ANZCTR search results

Preterm birth continues to be a major health problem throughout the world. Very preterm babies have to adapt to their new extra uterine environment to be able to survive, often with increased risks of abnormal neurodevelopmental outcomes in later life. A patent ductus arteriosus (PDA) is a frequent cardiovascular complication in this patient group, and many would receive treatment with either medication or surgical closure. However, meta-analysis of trials showed no improvement in clinical outcomes, even though PDA was reduced. It is possible that the treatment received is causing more harm than benefit or treatment is being directed at the wrong patient subgroups. A definitive trial, comparing current standard treatment (pharmacological treatment with supportive care) versus supportive care alone, is necessary to resolve doubts regarding the quality or conduct of prior studies. We hypothesise that there will be comparable outcomes between the 2 approaches, and that this data will support the start of a larger trial using neonatal and cardiology collaboration networks. The proposed study design where no open label pharmacological treatment is allowed will be able to describe the natural course of a PDA in preterm infants in the current era of perinatal care. It will allow for detailed prospective study of the PDA using conventional and novel echocardiography techniques to address the issue of which patient subgroups may benefit from treatment.

This is a clinical trial examining the effectiveness of a vitamin supplement, Hominax, in improving sperm health. We are testing whether Hominax can improve sperm health. It is possible that Hominax can help prevent damage to sperm. Men will be allocated to receive either Hominax for 24 weeks. Sperm samples will be tested to look for a difference in sperm health between the pre- and post-treatment.

This study aims to evaluate if whether using the “Deckled” incision improves post-operative scars compared to the standard straight line incision in people undergoing surgery for skin lesions. Who is it for? You may be eligible to join this study if you are aged 18 years or more and are scheduled to undergo any plastic surgery procedure involving excision of skin lesions. Study details Participants in this study will be randomly allocated (by chance) to one of two groups in an equal ratio. Participants will not be aware of the group/treatment they have been allocated to receive. For patients with multiple lesions, because each lesion is randomised, they may have both the "Deckled" incision or straight line incision performed. This study will help determine if “Deckled” incision has superior scar outcomes compared to the straight line incision approach.

Stress in the workplace is prevalent, with Australians reporting significantly lower overall workplace wellbeing in 2013 compared to previous years. Psychological injury is now the second most common cause of workplace compensation claims in Australia, and the direct cost to employers is estimated to be greater than $10 billion annual in terms of lost productivity. Thus, from an individual and public health perspective, there is an imperative to implement low risk, economically viable and effective programs to reduce workplace-stress and improve employee outcomes such as productivity, satisfaction and engagement. Mindfulness-based programs have become increasingly popular as a means of targeting enhanced wellness at work as well as combatting negative consequences of excessive workplace stress. Mindfulness involves making a commitment to being fully conscious in the present moment without judgement, in an attitude of openness and acceptance. To date, reviews report a small to moderate effect for mindfulness in reducing multiple negative dimensions of psychological distress including anxiety, depression and appraised stress, although this is not specific for the workplace setting. Further research into the benefit of mindfulness programs in reducing workplace stress and quality of productivity is warranted. This study aims to assess the effectiveness of structured, mindfulness-based program on decreasing work related stress and enhancing workplace wellbeing and engagement in fulltime university employees. Based on current available evidence, we hypothesise that mindfulness-based program participation will: 1. Improve employee work-related outcomes including workplace wellbeing and engagement 2. Reduce employee levels of stress, anxiety and improve mood

The primary purpose of this study is to systematically explore factors behind the low and uneven rates of breast reconstruction across Australia, It aims to identify practical ways to improve equity of access for women regardless of where they live, their age and ethnic/cultural backgrounds. It will produce acceptable, feasible and readily-translatable recommendations for practice and policy changes to address disparities in women’s breast reconstruction options. Who is it for? You may be eligible to participate in this study if you are a woman who has had mastectomy for breast cancer, a breast care nurse, a breast or plastic surgeon or a clinical or policy person involved in making decisions about breast reconstruction. Study details: The study will primarily involve one-off interviews, either face-to-face or by telephone, with eligible participants. It is hoped that the findings of this study will provide recommendations for practice and policy changes which improve the equity of access to breast reconstruction in Australia.

