ANZCTR search results

This first in human (FIH) Phase 1 study is a prospective, randomized, double-blind, placebo-controlled study designed to assess the safety, tolerability and PK, including the effect on PK of fed vs. fasting, of single oral ascending doses of BioE-1115 in healthy adult subjects followed by the safety, tolerability, PK and PD effects assessed as FS-DNL and RMR of multiple oral doses of BioE-1115 in healthy adult subjects. A total of up to approximately 121 subjects from both parts is expected to be enrolled in this study. Subjects will be recruited to participate in either a SAD cohort or MAD cohort but not both. Safety data for each cohort will be reviewed by a Safety Review Committee. The study will be conducted in 2 parts of 5 SAD and 4 MAD dose cohorts: Part A (SAD): Part A of the study will include a double-blind assessment of the safety, tolerability and PK, including the effect on PK of fed vs. fasting, of SAD of BioE-1115. Each SAD cohort will consist of 8 subjects, including 2 receiving placebo and 6 receiving BioE-1115, in fasting state. One of the cohorts may be called back to be redosed in a fed state. Part B (MAD): Part B of the study will include a double-blind assessment of the safety, tolerability, PK and PD assessed as FS-DNL and RMR of MAD of BioE-1115/placebo. Each MAD cohort consists of 15 subjects, including 3 receiving placebo and 12 receiving BioE-1115. MAD subjects will be dosed in a fasted state

Hemodialysis is life saving for patients with kidney failure. The contact of blood with an artificial environment may cause clots. Heparin is a substance that slows the formation of clots. However, this cannot be given to some patients who have high risk of bleeding. The aim of this research is to compare 5 different ways of providing heparin-free dialysis. These include intermittent saline flushes, artificial circuit coated with heparin, artificial circuit coated with heparin & intermittent saline flush, online predilution and predilution with coating of heparin. We aim to look at successful completion of dialysis without bleeding or clotting problems.

As Parkinson's Disease (PD) progresses, people develop significant mobility limitations and falls despite optimal medical care. The objective of the research is to help people with advancing PD and their families to live better by maintaining safe mobility for longer. Many of the impairments commonly associated with PD contribute to mobility limitations, including impaired balance , freezing of gait and cognitive impairment. The proposed project aims to to determine if a 6 month home based environmental, behavioral and exercise multi factorial intervention for people with PD improves mobility and safe mobility behaviors. Secondary aims are to determine the effect of the program on walking quantity and quality, leg muscle strength, FOG, concern about falling, activities of daily living and care partner burden.

This study will evaluate the effectiveness of electrical stimulation in improving swallowing function and quality of life among adults with MS with swallowing problems. Research around electrical stimulation suggests that there is considerable potential for participants of this project to improve their functional swallowing abilities and hence improving quality of life and emotional wellbeing.

This study will investigate the effects of intragastric administration of specific L-amino acids on gastric emptying, gut hormone release, glycaemic control and appetite perceptions in normal weight, overweight or obese type 2 diabetic patients. We hypothesize that the gastric emptying, gastrointestinal hormone, glycemic and appetite repsonses will be affected by specific L-amino acids in type 2 diabetic patients.

This project seeks to understand the effects of various forms of teacher professional development on teachers' practice and student outcomes. This research involves a 4-arm Randomised Controlled Trial to test the efficacy of Quality Teaching Rounds (trained in two modes), alongside an alternative (Peer Observation) professional development approach and a usual professional development practice control condition. Data will be collected from participating teachers via surveys, lesson observations and interviews. Data will be collected from participating students in the form of Progressive Achievement Tests (PATs) and surveys. We hypothesise that students taught by a teacher who has undertaken QTR will display greater positive achievement growth in mathematics, reading and science, and hold more positive perceptions of their own academic performance, their relationships with teachers, and the relevance of their schooling, compared with students whose teachers undertook alternate methods of professional development. We also hypothesise that teachers undertaking QTR will display gains in teaching quality, and improvements in morale, engagement, individual efficacy, and collective efficacy above that of teachers undertaking alternate methods of professional development.

Aim To determine the safety and efficacy of LUM/IVA in subjects >12 years of age with CF, homozygous for F508del mutation of CFTR and an FEV1<40% of predicted normal, by comparing those patients treated with LUM/IVA with a cohort of age and sex matched CF controls with another set of mutations that lead to severe CFTR dysfunction (belonging to Class I, II or III), with an FEV1<40%5.

This project is a pilot study in adults to investigate physiological measures as novel biomarkers of food addiction. Impaired physiological responses (e.g. heart rate variability, pupillary responses) have been found in other forms of dysfunctional eating patterns (e.g. binge eating, bulimia nervosa, obesity) and are linked to abnormal functioning of neural circulatory. This project will recruit males and females >18yrs to determine if physiological measures in response to visual food stimuli are associated with food addiction. It is hypothesised that adults presenting with moderate-severe food addiction symptom scores will have lower heart rate variability, increased sweat responses and greater attentional biases toward hyperpalatable foods (i.e. junk foods) compared to adults with low symptom scores.

Update The aim of this study is to assess the benefit of adding high precision radiotherapy to chemotherapy and surgery for the treatment of pancreatic cancer. Who is it for? You may be eligible for this study if you are aged 18 to 75 years old, have pancreatic cancer and have adequate liver function. You must not have received prior treatment for your pancreatic cancer. Study details Participants will be randomised by chance into two groups. Both of the groups will undergo a chemotherapy regimen which includes either one of the following drug combinations; 1) mFOLFIRINOX or 2) Gemcitabine/Nab-paclitaxel. One of the groups will have additional high precision radiotherapy called stereotactic radiotherapy. After this treatment, you may go on to have surgery.. Whether or not you have surgery, the treating team will then have a discussion with participants about further treatment with chemotherapy. All participants will complete a number of questionnaires, consent to their biopsies and resected tissue being analysed in a laboratory. Participants will be followed up for up to 4 years. This research may demonstrate that the addition of high precision radiotherapy to pancreatic cancer treatment improves patient outcomes and reduces the rates of cancer recurrence.

In patients with diabetes, foot ulceration and infection occur commonly, and are associated with significant morbidity and use of health service resources. Diabetic foot infections are usually associated with ulcers, and can spread from the soft tissue to involve underlying bone (osteomyelitis). Diabetic foot infection with osteomyelitis (DFO) is associated with delayed ulcer healing and increased risk of amputation. Current guidelines for treatment of osteomyelitis include a prolonged course (4–6 weeks) of intravenous antibiotics, However, this requires hospital admission and/or use of ambulatory care nursing services, as well as establishment of intravenous access for the duration of therapy, all of which place considerable burden on health services and the individual patient. Also, the antibiotic-related costs are much higher than oral therapy. Despite this, there is no evidence to suggest that oral therapy results in inferior outcomes. We hypothesise that, the use of oral antibiotics, particularly agents with high bioavailability, good tissue penetration and activity against the known or likely pathogens, might be effective and potentially less costly than intravenous therapy for DFO.