ANZCTR search results

The purpose of the study is to determine whether intermittent energy restriction is as effective as continuous energy restriction in achieving weight loss in people with type 2 diabetes

The etiology of mental ill-health is commonly complex and can often involve not one but a chain of genetic, environmental, social and psychological risk factors. Understanding these risk factors is essential to being able to identify children at risk of developing future mental health difficulties, planning appropriate timing of an intervention and ascertaining necessary treatment components for any intervention. Risk factors may be individual, familial and environmental characteristics that increase the likelihood of adverse developmental outcomes. Although no single risk factor is either necessary or sufficient in the development of a specific disorder, the commonly indicated risk factors in young children are parental psychopathology, temperament and prior symptomology. Parental psychopathology is commonly accepted as a risk factor for both genetic and environmental pathways towards childhood mental health problems. Family aggregation studies of both the offspring of clinically diagnosed parents and parents of children with mental health difficulties have demonstrated the heritability of mental disorders Connell and Goodman’s meta-analytic review investigated the associations between parental psychopathology and internalizing and externalizing disorders in their children. Based on the 230 articles identified on parental mental health concerns and childhood internalizing difficulties, the authors found that both maternal and paternal psychopathology significantly predicted childhood symptomology. It should be noted, however, that weighted mean effect sizes in this study were small. Additionally, it was found that effects were moderated by child factors, including age and gender, as well as type of parental diagnosis. These findings suggest that the relationship between parental psychopathology and child psychopathology is not a simple direct linear association. Rather, the interaction of parental influences and child influences is more likely to determine future symptomology. Despite an exponential increase in resilience research for children, there is currently a lack of evidence exploring how adult resilience affects the development of childhood resilience. As the link between vulnerability factors, protective factors and wellbeing in psychopathological pathways is unclear, it cannot be assumed that the heritability and modeling of psychopathology between parent and child directly indicates a similar link relationship for parent and child resilience. As such, this study will to explore both the relationship between parent-child resilience and symptomology and how resilience enhancement in parents affects children’s resilience and symptomology intervention outcomes.

This study will determine the effect of the use of circulating tumour DNA (ctDNA) to guide adjuvant chemotherapy on recurrence-free survival in stage II colon or rectal cancer patients Who is it for? You may be eligible to join this study if you are aged 18 years or above, and have been diagnosed with Stage II colon or rectal cancer and have had your cancer curatively resected. Study details Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will have blood samples taken and analysed for circulating tumour DNA (ctDNA) and be treated according to the ctDNA results. Those with positive ctDNA results will receive standard 5FU-based adjuvant chemotherapy (either single agent or combined with oxaliplatin), while those with negative ctDNA will not receive adjuvant chemotherapy. Participants in the other group will have a blood sample taken, but the ctDNA result will not be disclosed. Patients in this group will be treated according to standard clinical criteria at the discretion of the treating physician. Participants who had positive ctDNA results and are being treated with adjuvant chemotherapy will have monthly blood samples taken during treatment to track ctDNA levels. All participants will be followed up 3 monthly for 2 years, then 6 monthly for 3 years through their hospital for a total of five years for disease recurrence and survival.

Before birth, while a baby is in the mother’s womb, the baby’s lungs are filled with fluid and the baby gets oxygen from the placenta. Once the baby is born, the baby needs to transition to using the lungs to get oxygen. In the hours after birth, the baby’s body will reabsorb the lung fluid and the lungs will fill with air. The purpose of this study is to describe the normal filling of a newborn baby’s lungs with air over the first few hours of life using an ultrasound machine. We believe that with the knowledge gained in this study, we can improve our care for babies that need help breathing at birth. The lung ultrasound exams will be brief, limited to 2 minutes or less from the time of placing the ultrasound probe gently to your baby’s chest. The first two exams will be during the first 20 minutes after your baby is born and will be repeated when your baby is 1 hour old, 2 hours old, 4 to 6 hours old and 24 to 72 hours old. At 1 hour of life, the lung ultrasound exam will be slightly longer as we take images of the front, back and side of your baby’s chest to test if a specific location to place the probe is better than another.

