ANZCTR search results

Brief description of the study purpose This study will examine the safety and efficacy of romosozumab (a drug to treat bone loss) in patients with multiple myeloma who have had a skeletal related event despite bisphosphonate therapy. Who is it for? You may be eligible to join this study if you are aged 18 years and older, have been diagnosed with multiple myeloma and had a skeletal related event despite previous treatment with bisphosphonate therapy Study details All participants who choose to enrol in this study will receive an Romosozumab subcutaneously every 28 days for 12 cycles. Patients will also receive calcium and vitamin D supplementation. During and after completion of the treatment participants will be assessed for safety and effect of romosozumab. This will include monthly blood tests. A bone marrow biopsy will also be performed during screening for the study, following 12 months of treatment and at disease progression if this occurs during the study period. A CT skeletal survey will also be performed at screening and following 12 months of treatment and 12 months following completion of treatment. It is hoped that this research project will demonstrate that romosozumab is safe to administer to patients with multiple myeloma and identify any potential bone modifying effects of this drug in these patients

Despite the clear physical and mental health benefits of physical activity, as few as 13% of Australian women aged 45-64 years meet both the physical activity (150 minutes of moderate to vigorous activity per week) and strength (muscle strength twice per week) guidelines. Middle-aged and older adults are a priority for targeted physical activity programs, since physical capacity starts to decline at around age 50. This project aims to test the effectiveness of the Active Women over 50 program (intervention) on physical activity, over 6 months compared with a no intervention waitlist (control), among women aged 50 years and over. The intervention includes: 1) two health coaching sessions with a health coach, 2) behaviour change messages delivered by email or SMS over 6 months, 3) access to the Active Women Over 50 website, 4) access to a private Facebook group with other participants.

In the era of disease-specific treatments improving life expectancy for adults with Cystic Fibrosis (CF), we face new challenges in their metabolic health. Our project focuses on the highest-risk group, specifically adults with CF-related diabetes. We will use continuous glucose monitoring to gather detailed blood sugar data, along with body metrics, clinical information and patient-reported outcomes. Research evidence will be used to advocate for access to diabetes technology, inform management to prevent diabetes-related complications, and profile metabolic status. This endeavor will deliver novel insights that will also be foundational in informing strategies to optimise metabolic health in this population.

OLX75016 is being developed by OliX Pharmaceuticals as a treatment for patients with treatment of non-alcoholic steatohepatitis (NASH) and liver fibrosis. This study will evaluate the safety and tolerability of single and multiple ascending doses of OLX75016 in healthy volunteers. This study will be conducted in 2 parts : Part A (Single ascending dose) and Part B (Multiple ascending dose). Upto 58 Participants are expected to be engaged with the study for upto 56 days in Part A or upto 112 days in Part B of the study. OLX75016 and matching placebo will be administered as SC injections in the abdominal region in this study. Part A- Following confirmation of eligibility, participants will be randomized to receive OLX75016 or placebo prior to dose administration on Day 1. All participants will be confined to the clinic until the completion of all safety/tolerability and PK assessments on Day 3. Participants will be required to return to the clinic for additional outpatient safety/tolerability assessments on Day 4, 7, 14, 28 and 42. Participants will be discharged from each visit following completion of all safety assessments, the end of study (EoS) visit will be on Day 56. Part B - Following confirmation of eligibility, participants will be confined to the unit on Day -1 until Day 3. Participants will be randomized to receive OLX75016 or placebo prior to first dose administration (Day 1) and will be discharged following completion of all safety and PK assessments on Day 3. Participants will be required to attend the clinic on Days 4, 7 and 14 for safety and tolerability assessments. Participants will return to the clinic for a second confinement period from Day 28 to Day 31, with the second dose of OLX75016 or placebo administered on Day 29. Participants will be required to attend the clinic on Days 32, 35, 42, 56 and 84 for safety and tolerability assessments before the EoS visit on Day 112. It is hoped that the information learned from this study will help the sponsor learn more about how best to treat patients suffering from NASH and liver fibrosis in future. This research may also give rise to new or improved improvements.

GLP-1 RA therapies have shown promise in tackling the alarming obesity rates in Australia and the rest of the world. However, concerns have been raised about the therapy's durability once patients come off the medication and the its effect on vital fat-free mass. The aim of this research is to assess the degree to which holistic weight-loss services delivered through virtual asynchronous means can generate lasting body composition benefits. Patients will be randomly allocated into treatment and control groups to compare the effect of GLP-1 RA therapy in isolation versus GLP-1 therapy plus a comprehensive, personalised behavioural intervention. We believe that weight-loss, strength and fat-free mass outcomes will be significantly better in the treatment group at 6 months, and that these outcomes will be largely maintained 6 months after the end of treatment (12 months).

