ANZCTR search results

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.

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.

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.

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.

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.

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.

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

Randomised control trial of IV and oral paracetamol to assess the efficacy of pain relief. This project could act as a pilot study to form a basis for more extensive research to support the introduction of IV paracetamol for certain ED populations We hypothesize that patients receiving the IV paracetamol will have a more rapid reduction in pain score, larger reduction in pain scores and require less rescue analgesia than patients in the oral paracetamol group.

A cognitive behavioural and biopsychosocially-based program for decreasing symptoms of anxiety and depression (called LIFE FLeX) will be evaluated. The LIFE FLeX eHealth program will be placed within the Federation University eHealth Platform. People who visit the website will be invited to take part in the LIFE FLeX eHealth evaluation study. Those that consent will be given access to the LIFE FLeX program website immediately. LIFE FLeX is designed to provide people with information and strategies to address their anxiety and depressive symptoms and contains six ‘core’ modules, plus an Introduction module delivered over 7 weeks. There will also be a short ‘Booster’ Module released after post-assessment. Each module will take approximately 25 minutes to complete. In addition, in order to reinforce the module-based information, there are 20-30 minutes of offline activities each week. Participants will also receive automated emails (e.g., to remind them to log on, when to complete post/follow-up questionnaires) and will be asked several questions at the beginning of each week, to monitor their progress. Modules include text, graphics, audio, video, editable forms and downloads. Modules can be accessible via web, mobile or tablet devices. Participants will complete a pre-intervention assessment (Week 0), during intervention (Week 1-7) assessments, post-intervention assessment (Week 8) and a 1 and 3 month follow-up assessment (Week 12 & Week 20 respectively). It is expected that people who undertake LIFE FLeX will show reductions in anxiety and / or depressive symptoms at post and follow-up time points as well as increases in positive affect and emotional regulation.

A simple open trial will be used to evaluate the effectiveness of the Benzodiazepine eHealth program (BDZ eHealth) that provides psycho-education and gradual reduction information. BDZ eHealth can be accessed on multiple devices (desk top, tablet and mobile). People, who visit the website, either directly or through seeing the study advertised, will be invited to take part in the BDZ eHealth evaluation study. BDZ eHealth is designed to provide people with information and strategies to address their benzodiazepine use via five ‘core’ modules, plus an Introduction module. Each module will take approximately 20 minutes to complete. Participants will receive automated emails (e.g., on completion of a module, when to complete post/follow-up questionnaires) and will be asked several questions at the beginning of each week, to monitor their progress and activities. During the course of the study we strongly encourage participants to work with their doctor should they decide to reduce their benzodiazepine dosage as well as seek specialist benzodiazepine telephone support from Reconnexion. Participants will complete a pre-intervention assessment (Week 0), during intervention (Week 1 - 5) assessments, a post-intervention assessment (Week 6) and a 1 and 3 month follow-up assessment (Week 10 & Week 18 respectively). Participants will continue to have access to the program for the duration of the trial. Participants will be asked questions to ascertain reasons for engagement or lack of engagement with the program. It is expected that people who undertake BDZ eHealth will show reductions in their benzodiazepine dependency, anxiety and / or depressive symptoms at post and follow-up time points