ANZCTR search results

This study will be conducted as an adaptive design, randomized, parallel group study to evaluate the pharmacokinetics (PK) and safety of single IV doses of RYI-018 in healthy volunteers and repeat IV doses of RYI-018 in subjects with NAFLD. Part A of the study will be conducted as a double-blind, placebo controlled, randomized, single ascending dose study to determine the safety, tolerability, and PK of RYI-018 in healthy volunteers. During Part B of the study, subjects in each cohort shall be randomized to either RYI-018 or placebo. Three (3) cohorts which will include 20 subjects per cohort with 15 subjects randomized to receive active drug administered at weekly intervals and 5 subjects randomized to receive placebo in each cohort at weekly intervals, per the randomization plan. The primary objective of Part A of the study will be to assess the safety and tolerability of single IV ascending doses of RYI-018 when administered to healthy adult volunteers The primary objective of Part B of the study is to evaluate the safety and tolerability of multiple doses of RYI-018 after 4 weeks of dosing in subjects with NAFLD.

The aim of this pilot study is to compare loop electrosurgical excision procedure to cold knife cone biopsy for treatment of adenocarcinoma in situ. Who is it for? You may be eligible to join this study if you are a woman aged between 18 and 45 years old and have been diagnosed with adenocarcinoma in situ (AIS) with lesions amenable to single pass excision. Study details AIS most frequently occurs in young women (less than 45 years of age) who may wish to preserve their fertility. If this is the case, there are two treatment options available: cold knife cone (CKC) biopsy or loop electrosurgical excisional procedure (LEEP). In Australia, CKC is regarded as the 'gold standard' treatment for AIS. However, to date most AIS studies have been limited by small patient numbers and short follow-up periods. Further evidence is required to confirm if CKC is the superior treatment type for managing AIS. Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will have their lesions removed using LEEP, whilst participants in the other group will have their lesions removed using CKC. Following treatment, all participants will undergo the 'Test of Cure' management pathway which includes follow-up examinations at 6 and 12 months post-treatment. Assessments for early complications and patient satisfaction will occur 6 weeks post-treatment. We are hoping to perform a pilot research study to confirm the safety and feasibility of conducting a much larger clinical trial which would be the first to compare CKC and LEEP in this way. Study findings could potentially improve patients' experiences and alter treatment guidelines since potential advantages of LEEP include the avoidance of general anaesthesia, provision of treatment in an outpatient setting, lower morbidity and reduced rates of obstetric complications.

The primary purpose of this trial is to evaluate the efficacy of a behavioural intervention using Fitbit devices in increasing physical activity levels in gynaecological and colorectal cancer survivors at risk of cardiovascular disease. Who is it for? You may be eligible to enroll in this trial if you are aged 18 to 80 years, completed active cancer treatment for a gynaecological or colorectal cancer within the last 5 years, are currently in remission, and you are undergoing follow-up care at St. John of God Subiaco Hospital, WOMEN Centre in West Leederville or Hollywood Private Hospital in Nedlands, Western Australia. Study details All participants enrolled in this trial will be randomly allocated (by chance) to receive either the Fitbit behavioural intervention or standard care. Participants in the Fitbit behavioural intervention group will receive a Fitbit physical activity tracker device to be used to monitor activity during waking hours for 24 weeks. These participants will also receive two group information sessions in weeks 1 and 4, providing information on how to use the Fitbit and on setting and meeting physical activity goals. Participants in the standard care group will receive printed information relating to physical activity guidelines, but no Fitbit device or group sessions. After 24 weeks, they will be offered the option to try the Fitbit device for 6 weeks. Researchers will monitor physical activity levels over the 24 week intervention period, take height and weight measurements, and participants will be asked to complete questionnaires relating to their quality of life and levels of physical activity. It is hoped that the findings from this trial will evaluate whether this Fitbit behavioural intervention is feasible and effective for increasing physical activity levels in gynaecological and colorectal cancer survivors.

A laparoscopic sarcocolpopexy is an operation to treat recurrent vault prolpase in women with pelvic organ prolapse. It is a technically difficult operation to perform and is reported to have a long learning curve. (Claerhout F, Roovers JP, Lewi P, Verguts J, De Ridder D, Deprest J (2009) Implementation of laparoscopic sacrocolpopexy—a single centre’s experience. Int Urogynecol J Pelvic Floor Dysfunct 20(9):1119–1125.) We designed a prospective study aimed at mapping the learning curve of laparoscopic sacrocolpopexy in the setting of a structured learning programme for a urogynaecology fellow at the Royal Brisbane and Women’s Hospital (RBWH). The fellow had basic laparoscopic skills at the commencement of her fellow position and was required to assist in twenty laparoscopic sacrocolpopexies, video-edit two procedures and undertake laparoscopic suturing and knot tying training on a laparoscopic trainer for two hours per week for four weeks. After the completion of this structured learning programme, the fellow will begin performing LSC as the primary surgeon. A group of four experts involved in the training and teaching of LSC agreed that an adequate level of skill would be attained after performance of five consecutive laparoscopic sacrocolpopexies without intra-operative complications (visceral injury, conversion to laparotomy or vaginal surgery, estimated blood loss over 500mls) or Clavien-Dindo grade III-IV post-operative complications and with an operative time of under 90 minutes. Time taken to perform the operation was measured from peritoneal incision trocar placement until the peritoneum was closed over the mesh.

