ANZCTR search results

Temporal lobe epilepsy is the most common form of focal epilepsy, and is commonly resistant to treatment with anti-seizure medications (ASMs). Successful epilepsy surgery is dependent on accurate delineation (and resection) of the epileptogenic zone (EZ). Astrocytes are a type of immune cell within the brain which are activated in response to acute injury or insult. Studies have demonstrated that activated astrocytes are present in surgically resected tissue of people with epilepsy, with other studies suggesting dysfunctional astrocytes contribute to seizure generation and propagation in drug resistant epilepsy. 18F-FDED, binds to the mono-amine oxidase B enzyme which is expressed on the surface of activated astrocytes, thus the present study will evaluate 18F-FDED PET as a technique for localising the EZ in patients with focal epilepsy.

The Eating Well with MS study aims to evaluate the effectiveness of an online nutrition education program designed to improve diet quality and food literacy in people living with multiple sclerosis (MS). We hypothesize that participants who complete the program will demonstrate significant improvements in their diet quality, food literacy, and overall quality of life, symptoms, and disease progression, compared to those receiving standard care. The study seeks to provide accessible and practical tools to support healthier eating habits in individuals with MS.

This study aims to assess whether it is safe and possible to insert a hyaluronic acid gel spacer within the area between the vagina and rectum for patients who are undergoing brachytherapy for gynaecological cancers. Who is it for? You may be eligible for this study if you are female, aged 18 years or older, you have been diagnosed with cervical, uterine, and/or vaginal cancer and you will be undergoing MRI-guided high dose rate brachytherapy to treat your cancer. Study details Participants who choose to enrol in this study will undergo insertion of a gel spacer (Barrigel). Participants will have the spacer inserted under anaesthetic by the radiation oncologist prior to their second brachytherapy session. It is anticipated that the spacer will break down and be excreted by the body over 3-6 months. The researchers will also take additional MRI scans to determine the location and size of the spacer over a period of 12 months after insertion. It is hoped this research will determine that use of a gel spacer is safe and does not cause any unacceptable side effects for cancer patients who are undergoing MRI-guided brachytherapy. If this study finds that the spacer is safe and able to protect other organs that are not receiving therapy, a larger study enrolling a greater number of cancer patients may be undertaken.

Poor body image is a hallmark feature in the development of disordered eating behaviours, as well as other significant mental health concerns. This association however appears bidirectional. For example, previous studies have implicated several underlying psychological mechanisms as potential key gearwheels that has been incriminated in the development, escalation and maintenance of poor body image. Further, recent experimental has shown that neurocognitive processes (how we think, not just what we think) play a pivotal role in body image pathology. The original Body Project is an empirically proven peer-led group intervention programme that has shown to be efficacious in improving thin-body internalization in young women. In the current study, we propose a novel study to compare the efficacy of “The Body Project by comparing it to a “Body Plus Project” (the original Body Project plus an additional component of brain training in 96 women, (aged 18-35) in the Australian student and community sample. We aim to investigate and elucidate important, previously under-researched psychological and neurocognitive risk factors that have been incriminated in the development, escalation and maintenance of poor body image and related comorbidities. at post-treatment, 3-month and 6-month follow-up compared to the Body Project group. We also plan to obtain participant experience feedback to determine implementation aspects for further iterations of this intervention.

This study aims to assess the feasibility of delivering a caner-specific Stepping On program for older individuals who have recently completed or are receiving treatment for hematological cancer. Who is it for? You may be eligible to join this study if you are aged 65 years and older (45 years or older if you identify as Aboriginal or Torres Strait Islander). You are either currently undergoing or have recently completed treatment for hematological cancer and who are considered by their hematologist to be suitable to participate in the Stepping On program will be invited to participate. Study details All participants who meet the eligibility criteria in this study will undertake the 7-week Stepping On program that includes 2-hour attendance each week and a 2-hour booster session 2-months after completion of week 7. During and after the program you will be assessed for patient experience, leg strength and balance, program attendance and program related evaluation. It is hoped that this research project will assess whether the Stepping On program can be adapted for the specific needs of older adults receiving treatment for a blood cancer.

This is a phase 1 first in human study to assess the safety of OZ-001 and how this drug acts in the body in adults with solid tumours. OZ-001 may be indicated for use in patients with solid tumours, but a trial to test the amount of OZ-001 that is safe is needed before a trial into the effectiveness of OZ-001 in cancer patients can proceed. Who is it for? You may be eligible for this study if you are aged over 18 years and have a diagnosis of a solid tumour that is advanced/metastatic and refractory or intolerant to standard therapies or have refused standard therapy. Study details All patients who choose to enrol in this study will receive a single dose of OZ-001 daily for 28 days. All patients will have their vital signs checked (heart rate, blood pressure, temperature, etc), and will provide blood and urine samples for testing. It is hoped this research will determine the maximum dose of OZ-001 that can be administered safely without causing severe reactions. Once the dose of OZ-001 has been determined, a trial investigating the effectiveness of OZ-001 as a treatment for patients with solid tumours may proceed.

