ANZCTR search results

Physical activity is well known to improve health (physical, mental and social) when performed regularly. However, Australian men aged 35 to 54 years are not achieving sufficient levels and currently fall short on a number of health outcomes. Because of this, we are investigating the impact of a two different group-based 12-week exercise programs on the health and physical activity levels of men aged 35 to 54 years. One of the programs is focused around team-sport while the other group-circuit exercise. We hypothesize that greater social connections and exercising enjoyment will be generated through the team-sport program which will contribute to greater physical activity levels and health-related quality of life.

The purpose of the pivotal study is to assess the user acceptance and speech perception with the Nucleus 7 Series Sound Processors but used by adult Cochlear Implant recipients. The study will characterise the speech perception difference for sentences in noise using Australian Speech Test in Noise with BKB target sentences and words in quiet using consonant-nucleus-consontant (CNC) Words for Nucleus 7 Series Sound Processor variants and commercially available sound processors (CP802 and CP910/920).

This trial will observe the physiological gastrointestinal responses to a single dose (20 drops, 1.1 ml) of STW5-II, vs placebo, to investigate the mechanisms by which this herbal preparation may exert its gastrointestinal symptom relieving effects. Participants will attend two visits at which they will receive either STW5-II or placebo, and oesophago-gastric junction pressures will be measured for the following two hours. The hypothesis is that STW5-II will increase lower oesophageal sphincter pressure compared with placebo.

This study will investigate the safety, tolerability (how well a substance is tolerated by patients), and pharmacokinetics (PK, the measure of how the human body processes a substance) of different doses of Auceliciclib in patients with advanced solid tumours, locally advanced or metastatic cancer or high-grade glioma. Who is it for? You may be eligible to join this study if you are aged 18 and above, have been diagnosed with locally advanced or metastatic cancer (all solid tumours), locally advanced or metastatic cancer or high-grade glioma. Study details There are two stages to this study: 1) Dose escalation stage where 7 different doses of Auceliciclib will be used to determine the maximum tolerated dose for Auceliciclib in participants with any solid tumor. Each dose is administered once or twice daily (depending on cohort) on Day 1-28 of each 28 day cycle. 2) Recurrent GBM Combination Therapy Auceliciclib + TMZ combination therapy: Auceliciclib will be administered either once daily on Day 1-21 of each 28 -Day cycle or twice daily for Day 1-28 of each 28-Day cycle. TMZ will be administered concurrently once daily for Day 1-21 or Day 1-28 of each 28-Day cycle. Safety and tolerability will be assessed frequently in every cycle for both stages. PK for Auceliciclib in each cancer type will be assessed using blood samples. It is hoped Auceliciclib will demonstrate potent and superior growth inhibition of cancer cells, improving overall survival with less associated toxicities than other similar compounds in patients with advanced solid tumors.

Small silent strokes are a known complication after endovascular procedures done to treat brain aneurysms. This is due to small clots that could form around the coils or stents used to treat the aneurysm. Blood thinners are given after such procedures to prevent this. This trial attempts to assess the efficacy of the blood thinner enoxaparin, as to whether it is better to give patients 1mg/kg or 1.5mg/kg doses after endovascular procedures for brain aneurysms.

The purpose of this study is to test the implementation of a model of supportive care involving multidisciplinary pre-habilitation interventions for men affected by prostate cancer choosing radical prostatectomy (and if applicable, their partner/spouse). This study aims to improve couples' psychological adjustment and supportive self-management prior to radical cancer surgery. Who is it for? Men (18 years and over) with newly diagnosed localised prostate cancer opting for radical prostatectomy (and, if applicable, their partner/spouse). Study details: Participants in this study will be randomly allocated into one of two groups. One group will receive standard care currently available at their clinical site (provision of oral and written information and the contact details of a prostate cancer specialist nurse for additional support if required). The other group will undergo the pre-habilitation multimodal model of supportive care, which involves: informational materials, pelvic floor muscle training, an evidence based self-management seminar, tailored exercise programme and tailored sexual well-being information. It is anticipated that the outcomes of this study will drive forward service improvements, produce information to help patients and their families and help clinical teams choose the most appropriate model of supportive care.