A functioning intact anterior cruciate ligament (ACL) is important as it stabilizes movement of the tibia in relation to the femur, providing the stability required to participate in sporting activities. It is often injured leading to rupture resulting in knee instability and primary repair of the ligament is usually unsuccessful. Surgeons have be reconstructing the ACL since 1930 and technique has been continuously refined. Even after surgical reconstruction, a small percentage of patients continue to experience knee instability, especially rotatory instability. Recently a scientific paper identified an additional ligament called the anterolateral ligament (ALL). The ALL has been bio-mechanically examined and plays an important role in stabilizing the knee in the rotational axis. Patients will be invited to participate in the study if they are undergoing ACL reconstruction surgery. Prior to the surgery commencing, after they have had a general anesthetic, they will have their pivot shift assessed on the operating table. If the pivot shift is grade 3 (as described by Macintosh - tibia persistently subluxing anteriorly on the femur even with external rotation) then they will be randomised to ACL only or ACL and ALL reconstruction. In this study patients will undergo standard arthroscopic ACL reconstruction using a hamstring graft and be randomized to have their ALL reconstructed using a hamstring graft. The group that the patients are allocated to will be concealed from them, the additional ALL reconstruction requires only one, very small additional incision. Those not undergoing ALL reconstruction will not undergo any form of sham ALL reconstruction. The patients knee function will be assessed pre-operatively and post-operatively, using subjective patient reported scores and objectively assessed using range of motion. They will be followed up at two weeks, six weeks, three months, six months and 12 months. A secondary objective of the study will be correlating the findings of the Antero-lateral ligament on MRI with the pivot shift findings under anesthetic.

Patients with advanced chronic liver disease often become critically ill for many reasons including serious infections. When this occurs, their blood pressure may fall to dangerous levels and they may require admission to the Intensive Care Unit for treatment with intravenous fluids and infusions of drugs to support their circulation. The ideal amount of fluid to give to these patients is currently unknown and doctors currently choose what they believe is the best amount based on limited evidence. Some doctors prefer to give a lot of fluid and some prefer to give less, but it is unclear which strategy works best to help the patient and avoid complications. This study will try to work out the which of these two currently used treatment strategies is better for patients.

The aim of the pilot study is to establish whether low dose Atomoxetine can be clinically effective in reducing stress/anxiety, have a favourable effects on cardiovascular risk, by not increasing and possibly reducing weight, along with blood pressure, blood cholesterol and glucose. The plan is to recruit 20 clinically stable patients for a 4 week "run-in" to establish a clear baseline, then prescribe Atomoxetine for 8 weeks. In consenting patients a further 6 weeks of double blind placebo v active will follow. All participants will be evaluated with a full history and physical examination.

This is a study designed to determine intra-participant repeatability and diurnal variation of various eye reflexes using a Neuro-Ophthalmic Device (NODe). The NODe is a pre-release, prototype table top imaging device that consists of visual stimulus presentations through a standard tablet (iPAD like) and imaging hardware mounted inside of an enclosure which includes a nose-bridge and a chin-rest for patient alignment. The device intends to test neuro -pathology such as mild traumatic brain injury (mTBI or concussion) by assessing eye movements and pupil reactions in response to different visual stimuli presented on the tablet screen. The aim of this investigation is to determine the repeatability of this device in healthy participants with no previous history of concussion and diurnal variation of eye movements and pupil reaction. The study will be conducted in two phases with each phase including 10 participants. The initial visit will include the participant performing the NODe tests repeatedly for 10 times, while the remaining 6 visits (2 visits per day) will test diurnal variation and will run NODe set of tests once in each visit. The initial visit may take up to 2 hours, while the remaining 6 visits will take up to 15 minutes each to complete. The instrument has not yet been released commercially, but does not contain any components that could potentially cause eye or other injury.

The purpose of this project is to investigate whether a soluble fibre supplement alone or in combination with a probiotic is able to reduce inflammation in adults with asthma. Once ingested orally, soluble fibre- a normal component of the diet- acts as a prebiotic and is digested by healthy gut bacteria to produce short chain fatty acids (SCFAs). These SCFAs may be beneficial in reducing airway inflammation in asthma. Supplementing with healthy bacteria using a probiotic may also increase the production of SCFAs. The project involves a nine week intervention where 20 subjects with stable asthma will be allocated to take the prebiotic alone, prebiotic with probiotic and placebo supplements for 7 days each, in random order, with a two week washout period between each supplement phase. Subjects will not know which supplement they are receiving throughout the study.

This is a pilot, single blinded randomised controlled trial assessing whether a treat-to-target TRAb approach with anti-thyroid drugs (carbimazole) results in lower risk of relapse of hyperthyroidism after treatment cessation in Graves' disease patients, compared with standard fixed length care. In addition, this trial will provide estimates of changes in quality of life, health care utilisation, and assess feasibility of recruitment. It will provide data for a sample size calculation for a properly powered randomised controlled trial.