ANZCTR search results

Assessing the Impact of an Online Intervention (TrueNTH Testicular Cancer) on Men with Newly Diagnosed Testicular Cancer. Who is it for? If you are an adult male who has been diagnosed with testicular cancer in the last 4 weeks, and you have regular access to the internet on your home computer or smartphone you may eligible to participate in this study. Study details Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will have immediate access to TrueNTH TC, an online intervention with testicular cancer-related information and peer support, and will have access for 4 weeks after initial login. Participants in the other group will have 'delayed' access to the intervention one week after study enrolment and will have access for 4 weeks after initial login. Throughout the four week study period, participants will be asked to complete the stress questionnaires at set timepoints, either online through the TrueNTH TC website or during a telephone interview. It is hoped that access to the TrueNTH TC website will reduce the stress and anxiety levels of newly diagnosed testicular cancer patients.

The research project is testing a potential new treatment for Celiac disease called IMU-856. Before a new medicine can be approved for use in humans, it is necessary to confirm that it is safe and effective. This is done by carrying out clinical research studies such as this one. To purpose of this study is to assess the safety and tolerability of IMU-856 when administered as a single oral dose as a 14-day repeat oral dose to healthy volunteers and as a 28-day repeat dose in patients with CelD.

The GenesisCare Outcomes Registry (GCOR) was established in November 2008 and is designed to improve patient care and outcomes through greater understanding of events, treatment and outcomes. The Registry collects detailed clinical, procedural and outcomes data on GenesisCare patients undergoing Percutaneous Coronary Intervention (PCI) or Cardiac Implantable Electronic Device (CIED) implantations. In order to improve the quality care and guideline compliance in Australia with National Outcome Registries, the registry aims to capture 100% of GenesisCare patients to monitor and benchmark compliance, care and outcomes, provide a national set of risk adjusted, consumer-focused and current clinical performance indicators to reflect clinical variations and patient outcomes. The registry will also inform research and the scientific community on coronary disease through publications/presentations, support evidence-based therapies, create efficiencies in healthcare and contribute to reducing mortality and morbidity.

Foods containing starches that undergo less small intestinal digestion have important implications for human health. By escaping digestion in the upper gut, starch that reaches the large bowel (resistant starch, RS) becomes a substrate for microbial fermentation and leads to higher production of short chain fatty acids (SCFA). These acids are not only integral to bowel health and protection against DNA damage, but also influence metabolism of peripheral tissues, including skeletal muscle, adipose tissue depots and liver, and contribute to the regulation and strengthening of immune system function and responses to infection. Additionally, slowing the rate and extent of amylolysis in the small bowel lowers the glycaemic response to food and improves blood glucose control, which can contribute to the prevention and management of type-2 diabetes. Western diets typically contain little RS because staple foods, such as cereals, are highly processed and contain starches that are readily digested in the upper gut. Consequently, RS intakes are commonly below half the suggested level of 20 g of RS per day for providing a range of health benefits. To help address this, we developed a wheat variety that contains high levels of amylose, a type of starch that has low digestibility compared to conventional wheat varieties. Although bread made from this wheat variety has a lower glycemic impact compared to conventional bread, its RS content has not been established. The purpose of this study is to establish the RS content of refined and wholemeal breads made from a novel high amylose wheat (HAW). To do this, we directly quantified the physiological RS content of breads made from a conventional (low amylose) wheat and the novel HAW in healthy ileostomates. It is hypothesised that the new HAW flour contains substantially more resistant starch than the control conventional wheat flour.

The purpose of the study is to compare video animation with electronic consent processes to the traditional paperbased PICF method of consent in a clinical trial. Participants will still engage and discuss the clinical trial and their participation with research staff as standard. Participants in the "parent clinical trial" i.e. the larger study looking at orthopaedic rehabilitation post total hip and total knee replacements using apple watches and applications, can opt out of the video/animation study if they chose to while remaining in the parent study. Participants in the parents study, will be randomised to either the electronic/animation consent group or the paper based consent group. The electronic/animation consent group will be emailed a link to watch a video animation that will explain the parent study. This animation goes for 8 minutes. They will then be asked to review the electronic version of the study PICF to ensure they have reviewed the legal information such as who to contact for trail questions and/or complaints. Participants in both group will answer knowledge and satisfaction questions to determine how well they have understood their participation in the parent trial and their satisfaction with the method of consent. This project, aims to determine if electronic/animation consent shows equal or improved participant understanding, saves research staff time, enhances patient satisfaction within a clinical trial.

