ANZCTR search results

We want to assess the value of having physiotherapists and dietitians involved early and routinely when treating patients with constipation, obstructed defecation and/or faecal incontinence. It will help us to know the best way to care for people and may reduce the need for surgery. All participants will be gathered over a period of 2 years from a specialist colorectal pelvic floor waiting list. Participants will be a randomised into one of three groups; A, B and C, The study design was chosen to enable participants to be randomised to the groups whilst minimising the impact to outpatient services for other patients. • Group A: will receive physiotherapy and dietetics treatment concurrently for 6 months (research component). • Group B: will receive 6 months of physiotherapy treatment. After six months, participants have the option of continuing physiotherapy and adding dietetic treatment when they have progressed on the dietetic waiting list (standard care). • Group C: will receive 6 months of dietetic treatment. After six months, participants have the option of continuing dietetics and adding physiotherapy treatment when they have progressed on the physiotherapy waiting list (research component). The outcome measures are participant answered questionnaires on their experience of severity of symptoms and quality of life before and after intervention with dietetics &/or physiotherapy.

Medicinal cannabis predominantly containing cannabidiol (CBD) is often prescribed for the relief of cancer symptoms. However, it is illegal to drive in Queensland while taking tetrahydrocannabinol (THC) irrespective of whether it is for recreational or medicinal use. Unfortunately, very few CBD dominant products are completely free of THC, with most products containing traces of THC. Whether a CBD-dominant preparation with trace THC taken as an oil preparation would return a positive result on a roadside screening test is an important gap in the literature. Therefore, the aim of this study is to assess whether THC is detectable in saliva, blood, and urine after administration of CBD-dominant medicinal cannabinoid preparations in cancer patients. Who is it for? You may be eligible for this study if you are aged 18 years or over, have been diagnosed with cancer, are known to the Cancer Care Service, and are experiencing cancer-related symptoms. Study details Participants will be allocated to one of three treatment groups based upon doctor/patient preference and product availability, involving either LGP Classic CBD 50 (THC/CBD 0.2mg/50mg per mL), LGP Classic 1:100 (THC/CBD 1.5mg/100mg per mL), or LGP Classic CBD 1:20 (THC/CBD 1mg/20mg per mL) administered as an oral solution. Treatment will be administered for a total of 27 days, starting at a dose of 0.25ml daily and increasing every 3 days for the first 14 days, reaching a max dose of 1ml twice a day. The day 14 dose is then continued for days 15 - 27. If the participant experiences adverse effects, the dose can be reduced to the previously tolerated dose. If the dose is effective prior to day 14, continued titration is not required. Participants will be asked to return for study visits on days 7, 14, and 28 after commencing the treatment to collect saliva, urine, and blood samples for the detection of THC. During these visits, questionnaires regarding cancer symptoms will also be completed, as well as an assessment of any adverse effects experienced as a result of treatment. It is hoped that this study may show that CBD-dominant preparations do not produce a detectable level of THC in clinical samples, while showing an improvement in cancer symptoms with minimal side effects. This may help to inform advice given to patients taking medicinal cannabinoid preparations in future.

The purpose of the study is to test the effectiveness of a new treatment combination for patients with non-small cell lung cancer (NSCLC) whose tumour has a specific type of gene mutation called KRAS G12C. This mutation is believed to cause the tumour to grow and spread. Who is it for? You may be eligible for this study if you are aged 18 years and older, with either: a) newly diagnosed, treatment naïve metastatic (Stage IV) non-squamous NSCLC, or b) recurrent non-squamous NSCLC with no disease progression for at least 6 months following prior curative lung surgery and (neo)adjuvant chemotherapy, or prior curative concurrent chemoradiotherapy and immunotherapy maintenance, for non-resectable stage III cancer. Study details The new drug, sotorasib, is a tablet treatment which is targeted against the KRAS G12C gene mutation. Early results show that sotorasib is moderately active when given alone. The effectiveness of sotorasib might be increased when given in combination with other anti-cancer drugs. This study will investigate whether sotorasib used in combination with two chemotherapy drugs (called carboplatin and pemetrexed) and bevacizumab (which improves anti-cancer drug delivery), can result in better outcomes. The combination of carboplatin-pemetrexed-bevacizumab is a proven treatment for NSCLC.

The majority of paediatric infections are benign and viral in origin, more serious infections - particularly of bacterial causes - are important to diagnosis and treat promptly. So the purpose of this study is to look at a investigation called procalcitonin and see if it can be accurately used as a prediction of bacterial infection. Then to look at the level of procalcitonin, in patients with bacterial infections, and compare it to other inflammatory markers, assess it against a timeline from fever onset, and look at it in comparison of different age groups. In order to do this we will have clinicians in the paediatric emergency department fill in a form of relevant patients to highlight those suitable for the study. Then after diagnosis and discharge we will look at data (that is investigations performed) pertaining to procalcitonin and infections and use this information to come to conclusions. The hypothesis is that procalcitonin is a sensitive and specific marker of bacterial infections, superior in both its sensitivity and specificity, as well as its rise in relation to fever onset, to other inflammatory markers and will be a useful marker in diagnosing bacterial infections.

