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BRIEF BACKGROUND SUMMARY 1. Low serum testosterone levels are common in men with advanced liver disease 2. Symptoms and signs of testosterone deficiency are common in men with advanced liver disease 3. Low testosterone levels correlate with increased mortality in men with advanced liver disease HYPOTHESES 1. Testosterone therapy is not associated with significant adverse outcome in men with advanced liver disease 2. Testosterone treatment will increase muscle mass and bone mineral density in men with advanced liver disease SPECIFIC AIMS To conduct a single centre randomised controlled trial to assess the efficacy of 12 months of testosterone therapy in men with advanced liver disease and low serum testosterone

Many people live with the distress and difficulties arising from breathlessness which continues despite treatment of the disease which is causing it. Exercise is known to be important and helpful for breathlessness, but the breathlessness itself, inevitably triggered by exertion, often puts people off persisting with this. Simple measures such as the use of a hand held battery operated fan to give cool airflow to the face can be helpful in easing breathlessness. The fan is cheap, easy to use and to carry around and something that both patient and their carer can manage, but it has never been assessed to see whether such a simple device could support people to exercise more as part of their daily routine. However, it is likely that in order to test this question, we will need a big study with several research teams who have an interest in the area working together. This study is the first step in planning such a study involving colleagues in the UK and Australia. This first stage, therefore, is to see how we should set up such a study with regard to the following: 1. Will patient participants find the study we propose acceptable and practical? 2. What are the practicalities of working together with colleagues from the UK? 3. What number of participants would we need to make the full study able to answer our research question and is it possible to recruit sufficient numbers?

The need for this research study is evident as work-related upper extremity musculoskeletal disorders have become increasingly common conditions being treated by hand therapists in recent years. It is for this reason that there is a continual need to enhance treatment methods that are in line with current evidence-based interventions used with clients. With this increase in work-related overuse injuries, there is a strong demand for both effective treatments and improved self-management strategies for these longstanding, debilitating injuries. Kinesiotape, a form of elastic therapeutic tape, was developed by Dr. Kenso Kase in the 1970’s and is a relatively new elastic therapeutic tape used for treating a variety of injuries in clinical practice. The principle behind kinesiotape is the theory that it supports injured muscles and joints and helps to relieve pain by lifting the skin and allowing improved blood and lymph flow. Despite its popularity and widespread clinical use, there is relatively little high quality evidence available to support the effectiveness of kinesiotape for injuries, let alone specific upper limb overuse injuries. Amongst rehabilitation practitioners, there is a strong need for further research into the claims of kinesiotape’s effectiveness, especially due to its recent widespread use. More rigorous higher level evidence is required so practitioners can be informed about using this treatment modality with their patients. It is anticipated that the results of this research study will enhance evidence for the use of kinesiotape in treating upper limb overuse injuries at a broader level and, more specifically, lead to the development of a clinical pathway at Toowoomba Hand Therapy for the management of lateral epicondylitis with the use of kinesiotape. Aim 1: To assess the effectiveness of elastic therapeutic tape in treating lateral epicondylitis in adults when compared to sham tape or exercise, massage and activity modification advice. Aim 2: To assess the effectiveness of the use of elastic therapeutic tape in early return to work compared to sham tape or exercise, massage and activity modification advice. Aim 3: To investigate people’s experience with using elastic therapeutic tape, adherence with treatment and the impact on their recovery, function and return to pre-injury roles. It is hypothesised that the use of elastic therapeutic tape will play a role in the short term reduction of pain for people with lateral elbow tendinosis.

This randomised pilot study measured the effects of a group Mindfulness in Pregnancy Program (MiPP) on stress, depressive symptoms, and awareness of present moment experience, compared to an active control Pregnancy Support Group.

This trial will compare the clinical performance of formofilcon B silicone hydrogel and etafilcon A hydrogel contact lenses against commercial silicone hydrogel and hydrogel contact lenses when worn for 30 days. The hypothesis is the subjective responses with test lenses are not different to the control contact lenses.

1. Hypothesis We hypothesise that red and processed meat and refined grains negatively affect insulin sensitivity or insulin secretion, compared with dairy products, legumes, nuts and whole grains. 2.Aims If a dietary pattern rich in nuts, legumes, whole grains and dairy products improves insulin sensitivity, this study will strongly support the recommendation of this diet for people with no diabetes. If a dietary pattern high in red, processed meat and refined grains affects negatively insulin sensitivity, this outcome will provide a convincing rationale in reducing the amount of intake of red, processed meat and refined grains for those with insulin resistance. This study will provide clarification on dietary influences on insulin sensitivity and contribute to lowering risks of developing type 2 diabetes by changing the dietary patterns. 3. Primary and secondary endpoints The primary endpoint of this study is to assess insulin sensitivity and the secondary endpoint is to analyse the biomarkers of insulin resistance.

