ANZCTR search results

The purpose of this study is to conduct preliminary studies of a new version of an existing medication (called Herceptin) in healthy males. Who is this study for? You may be eligible for this study if you are a male aged 18 to 55 and you are in good health with no existing conditions. Study details: Participants in this study will be randomised (by chance) into three groups. All participants will receive a single dose of breast cancer medication infused through a needle in the arm. over a period of 90 minutes. The medication will be the same, but each group will receive a different version – EU-licensed, US-licensed and a new version. Neither participants nor those giving the medication will know which is being administered. As part of this study, participants will provide blood samples and answer questions about their general health. It is hoped this research will provide evidence the new version of the medication is equivalent to the existing licensed versions.

The purpose of this study is to test the clinical- and cost- effectiveness of a stepped care psychological interventions compared to treatment as usual for ageing adults with anxiety and depression within existing services representing public (urban, regional) and private mental health organisations. Evidence-based treatments are more likely to be incorporated within public services when they can demonstrate maximum cost-effectiveness. The results of this study will inform the translation of evidence-based stepped care models of psychological interventions for anxiety and depression in older adults into the Australian mental health system.

Over a third (36%) of patients on dialysis at Northern Health (NH) are obese and are often advised to achieve a weight of < 100kg or BMI<30kg/m2 before being waitlisted for kidney transplantation. Low calorie diets aim for low daily energy consumption and evidence supports they can achieve significant weight loss results. However, there is limited evidence on whether the use of low calorie diets in dialysis patients is safe. The aim of this research is to undertake a quasi-experimental study to determine if using a low calorie diet incorporating Optifast meal replacement products is a safe method of weight loss for dialysis patients with obesity who need to lose weight for kidney transplantation eligibility. Participants will be prescribed a low calorie diet for 12 weeks and monitored closely by the multidisciplinary renal team to ensure patient safety.

This is an open-label single-center study, to assess the safety, tolerability and efficacy of cannabidiol administered as ZYN002, a transdermal gel, for the treatment of child and adolescent patients with Autism Spectrum Disorder (ASD). Male and female patients with ASD will be treated for 14 weeks. Patients taking Anti Epileptic Drug medications will have an additional one or two week Taper Period after the completion of doing with ZYN002. Approximately 36 male and female patients, ages 4 to < 18 years, will receive ZYN002

The purpose of this study is to implement an online database which has the ability to easily collecting clinical data from patient sand orthopaedic surgeons. Participating clinics have been selected from Orthopaedic clinics that are located in a variety of hospitals in the SVHA group. This proves different environments to test the implementation. The aim is to ensure that the database is embedded into the clinic workflow to ensure that there burden required by patients and orthopaedic surgeons is low, which will encourage long term use. At conclusion of this study all sites will have an online data collection tool capable of reporting on patient suitability for TKR and their outcomes of the patients to surgeons due to the step-wedge trail design.

This study aims to generate new knowledge on the feasibility and effectiveness of pre-operative exercise training (‘prehabilitation’) to induce clinically relevant improvements in physical fitness (cardiopulmonary function) in patients with prostate, colorectal or breast cancer undergoing surgery in the Grampians region of Victoria. Who is it for? You may be eligible to join this study if you are aged 18 years or more, are scheduled for prostate, colorectal or breast cancer surgery, and are able to partake in exercise training. Study details Participants in this study will be randomly allocated (by chance) into one of two groups. Participants in one group will continue to receive usual care. Participants in the other group will undertake a supervised exercise training session once every three days (estimated four weeks) up to 3-5 days before surgery. Sessions will involve aerobic training on apparatus such as treadmill, stationary bicycle and cross-trainer for 45-60 minutes. All participants will undertake physical assessments at enrolment, post- exercise intervention completion (approximately 48 hrs pre-surgery), and at 30 days following surgery. They will also be required to complete questionnaires to measure quality of life and physical and emotional well-being. Given that the body of physical activity research in cancer prevention, management and therapy has focused almost entirely on post-operative exercise regimens, we are hoping to address this gap in the literature in regards to pre-operative exercise and provide a pathway to fixed pre-operative exercise model for future use in the Grampians region of Victoria

This study is aiming to examine the minimum dose of solar exposure required to cause cellular damage and induction of repair pathways. Who is it for? You may be eligible for this study if you are aged 18 years of age or older with skin type 1-3 fair skin. Study details Participants will receive graded sub-erythemal UV doses on their back equal to sunlight in Brisbane during summer at 7 am for 15, 30 and 40 minutes and skin biopsies will be collected 24 hours post UV exposure to analyse the level of cellular damage. A control site will also be biopsied to examine non-exposed UV skin. It is hoped this research will help to assess the current UV exposure guidelines and whether the suggested dose limit is safe or not.

Pressure injuries, also known as pressure ulcers, pressure sores or bedsores, are a usually preventable adverse outcome of hospitalisation. Pressure injuries may cause a patient pain or increase their hospital length of stay, and in severe cases may lead to death. Some pressure injuries are related to the use of medical devices, such as the nasal bridge when a non-invasive ventilation (NIV) mask is in place. These pressure injury may be prevented by a protective dressing applied over the nasal bridge. The aim of this study is to compare two dressings used over the nasal bridge for patients undergoing NIV therapy for pressure injury prevention. Patients initiated on NIV therapy within an Australian tertiary hospital who are recruited will be randomly allocated to have one of the dressings applied to their nasal bridge under the NIV mask. Until NIV therapy is ceased, or for up to 7 days, research and ward nurses will monitor the patient for pressure injury and collect information (e.g. information about pressure injury risk and prevention, NIV usage, nurse and patient satisfaction with the dressing). There is currently minimal research and no guidelines on which to base the decision of which dressing to use to prevent pressure injury when a patient is receiving acute NIV. The results of this study will provide information to assist in evaluating these dressings for future use in pressure injury prevention in NIV intervention. The results may present a way of selecting the most appropriate dressing for standard use or for meeting certain patient criteria.

The purpose of this study is to examine the colonisation potential of an existing probiotic in normal human tissue and cancerous tissue. Who is it for? You may be eligible for this study if you are aged 18 years or older, and are undergoing endoscopy for pre-cancer or cancerous bowel tissue or surgical resection at the Royal Adelaide Hospital or St Andrew's Hospital. Study details Participants will be randomly sorted into two groups according to chance. Each group will take two tablets per day for 14 to 28 days prior to surgery. In one group, the tablets will be probiotic bacteria, and in the other group the tablets will be sugar tablets – however participants will not know which tablets they are taking. The length of time from enrolment in the study until surgery will determine whether participants take tablets for 14 or 28 days. Participants will consent to their surgical samples being tested and a small blood sample sample (9 ml, equivalent to 2 teaspoons) being taken. It is hoped this research will provide information about where probiotics colonise the patient, so novel probiotic-based therapies can be developed.

The purpose of this study is to determine the effectiveness of a ‘wait and watch’ strategy in patients with rectal cancer who have completed chemoradiotherapy. Who is it for? You may be eligible for this study if you are an adult who has been diagnosed with advanced rectal cancer and will be undergoing chemoradiotherapy. Study details After chemoradiotherapy you will be reviewed for any evidence of cancer, through physical exams, imaging and sigmoidoscopy. If there is evidence of cancer you will have surgery to remove this cancer. If there is no evidence of cancer you will not have surgery but instead be followed up at set time points over 5 years, having further imaging, physical exams blood tests and sigmoidoscopies. it is hoped that this research will provide support for the pathway of not conducting surgery on patients who have no evidence of cancer after their chemoradiotherapy.