ANZCTR search results

BARISTA is a prospective, multi-centre bacterial genomics study of invasive Staphylococcus aureus infections that is currently recruiting the Austin Hospital and Royal Melbourne Hospital in Melbourne. Adult patients admitted for a monomicrobial sterile site infection (eg. blood, bone, or joint) are included, with up to a year follow-up. The study collects all clinical samples with growth of S. aureus (blood cultures but also bone, muscle, joint), and samples from recurrent infections within a year. Nasal swabs are collected at enrolment and after 6 and 12 months and in case of recurrence. EDTA blood is collected to extract cell-free DNA (cf-DNA).

This research is conducted to initially diagnose Cancer of Unknown Primary (CUP) at the DNA level using Somatic molecular profiling and tissue of origin assay and to measure the implementation of Optimal Care Pathway (OCP) . Who is it for? You may be eligible to join this study if you are aged 18 years and older, have suspected or confirmed CUP diagnosis and no prior treatment for CUP Study details All participants in this study will have treatment according to the optimal care pathway along with the use of tissue of origin classifier and comprehensive somatic mutation profiling. Participants will be asked to sign a consent form. Access to your health records may be required to help interpret the results; therefore, your participation will involve giving us permission to collect information about your cancer diagnosis and use of health services. This research will be monitored by Flinders Medical Centre Medical Oncology Department Clinical Trials unit. Participation in this study involves somatic molecular profiling and tissue of origin test which will be described in detail below. Somatic molecular profiling and tissue of origin assay Cancer cells have changes in their DNA (the "instruction book" for the cells in your body) that cause uncontrolled growth. When you were diagnosed with cancer, you had a piece of tissue removed from your tumour(s) (called a “biopsy”) to confirm what type of cancer it is. Testing on the tumour (somatic molecular profiling) may help identify where your cancer started. Furthermore, the test may identify genetic changes in your cancer that may respond to anti-cancer medicines. Your doctor may then tailor your treatment accordingly. Treatment in this research project will be determined and given by your treating doctors. The trial does NOT provide treatment. Participants will be followed-up every month to assess the outcomes of the matched/recognised therapies in participants. It is hoped that this research project might or might not improve your health but the information that is learned may help other people who have a similar medical condition in the future.

The purpose of this study is to assess the acceptability, safety, how your body interacts and the effectiveness of the EN002-gel in patients with non-melanoma skin cancer and precancerous lesions, including basal cell carcinoma (BCC), squamous cell carcinoma (SCC), Actinic keratosis (AK), and Bowen's disease (BD). Who is it for? You may be eligible for this trial if you are aged between 18 years or older, have been diagnosed with basal cell carcinoma (BCC), squamous cell carcinoma (SCC), Actinic keratosis (AK), or Bowen's disease (BD). Study details This study comprises two phases. Currently, Phase I clinical trials are underway in China and Australia. In Phase 1, participants will be grouped into small cohorts, with each group receiving topical administration of EN002-gel on affected skin once every 2 days for a duration of 3 weeks. We will test five different dose levels (0.008, 0.016, 0.027, 0.04, and 0.06 mg EN002 per cm^2) to assess the safety, tolerability, and EN002 gel concentration in the blood of patients with non-melanotic skin cancer. How many people will participate in this clinical trial? We anticipate enrolling approximately 25 participants from both Australia and China for the Phase I study. In Australia, two sites will participate, with a planned total of 8 participants. Australian subjects will be allocated to receive either 0.04 mg/cm^2 or 0.06 mg/cm^2 of EN002 based on when they participate in the study. The Phase II study comprises four cohorts, each representing different tumor or precancerous lesion types, including 35 cases of AK, 12 cases of SCC, 12 cases of BCC, and 11 cases of BD. This sums up to a total of 70 required participants for the Phase II study in China and Australia. The purpose and prospects of this clinical trial It is hoped that this clinical trial can help to evaluate the safety, tolerance and efficacy of EN002 gel in the treatment of non-melanoma skin cancer and other diseases, and provide a basis for the dosage and administration scheme of the subsequent phase of the trial.

Genicular artery embolisation (GAE) is a procedure involving injection of small particles into knee joint arteries. This inhibits growth of new blood vessels (neovascularity) and decreases inflammation, thereby reducing knee pain and disability. We proprose GAE offers an effective and minimally invasive alternative to treat knee pain in patients with TKR. Up to 20% of TKR patients are dissatisfied with pain control; GAE can provide a nonsurgical alternative to manage pain. We aim to perform a prospective, double-blinded, randomised control trial to assess the safety and efficacy of GAE compared with sham procedure in the treatment of knee pain in patients with TKRs.

This study is evaluating the safety, dosing, absorption and distribution of IMD-101, an innovative anti-cancer immunotherapy drug, in patients with advanced malignant solid tumours. Who is it for? You may be eligible for this study if you are an adult with histologically or cytologically confirmed advanced malignant solid tumours, including melanoma, non-small cell lung cancer (NSCLC), renal cell cancer, mesothelioma, and bladder cancer, and have failed standard of care treatment. IMD-101 is given 20 microgram/kg by intravenous infusion every 2 weeks for 3 times. When it's safe to do, 40 microgram, 80 microgram, 120 microgram, 180 microgram, or 240 microgram will be tested sequentially. Participants will also be asked to attend to visits for up to 6 weeks following commencement of IMD-101 for blood and urine tests, and physical examinations.