Study IPX233-B14-02 will evaluate the placebo-controlled safety and the PK of repeated once-daily doses of a 4 mg dose of an ER formulation of IPX233 in healthy adults.

The purpose of this study is to investigate the feasibility of a 12 week progressive resistance training program versus usual care in overweight women with polycystic ovary syndrome. Participants will be required to attend two baseline and two follow up session for 1-2 hours at the University of Western Sydney Campbelltown for the assessment of body composition, isometric strength, menstrual cycle and psychological status. On separate days participants will also be asked to undertake fasting blood samples first thing in the morning at Douglas Hanly Moir pathology. Upon completion of baseline testing participants will be randomised to either the PRT or usual care group and will be given to participants in a sealed envelope. Participants randomised to the PRT group will be required to exercise four sessions per week, where two sessions will be supervised at the University Western Sydney Campbelltown campus while the other two sessions will be unsupervised (i.e. home based). . If you are allocated to the usual care group, you will be required to continue with your usual care management for the duration of the trial. The researcher will contact you weekly to document for any adverse events or reactions. Participants will also be required to maintain a diary to record their menstrual cycle details such as cycle length (i.e. day one of period and day one of next period), signs and symptoms etc.

The study is evaluating if a mobile phone based system can support patients to monitor their side effects, promote the delivery of evidence based self-care advice in a timely manner, and mediate the role of nurses to effectively provide real-time patient support. Who is it for? You may be eligible to join this study if you are aged over 18 years and have a diagnosis of one of three haematological cancers (Hodgkin's Lymphoma, Non-Hodgkin’s Lymphoma or Chronic Lymphocytic Leukaemia), and are receiving four or more cycles of chemotherapy treatment. Trial details Participants in this study will be randomly (by chance) divided into one of two groups. Participants in one group will be required to complete a symptoms questionnaire twice daily on a device (morning and afternoon) from Cycle 1 - Cycle 4 of their chemotherapy treatment. The intervention nurse monitors symptoms and responds if any alerts are triggered. A red alert occurs if a patient reports a symptom requiring urgent attention, and an amber alert occurs if a patient reports a symptom requiring non-urgent attention. In the case of an alert, the nurse will contact the patient by phone and query the symptom, provide self-care advice and support. The device is a mobile phone enabled Android tablet. The handset contains an application that prompts patients to complete a side-effect assessment questionnaire by following instructions on the touch screen tablet. Normal phone functions are disabled. All patients will be provided with the android tablet device and SIM card for the trial. Participants in the second study group will continue to receive usual care, which involves the regular appointments with their medical treatment team, provision of hospital contact details and education about chemotherapy prior to first cycle.

This study aims to add hormone treatment (aromatase inhibitor (letrozole)) to standard neoadjuvant chemotherapy and find out if this treatment is more effective in reducing the size of large breast cancers before surgery. More effective down-staging of large breast cancers before surgery increases the likelihood of achieving a complete surgical resection and can increase the rate of breast conserving surgery. Who is it for? You may be eligible for this study if you have ER-positive, HER2-negative invasive breast cancer that is > 20 mm in size, and is suitable for neoadjuvant chemotherapy with the aim to have surgery - either breast conservation surgery or mastectomy. Trial Details Participants will be planned for 18-24 weeks (or 6 to 8 three-weekly cycles) of chemotherapy before surgery (mastectomy or breast conserving surgery). Participants will be randomised at a ratio of 2:1 to either standard chemotherapy plus letrozole (before surgery) or to standard chemotherapy alone (before surgery). The participants randomised to standard chemotherapy plus letrozole treatment will take a letrozole tablet once per day at the same time they are having their chemotherapy treatment. Participants who are pre- or perimenopausal will also have a goserelin implant inserted under their skin to stop their ovaries producing oestrogen. All participants will have pre-treatment bilateral mammogram, ipsilateral breast and axillary ultrasound, research core biopsies and marking of the tumour, MRI of the breast and serial research blood tests. Additional research core biopsies will be taken prior to the 3rd chemotherapy cycle (between week 6 and week 7 if receiving weekly chemotherapy). Participants will be clinically assessed prior to each chemotherapy cycle or once every 3 weeks if receiving weekly chemotherapy. A post-treatment breast MRI will be done prior to surgery. Research biopsies of the breast tumour are required from the tumour at surgery. The effectiveness of adding the hormone treatment (letrozole) will be assessed by the size of the tumour at surgery. There will be one post-surgery follow-up visit.