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The purpose of this research study is to implement and evaluate a toxicity-targeted intervention during treatment for cancer. Who is it for? You may be eligible to join this study if you aged 18 years or more and are a cancer patient undergoing any cancer treatment. Study details Participants in this study will be randomly allocated (by chance) to either 12-weeks of an exercise intervention or usual care. Participants in the exercise intervention group complete cardiorespiratory/aerobic, resistance, balance and stretching exercises on 3 days of the week; which are individually tailored to each intervention participant. Participants in both groups are required to undertake assessments both before, during and after the 12-week intervention period. These assessments are related to cancer-related fatigue, neurotoxicity development, cardiovascular disease risk development and other health measures (e.g. body composition, blood markers, overall body strength, cardiorespiratory fitness). Some participants will also be invited to attend a focus group discussion on the quality and feasibility of the intervention after intervention completion.

This study is aimed at patients with Type 2 diabetes diagnosed with fluid retention in the back of the eye called "diabetic macular oedema" (DME), a main cause of vision impairment in diabetic eye disease. Standard treatments include anti-vascular endothelial growth factor injections or laser therapy to the affected eye. These are invasive, costly and carry significant risks including risk of blindness. This study will investigate whether fenofibrate (an oral agent shown to slow progression of diabetic retinopathy) reduces DME and thereby reduce the standard treatment interventions required. Cost-effectiveness for standard treatment versus standard treatment with fenofibrate will be compared.

This study aims to examine efficacy of pelvic floor muscle exercises compared to standard care to improve bowel function following ileostomy/colostomy reversal following a diagnosis of rectal cancer. Who is it for? You may be eligible for this study if you are aged 18 or older, have had/have rectal cancer and have a temporary ileostomy or colostomy planned for a reversal procedure. Study details Participants will be randomly assigned (by chance) to either continue standard care or continue standard care in addition to pelvic floor muscle exercises. Participants in the exercises group will perform the exercises daily as instructed by the physiotherapist after initial assessment 6 weeks prior to reversal of stoma. Following stoma reversal participants randomised to PFME will be assessed by a physiotherapist again at 2 weeks , 3 months and 6 months. All participants , including those randomised to standard of care, will complete patient diary and quality of life assessments at 2 weeks, 3 months and 6 months after stoma reversal. It is hoped this research will contribute to improved quality of life in patients after their reversal surgery.

The aim of this study is to determine change in opiate dose in patients referred to NQPPMS after RADAR compared to individual pharmacist support or usual medical care. The secondary objective of this study is to assess whether a reduction in opioids is associated with improvements in quality of life using the EQ5D5L and we will conduct interviews with participants to obtain their perception of reducing opioids. Groups will be based on patient selfselection. Group 1; RADAR Group 2; individual telephone support from the pharmacist Group 3; those who do not wish to participate in either group or individual support; will receive normal medical care via GP. We will collect outcome measures at 3 months, 6 months and 1 year. We hope to study between 6 to 10 patients in each RADAR group and will match these with patients receiving individual pharmacist or GP support Based on our experience, we hope that patients attending the group will be more successful than those with GP care and that outcomes will be the same or better than pharmacist support.

This project aims to evaluate an online face-to-face communication training program (HEARhelp Online) for adults with hearing loss an their communication partners. HEARhelp Online is a simple, web-based intervention that addresses the need to make people more aware to speak to someone with hearing loss face-to-face. It is specifically tailored dyads comprising of an adult with hearing loss and a frequent communication partner and aims to improve face-to-face communication around the home. Participants will include a maximum of 517 dyads, who will be randomised to either the intervention group (HEARhelp Online + treatment as usual) or the control group (treatment as usual). Dyads in the intervention group will complete 5 online modules (which include information, videos and activities) over a 5 week period. It is hypothesised that participating in the HEARhelp Online training program (+ treatment as usual) will: (1) lead to significantly greater decrease in hearing disability experienced by adults with hearing loss and their communication partners, compared to the control group (treatment as usual), (2) Be more cost-effective, compared to control group (treatment as usual), (3) be associated with positive changes in capability, opportunity and motivation, and (4) be associated with positive changes in use of face-to-face communication training. Participants will be asked to complete surveys at baseline, week 7 (immediately post-intervention) and 4.5 months (3 months post-intervention). Participants may also be invited to participate in an interview at 4.5 months (3 months post-intervention). Data will be analysed using descriptive statistics, mixed effects models, a series of two-way mixed ANOVAs and qualitative interviews.

