ANZCTR search results

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.

There are no validated biomedical interventions for core social symptoms in autism spectrum disorder (ASD). Repetitive transcranial magnetic stimulation (rTMS) has been established as a safe, effective, and targeted technique for a range of brain-based disorders, including depression, migraine, and obsessive-compulsive disorder. While it has been trialled with some success in ASD, this work has been limited by small sample sizes, the heterogeneity of ASD, and less rigorous study designs. Young adults with ASD (aged 14-40, n = 150) will undergo four weeks (20 sessions) of either active or sham (i.e., placebo) rTMS to the right temporoparietal junction (rTPJ). The rTPJ is a key node of the "social brain," and it is underactive and underconnected in people with ASD. Participants will initially undergo a structural magnetic resonance imaging (sMRI) brain scan to allow accurate targeting of the rTMS coil. There will be five sites (Brisbane, Sydney, Melbourne, Adelaide, Perth), with each enrolling 30 participants (15 active, 15 sham). Assessments will be conducted at various points before and up to 6 months after treatment. Both participants and those conducting assessments will be blind to treatment condition. Mixed model analyses will be used to compare active and sham conditions across the assessment timepoints. If successful, this work will establish a first biomedical intervention for ASD, which will result in improved quality of life, participation, and mental health for the estimate 1 in 59 people affected.

Many people improve following discharge from conservative hospital treatment for low back pain (LBP), however some experience worsening LBP and seek additional care. The lack of support for patients after treatment discharge has been identified as a key driver for this clinical pattern. Introducing a discharge support system, incorporating referral to the NSW Health Get Healthy Service®, which delivers telephone and telehealth-based health coaching programs, has strong potential to bridge this clinical gap. Health coaching can improve physical activity levels in people with LBP. We will conduct a randomised controlled trial investigating the effectiveness and cost-effectiveness of a discharge support system (incorporating referral to the Get Healthy Service®) for improving pain, disability, and physical activity levels, in people recently discharged from hospital outpatient physiotherapy treatment, or from public or private physiotherapy, chiropractic or general practitioner care for chronic LBP. In-depth interviews will be conducted to identify factors contributing to intervention success, which will be used to inform the development of an implementation plan for upscaling the discharge support system across NSW LHDs.

The primary purpose of the study is to evaluate the implementation of a smartphone-app based model of care. Participants with heart failure will be provided with a smartphone app as well as equipment including a blood pressure machine, weighing scale and pulse oximeter. Participants will use the app to send their results daily to a monitoring team who will check for abnormal readings. Abnormal readings will be discussed with a doctor or nurse who is familiar with the participant, and treatment may be provided if necessary.

Mild head injury (MHI) in the elderly population is a very common presenting complaint to the emergency department. After assessment, the main decision health providers need to make is whether or not the patient requires a CT Brain to assess for significant intra-cranial injury such as intracranial haemorrhage. Current NSW Health Head Injury guidelines define a minor head injury as “a patient with an initial Glasgow Coma Score (GCS) of 14-15 on arrival at hospital following acute blunt head trauma with or without a definite history of loss of consciousness or post traumatic amnesia”. As a result of this broad definition, almost all patients in NSW who present to the emergency department after blunt head trauma undergo a CT scan. In comparison, the “Canadian CT Head Rule (CCHR)”, which is the most commonly used and validated clinical decision rule around head injury, defines MHI as a patient with a GCS of 13-15 and who has one of the following; sustains a period of loss of consciousness, post- traumatic amnesia or disorientation post head impact. Using this inclusion criteria, the CCHR definition and rule was shown to be 100% sensitive and 69% specific for the need for detecting need for neuro-surgical interventions post head injury. It was also 98% sensitive and 50% specific for detecting clinically significant brain injury. Our study will aim to assess whether the use of this more restrictive imaging strategy can safely reduce the number of CT Brains ordered post MHI in a regional NSW emergency department.

The aim of this study is to investigate clinical and patient reported outcomes following total ankle arthroplasty (TAA). The study will comprise a consecutive observational cohort with retrospective and prospective study design. Recruitment will include patients who have presented with ankle pathology to the principal investigators, Dr Andrew Wines and Dr Michael Symes, and elected to undergo TAA procedure. Patients will be presented with a Participant Information Sheet to inform them of the nature of the study and will be given an opportunity to provide informed consent for collection of their clinical data for research purposes via an opt-in approach. The data collection process will involve retrospective chart review and collection of patient demographic, treatment and clinical data as well as patient reported outcome scores collected routinely as part of the standard clinical pathway at the baseline presentation. Consenting patients will also be requested to complete a set of questionnaires (FAOS, satisfaction) to enable evaluation of patient reported outcomes as part of the post- treatment follow up. Aggregated pooled results will be deidentified, analysed and reported in the form of a manuscript for publication in a peer-review journal.

This study aims to assess the change in blood ketones seen in patients prescribed a very low carbohydrate diet (VLCD)before bariatric surgery. Patients on a VLCD have an increase in the blood levels of a chemical know as a"ketone' The level of measured ketones is different in each patient. Some diabetic medications can result in excessive levels of ketones in patients on VLCD. This study will help understand changes in blood ketones in patients undergoing bariatric surgery who are on VLCD who may or may not be on diabetic medications

The aim of this study was to investigate whether a nutritional intervention could enhance sleep by determining the effects on sleep quantity and quality as well as balance and cognitive function in healthy adults. Three trials were performed where different combinations of ingredients were provided and compared to a placebo in 18 healthy male participants.