ANZCTR search results

This is a Phase 1, multicenter, randomized, double-blind, placebo-controlled, sequential single-ascending-dose (SAD) followed by multiple-dose (MD) trial in healthy adult participants aged between 18 and 65 years old. Participants will be enrolled into 1 of 3 cohorts – each cohort testing a different dose of the study drug WIN027. Participants will be dosed as in-patients at the study site and then will be followed up with multiple follow-up visits over a period of 36 weeks. The study drug WIN027 is being developed for the treatment of moderate-to-severe uncontrolled asthma and chronic obstructive pulmonary disease.

This study is testing a new gel product called Tutelix™ TL150, which is injected between the prostate and the rectum in men with prostate cancer to act as a physical cushion ("spacer") during radiotherapy. Who is it for? You may be eligible to join this study if you are aged 18 years or above, have histologically confirmed adenocarcinoma of the prostate who is a candidate for external beam radiotherapy and have not had the prostate removed. Study details Participants will be randomly allocated (by chance) to one of two groups to receive either 1) Tutelix spacer and fiducial markers a week before radiotherapy or 2) fiducial marker insertion a week before radiotherapy. Fiducial markers are considered standard of care. Participants will undergo assessments to record medical history and current medications, PSA blood test results and radiotherapy planning MRI and CT scans and questionnaires. During the follow up period all participants will complete questionnaires, have visits with the study doctor to assess any adverse events and the patients who received the Tutelix spacer will also have MRI scans. These visits will occur at the end of radiotherapy treatment, 3 months, 6 months, 12 months and 18 months to determine the radiation dose received during radiotherapy, incidence of adverse events and quality of life. This study will assess the effectiveness and safety of the Tutelix spacer to improve outcomes for patients requiring radiotherapy for prostate cancer.

Approximately 12 healthy participants will take part in this study to compare how the body absorbs GV-100 when taken with food and without food. Each participant will receive the study drug under both conditions, with a 7-day break between doses. Participants will undergo screening, stay at the study center during dosing visits for monitoring, and attend a follow-up visit after completing the study. The study will only begin after earlier safety results have been reviewed and found acceptable.

In this trial, 48 healthy volunteers will undergo application of the CRAB device at a pressure of 20cmH2O for 2 minutes and 40cmH2O for a further 2 minutes. Volunteers will have their vital signs monitored with non-invasive blood pressure (BP), electrocardiogram (ECG) and pulse oximetry (SaO2). Volunteers will also complete a post intervention questionnaire regarding, discomfort, pain, difficulty breathing and the ability to provide additional anonymous feedback.

Agomelatine is a clinically validated medicine approved in some countries for the treatment of anxiety and depression, but its use has been limited because much of the drug is broken down by the liver before it reaches the bloodstream. GlyphAgo is an investigational oral prodrug of agomelatine designed to overcome this limitation and improve how the drug is absorbed in the body. This study will evaluate two doses of GlyphAgo to determine whether the potential sleep benefit in patients with anxiety symptoms and sleep disturbance, and whether it is safe and well tolerated.

After heart surgery, 30-90% of patients receiving medications to boost their blood pressure, which can lead to illness, death, and healthcare costs. In this study, we randomise patients to receive calcium infusions vs. a placebo (a lookalike medication with no effect) to assess if calcium can help reduce the burden of blood pressure boosting medications. We hypothesise that delivering calcium infusions in this trial is safe, and will show a preliminary signal in reducing vasopressor requirements.

This study aims to evaluate the safety and effectiveness of SIR9900 in adults with VEXAS syndrome. Participants will be randomly assigned to receive either SIR9900 or a matching placebo in addition to their standard medical care. The study will compare whether treatment with SIR9900 improves disease activity and clinical outcomes while remaining safe and well tolerated. Information collected during the study will help determine whether SIR9900 may be a potential treatment option for people with VEXAS syndrome.

This study is evaluating the safety of treating low- or intermediate-risk prostate cancer with a hybrid combination of high dose rate brachytherapy and stereotactic ablative body radiotherapy. Who is it for? This study is for adult patients (at least 18 years of age) with low- or intermediate-risk prostate cancer, with further eligibility criteria to be assessed by treating clinicians. Study details All participants will receive 1 administration of high dose rate (HDR) brachytherapy and 1 fraction of stereotactic ablative body radiotherapy (SABR). SABR will be delivered approximately 3-4 weeks after the HDR brachytherapy. Safety will be evaluated via rates and grades of toxicity experienced by the participants. It is hoped that findings from this study will help clinicians and researchers develop safe and cost-effective radiotherapy treatment regimens for prostate cancer.

This study aims to assess whether non-invasive methods (imaging and mouth swabs) can detect early signs of oral cancer in people with changes in the soft tissues of their mouth. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with an oral soft tissue disease, this may include oral cancer, periodontitis (gum disease), pre-cancerous tissue changes and other oral lesions; and you are undergoing treatment with a doctor or dentist for your condition. Study details All participants who choose to enrol in this study will be asked to attend an appointment at your usual treatment location . During the appointment, the dentist will use two types of camera to take regular and heat-sensitive images of the inside and outside of your mouth and will ask you to provide a saliva sample and cheek/tongue swabs for assessment. The appointment should take no more than 20 minutes. Individual image captures will not be provided to participants. Your care will continue as usual. It is hoped this research will determine whether these non-invasive methods can help doctors and dentists spot oral cancer earlier, which may reduce the need for unnecessary surgeries, and ideally would make the process easier and less stressful for patients. signs of oral cancer in people with changes in the soft tissues of their mouth. Instead of relying only on traditional biopsies, the study will test new tools—such as special cameras that take regular and heat-sensitive photos, and simple mouth rinse or gentle brush samples—to see if they can accurately identify which mouth changes are at risk of becoming cancer. The main idea is that these new, non-invasive methods can help doctors and dentists spot cancer earlier, reduce the need for unnecessary surgeries, and make the process easier and less stressful for patients. The study's hypothesis is that these non-invasive tools will be just as good, or better, than current methods at telling the difference between harmless and risky mouth changes, leading to earlier and more accurate treatment for those who need it.

This study investigated reductions in metacognitive beliefs as a mechanisms by which mindfulness training reduces anxiety and depression symptoms. It investigates whether increases in trait mindfulness through training reduces metacognitive beliefs, with a flow-on effect to reductions in mind-wandering, rumination and worry, which in turn reduce anxiety and depression symptoms. It does this through an 8-week intervention that combines mindfulness training and psychoeducation on emotions aimed at reducing maladaptive cognitive processes as a mechanism of symptom-reduction effects..