The study is a single-center, double-blind, dose-escalation, single-dose design to assess safety and tolerance of M8 and to identify a dose range for phase II study and to determine the maximum tolerated dose (MTD) of M8. M8 is expected to be indicated for the treatment of unstable angina pectoris of coronary heart disease (CHD), carotid atherosclerosis, and ischemic stroke sequelae. Forty (40) healthy subjects will be randomized with 5 dose level, 8 subjects per dose level (cohort). Eligible subjects will be sequentially enrolled into 5 dosing cohorts (2.4g (6 capsules), 4.8g (12 capsules), 7.2g (18 capsules), 9.6g (24 capsules), 12g (30 capsules), orally, single dose). The study will start with the lowest dose level given to the first cohort of eight subjects. Eligible subjects will be admitted to the unit on Day -1 and conduct all qualification assessments. Subjects will be allowed to leave the unit after all the 48 h assessments have been completed on Day 3 and will return for follow-up assessments on Day 5. After satisfactory review of the available safety and toleration data, the next dose level will be processed if the previous dose was well tolerated. If the previous dose was not well tolerated, after reviewing the safety data, and discussions between the Investigators, Medical Monitors from CRO and Sponsor, the same dose level may be repeated. If this dose level is well tolerated, the study will continue to the next higher dose. If this dose level is not well tolerated again, the MTD is defined at the prior lower dose level and the dose escalation will be stopped. Descriptive statistics will be performed for safety data (AE/SAE, 12-lead ECG, physical examinations, vital signs, and laboratory tests). The current version of the MedDRA will be used to code all AEs. Update Brief summary

Cardiovascular disease (CVD) is diagnosed in almost half of Indigenous Australians 55 years and over, and is the largest cause of premature deaths in this population. It is widely recognised that cardiac rehabilitation (CR) decreases mortality, improves risk profiles, decreases hospital admissions, increases medication adherence and improves quality of life in those diagnosed with CVD. The aim of this study is to evaluate the feasibility of a female only Aboriginal and Torres Strait Islander CR program in a non-Indigenous health service setting. It will evaluate both the combination of improving access to a CR service; and improving health workforce cultural safety through implementation of an 18-week program of weekly CR sessions consisting of 1 hour of exercise and 30 minutes of education delivered by a multidisciplinary team, including an Indigenous Health Worker. Data will be collected from participants at baseline, and at every sixth session attended. Assessment of health professionals’ cultural awareness and safety pre and post program will be evaluated via a questionnaire. Feasibility measures will include recruitment of participants, adherence to the CR program, drop-out rates and Qualitative data collection from both participants and health professionals will be analysed at the end of the program.

This research project is testing a new treatment for chronic rhinosinusitis by the use of a Chitosan-Dextran (Chitodex) gel mixed with medications to see if there is improved healing after sinus surgery and less infection. Chronic rhinosinusitis affects approximately 15% of the general population and is characterised by sinusitis symptoms persisting for more than 3 months. Patients who do not respond adequately to oral and topical steroids, antibiotics and nasal lavage require surgical management. The surgical procedure is termed endoscopic sinus surgery, and involves removing oedematous mucosa, pus and debris, as well as clearance of bony walls within the sinonasal cavity to open up blocked sinuses. Participants will receive the standard hospital information sheet about the sinus surgery, and will sign the standard hospital consent form for the sinus surgery. Purpose: The purpose of this research project is testing in sinus surgery whether adding two new antimicrobial agents (Deferiprone and Gallium-Protoporphyrin ) to a locally developed dissolvable nasal dressing (Chitodex gel) will improve the anti-microbial and wound-healing effects of Chitodex gel after sinus surgery compared to Chitodex alone. Procedure and Treatment: Under endoscopic guidance, each participant will have a sinus swab performed prior to surgery and then undergo the planned sinus surgery- Endoscopic sinus surgery (ESS) or ESS with frontal drill out At the end of the procedure, each participant will receive 10 ml of gel (Chitodex or Chitodex+ Deferiprone or Chitodex+ Deferiprone+ Gallium-Protoporphyrin) into one side of each of the three sinuses and the untreated side would be referred to as the control and receive routine standard of care. If the surgery is meant to produce a larger frontal sinus cavity (ESS with frontal drillout) 20 ml of gel would be applied or 20 ml of saline if you are in the control group. Post-operative care will proceed as per standard care after sinus surgery. Participants will return to the outpatient department 2 weeks, 6 weeks and 12 weeks after the surgery for post-operative review. During each visit we would perform a sinus swab and an endoscopic video recording of the sinuses. ;The recorded video examination will then be scored by an independent clinician, unaware of your treatment, for infection (pus), oedema, granulation tissue, and crusting using a standardised scoring scales.

