ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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33715 results sorted by trial registration date.
  • A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study of Single and Multiple Ascending Doses of GV-100 (Part3)

    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.

  • Assessing the safety of the Cardiac Return Air Blanket (CRAB) on healthy volunteers

    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.

  • A Phase 2a clinical research trial evaluating an investigational study drug (GlyphAgo/SPT-320) in adults with generalized anxiety disorder (GAD) and sleep disturbance.

    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.

  • Calcium for Lowering Vasopressor use in cardiac surgery: a phase II feasibility trial

    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.

  • A study evaluating the safety and effectiveness of SIR9900 compared with placebo in adults with VEXAS syndrome

    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.

  • Best of Both (BOB) Trial: A Feasibility Study of Hybrid High Dose Rate Brachytherapy and Stereotactic Ablative Body Radiotherapy for Low- and Intermediate-Risk Prostate Cancer

    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.

  • Non-invasive tools for assessing skin in the mouth

    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.

  • An eight-week mindfulness and psychoeducation program to investigate metacognitive beliefs as a mechanism of effect on anxiety and depression symptoms in a general population.

    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..

  • A pilot study evaluating the effects of deep brain stimulation (DBS) on sleep and pulmonary function in Parkinson's Disease (PEDS-PD study)

    Deep brain stimulation (DBS) is a treatment for Parkinson's disease that uses a small implanted device to send electrical signals to specific areas of the brain, helping to control movement symptoms. While DBS is known to improve movement, less is known about how it affects sleep quality and breathing (pulmonary function) in people with Parkinson's disease. This pilot study aims to find out what types of sleep and breathing problems occur in people with Parkinson's disease who have a DBS device. There are three common brain locations where the DBS device can be placed, and this study will compare how each of these affects sleep and breathing. Participants who already have a DBS device will attend the hospital for an overnight sleep study, and separately for breathing tests, both with their DBS switched on and again with it switched off, so researchers can see the difference stimulation makes. A comparison group of people with Parkinson's disease who don't have DBS (managed with medication only) will also complete the breathing tests, to help researchers understand whether any breathing changes are related to the DBS device itself, to Parkinson's disease more broadly, or to something else. By better understanding how DBS affects sleep and breathing, this research aims to help doctors make more informed decisions about DBS placement and management, and ultimately improve quality of life for people living with Parkinson's disease.

  • Multidisciplinary telehealth early intervention for patients with a recent diagnosis of functional neurological disorder (FND), with functional motor symptoms and/or functional dissociative seizures: the Epworth RESET-FND study

    Functional Neurological Disorder (FND) is a condition in which people experience neurological symptoms, such as movement difficulties or seizures, that are related to changes in brain functioning rather than structural neurological disease. FND can significantly affect physical functioning, emotional wellbeing, quality of life, and day-to-day activities. The purpose of this research project is to evaluate a new multidisciplinary telehealth treatment program called RESET-FND. RESET-FND combines neuropsychological therapy and physiotherapy delivered by telehealth by clinicians experienced in the management of FND. This study aims to determine whether the RESET-FND program improves symptoms, physical functioning, psychosocial wellbeing, and quality of life compared with a supportive therapy control intervention. As a randomised study, patients are randomly allocated to one of two study groups: The RESET-FND intervention group, or a supportive therapy control group. to assess the potential benefits of this REST-FND intervention as assessed over 12 months.

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