The primary purpose of this study is to evaluate the efficacy of bright light therapy for improving sleep and quality of life in children undergoing treatment for acute lymphoblastic leukaemia. Who is it for? You may be eligible to participate in this study if you are aged 3 to 9 years of age, and undergoing maintenance treatment for acute lymphoblastic leukaemia. Study details All participants enrolled in this study will be randomly allocated (by chance) to receive either bright light therapy or standard leukaemia care with no bright light therapy. Participants allocated to the bright light therapy group will be asked to wear a bright light visor for 30 minutes immediately after waking up each morning for the 84 days of the second maintenance treatment cycle. To assess sleep, fatigue, mood, and quality of life measures, researchers will use a combination of home-based assessment of sleep (actigraphy), a detailed sleep diary and questionnaires. The questionnaires will be completed by both the child and the parents at the beginning and the end of the light therapy, and six months after therapy, and will take approximately 30 minutes to complete at each time point. It is hoped that bright light therapy will provide a cost-effective method of improving sleep and quality of life for children undergoing treatment for acute lymphoblastic leukaemia who are a group at risk of development of potentially long-term sleep problems, increased psychological distress, poor treatment resilience and low quality of life.

The study aims to evaluate the sensitivity and specificity of Prostate Cancer Recurrence Sites by [68Ga]Gallium-labelled Prostate Specific Membrane Antigen Binding Ligand Positron Emission Tomography/Magnetic Resonance Imaging (PSMA PET/MRI) in Men with Biochemical Recurrence Following Definitive Therapy. Who is it for? You may be eligible to join this study if you are a male aged 18 years or above with pathologically diagnosed prostate cancer and biochemical cancer recurrence. Study details: All participants will undergo [68Ga]Gallium-labelled Prostate Specific Membrane Antigen Binding Ligand Positron Emission Tomography/Magnetic Resonance Imaging (PSMA PET/MRI). If the scans demonstrate a lesion that is amenable to biopsy or surgery, the participants will undergo CT or ultrasound guided biopsy or surgical excision as part of their clinical management. Once a sample has been obtained, the 1st sample will be used for immunohistologic analysis and the 2nd sample will be sent for in vitro culture and further analyses. If archived tissues are available, genomic comparison of primary tumour specimens and metastatic/recurrent lesions will be performed. At 6, 12, 18 and 24 months after the 68Ga-HBED-CC PET/MRI, relevant prostate cancer data will be used for further analysis. The information will include blood tests (Prostate Specific Antigen, Full Blood Count, Urea and Electrolytes, Calcium, Liver Function Tests), imaging (CT, PET, MR or Bone scan) and clinical history. The novel imaging technology may identify evidence of metastatic disease, undetected by standard of care imaging. This information could alter the treatment plan potentially. The benefits of the translational aspects of the study are that a proof of principle precision medicine program may be established to attempt in vitro assessment of a patients’ tumour in a clinically relevant timeframe and to also develop novel cell lines for basic research. This may lead in the future to a larger trial utilizing such data to guide treatment decisions in men with advanced prostate cancer.

There is evidence for a link between hypertension and gut dysbiosis, microbiotical profile and inflammation, and inflammation and cognition. We postulate Kyolic aged garlic extract to influence gut microbiota, and to restore gut dysbiosis in hypertensives. Our study will comprise a double-blind parallel randomised placebo-controlled trial of 3 months duration investigating the effect of Kyolic aged garlic extract on gut microbiota, inflammatory markers, and cognitive function in patients with high blood pressure.

The purpose of this study is to assess understanding of a clinical pathway for anxiety and depression screening and treatment in cancer patient. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and have a confirmed diagnosis of cancer. Study details Participants in this study will all receive website content (in a printed format) and a pamphlet which contain information about a clinical pathway for screening and treatment of anxiety and depression in cancer patients. Clinical pathways provide evidence-based recommendations to guide best practice and consistent care for specific patient concerns. This clinical pathway provides a pathway for screening, assessment, referral and treatment of anxiety and depression in cancer care. It was developed by a working group led by PoCoG at the University of Sydney. Focus groups and/or semi-structured interviews will then be conducted 2 weeks after participants receive the review materials. The focus groups and semi-structured interviews will collect feedback and assess participant’s understanding of clinical pathways. In this study, we will collect feedback so that we can improve the website content and pamphlet as well as determining patient understanding of a clinical pathway.

The purpose of this study is to investigate whether the Latarjet surgical procedure causes any detectable change in the strength of the biceps muscle post-operatively. If you agree to participate in the study, an appointment will be arranged for you to attend for a preoperative biceps strength test (about 15mins duration) at the University of Western Australia. This will involve taking measurements from a resistance machine similar to gym equipment which records your strength. We will also give you a short questionnaire on your shoulder function for you to complete which will take about 10-15 minutes. Your surgery and rehabilitation will not be affected. After 12 months have passed we will contact you by telephone to arrange a time for you to come in and repeat the strength test and questionnaire to see whether your biceps strength and shoulder function have changed.