Most of our vitamin D comes from spending time in the sun, but also a little comes from our diet. Importantly, research suggests that the amount of vitamin D that you have may affect the health of your muscles and therefore your strength, body composition and the amount of energy that your body uses at rest. However, we don’t know lots of things about this relationship and therefore we need to investigate it further. This is important because vitamin D may assist people to achieve a healthier body composition and perhaps help with the progression of exercise training (e.g., increasing muscle strength). The results of this study will help health professionals to clarify if higher levels of vitamin D are beneficial for achieving optimal muscle function and body composition.

Intervention and Objectives: -Intra-operatively measure the effect that posterior cruciate ligament (PCL) resection has on gap balancing by doing sequential flexion gap measurements before and after PCL resection using NAVIO robotic for primary posterior-stabilised total knee arthroplasties (PS TKA). -Determine if PCL resection induces a constant gap difference on the medial and lateral compartment in extension and at different flexion angles Hypothesis: Early complete release of the PCL during the exposure will change the flexion gap which will have clinical significant implication in the flexion gap balancing at the time of surgery Study Purpose; Midflexion instability has been flagged by the Australian Joint Replacement registry as an increasing cause of revision of Total Knee replacements. The aim of this study is to quantify flexion gap changes during surgery caused by releasing the PCL. It is hoped that quantifying this will allow more consistent results and improved survivorship after total knee replacement. -

This is a single-centre, randomised, double blind, single and multiple ascending dose study to assess the safety of AMP945, and how this drug acts in the body in healthy volunteers. AMP945 may be developed for use in patients with prostate cancer, or other diseases, but a trial of the drug in healthy volunteers is needed before trials in cancer patients can proceed. Who is it for? You may be eligible for this study if you are aged 18 to 50 years and are in good general health without a clinically significant medical history. People who have been diagnosed with cancer are not eligible for this study. Study details This trial will be conducted across three parts. In the first study (Part A), healthy volunteer participants will be assigned by chance to receive either a single dose of AMP945 or placebo, to be taken after a fasting period. All participants will have their vital signs checked (heart rate, blood pressure, temperature, etc), and will provide blood and urine samples for testing. If the drug appears safe, additional participants will be assigned by chance to receive a larger single dose of AMP945 or placebo, followed by blood and urine testing. This will continue until 5 doses have been tested. One group of Part A participants will return for Part B to receive either a single dose of AMP945 or placebo (same as received in Part A) immediately after a high fat meal. All participants will have their vital signs checked and will provide blood and urine samples for testing to determine the effect of food on AMP945. In the third study (Part C), healthy volunteer participants will be assigned by chance to receive either a multiple dose of AMP945 or placebo, to be taken after a fasting period each day for 7 days. All participants will have their vital signs checked and will provide blood and urine samples for testing. It is hoped this research will determine the doses of AMP945 that can be administered safely without causing severe reactions, and that may be effective. Once the doses of AMP945 have been determined in healthy volunteers, trials investigating the efficacy of AMP945 as a treatment for prostate cancer patients, or other diseases, may proceed.

Primary: Explore the impact of intensive inpatient treatment on PTSD and co-morbidities on an inpatient population, when compared to treatment as usual. Secondary: Determine if changes in outcomes are maintained at 3 month follow-up. Ethical approval will be obtained from the Human Research Ethics Committee, SWSLHD. Adolescents meeting inclusion criteria of PTSD will be considered for the study. After informed consent is obtained, they will be randomly allocated to receive either intensive Trauma Focussed-Cognitive Behaviour Therapy (TF-CBT) intervention or Treatment As Usual (TAU) intervention. Once eligibility in study is confirmed the young person will be allocated a participant number to ensure anonymity. eMR audit will extract basic demographic and clinical data and scores on mandatory outcome measures. Each participant will receive 9 sessions of allocated intervention. Following the end of treatment, the outcome measures will be completed again. Participants will then be contacted 3 months after treatment to complete outcome measures at follow up. The fidelity of the TF-CBT treatment given will be monitored using the TF-CBT Fidelity Measure.

This study will examine how much CBD is available in the blood when administered via a wafer dissolved under the tongue vs. oil that is swallowed. The study will also determine safety and side effects of CBD.