ANZCTR search results

In Australia, at least half of women aged 18 to 45 are overweight or obese. Women who are overweight or obese are at increased risk of some pregnancy complications. Babies of women who are overweight or obese are more likely to have birth weight above 4kg, which can put them at increased risk of childhood obesity. Our aim is to conduct a randomised trial of a dietary & lifestyle intervention prior to conception • To improve maternal nutrition, physical activity and healthy behaviours and • To evaluate the impact on maternal, newborn and child health outcomes. Our hypotheses are that this innovative public health approach will • Improve health outcomes for women, and their babies and children, who are otherwise at risk of chronic metabolic disease • Reduce health care costs and • Provide an evidence-based tool that can be readily scaled up for implementation in the community.

This study will assess the safety and effectiveness of an investigational agent (MSH2TR) used to detect lymph node spread of cancer in patients with a specific type of breast cancer, HER2-positive breast cancer. Who is it for? You may be eligible for this study if you are a female aged 18 or older, you have histologically confirmed HER2-positive primary breast cancer which you haven't had any prior treatment for (including surgery, radiotherapy, or systemic treatment) and you are scheduled for surgical intervention with lymph node detection by a specific diagnostic agent injection procedure being part of the surgical plan, or scheduled for a core biopsy of a lymph node that is clinically suspicious. Study details All enrolled participants will receive a subareolar (the pigmented area around the nipple) injection of the investigational agent after a baseline magnetic resonance imaging (MRI) scan on Day 1. The scan will last approximately 45 minutes. Participants will return for another MRI in 24 hours (Day 2) and on Day 4 to detect the lymph node spread. Also on Day 4, participants will have a tissue sample (biopsy) taken from a cancerous lymph nodes for further examination. The biopsy will be investigated for standard of care as well as a new imaging technique called magnetic relaxometry (MRX). As this study is investigating the safety of the investigational agent, participants will be asked to attend a series of seven (7) clinic visits where they will provide up to three (3) blood and urine samples. It is hoped this research will demonstrate that a single dose of MSH2TR is safe and well tolerated. It is also hoped that MSH2TR is an effective method for detecting HER-2 positive breast cancer that has spread to lymph nodes using MRI and MRX.

Bionomics Limited is developing BNC210 for the treatment of anxiety, and trauma- and stressor-related, disorders including Post-Traumatic Stress Disorder (PTSD). This single-centre study conducted in healthy volunteers, will evaluate the pharmacokinetics as well as the safety and tolerability, of multiple doses of an oral tablet formulation of BNC210, given over a 7-day period,

During hospitalisation for an acute illness, an estimated 23% to 33% of older adults experience low mobility. Low levels of activity and older age are predictors of functional deterioration and poor health outcomes during hospitalisation. Yet activity levels of hospitalised older Australians has not been investigated, with previous behaviour mapping research focusing on general rehabilitation and stroke. This project will use behaviour mapping to determine the activity levels of older adults admitted to an acute aged care ward in an Australian hospital due to sustaining a fall, and examine associations between activity levels and health-related variables (e.g. functional ability, community services use, discharge destination). Falls were selected as the condition to focus on among this population as it is one of the most common reasons for admission to hospital among older adults. This project will identify potential and modifiable risk factors that could be addressed to improve patient care and outcomes for older Australians.

Research suggests sarcopenia effects approximately 6-22% of older adults worldwide. With an ageing population the prevalence and impact of sarcopenia are likely to increase, however it remains under-researched and under-diagnosed. A simple algorithm was developed by the European Working Group on Sarcopenia in Older People (EWGSOP) to assess for sarcopenia using validated outcome measures. This algorithm could be incorporated into the routine assessment of older adults admitted to hospital, and provide valuable information on the prevalence of this disorder. The aims of this study are (i) investigate the prevalence of sarcopenia in older adults admitted to an Australian geriatric Medical Assessment Unit (MAU) using the EWGSOP's algorithm, and (ii) examine the association between participants’ demographic and health characteristics, and sarcopenia-related outcomes (grip strength, muscle mass and gait speed)..

