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This is a substudy of the Cancer Molecular Screening and Therapeutics (MoST) Program, which is registered on ANZCTR with ID ACTRN12616000908437. This substudy will evaluate the activity of trastuzumab emtansine (T-DM1) in patients with advanced tumours with HER2 amplification or mutations. Who is it for? You may be eligible to join the study if you are aged 18 years and older with either; a. advanced and/or metastatic solid tumour of any cell type that is no longer responding to treatment or unsuitable for standard therapies for that cancer type, or b. metastatic, non-squamous, non-small cell lung cancer (NSCLC) Participants will have tumours with HER2 alterations Study details Participants will continue to receive T-DM1 intravenously at a dose of 3.6 mg/kg every 21 days continuously as long as they and their doctor agree there is a benefit from treatment. Participants will undergo imaging assessments at 9 weekly intervals or as clinically indicated in order to evaluate tumour response. Safety and tolerability of treatment and health related quality of life during treatment will be assessed at 3 weekly intervals. We cannot guarantee that patients will receive any benefits from this study. This study is being carried out to improve the way we treat cancer patients who may have limited treatment options available to them. It is hoped that T-DM1 will be well tolerated and will improve outcomes for future patients, however, there may be no clear benefit from participation in this study.

The purpose of this study is to determine the clinical utility of therapy based on the result of a PET-scan for patients with follicular lymphoma. Who is it for? You may be eligible for this study if you are aged over 18 and have a documented diagnosis of follicular lymphoma What it involves Participants in this study will be divided into groups (PET-ve and PET +ve) based on their PET-scan. PET +ve patients will be randomised (by chance) into two groups. One group (called Arm A) will have the drug Rituximab through a needle in the arm every 8 weeks for up to 22 months. The other PET +ve group (called Arm B) will also have Rituximab, but will also receive a drug called Lenalidomide by orally every month for up to 24 months. PET –ve patients will also be randomised (by chance) into two groups. One group (called Arm A) will have the drug Rituximab through a needle in the arm every 8 weeks for up to 22 months. The other PET –ve group (called Arm B) will receive no treatment. All participants in all groups and arms will be monitored for disease progression by physical examination and PET scans throughout their time in the study. It is hoped this study will demonstrate effectiveness of Lenalidomide in converting PET positive patients to PET negative patients. It is also hoped this research will show no treatment to be as effective as the current maintenance treatment (Rituximab) in PET negative patients.

Functional dyspepsia affects 1 in 6 Australians with currently no cure for this condition. This study aims to test the effects of antibiotic therapy on gastrointestinal symptoms, meal related quality of life (QoL), anxiety and depression and the symptom response to a standardised nutrient challenge (active therapy is superior to placebo) in up to 100 patients with functional dyspepsia with and without non constipation irritable bowel syndrome (IBS) attending the Department of Gastroenterology at the Princess Alexandra Hospital. By defining the effects of interventions targeting the gastrointestinal microbiota with regard to symptoms and gut function, we will pave the path for a paradigm shift regarding both treatment and overall understanding of the pathophysiology of functional dyspepsia. This will change how patients with functional dyspepsia are treated, enabling for the first time, targeting of the underlying causes of functional dyspepsia, which may ultimately cure this condition.

Following acute blunt cervical injury, there is ongoing debate regarding the reliability of Computed Tomography (CT) and plain radiographs versus the need for Magnetic Resonance Imaging (MRI). The objectives of this study was to determine the incidence of new findings found on MRI following normal CT or plain radiographs in patients with persistent cervical tenderness, focal neurology or in patients who are clinically unevaluable; and to assess if the management was altered following MRI results.

Title: Malignant Hyperthermia - A new simple diagnostic test Malignant Hyperthermia is a life threatening uncommon complication associated with having an anaesthetic. It may be passed down through families from one generation to the next. Many people at risk of Malignant Hyperthermia may be confirmed by a simple genetic test. However all other patients require a sample of muscle (muscle biopsy) taken from the leg, to have special functional testing to confirm they are at risk of Malignant Hyperthermia – the in-vitro contracture test (IVCT). The muscle biopsy is taken from the leg, requiring a surgical operation and a general anaesthetic that is known to be safe with MH. Technical advancements have enabled the design of a new test on a very small component of the muscle obtained from a minor needle biopsy, under local anaesthetic. Through this project we will show this simple less invasive technique is a reliable test to determine a patient’s potential risk of malignant hyperthermia. On the east coast of Australia, we have two Malignant Hyperthermia testing units. The Malignant Hyperthermia Units at The Royal Melbourne Hospital (RMH), Victoria and The Children’s Hospital, Westmead, NSW have been established for more than 15 years, and offer assessment of malignant hyperthermia risk through consultation, the muscle biopsy test and genetic analysis. The Muscle Research Laboratory, The University of Queensland, has extensive experience and understanding of skeletal muscle functioning. We will combine the excellence of all departments to improve our understanding of malignant hyperthermia and develop this simple, cheaper less invasive testing for malignant hyperthermia risk. This study will have implications for providing a clear diagnosis for patients at risk of malignant hyperthermia, while being significantly less invasive than the current muscle biopsy test. A simple investigation acceptable to the general population will increase the number of patients agreeing to define their risk of malignant hyperthermia and thus contribute to safer anaesthesia for our community.