This study aims to define the prevalence of postural orthostatic tachycardia syndrome (POTS) amongst patients with chronic illness post SARS-CoV-2 (COVID-19) infection – also known as Long COVID syndrome (LCS). It also aims to unwrap the pathophysiological features of POTS amongst this cohort by defining the contribution of inflammation, neuroendocrine dysfunction, and autoimmunity towards their dysautonomia. A detailed clinical history, examination, autonomic testing and cardiac investigations will be undertaken. Additionally, blood work and urine analysis will characterize and quantify neuroendocrine, inflammatory, and immune biomarkers. Various symptom questionnaires will be used to delineate quality of life, symptom severity, cognitive function and psychological impact of LCS and POTS in these patients. We hypothesise that those with Long Covid Syndrome will present with a similar autonomic profile and symptomology consistent with those patients diagnosed with postural orthostatic tachycardia syndrome. Additionally we anticipate that neuroendocrine, inflammatory and immune markers will be similarly altered in those with POTS and LCS compared to healthy matched controls.

A randomised controlled trial will test the effectiveness of a support intervention in reducing symptoms of depression and burden of carers of people with dementia at 6-months. Carers residing in the community will be recruited via public and private geriatrician clinics and randomly allocated to usual care or the intervention. Usual care participants will receive standard care. Intervention participants will have access to a package of resources that support carers to monitor and manage symptoms/concerns of the person with dementia, as well as their own wellbeing. Components include: a hard copy manual of World Health Organisation (WHO) iSupport program, bi-monthly face-to-face group sessions, and monthly screening with telephone follow-up by a trained Intervention Facilitator. Outcome data, including carer depression, burden and proxy-rated symptoms of dementia will be collected via survey (hard copy, online or telephone as preferred by the participant) at baseline, 3 and 6 months follow-up.

Moderate-risk surgical patients appear to have a high incidence of early, often undetected, serious postoperative complications. This affects patients’ wellbeing and produces a high rate of unplanned postoperative hospital re-admissions. This is also costly, and patients unnecessarily fill inpatient beds. A trial of a new model of enhanced care after surgery (Advanced Recovery Room Care, ‘ARRC’) demonstrated that complications were quickly identified and expertly addressed. Re-admission days appeared to be decreased by 80%. Business and economic analysis showed (i) patients could expect 3 extra days at home, (ii) 4000 bed days could be freed annually, and (iii) better care at lesser cost (technically, ICER of -$600/day at home). Freeing hospital beds, and rapid cost savings, are especially important with current economic challenges with Covid. This trial re-introduces ARRC for Orthopaedic, Colorectal, Gynae-Oncology and Neurosurgery, then other specialties, to formally test the apparent benefits. It adds better risk assessment and triage tools. Datasets from patient progress and vital signs are used to improve patient risk stratification and triage at defined timepoints before, during, and after surgery, allowing better and earlier identification of patients (not) needing ongoing ARRC, reducing costs further. A Markov cost-effectiveness model provides the platform for cost effectiveness outcomes (Days at Home V Cost). This work addresses all Principles from a recent national summit on postoperative complications - https://thehiddenpandemic.com

This trial is based on findings from a studies conducted overseas which investigated the same product that will be used in this study to reduce weight. It was found to be very beneficial in these populations to reduce weight in people who are overweight, but we need to find out if it also assists people in Australia. Overweight is considered to be anyone who has a body mass index (BMI) between 25 to 29.9. This trial involves participation in a randomized controlled clinical trial which means being randomized to either a placebo or an active product group. There will be three trial sites, Lismore, Gold Coast or Brisbane. It will be conducted for 16 weeks (4 months) per person.