Perioperative respiratory adverse events (PRAE) are significant causes of morbidity and mortality in paediatric anaesthesia and represent a significant burden on resource allocation and utilisation in perioperative areas. Environmental factors are likely to significantly influence the risk of PRAE. Exposure to high levels of air pollution or pollen is likely to trigger airway symptoms in patients with existing airway sensitivity and reactivity, making them more likely to experience laryngospasm, bronchospasm and airway obstruction. Socioeconomic indices may also be meaningfully linked to risk of PRAE through intermediatory variables including diet and nutrition, poor health literacy and barriers to timely access to healthcare. We propose a study to examine how the risk of PRAE is influenced by such environmental exposures, this will allow anaesthetic management for at-risk paediatric patients to be appropriately planned and executed. This study will generate insight into how the changing social and environmental conditions might impact children’s health outcomes.

Moreover, melatonin is considered safe, cost-effective, and scalable, thus, a justifiable intervention for circadian mood disorders. To counter the previous clinical trials design flaws, the present study will employ a larger sample size allowing for high statistical power of analyses. Additionally, in the proposed target treatment approach, patients will be stratified based on SCRDs (Sleep and Circadian Rhythm Disturbance) to enhance the potential effectiveness of the intervention. In a recent proof-of-concept study utilizing agomelatine, a melatonin agonist and serotonin antagonist, for the treatment of major depressive disorder, adults with depression had significantly reduced symptoms after the intervention (Robillard et al., 2018). Moreover, sleep disturbances were significantly reduced, and a strong correlation between relative improvements in depression severity and some components of circadian rhythm disturbances was reported (Robillard et al., 2018). The overall aim of the study is to examine whether melatonin is a more effective early intervention for youth with depression and SCRDs compared to dCBT-I alone. Additionally, the study aims to investigate whether improvements in SCRDs causally mediate changes in depressive symptoms. The outcomes of this clinical trial will hold significant implications for early intervention in mood disorders. The findings have the potential to validate and strengthen the hypothesis that individuals with circadian depression may respond more favourably to sleep and circadian-based interventions, such as melatonin. This, in turn, could have transformative implications for personalised interventions in the treatment of mood disorders.

Pouchitis is the most common inflammatory condition for those living with an ileoanal pouch (whereby the large bowel is removed due to medically unresponsive ulcerative colitis (UC) or familial adenomatous polyposis (FAP) and its cause is largely unknown. We aim to assess whether specific diet components and psychological factors such as stress can predict pouchitis. We also aim to assess whether faecal calprotectin (a marker of inflammation found in faeces) can be used as a test to predict worsening in pouch function or pouchitis. This study will follow patients with an ileoanal pouch prospectively for 18 months to evaluate if diet, stress and faecal calprotectin play a role in predicting pouchitis or worsening of pouchitis. This is important because there are currently no dietary guidelines to help ileoanal pouch patients.

This study will assess the use of a dye (indocyanine green or ICG) to identify lymph nodes within the oesophagus and stomach during surgery to remove lymph nodes in patients with stomach and/or oesophageal cancer. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with oesophagus, gastro-oesophageal junction and/or stomach cancer and you will be undergoing surgery as the primary treatment for your cancer. Study details All participants who choose to enrol in this study will have an additional step of a dye injection (ICG) at the start of surgery. The planned surgery will then be conducted as per usual process with as many lymph nodes removed as are identified. At the end of the surgery, the surgeon will then use a near-infrared camera to scan the tissue to identify and remove any additional lymph nodes containing ICG in the surgical field. It is hoped this research will determine whether a greater number of lymph nodes can be identified and removed with the ICG dye and camera scanning compared to usual care. If this method is found to be more successful at identifying and removing lymph nodes for patients with oesophageal and stomach cancers, it may be included in the usual care practices to improve outcomes for future cancer patients.

Studies have shown that capsaicin may possibly be effective against weight gain and fat accumulation by inhibiting fat absorption and activating fat metabolism in the liver. Previous studies have demonstrated that it stimulates lipolysis, energy expenditure and thermogenesis. There is evidence that capsaicin stimulates resting energy expenditure, lipid mobilization and fat oxidation. It has also been found that ingestion after a glucose load promotes glucose consumption in young healthy males. This study will determine if the same effects are seen in young healthy females over the course of a normal oestrous cycle. The results of this study will then allow for translation to a pre-diabetic population to use capsaicin to augment diet and exercise to manage weight loss.