This study will investigate the potential link between a patients foot type and the impact of anti-pronatory interventions. The patients foot type will be defined as the level of pronation (how much the foot rolls in) based on the Foot Posture Index (FPI-6). The anti-pronatory interventions (measures used to stop the foot rolling in) will include a standard strapping technique using rigid sports tape and orthotic devices (inserts for shoes). Participants will be those aged over the age of 18 attending the Charles Sturt University podiatry service for treatment or foot pain or pathology, who are provided with an anti-pronatory intervention. Data collection will focus on the FPI-6, supination resistance test, lunge test, and 3D motion analysis. It is expected that different foot types will influence the biomechanical response to the intervention, however, this study will investigate the magnitude of those responses.

The Group Emotional and Relationship Skills (GEARS) program is a culturally informed, fully manualized and skills-based group program consisting of 12 x 120-minute sessions. There are six sessions on emotional regulation, and six sessions on interpersonal relationships. Common themes of the program are how chronic stress and trauma impact the culturally specific Service concepts of self and identity, and adversely affect emotional regulation and relationships, therefore adversely impacting mental health and functioning. The purpose of the 12-week program is to improve psychological functioning in day-to-day life, to provide participants with mental health psychoeducation about chronic stress and trauma and its effects on mental health, and an improved level of emotional stability and functional skills in managing themselves and their relationships. In real terms, this means a capacity to either engage or continue in further treatment (if/as required), and to continue their lives with a range of skill sets that will improve their capacity to tolerate distress, build resilience, and maintain their interpersonal relationships. As per the International Society for Traumatic Stress Studies (ISTSS) guidelines, this is a phase 1, generalised intervention that provides both stabilisation and skills building. It is not a treatment program as it specifically avoids addressing individual trauma. Stabilization therapies are associated with moderate to large effect sizes for PTSD, emotion regulation and social/interpersonal outcomes, and are more effective when combined with skills development. GEARS meets all these criteria and will be delivered by accredited peer facilitators and peer- and non-peer mental health clinicians in order to evaluate whether a skills based and manualised program delivered by counsellors is as effective as when delivered by more highly qualified non-peer mental health clinicians, Peers are considered to be those who have lived experience in Military, Police or first responder organisations, and have been targeted in order to utilise the benefits of having facilitators who have lived experience and therefore the appropriate cultural knowledge to relate to participants, and serve as role models for healthy functioning. The study outcomes will be the primary factors of psychological health (as measured by a composite of screening tools for common mental health conditions); emotional regulation, (as measured by two emotional regulation scales); and functioning, (as measured by disability, quality of life, and resilience scales). Secondary outcomes are suicidal ideation, physical health, and psycho-social factors, which are again measured by a composite of different scales.

This feasibility, randomised, open-label, parallel group study is to evaluate the safety and efficacy of TBB in reducing sacroiliac joint pain, lumbar spine pain, and symphysis pubic pain associated with third trimester pregnancy. 90 eligible participants will be randomised into either Group A, where they will use The Belly Bed, an advanced maternity airbed, until delivery; or Group B, where they will use their own bed until delivery. Participants will be asked to complete surveys, including the Visual Analog Scale (VAS) to determine whether TBB helped reduce pain.

The current study aims to investigate the efficacy and acceptability of a collaborative autism-specific Positive Behaviour Support service delivered to regional, rural and remote clients via video-conferencing technology.

The primary objective of this study is to determine, in people with COPD, if a mobile pulmonary rehabilitation (m-PR) program is equivalent to face-to-face pulmonary rehabilitation in terms of improvements in exercise capacity (six minute walk test) and health status (COPD Assessment Test [CAT]). Participants will be randomly allocated into an m-PR group (intervention, n=50) or face-to-face pulmonary rehabilitation group (control, n=50) in a 1:1 ratio favouring the m-PR group. The research trial will involve sites in NSW across the Northern Sydney Local Health District.