ANZCTR search results

This pilot study aims to investigate the safety and useability of robotically assisted echocardiographic examinations (echo). The technology is aimed to be deployed in any location (including regional and remote) and may be controlled remotely. Should this study be successful it will allow access of essential standard of care to cardiac patients in remote and rural areas.

The main aim of this study is to assess the ability of lung ultrasound to detect an immediate change in lung aeration in patients performing physiotherapist- prescribed lung expansion techniques after upper abdominal surgery. This study will also explore if there are differences between three different lung expansion techniques in improving lung aeration score as assessed using lung ultrasound and will assess the agreement between lung ultrasound and postoperative pulmonary complications as diagnosed using the Melbourne Group Score (MGS) in postoperative upper abdominal surgery patients. A multicentre study will be conducted. Participants will have their lung aeration assessed and scored on postoperative day 1 using bedside lung ultrasound. Those for whom loss of lung aeration is identified will then immediately receive a single physiotherapy treatment session of protocolised coached lung expansion techniques commonly used in clinical practice. The participant will receive either positive expiratory pressure bubble therapy, incentive spirometry or deep breathing exercises dependent on the site the participant is being cared at. Immediately following the lung expansion therapy session, a repeat lung ultrasound will be performed. All lung ultrasound scans, both pre and post- therapy, will be scored for lung aeration by an independent skilled assessor who is unaware of the timing of lung ultrasound (either pre or post) and the specific therapy provided. Participants who don't have reduced lung aeration on their first lung ultrasound will receive standard physiotherapy care at the discretion of the ward physiotherapist. All participants will have another lung ultrasound on postoperative day 2, and screened daily for the presence of a postoperative pulmonary complication using the Melbourne Group Score on postoperative days 1, 2 and 3.

This is a first-in-human, multi-centre, randomised, double blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics and immunogenicity of FB102-101 after multiple dose administration in participants with celiac disease. Who is it for? You may be eligible for this study if you are aged 18 to 65 years with a documented diagnosis of celiac disease confirmed by intestinal biopsy and positive celiac serology at least 12 months prior to Screening. Study details: The study will be conducted in a single cohort of participants with biopsy-confirmed, asymptomatic celiac disease who are adhering to a strict gluten free diet, All participants who choose to enrol in this study will receive multiple doses of FB102 or placebo. All participants will have their vital signs checked (heart rate, blood pressure, temperature, etc), and will provide blood and urine samples for testing of celiac disease biomarkers during and following a 16 day gluten challenge. Participants will also have an endoscopy and biopsies done at screening and Day 32. The data generated in this study may inform the design of future clinical studies in patients with autoimmune and inflammatory diseases such as celiac disease.

The study is to evaluate the safety and tolerability, plasma pharmacokinetics, and efficacy of RECCE®327 topical gel when applied to Acute Bacterial Skin and Skin Structure Infections. The study will consist of sequential enrolment of up to approximately 30 participants who present with an ABSSSI, and who meet all inclusion criteria and do not meet any exclusion criteria. Participants may be treated in either the outpatient or inpatient setting. RECCE®327 topical gel will be applied once daily for seven (7) days to an ABSSSI, followed by safety and efficacy evaluations, then a possible additional seven (7) day treatment period, with repeat safety and efficacy evaluations at the end of the treatment period.

The study has two parts: A and B. The following information is for part A. Part A of this study will test if it is safe to give 2 doses of fludrocortisone (study drug) to people with geographic atrophy (GA), which is an advanced form of age-related macular degeneration (AMD) and explore the effectiveness of 2 doses on GA progression. Age-related macular degeneration is a disease of the macula, an area in the retina found at the back of the eye, needed for sharp, clear vision and activities such as reading and sewing. The advanced vision threating form of dry AMD is known as GA, which refers to a region of the retina where the cells wither away and die, creating patchy area in the retina. Sometimes, the patchy area looks like a map to the doctor who is examining the retina, hence the term “geographic atrophy.”

This study is an interventional study. One arm is assigned to an intervention group, which entails health and lifestyle adjustments to see the effect on GBS colonisation in pregnancy. Both arms of the study will involve observation throughout pregnancy. The intervention study arm will be asked to undertake a 'bundle' of interventions-: • take vitamin D supplements if their levels are low (<50mmol) • take an oral probiotic daily • limit sugar intake (<30gms/day) • increasing pre/probiotic food intake (5 x week) • increase exercise to 3 hours per week • Complete a weekly survey to ascertain compliance • Participate in GBS Screening at 35-37 weeks as part of antenatal care Our hypothesis is that women in the intervention group will have lower rates of GBS at the 35-37 week screening.

Preterm infants, especially those born before 28 weeks of gestation, are at high risk of complications related to their brain and development. In this international research study conducted at multiple sites, cells (including stem cells) extracted from the baby’s own cord blood will be infused back to them. Babies will be randomised to treatment. It means half of the babies in the trial will receive their cord blood derived cells in the first two weeks of life (in some cases two infusions) in addition to routine neonatal intensive care, while the other half will only receive placebo treatment in the newborn intensive care unit. A randomised study is the most scientific way of assessing whether a treatment is beneficial. Further whether the baby receives the intervention will not be known to the parents, or the treating team. The main outcome studied in this trial will be baby’s survival at two years without major disability related to the brain. We expect that cord blood cell therapy may increase the baby’s chances of survival without any major disability, and if proven to be true at the end of this study, it may offer a new therapy for these vulnerable infants.

The study Sponsor (Parvus Therapeutics) is developing a new drug called PVT201 for the treatment of Primary Biliary Cholangitis (PBC). This research study will examine the safety and tolerability of PVT201 for humans. This is a double-blind, randomized, placebo-controlled study where 4 dose levels of PVT201 will be evaluated in healthy volunteers. All participants will receive a single dose of PVT201 or Placebo on Day 1 of the study and participants will be followed-up on Day 2 & Day 7 of the study.

This study will investigate the effect of post-exercise serum biomarkers in healthy volunteers on keratinocyte cancer cell lines Who is it for? This is a study in healthy volunteers. You may be eligible to join this study if you are aged between 25 and 40 years old and recreationally active and do not have any chronic illnesses or previous history of any type of skin cancer. Study details Participants in this study will be randomly allocated (by chance) to one of two groups: an exercise group, where the exercise will be a short bout of moderate intensity aerobic exercise (cycle ergometry) or a second group where participants will go about their daily activities (no cycle ergometry). All participants will provide blood prior to their activity, immediately after their activity and 24 hours after the activity. Participants in each group will do this three times every 4 weeks over a 12 -week period. Participants’ blood samples at each visit will be analysed for cell viability and immune biomarker levels. This project will provide clarity, through the investigation of underlying mechanistic factors, to a field that currently has conflicting and limiting evidence. This may ultimately benefit individuals with keratinocyte cancer, in a downstream fashion, by potentially identifying a novel effective adjuvant therapy.

The purpose of this study is to evaluate the extent of scar formation and to provide safety information for a new approach to scar formation after a surgical procedure. TetraDERM device uses the natural heat from the body to form an elastic hydrogel scaffold, the controls moisture within the wound bed whilst providing a cushioning effect physically to reduce the tension of the wound. TetraDERM creates an environment for new skin tissue to form that is similar to our bodies natural healing response. TetraDERM’s capability to control the hydration within the wound bed, to reduce wound tension and support healing work to reduce scar formation. There is a seperate ANZCTR application for cohort 1, this is the application for cohort 2 and 3. Up to 45 participants will be enrolled in cohorts 2 and 3 in Australia. There will be a total of 11 subject visits occurring over 12 months.