The purpose of the study is to investigate whether Sonidegib (an anti-cancer drug) is effective and safe to use in patients with advanced solid organ cancers that have a specific SMO/PTCH1 gene mutation or elevated Hedgehog protein levels. Who is it for? This study will involve an initial screening phase followed by an intervention/treatment phase. You may be eligible for the screening study if you are aged 18 years or older, you have been diagnosed with advanced solid organ cancer apart from advanced basal cell carcinoma and you have received at least one prior cancer treatment. Treatment naïve Individuals with a solid organ cancer that has no standard treatment may be eligible to screen. If the screening study identifies that your particular cancer expresses an SMO/PTCH1 gene mutation or an elevated Hedgehog protein level, you may be eligible to participate in the treatment phase. Additional health assessments to check your liver, kidney and heart function will be undertaken to determine eligibility for the treatment study. Study details All participants who chose to enrol in this study will firstly undergo an initial screening phase. This screening phase will involve providing a blood sample for testing, as well as allowing the study investigators to access previously collected tissue samples of your cancer for testing. Participants who meet the eligibility criteria for the treatment phase will be enrolled and asked to take an oral tablet, containing the study drug, Sonidegib, each day for a minimum of 8 weeks. Any participants who experience severe side effects while taking the study drug will be asked to stop taking the drug. Participants who do not experience severe side effects will be asked to continue taking the drug for a maximum of 12 months, unless they experience any spread of their cancer or later develop severe side effects to the drug. Participants will be asked to undergo CT scans once every 8 weeks while taking the study drug. It is hoped this research will determine whether a new anti-cancer treatment, Sonidegib, is safe to use in people with advanced solid cancers. If the drug is safe and is shown to reduce the size or activity of cancer cells in these patients, a larger randomised trial to assess the effect of Sonidegib may be undertaken.

The primary goal of this acute study is to compare breathing behaviour across various loads during parallel back squats between unstable load training (ULT) and traditional training (TRAD). Secondary objectives involve investigating the effects of stable versus unstable conditions across various loads on muscle activation, exercise stability, mechanical performance and perceptual fatigue. The primary hypothesis is that there will be a greater inspiratory volume, a higher rate of breaths, a longer duration of breath-holding, and a larger expiratory volume with an increase in load during squats in both the ULT and TRAD conditions.

In health-related disciplines such as nursing and medicine, practical assessment centre around high acuity simulated patients. In the emerging field of undergraduate paramedicine education, little research has explored this type of assessment nor the associated physiological and cognitive stress. We don't know whether this stress enhances or hinders learning? Acute stress response is well known to lead to performance degradation, so are these students being set up to fail when really educators should be encouraging learning as a priority. Research must be undertaken to determine how much physiological and cognitive stress is too much. Our hypothesis is that students who appraise a scenario as a threat will perform at a lower clinical ability than those who adopt a challenge appraisal.

The general aim of this pilot study is to establish correlations between parameters of electrical impedance tomography with standard clinical parameters. The specific aims are to: 1.Assess lung ventilation distribution in patients with high spinal injuries (T8 and above) 2.Collect clinical data on ventilatory mechanics including level of spinal deficits, ventilatory mechanics (invasive, non-invasive, ventilator settings) intraabdominal pressure, FiO2 ratio, and end tidal CO2 to arterial CO2 gap 3.Assess correlation between EIT parameters and clinical data Validity and reliability of EIT systems has been demonstrated in several studies, indicating that EIT may be effective in the assessment of ventilation distribution in patients with asthma, COPD and cystic fibrosis. Furthermore, EIT has also compared well with lung measures such as lung volumes and lung density quantified by CT. However, there is currently little or no studies of the use of EIT in monitoring of patients with restrictive lung disease, in particular patients with spinal injuries.

This purpose of this study is to assess the effectiveness of using Quitline as a referral pathway into lung cancer screening, and to assess whether combining Nicotine Replacement Therapy and Quitline telephone counselling interventions in current smokers is effective for people at risk of lung cancer. Who is it for? You may be eligible for this trial if you are aged between 50 – 80 years old, have a Prostate Lung Colorectal Ovarian model 2012 (PLCOm2012) score of >=1.51% and are a person who currently smokes with a 20-pack year smoking history. The PLCOm2012 model has been developed for lung cancer detection, and a score of >=1.51% means you are eligible for lung cancer screening. Study details Participants will be randomly allocated by chance (similar to flipping a coin) to the intervention group or the control group. Participants allocated to the intervention will be receive Nicotine Replacement Therapy and Quitline telephone counselling interventions for 12 months. While those participants who are randomised into the control group will Nicotine Replacement Therapy and Quitline telephone counselling interventions for 12 weeks (3 months). Participants who are eligible for lung cancer screening (based on certain criteria [PLCOm2012 > 1.5%, Have a > 20 pack year smoking history), will have a free CT scan of the lungs (within 12 months of enrolment in the study). Questionnaires will be collected every three months for the first year to assess the acceptability of the intervention and then once a year for 4 years to assess patient reported outcomes. It is hoped this intervention will help design a national Australian Lung Cancer Screening Program.