This is a randomised, double-masked, placebo-controlled, single and multiple Ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of SBI-100 Ophthalmic Emulsion in healthy adult participants. The study will enroll 48 healthy volunteers who will receive either study drug or placebo at the stay-in centre where they will be observed for any changes during the course of study period.

This project aims to determine whether a protocol of 30 minutes of exercise prescribed based on enjoyment can elicit similar physiological responses (heart rate, rating of perceived exertion, and blood pressure) compared to aerobic exercise prescribed based on intensity-driven guidelines (moderate intensity, 40-60% Heart rate). A secondary aim will be to determine if 4 weeks of enjoyment-driven aerobic exercise (three 40 minute sessions per week, 30 mins exercise, 5 mins each for pre post assessments) can provide similar benefits (aerobic capacity, physical and mental wellbeing) to a 4 week intensity-driven aerobic exercise program. I will recruit up to 40 adults (aged 18 years or older) to participate in a two phase randomised controlled clinical trial. Participants will complete a graded exercise test pre and post intervention. Measurements of current physical activity (PAQ), autonomous motivation to participate in exercise (BREQ3 questionnaire), symptoms of depression and anxiety (via the DASS-21 questionnaire) and psychological distress (using the K10) will also be measured. Participants will then be randomised in a cross-over design to complete an acute enjoyment-driven and an intensity driven exercise session, with one week washout in-between. All participants will then be randomised into parallel groups and complete 4 weeks (three 30 minute sessions per week) of either intensity-driven (standard prescription) or enjoyment driven (novel prescription) exercise. Affective response (FS), and HR, RPE and BP will be measured each session. Significance: This project proposes a transformative approach to exercise prescription whereby the focus of exercise prescription would shift away from objective intensity measures and instead centre on the individual’s level of enjoyment. If proven successful, this project has the potential to transform how exercise is prescribed and can be translated to the community and the health care system.

Sports betting has become one of the nation’s rapidly increasing forms of gambling addiction with $1.235 billion lost in 2017 - 18 , particularly in young males. This proposal is based on the recent publication from the SA Statewide Gambling Therapy Service, reporting the successful treatment of 6 young men with sports betting addiction using exposure therapy delivered face to face. The phase 1 pilot study aims to recruit 40 participants from all areas of SA using social media and provide cue exposure therapy (CET) for 10 sessions using mobile phone or internet.

Mothers of preterm infants often struggle to produce enough breast milk to meet the daily feed requirements of their infants, especially in the longer-term. This randomized multi-centre double-blind parallel controlled trial will evaluate the efficacy and safety of two commonly used galactagogues, Brewer’s yeast and beta-glucan, compared with placebo in improving maternal breast milk supply following preterm birth. Eligible women will be randomised to receive Brewer's yeast (1680 mg/day), Beta-glucan (250 mg/day) or placebo for 7 days, commencing within 72 hours of birth. The primary outcome will be assessed at day 7 following treatment initiation. All participants will undertake regular study assessments including at baseline (study enrolment), day 7 of treatment, postnatal day 21 and at infant discharge to home or term corrected (whichever comes first). Women will regularly undertake questionnaires evaluating demographics and lifestyle, breast health, milk expression, postnatal health, mental health and wellbeing, and infant feeding practices. Women will also undergo anthropometric assessment, and a breast milk, blood, urine, stool and buccal cell swab sample.

The aim of this study is to assess the feasibility and acceptability of the Living My Life Program for stroke survivors beyond 6 months post-stroke, living in rural and remote areas. The Living My Life Program is a digital health intervention, designed to support the participant to work towards their goals, using technology in a way that works for them, in their world. Case study design, informed by principles of co-design, will be used to trial the Program with stroke survivors living in rural and remote locations. Feasibility will be assessed according to pre-determined minimum success criteria. Acceptability will be explored through a brief survey and semi-structured interviews with stroke survivor participants. Learnings from the study will be used to refine the Living My Life Program for subsequent use.

This study aims to assess improvement in complex post-traumatic stress disorder symptoms in Aboriginal children in Out of Home Care (OOHC) after treatment with neurofeedback. It will also aim to assess improvement in the child’s self-concept, academic, social and personal functioning and the foster carer’s stress levels and confidence in parenting their foster child. Thirty Aboriginal children in OOHC aged 6-17 years will be recruited from a Hunter, NSW based Aboriginal community service. Baseline assessments to establish symptom levels in the domains of interest will be completed prior to offering a novel intervention, neurofeedback. This will consist of 32 treatment sessions over 24 weeks. Assessments to measure any change in symptom level will be conducted post neurofeedback. It is hypothesised that this intervention will be effective and acceptable in this vulnerable population.