are only seen in early childhood.

  • Perhexiline effects on inflammatory activation and insulin sensitivity in diabetics or pre-diabetics with heart disease

    Perhexiline is medication known to improve the efficiency of energy used by the heart. It works by reducing fatty acid and thereby improving glucose utilisation by the heart. The hypothesis of the current study is that perhexiline administration reduces pro-inflammatory markers, and improves insulin sensitivity. Analysis will be performed before and after perhexiline therapy in the diabetic patients, and further analysis will be performed to evaluate the extent of changes in the presence or absence of a type of commonly used heart medication in the diabetics (ACE-inhibitors).

  • A dose escalating open label study in Type 1 diabetic subjects, to assess the pharmacodynamics activity of transbuccal human recombinant insulin compared to subcutaneous human insulin.

    This study is a single site, open label, cross-over, eight arm study to compare the effect of treating subjects with type 1 diabetes mellitus (T1DM) using a film (via the inner cheek) to deliver recombinant human insulin and standard subcutaneous insulin administration. Participants will receive three (3) comparator arm treatments versus five (5) investigational product arms over approximately six (6) month study participation period. Twelve (12) patients will be recruited for the study, with the possibility of eighteen (18) patients being required.

  • Cure rate and side effects comparison between the sequential bismuth based quadruple therapy and the concomitant bismuth based quadruple therapy in treating patients carrying antibiotic resistant Helicobacter pylori strain.

    The primary aim of this study is to determine Efficacy of sequential bismuth based quadruple therapy versus concomitant bismuth based quadruple therapy in treating patients carrying antibiotic resistant Helicobacter pylori strain.

  • A randomised controlled trial of a telephone-based weight management program for patients with knee osteoarthritis who are overweight or obese.

    Excessive weight is the most significant behavioural risk factor leading to the onset and progression of knee osteoarthritis. Weight loss is recommended for all patients with knee osteoarthritis who are overweight or obese; however, this is rarely provided in clinical practice. This study will assess the effectiveness of a telephone-based weight management program in reducing weight and pain in patients with knee osteoarthritis who are overweight or obese. We hypotheses that patients receiving the telephone-based program will achieve an average weight loss of 5kg and an average decrease in pain score of 1.5 of 10 from baseline, compared to control patients receiving usual care.

  • Evaluation of the efficacy of oral enzymes for the treatment of carbohydrate intolerance in Irritable Bowel Syndrome.

    Irritable bowel syndrome (IBS) is a common disorder affecting 5-15% of Australians. Recently the Gastroenterology department research team at Monash University have created a dietary management approached for the treatment of IBS. The dietary approach termed the low FODMAP diet restricts poorly absorbed carbohydrates. The term FODMAPs denotes fermentable, oligo-, di-, mono-saccharides and polyols. These carbohydrates are poorly absorbed in the small intestinal lumen and therefore travel to the large intestine where they are fermented by colonic bacteria to produce products of hydrogen, methane, carbon dioxide and short chain fatty acids. The dietary approach uses a restrictive phase followed by a re-introduction phase to assess individual tolerance to the various FODMAP subgroups. The dietary restrictions however can be difficult to maintain, especially among patients with other food intolerances or dislikes. This is particularly relevant to vegetarians and vegans as legumes, a major source of protein, is restricted during the low FODMAP diet. The types of carbohydrates in legumes are unable to be digested in the human small intestine as humans do not have the enzyme to break them down; they are therefore often a trigger of IBS symptoms. In the USA and Europe there are tablets on the market which contain alpha-galactosidase, an enzyme to break down the carbohydrate’s present in legumes. A few studies have been conducted to assess the enzyme use in healthy controls, but there is limited research using them in patients with IBS. The aim of this study is to evaluate if the alpha-galactosidase enzyme can reduce breath hydrogen and symptoms in IBS. We hypothesize that there will be a reduction in both hydrogen and symptoms with the use of the alpha-galactosidase enzyme.

  • Patient function & pain control after total knee replacement: Is it improved by use of peri-articular or intra-articular infiltration ?

    Total knee replacement (TKR) is a common operation for knee arthritis. Effective pain control is important in post-operative recovery and rehabilitation. Recent studies have shown that injections of a mixture of medications into the tissues around the knee at the time of surgery can decrease the amount of pain experienced after surgery, leading to improved rehabilitation and a shorter hospital stay. We would like to determine if pain is better controlled with injections into the tissues around the knee joint (periarticular), compared to injections into the joint itself (intraarticular) at the time of total knee replacement surgery.

  • A pilot study of the effect of oral curcumin on lymphocyte count in patients with clinical stage 0/1 chronic lymphocytic leukemia.

    This study aims to determine if curcumin can delay progression of chronic lymphocytic leukemia in patients with early disease. Who is it for? You may be eligible join this study if you are a patient over the age of 40 who has been diagnosed with stage 0/1 chronic lymphocytic leukemia (absolute lymphocyte count > 20x10^9 lymphocytes/L). Trial details All participants in this trial will be given curcumin (derived from the spice turmeric) orally at a dose of 2g/day for 6 months. Participants will be assessed by blood test every 2 months over the 6 month study period in order to determine treatment response such as absolute change in lymphocyte count.

  • COlchicine to Prevent PeriprocEdural myocardial injury in Percutaneous Coronary Intervention (COPE-PCI Trial)

    This study aims (1) to define the atherosclerotic plaque characteristics, inflammation and microvascular physiology in patients with acute coronary syndromes; (2) to evaluate the impacts of colchicine on atherosclerotic plaques, inflammation and microvascular physiology in ACS; and (3) to correlate plaque morphology and coronary physiology with future cardiac events

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