The Action To promote brain HEalth iN Adults (ATHENA) pilot trial uses an RCT design and involves treatment with a low-dose triple combination pill of BP lowering agents or placebos. ATHENA will evaluate the feasibility, applicability, tolerability, safety and adherence of a risk reduction approach in a high-risk target population, evaluating a BP lowering intervention. In the current study, we will also test the feasibility of recruitment and assessment of a population with higher than average risk of dementia (i.e. DSM-V diagnosis of Minor Neurocognitive Disorder) remotely. The screening will be made through online assessments with subsequent telephone calls to assess eligibility and videoconference neuropsychological assessments.

The study aims to demonstrate that D-Tryptophan is safe and has pharmacokinetic tolerability and its therapy is associated with clinically significant reductions in biological markers of inflammation, wound area, and healing time compared to placebo in type 2 diabetic patients with diabetic foot ulcer (DFU).The study will have two phases, phase 1a (single ascending dose, SAD) being the single-dose escalation part. Based on the results of the Phase 1a trial, the study will be followed by phase 1b dose expansion part (multiple ascending doses, MAD) of the study, which will involve an increase in the number of participants and a treatment period of 12 weeks compared to placebo (control arm). study participants inlcude; 1.Subjects greater than or equal to 18 years of age diagnosed with type 2 diabetes on diet only or any diabetic medication regime. 2. Existing diabetes index foot ulcer grade A1 or higher according to the University of Texas Wound Classification System of Diabetic Foot Ulcers on the day of study inclusion. The study will be conducted on subjects attending High Risk Diabetes Foot Clinic at the Townsville Hospital and Kirwan Community Health after obtaining ethics approval and acquiring informed consent.

Inflammatory conditions of the lactating breast (ICLBs), such as engorgement, blocked duct, mastitis and breast abscess, commonly occur in the early postpartum period and all present with local breast inflammatory symptoms (e.g. breast pain, hardness/tightness, redness) and, often, systemic flu-like symptoms (e.g. fever, aches, chills, lethargy). These conditions are often debilitating for new mothers, having significant impact on their physical and emotional health and functioning, and are a commonly cited reason for premature stopping of breastfeeding. Therapeutic ultrasound (TUS) is the most common treatment used by Australian physiotherapists for women with ICLBs, however very few studies have looked at the effects of TUS on ICLBs. Additionally, physiotherapists across Australia currently use significantly different TUS settings for ICLB treatment. Physiotherapists from New South Wales and Victoria use high intensity TUS settings (to produce a heating effect), physiotherapists from Western Australia use low intensity TUS settings (a non-heating treatment) and some physiotherapists do not use TUS due to lack of evidence. Thus, the purpose of this study is to compare the use of these different TUS settings to treat ICLBs. We hypothesise that high intensity and low intensity TUS settings are more effective than no intensity TUS for reducing the severity of local inflammatory breast symptoms and systemic symptoms in women with ICLBs.

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 gastrointestinal motility will be measured for the following three hours. The hypothesis is that STW5-II will increase antral contractility compared with placebo.

Inflammation in the lungs and circulation can cause asthma symptoms and can be treated with anti-inflammatory medications. For people with severe asthma, the inflammation and associated asthma symptoms are still problematic despite treatment with high dose puffer medications. Eosinophils are a type of cell in the blood and airways that promote inflammation. Mepolizumab (Nucala) and benralizumab (Fasenra) are treatments that can be prescribed for people with a type of severe asthma who have high eosinophil counts in their blood. Mepolizumab and benralizumab lower the number of blood and airway eosinophils and have been shown to reduce asthma flare-ups by about half. Recent research has described some new biological functions of eosinophils in inflammation. This study will aim to determine if these eosinophil functions and other important inflammation processes are a) changed in severe asthma in people with or without high blood eosinophil counts and b) whether any inflammation remains in people treated with mepolizumab or benralizumab. This new knowledge could help researchers to develop new asthma medications and better use existing medications in the future.