Pregnant tobacco smokers with substance use problems are a highly vulnerable and priority population with an over-representation of Aboriginal women. To date, smoking cessation rates are negligible in this target group with few existing effective interventions to support them to quit smoking. This study aims to assess the feasibility and acceptability of the addition of current evidence-based smoking cessation care to routine prenatal care of women attending a substance use in pregnancy clinic. The package of care consists of financial incentives contingent on validated smoking reduction and abstinence; counselling for tobacco use in pregnancy and nicotine replacement therapy (short and long acting), tailored to individual needs. The intervention is single armed, using pre-post comparisons. A group of 100 women recruited from two NSW Health Substance Use in Pregnancy and Parenting Service (SUPPS) antenatal clinics will be provided the intervention. Comparison data will come from the electronic medical records of a historical control group comprising of women attending SUPPS antenatal services for one year prior to the commencement of the study. The study’s primary objectives are to: I. Assess the feasibility of addressing tobacco smoking amongst this population II. Evaluate the acceptability of addressing tobacco smoking and the intervention components among participants and staff of a substance use in pregnancy service. Its secondary objectives are to: I. Calculate the cost effectiveness of implementing the intervention into antenatal healthcare of women attending a substance use in pregnancy service II. Measure changes in tobacco smoking behaviours of study participants III. Examine the pregnancy and postpartum outcomes of study participants in comparison to those of a historical control group IV. Examine neonatal outcomes of infants born to study participants in comparison to those of a historical control group

Participation will entail answering a questionnaire and undergoing lower limb angiogram in which the Siemens Syngo PBV software will be used. It is important to emphasize that all included patients would undergo angiogram regardless of the study and that the participation on the study will allow the use of Siemens PBV software as adjunct during revascularisation and to have wound photos taken prior to revascularisation and during follow-up appointments. Clinical management, investigations and follow-up will be conducted as per standard of care practices. There is no requirement for additional follow-ups or tests as result of participation in the research. At recruitment Lower limb perfusion will be assessed using toe pressures and/or transcutaneous oxygen pressure and the WIfI classification system will be used to more precisely stratifying patients according to their initial disease burden. These are clinical information that are routinely obtained in the management of patients with diabetic foot ulcers. The WIfI classification was proposed in 2014 by the Society for Vascular Surgery for assessment of treatment limb which is especially applicable of patients with diabetic foot ulcer. The WIfI classification is intended to define the disease burden and allow accurate outcomes assessments and comparisons between similar groups of patients and alternative therapies. The WIfI classification system assesses three key components of a threatened limb (wound, ischemia, and foot infection), each with four grades of severity (none, mild, moderate, and severe) to predict the 1-year risk of amputation and benefit of revascularisation. WoundVue camera will be used for more accurate and reproducible assessment of wounds. It is a hand-held portable device that takes 2D and 3D images of wounds to objectively monitor wound healing. The device algorithms are able to interpret tissue types and automatically provide surface, volume and depth measurement. All participants will undergo an endovascular revascularisation procedure which will be performed by a Vascular Surgeon (Prof Robert Fitridge, Dr Ewan Macaulay, Dr Joseph Dawson, Dr Michael Herbert or Dr Kurian Mylankal) with vast experience in this procedure. The revascularisation aims to restore perfusion to the affected foot and subsequently promote wound healing, help to resolve infection and avoid or limit level of amputation. PBV which indicates the distribution of blood in lesions and surrounding tissue by means of color-coded cross-sectional blood volume maps will be assessed before and after angioplasty/stenting. Data on foot wound status, treatments administered and outcomes (wound healing or amputation) will be collected during follow up visits over 12 months. WoundVue camera will used for more accurate, frequent and reproducible assessment of wound healing. Details of data to be collected are giving in baseline data and follow up data forms