A single-case experimental design (SCED) with multiple baselines across participants will be conducted to evaluate the effect of a home-based self-directed EEG neurofeedback intervention for individuals with chronic pain. In this study, the primary and secondary outcome measures will be assessed daily across four phases: baseline, intervention, immediate follow-up, and 5-week follow-up. The daily assessments before, during, and after the intervention provide an objective basis for evaluating the treatment effect at an individual level, where participants serve as their own control. In a multiple-baseline design across participants, the intervention phase is initiated in a staggered sequence, resulting in varying duration of the baseline phase between participants. The multiple-baseline design estimates the effect of an intervention by demonstrating that any observed changes in the outcome measures are systematically aligned with the initiation of the intervention. In this study, we hypothesise that the EEG neurofeedback intervention has an effect on reducing pain severity and pain interference across participants when comparing the baseline phase to the intervention and the 5-week follow-up phases.

This study aims to evaluate the feasibility and benefits of molecular screening in participants with haematological malignancies. Who is it for? You may be eligible for this study if you are: - aged 18 years and older - have pathologically confirmed blood cancer at diagnosis or relapsed/refractory disease - have sufficient and accessible tissue for molecular screening - ECOG performance status 0, 1 or 2. Study details If a patient is suitable for the MoST-LLy study, their blood cancer is tested for genetic biomarkers that may guide future treatment/s. This process is called molecular screening or genetic panel testing. After a patient’s blood cancer is tested, a report is sent to the referring haematologist with information on (i) Any genetic biomarkers that were identified in the blood cancer and (ii) The types of treatment/s or clinical trials/s that may be suitable (if any are found). The intervention and results of the screening will be assessed for biomarker identification, treatment recommendations, patient and treatment metrics and clinical outcomes. It is hoped that this research project will contribute to a better understanding of blood cancers and blood cancer genomics that may help people with blood cancer in the future. The results will aim to show genetic screening is important to expedite translation of discovery into treatment options and ultimately better outcomes for blood cancer patients.

Chronic, non-healing foot and leg ulcers are often a result of reduced blood flow due to Peripheral Artery Disease (PAD) or other ischemic (reduced blood flow) conditions in patients with chronic diseases, including diabetes. These ulcers can compromise quality of life and increase the risk of serious infection and tissues necrosis (injury and death of the tissue). Periosteal distraction (PD) is a medical technique used to increased blood flow to the affected area of tissue (peripheral perfusion). It works by gently pulling on the thin tissue covering the tibia (periosteum). This tissue plays a key role in encouraging blood flow to the feet and ankles. The XPD system is a new medical device designed to facilitate PD. It consists of both external fixation and implanted components which are surgically fixated to the tibia to apply controlled stress to the periosteum in order to promote blood vessel formation and tissue regeneration. This is a multi-centre, open label, single arm study to evaluate the safety of the XPD System for PD in participants with hard to heal ulcers in the peripheral lower extremities (ankle and below). Chronic ulcers will be graded using the Wound, Ischemia, and foot Infection (WIFi) scale (W)1-2, (I)1-3, (fI)0-1 based on physician judgement. All patients will have a procedure for sharp debridement and installation of the XPD System to perform PD for 3 weeks. The patients will return at 4 weeks for removal of the device and begin an observation period for 16 additional weeks for a total of 20-week follow-up period.

Aim of the study This study aims to investigate the quality of life benefit of additional 0.5% cocaine mouthwash to institutional standard of care mucositis management in head and neck cancer patients undergoing radiotherapy or chemoradiotherapy. Who is it for? You may be eligible to join this study if you are aged 18 years and older and had a histologically confirmed head and neck cancer receiving radiotherapy or chemoradiotherapy with curative intent. Study details Eligible patients received standard of care mucositis management as per the established guidelines +/- cocaine mouthwash. During and after completion of the treatment participants will be assessed for quality of life, rate of analgesic prescription, physician assessed mucositis score, pain, number of hospital admissions, need for feeding tube and weight. It is hoped that this study will establish the benefit (or lack of) of cocaine mouthwash in the treatment of mucositis in head and neck cancer patients undergoing radiotherapy or chemoradiotherapy. Study Ethics The study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the Human Research Ethics Committee of the Sir Charles Gairdner Group (application number 12573). Written informed consent was obtained from all individual participants included in the study.