ANZCTR search results

This study is a retrospective, observational study comparing 4 different implantable loop recorders in terms of their accuracy in detecting different arrhythmia episode types. We hypothesized that there is no significant difference in accuracy between the different devices and episode types.

A Phase 1, randomized, double-blind, placebo-controlled, single ascending dose study in healthy, overweight and obese participants to investigate safety, tolerability and pharmacokinetics of KAI-9531 subcutaneous injection.This is a randomized, double-blind, placebo-controlled single ascending dose study evaluating the safety, tolerability and pharmacokinetics (PK) of a single subcutaneous (SC) administration of KAI-9531 at increasing dose levels from 1 mg to 6 mg.The purpose of the study is to examine the safety, tolerability and PK of KAI-9531 in a non-Asian and Asian population.

The purpose of this study is to improve the outcome of breast cancer patients who develop brain metastases. This will investigate the benefits of early detection of brain metastases using brain imaging. In patients diagnosed and currently being treated for advanced or metastatic breast cancer, current guidelines do not recommend routine brain imaging. Who is it for? You may be eligible to participate in this study if you are a female age 18 or over with diagnosed with metastatic breast cancer, ER-positive disease after second-line therapy and CDK4/6 inhibitors, plus more than two sites of bone metastasis or visceral metastasis as well as triple negative (TNBC) and human epidermal growth factor-2 positive (HER-2) patients. Study details Study participants will be screened for brain metastases using Computerised Tomography (CT scans) and patients will have 3 monthly CT scans of the brain for 2 years and then 6 monthly for 2 years. This will be organised by the oncology team and will last around 20 minutes for the procedure and will be undertaken by the radiographers in imaging units in collaboration with the radiologists, Throughout the study’s period, participant’s medical records and CT scan results will be reviewed and compared to historical data. It is hoped that the result from this study will help to determine whether routine brain imaging should be offered to patients with breast cancer.

Atopic dermatitis (eczema), is an inflammatory skin disease, presenting with an intense itch-scratch cycle, lesions, pain, sleep loss and lowered quality of life. The complex nature of atopic dermatitis, with chronic and often relapsing disease course, makes treatment difficult. Elimination diets have been used as a medical tool for atopic dermatitis and food allergy for decades, but current strategies are outdated. This is a new dietary study based on new research. The overall aim of this study is to evaluate the efficacy and safety of a novel dietary elimination protocol for the management of moderate to severe atopic dermatitis to reduce the severity of symptoms in affected individuals and improve the quality of life. Specifically, this study aims to investigate whether temporary elimination of dietary allergens (milk, egg and wheat), salicylates and histamine is an effective therapeutic strategy for adults with moderate-to-severe atopic dermatitis. General public statement We hypothesise that a temporary elimination of dietary allergens (milk, egg, and wheat), salicylates, and histamine will effectively reduce the severity of symptoms and improve the quality of life in adults with moderate-to-severe atopic dermatitis (eczema).

A Four-Part, Phase 1, First-in-Human, Single and Multiple-Ascending Dose and Drug-Drug Interaction Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral SCY-247 in Healthy Subjects. The current study is the first clinical administration of SCY-247 to be conducted in healthy adult subjects. It is a 4-part study combining where Part 4 will evaluate drug-drug interaction where 24 subjects will be enrolled across 2 cohorts. The study duration from screening to post study visit will be approximately 9 weeks for Part 4.

A Four-Part, Phase 1, First-in-Human, Single and Multiple-Ascending Dose and Drug-Drug Interaction Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral SCY-247 in Healthy Subjects. The current study is the first clinical administration of SCY-247 to be conducted in healthy adult subjects. It is a 4-part study combining Part 1: single ascending dose (SAD), Part 2: multiple ascending dose (MAD), Part 3: loading and maintenance doses,

Recently, a monitor called the Newborn Infant Parasympathetic Evaluation (NIPE) has been used to study pain in children under 2 years of age, as it assigns a numeric value to the pain response. It does this by analysing the variability of the heart rate, and studies have shown that it accurately tells us when the child is reacting to pain during surgery. For many surgeries, laparoscopic (key-hole) approaches are becoming more widely used. However, this is limited research investigating pain in laparoscopic inguinal hernia repair surgeries. We recently conducted a small study that showed that the addition Local Infiltration (anaesthetic injected into the area being operated on) may reduce pain in comparison with Caudal Block (anaesthetic injected into the base of the spine) alone. Therefore, our study aims to compare differences in pain during and after laparoscopic inguinal hernia surgery between children who receive local infiltration and children who receive caudal blocks, using the NIPE monitor. If this study is effective, it will potentially allow us to better prevent children from experiencing pain after surgery, by balancing the anaesthetic and pain medications in a more focussed way. It will also potentially clarify if one of the anaesthetic methods is associated with reduced pain during and after surgery.

This study aims to examine (1) the efficacy of using body imagery rescripting to improve self-compassion compared to psychoeducation, and (2) the underlying mechanism of body image rescripting as a single-session intervention for self-compassion. Previous research has shown that body imagery rescripting increases self-compassion more than a psychoeducation task, while also reducing disordered eating, and improving body acceptance (Pennesi & Wade, 2018; Zhou et al., 2020). However, the mechanism behind these effects remains unclear. Understanding the mechanisms of such effective single-session intervention can shed light on specific targets to address in eating disorder early intervention and treatment.

Acute respiratory infections (ARIs) are a leading cause of hospitalisation and preventable death among Aboriginal infants. The first microbes encountered by the infant gut shape systemic immune development and future susceptibility to infection. Through an international partnership, we propose a randomised controlled trial to determine if neonatal probiotics can reduce the risk of ARI in the first year of life. Eligible infants aged <=3 days will be randomised into two groups where one group will receive orally the active probiotics treatment and another group will receive a placebo for 7 consecutive days total. Participants will be followed up at 1-, 4- and 7-months besides their baseline and post intervention visits and medical-review only at 12 months. Secondary aims will evaluate safety, the gut microbiome and immune development.

Armidale was selected for the settlement of Ezidi refugees as part of Australia’s humanitarian resettlement program. Approximately, 600 refugees settled in Armidale from February 2018. One of the most frequently presented health conditions is chronic low back pain. Chronic low back pain was the reason for 62% of total referrals to the physiotherapy service of Armidale Rural Referral Hospital. Therefore, it was decided that a group program was needed to meet this need. The program was offered to any Ezidi patients with chronic low back pain. The duration of the program is for 8 weeks. The program included exercise classes and education sessions. This program ran for a 6 month period time. At the end of the 6 month period, an evaluation of the program will take place to assess benefit of continuation of the program and necessary modifications. There have been no previously reported studies evaluating the effectiveness of a group program for refugee populations with chronic low back pain. This study aims to assess the acceptance and effectiveness of such a group program.