Following successful use in tobacco control, health warnings on food products and at point-of-sale have been proposed as a potential obesity prevention measure. This study aims to investigate the efficacy of food product health warnings for promoting healthy dietary decision making. Additionally, the study aims to investigate the degree to which two key health warning design factors (text-based health warnings versus text-and-graphic health warnings; health warnings featuring positively versus negatively framed messages) influence health warning efficacy. Ninety-six participants will be recruited to complete a mixed design dietary self-control experiment conducted as a single session. The experiment features four stages; the rating stage, the unprimed decision stage, the priming stage, and the primed decision stage. In the first stage, participants will be shown a selection of 100 common Australian snack foods (including chocolate, chips, cookies, fruit, nuts and vegetables) and asked to provide subjective health and taste ratings for each food item. In the unprimed (baseline) decision stage, participants will be shown half of the food items they rated in the first stage and asked to indicate which of these items they would like to eat at the end of the experiment. Prior to the priming stage, participants will be randomly allocated to one of five health warning format conditions; text-based, negative framing (n = 16); graphic, negative framing (n = 16); text, positive framing (n = 16); graphic, positive framing (n = 16); control group (n = 32). During the priming stage, participants will be exposed to health warnings of their allocated format only. In the primed decision stage participants will be shown the remaining half of the snack food items and again asked to indicate which foods they would like to consume at the end of the experiment. A measure of dietary self-control will be calculated based on the proportion of healthy but not tasty items chosen for consumption and the number of unhealthy yet tasty items rejected. Participants will be granted one of their chosen items to eat and will be asked to complete demographic and dietary behaviour questionnaires at the end of the experiment.

“Periodontal diseases are chronic, microbially induced inflammatory disorders that affect the structures that support teeth” (Philstrom et al 2005) The treatment has traditionally been the thorough mechanical removal of the microbial environment; the biofilm. The aim of this study is to examine the clinical and microbial outcomes by the supplementary use of air polishing with erythritol powder.

Prosthetic joint infection is a common and expensive problem. Over 100,000 elective joint replacements are performed in Australia each year and this number is growing. Approximately 2% of these will become infected. Prosthetic Joint Infections are a devastating complication of joint replacement, as they are difficult to cure, and treatment generally involves multiple operations and prolonged courses of antibiotics. There is a lack of high quality evidence to inform us of the management of Prosthetic Joint Infections. Acute Prosthetic Joint Infection is most commonly managed with open debridement of the prosthesis, followed by a period of antibiotics, aiming for cure. Despite the overall burden to the health sector and variable outcomes for individuals there is a lack of high quality evidence to inform the management of these infections.The correct duration of intravenous antibiotics is unknown. Following surgical debridement, patients are treated for a variable period with intravenous antibiotics, followed in most cases by a course of oral antibiotics (ranging from none at all to over 12 months, depending on the institution and situation). However, there is a lack of evidence to guide decisions about choice and duration of antibiotic regimens. This uncertainty is reflected in international guidelines: the Infectious Diseases Society of America guidelines recommend “from 2 to 6 weeks” of IV antibiotics (with no guidance or evidence about how to choose this duration). The Musculoskeletal Infection Society guidelines also recommends between 2 and 6 weeks. Both guidelines also recommend 3 to 6 months of oral antibiotic therapy, In adults with acute prosthetic hip or knee joint infection treated with debridement and implant retention is 2 weeks of intravenous antibiotics superior to 6 weeks (with both arms receiving 10 to 12 weeks of oral antibiotic therapy), in terms of an ordinal outcome including clinical cure 12 months after randomisation and antibiotic-related adverse events.

Lateral epicondylalgia (tendinopathy of the wrist extensors at the lateral epicondyle) is a common condition seen in middle aged people, and despite this, best management is poorly understood. Isometric exercises have been shown as effective in treating tendinopathies in the lower limb, however no-one has investigated the impact of different exercise protocols on immediate pain in the upper limb, and thus for lateral epicondylalgia. A two part cross-over study will examine whether different isometric protocols have better results on pain in this condition, and whether the superior isometric exercise is better than isotonic exercise for immediate impact on lateral epicondylalgia.

The primary purpose of this pilot trial is to evaluate whether a full-scale clinical trial for gastrografin is feasible, and to provide an initial estimate of the efficacy of gastrografin for the resolution of malignant bowel obstruction (MBO). Who is it for? You may be eligible to participate in this trial if you are aged 18 or over and have been diagnosed with MBO. Study details All participants enrolled in this pilot trial will receive the same treatment. This involves a single oral dose of gastrografin administered as a 100ml solution. Participants will then be followed up for 5 days to assess whether the treatment has reached the bowel, whether it has been effective in clearing the obstruction and any side effects which may have occurred. It is hoped that the findings from this trial can be used to inform future clinical trials on the use of gastrografin in palliative care.

This study aims to determine whether insulin pump therapy can prevent nerve injury in patients with type 1 diabetes Who is it for? You can join this study if you have type 1 diabetes, aged 18-45 years and have not received insulin pump therapy before Trial details In this study, participants are randomly (by chance) divided into two groups. One group will receive an insulin pump free of charge for a period of 2 years. The other group will receive standard insulin injection therapy. Participants will undergo non-invasive nerve and eye tests to determine their suitability for the trial and when enrolled, will undergo these follow-up assessments at 6, 12, 18 and 24 months, coinciding with their usual endocrinology appointments. Both groups will receive continuous glucose monitoring at the beginning and end of the trial to determine the effect of glucose variability on nerve function. Participants will also undergo assessments of their quality of life specific to any nerve damage they may have.