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The aim of this project is to evaluate a recently developed mobile phone application (app) designed to reduce adolescent sleep problems, which are a common precursor to the onset of mental health problems. This project will investigate whether the sleep app is a feasible and acceptable tool to improve adolescent sleep, and whether there are any secondary effects on depression and anxiety. The app was developed by the research team, in collaboration with young people, who were consulted in a series of focus groups. We have used the information provided by adolescents to inform the concept and features of the app, which delivers evidence-based psychological strategies to address sleep problems, based on Cognitive Behavioural Therapy for Insomnia. The purpose of this project is to evaluate whether the app, Sleep Ninja, effectively reduces sleep problems experienced by young people with possible capacity to prevent common mental health problems such as depression and anxiety.

Participants will be admitted to the research clinical for three separate inpatient periods, each period separated by a minimum of 3 days. Participants will check in the afternoon before planned dosing and will stay inpatient for 24 hours after study medication for each inpatient period. In one period, a single dose of intravenous ketamine 10 mg will be administered and in the two other periods a single 25 mg ketamine wafer (two different formulations) will be administered under the tongue. No food or drink except water is allowed starting 10 hours before each study medication dose and for 4 hours after dosing. Water is restricted 1 hour before and after dosing.

This trial aims to assess whether treatment with duloxetine results in a reduction in chronic neuropathic symptoms experienced as a result of neurotoxic chemotherapy treatment. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and have had daily symptoms of peripheral neuropathy for at least 3 months after completing chemotherapy. Study details Participants in this study will be randomly allocated (by chance) to receive the drug duloxetine or placebo (inactive treatment) for 8 weeks. After a two week washout period, participants will switch conditions and receive placebo or study drug for another eight weeks. Those allocated to the study drug arm will be started on duloxetine 30 mg once daily, increasing to 60mg daily for weeks 2-7, and back to 30mg daily for week 8. Participants randomised to the control group will receive a daily placebo capsule to the dosage matching the treatment arm. Placebo tablets will look identical to duloxetine, and participants will not know which treatment they are receiving. All participants in the trial will receive duloxetine for 8 weeks. All participants will have liver and kidney function tests performed at baseline and at monthly intervals. Clinical examination, nerve conduction and excitability studies, functional assessment (nine-hole peg test) and self-report measures will be undertaken at baseline and after each 8 week treatment period. Patients will be asked to keep a symptom diary, which will be checked at each study visit.

This pilot study will gather preliminary data on the impact of Hippocampal Avoidance Technique for Whole Brain Radiotherapy on cognition and clinical feasibility for the treatment of brain metastases in patients with breast cancer Who is it for? You may be eligible to join this study if you are aged 18 years or above, have pathologically proven diagnosis of breast cancer stage IV disease with brain metastases which are outside of a 5 mm margin around either hippocampus Study details Whole brain radiotherapy (WBRT) is effective in providing local control of brain metastases and thereby preserving overall neurocognitive function as well as quality of life. Unfortunately, an adverse effect of WBRT is an often rapid decline in certain neurocognitive functions, particularly memory. This has been correlated with radiation induced injury thought to be crucial to memory formation. The planning of the treatment encompass the whole brain excluding the hippocampal avoidance regions, defined as the hippocampus with a 5 mm expansion. All participants will receive Whole Brain Radiotherapy using the Hippocampal Avoidance Technique of 10 radiotherapy sessions over a two-week period. The radiotherapy treatment will take approximately 5-10 minutes daily, however the total time in the department will be approximately an hour. Participants will be followed-up for up to 12 months after the completion of radiotherapy treatment in order to determine feasibility, safety, clinical benefit, survival rates and quality of life. Participants will also be asked to complete short verbal and written questionnaires to assess memory function and quality of life. These will be done before radiotherapy, on completion of radiotherapy and at follow-up appointments at 3, 6, 9 and 12 months. A CT scan and MRI scan of the head will be arranged prior to treatment, for the purpose of planning the radiotherapy. A follow-up brain MRI scan will be arranged at 3 months and 9 months after radiotherapy or when clinically indicated. This is consistent with current standard practice.

The aim of this project is to examine whether social media literacy mitigates the negative impact of social media engagement on body dissatisfaction, disordered eating and well-being. As a means to address this question, the impact of a brief, universal, class-room based social media literacy intervention for grade 7 and 8 girls and boys on these outcomes will be evaluated and the moderating effect of social media literacy examined.

This study will investigate the impact of consuming alcohol on the liking and characteristics of two different sets of savoury food snacks (newly developed food snacks, uncommon food snacks and common food snacks). Participants in this study will attend the study on two testing evenings and will be randomly allocated to a different set of snacks on each evening. Participants will drink a moderate dose of alcohol and then consume the provided snacks until they are comfortably full. They will be asked to complete questionnaires on their liking of the different snack foods including the flavour, appearance, mouth-feel and texture. Other data that will be collected from participants on each testing evening include multiple appetite and hunger ratings, blood samples collected to observe changes in biomarkers and breath alcohol concentration measurements. The results from this study will assist with the potential development of new food snacks to have when consuming alcohol for social drinkers.

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.