ANZCTR search results

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.

Depression and obesity in men are two of the largest public health concerns in Australia. These conditions also appear to be linked as men with overweight or obesity are ~30% more likely to develop depression than healthy weight men. Furthermore, men with depression are 43% more likely to develop obesity than men without depression. The SHED-IT: Recharge randomised trial (ACTRN12619001209189) tested a self-guided eHealth program combining lifestyle behaviour change advice and mental health support to reduce depression (and weight status) in men. It was the first RCT of an integrated mental and physical health intervention for men with depression. Results indicated significant and clinically meaningful intervention effects on both depressive symptoms and weight loss at post-intervention compared to the control group, which was maintained at 6-month follow up. However, because the program targeted physical and mental health it was unclear which components were most important for driving changes in the men's depressive symptoms. As such, the purpose of this pilot trial is the examine the feasibility and preliminary efficacy of comparing an online program focused only on lifestyle behaviour change to an online program focused only on mental health support for men with depression and overweight or obesity.

Like endometriosis, adenomyosis is a benign uterine disorder and is histologically defined by presence of endometrial tissue in the myometrium (muscle layer) of the uterus. The prevalence of adenomyosis is difficult to determine, since histological confirmation is necessary following surgical biopsy or more commonly hysterectomy. For women wanting to retain their uterus, hysterectomy is not an option. Imaging technologies (e.g. transvaginal ultrasound and MRI), are used as a less invasive method of diagnosis and detection, although they have limitations. The Australian Endometriosis Clinicians Collaborative (AECC): adenomyosis substudy is a prospective longitudinal clinical study that will: 1. compare diagnosis and treatment of adenomyosis with regards to impact on pain, bleeding patterns, general health symptoms and quality of life using validated questionnaires 2. determine cost-effectiveness of diagnostic and treatment options 3. establish a national biobank of adenomyosis (and endometriosis) for future research capacity. Outcomes will determine optimised diagnosis and treatment pathways for clinicians that improve quality of life for women with adenomyosis.